496 - IDFA HACCP Dairy Plant Manual 4.15.10 PDF

IDFA’s
HACCP PLANT MANUAL

with model HACCP plans for dairy products
2010 EDITION
IDFA's Dairy HACCP SAFETY
SYSTEM
This is a manual that provides technical recommendations for

development of a comprehensive Hazard Analysis and Critical Control
Points (HACCP) food safety system for the entire dairy industry.
Included in this manual are specific prerequisite programs, preliminary
steps, assessment of hazards, a hazard analysis guideline including
forms, the seven principles of HACCP and model HACCP programs
covering fluid milk, sour cream, yogurt, ice cream, novelties, frozen
yogurt, cheese, butter, evaporated and condensed milk, dry milk and dry
whey products. This manual also incorporates the latest
recommendations and requirements listed in the National Conference on
Interstate Milk Shipments (NCIMS) HACCP pilot program, the National
Advisory Committee for Microbiological Criteria in Food (NACMCF)
and Codex Alimentarius. Dairy plants will be successful implementing
HACCP if a solid foundation of prerequisites and good manufacturing
practices is already in place and serves as the basis for the HACCP food
safety system.
© IDFA September 2009
The International Dairy Foods Association (IDFA) is the Washington, D.C.-based trade association that provides government
relations, regulatory affairs, marketing, public relations, meetings and seminars, training, general management, and a host of
other services to the three dairy foods organizations representing processors, manufacturers, marketers and distributors of dairy
products.
IDFA was founded in 1990 in recognition of the many common concerns and issues facing the various segments of the dairy
foods industry. The three constituent organizations that make up IDFA are:
! Milk Industry Foundation

! National Cheese Institute
! International Ice Cream Association
For more information, please call our main office at (202) 737-4332.
September 2009
TABLE OF CONTENTS
Acknowledgments .........................................................................................................................................................5
Milestones of Milk History in the U.S...........................................................................................................................6
IDFA's Dairy HACCP Safety Program .........................................................................................................................7
HACCP - An Overview.................................................................................................................................................8
HACCP Definitions.....................................................................................................................................................11
Principles of HACCP...................................................................................................................................................14
Dairy Product Safety Hazard .......................................................................................................................................15
Identification of Potentially Hazardous Milk and Milk Products .. .......................................................................15
Benefits of the HACCP System.............................................................................................................................18
Comparison Table: PMO Traditional vs. HACCP Plant Program...... ................................................................. 21
Hazard Components ....................................................................................................................................................24
Biological Hazards..................................................................................................................................................24
Chemical Hazards............................................................................... ................................................................. 24
Physical Hazards ................................................................................ ................................................................. 25
By Source .............................................................................................................................................................27
Pathogen Growth Tables ......................................................................................................................................30
Prerequisites Program/GMPs.......................................................................................................................................32
Outline............. .....................................................................................................................................................32
Premise ..................................................................................................................................................................33
Water/Steam/Ice Safety ........................................................................................................................................37
Receiving/Storage/Transportation ........................................................................................................................40
Equipment Construction and Maintenance...........................................................................................................43
Personnel Training Program and Employee Health .............................................................................................44
Environmental and Processing Equipment Hygiene ............................................................................................49
Cleaning & Sanitation ..........................................................................................................................................50
Traceability and Recall.........................................................................................................................................52
Cross-contamination Prevention...........................................................................................................................54
Allergens ..............................................................................................................................................................54
General Adulteration ............................................................................................................................................57
Cross-contamination.............................................................................................................................................58
Prerequisite Worksheet - Blank............................................................................................................................61
Water Prerequisite Model.....................................................................................................................................62
Condition and Cleanliness of Processing Equipment Model................................................................................65
Temperature Control Model .................................................................................................................................68
Maintenance of Hand Washing and Toilet Facilities Model ................................................................................69
Recommended Guidelines for Controlling Environmental Contamination.................................................................71

Implementation and Maintenance of the HACCP Plan ...............................................................................................79
Letter of Intent (example) .............................................................................................................................80
Steps to HACCP Implementation

Step One - Assemble the HACCP Team .......................................................................................................81
Step Two - Describe Dairy Food and Its Distribution...................................................................................83
Step Three - Intended Use and Consumers of the Food ................................................................................84
Step Four - Develop and Verify a Flow Diagram..........................................................................................84
Step Five - Verify the Flow Diagram ............................................................................................................85
Principles of HACCP...................................................................................................................................................86
Principle 1 - Conduct a Hazard Analysis.......................................................................................................86
Hazard Analysis Decision Tree ..............................................................................................................92
Hazard Analysis Summary Table - Blank ...............................................................................................93
Hazard Analysis Summary Table - HTST & Vat Pasteurization ..........................................................94
Principle 2 - Critical Control Points ..............................................................................................................97
2 September 2009
Principle 3 - Critical Limits...........................................................................................................................97
Principle 4 - Monitoring/Inspection ..............................................................................................................98
Principle 5 - Corrective Actions ....................................................................................................................99
Corrective Action Log Form ..................................................................................................................100
Principle 6 - Verification and Validation ....................................................................................................101
Verification, Validation and Auditing in the HACCP Process...............................................................103
Verification and Validation Forms ..........................................................................................................104
Validation Example - Completed Form..................................................................................................106
Principle 7 - Records ...................................................................................................................................108
Centralized Listing of HACCP Records.................................................................................................109
Evaluating and Revising HACCP Systems ...............................................................................................................110
NCIMS HACCP Audit Checklist (form)............................................................................................................112
Example: Table of Contents for a Model HACCP Program...............................................................................117
IDFA's Recommended Model HACCP Programs Description for Dairy Products...................................................119
IDFA Grade "A" Products HACCP Models..............................................................................................................124

Reduced Fat Milk (2%) - Product Description Form.................................................................................................125
HACCP Flow Chart............................................................................................................................................126
Hazard Analysis Summary Table .......................................................................................................................127
HACCP Plan Summary Table ............................................................................................................................131
1% Lowfat Chocolate Milk - Product Description Form...........................................................................................132
HACCP Flow Chart............................................................................................................................................133
Cultured Lowfat Buttermilk - Product Description Form..........................................................................................138
HACCP Flow Chart............................................................................................................................................139
Hazard Plan Summary Table..............................................................................................................................142
Eggnog - Product Description Form..........................................................................................................................143
HACCP Flow Chart............................................................................................................................................144
Ultra- Pasteurized Half and Half - Product Description Form...................................................................................149
HACCP Flow Chart............................................................................................................................................150
Cultured Sour Cream - Product Description Form ....................................................................................................155
HACCP Flow Chart............................................................................................................................................156
Lowfat Plain Yogurt with 1% Butterfat.....................................................................................................................161
HACCP Flow Chart............................................................................................................................................162
Strawberry Pre-Stirred Lowfat Yogurt with 1% Butterfat - Product Description Form ............................................168
HACCP Flow Chart............................................................................................................................................169
HACCP Hazard Analysis Summary Table.........................................................................................................170
IDFA Frozen Desserts Models ..................................................................................................................................175
Vanilla Ice Cream- Product Description Form ..........................................................................................................176
HACCP Flow Chart............................................................................................................................................177
Ice Cream with Ingredient- Product Description Form .............................................................................................183
HACCP Flow Chart............................................................................................................................................184
3 September 2009
Chocolate Coated Ice Cream Bar- Product Description Form...................................................................................192
HACCP Flow Chart............................................................................................................................................193
Novelty- Product Description Form ..........................................................................................................................200
HACCP Flow Chart............................................................................................................................................201
Frozen Yogurt- Product Description Form................................................................................................................207
HACCP Flow Chart............................................................................................................................................208
IDFA Cheese Product HACCP Models.....................................................................................................................215
Cheese Starter Culture- Product Description Form ...................................................................................................216
HACCP Flow Chart............................................................................................................................................217
Cheddar Cheese-Blocks- Product Description Form .................................................................................................222
HACCP Flow Chart............................................................................................................................................223
Natural Shredded or Chunk Cheese- Product Description Form ...............................................................................231
"Chunks" Flow Diagram ....................................................................................................................................232
"Shred" Flow Diagram .......................................................................................................................................233
Shredded Cheese Hazard Analysis Summary Table...........................................................................................234
Mozzarella Cheese- Product Description Form.........................................................................................................237
HACCP Flow Chart............................................................................................................................................238
Swiss/Emmentaler Cheese- Product Description Form .............................................................................................246
HACCP Flow Chart............................................................................................................................................247
4% Cottage Cheese- Product Description Form ........................................................................................................255
HACCP Flow Chart............................................................................................................................................256
Fresh White Cheese (Soft).........................................................................................................................................263
HACCP Flow Chart............................................................................................................................................264
IDFA Butter Product HACCP Models ......................................................................................................................271

Butter- Product Description Form .............................................................................................................................272
HACCP Flow Chart............................................................................................................................................273
4 September 2009
ACKNOWLEDGMENTS
This document was first developed by an industry-wide task force of dairy processors representing a
broad spectrum of dairy products in 1994, with updates 1996 and 1998. As a result of a significant
evolution of thought and philosophy, it was recognized that IDFA's Dairy HACCP safety system manual
required a complete rewrite. IDFA established a dairy HACCP Initiative Task Force in March 2000
comprised of individuals with dairy HACCP knowledge originating from processing, academia and dairy
regulatory agencies. This Task Force, led by IDFA staff member Allen Sayler, investigated domestic
and international publications, the Canadian and Codex HACCP guidelines and regulations. The IDFA
dairy HACCP manual was then completely rewritten as a guide for the dairy processing industry based on
a thorough review of U.S., international and Codex standards. The International Dairy Foods Association
would like to recognize the following individuals for their work and contributions to this project, with
special recognition to Dr. John Rushing, Professor of Food Science at North Carolina State University for
guidance, drafting, editorial and philosophical support of the Task Force.
Ms. Michele Bradley, Kraft Foods N.A.

Dr. Thomas Everson, Grande Cheese Company
Mr. Paul Hill, Land-O-Sun Dairies, L.L.C. Suiza Foods Corp.
Mr. Tom Honse, AMPI
Mr. Loren Johnson, Wells Dairy Inc.
Mr. Phillip McMillan, Wells Dairy Inc.
Ms. Jodeen Meenderink, Meadow Gold Dairies, S.W. Region, Suiza Foods Corp.
Ms. Rebecca Piston, Garelick Farms of Maine, Suiza Food Corp.
Mr. David Robbins, Dean Foods Co.
Ms. Eva Rodrigez, Tropical Cheese, Inc.
Dr. John Rushing, Professor, North Carolina State University
Mr. Allen Sayler, IDFA
Ms. Marianne Smukowski, Wisconsin Center for Dairy Research
Ms. Michele A. Bradley, Kraft Foods N.A.
Dr. William Sveum, Kraft Foods N.A.
Dr. Mark Trail, Safeway Inc.
Mr. James Wittenberger, Foremost Farms
Ex-officio Members:
Mr. Rich Ellefson, Wells Dairy Inc.
Ms. Cary Frye, IDFA
Ms. Barbara Larson, Ice Cream Partners
Mr. Pierre Nadeau, National Dairy Council of Canada
Mr. John O’Connor, West Lynn Creamery Inc., Suiza Foods Corp.
Ms. Stephanie Olmsted , West Farm Foods
Dr. Merle Pierson, Professor, Virginia PolyTechnical Institute
Ms. Emer Power, Saputo Cheese USA Inc.
Mr. Gale Prince, The Kroger Co
Mr. Dean Sommers, Alto Dairy
Mr. Paul Wolfort, Dreyer’s Grand Ice Cream Inc.
5 September 2009
MILESTONES OF MILK HISTORY IN THE U.S.
1611 Cows arrive for Jamestown Colony.
1624 Cows reach Plymouth Colony.
1841 First regular shipment of milk by rail--Orange County to New York City.
1856 Pasteur experiments start.
Gail Borden received first patent on condensed milk from both U.S. and England.
1878 Continuous centrifugal cream separator invented by Dr. Gustav De Laval.
1884 Milk bottle invented by Dr. Hervey D. Thatcher, Potsdam, New York.
1886 Automatic bottle filler and capper patented.
1890 Tuberculin testing of dairy herds introduced. Test for fat content of milk and cream perfected by Dr.
S.M. Babcock.
1890 Sherman Anti-Trust Act establishes federal anti-monopoly policy.
1892 Certified milk originated by Dr. Henry L. Coit in Essex County, New Jersey.
1895 Commercial pasteurizing machines introduced.
Thistle milking machine introduces intermittent pulsation.
1908 First compulsory pasteurization law (Chicago) applying to all milk except that
from tuberculin tested cows.
1911 Automatic rotary bottle filler and capper perfected.
1914 Tank trucks first used for transporting milk.
1919 Homogenized milk sold successfully in Torrington, Connecticut.
1922 Capper-Volsted Act codifies agricultural cooperatives.
1932 Ways of increasing Vitamin D in milk made practicable.
First plastic coated paper milk cartons introduced commercially.
1937 Agricultural Marketing Agreement Act establishes federal milk marketing orders.
1938 First farm bulk tanks for milk began to replace milk cans.
1942 Every-other-day milk delivery started (initially as a war conservation measure).
1946 National School Lunch Act signed by President Truman
Vacuum pasteurization method perfected.
1948 Ultra-high temperature pasteurization is introduced.
1949 Agricultural Adjustment Act establishes dairy support price at $3.14/cwt.
1950 Milk vending machines win place in distribution.
1955 Flavor control equipment for milk is introduced commercially.
1964 Plastic milk container introduced commercially.
1968 Electronic testing for milk is introduced commercially marking the official acceptance of process.
1974 Nutrition labeling of fluid milk products begins.
1980 American Dairy Association launches the national introduction of the “REAL” (R) Seal dairy
symbol.
1981 UHT (ultra high temperature) milks gain national recognition.
1983 Creation of National Dairy Promotion and Research Board.
1988 Lower fat dairy products gain widespread acceptance. Lowfat and skim milk sales combined exceed
whole milk sales for first time.
1993 Mandatory animal drug residue testing program established.
1994 Recombinant bovine somatotropin (rBST) approved for commercial use in U.S.
Nutrition Labeling and Education Act requires mandatory nutrition labeling.
1995 Launch of processor-funded milk mustache advertising campaign.
2000 Federal milk marketing orders reformed; component pricing introduced.
6 September 2009
IDFA'S DAIRY HACCP SAFETY PROGRAM
Historically, the organizations that comprise the International Dairy Foods Association (IDFA);
Milk Industry Foundation, National Cheese Institute, and International Ice Cream Association have
provided leadership to the dairy industry in ensuring the safety and wholesomeness of dairy products.
Over the last century, members of these organizations have been committed to meeting consumer
expectations regarding pure, safe, and high-quality dairy products. Although dairy product safety is of the
highest importance, consumer's expectations are that all dairy products are highly nutritious and safe,
taking industry efforts for ensuring safe products for granted. They often do not understand that the
process is complex and tedious. The importance of this enormous commitment by the dairy industry can
not be minimized. Consumers entrust manufacturers with their health and well-being--we as processors
have the responsibility to uphold that trust.
As a result, an enormous safety network has been established by the dairy industry upon which
this trust has been placed. This system of "checks and balances" has been successful in assuring
consumer confidence in the safety of dairy products in the past, but the prescriptive “one size fits all” for
dairy processors and dairy products needs refining and updating to maintain effectiveness and focus food
safety resources in the correct areas. IDFA has embarked on a program that complements existing dairy
product programs and incorporates the latest knowledge and science into a HACCP food safety system.
IDFA's long-term strategy for product safety is to provide a uniform program for all dairy
products, reduce regulatory burdens, eliminate duplication of inspections and audits, and promote a dairy
product safety approach based on preventing food-borne illness. IDFA's Dairy HACCP Safety System is
focused primarily on Hazard Analysis and Critical Control Points (HACCP) as the fundamental tool to
implement this new strategy. This system identifies potential hazards in the product, process or
ingredient and establishes procedures to ensure appropriate control exists at key points in the system,
based on the application of science-based controls. This system requires documentation that these
controls are effective and continuously functioning. By no means should it be considered a
"freestanding" program. It is a system built upon a solid foundation provided by an appropriate
prerequisite program (e.g. facility and equipment maintenance, basic sanitation, good manufacturing
practices, training, recall programs, etc.) in order to be effective. IDFA believes that by establishing a
program centered on the basic precepts of HACCP, the dairy industry will increase the confidence in
dairy product safety and ensure that resources will be targeted in the most important areas.
IDFA is committed to a HACCP program that is free of the many complexities found in other
programs. IDFA's dairy HACCP program is strictly limited to critical control points (CCPs) supported by
a prerequisite program focused solely on food safety. In order to be effective, HACCP must be facility
based, product-specific and process specific. This manual fulfills this goal in that it contains "model
programs" for each product category (fluid milk products, frozen dessert products, cultured products,
butter and dry milk products). These model programs include product descriptions, process flow charts,
the accompanying hazard analysis, and CCP summary tables. Since HACCP is not a prescriptive
program, but one that is based on a solid hazard analysis, each plant will need to tailor these models to
their own specific conditions represented by their hazard analysis conducted by the dairy plant’s HACCP
team. In addition to providing a guide to model dairy programs, this manual is intended to be used as a
training manual for industry personnel including managers, the HACCP team and production line
employees.
IDFA’s complete HACCP services program that includes annual HACCP webinars as well as a
complete HACCP Certification Program, which is described below.
7 September 2009
 1st Level - Individual Certification includes: IDFA's HACCPlan.net Software Program, IDFA's
Dairy HACCP Manual, IDFA's Juice HACCP Manual, Off-Site Short Course Training (one
participant). IDFA will provide a certificate stating that the person has successfully completed
IDFA's HACCP training program, has passed a rigorous exam on accepted HACCP principles
and procedures, and is qualified to develop and implement a HACCP program.
 2nd Level - Program Certification includes all items listed in the 1st Level and in addition, a one-
time written review of the HACCP program for two products (desk audit), a one-time onsite audit
and written audit report by IDFA staff and documentation of HACCP program certification after
a successful audit of plant procedures (plaque for company). In this level of service, the HACCP
program in the participating plant will be certified by IDFA, as well as the staff member(s)
trained under the IDFA program.
 3rd Level - Comprehensive Certification includes all items listed in the 2nd Level and annual
one day, on-site training workshop for plant personnel, annual on-site inspection and report of
plant HACCP programs, renewed program certification with a successful audit, and the
availability of one IDFA staff member to be present for one announced state, federal, or customer
inspection per year. At this premier level of the IDFA HACCP Certification Program, all of
trained plant staff, as well the participating plant’s HACCP program will be certified by IDFA.
Plus, IDFA will support participating plants during announced inspections and will serve as your
HACCP advocate.
It is important for dairy plants to utilize and implement all of the HACCP tools to ensure
regulatory compliance and maximize HACCP’s food safety benefits. A plant should begin by
training employees at IDFA-sponsored HACCP short courses where the Dairy and Juice HACCP
manuals and other reference material will be used and practical exercises will reinforce HACCP
concepts. Plant employees should then utilize IDFA’s HACCPlan.net software to build the
HACCP program. Once completed, the written program should be sent to IDFA for a review
prior to implementation. Within 2 – 3 months after implementation, IDFA should be brought
into the plant to conduct an advisory visit. IDFA will prepare a report from this visit that will
allow the plant to make corrections in its HACCP system before it becomes too difficult to
change. Plant staff responsible for monitoring the HACCP system should attend IDFA’s
Verification/Validation webinar to obtain the knowledge and skills for auditing their plant’s
HACCP program. Finally, plants should bring IDFA on-site once a year to evaluate the HACCP
system and provide corrective advice. Utilizing the complete set of IDFA services will keep
dairy plants on a constantly improving food safety track that will have carry-over effects on food
quality as well.
HACCP - AN OVERVIEW
The use of the Hazard Analysis and Critical Control Point (HACCP) system is not new to the
dairy food industry. HACCP is a logical, simple, effective, but highly-structured system of food safety
control. It is a system designed to identify "hazards and/or critical situations" and produce a plan to
control these situations.
The HACCP system was introduced to the food industry as a "spin-off" of the space program
during the 1960s. The National Aeronautics and Space Administration (NASA) used HACCP to provide
assurance of the highest quality available for components of space vehicles. This program, to develop
assurance of product reliability, was carried over into the development of foods for astronauts.
The U.S. Army Natick Laboratories, in conjunction with NASA, began to develop the foods
needed for manned space exploration. They contracted with the Pillsbury Company to design and
8 September 2009
produce the first foods used in space. While Pillsbury struggled with certain problems, such as how to
keep food from crumbling in zero gravity, they also undertook the task to come as close as possible to
100% assurance that the foods they produced would be free of bacterial or viral pathogens.
The use of standard quality control methods for the food industry soon proved to be unworkable
for the task Pillsbury had undertaken. Either the appropriate level of food safety assurance was not
provided or product sampling would have been prohibitive to production of space foods. Pillsbury
discarded their standard quality control methods and began an extensive evaluation, in conjunction with
NASA and Natick Labs, to evaluate food safety. They soon realized that to be successful they would
have to implement a program which established effective control over their process, raw materials,
environment, and their people. In 1971, they introduced HACCP as a preventive system that enables
manufacturers to produce foods with a high degree of assurance that the foods were produced safely. If
the HACCP system is correctly implemented, there will be little requirement for the testing of final
product other than for verification purposes.
HACCP is a food safety management tool that provides a more structured approach to the control
of identified hazards than that achievable by traditional inspection and quality control procedures. It
starts with product design and provides a means to identify potential areas of concern, where failure has
not yet been experienced and is, therefore, particularly useful for new operations. HACCP provides a
logical basis for better decision making with respect to product safety. It provides dairy food
manufacturers with a greater assurance of control over product safety than is possible with end-product
testing. HACCP has international recognition as the most effective means of controlling foodborne
disease and is endorsed as such by the joint FAO/WHO Codex Alimentarius Commission.
The Food and Drug Administration and USDA’s Food Safety and Inspection Service have
implemented regulations that require HACCP plans for the production of seafood and meat products,
respectively. Dairy companies have experienced some of these requirements by virtue of using meat or
seafood as an ingredient. FDA’s intent to establish a mandatory juice HACCP program will impact the
dairy industry even more.
In 1999 through 2003, the National Conference on Interstate Milk Shippers piloted a voluntary
alternative HACCP food safety program. This program was intended to be a replacement for the
traditional NCIMS program of prescriptive inspections, state ratings and FDA ratings with the
accompanying arbitrary scoring system. The result of the NCIMS HACCP pilot program was the
adoption by the 2003 Conference of a completely voluntary HACCP alternative for Grade A dairy plants,
with in implementation date of January 1, 2004. Adoption of this proposal by the delegates allows any
Grade "A" dairy plant to utilize their HACCP program for regulatory compliance also. This manual
incorporates material that will allow a plant using the IDFA Dairy HACCP recommendations to be
prepared to participation in the voluntary NCIMS HACCP program.
As with other systems, there may be multiple ways of achieving the same results. HACCP has
undergone an evolution of thought and this new edition of the manual reflects current dairy HACCP
concepts and thinking, while maintaining harmony with internationally recognized HACCP principles.
One of the key advantages of the HACCP concept is that it will enable a dairy food manufacturing
company to move away from a philosophy of control based on testing (i.e., testing for failure) to a
preventive approach, whereby potential hazards are identified and controlled in the manufacturing
environment (i.e., prevention of product failure).
HACCP has many other benefits as well; it:
9 September 2009
1. Focuses on prevention through the use of appropriate technical resources to address hazards
throughout the production process.
2. Utilizes science-based food safety data and principles.
3. Has a history of delivering a high level of assurance of food product safety.
4. Lessens emphasis on end-product testing.
5. Places the primary responsibility for food safety on processors, where it belongs.
7. Achieves customer needs and expectations.
8. Serves as the basis for achieving third party certification under one of the Global Food Safety
Initiative (GFSI) schemes.
9. Provides juice processors with certainty that if developed and implemented correctly, it will
meet or exceed government food plant operational and food safety requirements.
The International Dairy Foods Association strongly supports the adoption of Hazard Analysis and
Critical Control Points (HACCP) principles. HACCP has been recognized internationally as a logical
tool toward a more modern, scientifically-based inspection system. The most important element of a
HACCP-based system is its preventive nature and the exercising of control throughout the manufacturing
process at critical steps. By doing so, defects which could impact on the safety of the food being
processed can be readily detected and corrected at these points before the product is completely
processed, packaged and consumed.
10 September 2009
HACCP DEFINITIONS
As defined by the National Advisory Committee on Microbiological Criteria for Foods

(NACMCF), HACCP is a systematic approach to be used in dairy food production as a means to assure
dairy product safety. In an effort to standardize the HACCP principles and to create uniformity in
training, the following definitions were developed. These include some interpretations pursuant to the
NCIMS HACCP pilot program.
Adulterated: If a food bears or contains any poisonous or deleterious substance which may render
it injurious to health, if a valuable constituent of the food has been in whole or in part omitted or
abstracted, or if the food contains a color additive which makes it unsafe. See the Federal Food,
Drug, and Cosmetic Act, section 402.
Allergen: A substance (usually the protein component), when consumed in a dairy product
causes other food causes an adverse reaction which involves the human immune system.
Audit: An evaluation of the entire milk plant, receiving station, transfer station facility, and
HACCP system to ensure compliance with the HACCP system and other NCIMS regulatory
requirements.
CCP Decision Tree: A sequence of questions to determine whether a control point is a CCP.
Cleaned: Washed with water of adequate sanitary quality.
Continuous Monitoring: Uninterrupted collection and recording of data, such as temperature on

a strip chart.
Control: (a) To manage the conditions of an operation to maintain compliance with established
criteria. (b) The state where correct procedures are being followed and criteria are being met.
Control Measure: Any action or activity that can be used to prevent, eliminate, or reduce a
significant hazard.
Control Point: Any step at which biological, chemical, or physical factors can be controlled.
Corrective Action: Procedures followed when a deviation occurs.
Criterion: A requirement on which a judgement or decision can be based.
Critical: A deficiency or nonconformity that is likely to result in an adverse health consequence

if left unmanaged.
Critical Control Point: Any point, step, or procedure at which control can be applied and a dairy
food safety hazard can be prevented, eliminated, or reduced to acceptable levels. A critical
control point is one that is concerned only with safety or health considerations.
Critical Limit: A maximum and/or minimum value to which a biological, chemical or physical
parameter must be controlled at a CCP to prevent, eliminate or reduce the potential of a food
safety hazard to an acceptable level.
11 September 2009
Dairy Foods HACCP Core Curriculum: For the purposes of dairy HACCP, the training
materials, a training program and an evaluation process to establish that all significant and
fundamental parts of the dairy HACCP program are mastered by dairy industry personnel
responsible for the implementation and operation of the HACCP system.
Deficiency: An element inadequate or missing from the requirements of the HACCP program or
of this document.
Deviation: A failure to meet a critical limit for a critical control point.
Documentation: Information/records available in a written, electronic or other form which can

be utilized to detect trends assisting the verification and validation of the prerequisite program
and HACCP plan.
Regulatory Audit: An evaluation conducted by state or FDA personnel of the processing plant,
receiving station, or transfer station facility to evaluate the industry’s HACCP system and
determine compliance with the written HACCP program and other associated regulatory
requirements.
HACCP (Hazard Analysis Critical Control Point): A systematic approach to the identification,
evaluation, and control of significant food safety hazards.
HACCP Plan: The written document specific to a product and process, which identifies CCP(s),
establishes critical limits, control and documentation and delineates procedures to be followed to
assure control based upon the seven principles of HACCP.
HACCP Program: The written HACCP plan and prerequisite program.
HACCP System: The implementation of the HACCP program.
HACCP Team: The group of people who are responsible for developing, implementing, and
maintaining the HACCP system.
Hazard: A biological, chemical, or physical agent that is of sufficient severity or is reasonably

likely to cause illness or injury in the absence of its control.
Hazard Analysis: The written and documented process of collecting and evaluating information
on hazards associated with the food under consideration to decide which are severe or of
sufficient likelihood to occur and must be addressed in the HACCP plan or prerequisite program.
Likelihood of Occurrence. Estimate (usually a percentage) based on judgment, experience,

statistical analysis and past occurrences as to whether an identified event may happened within a
given time frame. Sometimes categorized into “Probable (90 - 100%) - anticipated to occur
at least once within the timeframe specified”, “Likely (60% - 90%) – good chance to
occur within the time frame specified”, “Possible (20% - 60%) – not expected to occur
within the time frame specified, but judgment, experience, statistical analysis and history
from this or similar operations indicate it has happened in the past”, “Unlikely (0% -
10%) – judgment, experience, statistical analysis and history indicate it will not happened
12 September 2009
or has not happened in the past in this or similar operations within the time frame
specified”.
Listing Audit: An evaluation conducted by a State Rating Officer of the milk plant, receiving
station, transfer station, and HACCP system to ensure compliance with the HACCP program
system and other associated NCIMS regulatory requirements. Specific to the NCIMS program.
Monitor: To conduct a planned sequence of observations or measurements to assess whether a

CCP is under control and to produce an accurate record for future use in verification.
Non-Conformity: A failure to meet specified requirements of the HACCP prerequisite program.
Performance Standards: Specific regulatory requirements which are required to be incorporated

into the HACCP program even if not required by a plant’s hazard analysis (i.e. finished product
vitamin testing).
Prerequisite Programs: Procedures, including facility and equipment maintenance, basic

sanitation, Good Manufacturing Practices, training, recall programs, etc. that address operational
conditions providing the foundation for the HACCP program.
Preventive Measures: Physical, chemical, or other factors that can be used to manage an
identified health hazard.
Potentially Hazardous Food (Time/Temperature Control Safety Food - TCS): Food that
requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or
toxin formation.
Random Checks: Observations or measurements that are performed to supplement the scheduled
verification/validation evaluations required by the HACCP program.
Risk: An estimate of the likely occurrence of a hazard.
Sanitation Standard Operating Procedure (SSOP): The portion of the written prerequisite
program which is mandated by the regulatory authority (e.g. water safety, condition and
cleanliness of food contact surfaces, protection from adulteration, prevention of cross-
contamination, employee health and hygiene, pest control program, maintenance of hand washing
and toilet facilities, and proper labeling, storage and use of toxic compounds).
Sensitive Ingredient: Any ingredient known to have been associated with a hazard and for which
there is reason for concern. Includes ingredients that are known allergens.
Severity: The seriousness of a hazard. Sometimes categorized into “Catastrophic - results in

serious illness, injury or fatality”, “Major – loss of HACCP system control that could
result in serious illness or injury”, “Minor – inconsistencies in HACCP program
implementation that needs immediate correction, but does not significantly reduce system
safety.”
Step: A point, procedure, operation or stage in the food processing system from primary
production to final consumption.
13 September 2009
Target Levels: Criteria which are more stringent than critical limits and which are used by an
operator to make precise adjustments to reduce the risk of a deviation.
Toxic Compounds: Those substances that, at their commercially supplied concentration, are a
hazard to human health when inhaled, swallowed or absorbed through the skin. This determination is
dependent upon the substance's concentration during exposure.
Validation: The element of verification focused on collecting and evaluating scientific and
technical information to determine whether the prerequisite program and HACCP plan, when
properly implemented, will effectively control the hazard(s). Validation is conducted initially
when the HACCP program is implemented, at a fixed frequency or based on availability of new
scientific information, significant changes in the product, process, or hazards associated with the
HACCP program.
Verification: The use of methods, procedures, or tests in addition to those used in monitoring to
determine if the HACCP system has properly implemented the prerequisite program and HACCP
plan and/or whether there is a need for modification and revalidation.
PRINCIPLES OF HACCP
The following seven principles of HACCP were adapted by the National Advisory Committee on
Microbiological Criteria for Foods. IDFA has adopted these principles for a systematic approach to dairy
product safety:
1. Hazard Analysis: Conduct a hazard analysis associated with growing, harvesting, raw
materials and ingredients, processing, manufacture, distribution, marketing, preparation, and
consumption of the dairy food.
2. CCPS: Identify the Critical Control Points (CCPs) required to control the identified hazards
in the process.
3. Critical Limits: Establish the critical limits for preventive measures associated with each
identified CCP.
4. Monitoring: Establish CCP monitoring requirements. Establish procedures for using the
results of monitoring to adjust the process and maintain control.
5. Corrective Actions: Establish corrective actions to be taken when monitoring indicates that
there is a deviation from an established critical limit.
6. Verification and Validation: Establish procedures for verification that the HACCP system is
working correctly.
7. Recordkeeping: Establish effective record-keeping systems that document the HACCP plan.
14 September 2009
DAIRY PRODUCT SAFETY HAZARDS
Dairy product safety is of the highest importance. Lack of attention to food safety may result in
both personal injury to the consumer and economic loss to the dairy manufacturer. Manufacturing itself is
only one link in the food safety chain. However, often it is the last opportunity to ensure product safety
prior to use by the consumer. Therefore, the responsibility for ensuring the safety of dairy products rests
primarily with the manufacturer.
Personal injury exists in many forms: physical injury (chipped tooth), illness (salmonellosis) and
even death. The President’s Food Safety Initiative has enhanced the surveillance for foodborne illness.
Estimates for cases of foodborne illness in the U.S. exceed 76 million, with 5,000 deaths annually in the
United States. Three pathogens, Salmonella, Listeria, and Toxoplasma are responsible for 1500 of these
deaths per year. Most of these are never reported. The Center for Disease Control and Prevention (CDC)
reported that during the period between January 1988, to December 1997, there were approximately 5,200
foodborne-disease outbreaks affecting over 160,000 persons. Dairy products (cheese, ice cream and milk)
accounted for 64 of the outbreaks (1.24%) and 2,329 of the persons affected (1.43%). Two persons died
as a result of illness from eating dairy products; one was associated with ice cream, the other with cheese.
Many of the organisms of greatest concern today, e.g. Campylobacter jejuni, Escherichia coli
0157:H7,and Listeria monocytogenes, were not recognized as the cause of foodborne illness 20 years ago.
Historically, there have been several foodborne-disease outbreaks in the dairy industry.
Salmonella sp. contamination of cheddar cheese resulted in approximately 28,000 to 30,000 cases of
illness in Colorado (1976). Pasteurized milk, contaminated with Yersinia enterocolitica made several
thousand people ill in Arkansas (1982). In California, a soft Mexican-style cheese contaminated with
Listeria monocytogenes was linked to approximately 100 illnesses and 39 deaths (1985). In Chicago,
approximately 20,000 people were affected by Salmonella sp. contamination of pasteurized milk (1985).
More recently, an outbreak of Staphylococcus aureus enterotoxin in pasteurized milk has resulted in over
14,700 illnesses in Japan (2000).
While biological hazards are the primary food safety concern for many manufacturers, physical
and chemical hazards are also substantial. Allergens (a chemical hazard) accounted for 20% of the US
food product recalls for 1999. This was second only to microbiological contamination, which accounted
for 21% of recalls. During 1999, physical hazards accounted for 6% of FDA recalls.
Economic injury can be very important to both the manufacturer and the consumer. It is estimated
that food safety incidents cost industry, government and society $20 billion per year. Many businesses
never recover from an association with a foodborne-disease outbreak, closing their doors forever.
IDENTIFICATION OF POTENTIALLY HAZARDOUS MILK AND MILK PRODUCTS
Milk and milk products that require time/temperature control for safety (TCS) to limit pathogenic
microorganism growth or toxin formation includes:
1. Milk or milk products that are raw, heat-treated, pasteurized, or ultra-pasteurized; or

2. Except as specified in 3. below of this definition, a milk or milk product that because of the
interaction of it's aw and pH values is designated as Product Assessment (PA) as required in either Table
A or B as follows:
15 September 2009
Table A. Interaction of pH and aw for Control of Spores in Milk and Milk Products Pasteurized to Destroy
Pathogenic Vegetative Cells and Subsequently Packaged*
Aw values pH values
4.6 or less > 4.6 – 5.6 > 5.6
0.92 or less Non-TCS** Non-TCS
Non-TCS
> 0.92 - .95 Non-TCS Non-TCS PA***
> 0.95 Non-TCS PA PA
*Refer to Appendix R. for instruction in how to use Table A.

** TCS means TIME/TEMPERATURE CONTROL FOR SAFETY MILK AND MILK PRODUCTS.
*** PA means either that the product needs time and temperature control or further PRODUCT ASSESSMENT is
required to determine if the milk or milk product is Non-TCS.
Table B. Interaction of pH and aw for Control of Pathogenic Vegetative Cells and Spores in Milk and Milk
Products not Pasteurized or Pasteurized but not Packaged*
Aw values pH values
< 4.2 4.2 – 4.6 >4.6 – 5.0 > 5.0
< 0.88 Non-TCS Non-TCS Non-TCS Non-TCS
0.88 – 0.90 Non-TCS Non-TCS Non-TCS PA
> 0.90 – 0.92 Non-TCS Non-TCS PA PA
> 0.92 Non-TCS PA PA PA
* Refer to Appendix R. for instruction in how to use Table B.
This definition does not include:
1. A milk or milk product that because of it’s pH or aw value, or interaction of aw and pH values, is
designated as Non-TCS in Table A or B as specified in 2. above of this definition;
2. A milk or milk products, in an unopened hermetically sealed container, that is commercially
processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and
distribution;
3. A milk or milk product for which evidence (acceptable to FDA) demonstrates that time/ temperature
control for safety is not required as specified under this definition (such as, a product containing a
preservative known to inhibit pathogenic microorganisms, or other barriers to the growth of pathogenic
microorganisms, or a combination of barriers that inhibit the growth of pathogenic microorganisms); or
4. A milk or milk product that does not support the growth of pathogenic microorganisms as specified
under this definition even though the milk or milk product may contain a pathogenic microorganism or
chemical or physical contaminant at a level sufficient to cause illness or injury.
Another method to determine whether a milk or milk product requires time/temperature criteria for safety
is to use the decision tree below. A milk or milk product designated PA (further product assessment
required) in either Table A or B or as the result of using the decision tree below should be considered
TCS until sufficient information is provided to demonstrate the safety of the product. The PA will be an
evaluation of the product or product group’s ability to not support pathogenic growth. Means to
evaluate this assessment include (but are not limited to): literature review of similar products, inoculation
studies, expert risk assessment, and/or state regulatory assessment.
16 September 2009
Decision Tree for using pH, aw, or the Interaction of pH and aw to Determine if a Milk or Milk Product
Requires Time/Temperature for Safety
#1. Does the operator want to hold the milk

or milk product without using time or
temperature control?
NO YES
#2. Is the milk or milk
product pasteurized?
No further action required.
#3. Is the milk or milk product treated NO YES

using a method equivalent to
pasteurization, which is acceptable to
FDA?
#4. Is it packaged to prevent re-
contamination?
YES NO
NO YES
#5. Further PA or FDA accepted plant
documentation required.
#6. Using the milk or milk product’s
known aw and/or pH values, position the
#7. Use Table B milk or milk product in the appropriate
table.
#7. Use Table A

Non-TCS milk and
milk product may be
held out of Product
Assessment Non-TCS milk and milk Product
temperature or time product may be held out of Assessment
control and is Further PA or
evidence acceptable temperature or time control Further PA or
considered shelf- and is considered shelf- evidence
to FDA.
stable. stable. acceptable to
FDA.
Source Document: Evaluation and Definition of Potentially Hazardous Foods, IFT, 2001.
USING HACCP TO CONTROL HAZARDS
Dairy products may also present luxurious growth media that stimulate and encourage the growth
of opportunistic bacteria, including many foodborne pathogens. An understanding of the composition of
dairy products helps dairy manufacturers to identify “hurdles” to the growth of pathogenic
microorganisms and production of foodborne toxins. Included in the list of hurdles would be low water
activity (aw  0.85), low pH (less than 4.5), high salt levels (greater than 1%), high sugar content (>
45°Brix) and temperature (< 5°C).
17 September 2009
Through the proper implementation of a HACCP system, dairy processors can manage hazards
that relate to the safety of the foods they produce. The National Advisory Committee on Microbiological
Criteria for Foods (1997) defines a hazard as “A biological, chemical, or physical agent that is reasonably
likely to cause illness or injury in the absence of its control”. A hazard analysis (see “Steps to
Implementation”, Principle 1 for details) is used to evaluate each product and its processes to ensure that
the controls are in place to minimize the occurrence of potential hazards.
Historically, the dairy industry has relied on documents such as the Grade “A” Pasteurized Milk
Ordinance, the Dry Milk Ordinance and periodic physical inspections of facilities to ensure product
safety. Now, due to improved diagnosis and reporting of foodborne safety concerns, the dairy industry,
customers and consumers are more aware of emerging safety issues. Safety systems must function
continuously and the industry is moving toward more performance based standards. The dairy industry’s
goal is to be proactive rather than reactive, when protecting consumer’s health and safety. Several other
food industries (for example, meat and seafood) have had HACCP mandated for their processors. As an
added benefit, safety systems such as HACCP are recognized throughout the world as the standard by
which facilities must operate to compete in today’s global market place.
BENEFITS OF THE HACCP SYSTEM - GENERAL
Food safety is the primary concern in a dairy product HACCP system. However, the
wholesomeness and quality of the product may also be enhanced by proper implementation of HACCP
and associated prerequisite programs. There are many benefits for the manufacturer who successfully
implements this dairy product safety program. They include the following:
1. Increased consumer confidence in dairy products
2. Assured brand integrity
3. Decreased numbers of consumer complaints
4. Reduced incidence of product holds
5. Increased sales opportunities.
The HACCP plan should consider all potential hazard categories, biological, chemical, and physical.
Potential sources of hazards such as raw milk, condensation, foreign material and ingredients added after
pasteurization should be thoroughly analyzed. At each step of the process, control measures must be
identified for each hazard. Suppliers should be contacted regarding their HACCP systems so a
coordinated assessment of hazards and risks may be incorporated into dairy processor's HACCP plan.
BENEFITS OF THE HACCP SYSTEM - NCIMS VOLUNTARY PROGRAM
Background:
The adoption of HACCP, as an alternative to the Grade “A” Pasteurized Milk Ordinance (PMO) by the
2003 NCIMS Conference, was the result of 6 years of hard work by the NCIMS HACCP Committee that
oversaw two consecutive pilot studies involving 12 Grade “A” dairy plants and 8 State Regulatory
agencies. The Committee's Evaluation Team consisted of personnel representing the dairy industry, state
regulators, academia and FDA. It was charged with evaluating the effectiveness of the pilot programs.
The Team gathered data, comments and recommendations from industry, State Regulatory agencies and
FDA personnel during visits to each plant for each of the pilot studies. Based upon this data and
information, the NCIMS HACCP Committee modified the pilot program to improve and enhance the
effectiveness of a voluntary alternative NCIMS HACCP program.
The 2003 NCIMS Conference adopted proposal 316 that detailed HACCP as a voluntary alternative to the
traditional PMO-based inspection program for dairy plants, with an official implementation date of
18 September 2009
January 1, 2004. In order for a Grade “A” dairy plant to be listed as an NCIMS HACCP plant, the plant
and the State Regulatory Agency are required to exchange letters of commitment to work together in
establishing an NCIMS HACCP program in the Grade “A” dairy plant and a HACCP regulatory system
within the State. Once that occurs, the Grade “A” dairy plant is required to draft a written HACCP
program according to Appendix K and other requirements in the 2005 PMO, implement it, and
accumulate 60 days of records, before being eligible to have a state rating officer evaluate the HACCP
system. If rated and found acceptable, the plant and its Grade "A" products will be listed for a two year
period.
NCIMS HACCP Advantages for Plants:
The NCIMS HACCP alternative for regulatory audits, NCIMS Listing Audits and FDA Check Audits
provides a significant number of advantages for Grade “A” dairy plants over the traditional Grade "A"
system of State Regulatory Inspections, Ratings and FDA Check Ratings. Some of those advantages are
listed below.
1. NCIMS State HACCP listings are not scored as is the traditional rating system for plants (must score
a 90 or better to be listed), but instead are pass or fail. Of the approximately 74 plant audit items on
the NCIMS HACCP System Audit Report, marking any one or more of the nine Critical Listing
Element will result in no listing of the HACCP plant.
2. The traditional PMO-based plant inspection system requires a state enforcement rating every 2 years,
in addition to the plant rating with a score of 90 or better required in order to assure acceptance of
Grade "A" products from that Grade "A" plant by other State Regulatory agencies. Under HACCP,
the state enforcement rating has been replaced with a HACCP System Regulatory Agency Review
Report. This report asks almost the same questions as used in the traditional enforcement rating, but
the answers are recorded and no score is assigned. This state enforcement information is recorded
and shared with the State Regulatory agency in order to improve its regulatory HACCP program.
This information is also shared with FDA Regional Milk Specialists (RMS), who use it as part of
their state program evaluation, conducted about once every three years.
3. Under the HACCP alternative, if milk or milk product safety is in doubt based on State Regulatory
agency practices or performance, FDA shall immediately investigate and may audit other Grade “A”
dairy plants, receiving stations and transfer stations affected.
a. If there are substantial milk or milk product safety program weaknesses, FDA shall send a
notice to the Regulatory Agency with a copy to the Rating Agency. If after thirty (30) days,
FDA determines that the State Regulatory agency has not made correction(s) FDA shall notify
the affected industry and receiving States.
b. If FDA determines that the State is not able to fulfill its obligations under the NCIMS HACCP
Program and milk or milk product safety remains in doubt, FDA shall provide written
notification to receiving State specifying the reasons this determination was made and require
180 days from the date of the FDA notification to prove to FDA that the State has made
appropriate corrections and is once again able to fulfill its obligations under the NCIMS
HACCP Program.
c. After the 180 days, if the State is still unable to fulfill its obligations under the NCIMS HACCP
Program and milk or milk product safety remains in doubt, FDA will not accept new HACCP
listings from the State and FDA may audit the existing HACCP listings as necessary to protect
the public health.
3. HACCP plants are eligible for reduced numbers of State Regulatory audits. Under the traditional
PMO-based inspection program plants must be inspected 4 times per year, while HACCP-based
19 September 2009
plants must be audited at least 3 regulatory times during the first year and may become eligible for a
minimum of 2 regulatory audits per year after that, depending on plant performance and the State
Regulatory agencies agreement (details in Appendix 1).
4. HACCP plants are required to develop, with State Regulatory input, their own written HACCP food
safety program specific to each Grade "A" product produced by the plant. The state will audit the
dairy plant based on that written program. This flexibility allows HACCP plants to apply resources
to best meet food safety concerns, provided the same level of protection is achieved as under the
traditional PMO-based inspection program.
5. The "NCIMS HACCP Technical Resource Committee", made up of technical experts from industry,
State Regulatory Agencies, and FDA, resolves differences of opinion between dairy plants and state
or FDA regulators. This system has worked well, since all NCIMS stakeholders including the dairy
industry are represented on this committee.
6. HACCP plant personnel can be trained and authorized by the State Regulatory agency to conduct the
routine quarterly pasteurization equipment tests and sealing of equipment and also reseal
pasteurization equipment after routine maintenance or equipment failures that require breaking of
public health seals. The State Regulatory Agency must provide oversight for the six month
pasteurization equipment timing tests. Under the traditional PMO-based inspection program, plant
employees can be approved to test equipment and apply temporary (10 day) seals after maintenance
or equipment failure requires breaking of regulatory seals.
7. Records maintenance responsibility by the plant is defined in Appendix K of the 2005 PMO as well
as the plant's written HACCP program. These records are required to be provided to the state or FDA
auditor upon request. Most of these records will be the same as those maintained under the traditional
PMO-based plant inspection program; however, some will be new Required HACCP records
include:
a. Records documenting the ongoing application of the prerequisite program (PP), including a
brief written description, monitoring and correction records;
b. The written hazard analysis;
c. The written HACCP Plan;
d. Required HACCP documents and forms specified in a. through c. shall be dated or identified
with a version number. Each page shall be marked with a new date or version number
whenever that page is updated;
e. A Table of Contents and centralized list of the HACCP program records, by title,
documenting the ongoing application of the HACCP System;
f. A document change log identifying any changes in the required written HACCP program;
g. Records documenting the ongoing application of the written HACCP Plan that include:
(1) Monitoring of CCPs and their critical limits (CLs), including the recording of actual
times, temperatures, or other measurements, as prescribed in the milk plant’s, receiving
station’s or transfer station’s written HACCP Plan;
(2) Corrective actions, including all actions taken in response to a deviation;
(3) A centralized deviation log is required for all CCPs; and
(4) Plan validation dates.
h. Records documenting verification and validation of the HACCP System, including the
HACCP Plan, hazard analysis and PPs.
8. The NCIMS HACCP program has the ability to lower the rate of product withdrawal, recalls and
product rework because of its strong encouragement to train plant production staff. This can result
in improved net profits and possibly lower operational costs.
20 September 2009
9. An unexpected outcome in plants that implement HACCP is improved employee morale. It
appears that HACCP, through its emphasis on training, empowers HACCP-trained production
line workers to understand the plant food safety system, note potential problems, and take action
or bring the problem(s) to the attention of supervisory personnel, who are responsible for
correcting the identified problems.
Adjusting to Grade "A" HACCP: NCIMS HACCP plants are required to develop, with State
Regulatory input, their own written food safety program specific to each Grade A product
produced by the plant, and are audited, based on this written program. This can be a challenge,
particularly since the NCIMS PMO-based program has been around for 50 years and many states
and dairy plants are comfortable with it as their food safety program. A good analogy for putting
the acceptance of the new NCIMS HACCP program into perspective is it took the NCIMS PMObased
program 20 years before all states accepted it. NCIMS HACCP is only in the 6th full year of availability as
an alternative to the traditional PMO-based inspection program. Feedback from dairy plant managers
indicates there are parts of the traditional PMO-based inspection program they do not believe improves
food safety, but since they are familiar with it, they tolerate it. Some industry concerns about the NCIMS
HACCP program include a lack of experience with drafting their own NCIMS-based written HACCP
program and regulatory access to processing records. The NCIMS HACCP Implementation Training
Subcommittee, the International Dairy Foods Association (IDFA), and some universities provide detailed
training for industry personnel on the NCIMS HACCP program. Records access by state or FDA dairy
regulators is limited to those records identified in the written HACCP Program. Since this document is
written by the industry, records access is still very much managed by the dairy plant.
HACCP Support:
The NCIMS plant HACCP program is supported by the U.S. Food and Drug Administration
(FDA), many State Regulatory agencies and the dairy industry. The 2005, 2007 and 2009 NCIMS
Conferences considered and adopted a few minor adjustments to the HACCP program including
updating of forms. FDA concurred with the changes.
Comparison Between Plant Requirements in the PMO and HACCP:
A comparison between the traditional PMO-based inspection system and a HACCP-based system
For Grade “A” dairy plants can be found below. There are 12 plants in 7 states that are operating
under the NCIMS HACCP program (see below for specific plant names and locations). In addition, the
states of New York and Wisconsin have expressed a desire to list one or more of their Grade “A” dairy
plants under the HACCP alternative.
Requirement NCIMS Traditional Plant NCIMS HACCP Plant Audit Program (Appendix K in PMO)
Inspection Program
Initial Plant Start-up and Immediate, every two years after 60 days of HACCP records prior to eligibility, operate under both
Listing first listing. traditional PMO and PMO HACCP during this time. If a plant
wishes to be listed during this time, they are inspected and rated
under the traditional NCIMS plant program (non-HACCP).
Applicable PMO Utilize all applicable PMO Utilize Appendix K or the PMO as well as applicable sections of
Sections & Process for sections, as well as applicable the Methods and Procedures documents. After listing under the
New Plant Startup sections of the Methods and traditional PMO plant program, utilize the plant’s written HACCP
Procedures documents for plant program and 60 days of records. After acceptance by state
inspections and listing regulators, the state HACCP plant listing can be conducted.
Regulatory Oversight State inspections State audits by state employees that have completed required
HACCP training
Regulatory Every 3 months Initial Audit (after 60 days of HACCP records generated), second
Inspection/Audit audit within 30 to 45 days, then every 4 months the first year*, 6
Frequency months* if no repeat violations, no CLE on last 2 audits and no
product or water sample warning letters
* Unless the Regulatory Agency determines that a Greater
Frequency is warranted
Regulatory Insp./Audit FDA form 2359 FDA form 2359m
Checklist NCIMS HACCP SYSTEM REGULATORY Audit checklist
21 April 2010
Inspection Program
Regulatory Water Every 6 months Same as traditional PMO-based inspection program - every 6
Sample Frequency months
Regulatory Product 4 times in 6 months Same as traditional PMO-based inspection program - 4 times in
Sample Frequency 6 months
Regulatory Action comply with PMO (Section 6) Same, plus plant must document action taken on any violative
Product and water samples
samples
Immediate, frequency is a First rating only after 60 days of records accumulated, thereafter,
minimum of once every 2 years frequency is a minimum of once every two years.
Plant Listing
Procedures By FDA-Standardized State By FDA HACCP Standardized State Rating Officer with
Rating Officer (SRO) additional HACCP audit training
State rating/listing audit Must score 90 No scoring, pass-fail (must not have CLE violations)
State Enforcement Must score 90 State Regulatory Agency Review Report by SRO with each
Rating HACCP listing and evaluated by FDA. Incorporated into FDA
tri-annual state program review report and FDA may act as
specified in the Procedures
FDA Responsibility Check Ratings including FDA check ratings but no state enforcement rating approx.
sanitation compliance rating and every 3 years using the NCIMS HACCP System Audit Report
Enforcement rating approx. and state evaluation using the NCIMS HACCP System
every 3 years. Also, approx. Regulatory Agency Review Report;
every 3 years conduct State State Program Evaluations apprCreated by IDFAox. every 3
Program Evaluations years. If state weakness found, timeline set for state response,
FDA may audit HACCP listings and deny any further HACCP
listings from problem state as per the Procedures.
Interpretation of FDA NCIMS HACCP Implementation Committee
applicable documents
Pasteurization Comply with PMO item 16p Comply with PMO item 16p (pasteurization is a required CCP)
Industry Pasteurization Allowed, with Regulatory Allowed, with Regulatory approval, to conduct all routine
Equipment Testing approval, to test and apply quarterly testing and sealing of equipment. State Regulatory
temporary (10 day) seals. must oversee six month tests to include six month timing tests
for HTST and HHST pasteurization systems. Note: under
HACCP, a missed testing frequency is a CLE.
Required Training – State Inspectors - no training State auditors, state rating officers (SRO’s) & FDA RMS must
State Inspectors required; attend a NCIMS audit training course, FDA-standardized and
certified. After initial FDA HACCP certification, SROs and FDA
SROs & FDA RMS: SRO’s and FDA RMS must be RMS must attend FDA-sponsored training once every 3 years
FDA Certified and attend FDA- that includes HACCP audit training
sponsored training once every 3
years
Required Training - None HACCP Implementation experience may replace participation in
Industry a formal HACCP training course. Trained or experienced
person(s) must develop PP’s, HA, HP, review verification
records
Required Records Raw milk receiving, Past. Temps In addition, written Table of Contents, prerequisite program, flow
from recording charts, Past. diagram(s), hazard analysis, HACCP Plan & corrective actions,
Equip. Test, Appendix. N, CIP also HACCP records summary & deviation log, plus other
and COP records, cooling records documenting implementation of HACCP program (see
records, water and product Appendix K of the PMO)
sampling results (see PMO)
22 April 2010
Inspection Program
Records Retention As specified by PMO, Methods & In addition, HACCP records-1 yr, 2 yrs for equipment validation,
Procedures documents - shelf stable, or preserved products
generally 2 years
Written Prerequisite The PMO requires basic 8 Mandatory, others are required if they are "being relied upon
Program requirements in various parts of in the Hazard Analysis to reduce the likelihood of hazards such
the Section 7p items of sanitation that they are not reasonably likely to occur"
that may be part of HACCP
Prerequisite Programs.
Central Deviation Log None Required
Critical Listing Elements None

