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FSHN07-07

Hazard Analysis Critical Control Points (HACCP)


Principle 6: Establish Verification Procedures 1
Ronald H. Schmidt and Debby L. Newslow2

HACCP verification is defined as those • Validation.


activities, other than monitoring, that establish the
validity of the HACCP plan and ensure that the A. Critical Control Point Verification
HACCP system is operating according to the plan.
By definition, Critical Control Points (CCPs) are
Verification is done to determine:
the backbone of the HACCP plan with regard to
• that the HACCP plan is being implemented controlling food safety hazards. Therefore, it is
properly; important that all activities and procedures are
verified and accurate. CCP verification involves the
• that practices used are consistent with the following activities:
HACCP plan;
1. Verification of CCPs
• that the HACCP system is working to control
significant hazards; and Verification involves confirming that CCPs were
properly selected and/or whether other processing
• whether modifications of the HACCP plan are steps would be more appropriately defined as CCPs.
required to reduce the risk of recurrence of
deviations. 2. Verification of Critical Limits (CLs), CCP
Monitoring, and Corrective Actions
I. Elements of HACCP Verification
All CCP-related activities necessary to ensure
The primary components of verification are: compliance with the HACCP plan must be verified.
This includes establishing that all the responsible
• Critical Control Point (CCP) verification; individuals defined in the HACCP plan are
performing in accordance with the plan, that all
• HACCP system verification; and
monitoring procedures are appropriate and being
conducted at the appropriate frequency, and that the

1. This document is FSHN 07-07, one of a series of the Department of Food Science and Human Nutrition, Florida Cooperative Extension Service, IFAS,
University of Florida. First published August 2007. Please visit the EDIS Web site at http://edis.ifas.ufl.edu.
2. Ronald H. Schmidt, professor, Food Science and Human Nutrition Department, Cooperative Extension Service, Institute of Food and Agricultural Sciences,
University of Florida, Gainesville FL 32611, and Debby Newslow, Executive Director, D.L. Newslow and Associates, Inc.

The Institute of Food and Agricultural Sciences (IFAS) is an Equal Opportunity Institution authorized to provide research, educational information and
other services only to individuals and institutions that function with non-discrimination with respect to race, creed, color, religion, age, disability, sex,
sexual orientation, marital status, national origin, political opinions or affiliations. U.S. Department of Agriculture, Cooperative Extension Service,
University of Florida, IFAS, Florida A. & M. University Cooperative Extension Program, and Boards of County Commissioners Cooperating. Larry
Arrington, Dean
Hazard Analysis Critical Control Points (HACCP) Principle 6: Establish Verification.... 2

corrective action plan is appropriate and being those activities that involve the CCPs or backbone of
implemented as described in the plan. the plan. HACCP system verification involves those
activities that go beyond the written plan and, thus,
It may be desirable or necessary to check the apply to its implementation. Typical HACCP system
adequacy of monitoring by performing additional verification includes thorough review of the
sampling and testing. Such testing provides following:
information on the adequacy of monitoring
procedures by having another person perform the 1. Preliminary Steps
monitoring. In addition, independent testing may be
used to provide validation that the CCP is, in fact, Verification of the HACCP preliminary steps
controlling the identified hazard(s). includes a thorough evaluation as to whether:

3. Calibration • the HACCP team is adequate and functioning


in accordance with the plan;
Adequate monitoring of CCPs is dependent upon
accurate and precise measurements of the parameters • all products covered by the plan are properly
(e.g., temperature, pressure, pH, other parameters) to defined as to composition, processing, and
ensure that Critical Limits (CLs) are met. Thus, it is intended use; and
important that properly calibrated equipment is used
• the flow diagram is still accurate and
to make these measurements. The HACCP plan must
adequately describes the steps in the processing
describe instrument calibration procedures, note the
system.
frequency of calibration, list the individual(s)
responsible, and describe the documentation records 2. Prerequisite Programs
to be used.
Verification of all prerequisite programs (PPs)
4. CCP Records Review included in the HACCP plan must include, at a
minimum, an annual review of the written standard
A significant verification activity is the review of
operating procedures (SOPs) and other programs, as
all CCP records, including monitoring records,
well as auditing of records and documentation
corrective action records, calibration records, and any
proving that these procedures and programs are
other records related to the CCPs. Records are
implemented and operating in accordance with the
verified to ensure that all records are prepared and
plan. All instruments for detection or measurement
implemented according to procedures described in the
shall be calibrated (as described for CCP verification)
HACCP plan. This includes evaluation to ensure that
according to an appropriate procedure and frequency.
monitoring is being performed using appropriate
procedures and frequency, that responsible 3. Hazard Analysis
individuals are appropriately identified, and that the
documents are properly signed. In addition, Verification determines whether the procedures
verification provides assurance that all deviations of used in the hazard analysis are appropriate and
CLs are appropriately identified and recorded, that implemented as described in the HACCP plan, and
corrective actions are taken for every deviation and whether the sources of information were appropriate
are conducted according to the HACCP Plan, and all and used appropriately. In addition, the hazard
decisions are justified. analysis must also be validated (see discussion
below).
B. HACCP System Verification
4. HACCP System Records Review
While the HACCP plan is the written document
which delineates procedures, the HACCP system is While those records involved with CCPs are
the implementation of this plan. In CCP verification, discussed above, HACCP system verification
we are examining the HACCP plan: specifically, involves examining all other documentation and
records as to accuracy, completion, and
Hazard Analysis Critical Control Points (HACCP) Principle 6: Establish Verification.... 3