At a State Listing Audit or FDA Check Audit, can result in loss of
(CLEs)** listing if significant. (Observations of CLE related concerns and
anomalies that do not meet these criteria, should be discussed
with the milk plant, receiving station or transfer station being
audited and/or the Regulatory Agency but not marked on the
audit reports as a CLE or used to justify the removal of a listing).
At a State Regulatory audit will result in an increase in regulatory
audit frequency from at least every 6 months to at least every 4
months.
Employee Health PP Comply with PMO section 13 & Required Prerequisite, use PMO section 13 & 14 as guideline
14
Product flow diagrams None Required Required for each Grade "A" product
Corrective Action Plan Determined by State Regulatory Required, may be pre-establish or follow 5 requirements listed in
for Violation of Agency consulting with industry Appendix K
Regulatory (except in cases of imminent
Requirements health hazard)
Individual plant HACCP None required, verified or Annually, may be more frequent based on other triggers,
system Verification/ validated required frequency for CCP records verification
Validation
Technical Assistance – FDA Technical Resource Committee (concurrence by entire NCIMS
Q&As HACCP Implementation Committee)
** 9 Critical Listing Elements:

1. Flow Diagram and Hazard Analysis conducted & written for each kind of group of milk or milk product processed.
2. Written HACCP plan prepared for each kind or group of milk or milk product processed.
3. CL(s) are adequate to control the hazard identified.
4. Corrective action taken for products produced during a deviation from critical limits defined in the HACCP plan.
5. Calibration of CCP process monitoring instruments performed as required and at the frequency defined in the HACCP
plan.
6. Information on HACCP records not falsified.
7. Incoming milk supply from NCIMS listed source(s) with sanitation scores of 90 or better or acceptable HACCP Listing.
8. Drug residue control program implemented.
9. A series of observations that lead to a finding of a potential HACCP System failure that is likely to result in a compromise
to food safety.
23 April 2010
Hazard Components
Hazards to be considered in the hazard analysis are those reasonably likely to occur in the facility
that is developing the HACCP plan. Careful consideration must be given to all ingredients, every step in
the process and the finished product packaging and storage. The hazard analysis for each processing
facility, and for each product type within that facility, will be unique to that plant. When conducting the
hazard analysis the HACCP team should review adverse related events, utilize past experience, and
consult experts to determine if a hazard warrants inclusion in the hazard analysis.
Remember, hazards, as defined within HACCP relate to product safety. Also, hazards that are
included in the hazard analysis should be reasonably likely to occur in the process being evaluated,
associated with the product being processed and evaluated for each product and process within the
facility.
Biological hazards for dairy processors might include pathogenic bacteria, viruses, or parasites /
protozoa. The mere presence of microorganisms may not result in a hazard. Specific pathogenic bacteria
that have been linked to foodborne illness outbreaks associated with dairy products include Escherichia
coli, Listeria monocytogenes, Salmonella spp. and Staphylococcus aureus. Following is a table of
potential biological hazards found in foods; however, it might be more useful to group organisms by
characteristics necessary for growth and destruction. For example, most microorganisms in the vegetative
state are easily destroyed by pasteurization temperatures. The outgrowth of spores from spore-forming
microorganisms is inhibited by low pH. Toxin producing organisms usually require mesophilic growth
conditions to achieve large enough populations to produce toxins.
Potential Biological Hazards

Moderate with Potentially Moderate with
Severe Extensive Spread Limited Spread
 Brucella  Salmonella spp.  Bacillus cereus
 Clostridium botulinum  Enterotoxigenic Escherichia coli  Campylobacter jejuni and
 Listeria monocytogenes  Enteroinvasive Escherichia coli other species
 Salmonella typhi, paratyphi,  Shigella spp.  Clostridium perfringens
and dublin  Viruses  Staphylococcus aureus
 Shigella dysenteriae  Cryptosporidium protozoa  Aeromonas
 Hepatitus A and E  Giardia protozoa  Yersinia enterocolitica
 Escherichia coli 0157:H7  Parasites
Chemical hazards that might be considered in a dairy plant hazard analysis are listed below, but it must
be recognized that the likely or suspected level in a food is what determine whether it is a hazard or not.
Low levels may not pose a hazard in a food, while higher levels may. Causative agents, such as those
listed below may cause illness in susceptible individuals, if not properly addressed in a HACCP Program.
Potential Chemical Hazards

Natural Toxins  Mycotoxins
- Acute: Ochratoxin, Trichothecene, Zearalenone,
Aflatoxin
- Chronic: Aflatoxin, Sterigmatocystin, Patulin
 Other natural toxins
- Thyro-toxicosis
Metals  Copper
24 September 2009
Potential Chemical Hazards
 Cadmium
 Mercury
 Lead
Drug Residues  Beta-lactams
 Sulfonamides
 Tetracyclines
 Macrolides
 Others
Cleaner/Sanitizer Residues  Nitrates
 Phosphates
 Chlorinated Organics
 Iodophors
 Others
Pesticide Residues  Organo-phosphates
 Fumigants
 Others
Allergens  Egg and Egg Products
 Milk and Milk Products
 Peanuts and Peanut Products
 Fish (specific species)
 Crustaceans (specific species)
 Soy and Soy Products
 Tree Nuts
 Wheat and Wheat Products
Food Additives  Vitamins
 Colors
 Other food additives
Inadvertent or Toxic Chemicals  Equipment Cleaning Chemicals
 Lubricants
 Boiler Additives
 Water Treatment Additives
 Others
Physical hazards are those materials that are likely to cause injury or choking and must also be evaluated
within each dairy plant. Examples of physical hazards to consider would include glass, plastic or metal
fragments – particularly from packaging materials and processing equipment. Employee practices might
also influence the types of physical hazards to be considered in the processing facility.
Hard or sharp foreign objects in food may cause traumatic injury including laceration and perforation of
tissues of the mouth, tongue, throat, stomach and intestine as well as damage to the teeth and gums. Hard
or sharp natural components of a food ( e.g. bones in seafood, shell in nut products) are unlikely to cause
injury because of awareness on the part of the consumer that the component is a natural and intrinsic
component of a particular product. The exception occurs when the food label represents that the hard or
sharp component has been removed from the food, e.g., pitted olives. The presence of the naturally
occurring hard or sharp object in those situations (e.g., pit fragments in pitted olives) is unexpected and
may cause injury.
25 September 2009
Some guidance from the US Food & Drug Administration regarding the size of hard or foreign objects
which is considered a hazard to human health is listed below.
1. If the product contains a hard or sharp foreign object that measures 7 mm to 25 mm, in length; and
the product is ready-to-eat, or according to instructions or other guidance or requirements, it
requires only minimal preparation steps, e.g., heating, that would not eliminate, invalidate, or
neutralize the physical hazard prior to consumption.
2. If the product contains a hard or sharp foreign object less than 7 mm in length and if a special-risk
group, is among the intended consumers of the product.
3. The product contains a hard or sharp foreign object over 25 mm in length.
Physical objects that do not meet the above criteria are classified as "undesirable contaminants," but not
"physical hazards."
Potential Physical Hazards

Glass Fragments Other Extraneous Material
Wood Fragments  Nut Shells
Plastic Fragments  Fruit Pits (Cherry, Peach)
Metal Fragments, such as:  Fruit Material (Stems, Caps,
 Bolts Seeds)
 Nuts  Gaskets, O-Rings, etc.
 Bag Clips / Locks  Insect Parts
 Shavings  Other
Personal Effects, such as:
 Jewelry  Pens
 Earrings  Bandages
 Buttons  False fingernails
26 September 2009
POTENTIAL HAZARDS IDENTIFIED BY SOURCE
The following lists are not intended to be complete or comprehensive, but provide the reader with
extensive examples of the hazards specific to certain dairy products or their ingredients
CHEESE
Biological
• Listeria monocytogenes • Salmonella sp.
• Brucella sp. • Pathogenic Escherichia coli
• Staphylococcus aureus • Staphylococcal enterotoxin
• Campylobacter sp. • Shigella sp.
• Clostridium botulinum (shelf stable processed cheese types)
Chemical
• Nitrates, nitrites • Aflatoxin
• Pesticides
CHOCOLATE & CHOCOLATE SYRUP

Biological
• Salmonella sp.
CREAM - RAW
Biological
• Salmonella sp. • Listeria monocytogenes
• Clostridium perfringens • Pathogenic Escherichia coli
• Yersinia sp. • Campylobacter sp.
• Bacillus cereus • Brucella sp.
Chemical
• Therapeutic Drug Residues • Pesticides
• Sulfonamides
Physical
• Extraneous material
DRIED MILK PRODUCTS

Biological
• Salmonella sp. • Staphylococcus aureus
• Staphylococcal enterotoxin • Pathogenic Escherichia coli
• Listeria monocytogenes • Clostridium botulinum
• Clostridium perfringens
Chemical
• Sulfonamides • Therapeutic Drug Residues
• Pesticides
EVAPORATED/CONDENSED MILK AND MILK PRODUCTS

Biological
• Listeria monocytogenes • Pathogenic Escherichia coli
• Salmonella sp. • Staphylococcus aureus
• Staphylococcal enterotoxin • Bacillus cereus
27 September 2009
• Shigella sp. • Yersinia sp.
• Brucella sp. • Campylobacter sp.
• Clostridium perfringens • B. cereus
Chemical
• Sulfonamides • Therapeutic Drug Residues
• Pesticides
FRUIT - CANNED
Biological
• Mycotoxins • Salmonella
• S. aureus • Clostridium perringens
• Pathogenic E. coli • B. cereus
• Pesticides • Sulfonanimides
ICE CREAM ADDED AIR

Biological
• Mold spores • Listeria monocytogenes
• Pathogenic Escherichia coli • Staphylococcus aureus
Chemical
• Non-food chemical vapors (e.g. oil, ammonia) • Allergens (e.g. peanuts, tree nuts)
MICROBIAL FLORA FOR MOLD-RIPENED CHEESE

Biological
• Mycotoxigenic fungi
MILK - RAW
Biological
• Salmonella sp. • Listeria monocytogenes
• Clostridium perfringens • Pathogenic Escherichia coli
• Yersinia sp. • Campylobacter sp.
• Bacillus cereus • Shigella sp.
• Brucella sp.
Chemical
• Antibiotics • Pesticides
• Sulfonamides
Physical
• Insects • Soil
• Glass fragments • Wood Slivers
• Metal fragments • Foreign Material
NUTS
Biological
• Mycotoxigenic fungi • Salmonella sp.
28 September 2009
Chemical
• Fumigants • Toxins
Physical
• Foreign material (e.g., shell fragments) • Insects
PACKAGING MATERIAL
Biological
• Through damaged materials • From airborne pathogens
• From condensate
Physical
• Foreign material
SALT
Chemical
• Non-food grade impurities
Physical
• Foreign material
SWEETENING AGENTS (DRY)

Biological
• Salmonella sp. • Mold spores
SWEETENING AGENTS (LIQUID)

Biological
• Listeria monocytogenes • Clostridium botulinum spores (e.g., corn syrup,
• Mold spores honey)
WHEY (Dry, Liquid and Condensed)

Biological
• Staphylococcus aureus • Salmonella sp.
• Listeria monocytogenes • Pathogenic Escherichia coli
Chemical
• Staphylococcal enterotoxin
Physical
• Extraneous material
29 September 2009
Limiting Conditions for Pathogen Growth
Minimum Minimum Maximum Maximum Minimum Maximum Oxygen

Pathogen aw pH pH % Salt Temp Temp Requirement
Bacillus cereus 0.92 4.3 9.3 18 39.2°F 131°F Aerobe
4°C 55°C
Campylobacter jejuni 0.987 4.9 9.5 1.5 86°F 113°F Micro-aerophilic*
30°C 45°C
Clostridium botulinum, 0.935 4.6 9.0 10 50°F 118.4°F Anaerobe**
type A, and proteolytic B and F 10°C 48°C
Clostridium botulinum, 0.97 5.0 9.0 5 37.9°F 113°F Anaerobe**
type E, and nonproteolytic B and F 3.3°C 45°C
Clostridium perfringens 0.93 5.0 9.0 7 50°F 125.6°F Anaerobe**
10°C 52°C
Pathogenic strains of 0.95 4.0 9.0 6.5 44.6°F 120.9°F Facultative anaerobe***
Escherichia coli 7.0°C 49.4°C
Listeria monocytogenes 0.92 4.4 9.4 10 31.3°F 113°F Facultative anaerobe***
-0.4°C 45°C
Salmonella spp. 0.94 3.7 9.5 8 41.4°F 115.2°F Facultative anaerobe***
5.2°C 46.2°C
Shigella spp. 0.96 4.8 9.3 5.2 43°F 116.8°F Facultative anaerobe***
6.1°C 47.1°C
Staphylococcus aureus – growth 0.83 4.0 10.0 25 44.6°F 122°F Facultative anaerobe***
7°C 50°C
Staphylococcus aureus – toxin 0.85 4.0 9.8 10 50°F 118°F
10°C 48°C
Vibrio cholerae 0.97 5.0 10.0 6 50°F 109.4°F Facultative anaerobe***
10°C 43°C
Vibrio parahaemolyticus 0.94 4.8 11.0 10 41°F 111°F Facultative anaerobe***
5°C 44°C
Vibrio vulnificus 0.96 5.0 10.0 5 46.4°F 109.4°F Facultative anaerobe***
8°C 43°C
Yersinia enterocolitica 0.945 4.2 10.0 7 29.7°F 107.6°F Facultative anaerobe***
-1.3°C 42°C
* - Requires limited levels of oxygen

** - Requires the absence of oxygen
*** - Grows either with or without oxygen
30 September 2009
Time/Temperature Guidance for Controlling Pathogen Growth
and Toxin Formation
Maximum Cumulative
Potentially Hazardous Condition Product Temperature Exposure Time
Growth of Campylobacter jejuni 86-93°F (30-34°C) 48 hours
Above 93°F (above 34°C) 12 hours
Germination, growth, and toxin 50-70°F (10-21°C) 12 hours*
formation by Clostridium botulinum type A, Above 70°F (above 21°C) 4 hours*
and proteolytic B and F
Germination, growth, and toxin 37.9-50°F (3.3-10°C) 24 hours
formation by Clostridium botulinum type E, 51-70°F (11-21°C) 12 hours
and nonproteolytic B and F Above 70°F (above 21°C) 4 hours*
Growth of pathogenic strains of 44.6-50°F (7-10°C) 14 days
Escherichia coli 51-70°F (11-21°C) 6 hours
Growth of Listeria monocytogenes 31.3-50°F (-0.4-10°C) 2 days
51-70°F (11-21°C) 12 hours*
Above 70°F (above 21°C) 3 hours*
Growth of Salmonella species 41.4-50°F (5.2-10°C) 14 days
51-70°F (11-21°C) 6 hours
Growth of Shigella species 43-50°F (6.1-10°C) 14 days*
51-70°F (11-21°C) 6 hours*
Above 70°F (above 21°C) 3 hours*
Growth and toxin formation by 44.6-50°F (6.1-10°C) 14 days
Staphylococcus aureus 51-70°F (11-21°C) 12 hours*
Growth of Yersinia enterocolitica 29.7-50°F (-1.3-10°C) 1 days
51-70°F (11-21°C) 6 hours
Above 70°F (above 21°C) 2.5 hours
* - Additional data needed.
31 September 2009
PREREQUISITE PROGRAM
Prerequisite Programs & SSOPS
Prior to the development of HACCP plans under IDFA’s Dairy HACCP Safety System, there is a
requirement for dairy plants to have developed, documented, and implemented programs to control
factors that may not be directly related to product safety but serve as a foundation of a HACCP system.
These programs together are known as the “Prerequisite Program”. A prerequisite program should be
written, effectively checked, documented and controlled before attempting to develop the HACCP plan.
HACCP is not a stand-alone program but is part of a larger control system. The prerequisite
program is the universal procedure used to control the plant environment and operating conditions that
contribute to the production of a safe, wholesome dairy product. They represent the sum of programs,
practices and procedures that must be applied to design, produce and distribute safe products in a clean,
sanitary environment. Many of the conditions and practices are specified in Federal, State and Local
regulations and guidelines. Plant Standard Operating Procedure (SOP) and Good Manufacturing Practice
(GMP) programs serve as the basis for and are necessary in order to build a solid prerequisite program.
Outline for Development and Documentation of Prerequisite Program*

1. Identify mandatory or key prerequisites
2. Write brief description
3. Identify hazards reduced or eliminated
4. Identify records maintained to verify reduced or eliminated hazard.
5. Identify staff responsible for maintaining records
6. Written brief description of corrections
* See Prerequisite Program model form at the end of this section that allows the HACCP Team to
summarize the above information.
A prerequisite program should address applicable public health concerns identified in the latest
edition of the Pasteurized Milk Ordinance (PMO), 21 CFR Part 110, GMPs; Part 113, Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; and the National Advisory
Committee on Microbiological Criteria for Foods (NACMCF) Hazard Analysis and Critical Control Point
Principles and Application Guidelines. It is important to note that the voluntary PMO-based HACCP
program mandates eight prerequisites. These eight mandatory prerequisites, listed below, will be
addressed within the associated general prerequisites.
32 September 2009
1. Safety of water that comes into contact with food or food-contact surfaces, including ice.
2. Condition and cleanliness of the food contact surface.
3. Prevention of cross-contamination between food, food packaging material, food contact
surfaces and unsanitary objects. This includes contact between raw and processed product.
4. Maintenance of the hand washing and toilet facilities.
5. Protection from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing
agents, condensate and other chemical, physical or biological compounds.
6. Proper labeling, storage and use of toxic compounds.
7. Control of employee health conditions.
8. Exclusion of pests.
End product sampling and testing by the processing industry is not required. If included as part
of the verification step in a company’s HACCP plan, then those referenced industry testing records will
be available to the regulatory agency (usually FDA). Specific requirements regarding acceptable test
methods can be found in the Association of Official Analytical Chemists (AOAC) “Official Methods”
document.
The intent of this section is to provide guidance to plant management in the evaluation of existing
areas making up the prerequisite program or in the expansion into new areas. The importance of the
prerequisite program cannot be overstated. The prerequisite program is the foundation of a
comprehensive HACCP system and must be effective. If any hazard is not controlled, according to the
hazard analysis, then the prerequisite program may have to be adjusted or expanded or additional CCPs
may have to be identified, monitored, and maintained under the HACCP plan. A written and documented
prerequisite program that is a part of the complete dairy HACCP system is dependent upon the need to
control hazards identified in the hazard analysis. In summary, comprehensive, effective prerequisite
programs will simplify HACCP plans and will ensure that the integrity and comprehensiveness of the
HACCP program is maintained and that the manufactured product is safe.
The section below outlines examples of prerequisite areas including key environmental and
operational areas. A dairy plant’s prerequisite program may include some or all of the areas listed below,
depending on the hazard analysis. A corresponding checklist useful in reviewing the areas listed below
can be found in the section of the manual on “Evaluating and Revising HACCP Systems.
I. PREMISES
A. Outside Property B. Building & Personnel Traffic Patterns
C. Sanitary Facilities (PP#4)
II. WATER/STEAM/ICE SAFETY (PP#1)

A. Potable Water Supply B. Steam Supply
C. Ice Supply D. Cooling Waters
E. Reclaimed Water
III. RECEIVING/STORAGE/TRANSPORTATION
A. Supplier control
B. Receiving of raw materials, ingredients, and packaging materials
1. Specifications 2. Storage (PP#6)
C. Temperature Control Program D. Transportation Program
IV. EQUIPMENT PERFORMANCE AND MAINTENANCE PROGRAM (PP#2)

A. General Equipment Design B. Equipment Installation
C. Equipment Maintenance and Calibration
33 September 2009
V. PERSONNEL TRAINING PROGRAM AND EMPLOYEE HYGIENE
A. Training B. Hygienic Practices (PP#7)
C. Infectious Disease Policy (PP#7) D. Injury/Open Wound Policy (PP#7)
E. Controlled Access Policy (PP#7) F. Personnel Safety Program (PP#7)
VI. ENVIRONMENTAL AND PROCESSING EQUIPMENT HYGIENE PROGRAM

A. Manufacturing Controls
VII. CLEANING AND SANITATION PROGRAM

A. Interior Facility Cleaning B. Processing Equip. Cleaning and Sanitation (PP#2)
C. Pest Control (PP#8)
VIII. RECALL PROGRAM

A. Traceability B. Recall System
IX. CROSS-CONTAMINATION PREVENTION PROGRAM

A. Allergens (PP#5)
B. General Adulteration (PP #5)
C. Cross-Contamination (PP#3)
Please note that for dairy plants operating under the voluntary PMO-based HACCP program,
regulatory agencies prefer that the mandatory eight (8) prerequisites listed below and identified by
number above have all related records kept separate from other parts of the prerequisite program in order
to facilitate official regulatory audits. In these cases, the mandatory eight (8) prerequisites should be
identified separately from other parts of the plant's prerequisite program.
a. Safety of the water that comes into contact with milk or milk products or product-contact
surfaces, including steam and ice;
b. Condition and cleanliness of equipment product-contact surface;
c. Prevention of cross-contamination from insanitary objects and or practices to milk or milk
products or product-contact surfaces, packaging material and other food-contact surfaces,
including utensils, gloves, outer garments, etc., and from raw product to processed product;
d. Maintenance of hand washing, hand sanitizing, and toilet facilities;
e. Protection of milk or milk product, packaging material, and product-contact surfaces from
adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate
and other chemical, physical and biological contaminants;
f. Proper labeling, storage, and use of toxic compounds;
g. Control of employee health conditions, including employee exposure to high risk situations, that
could result in the microbiological contamination of milk or milk products, packaging materials,
and product-contact surfaces; and
h. Pest exclusion from the milk plant.
34 September 2009
I. PREMISES
Building and surroundings must be designed, constructed, and maintained in a manner to prevent
conditions that may result in the contamination of dairy products, their ingredients or packaging materials.
Dairy plants that use HACCP need to have an area of the prerequisite program in place to check, correct
and document all elements in this section.
Premises include all elements of the building and building surroundings: the outside property,
roadways, drainage, building design and construction, product flow, sanitary facilities, and water/air
safety. Adherence to this are of the prerequisite program is verified through the plant's written program
that outlines the procedures to be undertaken to ensure satisfactory conditions are maintained (e.g., areas
to be verified, tasks to be performed, person(s) responsible, verification frequencies, and records to be
kept).
A. Outside Property
Surrounds should be free of debris and refuse and is not in close proximity to any source
of pollution (e.g., objectionable odors, smoke, dust, or other contaminants). Refuse
disposal and storage areas should be properly maintained, with covered or closed
containers to prevent vector harborage.
Roadways, parking areas and shipping/receiving areas should be properly graded,

compacted, dust proof, and drained.
B. Building and Personnel Traffic Patterns
Buildings are of sound construction, maintained in good repair, and do not present any
microbiological, chemical, or physical hazards to the food. The construction and the
layout should reflect the approved blueprints when available.
The building and facilities should be designed to allow for:

 Suitable environmental conditions consistent with processing dairy products.
 Easy facility cleaning.
 Protection of contamination by extraneous materials.
 Prevention of access and harborage of pests and environmental contaminants.
 Space for satisfactory performance of all operations.
1. Design and Construction
Floors, walls, and ceiling materials, as well as various coating and joint sealant,
should be constructed of nonporous materials appropriate for their intended use.
Floors, walls, and ceilings should be constructed of material that is durable,

smooth, impervious, easily cleanable, and suitable for the production conditions
conducted in the area.
Floors should be sufficiently sloped for liquids to drain into trapped outlets where
appropriate.
Windows, if opened, should be equipped with tight-fitting screens.
35 September 2009
Doors should have smooth, non-absorbent surfaces, tight-fitting and self-closing,
where required.
Stairs, elevators, and other structures should be located and constructed to

prevent contamination of dairy product, ingredients and packaging materials.
Overhead structures should be designed and installed in a manner that prevents

contamination of dairy product, ingredients, and packaging materials and does
not hamper cleaning operations.
Lighting should be provided throughout the establishment to provide the

necessary illumination to meet the requirements of the working area. Light bulbs
and fixtures suspended over exposed dairy products, ingredients, or packaging
materials at any stage of production or storage should be shielded or otherwise
protected to prevent contamination by a physical hazard (glass) in case of
breakage.
Roof areas should be clean and sloped for proper drainage. Special attention in
drying operations, needs to be exercised to avoid the accumulation of airborne
particulate matter.
Ventilation should be provided to prevent a buildup of heat, steam, condensation,

or dust and to remove contaminated air. In microbiologically sensitive areas,
positive air pressure is strongly recommended. Ventilation openings should be
equipped with tight-fitting screens or otherwise protected with non-corrodible
material. Air intakes need to be properly filtered and located to prevent intake of
contaminated air.
Drainage and sewage systems should be equipped with appropriate traps and
vents, as directed by the local plumbing code. Plants should be designed and
constructed so that there is no cross-connection between the effluent of human
wastes and any other wastes in the plant. Covered containers should be provided
for the storage of solid waste and inedible material prior to removal from the
plant. These facilities should be designed to prevent contamination. Containers
used for waste should be covered, leak-proof and clearly identified.
2. Personnel Traffic Flow
The traffic pattern for employees and portable equipment should be established
to minimize potential contamination or adulteration of dairy product during
processing.
Job responsibilities for personnel, such as farm truck haulers and raw receiving
room employees should be determined in a way to minimize or eliminate the
need to pass through processing and packaging areas.
Movement of personnel, employees and visitors through the dairy plant and its
facilities should start in the processing and packaging areas and move toward the
raw receiving and external plant facilities.
36 September 2009
C. Sanitary Facilities
* This is a mandatory PP (#4-maintenance of hand washing and toilet facilities) under the
NCIMS HACCP program.
1. Washrooms, Lunchrooms, and Change Rooms
Washrooms should be equipped with self-closing doors, adequately ventilated

and maintained. Washrooms, lunchrooms, and change rooms should be separate
from and not lead directly into dairy processing areas.
2. Hand Washing and Sanitizing Facilities
Washrooms should have properly maintained, sufficient number of hand-washing

facilities, readily accessible in areas where plant employees may need them.
Hand sinks should be directly connected to sanitary drains. Hand washing

facilities should have hot and cold potable running water, soap, sanitary hand
drying supplies or devices, and a clean, covered waste receptacle.
Processing areas should contain a sufficient number of conveniently located,

properly trapped, hand washing stations connected directly to sanitary drains. In
the processing areas, remote controlled (e.g., foot, knee, timed) hand-washing
stations are recommended.
It is recommended that hand washing notices be posted in strategic points

throughout the processing facility to remind employees and visitors to wash
hands after use of a bathroom, prior to entering the processing and packaging
areas or prior to handling processed dairy products.
II. WATER/STEAM/ICE SAFETY

*This is a mandatory PP (#1-safety of water including ice) under the NCIMS HACCP
program
The dairy plant's water safety control program evaluates the microbiological, chemical,
and physical safety of source and in-plant water (from various points of usage). This water
includes the steam supply; cooling media, process waters, and ice supply. Elements of this
program may establish the frequency of testing, the control limits, the procedures for testing, the
person responsible, and the records to be kept. Records should be maintained on water quality
(laboratory tests results) and water treatments. This area of the prerequisite program should have
in place procedures to deal with water not meeting the specified standards.
A. Potable Water Supply
Potable hot and cold water should be used in food processing, handling,
packaging, and storage areas. This water should be provided at adequate
temperatures, pressures and in quantities sufficient for all operational and
cleanup needs.
For privately controlled water supplies, facilities that protect against

contamination should be provided for the disinfection, storage and distribution of
water.
37 September 2009
Verification of water safety might include bacteriological testing of water.
Testing should be done monthly for privately controlled water supplies,
semiannually for municipally-supplied water and on a monthly basis for other
sources. Records of water safety testing results should be maintained.
When chlorination or other treatment procedures are conducted on the premises,

some basic controls should be in place such as:
• metering device(s) for adding the correct concentration of chemical, with

features designed to readily indicate a malfunction.
• routine checks or automatic recording equipment to determine the total

available chlorine. This could include an automatic analyzer equipped
with a recorder and an alarm
Cross-connections between potable and non-potable water supply systems must

not exist. Non-potable water should not be used in food processing, handling,
packaging, or storage areas except for cow water. Cow water is defined as
condensing water reclaimed from the removal of water from milk and milk
products. All water piping, hoses, and other connections that could possibly
result in contamination must be equipped with a properly designed physical
break, anti-siphon or anti-backflow devices effective to prevent the specific
hazard.
B. Steam Supply
Steam coming into direct contact with food or food contact surfaces should
originate from potable water or other acceptable reclaimed water with no harmful
substances added. The steam supply capacity needs to be adequate for normal
operational requirements.
Boiler treatment chemicals should be used according to label directions and meet
EPA directives (21 CFR 173.310) for use in contact with food-contact surfaces or
in direct contact with foods, if use in this manner. Records on use, amounts and
time of treatment(s) should be maintained.
C. Ice Supply
Ice should be made from potable water that is frozen, handled, and stored using
equipment and procedures to protect it from contamination.
Bacteriological testing of ice should be done on a semiannual basis for plants

using municipal water supplies and on a monthly basis for plants using other
sources. Records of ice safety should be maintained.
D. Cooling Waters
Water treatment chemicals used in cooling water should be used according to

label directions and meet EPA directives (21 CFR 173.310) for use in contact
38 September 2009
with food-contact surfaces or in direct contact with foods, if use in this manner.
Records on use, amounts and time of treatment(s) should be maintained.
E. Reclaimed Water
Condensing water from milk evaporators and water reclaimed from milk and
milk products may be reused in a milk processing plant. Reclaimed (cow) water
should be treated and maintained in a condition so that no health hazard results
from its use and it should be of satisfactory organoleptic quality, with no off-
flavors, odors or slime formations.
Reclaimed water should have a separate distribution system that is readily

identified.
Samples from reclaimed water should be collected daily for two weeks following
initial approval of a new installation and semi-annually thereafter. It is
recommended that daily tests be conducted for one week following any repairs or
alteration to the reclaimed water collection, storage and distribution system.
Reclaimed water to be used for potable water purposes, including the production
of culinary steam and for pre-rinsing product surfaces, should meet the following
requirements:
1. The total plate count should be 500 cfu per milliliter or less.
2. The coliform count should be less than 1.
3. The organic content should be less than 12 mg/l as measured by the

chemical oxygen demand or permanganate-consumed test.
4. The standard turbidity should be less than 5 units.
5. Automatic fail-safe monitoring devices should be used to monitor and

automatically divert (to the sanitary sewer) any reclaimed water that
exceeds the above levels.
6. The water shall be sampled and tested organoleptically at weekly

intervals.
7. When approved chemicals (i.e. chlorine, ozone, etc.) are added, a daily
testing program for such added chemicals should be established
Reclaimed water may be used for cleaning solution make-up water, if items #1 –
7 listed above are met and:
a. There is no carry-over of water from one day to the next, and any
water collected is used promptly; or
b. The temperature of all water in the storage and distribution
system is maintained at 63oC (145oF) or higher by automatic
means; or
c. The water is treated with a suitable, approved chemical to
suppress bacterial propagation by means of an automatic
39 September 2009
proportioning device, prior to the water entering the storage
tank; and that,
d. Distribution lines and hose stations are clearly identified as
"limited use reclaimed water"; and
e. Water handling practices and guidelines are clearly described
and prominently displayed at appropriate locations within the
plant; and
f. Reclaimed water lines are not permanently connected to product
vessels unless there is a break to the atmosphere and sufficient
automatic controls to prevent the inadvertent addition of this
water to product streams.
Reclaimed water not meeting the requirements listed above may be used as boiler
feedwater for boilers not generating culinary steam, or in a thick, double walled,
enclosed heat exchangers.
III. RECEIVING/STORAGE/TRANSPORTATION
A. Supplier Control
1. Performance Criteria
Certification of some incoming material is an important component of a prerequisite

program. As a buyer of ingredients, packaging and other products used to produce dairy
products, a dairy plant should develop performance criteria for each raw material,
ingredient and packaging used for dairy products. These performance standards may
include:
 Durability criteria.
 Material or ingredient content.
 Certification of food-grade status for product ingredients and product contact
surfaces of packaging.
 Storage criteria.
 Certificates of Analysis (COAs).
 Letters of guarantee.
 Third party audits.
 Spot check of incoming ingredients.
 Supplier verification documentation.
2. Alternate Sources
Every dairy plant utilizes a multitude of suppliers for products, packaging and
ingredients. Since it is not uncommon for a problem to develop with a product,
packaging or ingredient related to quality, safety or availability, it is recommended that
part of the supplier control program include an alternate source of these items,
particularly when the item is critical to the processing of a product. The availability of
this list, which contains suppliers already determined to meet specified performance
criteria can reduce the potential for food safety problems as the result of an emergency
change in suppliers without time to evaluate performance.
40 September 2009
B. Receiving of Raw Materials, Ingredients, and Packaging Materials
Plants are responsible for receiving, inspecting, and storing ingredients, packaging
material, and incoming materials to prevent hazards that may contaminate food. Plants
should have a program in place to monitor and control all applicable elements in this
section and maintain the appropriate records. All products should be properly stored after
processing and be protect from contamination until shipped to the buyer or final
consumer.
Raw materials, ingredients, and packaging material should be monitored on receipt,

evaluated against the supplier control performance standard(s), stored and handled in a
sanitary manner, with records maintained. Handling and storage practices should prevent
or reduce the likelihood of contamination of raw materials, ingredients, and packaging
materials by direct or indirect contact with contaminated material.
Incoming materials should be received into an area separate from the processing area.
1. Specifications
All food additives and food ingredients should be food grade (i.e., they meet CFR
specifications or FD&C specifications and are safe and do not impact negatively
on the safety of the product). Product packaging materials should be appropriate
for their intended use.
2. Storage
This section covers incoming materials (including returned goods), finished product, and
non-food chemical storage.
a. Temperature and Humidity Controls
Where applicable, plants should have adequate means of establishing,

maintaining, and monitoring the temperature and the humidity of rooms where
raw materials, ingredients, packaging materials, and food are stored.
Records of monitoring should be maintained.
b. Raw Materials, Ingredients, and Packaging Materials
Raw materials, ingredients, and packaging materials should be handled and

stored in a manner to prevent damage, contamination and avoid growth of
microorganisms.
c. Finished Product
Storage conditions should ensure the safety of the food.
d. Returned or Damaged Goods
All partially used or damaged raw materials, packaging supplies and ingredients
need to be stored in a sanitary manner and be properly labeled.
41 September 2009
Returned or damaged goods should be clearly identified and stored in a
designated area for appropriate disposition. Conditions of storage need to ensure
the safety of the finished product.
e. Non-Food Chemicals
* This is a mandatory PP (#6-proper labeling, storage and use of toxic
compounds) under the NCIMS HACCP program.
Detergents, sanitizers, or other chemical agents in a dairy plant should be

properly labeled, stored, and used in a manner that prevents contamination of
food, packaging materials, and food contact surfaces. Chemicals should be
stored and handled in an area that is dry, well ventilated, and separate from all
food handling areas. Chemicals should be mixed and stored in clean, labeled
containers and dispensed and handled by properly-trained personnel.
C. Temperature Control Program
Dairy product safety is partially dependent upon a comprehensive temperature control

program that maintains dairy products and most of their perishable raw materials and
ingredients at 45F or less, unless otherwise noted on the label (i.e. dried or aseptic dairy
products).
A dairy product, raw material and ingredient temperature control program should include
frequent checking and recording of temperatures during receipt, processing and storage.
Some components of a temperature control program could include:
1. Incoming raw material and ingredient temperature – manual log.
2. Raw material and ingredient storage temperatures – continuous temperature

chart recorder(s).
3. Pasteurized storage temperatures – continuous temperature chart recorder(s).
4. Packaging surge tank temperatures – manual log or continuous temperature

chart recorder(s).
5. Product temperature immediately after packaging – manual log.
6. Product storage temperature prior to distribution – manual log.
7. Product distribution temperature – manual log.
8. Cooling water temperature at appropriate points in the process flow – manual

log or continuous temperature chart recorder(s).
After production, most frozen desserts should be maintained at -10F or less during
storage and distribution for both quality and safety reasons.
D. Transportation Program
42 September 2009
A prerequisite program may include a transportation program if the plant is responsible
for distributing to wholesalers or retailer’s dairy products in either a finished ready-to-eat
form or as an ingredient intended for further processing. This transportation program
should focus on temperature control (see above) and protecting the product from
contamination until it reaches its intended buyer.
Finished dairy products or dairy products intended for further processing need to be
transported in clean, well maintained trucks or rail cars dedicated to handling food or
food-grade ingredients and capable of:
• Establishing, maintaining, monitoring and documenting product temperature.

• Protecting the product from contamination.
IV. EQUIPMENT CONSTRUCTION AND MAINTENANCE

* This is a part of mandatory PP (#2-condition of food contact surfaces) under the
NCIMS HACCP Program.
Dairy plants should specify that all new processing equipment must comply with 3-A standards,
if a standard exists for that particular piece of equipment. This will assure that the prerequisite for
equipment construction is achieved. The equipment should be installed and maintained in a manner to
ensure ease of cleaning to reduce the likelihood of contamination. Plants need to have an adequate
program in place to monitor and control all elements in this section and maintain the appropriate records.
A. General Equipment Design
Equipment and utensils should be designed to meet 3-A Standards for dairy processing
equipment, be easily cleanable and maintained in a manner that prevents contamination
of food.
Equipment and utensils should be constructed of corrosion-resistant material.
Food contact surfaces should be non-absorbent, nontoxic, smooth, free from pitting,
unaffected by food, and able to withstand repeated cleaning and sanitizing. All
chemicals, lubricants, coatings, and paints used on equipment in contact with food are
appropriate for their intended use.
B. Equipment Installation
Equipment and utensils should be installed and stored to prevent contamination of food.
Adequate space should be provided within and around equipment. Equipment should be
designed to be accessible for cleaning, sanitizing, maintenance, and inspection. When
necessary, equipment should be properly vented.
Equipment should be maintained in a clean and sanitary manner in accordance with the
sanitation program.
Equipment and utensils used to handle inedible material should not be used to handle
edible material. Containers for inedible and waste material should be clearly identified
and leak proof.
43 September 2009
C. Equipment Maintenance and Calibration
1. Equipment Calibration
Monitoring devices and any equipment that could have an impact on food safety
should be listed together with their intended use. Protocols and calibration
methods should be established for those equipment and monitoring devices. This
may include thermometers, pH meters, Aw meters, refrigeration unit controls,
scales, recording thermometers, recording hygrometers, and other equipment and
monitoring devices.
The frequency of calibration, the responsible person, the monitoring and

verification procedures, the appropriate corrective actions, and the record
keeping should also be specified. If reagents are used for monitoring or
verification activities, procedures for keeping and calibrating the reagents need to
be documented. Required information on the calibration of the reagents includes
the frequency of testing for all reagents, the responsible person, the dating
system, the storage conditions, and the records to be maintained.
Metal detectors and magnet are both integral parts of processing for many dairy
products. These pieces of equipment must be monitored by assigned personnel
using specific protocol. This protocol should provide details on the size and type
of metal piece to be used to challenge the metal detector or magnet, the
frequency of challenge, how this is to be recorded, who is responsible for
conducting the monitoring and action to be taken when this equipment does not
perform properly.
2. Preventive Maintenance
A preventive maintenance program may or may not be a part of the prerequisite

program, depending on the hazard analysis. A preventative maintenance
program lists the equipment and utensils, the specific task including necessary
replacement parts, the frequency, responsible person, method of checking,
verification activities, and records to document that the task was completed.
V. PERSONNEL TRAINING PROGRAM AND EMPLOYEE HEALTH
HACCP is a PEOPLE PROGRAM! Training those people responsible for the development and
implementation of a HACCP program is essential. Employees must develop an awareness of safety and
create a proactive environment for dairy product safety. The successful introduction of a HACCP system
needs to be accompanied by both education and training. The information and training needs of staff will
vary and should be an ongoing, continuous process, not a one time event. Under the NCIMS HACCP
pilot, training of personnel is strongly encouraged and evaluated by state regulators. This training should
be taken be industry personnel responsible for developing the written HACCP program, verification and
validation of the HACCP system and conducting the pasteurization equipment testing and calibration.
As stated earlier, any HACCP system must have the full support of top-level management who
will need to be briefed about the positive benefits of using this approach to assure product safety. This
briefing should include the resource implications, especially in terms of time, people, and staff training
44 September 2009
requirements required to implement and maintain the system. Other managers and staff, whether or not
they are involved directly in the HACCP program, need to be briefed in general terms about the benefits
of this approach and their likely role in the resulting HACCP system. All personnel will need to be kept
informed of progress during the development and implementation of HACCP systems which involve their
area of responsibility. This may be done by information sheets, meetings, workshops, training sessions,
etc.
A. Training
The objective of the personnel training program is to provide an understanding of safe food
handling practices by all employees. The HACCP training program should be targeted, on an
ongoing basis, toward production, as well as supervisory and management personnel. A
procedure should be developed to verify the effectiveness of the training program.
It is suggested that dairy plant personnel be trained in four distinct groups:
1. Senior Management/CEO - general knowledge of HACCP principles, including

resource requirements.
2. HACCP Team - broad and detailed understanding of HACCP principles, program
development and implementation.
3. HACCP Coordinator - team leadership, broad and detailed understanding of HACCP
principles, written program development, implementation and employee training
strategies and verification/validation techniques.
4. On-line Employee - importance of specific areas of the prerequisite program and
CCPs that are their direct responsibility.
Production staff managers, supervisors, engineers, and operators will need training on two
levels to enable them to carry out responsibilities that result from a HACCP program.
• How the application of the HACCP program will affect an individual's work. For
example, staff that monitors the CCPs will need to know what corrective action(s) to
take when the process moves toward or exceeds a critical limit or control limit. Training
may also be needed for interpretation of the data produced from monitoring activities.
• Specific training in technical skills, e.g. taking an accurate and relevant temperature,
pH, chemical and other measurements.
HACCP Team members will need training in:
• fundamental principles of HACCP.

• hazard analysis principles.
• benefits of the HACCP system.
• development of written programs.
• implementation of the HACCP program.
• role of the team and all employees in efforts to implement and maintain the HACCP
dairy product safety program.
Both HACCP team members and production staff need to understand that team meetings,
verification audits, and changes arising from the findings of these activities all form part of
the HACCP feedback system. They are all aimed at achieving the objective of the program in
the most effective way.
45 September 2009
Newly hired personnel need to be made familiar with the HACCP system and equipped with
the necessary skills to carry out their role within it. This should be included with the new
employee training.
Establishments should have an adequate training program in place to monitor and control
necessary areas of the prerequisite program identified by the hazard analysis and maintain the
appropriate documentation.
All plant employees, including managers, supervisors, HACCP team members, production,
processing, receiving and load-out staff should have an individual HACCP training record
maintained for documenting training and determining additional and on-going training needs.
An individual HACCP training plan for each of the employees identified above could be
helpful to assure each employee’s HACCP training needs have been met.
Production personnel need to be trained to understand the critical elements for which they are
responsible, what the critical limits are, the importance of monitoring the limits, and the
action they must take if the limits are not met.
Ongoing training in personal hygiene and hygienic handling of food should be provided to
every food handler and to all persons entering food handling areas. A documentation system
should be established to provide records that personal hygiene training has been carried out
and is being monitored.
B. Hygienic Practices
*This is a mandatory PP (#7-employee health conditions) under the NCIMS HACCP
program.
1. Hand Wash Procedure: All persons entering a food production area should wash their
hands thoroughly with soap under warm, potable running water. Hands should be washed as
often as needed to remove soil or contamination and must be specifically washed after using
bathroom facilities, and after handling materials that may contaminate dairy products. If
required, employees should use disinfecting hand dips as part of a hand wash procedure.
2. Personal Cleanliness and Conduct: All persons working in food handling areas need to
maintain a high level of personal hygiene while on duty. Protective clothing, hair covering,
and footwear, functional to the operation in which the employee is engaged, should be worn
and maintained in a sanitary manner. Gloves, if worn, need to be clean and sanitary.
3. All persons entering food handling areas should remove objects from their person which
may fall into, or otherwise contaminate, food.
4. Tobacco, gum, food and liquid refreshments should not be permitted in food handling
areas.
5. Jewelry should be removed prior to entering food handling areas. Jewelry, including
medic alert bracelets that cannot be removed, should be covered.
6. Personal effects and street clothing should not be stored in food handling areas and should
be stored in a manner to prevent the contamination of food.
46 September 2009
C. Infectious Disease Policy
program.
There are a number of infectious diseases of concern for workers in a food processing plant.
The list below may be expanded by declaration of the Secretary of Health and Human
Services to include other diseased determined to be transmissible through the handling of
food.
 Hepatitis A virus  Salmonella typhi

 Shigella species  Norwalk and Norwalk-like Viruses
 Staphylococcus aureus  Streptococcus pyogenes
 Escherichia coli 0157:H7  enterohemorrhagic Escherichia coli
 Campylobacter jejuni  enterotoxigenic Escherichia coli
 Entamoeba histolytica  Giardia lamblia
 Non-typhoidal Salmonella  Rotovirus
 Taenia solium  Yersinia enterocolitica
 Vibrio cholerae
A dairy plant should have a written policy on infectious diseases as part of a prerequisite
program in the area on employee health. An example is listed below.
“No persons affected with any disease capable of being transmitted to others through
the contamination of food shall work at a milk plant in any capacity which brings
them into direct contact with finished products, such as pasteurized or aseptically
processed milk or milk products, or which brings them into direct contact with
associated pasteurized or aseptically processed milk product contact surfaces.”
Part of an infectious disease policy should include a new employee orientation that may
include signing a statement that acknowledges an understanding of the dairy plant’s
infectious disease policy. In addition, during designated times (for example, personnel
evaluation and review), a review of the policy should be conducted, with a statement signed
by the employee and filed stating the policy has been reviewed and understood.
Dairy plant employees (or applicants to whom a conditional offer of employment has been
made) shall be instructed by the dairy plant that the employee or applicant or applicants to
whom a conditional offer of employment has been made is responsible to report to the dairy
plant management, in a manner that allows the dairy plant to prevent the likelihood of disease
transmission of diseases that are transmissible through foods, if the employee or applicant or
applicants to whom a conditional offer of employment has been made.
In addition, the policy should have a “reporting” procedure that clearly states what conditions
might trigger a need to report, who to report to, how an employee or supervisor should report
an infectious disease incident and the response by management. There should be clear
guidance to determine whether the employee is receiving adequate treatment for the
particular disease they contracted, a list of eligible work areas that will not jeopardize the
safety of the dairy product or result in potential contamination of raw materials, ingredients or
packaging, and a monitoring mechanism to determine the progress of the employee in
achieving a cure.
47 September 2009
Circumstances that may result in an employee needing to report the possibility of an
infectious disease include:
 Exposure to a confirmed foodborne disease outbreak at an event such as a family

meal, church supper or ethnic festival.
 Involvement in prepared food implicated in the outbreak.
 Consumption of food implicated in the outbreak.
 Consumption of food at the event prepared by a person who is infected or ill.
 Residence in the same household as a person who attends or works in a day care
center or school, similar institution experiencing a confirmed outbreak.
 Presence of symptom associated with acute gastrointestinal illness such as:
abdominal cramps or discomfort, diarrhea, fever, loss of appetite for three or more
days, vomiting, and jaundice.
When a person who may have handled pasteurized or aseptically processed milk or milk
products or pasteurized or aseptically processed milk product contact surfaces meets one or
more of the conditions specified above, plant management should consider taking the
following action:
1. Immediately restricting that person from duties which require handling finished
product, such as pasteurized milk or milk products, or the handling of related product
contact surfaces. This restriction may be lifted after an appropriate medical clearance
or cessation of symptoms or both, according to the following criteria.
2. Immediate exclusion of the affected dairy products from distribution and use when
medically appropriate (i.e., a medical evaluation of the sequence of events indicates
that contamination of product may have occurred).
3. Immediate requesting of medical and bacteriological examination of the person at

risk. (Note: Persons at risk who decline to be examined may be reassigned to duties
where they will not be required to handle finished products, such as pasteurized or
aseptically processed milk or pasteurized or aseptically processed milk products and
associated product contact surfaces).
D. Injury/Open Wound Policy

program.
All persons having an open cut, wound, boil, or infected wound that is on the hands, wrists,
exposed portions of the arms or on any other part of the body should not handle food or
food contact surfaces unless the injury is completely protected by a secure, waterproof
covering. This covering should be maintained and changed regularly so there is no external
appearance of staining by bodily fluids.
E. Controlled Access
program.
48 September 2009
Access of personnel and visitors to processing, packaging and finished product storage
areas should be controlled to prevent contamination. All necessary precautions need to be
taken to prevent contamination, including the use of foot and hand sanitizer systems.
F. Personnel Safety
program.
Worker safety can have a direct impact on dairy product safety by minimizing injuries that
could affect the performance of the individual, thereby possibly compromising dairy
product safety. Worker training should include:
1. OSHA requirements for confined spaces. All dairy plants should have a confined
spaces plan in effect to allow access by employees to confined spaces, when necessary to
observe the cleaning, filling, emptying or other matters related to the operation of the
dairy plant.
2. OSHA rules on injury protection. Installation of guards, shields and other devices will
protect dairy plant personnel from injury. Use of hearing protection in areas of the plant
with high levels of operational noise will reduce hearing-related injury.
3. Interior air quality requirements. Adequate ventilation and proper storage of chemicals
will prevent unnecessary airborne exposure to hazardous materials.
For more information see the IDFA manuals on EPA and OSHA regulations.
VI. ENVIRONMENTAL AND PROCESSING EQUIPMENT HYGIENE
Dairy plants should have a part of the prerequisite program that addresses interior facility
cleaning, processing equipment cleaning and sanitation and pest control. These areas should be
controlled, checked, and documented. See the report in this manual titled "Recommended Guidelines for
Controlling Environmental and Product Contamination in Dairy Plants" for more specific details
regarding environmental and processing equipment hygiene. Recommended parts of this report that
apply to this item include:
 Post-pasteurization Contamination
 Airborne Contamination
 Plant Environment
A. Manufacturing Controls
Special attention should be given to cleaning and sanitation of all conveyor track and belt
systems throughout the plant. These have been demonstrated to be difficult to keep clean and
free from pathogenic organisms. These items of equipment should be cared for on a routine
schedule during plant cleanup (not during production runs when product and/or product contact
surfaces are exposed to the cleanup).
Floor drains should be frequently cleaned and periodically flushed with a sanitizing
solution. Floor drain covers and baskets should be removed from the production area, cleaned,
and sanitized after each production run. Under no circumstances should high pressure hoses be
used to clean drains. Note - Use of high pressure hoses may create aerosols which carry
49 September 2009
pathogenic organisms onto exposed product or product contact surfaces. Floors and drains should
be maintained to insure proper drainage. Consideration should be given to relocating drains away
from open product areas, and they must be accessible for cleaning and maintenance. A routine
cleaning, sanitizing, and inspection program should be established for casers, stackers, the
underside of equipment, and utility equipment such as parts tables, can dollies, etc. Use of hot
water in processing areas during production should be minimized to prevent the formation of
condensate while product is exposed. Condensate forms on cold surfaces in the presence of high
humidity, which is found in many dairy processing areas. Impervious materials such as tile,
metal, sealed cement, etc. should be used whenever possible to minimize harborages for
pathogenic microorganisms.
VII. CLEANING AND SANITATION
A. Interior Facility Cleaning
A written interior facility cleaning program should include the specific task, the
frequency, the person(s) responsible and a documentation system to record the completion of the
task. More details on the step-by-step procedures involved in completing the task should not be
incorporated into the prerequisite program, but may be documented in the plant’s SOP records.
The general housekeeping and the special sanitation procedures carried out during
cleaning operations may be specified by shift. (e.g., mid-shift cleanup).
The interior facility cleaning program should address cleaning of the floors, walls,
ceilings, lighting fixtures, overhead structures, drains, refrigeration units and non-processing
equipment external surfaces in the receiving, storage, processing, packaging and finished product
storage areas of a dairy processing plant.
A record of the effectiveness of an interior facility cleaning program can be developed

using ATP bioluminescence swabbing, microbiological swabbing or a visual review. The results
of any check methods should be recorded with information on the location, observation/result and
the person conducting the review.
B. Processing Equipment Cleaning and Sanitation

* This is a mandatory PP (#2- condition and cleanliness of the food contact surface) under
the NCIMS HACCP Program.
The cleaning and sanitation program should outline the methods to be used to achieve the
desired level of processing equipment cleanliness and microbiological safety. Cleaning and
sanitation procedures should be developed for processing equipment, utensils, and anything else
impacting on the safety of the food.
A processing equipment cleaning and sanitation program should include the following
information for each piece of processing equipment and utensil:
1. Brief description of the task.
2. Responsible individual.
3. Chemicals used.
4. Frequency.
5. Expected results.
6. Method of documentation.
50 September 2009
The specific step-by-step details of how a particular cleaning or sanitizing task is to be
accomplished should not be included in the prerequisite program documentation, but may be
found in a plant’s SOP program. Some examples of this information are:
• Special instructions for cleaning specific equipment.

• Cleaning equipment that is to be used, along with detailed instructions for its proper
operation (e.g., pressure, volume, etc.);
• Cleaner/sanitizer details including brand name, supplier representative, dilution and
use information, contact time, pH, foam consistency, manual preparation (scrubbing,
if necessary), etc.
• Pre-rinse and final rinse instructions.
• Sanitizing instructions, commercial and generic names, dilution factor, pH,
temperature, contact time.
• Safety instructions for products (MSDS information).
Processing equipment and utensils should be cleaned at the end of each day’s run and
sanitized immediately prior to the next use. Dairy plants interested in extending cleaning and
sanitizing cycles beyond the end of each day’s run may provide information to document the
safety of this procedure and its impact on the finished dairy product to the state regulatory agency
for review and acceptance.
Processing equipment and utensils that have been cleaned should be visually reviewed on
a routine basis to determine whether it is free of residue and foreign material before being used.
Processing equipment and utensils that have been sanitized can be checked by testing and
recording the sanitizer strength. ATP bioluminescence testing is another method used to
determine the effectiveness of an equipment sanitation program by swabbing product contact
surface to determine whether soil is present. If used to determine sanitation effectiveness, the
expected result and the actual results should be recorded for comparison by assigned personnel.
Clean-In-Place (CIP) cleaning and sanitizing systems may be segregated in such a way
that there are separate systems for processing equipment handling raw and pasteurized dairy
products and ingredients. These systems should be properly maintained with automated or
manual recording systems in place to document chemical strength, water temperature, water
pressures, and cycle time.
Hand-cleaned or Cleaned Out-of-Place (COP) systems require processing equipment

disassembly for cleaning, review, and sanitizing. These systems should utilize manual written
logs to document the specific pieces of processing equipment and utensils that were cleaned and
sanitized.
C. Pest Control
* This is a mandatory PP (#8-exclusion of pests) under the NCIMS HACCP Program.
Dairy plants should have a written, effective, and safe pest control program. The facility
should be constructed and maintained to exclude the entrance of birds, rodents and other animals.
A written pest control program should include:
• The name of a contact person and the extermination company responsible for pest
control.
51 September 2009
• The name of the plant employee responsible for the pest control program.
• Documentation of the list of extermination chemicals, traps and methods used.
• A map or location diagram of all bait and trap locations.
• The frequency of treatment and review of bait and trap locations.
• A overview report including the pest survey and control reports.
• MSDS sheets for chemicals used.
• Documentation of insurance, and licenses of persons applying pesticides and other
restricted use chemicals.
Chemicals under the plant’s control should be used according to manufacturers’

instructions and are appropriate for their intended use. Pest control chemicals must be stored and
used in a manner to prevent contamination of raw materials, ingredients, packaging and the
finished product.
Adherence to the written pest control program should be monitored and recorded.
Validation and verification of the pest control program is completed during on-site reviews of
areas for the presence of insect and rodent activity. Records of all monitoring results,
recommendations, and action taken should be maintained.
VII. TRACEABILITY AND RECALL1
The recall program should outline the procedures to be implemented in the event of a recall. The
objective of a written recall procedure is to ensure that an identified food is removed from the market as
efficiently, rapidly, and as completely as possible. A recall procedure should be written recognizing that
it can be put into operation at any time. The procedure should be tested to verify and validate its
effectiveness and include a recall effectiveness program.
A. Traceability
Every dairy plant that produces finished dairy products or sells bulk dairy products for
further processing should develop or have in place a system to trace products back through the
processing and distribution system to the point of origin as a raw ingredient. This system may
identify and separate product by runs, time of day, processing equipment used or other means to
segregate it from similar product processed on the same day.
Managing and organizing consumer complaints can be one method of evaluating product
problems and can serve as an early warning system for an effective recall program. How a
consumer complaints system is to be used may be specified in the prerequisite program on
product recalls, however, it is not necessary to include details on the consumer complaint system
or individual consumer complaint records. This information may be part of a plant's SOP
program.
B. Recall System
Every manufacturer of a food product should maintain a system of control that permits a
complete and rapid recall of any dairy product. The written recall procedure should include the
following:
1
See IDFA’s “FDA Inspection Manual” for additional information and guidance on recall programs.
52 September 2009
• Documentation pertaining to the product coding system. All products need to be
identified with a production date or code identifying each lot. Sufficient coding of product
should be developed, used, and explained in the written recall program to permit positive
identification and to facilitate an effective recall.
• Finished product distribution records should be maintained for a period of time that
exceeds the shelf-life of the product. Records need to be adequately designed, maintained
and easily accessible to facilitate the location of product in the event of a recall.
• Complaint files should be referenced in the recall program, but not included in detail.
Records documenting all related complaints and action taken should be maintained up-to-
date.
• Responsible individuals who will be part of the recall team should be specifically
identified along with their respective business and home telephone numbers. For each
individual, an alternate should be designated to act on their behalf in case of unavailability.
The roles and responsibilities of every member of the recall team should be clearly defined.
• The step by step procedures to follow in the event of a recall should be described. These
procedures will include the extent and the depth of the recall (i.e., consumer, retailer, or
wholesaler level) according to the recall classification, which may be self imposed or
determined by the state or federal regulators. Recall levels established by FDA are listed
below.
Class I: Reasonable probability that use of or exposure to violative product will cause
serious adverse health consequences or death.
Class II: Temporary or medically reversible adverse health consequences and in which
the probability of serious adverse health consequences is remote.
Class III: Consumption of or exposure to a product is not likely to cause adverse health
consequences.
• Means of notifying the affected customers in a manner appropriate to the type of hazard
should be clearly stated. The channels of communication (fax, telephone, radio, letter, email,
company website, or other means) to be used for trace-back and recovery of all affected
products should also be identified. Typical messages directed to consumers, retailers, or
wholesalers according to the severity of the hazards should also be included.
• Control measures for the returned recalled food should be detailed. This includes both
returned product and product still outside the control of the processing plant. The control
measures and the disposal of the affected product should be described according to the type
of hazard involved.
• Means of assessing the progress and efficacy of the recall are necessary including written
details of the method of checking the effectiveness of the recall.
• The recall program should be periodically tested by a mock recall to determine

effectiveness.
Any dairy processor who initiates a food safety related recall of food outside of their control should notify
the regulatory agency having jurisdiction as soon as practical with the following information:
53 September 2009
• Reason for the recall.
• Recalled product identification including name, product description, packaging
identification and size, code marks or lot numbers, plant number, date of production, date of
importation or exportation if applicable, etc.;
• The amount of recalled product involved, broken down as follows:
1. Total quantity of the recalled food originally produced.

2. Total quantity distributed at the time of the recall.
3. Total quantity remaining in the company's control.
4. Likely geographic areas of distribution, by areas, cities, states, and country (if
exported), along with retailers' and wholesalers' names and addresses.
• Information on any other product which could be affected by the same hazard.
VIII. CROSS-CONTAMINATION PREVENTION
Dairy plants should develop a cross-contamination prevention program as an important part of

their prerequisite program. Product flow should be established to prevent contamination of raw
materials, ingredients, packaging and the finished dairy product through physical, time or operational
separation. Plants should provide physical and operational separation of incompatible processing steps.
Some examples include case washing, ingredient, product and packaging dry storage, product returns,
etc.
Living quarters and areas where animals are kept should be completely separated from and not
open directly into areas where raw materials, ingredients, packaging materials or finished dairy products
are being handled, stored, processed or packaged.
A. Allergens
* This is a mandatory PP (#5-protection from adulteration) under the NCIMS HACCP
Program.
An allergen control program is an important part of any dairy plant’s prerequisite program. The
key to the use of allergens as ingredients in dairy products is that they must be handled, stored
and used in a manner that prevents unintended addition to these products that do not indicate their
presence on the label. The real public health difficulty for consumers occurs when this labeling is
not in place.
An allergen control program should include a listing of all allergens (other than of dairy
origin) to be used or might find their way into finished dairy products. This list should include
those allergens present in ingredients used in alternate formulations. In addition, the finished
dairy products that intentionally contain allergens, based on their formulation should be listed and
the ingredient label should be listed as well to make sure it properly lists the allergen. Details
should also include the storage location, method of addition to the juice beverage and disposal
plan for excess allergenic ingredients.
Food allergies and sensitivities can be collectively referred to as “individualistic adverse

reactions” to foods. These food-related illnesses are individualistic because they usually affect
only a small percentage of the population: most of us can eat the same foods with no ill effects.
Often, these diseases are grouped together under the general designation of “food allergies,” but it
must be recognized that this term covers a host of different health conditions. In fact, true food
54 September 2009
allergies represent only a fraction of the individualistic adverse reactions to foods. Part of the
information listed below was taken from a “Food Allergies and Sensitivities: A Scientific Status
Summary of the Institute of Food Technologists’ Expert Panel on Food Safety & Nutrition.”
Definitions:
Allergy-Like Food Intoxication: An adverse reaction to a food or food component occurring

as a result of the ingestion of chemical mediators of allergic disease. The only example of
this type of reaction is histamine poisoning, also known as “scombroid fish poisoning,” which
is most commonly associated with the consumption of spoiled tuna, mackerel, mahi-mahi,
and other fish.
Anaphylactoid Reaction: An adverse reaction to a food or food component caused by eating

substances that will release from the body’s cellular stores the chemical mediators (or
“triggers”) of allergic reactions, such as histamine (but without the interaction with IgE that
occurs in food anaphylaxis). Several foods, including strawberries, shellfish, and chocolate,
can allegedly induce such reactions.
Food Allergy: An adverse reaction to a food or food component (usually a protein) involving
reactions of the body’s immune system (immunological reactions). The term “food allergy”
should only be used to identify true, immunologically based allergies such as allergic
reactions to cow’s milk, eggs and peanuts.
- Type I Allergies – Also known as food anaphylaxis. Reactions usually occur within a few
minutes to several hours after consumption of the offending food.
- Type II and Type III Allergies – Neither of these have been associated with food.
- Type IV Allergies – Generally includes the delayed (over hours rather than minutes)
hypersensitivity-type allergic responses. Also called “cellular hypersensitivity” and generally
involves the reaction of certain sensitized cells, usually lymphocytes, to the specific chemical
substance (allergen) that triggers the allergic reaction.
Food Idiosyncrasy: An adverse reaction to a food or food component that occurs through
unknown mechanisms which even include psychosomatic illnesses. Examples would include
sulfite-induced asthma, tatrazine (a yellow dye #5 ingredient)-induced asthma, Chinese
Restaurant Syndrome, food associated migraine headache, and a variety of other illnesses.
Food Sensitivity: Individualistic adverse reactions to foods. The most common types of
food sensitivities include lactose intolerance and celiac disease (inherited, autoimmune
disease in which the lining of the small intestine is damaged from eating gluten and other
proteins found in wheat, barley, rye, and possibly oats.)
Metabolic Food Reaction: An adverse reaction to a food or food component that results
from a defect in metabolism (the processes by which a substance is handled in the body).
These reactions have also been called “food intolerances.” An example would be lactose
intolerance.
Nonallergic Food Reactions: Individualistic adverse reactions to food that does not involve
the immune system.
Secondary Food Sensitivity: An adverse reaction to a food or food component that occurs
with or after the effects of other conditions. Examples would include lactose intolerance
55 September 2009
secondary to gastrointestinal disorders (such as Crohn’s disease or ulcerative colitis) and
drug-induced sensitivities.
The food allergens listed below may produce serious allergenic reactions in susceptible
individuals.
1. Egg and egg products (Egg and egg products may be components of other materials such
as mayonnaise, meringue, and ovalbumin).
2. Milk and milk products (milk and milk products may be components of other materials
such as butter, buttermilk casein, cheese, cottage cheese, curds & whey, lactoglobulin,
malted milk, some margarines, milk chocolate, cream, custard, ice cream, nougat,
pudding, sodium caseinate, sour cream yogurt).
3. Peanut and peanut products (including peanut butter).
4. Tree Nuts (specifically brazil nut, walnut, hazelnut, filbert, cashew, almond, pine nut
(piñon, pinyon), pistachio, pecan, macadamia nut. Each type of tree nut should be
considered as an allergen distinct from the other listed tree nut allergens.
5. Fish (specific species are more likely than others to trigger an allergic reaction, i.e. cod)
6. Crustaceans not generally including bi-valves (specifically shrimp, crab, lobster, oyster,
scallop, crayfish, clam).
7. Soybean and soy bean-based products (soy bean and soy-bean based products may be
components of other materials such as meats containing soy-derived “vegetable protein”
or “textured vegetable protein”, miso, and tofu).
8. Wheat and wheat products (wheat and wheat products may be components of other
materials such as bran, bread crumbs, cereal extracts, cracker meal, farina, graham flour,
malt, wheat flour, wheat germ, wheat gluten, wheat starch).
Allergen Control Strategies: Food allergies and sensitivities can be best controlled by avoiding
the use of the allergen as an ingredient. If this is not possible, then all food ingredients that are
known allergens or cause a food allergy or sensitivity in humans must be stored, handled, used
and labeled in a manner to prevent contamination with other dairy and food products. Since
people with food allergies and sensitivities rely on food ingredient labels to protect themselves,
all ingredients in dairy products must be accurately listed by name in the food product ingredient
statement.
1. Food Labels: Dairy products may contain food allergens if the allergen is properly
identified on the ingredient statement. Compare the ingredient labels and the finished
packaged food label for the presence of allergens. Food products shall accurately and
completely list all allergenic foods by name in the ingredient statement.
2. Good Manufacturing Practices: All individuals involved with the receipt, storage, use,
processing and distribution of dairy products containing allergens should receive training
and be aware of the potential problems allergens may cause as well as specific
recommendations on the prevention of cross-contamination. Some suggested allergen
control practices include:
 Do not reclaim or rework any products that contain or may contain allergens into a
product that does not contain the exact same allergen.
 Products that contain allergens should be segregated and only reworked into products
containing exactly the same allergenic ingredients.
56 September 2009
 Fully investigate and document substitutions of ingredients that could result in an
inaccurate ingredient declaration on the package.
 Compare the ingredient labels and the finished packaged food label for the presence of
allergens. Be sure that any food allergen is listed accurately, by its specific name, on
the finished product label.
 Schedule products containing allergens to be processed and packaged last.
 Do not attempt to strain allergens from food for rework or reclaim. Straining nuts or nut
products from rework does not remove the allergenic substance (normally a protein)
from the food. Egg protein is impossible to filter or strain from dairy products.
 After running an allergen-containing product, the system must be cleaned,

documented and viewed directly to ensure that no allergens remain or cross-
contamination can occur.
B. General Adulteration
*This is a mandatory PP (#5-protection from adulteration) under the NCIMS HACCP
Program.
Adulteration of a juice beverage product refers to contamination of the product by a

physical or chemical hazard that could render the final product unsafe. Some of the more
common physical or chemical hazards that could cause adulteration in a juice product during
processing include:
 Water, sweet water or glycol
 Cleaning and/or sanitizing chemicals
 Metal and/or rubber shavings
 Undeclared allergens
 Undeclared ingredients
Adulteration prevention strategies include review of liquid piping to insure that the juice
beverage is not being adulterated by other liquids, cleaners or sanitizers; adequate process control
to prevent the addition of unintended ingredients including allergens and proper scheduling of
product runs to prevent any type of adulteration.
A thorough check should be made of sweet water and glycol systems. A scheduled
review program should be initiated to assure that they are properly protected and do not contain
harmful organisms. Any equipment, such as storage tanks, jacketed vessels, etc., that utilize
sweet water or glycol solutions should continue to be monitored periodically for leaks and cracks.
Contamination of product can be caused by contaminated sweet water and leaking plates.
It is important that all piping circuits be designed to eliminate trapping of washing or

sanitizing solutions or allowing product to collect during the operating day. The drain line must
be kept free, or have provisions to be kept free of solution or product except during use. All
piping circuits must be reviewed for potential problems. It is equally important to routinely
monitor for any possible cross-connections. Dairy plants should be evaluated for conditions such
as direct piping connections between pasteurized milk and raw milk lines, product to CIP circuits,
or pasteurized product to other potentially hazardous circuits. Blueprints should be reviewed on a
periodic basis and updated to reflect existing piping arrangements. This can only be
57 September 2009
accomplished by "walking" the blueprints through the plant and physically ensuring the
blueprints are accurate. Internal plant controls are needed to prevent any piping changes without
prior review by qualified authorities (plant management and/or regulatory agencies).
Reclaiming operations, by their very nature, are high risk enterprises which can result in
adulterated product and put the whole company in jeopardy if not carried out judiciously. Care
should be exercised to prevent reclaimed product from being inadvertently pumped through the
same lines as pasteurized product without cleaning and sanitizing the lines between uses. Other
reclaiming operations which are fraught with danger include:
 Not pasteurizing reclaimed or reworked product before reuse.

 Reuse of product which has been in distribution channels and may have been subjected to
temperature-abuse, tampered with, or exposed to chemical or biological contamination.
 Product in damaged containers where container integrity may have been compromised, or
when the outside of the container may be contaminated.
 Product that is beyond the normal shelf life. This product could contain microorganisms
which are capable of reproducing during refrigerated storage.
 Scrap or rework product which is handled differently from normal production (e.g., start up
and change over scrap, underweights, package/wrapper problems, product involved in line
jam-ups etc., that is held at elevated temperatures in barrels or buckets, then reworked back
into the product).
C. Cross-Contamination
*This is a mandatory SSOP (#3-prevention of cross-contamination) under the NCIMS
HACCP program.
Cross-contamination is understood to be the contamination of a juice beverage with a

microbiological hazard that could render the final product unsafe. This can occur in a number of
ways during processing. The most common cross-contamination problems are contact with
unclean processing equipment (see Prerequisite VI), mixing with pasteurized product with raw
product, or contamination from the processing environment.
Cracks and crevices in silo tanks, leaking valves, agitator shafts, shielding, and venting
are all areas where harmful organisms can be found. Improper welds and similar irregular
surfaces which can lead to inadequate cleaning and sanitizing should have been eliminated.
These areas should be monitored on a scheduled basis.
Processors should attempt to minimize the amount of handling, exposure to the plant
environment, and time/temperature abuse of the product after pasteurization (i.e., holding at
elevated temperatures for extended periods of time). This can be accomplished by keeping the
number of processing steps and storage time to the minimum following pasteurization.
The use of absorbent items, such as rags and sponges, should be eliminated to reduce
potential harborage and spreading of microorganisms in the plant environment. The use of
brushes should be segregated (i.e., using different brushes for internal and external surfaces).
Brushes should be maintained in good repair and properly stored when not in use and sanitized
between uses. Use of impervious materials (i.e., plastic or metal) is recommended. The use of
porous equipment, such as wooden handled tools, brushes, paddles, sponges, cloth, etc., should
not be used in production areas.
58 September 2009
Environmental contamination of product and product contact surfaces should be minimized at all
times (e.g., ice cream novelty lines and certain cheese processes tend to create a higher degree of
product exposure to both airborne and condensate contamination than many other product lines).
Exposure to these hazards may be minimized by using additional care and shielding.
Filling/packaging operations are other areas where product contamination can also occur.
Mandrels, drip shields, bottom and top breakers, prefilling coding equipment, deflector bars,
cutting blades and extruder heads, drain tables, box molders, brine tanks, and chill tanks are
critical areas where environmental contamination may occur. Overhead shielding, conveyors,
conveyor belts, chain rollers, supports, and lubricants should be constantly monitored. It is
important to incorporate a routine cleaning and sanitizing regimen for all conveyors. Blow
molding operations and handling of packaging materials need to be examined on a routine basis,
particularly where open containers/jugs are conveyed through non-processing areas.
Any product that has been mishandled, not protected from contamination, or which has
not been maintained at a temperature of 45F or less, should be discarded. External container
contamination may lead to product contamination. Breaking or slashing containers over a vat or
horn for reprocessing may introduce contamination into your product. This process should be
reviewed to eliminate potential hazards.
It is essential that if the product is to be reclaimed that proper holding temperatures and
sanitary practices, including container handling, be exercised. Repasteurization of all reclaimed
products is necessary and higher temperatures and/or longer holding times should be used.
Products returned from stores and outdated products which are being returned to the dairy plant
for disposal should be isolated from all other plant operations. Precautions should be taken to
prevent these areas from serving as a source of contamination. All equipment (i.e., tanks, pumps,
pipelines, etc.) used in this reclaiming operation should be constructed so they may be cleaned
and sanitized daily. The practice of reclaiming product should be seriously evaluated, in view
of the potential for product contamination.
Airborne contamination may act as a vehicle for allowing pathogenic organisms to enter
the production area. A comprehensive assessment of both processing and ventilating air utilized
within the plant should have been conducted. Heating, ventilating, and air conditioning (HVAC)
systems should be designed for easy cleaning and should be periodically cleaned. Condensate
drip pans and drain lines should be checked periodically to assure they are not providing
favorable environments for the growth of harmful organisms. It is recommended that dairy plants
assess the adequacy of their protective shielding. This assessment should include all product
contact surfaces as well as exposed product to assure they are not subject to possible
contamination by condensate, aerosols, dust, or other airborne contaminates. Air systems in
refrigerated areas should also be designed for easy cleaning and should be periodically cleaned.
HVAC systems should be properly designed and adjusted to maintain positive pressure in
areas where product is exposed (e.g., batching operations, filling, packaging). Air transfer from
potentially contaminated areas (e.g., raw product receiving, ingredient and supply storage) to
processing or packaging areas should be minimized.
Outside air should be filtered and free of condensate. Air flow should be determined and
controlled to eliminate direct blowing onto product, product contact surfaces, or filling and
packaging areas. Air filters must be of the type effective in preventing the passage of
microorganisms. Filters must be kept clean and replaced according to an established maintenance
schedule.
59 September 2009
Processing systems which incorporate air directly into the product, (e.g., frozen desserts)
must be designed to reduce potential contamination and must be easily cleanable. Process air
systems should contain appropriate filters to remove extraneous matter. Sanitary check valves
should be provided as necessary to prevent product backup into air lines. Air blow and agitation
equipment should be checked. Most air blow and agitation equipment is not satisfactorily
cleaned by usual CIP methods and should, therefore, be dismantled, manually cleaned, and
sanitized daily.
60 September 2009
Company Name: Prerequisite Program #
Company Address:
Prerequisite Program Name:
Date: Supersedes:
Prerequisite Work Sheet

1. Purpose (one to two
sentences)
2. Procedure - brief 1.
2.
description 3.
4.
Summary of Required Monitoring Documentation:
Verification (Who & Retention (Where &
Monitor (What & Who) Monitoring Frequency Monitoring Document Frequency) How Long)
Procedure #1
Procedure #2
Procedure #3
Procedure #4
Corrections:
61 September 2009
PREREQUISITE EXAMPLES AND FORMS
Prerequisite Program #1 Plant Name:
Safety of the water that comes into contact with Issue Date:
food or food contact surfaces including steam. Supersedes:
Approved by:
EXAMPLE
PURPOSE:
 Water for milk plant purposes, including recirculated cooling water, shall be from a system that is properly
constructed, protected and operated, and shall be accessible, adequate and of a safe sanitary quality.
 Whenever steam is used in contact with milk or milk products, it shall be of culinary quality with the use of
acceptable additives, as necessary.
Note: The Grade A Pasteurized Milk Ordinance (PMO) provides guidance for water as well as steam. The
administrative procedures will provide appropriate guidance for establishing specific procedures. The PMO also
provides guidance for construction and operation of water systems, recirculated cooling water systems and systems
used to generate culinary steam.
PROCEDURE SUMMARY:
1) Municipal Water
a) Test back-flow preventers annually by approved outside service.
b) Semi-annual testing for total coliform at corporate testing laboratory.
c) Review of plant water distribution system on an annual basis or after major changes to the system.
d) Quarterly testing for coliform of municipal water at source within the production environment.
2) Captive (Sweet) Water

a) Semi-annual testing for total aerobic plate count and total coliform by state.
b) Weekly testing for total aerobic plate count and total coliform by onsite laboratory.
c) Weekly testing of chlorine level, additions as needed.
d) Letter of continuous guarantee from supplier that captive water additives are of food grade quality.
3) Glycol
a) Semi-annual testing for total aerobic plate count and total coliform by state.
b) Monthly testing for total aerobic plate count and total coliform by onsite laboratory.
c) Letter of continuous guarantee from supplier that glycol additives are of food grade quality.
4) Boiler / Steam
a) Letter of continuous guarantee from supplier that boiler additives are of food grade quality.
b) Chemical Additive monitoring by chemical supplier representative.
5) Central Sanitizer System

a) Semi-annual testing for total aerobic plate count and total coliform at source.
RECORDS:
1) Municipal Water
a) Back-flow preventer inspection report located in Maintenance Engineer’s file.
b) Testing report provided by corporate lab and located in Quality Assurance Manager’s file.
c) Plant water distribution system review located in Quality Assurance Manager’s file.
d) Testing results available within the electronic system under “Plant Water” category.

a) State testing report located in onsite laboratory.
b) Onsite microbiological testing results located within the electronic system under “Plant Water” category.
c) Onsite chemical testing results located within the electronic system under “Plant Water” category.
d) Letter of continuous guarantee located in Quality Assurance Manager’s file.
62 September 2009
3) Glycol
a) State testing report located in onsite laboratory.
b) Onsite microbiological testing results located within the electronic system under “Plant Water” category.
c) Letter of continuous guarantee located in Quality Assurance Manager’s file.
4) Boiler / Steam
a) Letter of continuous guarantee located in Quality Assurance Manager’s file.
b) Chemical Additive representative service report located in Maintenance Engineer’s file.

a) Onsite microbiological testing results located within the electronic system under “Plant Water” category.
CORRECTIONS:
1) Municipal Water
a) Outside service to replace or repair back-flow preventer.
b) Resample and retest, if 2nd test fails investigate possible sources of contamination and notify municipality.
c) Make necessary changes.
d) Clean and sanitize or replace sampled source, retest.

a) Investigate source tank, review chemical concentrations and retest at onsite laboratory. Ensure timely regulatory
resampling.
b) Investigate source tank, review chemical concentrations and retest at onsite laboratory.
c) Review chemical concentration and make necessary changes.
d) Request letter from supplier.
3) Glycol
a) Investigate source tank, review chemical concentrations and retest at onsite laboratory. Ensure timely regulatory
resampling.
b) Investigate source tank and retest at onsite laboratory.
c) Request letter from supplier.
4) Boiler / Steam
a) Request letter from supplier.
b) Chemical representative makes changes as necessary.

a) Investigate, clean and sanitize or replace sampled source, retest.
Monitoring Monitoring Verification-Who Retention-Where

Monitor-What Monitor-Who Frequency Document & Frequency and How Long
Back-Flow Approved outside Semi-annual Back-flow Maintenance Maintenance
Preventer service preventer Engineer – semi- Engineer’s File –
inspection report annually 2 years
Municipal water Corporate testing Semi-annual Electronic Quality Assurance Quality Assurance
total coliform lab System, Manager – semi- manager’s File – 2
testing RBOLI21 report annually years
Plant water HACCP team Annual, or Plant water HACCP team – Quality Assurance
distribution system member, after major distribution annually manager’s File – 2
review Maintenance changes system review years
Engineer
Plant water source Laboratory Quarterly Electronic Quality Assurance Electronic System
testing Technicians System Supervisor – – 2 years
monthly
63 September 2009
State captive water State Semi-annual State captive Quality Assurance Laboratory File –
testing water testing Manager – semi- 2 years
report annual
Onsite captive Laboratory Weekly Electronic Quality Assurance Electronic System
water Technicians System Supervisor - – 2 years
microbiological monthly
testing
Onsite captive Laboratory Weekly Electronic Quality Assurance Electronic System
water chemical Technicians System Supervisor – – 2 years
testing monthly
Captive water Quality Assurance Annual, or Letter of Quality Assurance Quality Assurance
additive letter of Manager after changes continuous Supervisor – manager’s File – 2
continuous guarantee annually years
guarantee
State Glycol testing State Semi-annual State Glycol Quality Assurance Laboratory File –
testing report Manager semi- 2 years
annually
Onsite glycol Laboratory Weekly Electronic Quality Assurance Electronic System
microbiological Technicians System Supervisor – – 2 years
testing monthly
Glycol additive Quality Assurance Annual, or Letter of Quality Assurance Quality Assurance
letter of continuous Manager after changes continuous Supervisor – manager’s File – 2
guarantee guarantee annually years
Boiler additive Quality Assurance Annual, or Letter of Quality Assurance Quality Assurance
letter of continuous Manager after changes continuous Supervisor – manager’s File – 2
guarantee guarantee annually years
Onsite boiler Chemical Semi-annually Service Report Maintenance Maintenance
chemical testing Representative or more Engineer – annually Engineer’s File –
frequently if 2 years
needed
Onsite central Laboratory Semi-annual Electronic Quality Assurance Electronic System
sanitizer system Technicians System Supervisor – semi- – 2 years
microbiological annually
testing
64 September 2009
Condition and Cleanliness of Food Contact Issue Date:
Supersedes:
Surfaces. EXAMPLE Approved by:
PURPOSE:
 All food contact surfaces shall be properly designed, constructed and maintained to facilitate proper sanitation.
 All food contact surfaces shall be adequately and routinely cleaned and sanitized with chemicals approved for
food contact use.
Note: The Grade A Pasteurized Milk Ordinance (PMO) provides guidance for the condition and cleanliness of food
contact surfaces. The administrative procedures will provide appropriate guidance for establishing specific
procedures.
PROCEDURE SUMMARY:
6) Construction
a) Process change control review of equipment prior to use or when a process change is made.
b) Regulatory, third party and internal audits of equipment.
7) Cleanliness and Sanitation

a) Cleaning procedures (SSOP’s) for equipment
b) Preoperational Cleaning Verification
i) Fillers – Preoperational inspection, CIP chart
ii) HTST – Start up check list, CIP chart
iii) Tanks – Preoperational inspection, CIP chart
iv) Line Systems – CIP chart, verification of time and temperature
c) Cleaning Systems for Product Contact Surfaces
i) Chemical concentration check of CIP systems
ii) Periodic review of operation by chemical supplier representative
iii) Chemical concentration, time and temperature check of COP system
RECORDS:
6) Construction
a) Process change control form located in Quality Assurance Managers office.
b) Inspection reports and corrective action located in task keeper database, available on corporate computer network.

a) Daily cleaning checklist located in production office and SSOP’s available in online SSOP system located on plant
computer network
i) Preoperational inspection report located in production office. CIP charts located in production office.
ii) HTST start-up checklist located in production office. CIP chart located in production office.
iii) Preoperational checklist located in production office. CIP chart located in production office.
iv) CIP chart located in production office.
c) Cleaning Systems for Product Contact Surfaces
i) CIP System chemical concentration logs located in Sanitation Supervisors office. Current month’s records kept at
CIP systems.
ii) Chemical supplier representative’s CIP Vessel Performance Report kept electronically on plant computer network.
iii) Temperature recording chart and chemical concentration log located in production office.
CORRECTIONS:
1) Construction
65 September 2009
a) Make necessary changes as determined by process control review.
b) Make necessary changes as mandated by regulatory, third party and internal audits.

a) Supervisor verifies cleaning tasks were completed by the responsible operator. If unable to verify completion,
unconfirmed tasks will be completed.
i) Fillers – Failed preoperational inspection items cleaned until passes re-inspection. CIP Chart – Investigate and take
appropriate action, which may include rewashing of equipment, to verify equipment cleanliness.
ii) HTST – Failed start-up check list items (as relating to cleanliness of equipment) meets check list requirements. CIP
Chart - Investigate and take appropriate action, which may include rewashing of equipment, to verify equipment
cleanliness.
iii) Tanks - Failed preoperational inspection items cleaned until passes re-inspection. CIP Chart – Investigate and take
appropriate action, which may include rewashing of equipment, to verify equipment cleanliness.
iv) Line Systems - Investigate and take appropriate action, which may include rewashing of equipment, to verify
equipment cleanliness.
c) Cleaning Systems
i) Adjust chemical concentration to desired range and take appropriate action, which may include rewashing of
equipment, to verify equipment cleanliness.
ii) Review report and take appropriate action to maintain cleaning effectiveness.
iii) Investigate and take appropriate action, which may include rewashing of equipment, to verify equipment cleanliness.
Monitoring Verification-Who & Retention-Where

Monitor-What Monitor-Who Frequency Monitoring Frequency and How Long
Document
Process Change Plant Operations Prior to use or Process Change Quality Assurance Quality Assurance
Control Manager when a process Control Form Manager – weekly Managers office – 2
change is made years
Audits of Regulatory, third Regulatory – Inspection reports, Quality Assurance Task Keeper
equipment party and quality Quarterly corrective action Manager – quarterly database – 2 years
assurance Third Party – reports for all available
Annually records
Quality Assurance
– Monthly
Cleaning Production Every day of use Daily cleaning Quality Assurance Production Office,
procedures for Employee’s checklist, SSOP’s Department – weekly Online SSOP system
equipment – 2 years
Preoperational Quality Assurance Every day of use Preoperational Sanitation Supervisor Sanitation
inspection - Fillers Department, inspection report, – weekly Supervisors Office,
Production CIP chart Production Office –
Supervisor 2 years
Preoperational HTST Operator Every day of use HTST start-up Quality Assurance Production Office –
inspection – HTST checklist, CIP Manager – weekly 2 years
chart
Preoperational Production Every day of use Preoperational Sanitation Supervisor Production Office –
inspection – Tanks Employee’s inspection report, – weekly 2 years
CIP chart
Preoperational Production Every day of use CIP chart Sanitation Supervisor Production Office –
inspection – Line Employee’s – weekly 2 years
Systems
Chemical Production Every day of use CIP System Sanitation Supervisor CIP System,
concentration Employee’s chemical – weekly Production Office –
check of CIP concentration log 2 years
systems
66 September 2009
Monitoring Verification-Who & Retention-Where
Monitor-What Monitor-Who Frequency Monitoring Frequency and How Long
Document
Review of CIP Chemical Supplier Annually CIP Vessel Sanitation Supervisor Stored electronically
system Representative Performance – annually on network – 2 years
Report
Chemical Production Every day of use Temperature Sanitation Production Office –
concentration, time Employee’s recording chart and Supervisor- annually 2 years
and temperature chemical
check of COP concentration log
system
67 September 2009
Product Temperature Management Program Issue Date:
Supersedes:
EXAMPLE Approved by:
Goal: To have adequate means of establishing, maintaining and monitoring temperatures of:
 Raw materials/ingredients used in production.
 Finished product to ensure safe storage of the food.
 Distributed products.
Procedures:
1. Raw materials/ingredients temperature control.
a. Monitoring – Silo Storage Temperature Recording Charts
b. Monitoring – Incoming Milk Temperature Log
2. Finished Product Temperature Control

a. Monitoring – Finished Product Temperature Recording Charts.
b. Monitoring – Pasteurization Recording Charts
c. Other documentation – Daily Temperature Checks.
3. Pre-shipment Transport Requirements

a. Monitoring – Truck Inspection/Refrigeration Checks.