implementation. This includes examining the II. Procedural Aspects of HACCP


HACCP plan itself, prerequisite program records, Verification
written summaries and narratives for activities within
the plan, backup justification and related literature, HACCP verification must follow a
verification and calibration records, consumer well-conceived, written plan, with all activities
complaint records, and any other appropriate clearly defined. This plan must clearly identify the
documentation showing that the HACCP system is individuals responsible, the procedures to be used,
being implemented appropriately. and the frequency of verification. Those food
processing systems which fall under HACCP
C. Validation regulations should be aware of and follow regulatory
requirements for verification procedures, frequency,
HACCP validation is defined as that element of
and completion of records review.
verification focused on collecting and evaluating
scientific and technical information to determine A. Responsible Individuals
whether the HACCP plan, when properly
implemented, will effectively control the identified The HACCP team should perform all
food hazards. The verification activities described verification activities. In addition, it may be desirable
above are done to determine whether the HACCP to bring in a third-party HACCP auditor to do the
plan is being implement as required (i.e, whether you verification. In some instances, third-party
are doing what you said you were going to do). verification is required by customers. If under a
Validation, however, is done to determine whether regulatory HACCP program, verification is also done
the HACCP plan is working to control the significant under regulatory audits. While it is not recommended
hazards (i.e., whether you are doing the right things). that a regulatory audit be the only verification
Validation involves scientific and technical review of activity, these audits provide useful information.
the rationale behind each part of the HACCP plan,
from hazard analysis through each CCP verification B. Verification Procedures
strategy. More specifically, validation is done to
HACCP verification must be done using
determine that the:
scientifically sound procedures. Care should be taken
• Hazard analysis is appropriate and realistic; when identifying, developing, and implementing
these procedures.
• HACCP plan is controlling hazards; and
C. Frequency of Verification
• HACCP plan is based upon current science.
It is generally recommended (or required under
Validation involves re-examining the hazard HACCP regulations) that HACCP verification be
analysis, CCPs, CLs, monitoring activities, and other done at least annually, and whenever there is a
aspects of the HACCP plan to assure that the significant change in the food processing and
appropriate hazards are identified and that they are handling system. However, many HACCP
being controlled. This may involve either: verification activities (e.g., equipment calibration)
may require more frequent verification. The
• Evaluation of scientific literature; frequency should be determined by the HACCP team
after careful consideration and must be sufficient to
• External or third-party consultation and
ensure and document that the HACCP plan is being
validation of the processing system; or
implemented properly.
• Internal or in-plant observations or experiments.
HACCP validation is usually done initially and
then annually thereafter, and whenever significant
changes occur or factors warrant validation (e.g.,
new scientific data on hazards and control measures,
Hazard Analysis Critical Control Points (HACCP) Principle 6: Establish Verification.... 4

foodborne illness outbreaks, recurring deviations). In Food and Drug Administration Center for Food
addition, corrective actions may require revalidation. Safety and Applied Nutrition. (2001). Hazard
Based upon validation, the HACCP team shall analysis and critical control point (HACCP) systems.
determine if any changes in the hazard analysis or Code of Federal Regulations, Title 21, Part 120.
HACCP plan are required.
Food Safety and Inspection Service. (1996).
III. Verification Forms Pathogen reduction; hazard analysis and critical
control point (HACCP) systems. Final Rule, 25 July
While CCP verification may be generally 1996. Federal Register, 61, 38856-38906.
summarized in the HACCP Plan Form as shown in
Table 1, the HACCP team should develop forms to Food Safety and Inspection Service. (1996).
document all verification activities. A written Hazard analysis and critical control point (HACCP)
discussion of verification activities should also be systems. Code of Federal Regulations, Title 9, Part
included. Examples of a verification form and 417.
validation form are shown in Table 2 and Table 3,
International Dairy Foods Association (IDFA).
respectively.
(2006). Advanced HACCP Short Course for Dairy
References and Juice Products – Course Manual. IDFA,
Washington, DC.
Codex Alimentarius. (2003). Hazard analysis
and critical control point (HACCP) system and Scott, V. N., and Stevenson, K. E. (2006).
guidelines for its application. ANNEX to HACCP: A systematic approach to food safety.
Recommended International Code of Washington, D.C.: Food Products Association.
Practice/General Principles of Food Hygiene.
Schmidt, R. H., and Newslow, D. L. (2007).
CAC/RCP 1-1969, Rev 4. FAO/WHO Codex Hazard analysis critical control points (HACCP) –
Alimentarius Commission.
Getting started, preliminary steps (FSHN0701).
National Advisory Committee on Gainesville: Department of Food Science and Human
Microbiological Criteria for Foods (NACMCF). Nutrition, Florida Cooperative Extension Service,
(1998). Hazard analysis and critical control point Institute of Food and Agricultural Sciences,
principles and application guidelines. Journal of Food University of Florida. Retrieved July 24, 2007, from
Protection, 61, 762. http://edis.ifas.ufl.edu/FS137