Raw materials & Production Daily 1a. Silo Temp. Production Mgr – Production Dept.
Ingredients Supervisor Charts Weekly – 1 year
Raw materials & Milk Receiver Daily 1b. Milk Production Mgr. – Production Dept.
Ingredients Receiving Temp. weekly – 1 year
Log
Finished Products Warehouse Weekly 2a. Finished Warehouse Mgr. – Warehouse Dept.
Supervisor Product Temp. Weekly – 1 year
Charts
Finished Products – Production Daily 2b. Production Mgr. – Production Dept.
in-process Supervisor Pasteurization weekly – 1 year
Temp. Charts
Finished Products - Warehouse Daily 2c. Daily Temp. Warehouse Mgr. – Warehouse Dept.
packaged Supervisor Checks Weekly – 1 year
Finished Products - Warehouse Daily 3a. Transportion Warehouse Mgr. – Warehouse Dept.
packaged Supervisor Inspection & Weekly – 1 year
Temp. Log
Corrections:
 Corrections will be taken as needed at each step and noted on the monitoring form.
 Any correction that cannot be accomplished immediately will be reported to the appropriate supervisor to assess whether
the non-conformity presents a significant weakness or has a potential impact on the ability to produce a safe product. In
addition, the supervisor will assess whether immediate short term measures are needed to minimize the effect of the
problem on our product or operation.
 Corrections that cannot be addressed immediately will be given a timeline for correction in the Scheduled Correction Log
and will be reassessed on a weekly basis.
Signature: Date
68 September 2009
Prerequisite program # 4: Old North State Milk Company
Maintenance of Hand Washing and Toilet Facilities Page 1 of 2, September 8, 2009
Example Approved by___________________
PURPOSE:
 Toilet rooms shall not open directly into any room in which milk/milk products are processed. Toilet
rooms shall be completely enclosed and shall have tight-fitting, self-closing doors. Dressing rooms,
toilet rooms and fixtures shall be kept in a clean condition, in good repair and shall be well ventilated
and well lighted. Sewage and other liquid wastes shall be disposed of in a sanitary manner (from PMO
item 6p)
 Convenient hand washing facilities shall be provided, including hot and cold running water and or
warm water, soap and individual sanitary towels. Hand washing facilities shall be kept clean and in
good repair (from PMO Item 8p).
(Note: This is an example of how the PMO can be used to provide guidance for the prerequisite program.
In this situation, the PMO is referenced, but what we are interested in is the set of procedures we will put in
place that will be monitored and documented in the prerequisite program.)
PROCEDURE SUMMARY:
1. Restroom facilities and hand washing areas will be inspected and maintained by the last powder packer of
the shift, at the close of each shift.
2. A contract cleaning service will clean and perform scheduled maintenance on restrooms weekly.
3. Monthly plant audits will assess repair, ventilation and lighting.
4. Annual verification will assess adequacy and convenience of hand washing facilities
(Note: Prerequisite programs are broad areas of emphasis that need to have procedures established in order to
identify specific actions that are to be taken. A program may have multiple procedures that fix responsibilities
and assign frequencies.)
WHAT TO MONITOR:
1. At least once per shift the designated employee will perform the inspection of all facilities and clean and/or
maintain as needed using as a reference the checklist in PS#09951.
2. QC will check restrooms after contract cleaning before initialing the bill for payment.
3. The monthly plant audit walk-through team will assess repair, ventilation and lighting of restrooms.
4. The annual verification team will use a facilities inspection checklist and employee feedback to assess the
adequacy and convenience of hand washing stations in the work areas. The need for hand sanitizing
stations will also be assessed.
(Note: In some programs, it is difficult to separate the procedures, what to monitor and
documents and there is considerable redundancy when this format and these categories are used.
RECORDS
1. Inspection log of hand washing, toilet and sanitizing facilities (PS # 09951) to kept in Plant Supervisor’s
office when not in use. Completed documents are to be filed in Plant supervisor’s office and maintained
for a year.
2. Contract cleaning bills are submitted to Accounts Payable after initialed by QC. These are stored in the
Business Office and are maintained according to their policies.
3. The Monthly Plant Audit Form (PS#12345) includes section on restrooms-repair, ventilation, and lighting.
Forms are filed in the lab for at least two years.
69 September 2009
4. The Facilities Inspection Checklist for Annual Verification includes “Are hand washing and hand sanitizing
stations (if needed) adequate and convenient to the work areas?” Checklists are maintained in the Plant
Supervisor’s Office for two years.
(Note: The narrative nature of this section makes the identification and auditing of records
somewhat less convenient than when this material is presented in chart form as on the PP#1
example.)
Note from the above that procedures need be related to their monitoring and documentation directly in an
easy to follow manner.
CORRECTIONS:
1. Corrections will be taken as needed at each monitoring step and noted on the monitoring form.
2. Any correction that cannot be accomplished immediately will be reported to the appropriate supervisor to
assess whether the non-conformity presents a hazard, a potential impact on our ability to produce a quality
product or a legal violation. In addition the supervisor will assess whether temporary measures are needed
to minimize the effect of the non-conformity on our product or operation.
3. Corrections that cannot be addressed immediately will be given a timeline for correction in the Scheduled
Correction Log and will be reassessed at weekly supervisor’s meetings until corrected.
(Note: All corrections cannot be accomplished immediately, and some corrections have a higher
urgency than others. No identified non-conformance should be noted without a carefully
considered correction plan and a timeline to get it accomplished. Have a procedure to reassess
the timeline regularly and adjust as necessary to make sure the due date does not pass without
some action, if only to extend the timeline as necessary.)
DATE: SUPERSEDES:
SIGNATURE:
70 September 2009
Guidelines
Guidelines for controlling
contamination
RECOMMENDED GUIDELINES FOR CONTROLLING
ENVIRONMENTAL AND PRODUCT CONTAMINATION IN DAIRY
PLANTS
The guidelines should not stand alone but must be combined with adherence to basic sanitation
principles found in other documents such as the Pasteurized Milk Ordinance (PMO); applicable sections
of the Code of Federal Regulations and IDFA's Dairy Product Safety Manual. They should serve to
enhance already existing programs, and should be an integral part of the prerequisites for a dairy product
HACCP program. The guidelines are primarily directed at controlling environmental, post-pasteurization
contamination of product by microbiological organisms, such as Listeria, pathogenic E.coli, and Yersinia.
1. Pasteurization
Every plant should assess the adequacy of their pasteurization equipment to determine if it
satisfies the basic principle of pasteurization. The basic pasteurization principle is that "every particle of
milk or milk product be heated to at least a minimum temperature and held at that temperature for at least
the specified time in properly designed and operated equipment." Dairy products which contain higher
fat and/or added sugars or which are viscous (e.g., frozen dessert mixes, cream, eggnog, etc.) also require
higher pasteurization temperature and/or longer times. It is recommended that the minimum
pasteurization time/temperature combinations found in Table 1 below be exceeded where possible.
All pasteurization equipment must be properly designed, installed, and operated. A properly
designed, installed, and operating flow diversion device and properly operating pressure controls for
regenerator systems must be installed in all HTST pasteurizing systems. The heat exchanger (presses) of
HTST pasteurizer units need to be routinely opened and closely evaluated for stress cracks, pin holes,
gasketing, cleaning, etc. Holes in regenerator and cooling plates can develop and cause contamination.
All Grade "A" products must be pasteurized in the plant of final processing and packaging. It is
recommended that this practice also be followed for other products, such as frozen dessert mixes.
Vat Pasteurization
Many serious problems can also develop with vat pasteurization systems. These include: lack of
proper controls, leaking valves, improperly operated headspace heaters, and other serious defects.
All vat pasteurized products must meet the basic requirements for pasteurization as defined above
(i.e., pasteurization must be performed in equipment which is properly designed and operated, and which
insures that every particle of milk or milk products will be held continuously at the proper temperature for
the specified period of time). Controls must be accurate, valves and connections must not contain pockets
of cold milk, foam (an excellent insulator) should be minimized in the vat during heating and holding,
covers must remain in place during and following heating, etc.
The following items are critical if proper pasteurization is to be assured. Recording and
indicating thermometers must be present and functioning properly. The need for a headspace heater
functioning at 5F above minimum pasteurization temperatures is necessary to assure that any product
that enters into the headspace is also properly pasteurized. Valves should be inspected regularly to
prevent leaking and must be of a leak detection type.
71 September 2009
Table 1. MINIMUM PASTEURIZATION TEMPERATURES AND TIMES
PRODUCT TEMPERATURE TIME
Milk 145°F 30 minutes
161°F 15 seconds
191°F 1 second
194°F 0.5 second
201°F 0.1 second
204°F 0.05 second
212°F 0.01 second
Milk Products of 10% fat or 150°F 30 minutes

more or added sugar (1/2 & 1/2,
cream, chocolate milk, etc.) 166°F 15 seconds
191°F 1 second
194°F 0.5 second
201°F 0.1 second
204°F 0.05 second
212°F 0.01 second
Eggnog and Frozen dessert 155°F 30 minutes

mixes
175°F 25 seconds
180°F 15 seconds
2. Post-pasteurization Contamination
Dairy plants should review the adequacy of cleaning procedures for all processing and filling
equipment, as well as piping. Potential areas of post-pasteurization contamination should be determined
and corrected.
A thorough check should be made of sweet water and glycol systems. A scheduled review
program should be initiated to assure that they are properly protected and do not contain harmful
organisms. Any equipment, such as storage tanks, jacketed vessels, etc., that utilize sweet water or glycol
solutions should continue to be monitored periodically for leaks and cracks. Contamination of product
can be caused by contaminated sweet water and leaking plates.
Cracks and crevices in silo tanks, leaking valves, agitator shafts, shielding, and venting are all
areas where harmful organisms can be found. Improper welds and similar irregular surfaces that can lead
72 September 2009
to inadequate cleaning and sanitizing should be eliminated. These areas should be monitored on a
scheduled basis.
Cleaning and sanitizing regimens should be reviewed for proper times, temperatures, pressures,
and flow rates. It is important to determine that proper sanitizers are being used at the appropriate
strength and contact time. This review should have included an assessment of the effectiveness of the
cleaning and sanitizing regimen. It has been demonstrated that commonly used dairy and food plant
sanitizers are effective against organisms such as Listeria. Chlorine based sanitizers at 100 ppm, acid
anionics at 200 ppm, quaternary ammonium compounds at 100 ppm, and iodophors at 25 ppm are
recommended and have been demonstrated to be effective for control of Listeria. Consultation with
suppliers of sanitizing compounds is highly recommended to assure that the compound applied is
effective against the organism of concern. It must be stressed that sanitizers are not effective unless all
product surfaces are first cleaned.
It is important that all piping circuits be designed to eliminate trapping of washing or sanitizing
solutions or allowing product to collect during the operating day. The drain line must be kept free, or
have provisions to be kept free of solution or product except during use. All piping circuits must be
periodically reviewed for potential problems. It is equally important to routinely monitor for any possible
cross-connections.
Processors should attempt to minimize the amount of handling, exposure to the plant
environment, and time/temperature abuse of the product after pasteurization (i.e., holding at elevated
temperatures for extended periods of time). This can be accomplished by keeping the number of
processing steps and storage times following pasteurization to a minimum.
The use of absorbent items, such as rags and sponges, should be eliminated to reduce potential
harborage and spreading of microorganisms in the plant environment. The use of brushes should be
segregated (i.e., using different brushes for internal and external surfaces). Brushes should be maintained
in good repair and properly stored when not in use and sanitized between uses. Use of impervious
materials (i.e., plastic or metal) is recommended. The use of porous equipment, such as wooden handled
tools, brushes, paddles, sponges, cloth, etc., should be discouraged in production areas.
Environmental contamination of product and product contact surfaces should be minimized at all
times (e.g., ice cream novelty lines and certain cheese processes tend to create a higher degree of product
exposure to both airborne and condensate contamination than many other product lines). Exposure to
these hazards may be minimized by using additional care and shielding.
Filling/packaging operations are other areas where product contamination can occur. Mandrels,
drip shields, bottom and top breakers, pre-fill coding equipment, deflector bars, cutting blades and
extruder heads, drain tables, box molders, brine tanks, and chill tanks are critical areas where
environmental contamination may occur. Overhead shielding, conveyors, conveyor belts, chain rollers,
supports, and lubricants should be constantly monitored. It is important to incorporate a routine cleaning
and sanitizing regimen for all conveyors. Blow molding operations and handling of packaging materials
should be examined on a routine basis, particularly where open containers/jugs are conveyed through
non-processing areas.
Any product recovered from defoamer systems should be protected from contamination,
maintained at or below 45F at all times, and be repasteurized prior to incorporation into product. A
thorough review of the handling of imperfectly capped or filled containers/packages is suggested.
Particular emphasis should be directed at eliminating manual handling/filling/capping of
containers/packages.
73 September 2009
3. Cross-Connections
Dairy plants should be evaluated for conditions such as direct piping connections between
pasteurized milk and raw milk lines, product to CIP circuits, or pasteurized product to other potentially
hazardous circuits. Blueprints should be reviewed on a periodic basis and updated to reflect existing
piping arrangements. This can only be accomplished by "walking" the blueprints through the plant and
physically ensuring the blueprints are accurate. Internal plant controls are needed to prevent any piping
changes without prior review by qualified authorities (plant management and/or regulatory agencies).
4. Use of Returned Product and Reclaiming Operations
Reclaiming operations, by their very nature, are high risk enterprises which can put the whole
company in jeopardy if not carried out judiciously. Reclaiming of product has the potential of
introducing allergenic substances into products whose label does not indicate their presence.
Care should be exercised to prevent reclaimed product from being inadvertently pumped through
the same lines as pasteurized product without cleaning and sanitizing the lines between uses.
Other reclaiming operations that present significant risk include:
o Not pasteurizing reclaimed or reworked product before reuse.
o Reuse of product which has been in distribution channels and may have been subjected to
temperature-abuse, tampered with, or exposed to chemical or biological contamination.
o Product in damaged containers where container integrity may have been compromised, or
when the outside of the container may be contaminated.
o Product that is beyond the normal shelf life. This product could contain microorganisms
which are capable of reproducing during refrigerated storage.
o Scrap or rework product which is handled differently from normal production (e.g., start
up and change over scrap, under weights, package/wrapper problems, product involved in
line jam-ups etc., that is held at elevated temperatures in barrels or buckets, then
reworked back into the product).
The May, 2001 Grade "A" Pasteurized Milk Ordinance requires the following:
Item 5p. SEPARATE ROOMS - ADMINISTRATIVE PROCEDURES

2. "All returned packaged milk and milk products which have physically left the premises
of the processing plant shall be received, handled, and stored in separate rooms isolated from Grade A
dairy operations. Such separate areas or rooms shall be clearly defined and marked for such use."
Item 15p(A). PROTECTION FROM CONTAMINATION - ADMINISTRATIVE

PROCEDURES
2. "Packaged milk and milk products which have physically left the premises of the
processing plant are not repasteurized for Grade A use. The regulatory agency may, on a specific
individual request, authorize reprocessing of packaged milk and milk products, provided all other aspects
of this item, including proper storage temperature and container integrity are complied with. Provided,
that the repasteurization of milk and milk products shipped in transport tankers which have been
pasteurized at another Grade A plant and have been handled in a sanitary manner and maintained at 7ºC
74 September 2009
(45ºF) or less is permitted. Equipment, designated areas or rooms utilized for storage, processing, and
handling of returned packaged milk and milk products are maintained, operated, cleaned, and sanitized so
as to preclude contamination of Grade A products and equipment and the Grade A operations."
Item 15p(B)
4. "All milk and milk products which have overflowed, leaked, been spilled, or
improperly handled are discarded. Milk and milk products drained from processing equipment at the end
of a run, collected from a defoamer system, and milk solids rinsed from equipment, containers, or
pipelines shall be repasteurized only if such milk and milk products are handled in a sanitary manner and
maintained at 7ºC (45ºF) or less. When the handling and/or refrigeration of such milk and milk products
are not in compliance with this requirement, they shall be discarded. Milk and milk products from
damaged, punctured, or otherwise contaminated containers or product from out of code containers shall
not be repasteurized for Grade A use."
Any product that has been mishandled, not protected from contamination, or which has not been
maintained at a temperature of 45ºF or less, should be discarded. External carton contamination with
Listeria and Yersinia has occurred and may lead to product contamination. Breaking or slashing
containers over a vat or horn for reprocessing may introduce contamination into the product. This process
must be reviewed to eliminate potential hazards. It is essential that if the product is to be reclaimed that
proper holding temperatures and sanitary practices, including container handling, be exercised.
Repasteurization of all reclaimed products is necessary and higher temperatures and/or longer holding
times should be used. Products returned from stores and outdated products which are being returned to
the dairy plant for disposal should be isolated from all other plant operations. Precautions should be
taken to prevent these areas from serving as a source of contamination. All equipment (i.e., tanks, pumps,
pipelines, etc.) used in this reclaiming operation should be constructed so they may be cleaned and
sanitized daily.
The practice of reclaiming product should be seriously evaluated, in view of the potential for
environmental and product contamination. The plant may determine the risk outweighs any benefit of
reclaiming product.
5. Airborne Contamination
Airborne contamination may act as a vehicle for allowing pathogenic organisms to enter the
production area. A comprehensive assessment of both processing and ventilating air utilized within the
plant should be conducted. Heating, ventilating, and air conditioning (HVAC) systems should be
designed for easy cleaning and should be periodically cleaned. Condensate drip pans and drain lines
should be checked periodically to assure they are not providing favorable environments for the growth of
harmful organisms. It is recommended that dairy plants assess the adequacy of their protective shielding.
This assessment should include all product contact surfaces as well as exposed product to assure they are
not subject to possible contamination by condensate, aerosols, dust, or other airborne contaminates. Air
systems in refrigerated areas should also be designed for easy cleaning and should be periodically
cleaned.
HVAC systems should be properly designed and adjusted to maintain positive pressure in areas
where product is exposed (e.g., batching operations, filling, packaging). Air transfer from potentially
contaminated areas (e.g., raw product receiving, ingredient and supply storage) to processing or
packaging areas should be minimized.
Outside air should be filtered and free of condensate. Air flow should be determined and
controlled to eliminate direct blowing of outside unfiltered air onto product, product contact surfaces, or
75 September 2009
filling and packaging areas. Air filters must be of the type effective in preventing the passage of
microorganisms. Filters must be kept clean and replaced according to an established maintenance
schedule.
Processing systems which incorporate air directly into the product, (e.g., frozen desserts) must be
designed to reduce potential contamination and must be easily cleanable. Process air systems should
contain appropriate filters to remove extraneous matter. Sanitary check valves should be provided as
necessary to prevent product backup into air lines. Air blow and agitation equipment should be checked
routinely. Most air blow and agitation equipment is not satisfactorily cleaned by usual CIP methods and
should, therefore, be dismantled, manually cleaned, and sanitized daily.
6. Plant Environment (General)
In order to make safe, consistently excellent dairy products, one must start with high quality
ingredients that have been properly combined in a plant using current good manufacturing practices. The
general plant environment will have a significant impact on the safety and quality of the finished product.
Therefore, in the interest of both safety and quality, particular emphasis must be placed on the general
plant environment. Special consideration of refrigerated areas is necessary, in light of the growth
potential of certain organisms (i.e., Listeria, Yersinia) at refrigerated temperatures. Clean floors, walls,
and ceilings free from condensate and buildup is imperative.
Special attention should be given to cleaning and sanitization of all conveyor track and belt
systems throughout the plant. These have been demonstrated to be difficult to keep clean and free from
pathogenic organisms. These items of equipment should be cared for on a routine schedule during plant
cleanup (not during production runs when product and/or product contact surfaces are exposed to the
cleanup).
For chemical sanitizers to be effective on either the plant or equipment, all product residues must
first be removed by cleaning. The proper concentration of the sanitizer must be touching all surfaces to
be sanitized for at least the minimum recommended contact time. Note - Many CIP systems may not
meet these requirements (e.g., air agitators, valves that do not pulsate (open and close) during the CIP
cycle, etc). Caution is advised when significantly exceeding the recommended strengths of sanitizers to
avoid creating a chemical hazard to either the product or plant employees.
The pooling of milk, water, or other processing wastes, such as in ducts, floor plating, grouting,
cracks, holes, and other areas, should be minimized. Protection of product and containers from splash
during cleaning in storage rooms and coolers should be evaluated and any necessary corrective action
taken. Returned goods should be isolated in a properly identified holding area.
Practices which are conducive to the formation of aerosols (i.e., microscopic water droplets,
condensate formation, the use of high pressure hoses, unshielded pumps, etc.) should be minimized.
Listeria has been isolated from floor drains in processing and other areas. Because of this potential, floor
drains should not be located under or in close proximity to filling and packaging equipment.
Floor drains should be frequently cleaned and periodically flushed with a sanitizing solution.
Floor drain covers and baskets should be removed from the production area, cleaned, and sanitized after
each production run. Under no circumstances should high pressure hoses be used to clean drains. Note:
se of high pressure hoses may create aerosols which carry pathogenic organisms onto exposed product or
product contact surfaces. Floors and drains should be maintained to insure proper drainage.
Consideration should be given to relocating drains away from open product areas, and they must be
accessible for cleaning and maintenance. A routine cleaning, sanitizing, and inspection program should
76 September 2009
be established for casers, stackers, the underside of equipment, and utility equipment such as parts tables,
can dollies, etc. Use of hot water in processing areas during production should be minimized to prevent
the formation of condensate while product is exposed. Condensate forms on cold surfaces in the presence
of high humidity, which is found in many dairy processing areas. Impervious materials such as tile,
metal, sealed cement, etc. should be used whenever possible to minimize harborages for pathogenic
microorganisms.
7. Plant Traffic
Employees should be trained to be aware of and recognize the importance of cross contamination
problems within the plant. They need to be trained to avoid spreading pathogens from outside the plant
(i.e., home, farm, etc.) or from areas such as the machine shop or raw milk receiving area (manure from
farms carried in on trucks, raw milk, etc.). Listeria, Salmonella, pathogenic E. coli and other organisms
can be carried on clothing, boots, tools, etc. into the dairy plant.
A traffic pattern restricting access to dairy processing areas should be in place. Milk haulers and
all other nonprocessing operation personnel should be restricted from entering the processing areas. The
use of foot baths which contain disinfectants should be encouraged and monitored routinely for proper
disinfectant strength and cleanliness. A continuing review and restriction of the movement of pallets,
forklifts, and other similar equipment from raw milk, case wash, dock, or other such areas into
processing/packaging areas is necessary. Wooden pallets can become contaminated with pathogenic
organisms, such as Listeria. Movement of wooden equipment must be minimized in areas where product
is exposed.
8. Personal Cleanliness
Employees with obvious illnesses, infected cuts, abrasions, etc. should be excluded from
processing areas or other functions which can contaminate product, product-contact surfaces, or
packaging material. The use of tobacco products, chewing gum, or other food for employee consumption
should not be permitted in any production area. Employees should be restricted from entering a
production area with hairpins, rings, watches, pencils, etc. Special attention is needed to assure that street
clothes are not allowed in the processing area and that plant clothing (including rubber boots) does not
leave the plant. Laundering of all work clothing should be the plant's responsibility, and proper
procedures for storing and issuing clean clothing need to be developed. Of equal concern is a potential
problem associated with plant maintenance personnel working in raw milk areas and then working on
pasteurized milk equipment without adequate cleanup of hands, tools, clothing, etc.
It is recommended that uniforms be color coded by department to control movement of

employees into restricted areas. When the use of disposable single-service gloves is necessary to handle
exposed product contact surfaces during a production run, they must be maintained in an intact, clean, and
sanitary condition. Single-service gloves should be discarded whenever they become broken,
contaminated, or if removed for any reason.
Hand washing facilities must be properly designed and conveniently located near work stations.
Use of hand sanitizing stations is encouraged.
9. Sampling and Testing
It is recommended that particular emphasis be given to environmental sampling to detect any

unrecognized problems. Testing conducted by industry laboratories can play an important role in
successful management of sanitary practices. This testing should be a part of routine plant quality control
77 September 2009
operations. Testing is an additional tool that can be used to detect various conditions of plant sanitation,
as well as to monitor for unusual increases of bacterial counts during refrigerated storage.
Coliform testing can be used as an index for post-pasteurization contamination. Any coliform
level detected should generate a review of plant practices. However, the presence or absence of coliform
organisms may not correlate with the presence of some pathogenic organisms, such as Listeria.
All testing for pathogenic organisms should be done in separately isolated laboratories away from
dairy plants. Implementation of a HACCP program mitigates the need for end product testing.
See ”Evaluating and Revising HACCP Systems for a checklist to assist in the verification of a
dairy plant’s Prerequisite Program.
78 September 2009
IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN
The successful implementation of a HACCP plan is facilitated by commitment from top
management. This commitment is necessary in order to support the need for additional resources for
startup, initiation, and implementation. The next step is to establish a plan that describes the individuals
responsible for developing, implementing and maintaining the HACCP system. Initially, the HACCP
coordinator and the cross-functional team are selected and trained. An important aspect in developing
these teams is to assure that they have appropriate training. The team is then responsible for developing
the initial plan and coordinating its implementation. Different product teams can be appointed to develop
HACCP plans for specific products. Upon completion of the HACCP plan, operator procedures, forms
and procedures for monitoring and corrective action are developed. The production personnel who will be
responsible for monitoring and documenting need to be trained. Often it is a good idea to develop a
timeline for the activities involved in the initial implementation of the HACCP plan. Implementation of
the HACCP system involves the continual application of the monitoring, record-keeping, corrective
action procedures and other activities as described in the HACCP plan.
Maintaining an effective HACCP system depends largely on regularly scheduled verification

activities. The HACCP plan should be updated and revised as needed. An important aspect of
maintaining the HACCP system is to assure that all individuals involved are properly trained so they
understand their role and can effectively fulfill their responsibilities.
A separate HACCP plan must be developed for each dairy food. However, it may not be
necessary to have a separate HACCP plan for dairy foods which have similar processes and which do not
have significantly different hazards.
COMMITMENT BY MANAGEMENT
Prior to proceeding to the HACCP team selection, it is extremely important to get full
commitment to the HACCP initiative from all levels of management. Without a firm commitment of
time, personnel, and resources, the HACCP plan may be difficult, if not impossible to implement
effectively. The success of a HACCP system mandates educating and training management and
production personnel in the importance of their role in manufacturing safe dairy foods. This training
should also include information for the control of foodborne hazards related to all stages of the food
chain. It is important to recognize that production personnel must first understand what HACCP is and
then learn skills necessary to make it function properly. Specific training activities should include
working instructions and procedures that outline the tasks of production personnel monitoring each
critical control point (CCP).
PLANT MANAGEMENT MUST AGREE TO:
 Commit resources to support development, training and implementation of a HACCP

program
 Provide long term commitment
 Create an environment to encourage a change in culture
 Establish a tracking system to measure progress and benefits of the HACCP program
Listed on the next page is an example of a management letter of endorsement.
79 September 2009
DATE:
To: Name
Title
Address
Re: Letter of Endorsement, HACCP
As part of our continuing efforts to manufacture food under the safest possible
conditions that meet or exceed customer, company and government standards, the ABC
Milk Plant has adopted the Hazard Analysis and Critical Control Points (HACCP)
principles for food safety.
Both Corporate and Plant Management are fully committed to these principles and will provide the
necessary resources to implement a comprehensive HACCP food safety system. This system will include
development of a brief written prerequisite program, hazard analysis, monitoring, records and verification
program as well as employee training. We recognize that changes in processing equipment, product
formulation, scientific information and experience of the HACCP Team may require modification of the
written and implemented HACCP program. It is also understood that periodic updating of this “living”
program will be necessary to maintain its effectiveness. All affected company personnel are encouraged to
support the development and implementation of the HACCP program since its success is dependent upon the
commitment and contribution of our employees.
Approved By:
Plant Manager Date
Corporate Production Manager Date
President Date
80 September 2009
Preliminary
Tasks
Preliminary Tasks
STEPS TO HACCP IMPLEMENTATION
PRELIMINARY TASKS IN THE DEVELOPMENT OF A HACCP PLAN
Figure 1
Assemble the HACCP team

Describe the food and its distribution

Describe the intended use and consumers of the food

Develop a flow diagram, which describes the process

Verify the Flow Diagram
Step One: Assemble The HACCP Team

The first task in developing a HACCP plan is to assemble a HACCP team consisting of
individuals who have specific knowledge and expertise appropriate to the dairy product and process. It is
the team's responsibility to develop the HACCP plan. The team should be cross functional and include
individuals from areas such as engineering, production, sanitation, and quality assurance. The team
should also include plant personnel, who are involved in the operation, as they are more familiar with the
variability and limitations of the operation. In addition, this fosters a sense of ownership among those
who must implement the plan. The HACCP team may need assistance from outside experts who are
knowledgeable in the potential biological, chemical, and/or physical hazards associated with the product
and the process. However, a plan that is developed totally by outside sources, may be erroneous,
incomplete, and lacking in support at the local level. Due to the technical nature of the information
required for hazard analysis, it is recommended that experts who are knowledgeable in the dairy product
process should either participate in or verify the completeness of the hazard analysis and the HACCP
plan.
The HACCP Team needs to be multi-disciplinary with knowledge and experience in the following areas:
- quality assurance - engineering - production
- sanitation - microbiology - outside experts (if necessary)
81 September 2009
Plant HACCP Team (example)
Experience/
Name Title Education Responsibilities Timeline
John Warehouse/Cooler 4 yrs. Army Training of staff, development of March 31,
Smith Supervisor logistical support, necessary Prerequisite record 200-
Associate Degree systems in his area
in Business
Management
Paula Laboratory BS in Micro., Backup HACCP Team leader, March 31,
Garcia Supervisor worked in dairy development of water prerequisite 200-
labs for 10 years records, product testing records, spot
checks all other prerequisite records
Larry Production BS in Dairy Training of staff, development of March 31,
Waters Supervisor, 1st Science, worked necessary Prerequisite record 200-
Shift in dairy industry systems in his area, oversees past.
for 20 years operator & Past. CCP records,
verifies all past. CCP records within
3 days.
Wanda Quality Control MS in Dairy HACCP Team Leader, schedules and December
Bramm Supervisor Science/Food facilitates team meetings, 1, 200-Set
Microbiology responsible for all HACCP activities up first
being assigned to a HACCP Team Team
member and completed according to meeting,
team timeline, reports to plant etc.
manager, accompanies outside
HACCP auditors and regulatory
inspectors
Date of Document _____________________________
These individuals should have the knowledge and experience to correctly:
 conduct a hazard analysis,

 identify potential hazards,
 evaluate potential hazards and how they will be managed
 recommend controls, critical limits, and procedures for monitoring and verification
 recommend appropriate corrective actions when a deviation occurs,
 recommend research related to the HACCP plan if important information is not known, and
 verify and validate the HACCP plan
Once the HACCP team has been selected, their next responsibilities are to:
1. Select a trained HACCP coordinator

2. Prepare a Statement of intent
3. Develop an Action Plan
4. Identify resource needs
5. Establish a timetable for completion of written documentation, implementation, and oversight
82 September 2009
As the team conducts work, keep records (documentation) of points discussed and maintain an
action plan. Documentation of decisions may become very useful later. See the below model table that
should be used to capture important information about the HACCP Team and identify whether there is a
need for additional expertise, outside consultants or team members.
Step Two: Describe The Food And Its Distribution

The HACCP team first describes each dairy product manufactured. This consists of a general
description of the dairy product, ingredients, and processing methods as well as other pertinent
information.
The product description form should contain the following, as a minimum:

 Name of dairy product
 Food safety characteristics
 Packaging used
 Labeling Requirements
 Storage and Distribution
 Intended Consumer
 Intended Use
 Shelf Life
Examples of a product description form is located below.
[Somebody’s Plant Name] [Street Address][Anywhere, State, Country Zip]
Product Description Form – Reduced Fat Milk

Formal Product Name: Reduced Fat Milk (2%)
Food Safety Characteristics: Support growth of a number of pathogens. No natural protective characteristics.
Ingredient Statement Reduced Fat Milk, Vitamin A Palmitate, Vitamin D3
Packaging Used: High Density Polyethylene gallon container with a polypropylene snap-on screw-off
tamper evident cap. Labels are self adhesive and applied prior to filling. Code date is
printed via coding equipment after capping
Labeling Requirements: Keep refrigerated, Grade “A”, Pasteurized, Homogenized, Vitamin A & D added, 30%
less fat than regular milk
Storage and Distribution: Product is cased in standard milk cases – four units per case. Temperature of storage is 
45°F. Distributed using refrigerated trucks ( 45°F) to wholesale and retail outlets.
Intended Consumers: Consumers of all ages consume this product.
Intended Use: Ready to serve product. May also be used as an ingredient in preparing meals.
Shelf Life: 16 days under proper refrigeration.
Approved by: ______________________________________

Date: _____________________________________________
83 September 2009
[Somebody’s Plant Name] [Street Address][Anywhere, State, Country Zip]
Product Description Form – Cheddar Cheese

Formal Product Name: Cheddar Cheese
Food Safety Characteristics: pH (4.9 to 5.4)
Ingredients: Raw milk, NDM, bulk starter culture, culture, enzymes, color, salt, natamycin
Packaging Used: 40# block vacuum sealed in poly bag and stored in a corrugated box.
Labeling Requirements: Keep refrigerated.
Storage and Distribution: Product is stored at  45°F. Distributed for further processing in refrigerated trucks (
45°F).
Intended Use: Ready to serve product. May also be used as an ingredient in preparing meals. May be
processed further into small chunks or shredded.
Shelf Life: Three (3) to twelve (12) months under proper refrigeration.
Approved by: ______________________________________
Date: _____________________________________________
Step Three: Intended Use And Consumers Of The Food (see form above)
The intended use of the dairy food should be based upon intended use of the dairy food by end-
users, consumers, and consumer target groups. The intended consumers may be the general public or a
particular segment of the population (i.e. infants, elderly, etc.) component of another food (dairy or non-
dairy), or non-food product. The use of the food may be for direct consumption as an ingredient in
another food or for non-food uses.
Step Four: Develop A Flow Diagram That Describes The Process

The purpose of a flow diagram is to provide a clear, simple outline of the steps involved in the
process. The scope of the flow diagram must cover all the steps in the process, which are directly under
the control of the establishment. In addition, the flow diagram can include steps in the process, which are
before and after the processing that occurs in the plan. The flow diagram need not be as complex as
engineering drawings. A block type flow diagram is sufficiently descriptive. Also, a simple schematic of
the facility is often useful in understanding and evaluating product and process flow. Points to consider
in establishing your diagram may include:
• All process steps where raw materials/ingredients and packaging are used
• All raw materials/ingredients
• All process steps in production (generally does not include valves and pumps)
• Product recycle/rework loops
• Storage and distribution
• Air and gases used in contact with product
84 September 2009
Step Five: Verify The Flow Diagram
The HACCP team should perform an on-site review of the operation to verify the accuracy and
completeness of the flow diagram. The flow diagram should be reviewed periodically, modified, updated
and documented, as necessary. It is recommended to take the diagram out to the production floor and
walk through the steps to ensure the diagram's accuracy. An example of an effective flow diagram is
shown below.
85 September 2009
HACCP Plan Development
Development
HAACP Plan
THE PRINCIPLES OF HACCP
There are seven principles in establishing an effective HACCP program
1. CONDUCT A HAZARD ANALYSIS

2. DETERMINE CRITICAL CONTROL POINTS (CCPS)
3. ESTABLISH CRITICAL LIMITS
4. ESTABLISH MONITORING PROCEDURES
5. ESTABLISH CORRECTIVE ACTIONS
6. ESTABLISH VERIFICATION PROCEDURES
7. ESTABLISH RECORD-KEEPING AND DOCUMENTATION PROCEDURES
During the evaluation of the seven principles of HACCP, the Hazard Analysis table and the HACCP Plan
Summary Table will be completed and be your written working documents. These documents will
contain the information that will serve as the justification and basis for your HACCP plan. be referenced
throughout the seven principles. See a template of the Hazard Analysis Table and the HACCP Plan
Summary Table at the end of this section.
CONDUCT A HAZARD ANALYSIS—PRINCIPLE 1

A thorough hazard analysis is the key to preparing an effective HACCP plan. The word hazard as used in
this document is limited to safety. If the hazard analysis is not done correctly and the hazards warranting
control within the HACCP system are not identified, the plan will not be effective regardless of how well
it is implemented.
The purpose of the hazard analysis is to develop and evaluation a list of hazards. A hazard is any
biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of
its control. It is important to consider in the hazard analysis, the ingredients, raw materials, each
processing step, product storage, distribution, and use by the consumer. When conducting a hazard
analysis, safety concerns must be differentiated from quality concerns. The team must consider what
preventive measures, if any exist which can be applied for each hazard. All decisions of the HACCP
Team regarding hazard analysis must be documented, regardless of whether the hazard is included in the
hazard in the Hazard Analysis Table or discarded because of low likelihood (see definition at beginning
of Manual).
The HACCP team conducts a hazard analysis and identifies appropriate control measures
using two separate but related steps called hazard identification and hazard evaluation. The hazard
identification and evaluation accomplish three objectives:
 The hazards are identified at each processing step and for each ingredient and material used.
 The hazards are evaluated to determine their severity and likelihood of occurrence.
 The analysis provides a basis for determining control measures such as CCPs in Principle 2.
The purpose of hazard identification is to develop a list of potential hazards, based on historical
operations, HACCP Team experience, scientific literature, governmental requirements, etc. This can be
regarded as a brain storming session. During this stage, the HACCP team reviews the ingredients and
packaging used in the product, the processing activities conducted and the equipment used at each step in
86 September 2009
the process, product storage, distribution, the intended use and consumers of the product. Based on this
review, the team develops a list of potential biological, chemical or physical hazards, which may be
introduced, increased, or controlled at each step in the production process. Hazard identification should
not try to develop an exhaustive list of hazards at each processing step, ingredient addition or material
addition in the flow diagram. Common sense should be used to identify likely hazards.
The following questions may be a useful tool in identifying hazards (A more extensive list may be found
in Appendix C of the NACMCF document):
1. Does the juice beverage contain any ingredients that may present microbiological hazards,
chemical hazards, or physical hazards? For additional information see hazards section.
2. Does the juice beverage permit survival or multiplication of pathogens and/or toxin formation in
the raw state or during processing (example, patulin in apples)?
3. Will the juice beverage permit survival or multiplication of pathogens and/or toxin formation
during subsequent steps (processing, storage, or distribution)?
4. Are there other similar juice beverage in the marketplace? What has been the safety record for
these juice beverages?
5. Does the process include a controllable processing step that destroys pathogens and meet the 5-
log reduction requirement of FDA's Juice HACCP regulation?
6. Is the juice beverage commercially sterile?
7. Does the microbial population change during the normal time the juice beverage is stored prior to
consumption?
8. Will the equipment provide the time-temperature control that is necessary for safe juice
beverages?
9. Can the equipment be sufficiently monitored and controlled so the process will be within the
tolerances required to produce a safe juice beverage?
10. Is there a chance for juice beverage contamination with hazardous substances?
11. Are there metal detectors, thermometers, sifters, filters, screens etc. used to enhance consumer
safety?
12. What is the likely use of your end product?
13. Are packaging materials a possible source of a hazard?
The next step in the Hazard Analysis is hazard evaluation. After the list of potential hazards is assembled,
the hazard evaluation is conducted. The HACCP team must decide which potential hazards must be
addressed in the HACCP plan. During this stage, each potential hazard is evaluated based on the severity
of the potential hazard and its likelihood of occurrence. Severity is the seriousness of the consequences of
exposure to the hazard. During the evaluation of each potential hazard, the food, its method of
preparation, transportation, storage and persons likely to consume the product should be considered to
determine how each of these factors may influences the likely occurrence and severity of the hazard being
87 September 2009
controlled. The team must consider the influence of likely procedures for manufacturing and storage and
whether the intended consumers are susceptible to a potential hazard. The HACCP team may have to rely
upon knowledgeable persons to assist in the hazard evaluation. Hazard evaluation can be conducted using
the decision tree found later in this section and the results recorded on the Hazard Analysis table also
found later in this section. Hazards that are not severe or not reasonably likely to occur would not require
further consideration within a HACCP plan.
Upon completion of the hazard analysis, those hazards expected during normal processing
operations and associated with each step in the flow diagram should be listed along with any control
measures to control the hazards. For example, if a HACCP team were to conduct a hazard analysis for
the manufacture of yogurt, possible pathogens in the raw milk would be identified as a potential hazard.
Thus, pasteurization would be the control measure and a likely critical control point.
Hazard identification and evaluation as outlined in above may eventually be assisted by

biological risk assessments, as they become available. While the process and output of a risk assessment
(NACMCF, 1997) is significantly different from a hazard analysis, the identification of hazards of
concern and the hazard evaluation may be facilitated by information from risk assessments. Thus, as risk
assessments addressing specific hazards or control factors become available, the HACCP team should
take these into consideration.
Let’s take a look at an example of some of the hazards for microbial contaminants as we might
identify them along with their control measures.
HAZARD CONTROL MEASURES
Presence of pathogens Destroyed by pasteurization
Recontamination by pathogens Controlled by SSOP and C/S procedures
Growth of pathogens & toxin production Controlled by Incoming Ingredient Prerequisite

program, product handling GMPs, and refrigeration
The hazard summary can be presented in several ways. Our format is the attached "Hazard
Analysis Summary Table". Another could be a narrative summary of the HACCP team’s hazard analysis
considerations and a summary table listing only the hazards and associated control measures as in the
example above
88 September 2009
Examples of How the Stages of Hazard Analysis are used to Identify and Evaluate Hazards*
Custards containing eggs

Hazard Analysis Stage Incoming raw milk produced as frozen deserts Frozen deserts
Stage 1 Determine potential Enteric pathogens (i.e., E. Salmonella in finished Staphylococcus aureus in
Hazard hazards associated coli O157:H7 and product. frozen product.
Identification with product Salmonella
Stage 2 Assess severity of Epidemiological evidence Salmonellosis is a food Certain strains of S. aureus
Hazard health consequences if indicates that these borne infection causing a produce an enterotoxin which
Evaluation potential hazard is not pathogens cause severe moderate to severe illness can cause a moderate
properly controlled. health effects including that can be caused by foodborne illness.
death among children and ingestion of only a few cells
elderly. Unpasteurized milk of Salmonella.
has been linked to disease
from these pathogens.
Determine likelihood E. coli 0157:H7 is both Product is made with liquid Product may be contaminated
of occurrence of likely to occur in raw milk eggs which have been with
potential hazard if not as well as other enteric associated with past S. aureus due to post-
properly controlled. pathogens outbreaks of salmonellosis. pasteurization contamination.
Recent problems with Enterotoxin capable of
Salmonella serotype causing illness will only occur
enteritidis in eggs cause as S. aureus multiplies to
increased concern. about 1,000,000 /g. Cooling
Probability of Salmonella and subsequent freezing
spp. in raw eggs cannot be prevent growth of S. aureus,
ruled out thus the potential for
enterotoxin formation is very
If not effectively controlled, low.
some consumers are likely to
be exposed to Salmonella
from this food.
Using information The HACCP team decides HACCP team determines The HACCP team determines
above, determine if that enteric pathogens are that if the potential hazard is that the potential for
this potential hazard is hazards for this product. not properly controlled, enterotoxin formation is very
to be addressed in the Sanitation and temperature consumption of product is low. However, it is still
HACCP plan. control will not destroy likely to result in an desirable to keep the initial
these pathogens. unacceptable health risk, number of S. aureus
organisms low. Employee
practices that
minimize contamination,
cooling of mixes and freezing
have been adequate to control
this potential hazard.
Hazards must he addressed Hazard must he addressed in Potential hazard does not need
in the plan. the plan. to be addressed in plan.
For illustrative purposes only. The potential hazards identified may not be the only hazards associated with the products listed.
The responses may be different for different establishments.
89 September 2009
The following questions may be a useful tool in assessing hazards: (A more extensive list may
be found in Appendix C of the NACMCF document)
1. Does the dairy product contain any ingredients that may present microbiological hazards,
chemical hazards, or physical hazards? For additional information see hazards section.
2. Does the dairy product permit survival or multiplication of pathogens and/or toxin
formation in the dairy food during processing?
3. Will the dairy product permit survival or multiplication of pathogens and/or toxin
formation during subsequent steps in the dairy food chain?
4. Are there other similar dairy products in the marketplace? What has been the safety
record for these dairy products?
5. Does the process include a controllable processing step that destroys pathogens?
6. Is the dairy product commercially sterile?
8. Does the microbial population change during the normal time the dairy food is stored
prior to consumption?
8. Will the equipment provide the time-temperature control that is necessary for safe dairy
food?
9. Can the equipment be sufficiently monitored and controlled so the process will be within
the tolerances required to produce a safe dairy product?
10. Is there a chance for dairy product contamination with hazardous substances?
11. Are there metal detectors, thermometers, sifters, filters, screens etc. used to enhance
consumer safety?
14. What is the likely use of the end product?
Upon completion of the hazard analysis, the significant hazards associated with each step in the
flow diagram should be listed along with any control measures to control the hazards. For example, if a
HACCP team were to conduct a hazard analysis for the manufacture of yogurt, possible pathogens in the
raw milk would be identified as a potential hazard. Thus, pasteurization would be the control measure.
Hazard identification and evaluation as outlined above may eventually be assisted by biological
risk assessments, as they become available. While the process and output of a risk assessment
(NACMCF, 1997) is significantly different from a hazard analysis, the identification of hazards of
concern and the hazard evaluation may be facilitated by information from risk assessments. Thus, as risk
assessments addressing specific hazards or control factors become available, the HACCP team should
take these into consideration.
90 September 2009
The following is an example of biological hazards (in this case pathogenic bacteria) and associated
control measures that might be considered.
HAZARD MEASURES
Presence of pathogens Eliminated or reduced to acceptable levels by pasteurization
Post-pasteurization contamination by pathogens Managed by GMP and prerequisite on equipment construction,

cleaning, and sanitizing
Growth of pathogens & toxin production Managed by Prerequisite program and cooling
The hazard summary can be presented in several ways. One format is the attached Hazard Analysis
Summary Table. Another could be a narrative summary of the HACCP team’s hazard analysis
considerations and a summary table listing only the hazards and associated control measures as in the
example above.
91 September 2009
MODIFIED DECISION TREE FOR
Q1. Is the hazard identified at HACCP
this step of sufficient likelihood
of occurrence to warrant its
control?
N NO Not a CCP
YES
Q2. Identify the Prerequisite Program or
procedure step which reduces the
Q3. Does the control measure for the hazard exist likelihood of occurrence of the hazard to
YES
at this step? ensure that control at this step is not
necessary.
NO
YES
YES Modify this step, process, or product

Is control at this step to eliminate this hazard or provide a
necessary? control measure, then revisit the
hazard analysis
NO
Proceed to the step where a control measure

exists for this hazard and begin at Q4.
Q4. Does this step prevent, reduce or

YES
eliminate the likely occurrence of the hazard CCP
to an acceptable level?
NO
Q5. Could contamination with the identified hazard occur in excess of the safe or
acceptable level or could it increase to an unacceptable level?
YES NO
Q6. Will a subsequent step eliminate the identified hazard or This step is
reduce its likely occurrence to a safe level? not a CCP
YES NO
Subsequent CCP (Control at this step is necessary to prevent or reduce

step is the the risk of a hazard but may not eliminate it.)
CCP.
92 September 2009
Hazard Analysis Summary Table
(Q1-Q6 refer to the Modified Dairy HACCP Decision Tree)
Q1. Is the hazard Q3 – Q6. Does a

identified at this step control measure exist
of sufficient Q2. Identify the at this step to prevent,
Identify the likelihood of Prerequisite Program reduce or eliminate the
occurrence to or procedure which
Process Potential Hazard likely occurrence of a
warrant its control? reduces the likelihood
Step/ hazard to an
 If "yes", then or severity of the
Ingredient  Biological (B) proceed to Q3 hazard to ensure that acceptable level?
or Input  Chemical (C)  If "no", stop and control at this step is If “yes”, document as a
 Physical (P) document at Q2 not necessary. CCP
If “no”, indicate where
control exists.
Product Description:
Firm Name: Firm Address:
Method of Storage & Distribution:
Intended Use & Consumer:
Signature: Date:
93 September 2009
HACCP PLAN SUMMARY TABLE - MODEL CCP ON CONTINUOUS FLOW (HTST & HHST) PASTEURIZATION - NCIMS
Critical Hazard(s) Critical Limits Monitoring Corrective CCP Verification ** Records
Control Action(s)* and ***
Point
(CCP) What How Frequency Who
Milk and Milk Biological- Time & Temperature at Continuo At least Pasteurizer Manually divert Record Review CCP Records -
Products Vegetative Temperature. the exit of the us Temp. once per Operator flow of product Pasteurizer
Pasteurization Pathogens 161°F for holding tube Recorder shift by the Pasteurizer charts Charts
(HTST and (non-spore minimum of 15 Chart operator Isolate the affected verified
HHST) formers) seconds product Corrective
Equipment Function Action Records
Evaluate and Checks
Note: Assuring determine CCP
that the minimum disposition of the Operator performs Verification-
holding times are product (reprocess required daily tests Records,
met in systems or disposal) and record on the including
which use a sealed temperature charts equipment
timing pump Residence time in Flow Pasteurizer Document actions testing records
would be CCP the holding tube Recorder Continuous Operator Authorized plant
verification, i.e. in continuous Chart during Note: Utilize 5 person (supervised by
equipment flow pasteurizers Operation corrective action regulatory when
calibration with magnetic steps recognized by required) conducts
flow meter based NCIMS HACCP checks listed in the
timing systems program Milk Plant Equipment
Test Report (FDA
Form 2359b)
Seals:
Verify required
regulatory seals daily
*A properly operating HTST or HHST pasteurization system will divert raw product to the balance tank when predetermined set points are not met.
**Every particle of milk or milk is heated in a properly designed, calibrated and operated pasteurizer, to one of the temperature and time combinations specified in the current
Grade A PMO.
***Pressure in the regenerator of continuous flow pasteurizers, and in the case of HHST pasteurizers as required in the holding tubes, across steam injectors and within infusion
chambers, shall be addressed in the HACCP Plan and managed as CCP verification(s).
Product Description: Method of Storage and Distribution:

Intended Use and Consumer:
Signature: Date:
September 2009
94
HACCP PLAN SUMMARY TABLE – MODEL CCP ON CONTINUOUS-FLOW (HTST AND HHST) PASTEURIZATION WITH
MAGNETIC FLOW METER-BASED TIMING SYSTEM
Critical Hazard(s) Critical Limits Monitoring Corrective CCP Records
Control Action(s)* Verification** and
Point ***
(CCP) What How Frequency Who
Milk and Milk Biological- Time and Temperature at Temp. Continuous Pasteurizer Manually divert Record Review: Pasteurizer
Products Vegetative Temperature the exit of the Recorder during Operator flow of product Charts
Pasteurization Pathogens holding tube Chart Operation Pasteurizer charts
(HTST and (non-spore NOTE: Assuring that Isolate the verified
HHST) formers) the minimum holding affected product Corrective
times are met in Equipment Action
systems which use a Evaluate and Function Checks: Records
sealed timing pump determine
would be as CCP disposition of the Operator performs
verification during product required daily tests
required equipment (reprocess or and record on the
calibration. disposal) temperature charts. CCP
Verification
Flow rate in Document actions Authorized plant - Records,
forward flow in Flow Continuous Pasteurizer person (supervised by including
the holding Recorder during Operator regulatory when equipment
tube (to verify Chart Operation required) conducts testing
minimum checks listed in the records
holding time) Milk Plant
in continuous Equipment Test
flow Report (FDA Form
pasteurizers 2359b).
with magnetic
flow meter Seals: Verify
based timing required regulatory
systems. seals daily
* A properly operating HTST or HHST pasteurization system will divert raw product to the constant-level tank when predetermined set points are not met.
**Every particle of milk or milk is heated, in a properly designed, calibrated and operated pasteurizer, to one of the temperature and time combinations specified in the current Gra
*** Pressures in the regenerator of continuous-flow pasteurizers, and in the case of HHST pasteurizers as required in the holding tubes, across steam injectors,
and within infusion chambers shall be addressed in the HACCP Plan and managed as CCP verification(s).

Signature: Date:
September 2009
95
HACCP PLAN SUMMARY TABLE FOR MODEL CCP ON VAT PASTEURIZATION - NCIMS
Critical Hazard(s) Critical Limits Monitoring Corrective CCP Verification Records
Control Action(s)
Point
(CCP)
What How Frequency Who
During Record Review Pasteurizer
Milk and Milk Biological- 145°F with a Time and Temp. Continuous Pasteurizer Pasteurization: Pasteurizer charts Charts
Products Vegetative holding time of temperatures Record during Operator Continue verified
Pasteurization Pathogens a minimum of (in a vat that is er Chart Operation pasteurization
(Vat) (non-spore 30 minutes. continuously until the Equipment Function
time/temperature
formers) agitated to Checks
criteria have been
The air space assure that met. If the Corrective
thermometer there is no time/temperature Operator performs Action Records
must indicate a more than 1OF criteria cannot be required observation of
minimum of (0.5oC) met, in two (2) indicating and airspace
150°F. difference hours, an thermometers for each
between the evaluation need batch (air space checked
warmest and sot be made as to at both the beginning CCP
the disposition of
the coldest and the end of the Verification
the product
product in the holding time) and Records,
vat during recorded on the chart including
After
processing) equipment
Pasteurization
including Authorized plant person testing records
(i.e., during the
minimum (supervised by
record review):
required time, If the product is regulatory when
product found not to have required) conducts
temperature met the critical checks listed in the Milk
and air space time/temperature, Plant Equipment Test
temperatures place all affected Report (FDA Form
finished product 2359b)
on hold, and
evaluate to
Seals:
determine product
distribution, i.e., Verify required
reprocess or regulatory seals daily if
destroy applicable
Signature: Date:
September 2009
96
DETERMINE CRITICAL CONTROL POINTS (CCPs)—PRINCIPLE 2
A critical control point (CCP) is defined as a step at which control can be applied and is essential
to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The hazard analysis
conducted under Principle #1 has identified areas where it is necessary to implement control measures.
The Prerequisite Program may be used to control many of the identified hazards. Any hazards not
controlled through prerequisite programs must be identified as CCPs. CCPs may vary depending on the
hazard analysis, plant, product, and production method.
Information developed during the hazard analysis should enable the HACCP team to identify
which steps in the process are CCPs. Identification of each CCP can be facilitated by the use of the CCP
decision tree. Although application of the CCP decision tree can be useful in determining if a particular
step is a CCP for a previously identified hazard, it is merely a tool and not a mandatory element of
HACCP. A CCP decision tree is not a substitute for expert knowledge.
Different facilities preparing the same dairy product can differ in the risk of hazards and the
points, steps, or procedures, which are CCPs. This can be due to differences in each facility layout,
equipment, selection of ingredients (including raw vs. pasteurized milk), or the process that is employed.
Once the critical control point has been identified, it should be transferred to Column 1 on the
HACCP summary Table. The Hazard should be transferred to Column 2 on the same form.
A decision tree for the dairy HACCP initiatives is shown on the next page as a guide for use in
determining whether a hazard is controlled by an existing prerequisite program, whether there is a need to
develop a new prerequisite program or if a CCP is needed at that process flow step.
ESTABLISHMENT OF CRITICAL LIMITS – PRINCIPLE 3

A critical limit (scientifically- based) is a maximum and/or minimum value to which a biological,
chemical, or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an
acceptable level the occurrence of a food safety hazard. A critical limit is used to distinguish between
safe and unsafe operating conditions at a CCP. Critical limits should not be confused with operational
limits, which are established for reasons other than food safety. Critical limits must be met to ensure the
safety of the dairy product. Critical limits may be derived from sources such as regulatory standards and
guidelines, literature searches, experimental studies, and experts. Critical limits are parameters, which
may be established for control measures and include:
• Temperature
• Time
• Water Activity (Aw)
• pH
• Titratable Acidity
• Drug Residues safe or tolerance levels
Example of critical limits the “given” critical control point commonly used in the dairy industry include:
• Pasteurization times and temperatures
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Once the critical limit has been established, it should be placed in the column 3 of the HACCP Plan
Summary Table
ESTABLISH MONITORING PROCEDURES—PRINCIPLE 4

Monitoring is a planned sequence of observations or measurements used to assess whether a CCP
is under control and produce an accurate record for future use in verification. Monitoring serves three
purposes:
1. Monitoring is essential to dairy product food safety management in that it tracks the system's
operation.
2. Monitoring is used to determine when there is loss of control and a deviation occurs at a
CCP (i.e., exceeding the critical limit). Corrective action must be taken.
3. Monitoring provides written documentation for use in verification of the HACCP plan.
Because of the potentially serious consequences of a deviation, monitoring procedures must be

effective. Continuous monitoring is possible with many types of physical and chemical methods, for
example, the time and temperature of pasteurization. Monitoring equipment must be carefully calibrated
for accuracy. When it is not possible to monitor a critical limit on a continuous basis, it is necessary to
establish the monitoring interval, which will be reliable enough to indicate the hazard is under control.
Assignment of the responsibility for monitoring is an important consideration for each CCP.
Specific assignments will depend on the number of CCPs and critical limit and the complexity of
monitoring. Those individuals monitoring CCPs must:
 Be trained in the technique used to monitor each critical limit

 Fully understand the purpose and importance of monitoring
 Have ready access to the monitoring activity
 Accurately report the monitoring activity
The person responsible for monitoring must also inform management when a process or product
does not meet critical limits so that immediate corrective action can be taken.
Most monitoring procedures for CCPs will need to be done rapidly because they relate to on-line
processes and there will not be time for lengthy analytical testing. Microbiological testing is seldom, if
ever, effective for monitoring CCPs due to the time required to conduct tests. Therefore, physical and
chemical measurements are preferred because they may be conducted rapidly and can indicate the
conditions of microbiological control in the process.
The following areas must be addressed when considering monitoring/inspection:
• Monitoring Controls
- Need to know correct control points (critical) before establishing monitoring programs.
- Most CCPs are straightforward and monitoring is designed to measure if the CCP is In or
Out of control.
• Frequency
- Will vary depending on type and degree of risk
- Continuous monitoring and recording are to be preferred in most situations
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• Responsibility
- Position title assigned
- Work station
Once established, the monitoring procedures should be transferred to columns 4,5,6,7 on the
HACCP Plan Summary Table. The records utilized to monitor the critical limit(s) should be placed in
column 10 on the HACCP Plan Summary Table.
ESTABLISH CORRECTIVE ACTIONS—PRINCIPLE 5

Corrective Actions are procedures to be followed when a deviation occurs. Because of variations
in CCPs for different dairy products and the diversity of possible deviations, specific corrective action
plans must be developed for each CCP. At a minimum, the production personnel shall have the
responsibility and the authority to take corrective actions such as notifying a supervisor or shutting down
the production line. Corrective actions must demonstrate the CCP has been brought under control.
Individuals who have a thorough understanding of the dairy process, product, and HACCP plan are to be
assigned responsibility for taking corrective action. Corrective action procedures must be documented in
the HACCP plan.
Pre-determined written corrective action plans should address the following:

● Halting production of the product
● Isolating the affected product
● Bringing process under control and documenting
● Determine the disposition of the product
● Determination of the root cause of the deviation.
If not pre-determined, documentation of a corrective action taken after a deviation should address
the following to comply with the NCIMS HACCP Program for Grade “A” dairy products and is a
good list for use by any plant when documenting a corrective action.
1. Segregate and hold the affected product;
2. Perform a review to determine the acceptability of the affected product. The review shall be
performed by individuals who have adequate training or experience in Juice HACCP;
3. Take corrective action, when necessary, to ensure that no affected product enters commerce
that is either injurious to health or is otherwise adulterated as a result of the deviation;
4. Take corrective action to correct the cause of the deviation; and
5. Perform or obtain timely verification by an individual or individuals who have been trained in
Juice HACCP to determine whether modification of the HACCP plan is required to reduce
the risk of recurrence of the deviation, and to modify the HACCP plan as necessary.
Responsibilities
 Effect of deviation on safety: If difficult to establish, testing and final disposition of the dairy
product must be agreed to by the appropriate individuals.
 Identification of questionable lots and corrective action must be part of records.
 Records must be kept for a reasonable period after the expected end of shelf life of the dairy
product.
Exceeding the Limit: Decisions must be based on the fact that exceeding the limit may indicate:
 Evidence or existence of a direct health hazard.
 Evidence that a direct health hazard could develop.
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 Indications that a dairy product was not produced under conditions assuring safety..
 Evidence that a CCP is not under control.
Once the corrective actions have been established they should be transferred to Column 8 on the HACCP Plan
Summary Table.
SUBJECT Corrective Action Log
PLANT NAME
ADDRESS
Deviation #1
TODAY’S DATE: DATE OF INCIDENT:
DATE REPORTED: REPORTED BY:
EXPLAIN CCP CRITICAL LIMIT DEVIATION:
PRODUCT / PROCESS INVOLVED
 Product Name and Description:
 Code Date(s):
 Date(s) of Manufacture:
 Production Line #:
CORRECTIVE ACTION: ACTION TAKEN
1. Segregate and hold the affected product until 2. and 3. are completed Yes No Date:
Comments
2. Perform or obtain a review to determine the acceptability of the Yes No Date:
affected product for distribution. The review shall be performed by an Comments
individual or individuals qualified by training or experience to perform
such a review;
3. Take corrective action, when necessary, with respect to the affected Yes No Date:
product to ensure that no product is allowed to enter commerce that is Comments
either injurious to health or is otherwise adulterated as a result of the
deviation;
4. Take corrective action, when necessary, to correct the cause of the Yes No Date:
deviation; and Comments
5. Perform or obtain timely validation by a qualified individual(s), as Yes No Date:
required in Appendix K, to determine whether modification of the
HACCP Plan is required to reduce the risk of recurrence of the
deviation, and modify the HACCP Plan as necessary. Comments
DISPOSITION OF PRODUCT ROOT CAUSE OF DEVIATION
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ESTABLISH VERIFICATION PROCEDURES—PRINCIPLE 6
VERIFICATION PLAN
Classification of Activity,
i.e. CCP records, Responsible Outcome &
Specific Activity corrective actions, Verifier Frequency Comments
equipment calibration, etc.
Verification is addressed in two ways in the HACCP Plan. First is establishing verification on the
HACCP Plan Summary Table and establishing internal verification monitoring. In both situation
documentation is critical.
Verification is the activity designed to insure that the monitoring program is operating according
to the requirements of the HACCP program. The verification format at this point is determined by the
HACCP team as to what actions will be taken in reference to the critical control point(s) and is placed in
Column 9 on the HACCP Plan Summary Table.
Once verification has been established, the internal verification monitoring programs can be
developed.
Internal Verification Monitoring can be utilized to ensure that the HACCP plan is functioning
effectively rather than relying on end product sampling. Firms must rely on frequent reviews of their
HACCP plan for effectiveness.
EXAMPLES OF INTERNAL VERIFICATION MONITORING MAY INCLUDE
 Establishment of appropriate verification monitoring schedules. This must be established on

a routine basis and may include continuous or periodic monitoring and involve plant
personnel, managers, and/or the HACCP team.
 Review of the critical control point records at specified frequency.
 Visual verification of operations to observe if the critical control points are under control.
 When dairy products have been implicated as a vehicle of food born disease.
 When requested by a consultant
 To verify that changes have been implemented correctly after a HACCP plan has been
modified.
 Based on consumer feedback
Verification reports should include:
 Status of records associated with CCP monitoring.

 Direct monitoring data of the CCP while in operation.
 Calibration and testing of monitoring equipment.
 Deviations and corrective actions.
 Training and knowledge of individuals responsible for monitoring CCPs.
 A check off chart to show the records have been verified.
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At this point if internal verification monitoring is not acceptable to resolve the issues the HACCP team
may have to validate the HACCP plan as described in the next section.
VALIDATING THE HACCP PLANS
VALIDATION PLAN
Specific Activity Narrative of Specific Name of Date of Outcome and
Activity (example) Validator Validation Action Items
The HACCP team should conduct a validation of the HACCP plan annually or at any time when
the process is altered.
The scientific or technical process to validate the HACCP plan, critical control pints, and critical
limits are satisfactory to guarantee that adequate controls are in place to reduce hazards. On a minimum
basis the HACCP plan must be validated by the HACCP team. In addition the validation process may
need to occur if the verification process does not solve an issue identified.
The HACCP team should validate the HACCP plan on an annual basis by reviewing the
following items.
 The effectiveness of the process

 The accuracy of the flow diagram
 The completeness of the HACCP Plan
 The soundness of the Hazard Analysis
 The appropriateness of the critical control points
 The scientific justification for the critical limits
 The comprehensiveness of the corrective actions
 The effectiveness of the monitoring programs and the record keeping.
In addition to the annual validation some situations that require validations are listed below.
 New potential hazard for that dairy food

New pathogens
New CCPs
 New scientific data available
 Recall of Dairy Products
 Response to new dairy product development
Raw materials change
Preparation and processing change
Formulation change
Packaging change
New uses of dairy product by consumers
 Response to manufacturing change
Changes in dairy product flow in plant
Equipment change
 When dairy products have been implicated as a vehicle of foodborne disease.
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 Based on consumer feedback
 Based on product evaluations
 Response to regulatory inspection/change
Verification, Validation and Auditing In the HACCP Process

Successful HACCP management requires the establishment of procedures that verify the HACCP
system is working correctly. Quality audits whether internal or external are used to provide objective
evidence that a facility has implemented and maintained an effective food safety system. The audit
process is a planned, independent, documented assessment that determines whether requirements for food
safety are being achieved. An effective audit program will assess compliance, system effectiveness, and
identify opportunities for continuous improvement.
There are three types of audits necessary to support the HACCP system. Production floor audits
conducted by internal groups, HACCP program audits made by internal groups and third parties, and a
HACCP validation audit performed by a third party audit group. Fundamental to the audit process is the
belief that they benefit management, are performed by qualified individuals, are based on standards,
conclusions are only drawn from facts, and are focused on systems.
Floor supervisors, lead individuals, or internal auditors can perform production floor audits. These
individuals must be familiar with basic audit techniques and have process/system knowledge. Methods
include record review, observation, sampling, and use of short checklists. Results should be reported
internally and used to develop corrective action plans if deficiencies are noted. The audit frequency will
vary depending on results.
The plant HACCP team or internal auditing group can perform HACCP program audits. Like the
production floor audit this is not an independent assessment of the HACCP system but does provide a
more in depth verification of effectiveness. Training requirement include intermediate auditing
techniques and knowledge of the facility's internal management structure, HACCP program, and
processing system. Methods include record review, observation, interviews, sampling and testing, and
checklists. These audits should be conducted at least quarterly with the results reported internally using
formal documentation. This process can also be used to verify corrective actions have been successfully
implemented.
A corporate team or external party performs HACCP validation audits. Training for these
individuals includes advanced audit techniques, process/system knowledge, and food safety expertise.
Methods include record review including management controls, observation and interviews of operators,
supervisors, and management, sampling and testing, and comprehensive checklists. This independent
audit is formally documented for distribution with-in the plant and corporate structure and should be
conducted annually.
Audits are used to assess system health and identify opportunities for improvement. If gaps are
noted in a facility's HACCP system the root cause of the deficiency must be determined and corrective
actions identified. The three levels of auditing discussed can be used to enhance the effectiveness of the
facility's corrective action program.
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VERIFICATION PLAN (Example only)
Reason for Review:
Review Conducted By: Date of Review:
Specific Name of Date Con-

Activity Narrative of Specific Activity Verifier ducted Outcome and Follow-up
HACCP Team Compare active HACCP Team Chris Bunch May 2, Need to update list for new HACCP Team Member
Members members with written list, frequency 2009
of meetings, etc.
Consumer & Determine whether consumer mix & Chris Bunch “ Consumer mix unchanged, added Nebraska
Distribution distribution have changed
Hazard Flow Diagram for Each Product Jeanne May 4, Break out past. into separate elements
Analysis Smith 2009
All products included " " Eggnog not included
All Flow Diagram Elements on H.A. " " Rework on Flow Diagram missed
Hazards specifically identified “ “ Identify specific biological hazards
All hazards addressed by PP or CCP " " OK
All hazards "reasonably likely to " " Did not address metal fragments
occur" addressed
CCPs properly identified “ “ Label CCPs with #1, #2, etc.
HACCP Plan All CCPs from H.A. included Steve Janish May 6, OK
2009
All CCPs have critical limits " " OK
HACCP Plan CCP monitoring records support C.L. " " Temp for past. is operating limit
Monitoring records support critical “ “ Missing records from 4/2-5/08
limits
Responsible person identified " " OK
Deviations documentation Steve Janish " None for this period
Corrective Action Plan followed " " No deviations this period
September 2009
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Specific Name of Date Con-
Activity Narrative of Specific Activity Verifier ducted Outcome and Follow-up
CCP records consistently identified “ May 6, Select one name for past. seal record
2009
Monitoring records signed & dated " " OK
Calibration of Past. Equipment check record Hugh May 10, All tests run, seals in place at 3 month freq.
CCP O'Hare 2009
Monitoring Vitamin pump calibration & weekly “ “ Pump not calibrated for last 3 months
Instruments use reconciliation
Prerequisite All PPs identified in H.A. exist Craig May 4, No documentation of Temp. Management PP
Programs Stevenson 2009
All PPs identified in H.A. exist “ “ Missing Temp. Man. PP
All PPs have written narrative " " See above. More detail needed on PP#3-Equip.
Cleaning
All PP records exist & current " " Pest PP lack records for 3 months
All PP monitoring records signed & “ “ No date or sign. for ingredient COAs
dated
Consumer Weekly Summaries complete Amy May 2, No summaries for March
Complaints Rhodes 2009
Follow-up of all sensory & illness " " Taste complaint of April 2 with no info
complaints
Mock Recalls Written mock recall program exists Poly Vander May 6, Yes
with effectiveness criteria Wal 2009
Mock recall conducted in last 6 " " Yes
months
Effectiveness criteria met " " No, only 90% of buyers contacted
September 2009
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VALIDATION PLAN (Example Only)
Reason for Review:

Review Conducted By: Date of Review:
Specific Narrative of Specific Name of Date of Outcome and Action Items

Activity Activity (example) Validator Validation
1. Review of Plant No recalls or only one market Kitty Smith April 15, 2009 No changes to the written HACCP program were necessary. It is
History since _______ withdrawal activity recorded for the recommended that training of substitutes and replacement staff on
products covered under this written documenting the receipt of incoming packaging and ingredients be
HACCP Program during the last 12 increased to once every three months.
months. Market withdrawal based on
product packaging mix-up.
Employee training and the
prerequisite on incoming packaging
and ingredients strengthened.
2. Review of All consumer complaints for the last Kitty Smith April 15, 2009 Recommend a weekly summary of all consumer complaints for
Consumer Complaint 12 months addressed without the product covered under the written HACCP program be circulated
Files since need to modify the HACCP program to plant QA and the plant manager.
______________ other than one incident. See #1.
3. Identifying emerging hazards specific to products covered
under the HACCP program.
a. Experts contacted i.e. contacted Allen Sayler, IDFA; Sarah Jones April 12, 2009 All experts contacted did not identify any new hazards or change
regarding emerging Steve Murphy, Cornell University; in the importance of existing hazards identified in the Hazard
new hazards and dairy Dr. Ron Schmidt, U. of Florida; Dr. Analysis for the products covered in the written HACCP program.
industry trends: John Rushing, NC State University;
Dr. Rusty Bishop, Wisconsin Center
for Dairy Research; Dr. John
Partridge, Michigan State University,
Dr. Linda Harris, U. of Cal. Davis;
etc.
b. Scientific Literature Completed an internet search on key Jim Martin April 10 - 15, Located 35 scientific articles written over the last 12 months on
Search Conducted words, xx, xxx, xxxx and xxxxx . 2009 the products covered under the written HACCP program with no
Also did a library search of the new hazards identified.
following scientific journals and
September 2009
106
Specific Narrative of Specific Name of Date of Outcome and Action Items
Activity Activity (example) Validator Validation
trade industry publications.
XXXXXXXXXXXXXXXXXX
c. Evaluated the Center Reviewed the CDC website Kitty Smith April 15, 2009 The trends of food borne outbreaks for calendar year 2007 did not
for Disease Control's (http://www.cdc.gov/ncidod/diseases/ identify any new pathogens of concern for dairy products and the
Morbidity & Mortality food/index.htm) and gathered number of outbreaks attributed to dairy products covered in the
data for dairy products information on food borne outbreaks HACCP program dropped by 0.5%.
covered under HACCP related to dairy products and their
program - causes.
d. Reviewed FDA food Reviewed the FDA website Sarah Smith April 18, 2009 Of the 20 recalls of dairy products during the last 12 months, 17
recall data for the last (http://www.fda.gov/oc/po/firmrecall were based on allergen concerns and lack of labeling with 2 based
12 months for products s/archive.html) on food recalls over on microbial contamination with listeria or pathogenic e.coli, and
covered under the the past 12 months eight based on consumption of raw milk. All pathogens are
written HACCP included in the current Hazard Analysis.
program
4. In-depth review of Did a step-by-step review of all 5 HACCP Team April 20 - 25, No changes made to the written hazard analysis for all 5 dairy
the written hazard hazard analysis, based on 2009 products covered under the written HACCP program.
analysis for each information gathered from items 1, 2
product covered by the & 3 a-d
HACCP program.
5. Based on outcome Reviewed the HACCP Plan HACCP Team April 22 - 27, No changes made to the written HACCP Plan Summary table for
of #4, validation of the Summary Table for all 5 dairy 2009 all 5 products covered under the written HACCP program.
CCPs and critical products covered under the written
limits. HACCP program
6. Validate the written Reviewed the written prerequisite HACCP Team April 22 - 27, Made changes to strengthen the training of new and replacement
prerequisite sections, sections, GMPS and SSOPS for all 5 2009 workers in reviewing incoming packaging, ingredient and other
GMPS and SSOPS dairy products based on the new materials. Added an additional supervisory requirement to review
information from items 1, 2 & 3a-d. this new manual log within 48 hours.
7. Implementation of Briefed plant management and HACCP Team April 30, 2009 Based on management and employee feedback, will work to
changes from conducted a HACCP training session review COA and letters of guarantee program within the
validation of the for all production employees on prerequisite on receiving/incoming materials.
written HACCP HACCP and outcome of the
program. validation.
September 2009
107
RECORDS—PRINCIPLE 7
Records that are being used to monitor control points should be placed in column #10 on the HACCP Plan
Summary Table. Records utilized in the total HACCP system may include the following. All of the following should be
documented. It is strongly recommended that an inventory (see example below) of all HACCP records be made as soon at the
HACCP written program has been completed. This inventory summary is very useful in evaluating the HACCP program to
make sure all identified records have actually been established in the HACCP system.
The HACCP Plan
• Listing of the HACCP team and assigned responsibilities,

• Statement of Intent
• Description of the dairy product and its intended use,
• Flow diagram for the entire dairy manufacturing process indicating CCPs,
• Monitoring system,
• Corrective action plans for deviations from critical limits,
• Procedures for verification of HACCP system,
• Records for all CCPs
• Hazard analysis
• Procedures for Validation
The following records must be available for review:
1. Training - Documentation showing that all individuals have been properly trained in their role in monitoring critical
control point(s) identified in the HACCP Plan Summary Table.
2. Processing
Records showing that the monitoring of the CCP is in place
Example for HTST or Vat Pasteurization: temperature records
Example for Magnetic flow meter-based Pasteurization: temperature and flow rate records
3. Deviation Logs
Documentation must be completed in the event of a deviation from a critical limit for a critical control point. A
centralized deviation/corrective action log is required under the NCIMS HACCP pilot program
4. Verification and Validation Records

Records showing that validation occurred at a minimum of annually or as necessary.
Records show a routine verification of control charts.
5. Records to show any major changes to the HACCP plan.
108 September 2009

SUBJECT ISSUE DATE
Centralized List of HACCP
Program Records
PLANT NAME SUPERSEDES PAGE
ADDRESS 109 of 53
The purpose of this checklist is to assist the plant HACCP team in demonstrating that those records normally
required. This checklist may also serve as a tool for internal and external HACCP auditors.
Record Most
Available Current Comments
Version
( = yes)
( = yes)
Required HACCP documents including forms are dated or identified with NA

current version number. Each page is marked with a new date or version
number whenever that page is updated. Most current versions used.
Table of Contents
Centralized List of HACCP Program Records
Document Change Log
Process Flow Diagram (s)
Product Description(s)
Written Hazard Analysis(s) for each product
CCP HACCP Plan Summary(s) for each product.
CCP Monitoring Documents
Centralized Deviation Log
HACCP System Verification Documentation (including calibration of CCP
monitoring equipment (i.e. past. equipment checks); review of CCP
monitoring records, corrective action records, and calibration records; and
plant signatures and date on these records)
HACCP System Validation Documentation (Annually or when changes are
made in raw materials or source of raw materials; product formulation;
processing methods or systems, including computers and their software;
packaging; finished product distribution systems; or the intended use or
intended consumers of the finished product and consumer complaints)
Prerequisite Program #1 – Safety of Water
 Monitoring Records related to this PP (list records by name)
 Nonconformity correction records related to this PP.
Prerequisite Program #2 – Condition and Cleanliness of Food Contact
Surfaces
 Monitoring Records related to this PP
Prerequisite Program #3 – Prevention of Cross-Contamination
Prerequisite Program #4 – Maintenance of Hand Washing and Sanitizing
and Toilet Facilities
Prerequisite Program #5 – Protection from Adulteration
September 2009
109
Record Most
Available Current Comments
Version
( = yes)
( = yes)

Prerequisite Program #6 – Proper Labeling, Storage, and Use of Toxic
Compounds
Prerequisite Program #7 – Control of Employee Health Condition
Prerequisite Program #8 – Exclusion of Pests
Other Prerequisite Programs that are relied upon in the Hazard Analysis to
reduce the likelihood of a potential hazard (List each separately, add rows
as needed)
Other Applicable NCIMS Requirements – Appendix K (list each separately,
add rows as needed)
 Monitoring Records related to these requirements
 Nonconformity correction records related to these requirements
SUMMARY
The first element of a successful HACCP plan is the completion of the seven principles. Training and
documentation are the second element to a successful plan. The hazard analysis and HACCP Plan Summary Table
become the effective working documents and must be utilized on a daily basis to insure production of safe and
wholesome dairy products.
EVALUATING AND REVISING HACCP SYSTEMS

A full review should take place at least annually, and should include:
 Verification of the HACCP Plan

 Validation of Hazard Analysis, CCPs, critical limits, and monitoring
 Assessment of CCP(s)
Other situations that trigger an evaluation:
 New potential hazard for that dairy food

- New pathogens
- New CCPs
 Existing HACCP out of date
- Processing equipment change
- Ingredient change
- Records not available
- Changes in production
- Problems discovered
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110
 Response to new dairy product development
- Raw materials change
- Preparation and processing change
- Formulation change
- Packaging change
- Distribution, storage, or display system change
- New uses of dairy product by consumers
 Response to manufacturing change
- Changes in dairy product flow in plant
- Equipment change
- Shift changes, especially if it affects cleaning
- Changes in storage or distribution
 Response to regulatory inspection/change
 Combination of above
- Increased risk of a hazard
- To strengthen program
- To document HACCP program
Documentation:
 Flow diagram
- Raw materials handling
- In process preparation
- Finished dairy product packaging and handling
- Storage and distribution
- Point of sale handling
- Intended use
 Ingredient specifications and supplier criteria
 Hazard categories of materials throughout process
 CCP critical limit monitoring records
 Complete Research & Development and Quality Assurance specifications for all materials
How to make evaluations:
 Check accuracy of flow diagram

 Check accuracy of description
 Evaluate Critical Control Points
Who should conduct an evaluation and implement program:
 Team Effort
- Research & Development
- Quality Assurance
- Outside help
September 2009
111
Department of Health and Human Services MILK PLANT, RECEIVING STATION OR TRANSFER STATION
Food and Drug Administration NCIMS HACCP SYSTEM AUDIT REPORT
DATE TYPE OF AUDIT
STATE REGULATORY* STATE REGULATORY FOLLOW-UP STATE LISTING FDA AUDIT OF LISTING
FIRM NAME LICENSE/PERMIT NO. IMS PLANT NO.
ADDRESS (Line 1)
ADDRESS (Line 2) CITY STATE ZIP CODE
IMS LISTED PRODUCT(S) MANUFACTURED AND REVIEWED Prerequisite Program(s) Issue Date(s)
Hazard Analysis HACCP Plan

Issue Date(s) Issue Date(s)
ITEMS MARKED DID NOT MEET THE NCIMS HACCP PROGRAM CRITERIA DESCRIBED BELOW
Starred  Items are Critical Listing Elements
*NOTE: This regulatory NCIMS System Audit Report of your plant, receiving station, or transfer station serves as a notification of the intent to suspend your permit if items marked on this audit report
are not in compliance at the time of the next regulatory audit or within established timelines. (Refer to PMO Sections 3 and 6, and Appendix K. for details.)
Section 1 HAZARD ANALYSIS Section 6 HACCP PLAN CORRECTIVE ACTION

A. Flow Diagram and Hazard Analysis conducted and written for each kind or A. Corrective actions when defined in the HACCP Plan were followed when
group of milk or milk product processed.** deviations occurred.
B. Written Hazard Analysis identifies all potential milk or milk product safety
hazards and determines those that are reasonably likely to occur (including B. Predetermined corrective actions defined in the HACCP Plan ensure the cause
hazards within and outside the processing plant environment). of the deviation is corrected.
C. Written Hazard Analysis reassessed after changes in raw materials, formulations, C. Corrective action taken for products produced during a deviation from CL(s)
processing methods/systems, distribution, intended use or consumers. defined in the HACCP Plan.**
D. Written Hazard Analysis signed and dated as required.
D. Affected milk or milk product produced during the deviation segregated and held,
Section 2 HACCP PLAN AND a review to determine product acceptability performed, AND
A. Written HACCP Plan prepared for each kind or group of milk or milk product corrective action taken to ensure that no adulterated milk and/or milk product
processed.** that is injurious to health enters commerce.
B. Written HACCP Plan implemented. E. Cause of deviation was corrected.

C. Written HACCP Plan identifies all milk or milk product safety hazards that are
reasonably likely to occur. F. Reassessment of HACCP Plan performed and modified accordingly.
D. Written HACCP Plan signed and dated as required.
G. Corrective actions documented.
Section 7 HACCP PLAN VERIFICATION & VALIDATION

Section 3 HACCP PLAN CRITICAL CONTROL POINTS (CCP) A. HACCP plan defines verification procedures, including frequency.
A. HACCP Plan lists CCP(s) for each milk or milk product safety hazard identified
B. Verification activities are conducted and comply with HACCP Plan.
as reasonably likely to occur.
B. CCP(s) identified are adequate control measures for the milk or milk product C. Reassessment of HACCP Plan conducted annually, OR
safety hazard(s) identified.
C. Control measures associated with CCP(s) listed are appropriate at the 1. After changes that could affect the hazard analysis, OR
processing step identified.
2. After significant changes in the operation including raw materials and/or
Section 4 HACCP PLAN CRITICAL LIMITS (CL) source, product formulation, processing methods/systems, distribution
A. HACCP Plan lists critical limits for each CCP. intended use or intended consumer.
B. CL(s) are adequate to control the hazard identified.** D. Calibration of CCP process monitoring instruments performed as required and at
C. CL(s) are achievable with existing monitoring instruments or procedures. the frequency defined in the HACCP Plan.**
D. CL(s) are met.
E. CCP monitoring records reviewed and document that values are within CL(s)
Section 5 HACCP PLAN MONITORING as required.
A. HACCP Plan defines monitoring procedures for each CCP. (what, how, F. Corrective action record reviewed as required.
frequency, whom, etc.)
B. Monitoring procedures as defined in the HACCP Plan followed. G. Calibration records and end product or in-process testing results defined in
HACCP Plan reviewed as required.
C. Monitoring procedures as defined in the HACCP Plan adequately measure
CL(s) at each CCP.
H. Records reviewed as required, including date and signature.
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D. Monitoring record data consistent with the actual value(s) observed during
the audit.
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Milk Plant, Receiving Station or Transfer Station – NCIMS HACCP SYSTEM AUDIT REPORT
ITEMS MARKED DID NOT MEET THE NCIMS HACCP PROGRAM CRITERIA DESCRIBED BELOW
Starred  Items are Critical Listing Elements
Section 8 HACCP SYSTEM RECORDS Section 10 OTHER NCIMS REQUIREMENTS
A. Required information included in the record, e.g., name/location of processor A. Incoming milk supply from NCIMS listed source(s) with sanitation scores
and/or date/time of activity and/or signature/initials of person performing of 90 or better or acceptable HACCP Listing.**
operation and/or identity of product/product code.
B. Drug residue control program implemented.**
B. Processing/other information entered on record at time observed.
C. Drug residue control program records complete.
C. Records retained as required, e.g., one year for refrigerated products and two
years for preserved, shelf-stable or frozen products.
D. Labeling compliance as required.
D. Records relating to adequacy of equipment or processes retained for 2 years.
E. Prevention of adulteration of milk products.
E. HACCP records correct, complete and available for official review
F. Regulatory samples comply with standards.
F. Information on HACCP records not falsified.**
G. Pasteurization Equipment design and construction.
Section 9 HACCP SYSTEM PREREQUISITE PROGRAMS (PPs)
H. Approved Laboratory Utilized - (if not, Rating not conducted)
A. Required PP written, implemented, and in substantial compliance by firm.
I. Other items as noted.
1. Safety of the water that comes into contact with milk or milk contact
surfaces (including steam and ice); Section 11 HACCP SYSTEM TRAINING (Individuals trained according to
Appendix K or alternatively, have equivalent job experience)
2. Condition and cleanliness of equipment milk contact surfaces. A. PPs developed by trained personnel.
3. Prevention of cross contamination from unsanitary objects and/or B. Hazard Analysis developed by trained personnel.
practices to milk and milk products, packaging material and other milk
contact surfaces, including utensils, gloves, outer garments, etc., and C. HACCP Plan developed by trained personnel.
from raw product to processed product;
D. HACCP Plan validation, modification or reassessment performed by trained
4. Maintenance of hand washing, hand sanitizing, and toilet facilities; personnel.
E. HACCP Plan records review performed by trained personnel.
5. Protection of milk and milk product, milk packaging material, and milk
contact surfaces from adulteration with lubricants, fuel, pesticides, Section 12 HACCP SYSTEM AUDIT FOLLOW-UP ACTION
cleaning compounds, sanitizing agents, condensate and other chemical,
physical and biological contaminants;
A. Previous audit findings corrected.
6. Proper labeling, storage, and use of toxic compounds.
B. Previous audit findings remain corrected at time of this audit.
7. Control of employee health conditions that could result in the microbio-
logical contamination of milk and milk products, milk packaging C. A series of observations that lead to a finding of a potential HACCP System
materials, and milk contact surfaces; and failure that is likely to result in a compromise to milk or milk product safety.**
B. Additional PP’s required or justified by the hazard analysis are written and
implemented by firm.
C. PP conditions and practices monitored as required
D. PP monitoring performed at a frequency to ensure conformance.

Refer to attached Audit Discussion sheet(s) for details.
E. Corrections performed in a timely manner when PP monitoring records reflect
deficiencies or non-conformities.
F. PP audited by firm.
G. PP monitoring records adequately reflect conditions observed.
H. PP signed and dated as required.
NAME OF AUDITOR(S) (Please Print
SIGNATURE DATE
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SIGNATURE DATE
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NCIMS HACCP SYSTEM AUDIT REPORT DISCUSSION SHEET
FIRM NAME DATE OF AUDIT
EXPLANATION OF DEVIATION/DEFICIENCIES/NON-CONFORMITIES THAT DID NOT

MEET
THE NCIMS HACCP PROGRAM CRITERIA
(Use additional sheets as necessary if entry field is non-expandable.)
NOTE: When State Regulatory Audits are conducted, timelines for corrections of all
identified deviations, deficiencies and non-conformities must be established.
Comments:
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Table of Contents for USA HACCP Program
1. Introduction:
a. Letter of Management Commitment...........................................................................................4
b. Principles of HACCP..................................................................................................................5
c. Background documents including page on company history including current products
covered under the HACCP program – news stories....................................................................6
d. Staff organizational chart for the plant operation........................................................................8
e. Front Plant view plus overheat view of the plant (floor layout) .................................................9
f. Product Flow diagram................................................................................................................10
g. Company policy on Hold and Release and returned product
disposition...................................................................................................................................11
h. Name of each HACCP team member with a brief bio for each. Include a log of team
meetings, who attended, date and time and agenda of meeting.................................................12
2. Plant GMPs and Prerequisite Program:

a. Written summary of ice cream plant GMPs...............................................................................14
b. Written description of ice cream plant prerequisites including a brief statement on
document control (will provide some examples):
i. Water Safety........................................................................................................................31
ii. Condition and Cleanliness of Processing Equipment – address pre-op startup
inspection, master sanitation schedule, and limited inclusion of Preventative
Maintenance to specific processing equipment preventative maintenance.......................32
iii. Cross-Contamination – micro-based hazards, raw to past. product, etc.............................35
iv. Adulteration:........................................................................................................................37
1. Chemical based micro hazards, allergens
2. Cleaning chemical and toxic compound labeling, use and storage
v. Temperature control – identify target temperatures for receipt of ingredients, storage
of ingredients, storage of final product(s) and distribution of final product(s)..................39
vi. Personnel Training, Employee, Visitor and Contractor Hygiene – see PMO
Section 13 & 14 for suggested items to be included in a company employee manual
or policy on this subject. Identify training frequency as part of documentation
supporting this prerequisite.................................................................................................40
vii. Receiving/Storage/Transport – address ingredient and package receiving, specifications,
storage and distribution of final product(s).........................................................................42
viii. Product Tracing and Market Withdrawals – include section on customer feedback
summary information and mock recall procedures.............................................................44
ix. Pest Control – include floor diagram and location of all pest stations, electrocutors, bait
stations, etc. Address frequency of review for outside contractor’s records......................49
x. Maintenance of hand washing, employee break room and bathroom facilities....................53
xi. Facility Maintenance – includes grounds and outside maintenance (buildings, fence
and everything between) and inside processing facility maintenance..................................54
xii. Air Safety – focused primarily at air entrainment into the ice cream mix during .freezing.55
c. Ingredient/Packaging Assessment................................................................................................56
3. Plant HACCP Plan:

a. Product description & Flow Diagrams
i. Product A...................................................................................................................57
ii. Product B...................................................................................................................59
iii. Product C...................................................................................................................61
iv. Product D...................................................................................................................63
v. Product E....................................................................................................................65
b. Hazard analysis for each product based on those hazards from the hazard identification ..........67
c. HACCP Plan summary table recording details of CCPs..............................................................72
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d. Corrective Action blank form with 5 standard steps – see IDFA recommended form...........73
e. Verification and Validation Narrative and forms....................................................................74
4. Appendix:
a. Summary of all records identified in the written HACCP program........................................79
b. Document change log that identifies date and items changed, with signature........................86
c. Pre-operational Start-up Checklist...........................................................................................87
d. Procedure and Record for the Metal Detector.........................................................................88
e. Daily Cleaning & Sanitation Log............................................................................................89
f. Monthly Internal Inspection Report Form...............................................................................90
g. Processing Equipment Maintenance Program and Form.........................................................91
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Model HACCP Programs
Model HACCP
Programs
MODEL HACCP PROGRAMS
Generic HACCP plans can serve as useful guidelines; however, it is essential that the
unique conditions within each dairy facility be considered during the development of a HACCP
plan. Subtle differences in product raw materials and manufacturing require managers to
examine CCPs line-by-line and plant-by-plant.
The following model/generic HACCP plans have been developed to serve as guidelines
upon which individuals can build their HACCP programs. A product description, flow diagram,
hazard analysis table, and CCP description table are included. Keep in mind, SIMPLE and
straightforward are the keys to a successful HACCP plan. Periodic reviews and modifications
are necessary, particularly where new steps, equipment or ingredients are added to processing, or
where new hazards are identified through outbreaks, industry experience or new scientific
evidence.
GRADE “A” PRODUCTS:
REDUCED FAT MILK (2%): The reduced fat milk model is based on a typical HTST system
(without a magnetic flow meter) and includes a CCP that was developed to address the presence
of vegetative pathogens in raw milk. This plan can be modified or adapted for other fluid white
milks (for example, Homogenized Milk, or Skim Milk) and pasteurization systems (for example,
magnetic flow meter systems, or vat pasteurization).
1% LOWFAT CHOCOLATE MILK: The lowfat milk model is based on a typical HTST
system (without a magnetic flow meter) and includes a CCP that was developed to address the
presence of vegetative pathogens in raw milk. This model utilizes pasteurized milk in the
formulation of the chocolate milk. This plan could be modified to utilize for other fluid white
milks (for example, raw milk, Homogenized Milk, or Skim Milk) and pasteurization systems (for
example, magnetic flow meter systems, or vat pasteurization) in the formulation of the chocolate
milk. Other considerations might include different sweetener systems and processing steps that
may introduce other hazards.
CULTURED LOWFAT BUTTERMILK: The cultured lowfat buttermilk model references

the reduced fat milk HACCP plan for the pasteurized milk ingredient. This model also utilizes a
freeze dried starter culture and is based on a traditional vat pasteurization system. This plan
could be modified to include preparation based on other starter culture systems. Other
considerations might include different pasteurization systems, acidification instead of culturing,
additional ingredients, and processing steps that might introduce additional hazards.
EGGNOG: The eggnog model includes receipt and storage of a pasteurized liquid eggnog base
that must be managed due to the allergen characteristics of eggs. This model utilizes a
traditional HTST pasteurization system for the finished product. Other considerations might
include differences in ingredients and pasteurization systems that might introduce additional
hazards.
ULTRA PASTEURIZED HALF AND HALF: The half and half model utilizes an ultra-high
temperature pasteurization system that provides an extended shelf life for this product. Two
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preservative ingredients are also added to this product. Other considerations would include
additional ingredients or processing steps that might introduce additional hazards.
CULTURED SOUR CREAM: The cultured sour cream model utilizes high temperature short
time pasteurization and direct set freeze-dried cultures for development of the correct pH level
prior to breaking. This is a full-fat product. Other options for a sour cream include lower-fat
products, acid-set versus culture set, vat culture development and vat pasteurization of the cream
prior to culturing or acid set.
LOWFAT PLAIN YOGURT WITH 1% MILKFAT: The lowfat plain yogurt model is based
on a typical HTST system (without a magnetic flow meter) and includes a CCP that was
developed to address the presence of vegetative pathogens in raw milk. This plan can be
modified or adapted for other non-flavored or non-fruited products such as nonfat plain yogurt.
This may also be adapted for different pasteurization systems (for example, magnetic flow meter
systems, and vat pasteurization). The model program for plain yogurt includes CCPs that were
developed to address dairy ingredient receiving, storage, and pasteurization. All non-dairy
incoming ingredients (dry and liquid) are assumed to be non-sensitive ingredients that do not
require time/temperature limitations for storage. Initial microbiological concerns for these
products are addressed in manufacturer specifications. A hazard analysis should be conducted if
any changes are made to the program to determine if the change creates a CCP.
STRAWBERRY PRE-STIRRED LOWFAT YOGURT WITH 1% BUTTERFAT: The

Strawberry Pre-Stirred Lowfat Yogurt model is based on a typical HTST system (without a
magnetic flow meter) and includes a CCP that was developed to address the presence of
vegetative pathogens in raw milk. This plan can be modified or adapted for other flavored or
fruited products such as coffee, lemon, blueberry or peach. This may also be adapted for
different pasteurization systems (for example, magnetic flow meter systems, and vat
pasteurization).
FROZEN DESSERTS:
VANILLA ICE CREAM: The vanilla ice cream model is based on a typical HTST system
(without a magnetic flow meter) and includes a CCP that was developed to address the presence
of vegetative pathogens in raw milk and other raw ingredients added before the pasteurization
step. The vanilla ice cream model includes dairy ingredient receiving, storage, pasteurization,
metal detection, including rework, meltdown and refreeze that can be removed depending on the
specific product and process. Any product held for meltdown is subject to contamination and
microbial growth and should be repasteurized. All non-dairy incoming ingredients (dry and
liquid) are assumed to be non-sensitive ingredients that do not require time/temperature
limitations for storage, unless noted. Initial microbiological concerns for these products are
addressed in manufacturer specifications. The possibility of allergen through the use of eggs in
French Vanilla Ice Cream need to be addressed in the hazard analysis.
ICE CREAM w/INGREDIENT: The ice cream with ingredients model based on a typical
HTST system (without a magnetic flow meter) and includes a CCP that was developed to
address the presence of vegetative pathogens in raw milk and other raw ingredients added before
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the pasteurization step. The ice cream with ingredients model includes dairy ingredient
receiving, storage, pasteurization, metal detection, including rework, meltdown and refreeze that
can be removed depending on the specific product and process. Any product held for meltdown
is subject to allergen contamination and microbial growth and should be repasteurized. All non-
dairy incoming ingredients (dry and liquid) are assumed to be non-sensitive ingredients that do
not require time/temperature limitations for storage, unless noted. Initial microbiological
concerns for these products are addressed in manufacturer specifications. The possibility of
allergen contamination must be included in and addressed by the hazard analysis. Serious
allergen problems from ingredients (i.e., peanuts, coloring, flavorings, stabilizers, etc.) and
improper labeling need to be including into HACCP program control measurers.
CHOCOLATE COATED ICE CREAM BAR: The chocolate coated bar model is based on a
typical HTST system (without magnetic flow meter) and includes a CCP that was developed to
address the presence of vegetative pathogens in raw milk and other raw ingredients added before
the pasteurization step. This plan can be modified or adapted for other stick novelties (extruded
bars, crunch bars, pops, etc.) and pasteurization systems (magnetic flow meter systems or vat
pasteurization).
NOVELTY: The novelty model is based on a typical HTST system (without magnetic flow
meter) and includes a CCP that was developed to address the presence of vegetative pathogens in
raw milk and other raw ingredients added before the pasteurization step. This plan can be
modified or adapted for other novelties (cups, tubes, cones, etc) or adapted for other novelties
and pasteurization systems (magnetic flow meter systems or vat pasteurization).
FROZEN YOGURT: The frozen yogurt model is based on a typical HTST system (without
magnetic flow meter) and includes a CCP that was developed to address the presence of
vegetative pathogens in raw milk and other raw ingredients added before the pasteurization step.
All non-dairy incoming ingredients (dry and liquid) are assumed to be non-sensitive ingredients
that do not require time/temperature limitations for storage. Initial microbiological concerns for
these products are addressed in manufacturer specifications. Rework and refreeze are addressed
in this model program, but can be removed depending on the specific process. Refreeze
indicates product sent immediately back to the flavor vat prior to refreeze and has little, if any,
storage time. Any product held for meltdown has the potential for microbial growth or allergen
cross-contamination. This plan can be modified or adapted for other bulk frozen yogurts and
pasteurization systems (magnetic flow meter systems or vat pasteurization).
CHEESES:
CHEESE STARTER: Cheese starters are typically combinations of bacteria that produce lactic
acid and flavor compounds during the cheesemaking and subsequent ripening processes. The
bacteria produce lactic acid from lactose in the milk, which assists the coagulating enzymes.
Further acid development in the curd lowers pH and expels moisture giving the finished cheese a
characteristic pH and moisture. During the cheese ripening process, enzymes from the starter
culture produce peptides, free fatty acids and organic acids that give the cheese its characteristic
flavor.
Starters may be added to the cheese vat as either bulk starters or frozen direct sets. Bulk starters
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are prepared ahead of the cheese make by fermentation in a pasteurized whey and / or milk based
culture medium. Pasteurization in this model is HTST, but it is common in the industry to utilize
vat pasteurization of the culture medium. This is required to eliminate pathogens and non starter
bacteria prior to inoculation. The bulk starter fermentation is typically inoculated with frozen
culture from a commercial starter manufacturer. Frozen direct sets cultures may also be
purchased from commercial starter manufacturers and are added directly to the cheese vat. All
commercial starter cultures are tested by the manufacturer to be free from pathogens and non
starter bacteria.
NATURAL SHREDDED AND CHUNK CHEESE: The model for these products should be
used with either the Cheddar Cheese model or the Mozzarella Cheese model since the flow
diagram begins at the point where the natural cheese has already been processed. Listeria as a
pathogen can be a significant issue and should be addressed specifically in the hazard analysis.
As there is not “kill” step for this product, pathogen control must result from effective
prerequisite programs and GMPs.
CHEDDAR CHEESE: The model program for cheddar cheese includes the use of bulk starter
and an HTST system for pasteurizing all dairy ingredients. This model is for the production of
cheddar cheese uses the stirred curd method with the curd placed in blocks that will be aged,
stored, and cut to consumer sized packages. All non-dairy incoming ingredients (dry and liquid)
are assumed to be non-sensitive ingredients that do not require time/temperature limitations for
storage. Initial microbiological concerns for these products are addressed in manufacturer
specifications. End product specifications involving parameters such as pH, salt, water activity
(Aw), and solids levels must be evaluated to ensure safety of the product. The model can be
modified for the production of cheddar cheese in 640 wooden boxes for commercial sale and
further processing. Careful attention must be given to all post-pasteurization contamination
issues. Cheddar cheese can be a template for All American and similar specialty cheese
varieties.
MOZZARELLA CHEESE: The typical mozzarella cheese process includes an additional

heating step beyond that for cheddar, which can provide an additional measure of microbial
lethality. However, the chill tank and brining step can also add the potential for growth of
additional psychotropics and pathogens. Careful attention must be given to all post-
pasteurization contamination issues i.e. cheese manufacturing ingredients, potential ingredients
added after brining (smoke), processing steps, etc.
The model program for mozzarella cheese includes CCPs that were developed to address dairy
ingredient receiving, storage, cream storage, pasteurization, and metal detection. All non-dairy
incoming ingredients (dry and liquid) are assumed to be non-sensitive ingredients that do not
require time/temperature limitations for storage. Initial microbiological concerns for these
products are addressed in manufacturer specifications. A hazard analysis should be conducted if
any changes are made to the program to determine if the change creates a hazard.
SWISS/EMMENTALER CHEESE: The model program for swiss/emmentaler cheese

includes the use of bulk starter and an HTST system for pasteurizing all dairy ingredients. This
model is for the production of cheddar cheese uses hydrogen peroxide, lactic & proprionic
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cultures and clotting enzymes, using the stirred curd method with the curd placed in
hoops that will be pressed, salted using brine, aged until proper eye formation, salted
again, stored for further curing, then cut to consumer sized packages. All non-dairy
incoming ingredients (dry and
liquid) are assumed to be non-sensitive ingredients that do not require time/temperature
limitations for storage. Initial microbiological concerns for these products are addressed
in manufacturer specifications. End product specifications involving parameters such as
pH, salt, water activity (Aw), and solids levels must be evaluated to ensure safety of the
product. Careful
attention must be given to all post-pasteurization contamination issues. The swiss cheese
model is based on manufacturing practices as defined in the federal standard of identify
and commonly used by U.S. manufacturers.
4% COTTAGE CHEESE: The cottage cheese model program includes CCPs for raw
milk receiving and storage, raw skim and cream storage, culture media pasteurization,
and pasteurization. All non-dairy incoming ingredients (dry and liquid) are assumed to be
nonsensitive ingredients that do not require time/temperature limitations for storage.
Initial microbiological concerns for these products are addressed in manufacturer
specifications. A hazard analysis should be conducted if any changes are made to the
program to determine if the change creates a CCP.
SOFT CHEESE: The model soft cheese of the Hispanic variety includes raw milk
receiving and storage, dairy and non-dairy ingredient receiving and storage, HTST
pasteurization of the dairy ingredients, vat cooking, use of moulds, metal detection,
storage and distribution. These types of cheese have a history of post-pasteurization
listeria contamination so extra focus should
be placed on the equipment and environmental cleaning prerequisites.
BUTTER: The model program for butter includes use of raw milk and cream as
incoming
ingredients. Necessary prerequisites address cream receiving, dairy ingredient storage,
HTST pasteurization, and metal detection. The butter type used in this model utilizes
microfix technology and captures buttermilk for other uses. A hazard analysis should be
conducted if changes are made to the program to determine if the change creates a
hazard.
DRIED DAIRY PRODUCTS: This category of dairy products includes dried milk
products, dried whey products and dried lactose products. Dried milk products include
such product as full fat dried milk, partial fat dried milks, nonfat dried milk products and
skim milk powder products. Dried whey products include such products such as various
percentages of whey powder, whey protein isolate, and whey protein concentrates. These
products originate from various cheese-making operations and therefore, their HACCP
Plans will address all processing steps after draining of the whey from the cheese curds.
Dried lactose products are derived from the whey stream and therefore, the HACCP Plan
will address processing steps after being filter-separated from the liquid whey stream.
123
IDFA
GRADE “A” PRODUCT
HACCP MODELS
124
[Somebody’s Plant Name]
[Street Address]
[Anywhere, State, Country Zip]
Product Description Form