Food and Drug Administration Center for Food Schmidt, R. H., and Newslow, D. L. (2007).
Safety and Applied Nutrition. (1995). Procedures for Hazard analysis critical control points (HACCP) –
the safety and sanitary processing and importing of Prerequisite programs (FSHN0702). Gainesville:
fish and fishery products. Final Rule, 18 Dec. 1995. Department of Food Science and Human Nutrition,
Federal Register, 60, 65095-65202. Florida Cooperative Extension Service, Institute of
Food and Agricultural Sciences, University of
Food and Drug Administration Center for Food Florida. Retrieved July 24, 2007, from
Safety and Applied Nutrition. (1995). Fish and http://edis.ifas.ufl.edu/FS138
fishery products. Code of Federal Regulations, Title
21, Part 123. Schmidt, R. H., and Newslow, D. L. (2007).
Hazard analysis critical control points (HACCP) –
Food and Drug Administration Center for Food Principle 1: Conduct a Hazard Analysis
Safety and Applied Nutrition. (2001). Hazard (FSHN0703). Gainesville: Department of Food
analysis and critical control point (HAACP) (sic) Science and Human Nutritions, Florida Cooperative
procedures for the safe and sanitary processing and Extension Service, Institute of Food and Agricultural
importing of juice. Final Rule, 19 Jan. 2001. Federal Sciences, University of Florida. Retrieved August 1,
Register, 66, 6137-6202. 2007, from http://edis.ifas.ufl.edu/FS139
Hazard Analysis Critical Control Points (HACCP) Principle 6: Establish Verification.... 5

Schmidt, R. H., and Newslow, D. L. (2007).


Hazard analysis critical control points (HACCP) –
Principle 2: Determine Critical Control Points
(CCPs) (FSHN0704). Gainesville: Department of
Food Science and Human Nutrition, Florida
Cooperative Extension Service, Institute of Food and
Agricultural Sciences, University of Florida.
Retrieved August 1, 2007, from
http://edis.ifas.ufl.edu/FS140

Schmidt, R. H., and Newslow, D. L. (2007).


Hazard analysis critical control points (HACCP) –
Principle 3: Establish Critical Limits and Principle
4: Monitoring Critical Control Points (CCPs)
(FSHN0705). Gainesville: Department of Food
Science and Human Nutrition, Florida Cooperative
Extension Service, Institute of Food and Agricultural
Sciences, University of Florida. Retrieved August 15,
2007, from http://edis.ifas.ufl.edu/FS141

Schmidt, R. H., and Newslow, D. L. (2007).


Hazard analysis critical control points (HACCP) –
Principle 5: Establish Corrective Actions
(FSHN0706). Gainesville: Department of Food
Science and Human Nutrition, Florida Cooperative
Extension Service, Institute of Food and Agricultural
Sciences, University of Florida. Retrieved August 30,
2007, from http://edis.ifas.ufl.edu/FS142
Hazard Analysis Critical Control Points (HACCP) Principle 6: Establish Verification.... 6

Table 1. HACCP Plan Form

HACCP Plan Form


Critical Hazard(s) Critical Monitoring Corrective Verification Record-
Control Limits for Actions Activities Keeping
Point Each Procedures
(CCP) Control What How Frequency Who
Measure

CCP#1 – Vegetative 161° F for Temperature Check and Every 2 hours Pasteurizer Manually divert Thermometer
1
HTST Pathogens 15 sec. (F) sign off on Operator flow; Calibration - per
Pasteurizer continuous Isolate affected Past. Milk Ord.
chart recorder product; (PMO)
Request procedures.
evaluation by Pressure diff.
QA; checks;
Calibrate and Equipment
adjust as calibration;
necessary; Seal checks;
Follow Pressure checks;
Corrective Supervisory
Action Plan for review and sign
disposition and off on recorder
documentation charts
Hazard Analysis Critical Control Points (HACCP) Principle 6: Establish Verification.... 7

Table 2. Example of a HACCP Verification Form

HACCP VERIFICATION
Date of Specific Activity Being Summary of Verification Name of Verifier Expected Outcome and
Verification Verified (hazard Activities Frequency of Actions
analysis, CCPs, Verification Taken
corrective actions, Activity (as
equipment, etc.) defined in
HACCP plan)

Table 3. Example of a HACCP Validation Form

HACCP VALIDATION
Date of Summary of Validation Activities Name of Expected Outcome and
Validation Validator Frequency of Validation Actions Taken
Activity
(as defined in
HACCP plan)

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