Formal Product Name: Reduced Fat Milk (2%)
Food Safety Characteristics: Support growth of a number of pathogens. No natural protective

characteristics.
Ingredient Statement Reduced Fat Milk, Vitamin A Palmitate, Vitamin D3
Packaging Used: High Density Polyethylene gallon container with a polypropylene snap-on
screw-off tamper evident cap. Labels are self adhesive and applied prior to
filling. Code date is printed via coding equipment after capping
Labeling Requirements: Keep refrigerated, Grade “A”, Pasteurized, Homogenized, Vitamin A & D
added, 30% less fat than regular milk
Storage and Distribution: Product is cased in standard milk cases – four units per case. Temperature
of storage is  45°F. Distributed using refrigerated trucks ( 45°F) to
wholesale and retail outlets.
Intended Use: Ready to serve product. May also be used as an ingredient in preparing
meals.
Approved by: ______________________________
Date: _____________________________________
125
REDUCED FAT MILK (2%)
HACCP FLOW CHART
Raw Milk Receiving
Raw Milk Filtration
Raw Milk Storage
Raw Milk Regenerator
Separator
Heat Treated Cream Storage
Vitamin Addition Homogenizer
HTST 1
Pasteurized Milk Regenerator
Pasteurized Milk Cooling
Pasteurized Milk Storage
Filling Packaging Material
Cold Storage & Distribution
126
Reduced Fat Milk (2%) Hazard Analysis Summary Table
Product Name:_________________________________ Plant Name: ____________________________________________
Date:__________________________________________________ Plant Address:_____________________________________________________
Q1. Is the hazard

identified at this
step of sufficient
Identify the likelihood of
Potential Hazard occurrence to Q3 – Q6. Does a control measure
Process warrant its control? exist at this step to prevent, reduce
Step/  Biological (B)  If "yes", then or eliminate the likely occurrence of
Ingredient  Chemical (C) proceed to Q3 Q2. Identify the Prerequisite Program or procedure step which a hazard to an acceptable level?
or Input  Physical (P)  If "no", stop and reduces the likelihood or severity of the hazard to ensure that control If “yes”, document as a CCP
document at Q2 at this step is not necessary. If “no”, indicate where this will
happen.
Raw Milk B – Vegetative Yes None No – Control will occur at
Receiving Pathogens pasteurization
C - Toxins from No 1. Supplier guarantee program and incoming ingredient PP
temperature abuse
C – Beta Lactam No 2. Incoming ingredient PP following the guidelines established under
Drug Residues Appendix N of the PMO.
Filtration B – Vegetative No 1. Filtration PP – clean or replace daily
Pathogens
P – Foreign Material No 2. Equipment cleaning and equipment maintenance PP in place to ensure
foreign materials removed.
Raw Milk B – Vegetative No 1. Temperature control PP
Storage Pathogens growth
C - Toxin Production No 2. Temperature control PP
C – Contamination No 3. Equipment cleaning PP
from Residual
Cleaning and
Sanitizing Agents
Raw Milk B – Vegetative No 1. Equipment cleaning PP
Regenerator Pathogens
Separator / B – Vegetative No 1. Equipment cleaning PP
Clarifier Pathogens
Heat Treated B – Vegetative No 1. Equipment cleaning PP
Cream Pathogens
Storage C - Toxin Production No 2. Temperature control PP
from Residual
Cleaning and
Sanitizing Agents
127
Q1. Is the hazard
identified at this
step of sufficient
Identify the likelihood of
Potential Hazard occurrence to Q3 – Q6. Does a control measure
Process warrant its control? exist at this step to prevent, reduce
Step/  Biological (B)  If "yes", then or eliminate the likely occurrence of
Ingredient  Chemical (C) proceed to Q3 Q2. Identify the Prerequisite Program or procedure step which a hazard to an acceptable level?
or Input  Physical (P)  If "no", stop and reduces the likelihood or severity of the hazard to ensure that control If “yes”, document as a CCP
document at Q2 at this step is not necessary. If “no”, indicate where this will
happen.
Vitamin C – Vitamin Toxicity No 1. Vitamin control PP to monitor and reconcile vitamin usage and
Addition calibrate equipment.
Homogeniza B – Vegetative No 1. Equipment cleaning PP in place regarding cleaning, sanitizing and
tion Pathogens inspection of equipment.
Pasteuriza- B – Vegetative Yes None Yes – control of pathogens from prior

tion (HTST Pathogens steps
without a C – Boiler Additives No 1. Water Safety PP controls us of boiler additives to meet
magnetic 21CFR173.310 in the water safety pre-requisite program..
flow meter
system)
Pasteurized B – Cross No 1. Equipment maintenance PP
Milk Contamination with
Regenerator Raw Milk Containing
Pathogens
Pasteurized C – Cross No 1. Equipment maintenance & cleaning PP
Milk Contamination with 2. Water safety PP in place to meet 21CFR184.1666 and
Cooling Cooling Water 21CFR182.6285 as well as microbiological standards.
Additives (Glycol)
Pasteurized B – Vegetative No 1. Temperature control and equipment cleaning PP.
Milk Pathogen Growth
Storage C – Contamination No 2. Equipment cleaning PP
from Residual
Cleaning and
Sanitizing Agents
Packaging P – Foreign Material No 1. COA/supplier guarantee program as well as an incoming materials PP
Material
Filling B – Vegetative No 1. Equipment cleaning and equipment maintenance PP
Pathogens
129
P – Foreign Material No 2. Equipment/filter maintenance/filter PP
(metal)
from Residual
Cleaning and
Sanitizing Agents
Refrigerated B – Pathogens No Packaged product protected from all common hazards
Storage and C – Contaminants No
Distribution P – Foreign Materials No
130
HACCP PLAN SUMMARY TABLE
Product Name: REDUCED FAT MILK (2%)
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Critical Control Hazards Critical Limits Monitoring Corrective Verification Records
Point (CCP) for each Control Measure Action(s)

Milk and Milk Biological- Time & Temperature at Continuou At least Pasteuri Manually divert flow of Record Review CCP Records -
Products Vegetative Temperature. the exit of the s Temp. once per zer product Pasteurizer Charts
Pasteurization Pathogens 161°F for minimum holding tube Recorder shift by Operator Pasteurizer
(HTST and HHST) (non-spore formers) of 15 seconds Chart the Isolate the affected charts verified Corrective Action
operator product including cut-in Records
Residence time in and cut-out
the holding tube Evaluate and determine performed, CCP Verification-
in continuous disposition of the indicating versus Records, including
flow pasteurizers Flow Continuou Pasteuri product (reprocess or recording temps equipment testing
Note: Assuring that with magnetic Recorder s during zer disposal) compared, seal records
the minimum holding flow meter based Chart Operation Operator checks made,
times are met in timing systems Document actions authorized
systems which use a supervisory
sealed timing pump Note: Utilize 5 review and sign-
would be CCP corrective action steps off of recording
verification, i.e. recognized by NCIMS charts
equipment HACCP program
calibration Equipment
Function
Checks
Product Description: ___________________________________________________________________________

Firm Name: _______________________Firm Address: ________________________________________________
Method of Storage & Distribution: _________________________________________________________________
Intended Use & Consumer: _______________________________________________________Signature: ______________________________________________Date: __________________
131
[Street Address]

Formal Product Name: 1% Lowfat Chocolate Milk

characteristics.
Ingredient Statement Lowfat Milk, Cocoa powder, HFCS, Vitamin A Palmitate, Vitamin D3
Packaging Used: High Density Polyethylene gallon container with a polypropylene snap-on
screw-off tamper evident cap. Labels are self adhesive and applied prior to
filling. Code date is printed via coding equipment after capping.
added
Storage and Distribution: Product is cased in standard milk cases – four units per case. Temperature
of storage is  45°F. Distributed using refrigerated trucks ( 45°F) to
meals.
Approved by: ______________________________
Date: _____________________________________
132
1% LOWFAT CHOCOLATE MILK
HACCP FLOW CHART
Issue Date: __________ Signature: ____________
Raw Milk Receiving
Raw Milk Filtration
Raw Milk Storage
Raw Milk Regenerator HTST #1
Vitamin Addition
Separator
Homogenizer Liquid Sugar Receiving
Heat Treated HTST #1 Liquid Sugar Storage

Ingredient
Cream Storage Cocoa Flavor
Receiving
Heat Treated Regenerator & Cooler

Cream Loadout HTST #1 Cocoa Flavor
Storage
Batch Tank Blender -

Ingredient Addition
Raw Regenerator HTST #2
Homogenizer
HTST #2
Regenerator & Cooler HTST #2
Pasteurized Storage
Packaging Material Filler Cold Storage and Distribution
133
1% Lowfat Chocolate Milk Hazard Analysis Summary Table
Q1. Is the hazard

identified at this
step of sufficient Q3 – Q6. Does a control measure
Identify the likelihood of exist at this step to prevent, reduce
Potential Hazard occurrence to or eliminate the likely occurrence of
Process warrant its control? a hazard to an acceptable level?
Step/  Biological (B)  If "yes", then Q2. Identify the Prerequisite Program or procedure step which If “yes”, document as a CCP
Ingredient  Chemical (C) proceed to Q3 reduces the likelihood or severity of the hazard to ensure that control If “no”, indicate where this will
or Input  Physical (P)  If "no", stop and at this step is not necessary. happen.
document at Q2
C - Toxins from No 1. Supplier guarantee program and incoming ingredient PP
temperature abuse
Pathogens
P – Foreign Material No 2. Equipment cleaning and equipment maintenance PP in place to ensure
foreign materials removed.
Raw Milk B – Vegetative No 1. Temperature control PP
from Residual
Cleaning and
Sanitizing Agents
Raw Milk B – Vegetative No 1. Equipment cleaning PP
Regen. #1 Pathogens
Separator / B – Vegetative No 1. Equipment cleaning PP
Clarifier Pathogens
Heat Treated B – Vegetative No 1. Temperature Management PP
Cream Pathogens
Storage C - Toxin Production 2. Temperature Management PP
C – Contamination No 3. Equipment cleaning and temperature control PP
from Residual
Cleaning and
Sanitizing Agents
Vitamin C – Vitamin Toxicity No 1. Vitamin control PP to monitor and reconcile vitamin usage and
Addition calibrate equipment.
Homogeniza B – Vegetative No 1. Equipment cleaning PP
tion Pathogens
134
Q1. Is the hazard
identified at this
document at Q2
tion #1 Pathogens steps
(HTST C – Boiler Additives No 1. Water Safety PP controls us of boiler additives to meet 21CFR173.310
without a in the water safety pre-requisite program..
mag.. flow
meter)
Pasteurized B – Cross No 1. Equipment maintenance PP addresses equipment function
Milk Regen. Contamination with
#1 Raw Milk Containing
Vegetative Pathogens
Pasteurized C – Cross No 1. Equipment maintenance and water safety PP in place to meet
Milk Contamination with 21CFR184.1666 and 21CFR182.6285 as well as microbiological
Cooling #1 Cooling Water standards.
Additives (Glycol)
Liquid B – Vegetative No 1. COA/Supplier guarantee program and equipment cleaning PP
Sugar Pathogens
Receiving C – Contaminates No
P – Foreign material No
Liquid B – Vegetative No 1. Equipment cleaning & UV light PP
Sugar Pathogens
Storage C – Residual cleaning No
and sanitizing agents
Cocoa B – Vegetative No 1. COA/Supplier guarantee program and incoming ingredient storage PP
Flavor Pathogens
and Storage P – Foreign material No
Blender – B – Vegetative No 1. Equipment cleaning PP
Ingredient Pathogens
Addition P – Foreign Material No 2. Material Handling GMP
(packaging material,
pallet fragments,
foreign objects in
ingredients)
Batch Tank B – Vegetative No 1. Equipment cleaning PP
Pathogens
Raw Milk B – Vegetative No 1. Equipment cleaning and equipment maintenance PP
135
Q1. Is the hazard
identified at this
document at Q2
Regen. #2 Pathogen
Homogeniza B – Vegetative No 1. Equipment cleaning and equipment maintenance PP
tion Pathogens
tion #2 Pathogens steps
(HTST C – Boiler Additives No 1. Water Safety PP controls us of boiler additives to meet 21CFR173.310
without in the water safety pre-requisite program..
mag. flow
meter)
Pasteurized B – Cross No 1. Equipment maintenance PP address equipment function
Milk Regen. Contamination with
#2 Raw Milk Containing
Pathogens
Pasteurized C – Cross No 1. Equipment maintenance & cleaning PP.
Milk Contamination with 2. Water safety PP in place to meet 21CFR184.1666 and
Cooling #2 Cooling Water 21CFR182.6285 as well as microbiological standards.
Pasteurized B – Vegetative No 1. Temperature management PP
Milk Pathogen Growth
Storage C – Contamination No 2. Equipment cleaning and sanitizing PP
from Residual
Cleaning and
Sanitizing Agents
Packaging P – Foreign Material No 1. COA/supplier guarantee program and incoming materials storage PP
Material
Pathogen
P – Foreign Material No
C – Contamination No
from Residual
Cleaning and
Sanitizing Agents
Refrigerated B – Vegetative No Package product protected from all common hazards
Storage and Pathogens
Distribution C – Contaminants No
P – Foreign Materials No
136
Product Name: CHOCOLATE LOWFAT MILK (2%)
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

Pasteurizer #1 & #2: Biological- Time & Temperature. Temperatu Continuou At least Pasteuri Manually divert flow of Record Review CCP Records -
Milk and Milk Vegetative 161°F for minimum re at the s Temp. once per zer product Pasteurizer Charts
Products Pathogens of 15 seconds exit of the Recorder shift by Operator Pasteurizer
Pasteurization (non-spore formers) holding Chart the Isolate the affected charts verified Corrective Action
(HTST and HHST) tube operator product including cut-in Records
and cut-out
Evaluate and determine performed, CCP Verification-
Residence disposition of the indicating versus Records, including
Note: Assuring that time in the Flow Continuou Pasteuri product (reprocess or recording temps equipment testing
the minimum holding holding Recorder s during zer disposal) compared, seal records
times are met in tube in Chart Operation Operator checks made,
systems which use a continuous Document actions authorized
sealed timing pump flow supervisory
would be CCP pasteur- Note: Utilize 5 review and sign-
verification, i.e. izers with corrective action steps off of recording
equipment calibration magnetic recognized by NCIMS charts
flow meter HACCP program
based Equipment
timing Function
systems Checks

137
[Street Address]

Formal Product Name: Cultured Lowfat Buttermilk
Food Safety Characteristics: Support growth of a number of pathogens, although pH does retards some
pathogen growth.
Ingredient Statement Nonfat Milk, cultures, enzymes, Vitamin A Palmitate, Vitamin D3
Packaging Used: Multi-layered paperboard with outer and inner wax coating, skived edges,
and heat-sealed gable-top pouring spout in pint, quart, half-gallon and
gallon sizes. Code date is printed via coding equipment after pouring
spout is sealed.
Labeling Requirements: Keep refrigerated, Grade “A”, Pasteurized

Storage and Distribution: Product is cased in standard milk cases. Temperature of storage is  45°F.
Distributed using refrigerated trucks ( 45°F) to wholesale and retail
outlets.
Intended Consumers: Consumers primarily institutional, bakeries and elderly retail customers.
Intended Use: Ready to serve product. May also be used as an ingredient in baking.
Approved by: ______________________________
Date: _____________________________________
138
CULTURED LOWFAT BUTTERMILK
HACCP FLOW CHART
Pasteurized / Homogenized 0.5% Fat Milk Storage

(See Reduced Fat Milk HACCP flow chart)
Dry Ingredient Receiving

and Storage
(Salt)
Blender
VAT PASTEURIZATION
Freeze Dried Starter Culture

Receipt and Storage
Set Tank
(hot water and glycol jackets)
Packaging Receipt and Storage
Filler
Storage and Distribution
139
Cultured Lowfat Buttermilk Hazard Analysis Summary Table
Q1. Is the hazard

identified at this step
of sufficient likelihood Q3 – Q6. Does a control measure
Identify the of occurrence to exist at this step to prevent,
Potential Hazard warrant its control? reduce or eliminate the likely
Process Step/  If "yes", then Q2. Identify the Prerequisite Program or procedure step which occurrence of a hazard to an
Ingredient or  Biological (B) proceed to Q3 reduces the likelihood or severity of the hazard to ensure that acceptable level?
Input  Chemical (C)  If "no", stop and control at this step is not necessary. If “yes”, document as a CCP
 Physical (P) document at Q2 If “no”, indicate where this will
happen.
Pasteurized / B – Vegetative Yes None No – Control will occur at
Homogenized Pathogens pasteurization step
Lowfat Milk C - Toxins No 1. Temperature control and equipment cleaning PP
Storage Production
from Residual
Cleaning and
Sanitizing Agents
Dry B – Vegetative No 1. COA/supplier guarantee and incoming ingredient storage PP
Receiving and C – Contaminates No
Storage P – Foreign material No
Blender – B – Vegetative Yes None No – Control will occur at
Ingredient Pathogens pasteurization step
Addition P – Foreign Material No 1. Equipment cleaning PP
(packaging material, 2. Material Handling GMP
pallet fragments,
foreign objects in
ingredients)
Vat B – Vegetative Yes None Yes – control of pathogens from
Pasteurization Pathogens prior steps
C – Boiler Additives No 1. Water safety PP in place that meets 21CFR173.310
Freeze Dried B – Vegetative No 1. COA/supplier guarantee and incoming ingredient storage PP
Starter Pathogens
Culture C – Contaminates No
Receipt and P – Foreign material No
Storage
140
Q1. Is the hazard
of sufficient likelihood Q3 – Q6. Does a control measure
Identify the of occurrence to exist at this step to prevent,
Potential Hazard warrant its control? reduce or eliminate the likely
Process Step/  If "yes", then Q2. Identify the Prerequisite Program or procedure step which occurrence of a hazard to an
Ingredient or  Biological (B) proceed to Q3 reduces the likelihood or severity of the hazard to ensure that acceptable level?
Input  Chemical (C)  If "no", stop and control at this step is not necessary. If “yes”, document as a CCP
 Physical (P) document at Q2 If “no”, indicate where this will
happen.
Set Tank B – Vegetative No 1. Equipment cleaning PP
Pathogens
C – Contamination No 2. Water safety PP in place for cooling water additives to meet
by boiler additives 21CFR184.1666 and 21CFR182.6285. Boiler additives meet
or glycol 21CFR173.310 in the water safety pre-requisite program.
from Residual
Cleaning and
Sanitizing Agents
Packaging P – Foreign Material No 1. COA/supplier guarantee and incoming materials storage PP
Material
Pathogen s
C – Contamination No
from Residual
Cleaning and
Sanitizing Agents
Refrigerated B – Vegetative No Packaged product protected from all common hazards.
P – Foreign No
Materials
141
Product Name: Cultured Lowfat Buttermilk
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

Vat Pasteurization B – Vegetative Pathogens The temperature as measured by Temperature Check and Thermometer Pasteurizer / Continue pasteurization until time 1. Indicating vs Temperature charts
(with continuous agitation) the air space indicating (°F) sign-off on checks done at Operator / temperature criteria are met. recording thermometer
thermometer must be at a recording beginning and comparison. Corrective action
minimum of 145°F. Time (Min) charts. end of holding If more than two hours has 2. Supervisory review records.
time. elapsed isolate the product and and sign-off on
The holding time must be a Record both contact QA. recording charts. CCP verification
minimum of 30 minutes. air space and Annotate the 3. Equipment records.
indicating batch Disposition the product. calibration.
The air space thermometer must Time (Min) thermometer information Calibration of Equipment calibration
indicate a minimum of 150°F. temperatures. for each batch Document actions. thermometers. records.
on the 4. Time calibration of
recording chart controller.
chart. 5. Seal checks.
Product Description: ___________________________________________________________________________________________________________________________________________

Firm Name: ______________________________________________________________________Firm Address: ________________________________________________________________
Method of Storage & Distribution: ________________________________________________________________________________________________________________________________
142
[Street Address]

Formal Product Name: Eggnog

characteristics.
Ingredient Statement Lowfat Milk, eggnog flavor base, nutmeg, Vitamin A Palmitate, Vitamin
D3
and heat-sealed gable-top pouring spout in pint, quart, and half-gallon
sizes. Code date is printed via coding equipment after pouring spout is
sealed.
added, “contains pasteurized eggs” on prinicipal display panel for allergen
concerns
outlets.
Intended Consumers: Primarily consumed by adults during holiday and New Years season.
other drinks, sometimes alcoholic in nature.
Approved by: ______________________________
Date: _____________________________________________
143
EGGNOG
HACCP FLOW CHART
Raw Milk Receiving
Raw Milk Storage

Liquid
Ingredient Receiving
(Pasteurized Eggnog Base)
Raw Cream Storage Batch Tank
HTST
Pasteurized Storage
Packaging Filler
Cold Storage & Distribution
144
EGGNOG Hazard Analysis Summary Table
Q1. Is the hazard

identified at this
Identify the likelihood of Q2. Identify the Prerequisite Program or procedure step which exist at this step to prevent, reduce
Potential Hazard occurrence to reduces the likelihood or severity of the hazard to ensure that control or eliminate the likely occurrence of
Process Step/ warrant its control? at this step is not necessary. a hazard to an acceptable level?
Ingredient or  Biological (B)  If "yes", then If “yes”, document as a CCP
Input  Chemical (C) proceed to Q3 If “no”, indicate where this will
 Physical (P)  If "no", stop and happen.
document at Q2
C - Toxins No 1. Supplier guarantee program and incoming ingredient PP
Production
Raw Milk B – Vegetative No 1. Temperature management PP
Storage Pathogens Growth
C - Toxins No 2. Temperature management PP
Production
from Residual
Cleaning and
Sanitizing Agents
Raw Cream B – Vegetative No 1. Temperature management PP
C - Toxins No 2. Temperature management PP
Production
from Residual
Cleaning and
Sanitizing Agents
145
Q1. Is the hazard
identified at this
document at Q2
Liquid B – Vegetative No 1. COA/supplier guarantee and incoming ingredient storage PP
Ingredient Pathogen-Presence 2. Temperature Management PP
Receiving and & Growth
Storage C – Contaminants No
(Pasteurized (egg is an allergen) 3. COA/supplier guarantee and incoming ingredient storage PP
Eggnog Base)
Batch Tank B – Vegetative Yes None No – Control will occur at
Pathogens pasteurization
Pasteurization B – Vegetative Yes None Yes – control of pathogens from prior
(HTST Pathogens steps
without mag. C – Boiler No 1. Water Safety PP controls us of boiler additives to meet 21CFR173.310
flow meter) Additives in the water safety pre-requisite program..
Eggnog Pathogen Growth
Storage C – Contamination No 2. Equipment cleaning and sanitizing PP
from Residual
Cleaning and
Sanitizing Agents
Packaging P – Foreign No 1. COA/supplier guarantee program and incoming materials storage PP
Material Material
Receiving &
Storage
Pathogens
P – Foreign
Material
C – Contamination
from Residual
Cleaning and
146
Q1. Is the hazard
identified at this
document at Q2
Sanitizing Agents
Refrigerated B – Vegetative No Packaged product protected from all common pathogens.
Storage and Pathogens No
P – Foreign
Materials
147
Product Name: EGGNOG
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

Milk and Milk Biological- Time & Temperature. Temperatu Continuou At least Pasteuri Manually divert flow of Record Review CCP Records -
Products Vegetative 175°F for minimum re at the s Temp. once per zer product Pasteurizer Charts
Pasteurization Pathogens of 25 seconds exit of the Recorder shift by Operator Pasteurizer
(HTST and HHST) (non-spore formers) holding Chart the Isolate the affected charts verified Corrective Action
tube operator product including cut-in Records
and cut-out
based Equipment
timing Function
systems Checks

148
[Street Address]

Formal Product Name: Ultra-Pasteurized Half and Half

characteristics.
Ingredient Statement Nonfat Milk, milk, HFCS, artificial color, sugar, dipotassium phosphate,
sodium citrate, mono & diglycerides, carrageenan, natural and artificial
flavors, Vitamin A Palmitate
and heat-sealed gable-top pouring spout in half-pint, pint, and quart sizes.
Code date is printed via coding equipment after pouring spout is sealed.
Labeling Requirements: Keep refrigerated after opening, Grade “A”, Ultra-Pasteurized
outlets.
Intended Consumers: Primarily consumed by adults in coffee and tea as well as some use by
consumer and commercial bakers.
Intended Use: Ready to serve product as flavor enhancer for coffee and tea. May also be
used as an ingredient for baking by individual consumers and commercial
bakeries.
Approved by: ______________________________
Date: _____________________________________
149
ULTRA PASTEURIZED HALF AND HALF
HACCP FLOW CHART
Heat Treated
Raw Milk Receiving Food Additive Receiving Cream Receiving
Raw Milk Storage Food Additive Storage Cream Storage
Pre Blend Silo
Homogenizer
UHT PASTEURIZER
Pasteurized Half and Half Storage
Packaging Material
Receipt and Storage
UP Filler
Storage and Distribution
150
Ultra-Pasteurized Half & Half Hazard Analysis Summary Table
Q1. Is the hazard

of sufficient Q3 – Q6. Does a control
Identify the likelihood of Q2. Identify the Prerequisite Program or procedure step which measure exist at this step to
Potential Hazard occurrence to reduces the likelihood or severity of the hazard to ensure that prevent, reduce or eliminate
Process Step/ warrant its control? control at this step is not necessary. the likely occurrence of a
Ingredient or  Biological (B)  If "yes", then hazard to an acceptable level?
Input  Chemical (C) proceed to Q3 If “yes”, document as a CCP
 Physical (P)  If "no", stop and If “no”, indicate where this
document at Q2 will happen.
Raw Milk B - Vegetative Yes None No – Control will occur at
C - Toxin No 1. Supplier guarantee program and incoming ingredient PP
Production
C - Beta Lactam No 2. Incoming ingredient PP following the guidelines established under
Raw Milk B - Vegetative No 1. Temperature management PP
C - Toxin No 2. Temperature management PP
Production
C - Residual No 3. Equipment cleaning PP
Cleaning and
Sanitizing Agents
Heat Treated B - Vegetative Yes None No – Control will occur at
Cream Pathogens pasteurization
Receiving C - Toxin No 1. Supplier guarantee program and incoming ingredient PP
Production
C - Beta Lactam No 2. Incoming ingredient PP following the guidelines established under
Heat Treated B - Vegetative No 1. Temperature management PP
Cream Pathogens Growth
Storage C - Toxin No 2. Temperature management PP
Production
C - Residual 3. Equipment cleaning PP
Cleaning and No
Sanitizing Agents
151
Q1. Is the hazard
Food B - Vegetative No 1. COA/supplier guarantee
Additive Pathogens 2. Incoming ingredient & storage PP
Ingredient P - Foreign material No
Receiving & C - Hazardous No
Storage material
(Disodium
Phosphate,
Sodium
Citrate.,etc)
Pre – Blend B - Vegetative No 1. Temperature management PP
Silo Pathogens Growth
production
C - Residual 3. Equipment cleaning PP
Cleaning and No
Sanitizing Agents
Homogenizati B - Vegetative No 1. Equipment cleaning PP

on Pathogens
Pasteurization B - Vegetative Yes None Yes – CCP for control of
(UHT without Pathogens pathogens from prior steps
a magnetic C - Boiler Additives No 1. PP for Water Safety controls use of boiler additives to meet
flow meter 21CFR173.310.
system)
Pasteurized B - Vegetative No 1. Temperature management PP
Half & Half Pathogens Growth
Production
C - Residual No 2. Equipment cleaning PP
Cleaning and
Sanitizing Agents
152
Q1. Is the hazard
Packaging B - Vegetative No 1. COA/supplier guarantee program and incoming materials storage PP
Material Pathogens
Receiving and P - Foreign material No
Storage C - Hazardous No
material
Filling B - Vegetative No 1. Equipment cleaning and equipment maintenance PP
Pathogens
P - Foreign Material No
C - Residual No
Cleaning and
Sanitizing Agents
Refrigerated B - Vegetative No Packaged product protected from all common pathogens.
Distribution C - Contaminants No
P - Foreign No
Materials
153
Product Name: ULTRA PASTEURIZED HALF AND HALF
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

Milk and Milk Biological- Time & Temperature. Temperatu Continuou At least Pasteuri Manually divert flow of Record Review CCP Records -
Products Vegetative 260°F for minimum re at the s Temp. once per zer product Pasteurizer Charts
UHT Heat Treatment Pathogens of 2 seconds exit of the Recorder shift by Operator Pasteurizer
(non-spore formers) holding Chart the Isolate the affected charts verified Corrective Action
tube operator product including cut-in Records
and cut-out
based Equipment
timing Function
systems Checks

154
[Street Address]

Formal Product Name: Cultured Sour Cream

characteristics.
Ingredient Statement Cultured cream, nonfat milk, nonfat dry milk, food starch – modified, guar
gum, sodium citrate, carrageenan, locust bean gum, enzymes and cultures
Packaging Used: High Density Polypropylene in 8 oz, 12 oz, 16 oz, 24 oz, 3 pound, 5-pound
and 30-pound containers with a high-density polypropylene tamper evident
snap cap with heat-shrink plastic band. Code date is printed via coding
equipment after capping on the bottom.
Labeling Requirements: Keep refrigerated, Grade “A”, Pasteurized, Cultured
Storage and Distribution: Packed in corregated boxes with plastic liner. Product is cased in standard
milk cases. Temperature of storage is  45°F. Distributed using
refrigerated trucks ( 45°F) to wholesale and retail outlets.
Intended Consumers: Consumed by the general public of all ages and well as retail restaurants
and institutions serving captured populations.
Intended Use: Ready to serve product. May also be used as an ingredient for dips, ready-
to-eat salads and ethnic foods, both by consumers and for commercial
purposes.
Approved by: ______________________________
Date:_____________________________________
155
CULTURED SOUR CREAM FLOW
CHART
DRY INGREDIENT RECEIVING
RAW MILK RECEIVING

Heat Treated
Cream Receiving
SOCK FILTER
HEAT TREATED
CREAM STORAGE
RAW MILK STORAGE
BLENDING
RAW MILK REGENERATION
PASTEURIZATION
CULTURE
ADDITION SOUR CREAM SET
PACKAGING
RECEIVING
SOUR CREAM BREAK
PACKAGING PACKAGING & BANDING

STORAGE METAL
DETECTOR
CASING
REFRIGERATED
STORAGE
DISTRIBUTION
156
Cultured Sour Cream Hazard Analysis Summary Table
Q1. Is the hazard

identified at this
Identify the likelihood of Q2. Identify the Prerequisite Program or exist at this step to prevent, reduce
Potential Hazard occurrence to procedure step which reduces the or eliminate the likely occurrence of
Process Step/ warrant its control? likelihood or severity of the hazard to a hazard to an acceptable level?
Ingredient or  Biological (B)  If "yes", then ensure that control at this step is not If “yes”, document as a CCP
Input  Chemical (C) proceed to Q3 necessary. If “no”, indicate where this will
document at Q2
Dry Ingredient B – Vegetative No 1. COA/supplier guarantee
Receiving & Pathogens 2. Incoming ingredient storage PP
Storage C – Contaminates No
Raw Milk B – Presence of Yes None No-control will occur at pasteurization
Receiving Pathogens
C - Toxin Production No 1. Supplier guarantee program and incoming
ingredient PP
C – Beta Lactam Drug No 2. Incoming ingredient PP following the
Residues guidelines established under Appendix N of
the PMO.
Pathogens
P – Foreign Material No 2. Equipment cleaning and equipment
maintenance PP
Raw Milk B – Vegetative No 1. Temperature management PP
C - Toxin Production No 2. Temperature management PP
from Residual
Cleaning and
Sanitizing Agents
Heat Treated B – Vegetative Yes None No-control will occur at pasteurization
Cream Receiving Pathogens
C - Toxin Production No 1. Supplier guarantee program and incoming
ingredient PP
Heat Treated B – Vegetative No 1. Temperature management PP
Cream Storage Pathogens Growth
157
Q1. Is the hazard
identified at this
document at Q2
C – Contamination 3. Equipment cleaning PP
from Residual
Cleaning and
Sanitizing Agents
Blending B – Vegetative Yes None No – Control will occur at
Pathogens pasteurization step
P – Foreign Material No 1. Equipment cleaning PP
pallet fragments,
foreign objects in
ingredients)
Pathogens steps
C – Boiler Additives No 1. Water safety PP in place that meets
21CFR173.310
Culture Grwoth B – Vegetative No 1. Equipment cleaning PP
& Addition Pathogens
C – Toxin Production No 2. Temperature management PP
Sour Cream Set B - Vegetative No 1. Equipment cleaning PP
& Break Pathogens
Packaging B - Vegetative No 1. COA/supplier guarantee program and
Receiving & Pathogens incoming materials storage PP
Storage P - Foreign material No
C - Hazardous material No
Packaging & B - Vegetative No 1. Equipment cleaning and equipment
Banding Pathogens maintenance PP
C - Residual Cleaning No
and Sanitizing Agents
Metal Detection P – Metal No 1. Equipment maintenance PP
contamination
Casing None Packaged product protected from all hazards
158
Q1. Is the hazard
identified at this
document at Q2
Refrigerated B – Pathogens No Packaged product protected from all hazards.
Storage And C – Contaminants No
Distribution P – Foreign Materials No
159
Product Name: Cultured Sour Cream
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Critical Control Point Hazards Critical Limits for Corrective Verification Records
(CCP) each Control Monitoring Action(s)
Measure
Milk and Milk Biological- Time & Temperature at Continuous At least once per Pasteurizer Manually divert Record Review CCP Records
Products Vegetative Temperature. the exit of the Temp. Recorder shift by the Operator flow of product - Pasteurizer
Pasteurization Pathogens 166°F for holding tube Chart operator Pasteurizer Charts
(HTST and HHST) (non-spore minimum of 15 Isolate the charts verified
formers) seconds affected product including cut-in Corrective
and cut-out Action
Note: Assuring Residence time Continuous Evaluate and performed, Records
that the in the holding Flow Recorder during Pasteurizer determine indicating
minimum tube in Chart Operation Operator disposition of the versus recording CCP
holding times are continuous flow product temps Verification-
met in systems pasteur-izers (reprocess or compared, seal Records,
which use a with magnetic disposal) checks made, including
sealed timing flow meter authorized equipment
pump would be based timing Document actions supervisory testing
CCP systems review and sign- records
verification, i.e. Note: Utilize 5 off of recording
equipment corrective action charts
calibration steps recognized
by NCIMS Equipment
HACCP program Function
Checks
Vat Pasteurization B – Vegetative The temperature as Temperature (°F) Check and sign-off on Thermometer checks Pasteurizer / Continue pasteurization 1. Indicating vs Temperature charts
(with continuous agitation) Pathogens measured by the air recording charts. done at beginning and Operator until time / temperature recording thermometer
space indicating Time (Min) end of holding time. criteria are met. comparison. Corrective action
thermometer must be at Record both air space 2. Supervisory review records.
a minimum of 150°F. and indicating Annotate the batch If more than two hours and sign-off on
thermometer information for each has elapsed isolate the recording charts. CCP verification
The holding time must temperatures. batch on the recording product and contact QA. 3. Equipment records.
be a minimum of 30 Time (Min) chart. calibration.
minutes. Disposition the product. Calibration of Equipment
thermometers. calibration records.
The air space Document actions. 4. Time calibration of
thermometer must chart controller.
indicate a minimum of 5. Seal checks.
155°F.
Intended Use & Consumer: __________________________________________Signature: __________________________Date: ______________
160
[Street Address]

Formal Product Name: Lowfat Plain Yogurt with 1% Butterfat
Food Safety Characteristics: Support growth of a number of pathogens. Very limited natural protective
characteristic other than competitive inhibition.
Ingredient Statement: Cultured Grade A Fat Free Milk, Grade A Milk, Modified Food Starch, Kosher
Gelatin.
Packaging Used: Printed polypropylene thermoform cup with a heat-sealable laminated foil (tamper
evident) and a high density polyethylene lid. Code date is printed via coding
equipment after capping.
Labeling Requirements: Keep refrigerated, Grade “A”, Pasteurized, Contains live organisms (if true)
Storage and Distribution: Product is cased in standard milk cases in palletized units. Temperature of storage is 
45°F. Distributed using refrigerated trucks (at  45°F) to wholesale and retail outlets.
Approved by: ______________________________
Date:
161
Dairy Ingredient
Receiving
Lowfat Plain Yogurt
Non-Dairy
with
Package Material
Receiving
Ingredient
Receiving 1% Butterfat
Dairy Storage
Culture Receiving
Separation
Case Receiving
Cream Storage Skim Storage
Pallet Receiving
Blending /
Standardization
Pasteurization
Fermentation Culture Storage
Cooling
Pasteurized
Unitizing
Storage
Filling Palletizing
Sealing Cold Storage
Lidding Distribution
Coding
162
Lowfat Plain Yogurt w/1% Butterfat Hazard Analysis Summary Table
Q1. Is the hazard

of sufficient
likelihood of Q2. Identify the Prerequisite Program or procedure step which Q3 – Q6. Does a control measure
Identify the occurrence to reduces the likelihood or severity of the hazard to ensure that exist at this step to prevent, reduce
Potential Hazard warrant its control? control at this step is not necessary. or eliminate the likely occurrence of
Process Step/  If "yes", then a hazard to an acceptable level?
Ingredient or  Biological (B) proceed to Q3 If “yes”, document as a CCP
Input  Chemical (C)  If "no", stop and If “no”, indicate where this will
 Physical (P) document at Q2 happen.
Package B - Vegetative No 1. COA/supplier guarantee program and incoming materials storage PP
Material Pathogens
Receiving & P - Foreign material No 2. Incoming ingredient and temperature management PP
Storage C - Hazardous No
material
Pallet B – Vegetative No 1. COA/supplier guarantee program and incoming materials storage PP
Receiving & Pathogens 2. Incoming ingredient and temperature management PP
Storage
Case B – Vegetative No 1. COA/supplier guarantee program and incoming materials storage PP
Receiving & Pathogens 2. Incoming ingredient and temperature management PP
Storage
Non-Dairy B – Vegetative Yes None or No – Control will occur at
Ingredient Pathogens Non-dairy ingredient have low water activity or pH pasteurization step
Receiving & C – Contaminates No 1. COA/supplier guarantee and incoming ingredient storage PP
Storage P – Foreign material No 2. Incoming ingredient and temperature management PP
Culture B – Vegetative No 1. Incoming ingredient and temperature management PP
Receiving & Pathogens presence 2. COA/supplier guarantee and incoming ingredient storage PP
Storage or growth
Dairy B – Vegetative Yes None No – Pathogens will be eliminated at
Ingredient Pathogens Pasteurization.
Receiving C – Beta Lactam No 1. Incoming ingredient PP following Appendix N of the PMO.
Drug Residues
P – Foreign Material No 2. COA/Supplier guarantee and equipment maintenance PPs
163
Q1. Is the hazard
of sufficient
Dairy Storage B – Vegetative No 1. Temperature management PP
Pathogens growth
from Residual
Cleaning and
Sanitizing Agents
Separation B – Vegetative No 1. Equipment cleaning PP
Pathogens
Cream B – Vegetative No 1. Temperature management PP
from Residual
Cleaning and
Sanitizing Agents
Skim Storage B – Vegetative No 1. Temperature management PP
Pathogens growth
from Residual
Cleaning and
Sanitizing Agents
Blending / B – Vegetative Yes None No – Control will occur at
Standardizati Pathogens pasteurization step
on P – Foreign Material No 1. Equipment cleaning PP
pallet fragments,
foreign objects in
164
Q1. Is the hazard
of sufficient
ingredients)
tion Pathogens steps
Fermentation B – Vegetative No 1. Equipment cleaning PP
& Cooling Pathogens presence
or growth
from Residual
Cleaning and
Sanitizing Agents
Storage Pathogens presence
or growth
from Residual
Cleaning and
Sanitizing Agents
Pathogens
Lidding and B – Vegetative No 1. Equipment cleaning and equipment maintenance PP
Sealing Pathogens
P – Foreign Material No 2. Material handling GMP
165
Q1. Is the hazard
of sufficient
Coding None – This step .
should not introduce
hazards to properly
packaged product
Unitizing & None – This step
Palletizing should not introduce
hazards to properly
packaged product
Storage And Pathogens No
P – Foreign Materials
166
PRODUCT NAME: Plain Lowfat Yogurt with 1% Butterfat
Critical (2) (3) (4) (5) (6) (7) (8) (9) (10)
Control Point
(CCP)
Critical Limits Monitoring
for Each What How Frequency Who Corrective
Hazards Control Measure Actions Verification Records
Pasteurization B – Vegetative Pathogens The temperature as measured at the Temperature (°F) Check and sign- Monitoring is Pasteurizer / Manually divert flow 1. Cut in - Cut out Temperature recording charts
(Properly functioning HTST with a exit of the extended holding tube, off on temperature done by the Operator of product. performed.
magnetic flow meter system must be at a minimum of 161°F. Flow Rate and flow recording operator after 2. Indicating vs Product flow charts
between low flow charts. every 2 hours and Isolate the affected recording thermometer
The flow rate through the holding set point and high after each product product. comparison Corrective action records.
tube must meet the following flow set point run. 3. Pressure diff. checks
criteria: (gpm) Request evaluation by 4. Supervisory review CCP verification records.
QA. and sign-off on recording
Low Flow_____gpm charts. Equipment calibration
Disposition the 5. Equipment calibration. records.
High Flow_____gpm product. 6. Seal checks.
Document actions.
Vat Pasteurization B – Vegetative Pathogens The temperature as measured by the Temperature (°F) Check and sign- Thermometer Pasteurizer / Continue 1. Indicating vs Temperature charts
(with continuous agitation) air space indicating thermometer off on recording checks done at Operator pasteurization until recording thermometer
must be at a minimum of 145°F. Time (Min) charts. beginning and end time / temperature comparison. Corrective action records.
of holding time. criteria are met. 2. Supervisory review
The holding time must be a Record both air and sign-off on recording CCP verification records.
minimum of 30 minutes. space and Annotate the batch If more than two hours charts.
indicating information for has elapsed isolate the 3. Equipment Equipment calibration
The air space thermometer must Time (Min) thermometer each batch on the product and contact calibration. records.
indicate a minimum of 150°F. temperatures. recording chart. QA. Calibration of
thermometers.
Disposition the 4. Time calibration of
product. chart controller.
5. Seal checks.
Document actions.
Intended Use & Consumer: ______________________________________________Signature: __________________________________________Date: __________________
167
[Street Address]

Formal Product Name: Strawberry Pre-Stirred Lowfat Yogurt with 1% Butterfat
Food Safety Characteristics: Support growth of a number of pathogens. Very limited natural protective
characteristic other than competitive inhibition.
Ingredient Statement: Cultured Grade A Fat Free Milk, Grade A Milk, High Fructose Corn Syrup,
Strawberries, Modified Food Starch, Sugar, Kosher Gelatin, Natural Flavors, Annatto
and Red #40.
Packaging Used: Printed polypropylene thermoform cup with a heat-sealable laminated foil (tamper
evident) and a high density polyethylene lid. Code date is printed via coding
equipment after capping.
Labeling Requirements: Keep refrigerated, Grade “A”, Pasteurized, Contains live organisms (if true)
Storage and Distribution: Product is cased in standard milk cases in palletized units. Temperature of storage is
 45°F. Distributed using refrigerated trucks (at  45°F) to wholesale and retail
outlets.
Approved by: ______________________________
Date:
168
Dairy Ingredient
Strawberry Pre-Stirred
Receiving
Lowfat Yogurt
Package Material
Non-Dairy
Ingredient
with
Receiving
Receiving
Dairy Storage 1% Butterfat
Culture Receiving
Separation
Fruit Receiving
Cream Storage Skim Storage
Blending /
Standardization
Pasteurization
Pallet Receiving
Fermentation Culture Storage
Cooling
Pasteurized
Coding
Storage
Fruit Blending Fruit Storage Unitizing
Filling Palletizing
Sealing Cold Storage
Lidding Distribution
169
Strawberry Lowfat Yogurt Hazard Analysis Summary Table
Q1. Is the hazard

of sufficient
Package B - Vegetative No 1. COA/supplier guarantee program and incoming materials storage PP
Material Pathogens
Receiving P - Foreign material No
C - Hazardous No
material
Pallet B – Vegetative No 1. COA/supplier guarantee program and incoming materials storage PP
Receiving Pathogens
Case B – Vegetative No 1. COA/supplier guarantee program and incoming materials storage PP
Receiving Pathogens
Non-Dairy B – Vegetative No 1. COA/supplier guarantee and incoming ingredient storage PP
Non-Dairy B – Vegetative No 1. Incoming ingredient and temperature management PP
Ingredient Pathogens 2. Material Handling GMPs
Storage
Fruit B – Vegetative No 1. COA/supplier guarantee and incoming ingredient storage PP
Receiving Pathogens
(not raw) C – Contaminates No
Dairy B – Vegetative Yes None No – Pathogens will be eliminated at
Ingredient Pathogens Pasteurization.
Receiving C – Beta Lactam No 1. Incoming ingredient PP following Appendix N of the PMO.
Drug Residues
P – Foreign Material No 2. COA/Supplier guarantee and equipment maintenance PPs
170
Q1. Is the hazard
of sufficient
Dairy Storage B – Vegetative No 1. Temperature management PP
Pathogens growth
from Residual
Cleaning and
Sanitizing Agents
Separation B – Vegetative No 1. Equipment cleaning PP
Pathogens
from Residual
Cleaning and
Sanitizing Agents
Skim Storage B – Vegetative No 1. Temperature management PP
Pathogens
from Residual
Cleaning and
Sanitizing Agents
Blending / B – Vegetative Yes None No – Control will occur at
Standardizati Pathogens pasteurization step
on P – Foreign Material No 1. Equipment cleaning PP
pallet fragments,
foreign objects in
171
Q1. Is the hazard
of sufficient
ingredients)
Pathogens steps
Fermentation B – Vegetative No 1. Equipment Cleaning PP

Pathogens presence
or growth
from Residual
Cleaning and
Sanitizing Agents
Pasteurized B – Vegetative No 1. Temperature management and equipment cleaning PP
Storage Pathogens presence
or growth
from Residual
Cleaning and
Sanitizing Agents
Fruit B – Vegetative No 1. Material Handling GMPs
Blending Pathogens
P – Foreign Material No 1. Equipment cleaning PP
pallet fragments,
foreign objects in
ingredients)
172
Q1. Is the hazard
of sufficient
Pathogens
Lidding and B – Vegetative No 1. Equipment cleaning and equipment maintenance PP
Sealing Pathogens
P – Foreign Material No 2. Material handling GMP
Coding None – This step
should not introduce
hazards to properly
packaged product
Unitizing an d None – This step
Palletizing should not introduce
hazards to properly
packaged product
Storage And Pathogens No
P – Foreign Materials
Product Description: Strawberry Pre-Stirred Lowfat Yogurt with 1% Butterfat
173
PRODUCT NAME: Strawberry Pre-Stirred Lowfat Yogurt with 1% Butterfat
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Critical Critical Limits Monitoring

Control Point for Each What How Frequency Who Corrective
(CCP) Hazards Control Measure Actions Verification Records
Pasteurization B – Vegetative The temperature as measured at the exit of the Temperature (°F) Check and sign- Monitoring is done Pasteurizer / Manually divert 1. Cut in - Cut out Temperature recording charts
(Properly functioning Pathogens extended holding tube, must be at a minimum off on temperature by the operator after Operator flow of product. performed.
HTST with a magnetic of 166°F. Flow Rate and flow every 2 hours and 2. Indicating vs recording Product flow charts
flow meter system between low flow recording charts. after each product Isolate the affected thermometer comparison
The flow rate through the holding tube must set point and high run. product. 3. Pressure diff. checks Corrective action records.
meet the following criteria: flow set point 4. Supervisory review and
(gpm) Request evaluation sign-off on recording CCP verification records.
Low Flow_____gpm by QA. charts.
5. Equipment calibration. Equipment calibration records.
High Flow_____gpm Disposition the 6. Seal checks.
product.
Document actions.
Vat Pasteurization B – Vegetative The temperature as measured by the air space Temperature (°F) Check and sign- Thermometer checks Pasteurizer / Continue 1. Indicating vs recording Temperature charts
(with continuous Pathogens indicating thermometer must be at a off on recording done at beginning Operator pasteurization thermometer comparison.
agitation) minimum of 150°F. Time (Min) charts. and end of holding until time / 2. Supervisory review and Corrective action records.
time. temperature sign-off on recording
The holding time must be a minimum of 30 Record both air criteria are met. charts. CCP verification records.
minutes. space and Annotate the batch 3. Equipment calibration.
indicating information for each If more than two Calibration of Equipment calibration records.
The air space thermometer must indicate a Time (Min) thermometer batch on the hours has elapsed thermometers.
minimum of 155°F. temperatures. recording chart. isolate the product 4. Time calibration of
and contact QA. chart controller.
5. Seal checks.
Disposition the
product.
Document actions.
Intended Use & Consumer: _________________________________________Signature: _____________________________________Date: __________________
174
IDFA
FROZEN DESSERTS
MODELS
175
[Street Address]

Formal Product Name: Vanilla Ice Cream
Food Safety Characteristics: Pasteurized Product that supports growth of a number of pathogens.
Protective characteristics dependent on storage <0°F.
Packaging Used: High Density Polypropylene in 3 oz, 4 oz, Pints, Quarts Round Half
Gallons, Gallons, 4 qt Pails, and 5qt Pails. Multi-layered paperboard with
outer and inner wax coating, skived edges and heat-sealed side tab for
square Half Gallon and 3 Gallons Tubs.
Labeling Requirements: Keep Frozen
Storage and Distribution: Product is stored at  -20°F. Distributed for further processing in
refrigerated trucks (-20°F).
Intended Use: Ready to eat product.
Shelf Life: 1 year under proper refrigeration
Approved by: ______________________________
Date: _____________________________________
176
Vanilla Ice Cream
Dry Ingredient Dairy Ingredient Non-Dairy Liquid
Receiving Receiving Receiving
Dry Ingredient Dairy Storage Non-Dairy

Storage Storage
Clarifier/Separator
Blending
Homogenization Pasteurization Rework Storage
Pasteurized Mix
Storage
Rework
Flavor Flavor Vat for Rework
Refreeze Meltdown
Air Freezing
Packaging
Metal Detector
Hardening Storage Distribution
177
Vanilla Ice Cream Hazard Analysis Summary Table
Q1. Is the hazard

identified at this step Q3 – Q6. Does a control measure
severe and of exist at this step to prevent,
Identify the sufficient likelihood Q2. Identify the Prerequisite Program or reduce or eliminate the likely
Potential Hazard of occurrence to procedure step which reduces the likelihood or occurrence of a hazard to an
Process Step/ warrant its control? severity of the hazard to ensure that control at acceptable level?
Ingredient or  Biological (B)  If "yes", then this step is not necessary. If “yes”, document as a CCP
 Physical (P)  If "no", stop and happened.
document at Q2
Dairy B - Vegetative Yes None No – Controlled at HTST
Ingredient Pathogens Pasteurizer
Receiving C - Toxin Production No 1. Incoming ingredient PP
C - Beta Lactam Drug No 2. Temperature management PP
Residues 3. Incoming ingredient PP with drug screening
program as per PMO, Appendix N
Dairy B - Vegetative No 1. Temperature management PP
Ingredient Pathogens growth
Storage C - Toxin Production No 2. Temperature management PP
C - Cleaning &
Sanitizing Chemicals No 3. Equipment cleaning and sanitizing PP
Clarifier/ B - Vegetative No 1. Equipment cleaning and sanitizing PP
Separator Pathogens
Dry Dairy C - Contaminants No 1. COA/Supplier guarantee program
Ingredient 2. Incoming ingredient PP
Receiving
Dry Dairy B - Vegetative No 1. Incoming Ingredient PP
Storage C - Chemical No 2. Equipment cleaning and sanitizing PP
contaminants
Non-Dairy B – Vegetative No 1. COA/Supplier guarantee PP
Liquid Pathogens
Receiving C – Contaminants No 2. COA/Supplier guarantee PP
P – Foreign material No 3. Incoming ingredient PP
178
Q1. Is the hazard
document at Q2
Non-Dairy B – Vegetative No 1. Temperature management PP
Liquid Pathogens growth
3. Ingredient storage PP
Blending B – Vegetative Yes None No – Controlled at HTST
Pathogens Pasteurizer
C - Allergens No 1. Allergen control PP
P – Foreign Material No 2. Material Handling GMP
pallet fragments,
foreign objects in
ingredients)
Homogeni- B – Vegetative No 1. Equipment cleaning and sanitizing PP
zation Pathogens
Pasteuriza- B – Vegetative Yes None Yes – control of vegetative
tion (HTST Pathogens pathogens from prior steps
without a C – Boiler Additives No 1. Water Safety PP controls use of boiler
magnetic additives to meet 21CFR173.310 in the water
flow meter safety pre-requisite program.
system)
Past. Mix B – Vegetative No 1. Temperature management PP
Storage Pathogens
C - Cleaning and No 2. Equipment cleaning and sanitizing PP
Sanitizing Chemicals
Flavoring B – Vegetative No 1. COA/Supplier guarantee program
Receiving & Pathogens 2. Incoming ingredient receiving &
Storage C – Contaminants No storage PP
P – Foreign matter No
179
Q1. Is the hazard
document at Q2
Flavor Vat B – Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
P – Foreign Material No 2. Material handling GMPs
pallet fragments,
foreign objects in
ingredients)
Air B – Vegetative No 1. Air Safety PP
Pathogens
C – Contaminates No
Freezing B – Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens 2. Materials handling GMPs
Packaging B – Vegetative No 1. COA/Supplier Verification PP
Pathogens
C – Contaminants No
P – Foreign Matter No
Rework for B – Vegetative Yes None No - Controlled at HTST
Refreeze Pathogens Pasteurizer
C - Toxin production No 1. Temperature control PP
C – Allergens 2. Equipment cleaning and sanitizing PP
No 3. Allergen control PP
Rework B – Vegetative Yes None No - Controlled at HTST
Meltdown Pathogens Pasteurizer
C - Toxin production No 1. Temperature management PP
C – Allergens 2. Equipment cleaning and sanitizing PP
No 3. Allergen control PP
180
Q1. Is the hazard
document at Q2
Rework B – Vegetative No 1. Temperature management PP
Storage Pathogens
C – Allergens No 2. Allergen control PP
C – Toxin production No 3. Temperature management PP
C-Cleaning and
Sanitizing Chemicals No 4. Equipment cleaning and sanitizing PP
Metal P – Metal No 1. Equipment performance and maintenance
Detection contamination PP
Hardening None
Refrigerated B - Vegetative No 1. Temperature Control PP
Storage Pathogens
C - Contaminants No 2. Facility Maintenance PP
P - Foreign Materials No 3. Facility Maintenance PP
Distribution B - Vegetative No Packaged product protected from all common
Pathogens hazards.
C - Contaminants No
P - Foreign Materials No

Intended Use & Consumer: _______________________________________________________
Signature: ______________________________________________Date: __________________
181
Product Name: Vanilla Ice Cream
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Critical Control Hazards Critical Monitoring Corrective Verificatio Records
Point (CCP) Limits Action(s) n
for each
Control
Measure
Milk and Milk Biological- Time & Temperature. Temperature at Continuous At least once per Pasteurizer Manually divert flow Record Review CCP Records -
Products Vegetative Pathogens 175°F for minimum of 25 the exit of the Temp. shift by the operator Operator of product Pasteurizer Charts
Pasteurization (non-spore formers) seconds holding tube Recorder Pasteurizer charts
(HTST and HHST) Chart Isolate the affected verified including Corrective Action
product cut-in and cut-out Records
Residence time Continuous during performed,
in the holding Operation Evaluate and indicating versus CCP Verification-
tube in Pasteurizer determine disposition recording temps Records, including
Note: Assuring that the continuous Flow Operator of the product compared, seal equipment testing
minimum holding times flow Recorder (reprocess or disposal) checks made, records
are met in systems which pasteurizers Chart authorized
use a sealed timing pump with magnetic Document actions supervisory review
would be CCP flow meter and sign-off of
verification, i.e. based timing Note: Utilize 5 recording charts
equipment calibration systems corrective action steps
recognized by NCIMS Equipment
HACCP program Function Checks
Vat Pasteurization B – Vegetative The temperature as Temperature Check and Thermometer checks Pasteurizer / Continue 1. Indicating vs Temperature charts
(with continuous agitation) Pathogens measured by the air space (°F) sign-off on done at beginning Operator pasteurization until recording
indicating thermometer recording and end of holding time / temperature thermometer Corrective action records.
must be at a minimum of Time (Min) charts. time. criteria are met. comparison.
155°F. 2. Supervisory CCP verification records.
Record both Annotate the batch If more than two hours review and sign-off
The holding time must be air space information for each has elapsed isolate the on recording charts. Equipment calibration
a minimum of 30 minutes. and batch on the product and contact 3. Equipment records.
Time (Min) indicating recording chart. QA. calibration.
The air space thermomete Calibration of
thermometer must r Disposition the thermometers.
indicate a minimum of temperature product. 4. Time calibration
160°F. s. of chart controller.
Document actions. 5. Seal checks.

Signature: ______________________________________________Date: __________________
182
[Street Address]

Formal Product Name: Ice Cream w/ Ingredient
Food Safety Characteristics: Pasteurized product that supports growth of a number of pathogens.
Approved by: ______________________________
Date:_____________________________________
183
Ice Cream w/Ingredient

Storage Storage
Clarifier/Separator
Blending
Homogenization Pasteurization
Rework Storage
Pasteurized Mix
Storage
Flavor Flavor Vat Rework

for Rework
Refreeze Meltdown
Air Freezing
Friut Ingredient Fruit Feeder
Revel Ingredient Revel Pump
Packaging
Metal Detector
184
Ice Cream w/Ingredient Hazard Analysis Summary Table
Q1. Is the hazard

identified at this Q3 – Q6. Does a control measure
step severe and of exist at this step to prevent,
Identify the sufficient likelihood Q2. Identify the Prerequisite Program or procedure reduce or eliminate the likely
Potential Hazard of occurrence to step which reduces the likelihood or severity of the occurrence of a hazard to an
Process Step/ warrant its control? hazard to ensure that control at this step is not acceptable level?
Ingredient or  Biological (B)  If "yes", then necessary. If “yes”, document as a CCP
document at Q2
Receiving C - Toxin No 1. Incoming ingredient PP
Production 2. Temperature management PP
C - Beta Lactam No 3. Incoming ingredient PP with drug screening
Drug Residues program as per PMO, Appendix N
Dairy B – Vegetative No 1. Temperature management PP
Production
C-Cleaning & No 3. Equipment cleaning and sanitizing PP
Sanitizing
Chemicals
Clarifier/ B – Vegetative No 1. Equipment cleaning and sanitizing PP
Separator Pathogens
Dry Dairy C – Contaminants No 1. COA/Supplier guarantee program
Receiving
Dry Dairy B – Vegetative No 1. Incoming Ingredient PP
Storage C – Contaminants No 2. Equipment cleaning and sanitizing PP
185
Q1. Is the hazard
document at Q2
Liquid Pathogens
P – Foreign materia No 3. Incoming Ingredient PP
Liquid Pathogens
Storage C – Toxin No 2. Equipment cleaning and sanitizing PP
Production 3. Ingredient storage PP
Blending B – Vegetative Yes None, but Equipment cleaning and sanitizing PP No – Controlled at HTST
Pathogens assists Pasteurizer
C - Allergens No
P – Foreign No 2. Allergen control PP
Material 3. Material Handling GMP
(packaging
material, pallet
fragments, foreign
objects in
ingredients)
zation Pathogens
tion Pathogens pathogens from prior steps
C – Boiler No 1. Water Safety PP manages use of boiler additives
Additives to meet 21CFR173.310 in the water safety pre-
requisite program.
Storage Pathogens
186
Q1. Is the hazard
document at Q2
Sanitizing
Chemicals
Receiving Pathogens 2. Incoming ingredient receiving & storage PP
& Storage C – Contaminants No
Pathogens
P – Foreign No 2. Material handling GMPs
Material
(packaging
material, pallet
fragments, foreign
objects in
ingredients)
Pathogens
Fruit B – Vegetative No 1. COA/Supplier guarantee program
Ingredient Pathogen
Receiving C - Contaminants No 2. Incoming ingredient PP
Fruit B – Vegetative No 1. Temperature control PP
Storage C - Contaminants No 2. Incoming ingredient storage PP
187
Q1. Is the hazard
document at Q2
Fruit B – Vegetative No 1. Equipment cleaning and sanitizing PP
Feeder Pathogens
P – Foreign No 3. Material Handling GMP
Material
(packaging
material, pallet
fragments,
foreign objects in
ingredients)
Revel B – Vegetative No 1. COA/Supplier guarantee program
Receiving C – Contaminants No 2. Incoming ingredient PP
P – Foreign No 3. Incoming ingredient PP
Matter
Revel B – Vegetative No 1. Temperature management PP
Storage C - Contaminants 2. Incoming ingredient storage PP
Revel B – Vegetative No 1. Equipment cleaning and sanitizing PP
Pump Pathogens
Material
(packaging
material, pallet
fragments, foreign
objects in
188
Q1. Is the hazard
document at Q2
ingredients)

Pathogens 2. GMP program
Receiving Pathogens
& Storage C – Contaminants No 2. Incoming materials storage PP
P – Foreign No 3. Incoming materials storage PP
Matter
Rework for B – Vegetative Yes None No-Controlled by HTST
Refreeze Pathogens Pasteurization
C - Contaminants 1. Temperature management PP
C – Allergens No 2. Equipment cleaning and sanitizing PP
3. Allergen control PP
Rework B – Vegetative Yes No-Controlled by HTST
Meltdown Pathogens Pasteurization
C – Toxin No 1. Temperature management PP
production 2. Equipment cleaning and sanitizing PP
Storage Pathogens
production
C-Cleaning and No 4. Equipment cleaning and sanitizing PP
Sanitizing
189
Q1. Is the hazard
document at Q2
Chemicals
Metal P – Metal No 1. Equipment design and maintenance PP
Detection contamination
Hardening None
Storage Pathogens
P - Foreign No 3. Facility Maintenance PP
Materials
Pathogens hazards.
C - Contaminants No
P - Foreign No
Materials

Signature: ______________________________________________Date: __________________
190
Product Name: Ice Cram w/Ingredient
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Critical Control Hazards Critical Monitoring Corrective Verificatio Records
Point (CCP) Limits Action(s) n
for each
Control
Measure
Milk and Milk Biological- Time & Temperature. Temperature Continuous At least once per Pasteurizer Manually divert flow Record Review CCP Records -
Products Vegetative Pathogens 175°F for minimum of 25 at the exit of Temp. shift by the operator Operator of product Pasteurizer Charts
Pasteurization (non-spore formers) seconds the holding Recorder Pasteurizer charts
(HTST and HHST) tube Chart Isolate the affected verified including Corrective Action
product cut-in and cut-out Records
Continuous during performed,
Residence Operation Evaluate and indicating versus CCP Verification-
time in the Pasteurizer determine disposition recording temps Records, including
Note: Assuring that the holding tube Flow Operator of the product compared, seal equipment testing
minimum holding times in continuous Recorder (reprocess or disposal) checks made, records
are met in systems which flow Chart authorized
use a sealed timing pump pasteurizers Document actions supervisory review
would be CCP with magnetic and sign-off of
verification, i.e. flow meter Note: Utilize 5 recording charts
equipment calibration based timing corrective action steps
systems recognized by NCIMS Equipment
HACCP program Function Checks
Vat Pasteurization B – Vegetative The temperature as Temperature Check and Thermometer checks Pasteurizer / Continue 1. Indicating vs Temperature charts
(with continuous agitation) Pathogens measured by the air space (°F) sign-off on done at beginning Operator pasteurization until recording
indicating thermometer recording and end of holding time / temperature thermometer Corrective action records.
must be at a minimum of Time (Min) charts. time. criteria are met. comparison.
155°F. 2. Supervisory CCP verification records.
Record both Annotate the batch If more than two hours review and sign-off
The holding time must be air space and information for each has elapsed isolate the on recording charts. Equipment calibration
a minimum of 30 minutes. indicating batch on the product and contact 3. Equipment records.
Time (Min) thermometer recording chart. QA. calibration.
The air space temperatures. Calibration of
thermometer must Disposition the thermometers.
indicate a minimum of product. 4. Time calibration
160°F. of chart controller.

Signature: ______________________________________________Date: __________________
191
[Street Address]

Formal Product Name: Chocolate Coated Ice Cream Bar
Packaging Used: Multi-layered paper with plasticized outer and inner coating and end seal
w/hot glue strip. Packaged 18 units to a cardboard box with top seal w/hot
food grade glue.
Labeling Requirements: Keep Frozen , Not for individual sale.
Approved by: ________________________
Date:_______________________________
192
Chocolate Coated Bar (no rework)
Dairy Storage
Dry Ingredient Non-Dairy
Storage Clarifier/Separator Storage
Blending
Pasteurized Mix
Storage
Flavor Flavor Vat
Air Freezing
Sticks Mould
Chocolate Dip Tank
Lift Arms
Wrapper Wrap
Boxer Packaging
Metal Detector
193
Chocolate Coated Bar Hazard Analysis Summary Table
Q1. Is the hazard

Identify the step severe and of exist at this step to prevent, reduce
Potential Hazard sufficient likelihood Q2. Identify the Prerequisite Program or procedure or eliminate the likely occurrence
Process Step/ of occurrence to step which reduces the likelihood or severity of the of a hazard to an acceptable level?
Ingredient or  Biological (B) warrant its control? hazard to ensure that control at this step is not If “yes”, document as a CCP
Input  Chemical (C)  If "yes", then necessary. If “no”, indicate where this will
 Physical (P) proceed to Q3 happen.
 If "no", stop and
document at Q2
Production 2. Temperature management PP
Production
Sanitizing
Chemicals
Separator Pathogens
Dry Dairy C - Contaminants No 1. COA/Supplier guarantee program
Receiving
Dry Dairy C - Contaminants No 1. Ingredient storage PP
Ingredient
Storage
Non-Dairy B – Vegetative Yes None No – Controlled at HTST
Liquid Pathogens Pasteurizer
194
Q1. Is the hazard
document at Q2
P – Foreign material No 2. COA/Supplier guarantee PP
Non-Dairy B – Vegetative No 1. Temperature control
Storage Pathogens 2. Equipment cleaning and sanitizing PP
Blending B – Vegetative Yes None, but Equipment cleaning and sanitizing PP No - Controlled at HTST
Pathogens assists Pasteurization
C - Allergens No
P – Foreign Material No 2. Allergen control PP
pallet fragments,
foreign objects in
ingredients)
zation Pathogens

C – Boiler Additives No 1. Water Safety PP controls use of boiler additives
to meet 21CFR173.310 in the water safety pre-
requisite program.
Storage Pathogens
Sanitizing
Chemicals
Receiving Pathogens 2. Incoming ingredient receiving and storage
& Storage C – Contaminants No PP
195
Q1. Is the hazard
document at Q2
Pathogens
pallet fragments,
foreign objects in
ingredients)
Pathogens
Sticks- B – Vegetative No 1. COA/Supplier Verification PP
Receiving Pathogens 2. Incoming materials storage PP
and Storage C – Contaminants No
Mould B – Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
pallet fragments,
foreign objects in
ingredients)
Chocolate B – Vegetative No 1. COA/Supplier guarantee program
Receiving Pathogens
and Storage C – Contaminants No 2. Incoming ingredient storage PP
196
Q1. Is the hazard
document at Q2
Dip Tank B – Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
pallet fragments,
foreign objects in
ingredients)
Lift Arms B – Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
pallet fragments,
foreign objects in
ingredients)
Wrap B – Vegetative No 1. COA/Supplier Verification PP
Receiving Pathogens
and Storage C – Contaminants No 2. Incoming materials PP
Wrapper B – Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens 2. GMP on packaging
Receiving Pathogens
and Storage C – Contaminants No 2. Incoming materials PP
Packaging B - Vegetative No Packaged product protected from all common
Pathogens hazards.
C - Contaminants No
P - Foreign No
Materials
197
Q1. Is the hazard
document at Q2
Boxer C - Contaminants No 1. Equipment cleaning and sanitizing PP
Hardening None
Storage Pathogens
P - Foreign No
Materials
Pathogens hazards.
C - Contaminants No
P - Foreign No
Materials

Signature: ______________________________________________Date: __________________
198
Product Name: Chocolate Coated Bar
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Critical Hazards Critical Limits Monitoring Corrective Verification Records
Control for each Control Action(s)
Point (CCP) Measure

Milk and Milk Biological- Time & Temperature. Temperatur Continuous At least once per Pasteurizer Manually divert flow of product Record Review CCP Records - Pasteurizer
Products Vegetative Pathogens 175°F for minimum of 25 e at the exit Temp. shift by the Operator Charts
Pasteurization (non-spore formers) seconds of the Recorder operator Isolate the affected product Pasteurizer charts
(HTST and HHST) holding tube Chart verified including cut-in Corrective Action Records
Evaluate and determine and cut-out performed,
disposition of the product indicating versus CCP Verification- Records,
Residence Continuous (reprocess or disposal) recording temps including equipment
time in the during Operation Pasteurizer compared, seal checks testing records
Note: Assuring that the holding tube Flow Operator Document actions made, authorized
minimum holding times are met in Recorder supervisory review and
in systems which use a sealed continuous Chart Note: Utilize 5 corrective action sign-off of recording
timing pump would be CCP flow steps recognized by NCIMS charts
verification, i.e. equipment pasteurizers HACCP program
calibration with Equipment Function
magnetic Checks
flow meter
based
timing
systems
Vat Pasteurization B – Vegetative Pathogens The temperature as measured by Temperatur Check and Thermometer Pasteurizer / Continue pasteurization until 1. Indicating vs Temperature charts
(with continuous the air space indicating e (°F) sign-off on checks done at Operator time / temperature criteria are recording thermometer
agitation) thermometer must be at a recording beginning and met. comparison. Corrective action records.
minimum of 155°F. Time (Min) charts. end of holding 2. Supervisory review
time. If more than two hours has and sign-off on CCP verification records.
The holding time must be a Record both elapsed isolate the product and recording charts.
minimum of 30 minutes. air space Annotate the contact QA. 3. Equipment Equipment calibration
and batch information calibration. records.
The air space thermometer must Time (Min) indicating for each batch on Disposition the product. Calibration of
indicate a minimum of 160°F. thermomete the recording thermometers.
r chart. Document actions. 4. Time calibration of
temperature chart controller.
s. 5. Seal checks.

Signature: ______________________________________________Date: __________________
199
[Street Address]

Formal Product Name: Novelty
Packaging Used: Multi-layered paper with plasticized outer and inner coating and end seal
w/hot glue strip with wooden stick inserted into product. Packaged 18
units to a cardboard box with top seal w/hot food grade glue.
Labeling Requirements: Keep Frozen, Not for individual sale.
Approved by: _____________________
Date:____________________________
200
Novelty (no rework)

Storage Storage
Clarifier/Separator
Blending
Pasteurized Mix
Storage
Flavor Flavor Vat
Air Freezing
Wafers Sandwich Machine
Packaging
Metal Detector
201
Novelty Hazard Analysis Summary Table
Q1. Is the hazard

identified at this Q3 – Q6. Does a control
step severe and of measure exist at this step to
Identify the sufficient likelihood Q2. Identify the Prerequisite Program or procedure prevent, reduce or eliminate the
Potential Hazard of occurrence to step which reduces the likelihood or severity of the likely occurrence of a hazard to
Process Step/ warrant its control? hazard to ensure that control at this step is not an acceptable level?
document at Q2
Production 2. Temperature control PP
Production
Sanitizing
Chemicals
Separator Pathogens
Dry Dairy C – Contaminants No 1. COA/Supplier guarantee program
Receiving
Dry Dairy B – Vegetative No 1. Ingredient storage PP
Storage C – Contaminants 2. Equipment cleaning and sanitizing PP
Liquid Pathogens
202
Q1. Is the hazard
document at Q2
P – Foreign materia No 3. Incoming Ingredient PP
Storage Pathogens
C – Toxin No 2. Equipment cleaning and sanitizing PP
Blending B – Vegetative Yes None, but equipment cleaning and sanitizing PP No – Controlled at HTST
Pathogens assists Pasteurizer
C - Allergens No
P – Foreign No 2. Allergen control PP
Material 3. Material Handling GMP
(packaging
material, pallet
fragments, foreign
objects in
ingredients)
zation Pathogens
C – Boiler No 1. Water Safety PP controls use of boiler additives
Additives to meet 21CFR173.310 in the water safety pre-
requisite program.
Storage Pathogens
Sanitizing
Chemicals
203
Q1. Is the hazard
document at Q2
Receiving & Pathogens
Storage C – Contaminants No 2. Incoming ingredient receiving & storage PP
Pathogens
P – Foreign No 2. Material handling GMPs
Material
(packaging
material, pallet
fragments, foreign
objects in
ingredients)
Pathogens
Cookie B – Vegetative No 1. COA/Supplier guarantee program
Wafers Pathogens
Receiving C – Contaminants No 2. Incoming ingredient storage PP
and Storage P – Foreign No
matter
Sandwich B – Vegetative No 1. Equipment cleaning and sanitizing PP
Assembly Pathogens
Machine P – Foreign No 2. Material handling GMPs
204
Q1. Is the hazard
document at Q2
Material
(packaging
material, pallet
fragments, foreign
objects in
ingredients)
Packaging B - Vegetative No Packaged product protected from all common
Pathogens hazards.
C - Contaminants No
P - Foreign No
Materials
Hardening None
Refrigerated B - Vegetative No 1. Temperature management PP
Storage Pathogens
Materials
Pathogens hazards.
C - Contaminants No
P - Foreign No
Materials
Signature: ______________________________________________Date: __________________
205
Product Name: Novelty
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Critical Hazards Critical Limits Monitoring Corrective Verification Records
Control for each Control Action(s)
Point (CCP) Measure

Milk and Milk Biological- Time & Temperature. Temperatur Continuous At least once per Pasteurizer Manually divert flow Record Review CCP Records - Pasteurizer
Products Vegetative Pathogens 175°F for minimum of 25 e at the exit Temp. shift by the Operator of product Charts
Pasteurization (non-spore formers) seconds of the Recorder operator Pasteurizer charts
(HTST and HHST) holding tube Chart Isolate the affected verified including Corrective Action Records
product cut-in and cut-out
performed, indicating CCP Verification- Records,
Residence Continuous Evaluate and versus recording including equipment testing
time in the during Operation Pasteurizer determine disposition temps compared, seal records
Note: Assuring that the holding tube Flow Operator of the product checks made,
minimum holding times are met in Recorder (reprocess or disposal) authorized
in systems which use a sealed continuous Chart supervisory review
timing pump would be CCP flow Document actions and sign-off of
verification, i.e. equipment pasteurizers recording charts
calibration with Note: Utilize 5
magnetic corrective action steps Equipment
flow meter recognized by NCIMS Function Checks
based HACCP program
timing
systems
Vat Pasteurization B – Vegetative Pathogens The temperature as measured by Temperatur Check and Thermometer Pasteurizer / Continue 1. Indicating vs. Temperature charts
(with continuous the air space indicating e (°F) sign-off on checks done at Operator pasteurization until recording
agitation) thermometer must be at a recording beginning and time / temperature thermometer Corrective action records.
minimum of 155°F. Time (Min) charts. end of holding criteria are met. comparison.
time. 2. Supervisory CCP verification records.
The holding time must be a Record both If more than two hours review and sign-off
minimum of 30 minutes. air space Annotate the has elapsed isolate the on recording charts. Equipment calibration
and batch information product and contact 3. Equipment records.
The air space thermometer must Time (Min) indicating for each batch on QA. calibration.
indicate a minimum of 160°F. thermomete the recording Calibration of
r chart. Disposition the thermometers.
temperature product. 4. Time calibration
s. of chart controller.

Signature: ______________________________________________Date: __________________
206
[Street Address]

Formal Product Name: Frozen Yogurt
Food Safety Characteristics: Pasteurized product with added Active Bacteria that supports growth of a
number of pathogens. Protective characteristics dependent on storage
<0°F and some competitive inhibition.
Approved by: ________________________
Date: _______________________________
207
Frozen Yogurt

Storage Storage
Clarifier/Separator
Blending
Homogenization Pasteurization Rework Storage
Culture
Pasteurized Mix
Storage
Culture Tank
Rework
Flavor Flavor Vat for Rework
Refreeze Meltdown
Air Freezing
Packaging
Metal Detector
208
Hazard Analysis Summary Table Frozen Yogurt
Q1. Is the hazard

identified at this
step severe and of Q3 – Q6. Does a control
Identify the sufficient likelihood Q2. Identify the Prerequisite Program or procedure measure exist at this step to
Potential Hazard of occurrence to step which reduces the likelihood or severity of the prevent, reduce or eliminate the
Process Step/ warrant its control? hazard to ensure that control at this step is not likely occurrence of a hazard to
Ingredient or  Biological (B)  If "yes", then necessary. an acceptable level?
 Physical (P)  If "no", stop and If “no”, indicate where this will
document at Q2 happened.
Production 2. Temperature control PP
C-Cleaning & 3. Equipment cleaning and sanitizing PP
Sanitizing Chemicals No
Separator Pathogens
Dry Dairy B – Vegetative No 1. COA/Supplier guarantee program
Ingredient Pathogen 1. Incoming ingredient PP
Receiving
Dry Dairy B – Vegetative No 1. Ingredient storage PP
Storage C - Contaminants No 2. Equipment cleaning and sanitizing PP
Non-Dairy B – Vegetative No 1. COA/Supplier guarantee PP No – Controlled at HTST
Liquid Pathogens Pasteurizer
P – Foreign material No 3. Incoming ingredient PP
209
Q1. Is the hazard
identified at this
Liquid Pathogens
Storage C – Toxin No 2. Equipment cleaning and sanitizing PP
Blending B – Vegetative Yes None, but Equipment cleaning and sanitizing PP No - Controlled at HTST
Pathogens assists Pasteurization
C - Allergens No
P – Foreign Material No 2. Allergen control PP
pallet fragments,
foreign objects in
ingredients)
zation Pathogens
C – Boiler Additives No 1. Water Safety PP manages use of boiler additives
requisite program.
Storage Pathogens
Culture B - Vegetative No 1. COA/Supplier guarantee program
Pathogens
C - Contaminants No 2. Incoming ingredient PP
210
Q1. Is the hazard
identified at this
Culture B – Vegetative No 1. Temperature management PP
Tank Pathogens
C - Cleaning and No 2.. Material Handling GMP
Sanitizing Chemicals 3. Equipment cleaning and sanitizing PP
& color(s) Pathogens 2. Incoming ingredient receiving & storage PP
Receiving C – Contaminants No
& Storage P – Foreign matter No
Pathogens
pallet fragments,
foreign objects in
ingredients)
Pathogens
Receiving Pathogens
and Storage C – Contaminants No 2. Incoming materials storage PP
P – Foreign Matter No 3. Incoming materials storage PP
211
Q1. Is the hazard
identified at this
Rework for B – Vegetative Yes None No-Controlled by HTST
Refreeze Pathogens Pasteurization
C - Contaminants No 1. Temperature management PP
C – Allergens No 2. Equipment cleaning and sanitizing PP
3. Allergen control PP
Rework B – Vegetative Yes None No-Controlled by HTST
Meltdown Pathogens Pasteurization
production 2. Equipment cleaning and sanitizing PP
Storage Pathogens
production
C-Cleaning and No 4. Equipment cleaning and sanitizing PP
Hardening None
Storage Pathogens
P - Foreign Materials No 3. Facility Maintenance PP
Pathogens hazards.
212
Q1. Is the hazard
identified at this
Signature: ______________________________________________Date: __________________
213
Product Name: Frozen Yogurt
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Point (CCP) for each Control Action(s)
Measure

Milk and Milk Biological- Time & Temperature. Temperatu Continuous At least once per Pasteurizer Manually divert flow Record Review CCP Records - Pasteurizer
Products Vegetative Pathogens 175°F for minimum of 25 re at the Temp. shift by the Operator of product Charts
Pasteurization (non-spore formers) seconds exit of the Recorder operator Pasteurizer charts verified
(HTST and HHST) holding Chart Isolate the affected including cut-in and cut-out Corrective Action Records
tube product performed, indicating versus
recording temps compared, CCP Verification- Records,
Continuous Evaluate and seal checks made, authorized including equipment testing
Residence during Operation Pasteurizer determine disposition supervisory review and sign- records
Note: Assuring that the time in the Flow Operator of the product off of recording charts
minimum holding times are met holding Recorder (reprocess or disposal)
in systems which use a sealed tube in Chart Equipment Function Checks
timing pump would be CCP continuou Document actions
verification, i.e. equipment s flow
calibration pasteurize Note: Utilize 5
rs with corrective action steps
magnetic recognized by NCIMS
based
timing
systems
Vat Pasteurization B – Vegetative The temperature as measured by Temperatu Check and Thermometer Pasteurizer / Continue 1. Indicating vs recording Temperature charts
(with continuous Pathogens the air space indicating re (°F) sign-off on checks done at Operator pasteurization until thermometer comparison.
agitation) thermometer must be at a recording beginning and time / temperature 2. Supervisory review and Corrective action records.
minimum of 155°F. Time charts. end of holding criteria are met. sign-off on recording charts.
(Min) time. 3. Equipment calibration. CCP verification records.
The holding time must be a Record both If more than two hours Calibration of thermometers.
minimum of 30 minutes. air space Annotate the has elapsed isolate the 4. Time calibration of chart Equipment calibration
and batch information product and contact controller. records.
The air space thermometer must indicating for each batch on QA. 5. Seal checks.
indicate a minimum of 160°F. Time thermomete the recording
(Min) r chart. Disposition the
temperature product.
s.
Document actions.

Signature: ______________________________________________Date: __________________
214
IDFA
CHEESE PRODUCT
HACCP MODELS
215
[Street Address]

Formal Product Name: Cheese Starter Culture
Food Safety Characteristics: Active Bacterial culture that is freeze dried and vacuum packed. Unlikely
to support growth of pathogens. Protective characteristics dependent on
storage <0°F, low water activity and competitive inhibition.
Ingredients Statement: Selected lactobacillus bacterial cultures freeze dried in media

Packaging Used: High Density Polypropylene heat-sealed bags or hermetically sealed metal
cans.
Storage and Distribution: Product is stored at  -20°F.
Intended Consumers: Dairy plants processing cheese.
Intended Use: Either for direct set of cheese vats or for preparation of bulk starter media.
Approved by: _____________________
Date: ____________________________________
216
Starter Culture (Bulk Starter) Flow Diagram
Dry Ingredient Dairy Ingredient
Receiving Receiving
Dry Ingredient Storage Cold Storage Dairy Ingredient

Storage
Rehydration &Storage Water
Blend Tank RawMilk
Pasteurization
Culture Addition
Bulk Culture Storage
Transfer to Cheese Vat
217
Starter Addition Hazard Analysis Summary
Q1. Is the hazard

of sufficient Q3 – Q6. Does a control measure
Identify the likelihood of Q2. Identify the Prerequisite Program or procedure that exist at this step to prevent, reduce
occurrence to reduces the likelihood of occurrence of the hazard to ensure or eliminate the likely occurrence
specific
Process warrant its control? that control at this step is not necessary. of a hazard to an acceptable level?
Step/ Potential Hazard  If "yes", then If “yes”, document as a CCP
Ingredient proceed to Q3 If “no”, indicate where this will
or Input  Biological (B)  If "no", stop and happen.
 Chemical (C) document at Q2
 Physical (P)
Starter B - Vegetative No 1. COA/Supplier Guarantee PP
media dry Pathogen
ingredient C- No 2. COA/Supplier Guarantee PP
receiving Contaminants No 3. Incoming ingredient PP
P - Foreign
material
Dry C- No 1. Ingredient storage PP
ingredient Contaminants
storage
Water B- Vegetative No 1. Water Safety PP
Pathogens
C-Contaminants No
Rehydrate B - Vegetative Yes None No, control at pasteurization
and store Pathogens step.
P - Foreign No 1. Equipment and cleaning PP
material 2. Adulteration & contamination PP
Dairy B - Vegetative Yes None No, controlled at pasteurization
Ingredient Pathogens step.
Production No 2. COA/Supplier Guarantee PP
C - Beta Lactam 3. Incoming ingredient PP with drug screening program as
Drug Residues per PMO, Appendix N
218
Q1. Is the hazard
specific
 Physical (P)
Dairy B - Vegetative No 1. Temperature control PP
Storage Growth No 2. Equipment cleaning and sanitizing PP
C - Toxin
Production No
C - Cleaning &
Sanitizing
Chemicals
Blend tank B – Vegetative Yes None No – Controlled at HTST
C - Contaminants No 1. Equipment cleaning and sanitizing PP
Material
(packaging
material, pallet
fragments,
foreign objects in
ingredients)
Pasteuriza B – Vegetative Yes None Yes – control of vegetative
-tion Pathogens pathogens from prior steps
C – Boiler No 1. Water Safety PP controls use of boiler additives to meet
Additives 21CFR173.310 in the water safety pre-requisite program.
Culture B – Vegetative No 1. Equipment cleaning and sanitizing PP
Addition Pathogens
Material
Bulk B – Vegetative No 1. Temperature control PP
Culture Pathogens
Storage C - Toxin No 2. Equipment cleaning and sanitizing PP
219
Q1. Is the hazard
specific
 Physical (P)
Production
C - Cleaning and
Sanitizing
Chemicals
Transfer B – Vegetative No 1. Equipment cleaning and sanitizing PP
to Cheese Pathogens
Vat C - Cleaning and No 2. Equipment cleaning and sanitizing PP
Sanitizing
Chemicals
P – Foreign No 3. Processing GMPs
Material
(packaging
material, pallet
fragments,
foreign objects in
ingredients)
Signature: ______________________________________________Date: __________________
220
Product Name: Starter Culture
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

Milk and Milk Biological- Time & Temperature. Temperat Continuou At least Pasteuri Manually divert flow of Record Review CCP Records -
Products Vegetative 161°F for minimum of ure at the s Temp. once per zer product Pasteurizer Charts
Pasteurization Pathogens 15 seconds exit of Recorder shift by Operator Pasteurizer
(HTST and HHST) (non-spore formers) the Chart the Isolate the affected charts verified Corrective Action
holding operator product including cut-in Records
tube and cut-out
disposition of the indicating versus Records, including
Note: Assuring that the Residenc Flow Continuou Pasteuri product (reprocess or recording temps equipment testing
minimum holding e time in Recorder s during zer disposal) compared, seal records
times are met in the Chart Operation Operator checks made,
systems which use a holding Document actions authorized
sealed timing pump tube in supervisory
would be CCP continuo Note: Utilize 5 review and sign-
verification, i.e. us flow corrective action steps off of recording
equipment calibration pasteuriz recognized by NCIMS charts
ers with HACCP program
magnetic Equipment
flow Function
meter Checks
based
timing
systems
thermometer must be at a recording beginning and comparison. Corrective action records.
minimum of 145°F. Time (Min) charts. end of holding If more than two hours has 2. Supervisory review
time. elapsed isolate the product and and sign-off on CCP verification records.
The holding time must be a Record both contact QA. recording charts.
minimum of 30 minutes. air space and Annotate the 3. Equipment Equipment calibration
indicating batch Disposition the product. calibration. records.
The air space thermometer must Time (Min) thermometer information Calibration of
indicate a minimum of 150°F. temperatures. for each batch Document actions. thermometers.

Signature: ______________________________________________Date: __________________
221
[Street Address]

Formal Product Name: Cheddar Cheese – Blocks
Food Safety Characteristics: All dairy ingredients are pasteurized. Supports some growth of a number
of pathogens during processing and early aging; however natural pH of
5.0 – 5.25 retards or kills pathogens over time.
Ingredient Statement Milk of all fat levels, cream, nonfat dry milk, salt, color, calcium
chloride, and cultures
Packaging Used: Final package is high density polypropylene bag shrink-wrapped and heat
sealed. Code date is printed via coding equipment after packaging.
Labeling Requirements: Keep refrigerated
Storage and Distribution: Initially stored in plastic lined square metal boxes for aging (40# blocks).
After aging, the blocks are cut into consumer-sized packages, placed in
plastic bags, sealed and stored  45°F. Distributed using refrigerated
trucks ( 45°F) to wholesale and retail outlets.
to-eat salad, hot dishes, both by consumers and for commercial purposes.
Shelf Life: 1 year under proper refrigeration.
Approved by: ______________________________
Date:_____________________________________
222
Cheddar Cheese
Raw Milk Receiving
Dry Dairy Ingredient Filter

Receiving
Raw Milk Storage
Dry Dairy Ingredient
Storage Clarifier/Separator Heat Treatment Cream Storage
Water Blend Ingredients

Rehydrate &
Storage Pasteurization
Starter Addition
Non-Dairy Receiving Cheese Vat
Drain Table Whey Storage

Non-Dairy Storage
Fines
Clarifier/Separator Whey Processing
Rennet Box/Mold Filling
CaCl2 Whey Cream Storage
Color
Vacuum Chamber/Press
Heat Treatment
NaCl
Metal Detector Storage
Packaging Storage Distribution
223
Cheddar Cheese Hazard Analysis Summary
Q1. Is the hazard

identified at this
Identify the specific likelihood of Q2. Identify the Prerequisite Program or procedure that exist at this step to prevent, reduce
occurrence to reduces the likelihood of occurrence of the hazard to or eliminate the likely occurrence
Potential Hazard
Process Step/ warrant its control? ensure that control at this step is not necessary. of a hazard to an acceptable level?
Ingredient or  If "yes", then If “yes”, document as a CCP
 Biological (B)
Input proceed to Q3 If “no”, indicate where this will
 Chemical (C) happen.
 Physical (P)
document at Q2
Note: See Starter Culture Hazard Analysis for processing of culture prior to addition
Raw milk B - Vegetative Yes None No, controlled at HTST
Receiving Pathogens pasteurization step.
C - Toxin No 1. Incoming ingredient PP
Production 2. COA/Supplier Guarantee PP
C - Beta Lactam No 3. Incoming ingredient PP with drug screening program
Drug Residues as per PMO, Appendix N
Filtration B - Vegetative No 1. Filtration PP – clean or replace daily
Pathogens
P - Foreign No 2. Equipment cleaning and sanitizing PP
material
Raw milk B - Vegetative 1. Temperature Control PP
C - Toxin No 2. Temperature Control PP
Production
C - Residual No 3. Equipment cleaning & sanitizing PP
Cleaning and
Sanitizing Agents
Separator Pathogens
Cream Heat B-Vegetative No 1. Equipment cleaning & sanitizing PP
treatment Pathogens
storage Pathogen Growth 2. Equipment cleaning & sanitizing PP
224
Q1. Is the hazard
identified at this
Potential Hazard
 Biological (B)
 Physical (P)
document at Q2
Production 4. Equipment cleaning & sanitizing PP
C - Residual
Cleaning and
Sanitizing Agents
Dry B - Vegetative No 1. COA/Supplier Guarantee PP
Ingredient Pathogen
Receiving P - Foreign No 2. Incoming ingredient PP
material
C - Hazardous No 3. COA/Supplier Guarantee PP
material
Dry C - Contaminants No 1. Ingredient storage PP
Ingredient
Storage
Non-dairy B -Vegetative No 1. COA/Supplier Guarantee PP
receiving Pathogen
(Rennet, P - Foreign No 2. Incoming ingredient PP
CaCl2,Color, material
salt) C - Contaminants No 3. COA/Supplier Guarantee PP
Non-dairy C - Contaminants No 1. Ingredient storage PP
storage
(Rennet,
CaCl2,Color,
salt)
Water B - Vegetative No 1. Water Safety PP
Pathogens
C - Contaminants No
Rehydrate B - Vegetative Yes None No, controlled at HTST
and store Pathogens pasteurization step.
225
Q1. Is the hazard
identified at this
Potential Hazard
 Biological (B)
 Physical (P)
document at Q2
P-Foreign material No 1. Material handling GMP
2. Equipment cleaning and sanitizing PP
Blend tank B - Vegetative Yes None No, controlled at HTST
Pathogens pasteurization step.
P - Foreign No 2. Material handling GMP
material
Pasteuriza- B - Vegetative Yes None Yes, control of vegetative
C - Boiler No 1. Water Safety PP controls use of boiler additives to
Additives meet 21CFR173.310
Starter B - Vegetative No 1. Adulteration & contamination PP
addition Pathogens
Material
Cheese vat B - Vegetative No 1. Equipment cleaning and sanitizing PP
(culture, Pathogens
setting, C - Residual No 2. Production GMPs
curding & Cleaning and
draining) Sanitizing Agents
P - Foreign No 3. Adulteration and contamination PP
material
Salt C - Contaminants No 1. COA/Supplier Guarantee PP
2. Incoming ingredient PP
3. Production GMPs
Drain table B - Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
C - Residual No 2. Equipment cleaning and sanitizing PP
Cleaning and
226
Q1. Is the hazard
identified at this
Potential Hazard
 Biological (B)
 Physical (P)
document at Q2
Sanitizing Agents
P - Foreign No 3. Adulteration and contamination PP
material
Whey B - Vegetative No 1. Equipment and sanitizing PP
Storage Pathogens
Production
C - Residual No 3. Equipment and sanitizing PP
Cleaning and
Sanitizing Agents
Clarifier/ B - Vegetative No 1. Equipment cleaning & sanitizing PP
Separator Pathogens
Whey cream B - Vegetative No 1. Temperature management PP
production
C - Residual 3. Equipment cleaning & sanitizing PP
Cleaning and No
Sanitizing Agents
Fines B - Vegetative No 1. Filtration PP – clean daily
Screening Pathogens
P - Foreign No 2. Equipment cleaning & sanitizing PP
Materials
Box/mold B - Vegetative No 1. Equipment cleaning and sanitizing PP

filling Pathogens
C - Residual No 2. Production GMPs
Cleaning and
Sanitizing Agents
227
Q1. Is the hazard
identified at this
Potential Hazard
 Biological (B)
 Physical (P)
document at Q2
material
Vacuum B - Vegetative No 1. Equipment cleaning and sanitizing PP
chamber/ Pathogens 2. Production GMPs
press C - Residual No
Cleaning and
Sanitizing Agents
P - Foreign No
material
Metal P - Metal No 1.Metal Detection PP
detector Fragments
equipment
Storage & B - Vegetative No 1. Facility Maintenance PP
Aging Pathogens 2. Temperature management PP
C - Contaminants No
P - Foreign No
Materials
Packaging B - Vegetative No 1. COA/Supplier verification PP
Material Pathogens
Receiving C - Contaminants No 2. Incoming materials receiving & storage PP
and Storage P - Foreign
material No
Packaging B - Vegetative No 1. Production GMPs
Pathogens 2. Equipment cleaning & sanitizing PP
P - Foreign No
Material
C - Residual No
Cleaning and
Sanitizing Agents
228
Q1. Is the hazard
identified at this
Potential Hazard
 Biological (B)
 Physical (P)
document at Q2
Refrigerated B - Vegetative No 1.Temperature management PP
Storage Pathogens
C - Contaminants No Packaged product protected from all common hazards.
P - Foreign No
Materials
Distribution B - Vegetative No 1. Temperature management PP

Pathogens
P - Foreign No
Materials

Signature: ______________________________________________Date: __________________
229
Product Name: Cheddar Cheese -Blocks
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Point (CCP) For each Control Measure Action(s)

Milk and Milk Biological- Time & Temperature. Temperatu Continuous At least Pasteuriz Manually divert flow of Record Review CCP Records -
Products Vegetative Pathogens 161°F for minimum of 15 re at the Temp. once per er product Pasteurizer Charts
Pasteurization (non-spore formers) seconds exit of the Recorder shift by the Operator Pasteurizer charts
(HTST and HHST) holding Chart operator Isolate the affected product verified including Corrective Action
tube cut-in and cut-out Records
Evaluate and determine performed,
disposition of the product indicating versus CCP Verification-
Residence Continuous (reprocess or disposal) recording temps Records, including
Note: Assuring that the time in the Flow during Pasteuriz compared, seal equipment testing
minimum holding times holding Recorder Operation er Document actions checks made, records
are met in systems which tube in Chart Operator authorized
use a sealed timing pump continuou Note: Utilize 5 corrective supervisory review
would be CCP s flow action steps recognized by and sign-off of
verification, i.e. pasteurizer NCIMS HACCP program recording charts
equipment calibration s with
magnetic Equipment
flow meter Function Checks
based
timing
systems

Signature: ______________________________________________Date: __________________
230
[Street Address]

Formal Product Name: Natural Shredded or Chunk Cheese (also may work for string cheese)
Food Safety Characteristics: All dairy ingredients are pasteurized. Supports some growth of pathogens
during processing and early aging; however natural pH of 5.0 – 5.4 retards
or kills pathogens over time.
Ingredient Statement Milk of all fat levels, cream, nonfat dry milk, salt, color, calcium chloride,
and cultures, anti-mycotic (for mold control)
Packaging Used: Multi-layered package, high density polypropylene bag shrink-wrapped and heat
sealed. Gas flushed with CO2 and N2 to reduced residual O2 content to
3%. Code date is printed via coding equipment after packaging.
Labeling Requirements: Keep refrigerated,
Storage and Distribution: After aging, blocks natural cheese are shredded into consumer-sized
packages, placed in plastic bags, sealed and stored  45°F. Distributed
using refrigerated trucks ( 45°F) to wholesale and retail outlets.
to-eat salad, hot dishes, both by consumers and for commercial purposes.
Approved by: _____________________
Date:____________________________
231
“Chunks” Flow Diagram
Cheese Block Receiving
Cheese Block Storage
Knockdown, Stripping Distribution

Cleaning
Slabber Cold Storage
Wire Chopper Processed Trim
Packaging Storage Check Weigher Loose Trim

Shred
Packaging Supplies Packaging Equipment Cheese
Wrapper Coding
Line
Metal Detector
Co2/N2 Addition
Hand Casing
Case Taping
Case Coding
Hand Palletizing
Cold Storage
Distribution
232
“Shred” Flow Diagram
Cheese Block Receiving
Cheese Block Storage
Knock Down, Stripping Cleaning
Wireharp Cutter
Dry Ingredient Storage Shredder Loose Trim
Free Flow Agent
Tumbler Antimycotic Addition
Packaging Supplies Bag Filler Wrapper Coding
Packaging Storage Metal Detector
CO 2/N2 Addition
Hand Casing
Case Taping Case Coding
Hand Palletizing
Cold Storage
Distribution
233
Shredded Cheese Hazard Analysis Summary
Q1. Is the hazard

identified at this
specific
 Physical (P)
Cheese B- Vegetative No 1. COA/Supplier Guarantee PP
Block Pathogens
Receiving C - Contaminants No 2. Incoming Ingredient PP
P-Foreign material No
Cheese B- Vegetative No 1. Temperature management PP
Block Pathogens
Storage C - Contaminants No 2. Incoming Ingredient Storage PP
Knock B- Vegetative No 1. Equipment cleaning and sanitizing PP
down, Pathogens 2. Materials handling GMP
stripping, C – Contaminants No
cleaning P-Foreign material No
Wire harp B- Vegetative No 1. Equipment cleaning and sanitizing PP
cutter Pathogens
P-Foreign material No 2. Equipment design and maintenance PP
Shredder B- Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
Tumbler B- Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
Loose trim B- Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
234
Q1. Is the hazard
identified at this
specific
 Physical (P)
Ingredient B – Vegetative No 1. Temperature management PP
Receiving Pathogens
and Storage C - Contaminants No 2. COA/Supplier Guarantee PP
3. Incoming ingredient PP
Antimyco- B- Vegetative No 1. COA/Supplier Guarantee PP
tic Addition Pathogens 2. Materials handling GMP
Free flow B- Vegetative No 1. COA/Supplier Guarantee PP
agent Pathogens 2. Materials handling GMP
Addition P-Foreign material No
Packaging B - Vegetative No 1. COA/Supplier Guarantee PP
Receiving Pathogens 2. Incoming packaging PP
C - Contaminants No
Packaging C - Contaminants No 1. Incoming packaging storage PP
Storage
Bag filler B- Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
P-Foreign material No 2. Production GMP
Wrapper None No
coding
Co2/N2 C – contaminants No 1. COA/Supplier guarantee PP
Addition 2. Incoming ingredient PP
Metal P-Metal fragments No 1.Metal detection PP
detector from equipment
Hand B- Vegetative No 1. Material handling GMP
casing Pathogens
C - Contaminants No
P - Foreign No
235
Q1. Is the hazard
identified at this
specific
 Physical (P)
material
Case None
taping,
Case
coding
Hand None
palletizing
Cold B – Vegetative No 1. Temperature management PP

storage Pathogen growth
C – Toxin
Production
Distribu- None
tion

Signature: ______________________________________________Date: _________________
236
[Street Address]

Formal Product Name: Mozzarella Cheese
Food Safety Characteristics: All dairy ingredients are pasteurized. Active fermentation with acid
development retards pathogen growth during curd formation. May
support some growth of pathogens during late processing and early aging;
natural pH of around 5.2.
Ingredient Statement Milk of all fat levels from cows or water buffalo, cream, nonfat dry milk,
cultures & enzymes, vinegar, salt, and color.
Packaging Used: Final package is high density polypropylene bag shrink-wrapped and heat
sealed. Code date is printed via coding equipment after packaging.
Storage and Distribution: After a short aging period, the wheels or blocks are cut into consumer-
sized packages, placed in plastic bags, sealed and stored  45°F.
outlets.
and institutions serving captured populations for cooking purposes.
Intended Use: Ready to serve product. May also be used in slice or shredded as a topping
on pizzas, ready-to-eat salad, hot dishes, and sandwiches both by
consumers and for commercial purposes.
Shelf Life: 60 days under proper conditions.
Approved by: ______________________________
Date: ____________________________________
237
Mozzarella Cheese
Raw Milk Receiving

Receiving
Raw Milk Storage
Dry Dairy Ingredient
Water Blend Ingredients

Rehydrate &
Storage Pasteurization
Starter Addition

Non-Dairy Storage
Fines
Rennet
CaCl2 Mixer Whey Cream Storage
Vinegar
Molder
Brining Packaging Heat Treatment Whey Cream
NaCl Materials Storage
Chill Tank
Metal Detector Packaging

Storage & Aging Storage Distribution
238
Mozzarella Cheese Hazard Analysis Summary
Q1. Is the hazard

specific
Process Step/ warrant its control? that control at this step is not necessary. of a hazard to an acceptable level?
Ingredient or Potential Hazard  If "yes", then If “yes”, document as a CCP
 Biological (B)  If "no", stop and happen.
 Physical (P)
Raw milk B - Vegetative Yes None No, controlled at HTST
Receiving Pathogens pasteurization step.
Filtration B - Vegetative No 1. Filtration PP – clean or replace dailiy
Pathogens
material
Raw milk B - Vegetative No 1. Temperature management PP
Storage Pathogens
Growth No 2. Temperature management PP
C - Toxin
Production No 3. Equipment cleaning & sanitizing PP
C - Residual
Cleaning and
Sanitizing Agents
Separator Pathogens
treatment Pathogens
production
239
Q1. Is the hazard
specific
 Physical (P)
Cream B - Toxin No 1. Temperature control PP
storage Production
Growth No 2. Equipment cleaning & sanitizing PP
C - Residual
Cleaning and
Sanitizing Agents
Dry B - Vegetative No 1. COA/Supplier Guarantee PP
Ingredient Pathogen
Receiving P - Foreign No 2. Incoming ingredient PP
material
C - Hazardous No
material
Dry C - Contaminants No 1. Ingredient storage PP
Ingredient
Storage
Non-dairy B -Vegetative No 1. COA/Supplier Guarantee PP
Receiving Pathogen
(Enzymes, P - Foreign No 2. Incoming ingredient PP
salt, vinegar, material
salt, color) C - Contaminants No
ingredient
storage
Pathogens
C - Contaminants No
and storage Pathogens pasteurization step.
P-Foreign No 1. Temperatures management PP
material 2. Equipment cleaning and sanitizing PP
240
Q1. Is the hazard
specific
 Physical (P)
Blend tank B - Vegetative Yes None No, controlled at HTST
Pathogens pasteurization step.
material
Pasteuriza- B - Vegetative Yes None Yes, control of vegetative
C - Boiler No 1. Water Safety PP controls use of boiler additives to
Additives meet 21CFR173.310
Starter B - Vegetative No 1. Material handling GMP
addition Pathogens
P - Foreign No
Material
(culture Pathogens 2. Production GMPs
setting, C - Residual No 3. Equipment cleaning and sanitizing PP
material
Rennet, C - Contaminants No 1. Material Handling GMPs
CaCl2, P - Foreign No
Vinegar Objects
Addition
Salt C - Contaminants No 1. Material Handling GMPs
Addition P - Foreign No
Objects
Pathogens 2. Production GMPs
241
Q1. Is the hazard
specific
 Physical (P)
Cleaning and
Sanitizing Agents
material
Whey B - Vegetative No 1. Temperature management PP
Storage Pathogens
Growth No 2. Temperature management PP
C - Toxin
Production No 3. Equipment and sanitizing PP
C - Residual
Cleaning and
Sanitizing Agents
Separator Pathogens
Whey B - Vegetative No 1. Equipment cleaning and sanitizing PP
Cream Heat Pathogens
Treatment
Cream Pathogens
Storage Growth
production
Cleaning and
Sanitizing Agents
Fines B— Vegetative No 1. Equipment cleaning and sanitizing PP
P—Foreign No 4. Equipment cleaning and sanitizing PP
242
Q1. Is the hazard
specific
 Physical (P)
material
Mixer B - Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens 2. Material handling GMP
C - Contaminants No
P - Foreign No
material
Molder B - Vegetative No 1. Equipment cleaning and sanitizing PP
C - Residual No
Cleaning and
Sanitizing Agents
P - Foreign No
material
Chill tank B - Vegetative No 1. Water control PP
Pathogens
C - Contaminants
Brining B - Vegetative No 1. Water control PP (Brining solution eliminates
Pathogens vegetative pathogens and prevents their growth
Metal P - Metal No 1. Metal Detection PP
detector Fragments -
equipment
Storage and B - Vegetative No 1. Temperature management PP
Aging Pathogens
Materials
Material Pathogens
and Storage P - Foreign
243
Q1. Is the hazard
specific
 Physical (P)
material No
Packaging B - Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
P - Foreign No 2. Production GMPs
Material
Cleaning and
Sanitizing Agents
Storage Pathogens
P - Foreign No
Materials
Pathogens
P - Foreign No
Materials
Signature: ______________________________________________Date: _________________
244
Product Name: Mozzarella Cheese
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

magnetic Equipment
based
timing
systems

Signature: ______________________________________________Date: __________________
245
[Street Address]

Formal Product Name: Swiss/Emmentaler Cheese
Food Safety Characteristics: All dairy ingredients are pasteurized. Supports some growth of a number of pathogens
i.e. pH, water activity, etc. during processing and early aging; however natural pH (approx. 5.6) and low water
activity retards or kills pathogens over time.
Ingredients Statement: Milk of all fat levels from cow, cream, concentrated milk, nonfat dry milk,
rennet, enzymes, other setting agents, cultures, salt, calcium chloride,
antimycotic agents, and benzoyl peroxide, hydrogen peroxide, or other
bleaching agents.
Packaging Used: Final package is high density polypropylene bag shrink-wrapped and heat sealed. Code
date is printed via coding equipment after packaging.
Storage and Distribution: Initially stored as brined blocks in film-lined square metal boxes for aging and eye
development. After aging and eye formation, the blocks are cut into consumer-sized
packages, placed in plastic bags, sealed and stored  45°F. Distributed using refrigerated
trucks ( 45°F) to wholesale and retail outlets.
Intended Consumers: Consumed by the general public of all ages and well as retail restaurants and institutions
serving captured populations.
Intended Use: Ready to serve product usually used on hot and cold sandwiches by consumers and fast
food restaurants.. May also be used as an ingredient for many foods, both by consumers
and for commercial purposes.
Approved by:____________________________
Date: __________________________________
246
Swiss/Emmentaler Cheese
Raw Milk Receiving

Receiving
Raw Milk Storage
Dry Dairy Ingredient Rehydrate &
Storage
Blend Ingredients
Pasteurization
Water
Starter Addition

Non-Dairy Storage
Fines
Rennet Box/Mold Filling
CaCl2 Whey Cream
Decolorants
Brining
NaCl
Packaging Material Packaging
Metal Detector Cooling Casing Storage Distribution
247
Swiss/Emmentaler Cheese Hazard Analysis Summary Table
Date:_____________________________________________ Plant Address:________________________________________________
Q1. Is the hazard

identified at this step of
sufficient likelihood of Q3 – Q6. Does a control measure
Identify the specific occurrence to warrant Q2. Identify the Prerequisite Program or procedure that exist at this step to prevent, reduce
its control? reduces the likelihood of occurrence of the hazard to or eliminate the likely occurrence
Potential Hazard
Process Step/  If "yes", then ensure that control at this step is not necessary. of a hazard to an acceptable level?
Ingredient or proceed to Q3 If “yes”, document as a CCP
 Biological (B)
Input  If "no", stop and If “no”, indicate where this will
document at Q2
 Physical (P)
Raw Milk B - Vegetative Yes None No, controlled at pasteurization
Receiving Pathogens step.
(raw milk, C - Toxin No 1. Incoming ingredient PP
cream, etc.) Production 2. COA/Supplier Guarantee PP
Pathogen
P - Foreign No 2. Equipment cleaning, sanitizing & maintenance PP to
material ensure foreign material is removed
Production
C - Cleaning & No 3. Equipment cleaning and sanitizing PP
Sanitizing
Chemicals
Separator Pathogens
treatment Pathogens
Production
248
Q1. Is the hazard
Potential Hazard
 Biological (B)
document at Q2
 Physical (P)
Heat Treated B – Vegetative No 1. Temperature management PP
Cream Pathogen Growth
storage C - Toxin No 2. Temperature management PP
production
Cleaning and
Sanitizing Agents
Non-dairy B – Vegetative No 1. COA/Supplier guarantee PP
Ingredient Pathogens 2. Incoming ingredient PP
(Rennet, P – Foreign material No
CaCl2, Color,
Salt)
Ingredient
Storage
(Rennet,
CaCl2, Color,
Salt)
Dry Dairy B - Vegetative No 1. COA/Supplier guarantee PP
Ingredient Pathogen 2. Incoming ingredient PP
Receiving P - Foreign No
material
C - Hazardous No
material
Dry Dairy C - Contaminants No 1. Ingredient storage PP
Ingredient
Storage
249
Q1. Is the hazard
Potential Hazard
 Biological (B)
document at Q2
 Physical (P)
Pathogens
C - Contaminants No
and storage Pathogens pasteurization step.
P-Foreign material No 1. Temperatures management PP
2. Equipment cleaning and sanitizing PP
Blend B – Vegetative Yes None No – Controlled at HTST
Ingredients Pathogens Pasteurizer
Material
(packaging
material, pallet
fragments, foreign
objects in
ingredients)
without a C – Boiler No 1. Water Safety PP controls use of boiler additives to
magnetic Additives meet 21CFR173.310 in the water safety pre-requisite
flow meter) program.
Starter B - Vegetative No 1. Material Handling GMP
Addition Pathogens
P - Foreign No
Material
(culture Pathogens 2. Production GMPs
setting, C - Residual No 3. Equipment cleaning and sanitizing PP
250
Q1. Is the hazard
Potential Hazard
 Biological (B)
document at Q2
 Physical (P)
material
Cleaning and
Sanitizing Agents
material
Production
Cleaning and
Sanitizing Agents
Separator Pathogens
Whey B - Vegetative No 1. Equipment cleaning and sanitizing PP
Cream Heat Pathogens
Treatment
Cream Pathogens Growth
production
Cleaning and
Sanitizing Agents
251
Q1. Is the hazard
Potential Hazard
 Biological (B)
document at Q2
 Physical (P)
Fines B - Vegetative No 1. Equipment cleaning and sanitizing PP
C – Contaminants No 3. Equipment cleaning and sanitizing PP
P – Foreign No 4. Equipment cleaning and sanitizing PP
Material
(packaging
material, pallet
fragments, foreign
objects in
ingredients)
Rennet, C - Contaminants No 1. Material Handling GMPs
CaCl2, P - Physical No
Decolorant
Addition
Salt C - Contaminants No 1. Material Handling GMPs
Addition P - Physical No
Box/Mold B - Vegetative No 1. Equipment cleaning and sanitizing PP
Filling Pathogens 2. Production GMPs
C - Residual No
Cleaning and
Sanitizing Agents
P - Foreign No
material
Brining B - Vegetative No 1. Water control PP (Brining solution eliminates
Pathogens vegetative pathogens and prevents their growth
Material Pathogens
and Storage P - Foreign No 3. Incoming materials receiving & storage PP
material
252
Q1. Is the hazard
Potential Hazard
 Biological (B)
document at Q2
 Physical (P)
Pathogens
P - Foreign No 2. Production GMPs
Material
Cleaning and
Sanitizing Agents
Detector contamination
Cooling B - Vegetative No 1. Temperature management PP
Pathogens
P - Foreign Matter No
Casing B - Vegetative No 1. COA/Supplier Verification PP
Pathogens
P - Foreign Matter No
Storage Pathogens
P - Foreign No
Materials
Pathogens
P - Foreign No
Materials
253
Product Name:_____ Swiss/Emmentaler Cheese_______________________________

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Point (CCP) For each Critical Control Point Action(s)

Milk and Milk Biological- Time & Temperature. Temperat Continuous At least once Pasteurize Manually divert flow of Record Review CCP Records -
Products Vegetative Pathogens 161°F for minimum of 15 ure at the Temp. per shift by r product Pasteurizer Charts
Pasteurization (non-spore formers) seconds exit of the Recorder the operator Operator Pasteurizer charts
(HTST and HHST) holding Chart Isolate the affected verified including Corrective Action
tube product cut-in and cut-out Records
performed,
Continuous Evaluate and determine indicating versus CCP Verification-
Residence during disposition of the product recording temps Records, including
Note: Assuring that the time in Flow Operation Pasteurize (reprocess or disposal) compared, seal equipment testing
minimum holding times the Recorder r checks made, records
are met in systems which holding Chart Operator Document actions authorized
use a sealed timing pump tube in supervisory review
would be CCP continuou Note: Utilize 5 corrective and sign-off of
verification, i.e. s flow action steps recognized by recording charts
equipment calibration pasteurize NCIMS HACCP program
rs with Equipment
magnetic Function Checks
flow
meter
based
timing
systems
Vat Pasteurization B – Vegetative Pathogens The temperature as measured by Temperature Check and Thermometer Pasteurizer / Continue pasteurization until 1. Indicating vs recording Temperature charts
(with continuous agitation) the air space indicating (°F) sign-off on checks done at Operator time / temperature criteria are thermometer comparison.
thermometer must be at a recording beginning and met. 2. Supervisory review Corrective action records.
minimum of 150°F. Time (Min) charts. end of holding and sign-off on recording
time. If more than two hours has charts. CCP verification records.
The holding time must be a Record both elapsed isolate the product and 3. Equipment calibration.
minimum of 30 minutes. air space and Annotate the contact QA. Calibration of Equipment calibration
indicating batch thermometers. records.
The air space thermometer must Time (Min) thermometer information for Disposition the product. 4. Time calibration of
indicate a minimum of 155°F. temperatures. each batch on chart controller.
the recording Document actions. 5. Seal checks.
chart.

Signature: ______________________________________________Date: __________________
254
[Street Address]

Formal Product Name: 4% Cottage Cheese
Food Safety Characteristics: All dairy ingredients are pasteurized. Active fermentation with acid
development retards pathogen growth during curd formation. May
support some growth of pathogens during late processing and early aging;
natural pH of around 5.0 prior to creaming.
Ingredient Statement Cultured Grade A Skim milk, cream, nonfat dry milk, whey, salt, guar gum,
mono and diglycerides, sorbic acid (a mold inhibitor), carrageenan, polysorbate
80, locust bean gum, phosphoric acid, natural and artifical flavors, enzymes,
vitamin A palmitate, vitamin D3
Packaging Used: This product is filled in 8 oz, 12 oz, 16 oz, 24 oz, 3 pound, 5-pound and 30-
pound polypropylene containers and lids. All retail packages are banded with a
tamper resistant seal. Code date is printed via coding equipment after
packaging.
Storage and Distribution: The product is immediately ready for distribution, sale and consumption
after packaging. It is stored  45°F. Distributed using refrigerated trucks
( 45°F) to wholesale and retail outlets.
and institutions serving captured populations for cooking purposes.
Intended Use: Ready to serve product. May also be used as an ingredient in Italian and
other cultural foods.
Shelf Life: 40 days under ideal conditions.
Approved by: ______________________________
Date: ____________________________________
255
4 % COTTAGE CHEESE FLOW CHART
WATER MEDIA RAW INGREDIENT RECEIVING DRY INGREDIENTS

POWDER
RAW MILK
RECEIVING
MEDIA BLENDING
CREAM DRESSING
SOCK FILTER STORAGE BLENDING
VAT PASTEURIZATION
RAW MILK
STORAGE DRESSING
FROZEN PASTEURIZATION
COOLING CULTURE
ADDITION RAW MILK
REGENERATION HEAT TREATING
CREAM
SEPARATION
DRESSING COOLING &
CULTURE SET
STORAGE
VITAMIN ADDITION
CULTURE BREAK &
COOLING
SKIM PASTEURIZATION
RENNET
CULTURE STORAGE ADDITION
BULK CULTURE COTTAGE CHEESE VAT

ADDITION (SET, CUT & COOK)
WHEY COOLING
& STORAGE WHEY DRAINING
WATER TREATED
TREATMENT WATER CURD WASH
WITH STORAGE
CHLORINE
CREAMING
DISTRIBUTION
PACKAGING PACKAGING
RECEIVING STORAGE
PACKAGING & BANDING
REFRIGERATED
METAL DETECTION CASING
STORAGE
256
4% Cottage Cheese Hazard Analysis Summary
Q1. Is the hazard
identified at this
step of sufficient Q3 – Q6. Does a control measure exist at this step to
Identify the specific likelihood of Q2. Identify the Prerequisite Program or prevent, reduce or eliminate the likely occurrence of
occurrence to procedure that reduces the likelihood of a hazard to an acceptable level?
Potential Hazard
Process Step/ warrant its control? occurrence of the hazard to ensure that If “yes”, document as a CCP
Ingredient or  If "yes", then control at this step is not necessary. If “no”, indicate where this will happen.
 Biological (B)
Input proceed to Q3
 Chemical (C)
 Physical (P)
document at Q2
Raw Milk B - Vegetative Yes None No, controlled at pasteurization step.
Receiving Pathogens
C - Beta Lactam No 3. Incoming ingredient PP with drug
Drug Residues screening program as per PMO, Appendix N
Pathogen 2. Equipment cleaning and sanitizing PP
P - Foreign material No
Production
Sanitizing
Chemicals
Raw Ingredient B - Vegetative No 1. Temperature managment PP
Receiving & Pathogens 1. COA/Supplier guarantee PP
Storage C - Contamination No 2. Incoming ingredient PP
(culture, rennet.
vitamins)
Dry ingredient B - Vegetative No 1. COA/Supplier guarantee PP
receiving (dry Pathogen 2. Incoming ingredient PP
milk, rennet, P - Foreign material No
salt, etc) C - Hazardous No
material
257
Q1. Is the hazard
identified at this
Potential Hazard
 Biological (B)
Input proceed to Q3
 Chemical (C)
 Physical (P)
document at Q2
Dry ingredient B – Vegetative No 1. Ingredient storage PP
storage Pathogens
C - Contaminants No
Raw milk B – Vegetative No 1. Equipment cleaning and sanitizing PP
regeneration Pathogens 2. Cross contamination PP
Separator B – Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
Cream Heat B – Vegetative No 1. Equipment cleaning and sanitizing PP
Treatment Pathogens
Cream Storage B – Vegetative No 1. Temperature management PP
Pathogens
C - Toxin production No 2. Temperature management PP
Cleaning and
Sanitizing Agents
Skim B – Vegetative Yes None Yes – control of vegetative pathogens from prior
Pasteurization Pathogens steps
(HTST w/o C – Boiler Additives No 1. Water Safety PP controls use of boiler
mag. additives to meet 21CFR173.310 in the water
flowmeter) safety pre-requisite program.
Vitamin A C – Vitamin No 1. Adulteration PP addresses vitamin
Addition Toxicity addition and weekly reconciliation.
Starter B - Vegetative No 1. Material Handling GMP
Addition (see Pathogens
HACCP model P - Foreign Material No
for complete
hazard
analysis)
Rennet B - Vegetative No 1. Material Handling GMP
Addition Pathogens
258
Q1. Is the hazard
identified at this
Potential Hazard
 Biological (B)
Input proceed to Q3
 Chemical (C)
 Physical (P)
document at Q2
Cottage Cheese B - Vegetative No 1. Equipment cleaning and sanitizing PP
vat fill, set, cut Pathogens 2. Production GMPs
and cook C - Residual No 3. Adulteration and contamination PP
Cleaning and
Sanitizing Agents
Whey Draining B - Vegetative No 1. Equipment cleaning and sanitizing PP
C - Residual No 3. Adulteration and contamination PP
Cleaning and
Sanitizing Agents
Whey Cooling B - Vegetative No 1. Temperature management PP
and Storage Pathogens Growth
Production
Cleaning and
Sanitizing Agents
Water C - Contaminants No 1. Water Supply PP
Treatment
w/Chlorine
Chlorinated B - Vegetative No 1. Water Supply PP
Water Storage Pathogens 2. Equipment cleaning and sanitizing PP
C - Contaminants No
Water Addition B – Vegetative No 1. Water safety PP
Pathogens 2. Material Handling GMPs
Curd Wash B – Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens 2. Material Handling GMPs
C - Contaminants No 3. Adulteration and contamination PP
259
Q1. Is the hazard
identified at this
Potential Hazard
 Biological (B)
Input proceed to Q3
 Chemical (C)
 Physical (P)
document at Q2
Cream B – Vegetative Yes None No – Controlled at HTST Pasteurizer
Dressing Pathogens
Blending C - Contaminants No 1. Equipment cleaning and sanitizing PP
P – Foreign Material No 2. Material Handling GMP
pallet fragments,
foreign objects in
ingredients)
Cream B – Vegetative Yes None Yes – control of vegetative pathogens from prior
Dressing Pathogens steps
Pasteurization C – Boiler Additives No 1. Water Safety PP controls use of boiler
(HTST w/o additives to meet 21CFR173.310 in the water
mag. safety pre-requisite program.
flowmeter)
Dressing Pathogens
Cooling & C - Cleaning and No 2. Equipment cleaning and sanitizing PP
Storage Sanitizing
Chemicals
Creaming B – Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
C - Contaminants No 2. Material Handling GMP
P – Foreign Material No 3. Adulteration and contamination PP
pallet fragments,
foreign objects in
ingredients)
Receiving Pathogens
C - Contaminants No 2. Incoming materials receiving & storage
260
Q1. Is the hazard
identified at this
Potential Hazard
 Biological (B)
Input proceed to Q3
 Chemical (C)
 Physical (P)
document at Q2
P - Foreign material No PP
Packaging C - Contaminants No 1. Incoming materials storage PP
Storage P - Foreign material No
Packaging & B - Vegetative No 1. Equipment cleaning and sanitizing PP
Banding Pathogens
P - Foreign Material No 2. Production GMPs
C - Residual 3. Equipment cleaning and sanitizing PP
Cleaning and No
Sanitizing Agents
Casing B - Vegetative No 1. COA/Supplier Verification PP
Pathogens
C - Contaminants No Packaged product protected from all
P - Foreign Matter No common hazards.
Refrigeration, B - Vegetative No 1. Temperature management PP
Storage Pathogens
P - Foreign No common hazards.
Materials
Pathogens
P - Foreign No common hazards.
Materials
261
Product Name: 4% Cottage Cheese
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

magnetic Equipment
based
timing
systems

Signature: ______________________________________________Date: __________________
262
[Street Address]

Formal Product Name: Fresh White Cheese (Soft)
Food Safety Characteristics: Supports growth of pathogens, higher water activity and pH than American-style
i.e. pH, water activity, etc. cheeses. Active bacterial culture is freeze dried and vacuum packed. Unlikely to
support growth of pathogens. All dairy ingredients are pasteurized. Active fermentation
with acid development retards pathogen growth during curd formation. May support
some growth of pathogens during late processing and early aging; natural pH of around
5.2.
Ingredients Statement: Milk of all fat levels from cow, goats or sheep, cream, skim milk,
concentrated milk, nonfat dry milk, rennet, enzymes, other setting agents,
cultures, salt, calcium chloride, and color.
Packaging Used: Final package is high density polypropylene bag shrink-wrapped and heat sealed. Code
date is printed via coding equipment after packaging. This product is packed in 12 oz, 18
oz, 1.5 lbs, 2.5 lbs, and 5 lbs
Storage and Distribution: After a short aging period, the blocks are cut into consumer-sized packages, placed in
plastic bags, sealed and stored  45°F. Distributed using refrigerated trucks ( 45°F) to
Intended Consumers: This product is primarily marketed to Hispanic consumers of all ages, but consumption
expanding into traditional cheese consuming population of all ages and well as retail
restaurants and institutions for cooking purposes.
Intended Use: Ready to serve product. May also be used in slice, shredded or in chucks as an ingredient
in other foods, ready-to-eat salad, hot dishes, and sandwiches both by consumers and for
commercial purposes.
Shelf Life: 75 days under proper conditions.
Approved by: ______________________________________
Date: _____________________________________________
263
FRESH WHITE CHEESE FLOW DIAGRAM CHART
DAIRY INGREDIENT RECEIVING
FILTER
DAIRY INGREDIENT STORAGE
NON-DAIRY INGREDIENT
BLEND STANDARDIZATION
RECEIVING/STORAGE
HTST PASTEURIZATION
CHEESE SETTING/COOKING/CUTTING(VAT)
WHEY DRAINING
WHEY STORAGE STARTER ADDITION
SALT ADDITION & MIXING
MOLD FILLING
CHEESE PRESSING & CUTTING
PACKAGING PACKAGING MATERIAL
METAL DETECTOR
COOLING
CASING
STORAGE
DISTRIBUTION
264
Fresh White Cheese Hazard Analysis Summary Table
Date:_____________________________________________ Plant Address:________________________________________________
Q1. Is the hazard

Potential Hazard
 Biological (B)
document at Q2
 Physical (P)
B - Vegetative Yes None No – Controlled at HTST
Dairy Pasteurizer
Pathogens
Ingredient
C - Toxin Production No 1. Incoming ingredient PP
Receiving
(raw milk, C - Beta Lactam No 2. Temperature control PP
cream, etc.) Drug Residues 3. Incoming ingredient PP with drug screening program
as per PMO, Appendix N
B - Vegetative No 1. Filtration PP – clean or replace daily
Filtration Pathogen
material
B - Vegetative No 1. Temperature management PP
Dairy Pathogen Growth
Ingredient C - Toxin No 2. Temperature management PP
Storage Production
Sanitizing
Chemicals
Non-dairy B – Vegetative No 1. COA/Supplier guarantee PP
Ingredient Pathogens 2. Incoming ingredient PP
(Rennet, P – Foreign material No
CaCl2, Salt)
265
Q1. Is the hazard
Potential Hazard
 Biological (B)
document at Q2
 Physical (P)
Ingredient
Storage
(Rennet,
CaCl2, Salt)
B – Vegetative Yes None No – Controlled at HTST
Blend P – Foreign No 2. Material Handling GMP
Standardi-
Material
zation
(packaging
material, pallet
fragments, foreign
objects in
ingredients)
without a C – Boiler No 1. Water Safety PP controls use of boiler additives to
magnetic Additives meet 21CFR173.310 in the water safety pre-requisite
flow meter program.
system)
B - Vegetative No 1. Material Handling GMP
Starter Pathogens
Addition P - Foreign No
Material
Cheese B - Vegetative No 1. Equipment cleaning and sanitizing PP
Setting, Pathogens 2. Production GMPs
Cutting &
Cooking
266
Q1. Is the hazard
Potential Hazard
 Biological (B)
document at Q2
 Physical (P)
(Vat) Cleaning and
Sanitizing Agents
No
P - Foreign
material
B - Vegetative No 1. Equipment cleaning and sanitizing PP
Whey
draining
Cleaning and
Sanitizing Agents
P - Foreign No
material
Pathogen Growth
Whey Storage Production
C - Residual No 3. Equipment and sanitizing PP
Cleaning and
Sanitizing Agents
Material
Salt Addition (packaging
& Mixing material, pallet
fragments, foreign
objects in
ingredients)
Mold Filling B - Vegetative No 1. Equipment cleaning and sanitizing PP
267
Q1. Is the hazard
Potential Hazard
 Biological (B)
document at Q2
 Physical (P)
Cleaning and
Sanitizing Agents
P - Foreign No
material
B - Vegatative No 1. Equipment cleaning and sanitizing PP
Press & C - Residual No 3. Adulteration and contamination PP
Cutting Cleaning and
Sanitizing Agents
P - Foreign No
material
Material Pathogens
and Storage P - Foreign No
material
P - Foreign No 3. Adulteration & contamination PP
Material
C - Residual No
Cleaning and
Sanitizing Agents
268
Q1. Is the hazard
Potential Hazard
 Biological (B)
document at Q2
 Physical (P)
Metal P – Metal No 1. Metal Detection PP
Detector contamination
B – Vegetative No 1. Temperature management PP

Cooling
Pathogen Growth
B – Vegetative No 1. COA/Supplier Verification PP
Pathogens 2. Material handling GMP
Casing C – Contaminants No
P – Foreign No
Matter
Refrigerated Pathogens
Storage C - Contaminants No Packaged product protected from all common hazards.
P - Foreign No
Materials
Pathogens
Distribution
P - Foreign No
Materials
269
Product Name:___ Fresh White Cheese (Soft)___

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Point (CCP) For each Critical Control Point Action(s)

Milk and Milk Biological- Time & Temperature. Temperatu Continuous At least once Pasteurize Manually divert flow of Record Review CCP Records -
Products Vegetative Pathogens 161°F for minimum of 15 re at the Temp. per shift by r product Pasteurizer Charts
Pasteurization (non-spore formers) seconds exit of the Recorder the operator Operator Pasteurizer charts
(HTST and HHST) holding Chart Isolate the affected verified including Corrective Action
tube product cut-in and cut-out Records
performed,
Continuous Evaluate and determine indicating versus CCP Verification-
Residence during disposition of the product recording temps Records, including
Note: Assuring that the time in the Flow Operation Pasteurize (reprocess or disposal) compared, seal equipment testing
minimum holding times holding Recorder r checks made, records
are met in systems which tube in Chart Operator Document actions authorized
use a sealed timing pump continuou supervisory review
would be CCP s flow Note: Utilize 5 corrective and sign-off of
verification, i.e. pasteurizer action steps recognized by recording charts
equipment calibration s with NCIMS HACCP program
magnetic Equipment
based
timing
systems
Vat Pasteurization B – Vegetative Pathogens The temperature as measured by Temperature Check and Thermometer Pasteurizer / Continue pasteurization until 1. Indicating vs recording Temperature charts
(with continuous agitation) the air space indicating (°F) sign-off on checks done at Operator time / temperature criteria are thermometer comparison.
thermometer must be at a recording beginning and met. 2. Supervisory review Corrective action records.
minimum of 150°F. Time (Min) charts. end of holding and sign-off on recording
time. If more than two hours has charts. CCP verification records.
The holding time must be a Record both elapsed isolate the product and 3. Equipment calibration.
minimum of 30 minutes. air space and Annotate the contact QA. Calibration of Equipment calibration
indicating batch thermometers. records.
The air space thermometer must Time (Min) thermometer information for Disposition the product. 4. Time calibration of
indicate a minimum of 155°F. temperatures. each batch on chart controller.
the recording Document actions. 5. Seal checks.
chart.

Signature: ______________________________________________Date: __________________
270
BUTTER
271
[Street Address]

Formal Product Name: Butter
Food Safety Characteristics: All ingredients are pasteurized except for coloring and salt. High free-
fatty-acid content, elevated salt level (1.8%)
Ingredients Statement: Milk, cream, salt, coloring, starter distillate

Packaging Used: Sealed in parchment, waxed paper, poly tubes, and plastic tubs in various
retail sizes as well as food-service and industrial 20#, 30#, and 40# plastic
film-lined corrugated paper boxes.
Labeling Requirements: Keep refrigerated.
Storage and Distribution: Product is stored at  45°F. Distributed for further processing in
refrigerated trucks ( 45°F).
Intended Consumers: Retail consumers of all ages, as well as commercial and industrial
accounts.
Intended Use: Ready to serve product. May also be used as an ingredient in

cooking/baking or meal preparation.
Shelf Life: Three (3) to twelve (12) months under proper refrigeration.
Approved by: ______________________________
Date: _____________________________________
272
Butter
Dairy Receiving
Filter / Screen
Raw S kim Storage Separator Raw Cream Storage
Past. Cream Storage Past.Cream
Cream Pre-Heat
Starter
Distillate
Salt
Buttermilk
Churn
Storage Color
Water
Butter S ilo Bulk Butter Storage
Packaging Material Microfix

Packaging
Receiving & Stor age
Palletizing Metal Detector
Storage
Distribution
273
Butter Hazard Analysis Summary Table
Q1. Is the hazard
of sufficient Q3 – Q6. Does a control measure exist at
Identify the specific likelihood of Q2. Identify the Prerequisite Program or procedure this step to prevent, reduce or eliminate
occurrence to that reduces the likelihood of occurrence of the the likely occurrence of a hazard to an
Potential Hazard
Ingredient or  If "yes", then necessary. If “yes”, document as a CCP
 Biological (B)
Input proceed to Q3 If “no”, indicate where this will happen.
 Chemical (C)
 Physical (P)
document at Q2
Dairy B - Vegetative Yes None No, controlled at pasteurization step.
Receiving Pathogens
(milk or C - Toxin No 1. Incoming ingredient PP
cream) Production 2. COA/Supplier Guarantee PP
Pathogen
P - Foreign material No 2. Equipment cleaning and sanitizing PP
Raw Dairy B - Vegetative No 1. Temperature management PP
Storage Pathogen Growth
C - Cleaning & 3. Equipment cleaning and sanitizing PP
Sanitizing Chemicals No
Separator B - Vegetative No 1. Equipment cleaning and sanitizing PP
Pathogens
Raw B - Vegetative No 1. Temperature management PP
Skim Pathogen Growth No
Storage C - Toxin production 2. Temperature management PP
Cleaning and
Sanitizing Agents
Raw B - Vegetative No 1. Temperature management PP
Cream Pathogen Growth No
274
Q1. Is the hazard
Potential Hazard
 Biological (B)
 Chemical (C)
 Physical (P)
document at Q2
Storage C - Toxin production 2. Temperature management PP
Cleaning and
Sanitizing Agents
Cream B – Vegetative Yes None Yes – control of vegetative pathogens
Pasteurization Pathogens from prior steps
C – Boiler Additives No 1. Water Safety PP controls use of boiler additives
requisite program.
Pasteurized B - Vegetative No 1. Temperature management PP
Cream Pathogens
Storage C - Toxin production No 2. Temperature management PP
Cleaning and
Sanitizing Agents
Cream Pre- B – Vegetative No 2. Equipment cleaning and sanitizing PP
Heat (if Pathogens
needed)
Churn B - Vegetative No 1. Equipment cleaning and saniziting PP
C – Cleaning and No
Sanitizing
Chemicals No
P - Foreign
Material
275
Q1. Is the hazard
Potential Hazard
 Biological (B)
 Chemical (C)
 Physical (P)
document at Q2
Starter B – Vegetative No 1. Material Handling GMP
Distillate Pathogens
Addition C - Contaminants No
pallet fragments,
foreign objects in
ingredients)
Salt Addition C - Contaminants No 1. Material Handling GMP
pallet fragments,
foreign objects in
ingredients)
Color C - Contaminants No 1. Material Handling GMP
Addition
Water B – Vegetative No 1. Water Safety PP
Pathogen
C - Contaminants No
Water B – Vegetative No 1. Water safety PP
Addition Pathogens 2. Material Handling GMP
Buttermilk B - Vegetative No 1. Temperature management PP
storage Pathogen Growth
Cleaning and
276
Q1. Is the hazard
Potential Hazard
 Biological (B)
 Chemical (C)
 Physical (P)
document at Q2
Sanitizing Agents
Butter Silo B - Vegetative No 1. Equipment cleaning & sanitizing PP

(Butter Boat) Pathogens 2. Adulteration and contamination PP
C - Residual No
Cleaning and
Sanitizing Agents
Bulk B - Vegetative No 1. Equipment cleaning & sanitizing PP
Butter Pathogens 2. Temperature management PP
Storage C - Residual No
Cleaning and
Sanitizing Agents
Microfix B - Vegetative No 1. Equipment cleaning & sanitizing PP
Unit Pathogens
C - Residual No
Cleaning and
Sanitizing Agents
Packaging B – Vegetative No 1. COA/Supplier guarantee PP
Receiving Pathogens 2. Incoming ingredient PP
P – Foreign No
material
277
Q1. Is the hazard
Potential Hazard
 Biological (B)
 Chemical (C)
 Physical (P)
document at Q2
Packaging B - Vegetative No 1. Incoming materials storage PP
Material Pathogens
Storage C - Contaminants No
P - Foreign No 3. Adulteration & contamination PP
Material
C - Residual No
Cleaning and
Sanitizing Agents
Metal P – Metal No 1. Metal Detection PP
Palletizing None
Storage B - Vegetative No Packaged product protected from all common
Pathogens hazards.
C - Contaminants No
Pathogens hazards.
C - Contaminants No
278
Product Name: Butter
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

magnetic Equipment
based
timing
systems

Signature: ______________________________________________Date: __________________
279

496 - IDFA HACCP Dairy Plant Manual 4.15.10 PDF

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496 - IDFA HACCP Dairy Plant Manual 4.15.10 PDF

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IDFA’s

HACCP PLANT MANUAL

This is a manual that provides technical recommendations for

© IDFA September 2009

! Milk Industry Foundation

Recommended Guidelines for Controlling Environmental Contamination.................................................................71

Steps to HACCP Implementation

IDFA's Recommended Model HACCP Programs Description for Dairy Products...................................................119

IDFA Grade "A" Products HACCP Models..............................................................................................................124

IDFA Butter Product HACCP Models ......................................................................................................................271

Ms. Michele Bradley, Kraft Foods N.A.

HACCP has many other benefits as well; it:

As defined by the National Advisory Committee on Microbiological Criteria for Foods

Cleaned: Washed with water of adequate sanitary quality.

Continuous Monitoring: Uninterrupted collection and recording of data, such as temperature on

Corrective Action: Procedures followed when a deviation occurs.

Criterion: A requirement on which a judgement or decision can be based.

Critical: A deficiency or nonconformity that is likely to result in an adverse health consequence

Deviation: A failure to meet a critical limit for a critical control point.

Documentation: Information/records available in a written, electronic or other form which can

HACCP Program: The written HACCP plan and prerequisite program.

HACCP System: The implementation of the HACCP program.

Hazard: A biological, chemical, or physical agent that is of sufficient severity or is reasonably

Likelihood of Occurrence. Estimate (usually a percentage) based on judgment, experience,

Monitor: To conduct a planned sequence of observations or measurements to assess whether a

Non-Conformity: A failure to meet specified requirements of the HACCP prerequisite program.

Performance Standards: Specific regulatory requirements which are required to be incorporated

Prerequisite Programs: Procedures, including facility and equipment maintenance, basic

Risk: An estimate of the likely occurrence of a hazard.

Severity: The seriousness of a hazard. Sometimes categorized into “Catastrophic - results in

IDENTIFICATION OF POTENTIALLY HAZARDOUS MILK AND MILK PRODUCTS

1. Milk or milk products that are raw, heat-treated, pasteurized, or ultra-pasteurized; or

*Refer to Appendix R. for instruction in how to use Table A.

* Refer to Appendix R. for instruction in how to use Table B.

This definition does not include:

#1. Does the operator want to hold the milk

#3. Is the milk or milk product treated NO YES

#7. Use Table A

USING HACCP TO CONTROL HAZARDS

BENEFITS OF THE HACCP SYSTEM - GENERAL

BENEFITS OF THE HACCP SYSTEM - NCIMS VOLUNTARY PROGRAM

NCIMS HACCP Advantages for Plants:

Critical Listing Elements None

** 9 Critical Listing Elements:

Potential Biological Hazards

Potential Chemical Hazards

3. The product contains a hard or sharp foreign object over 25 mm in length.

Potential Physical Hazards

CHOCOLATE & CHOCOLATE SYRUP

DRIED MILK PRODUCTS

EVAPORATED/CONDENSED MILK AND MILK PRODUCTS

ICE CREAM ADDED AIR

MICROBIAL FLORA FOR MOLD-RIPENED CHEESE

SWEETENING AGENTS (DRY)

SWEETENING AGENTS (LIQUID)

WHEY (Dry, Liquid and Condensed)

Minimum Minimum Maximum Maximum Minimum Maximum Oxygen

* - Requires limited levels of oxygen

* - Additional data needed.

Prerequisite Programs & SSOPS

Outline for Development and Documentation of Prerequisite Program*

II. WATER/STEAM/ICE SAFETY (PP#1)

IV. EQUIPMENT PERFORMANCE AND MAINTENANCE PROGRAM (PP#2)