SAFE Food Safety Audit Checklist

Supplier Audits for Food Excellence
Food Safety Audit Checklist
The FPA-SAFE Program tests knowledge of principles of food safety and quality systems auditing, but does not assess or assure the competency or performance of auditors or constitute the endorsement, approval, or referral of any particular company or Auditee.
Date of Issue 08/17/06
Supersedes Date Version Approval Page Number 06/06/06 4 KPW 1 of 54 Copyright 2006 by the Food Products Association. All rights reserved.
Cover Page
Facility Name: Facility Location: Facility Address: Facility City: Facility State/Province: Facility Area / Region: Facility Country: Facility Postal Code: Is the facility required to be registered with the U.S. FDA? Is the facility registered with the U.S. FDA? Does this facility audit their supplier either through a first/second/third party audit? Identify the Standard Owner (e.g., BRC, SQF, IFS, etc.): What other type of audit has been conducted at this facility (e.g., Social Responsibility, FSIS, Humane Slaughter, etc.): Overview of Site, Operation and Scope of Products Produced: Products Produced: Processing Method: Type of Primary Packaging (e.g., poly, metal cans, aseptic, etc.): Sizes of Primary Packaging: New Product(s) Offering: Channels of Trade (Retail, Wholesale, International, etc.): Hours of Operation: Months of Operation (e.g., January March; January December): Structure Size, Construction and Design: Year Built: Year(s) Updated: Size of Facility: Number of Employees: Property Size: Neighboring Land Use: Building Materials, Exterior Walls: Building Material, Interior Walls: Building Material, Floors: Building Material, Exterior Roof: Building Material, Interior Ceiling: Areas of the Plant Excluded from the Audit: Audit Date: Length of Audit: Facility Personnel: Exit Interview With: Date of Last SAFE Audit:
FOOD PRODUCTS ASSOCIATION SUPPLIER AUDITS FOR FOOD EXCELLENCE FOOD SAFETY AUDIT Guidance on the Application and Interpretation of the Audit Report: The audit is designed to qualitatively / quantitatively describe the site's Food Safety and Quality Systems, which are described in five categories. The auditor shall assess the site's performance, relative to the checklist criteria. The audit checklist is available to the supplier on the web site at www.fpa-safe.org. It is recommended that the supplier utilize the audit checklist to perform a self-assessment prior to the scheduled audit. The audit is not scored, as are most traditional audits (e.g., by the auditor); however, SAFE does provide an on-line scoring algorithm to be utilized by the user / customer of the report, if they choose to score the audit according to their business model. The auditor provides descriptive observations and a summary for each section to guide the recipient (customer) to an understanding of how the facility manages their Food Safety, Security and Quality Systems. The audit report is based on the objective evidence provided to the auditor and observations of how the items in the checklist are deployed on the facility's factory floor. The customer is able to interpret the results of each audit relative to their own expectations and methods for measurement. The auditor may provide verbal guidance / consulting during the audit but is not permitted to include such comments in the written report. Facilities have 30 days after receiving the draft audit report to respond to all judgments rated "Substantially Meets" or below. FPA-SAFE understands from the users of this report that they wish to see responses to all issues identified during the SAFE audit; however, FPA-SAFE only mandates, through the FPA-SAFE Policy and Procedures, that corrective actions be placed in the "Facility's Responses to the Auditors Observations" for any identified critical failure. Should the facility choose not to respond to any judgment rated "Substantially Meets" and below, FPA-SAFE will check with the auditee one time to verify that this is the condition the auditee wants the report to be posted to the Internet. After verification, this report will be uploaded to the secure web page in that condition which is determined by the auditee.
There are six Auditor Judgments used for summarizing the various Sections to the checklist: Fully Meets Meets or exceeds the intent of the checklist in design and execution. Meets or exceeds the intent of the checklist in design and execution. Evidence indicates system is effective. An effective, well-developed and executed system. All checklist criteria for the section have been addressed, as applicable to this facilitys programs. Procedures are established, maintained and documented where so noted in the checklist, and can be corroborated by multiple parties and verified by objective evidence. Evidence indicates a good, functional system is in place. However, 1) a few applicable, minor audit checklist elements are not followed, 2) minor inconsistencies exist between implementation versus documented procedure, 3) minor examples are evident of flawed record keeping, and / or 4) informal practices cannot be corroborated by multiple parties or objective evidence. (The term "minor" as used in this definition means that the observation is one that, if left uncorrected, could not adversely impact product quality, safety or security.) Evidence indicates a semi-functional system is in place. However, 1) most applicable, minor audit checklist elements are not followed, 2) implementation has little resemblance to documented procedure, and / or 3) record keeping is misleading, inaccurate or nonexistent. (The term "minor" as used in this definition means that the observation is one that, if left uncorrected, could not adversely impact product quality, safety or security.)
Substantially Meets
Most of the elements established by the SAFE Audit Checklist were in place. (Almost Fully Meets)
Partially Meets
Most of the elements established by the SAFE Audit Checklist were not in place (Almost a Does Not Meet)
Does Not Meet
Key system elements of checklist missing and / or poorly designed and / or poorly executed.
Critical Failure
Not Applicable / Auditable
Evidence indicates system is not effectively developed or implemented. System is poorly designed or not followed. Multiple applicable checklist criteria for the section are missing or not performed. Multiple or repetitive deviations observed in execution or key records. Clear evidence or direct Critical violation of GMPs with practices or conditions observation of conditions leading to confirmed or highly probable adulteration of that would allow product, or significant deficiencies in required adulterated product to be regulatory programs, likely to result in product recall or placed into commerce and facility closure; and deficiencies likely would have gone / or a clear regulatory undetected in the absence of the auditor. failure likely to result in product recall, facility closure or further regulatory action. A system that is not Systems described in this section are not needed needed or major portions because of the nature of products or processes at this are not controlled at this facility, or systems are controlled somewhere other facility. than by the facility, e.g., corporate, and there is insufficient direct evidence for the auditor to verify actual practices of the key criteria in the section or judge their consistency or effectiveness.
The auditor may provide verbal or off-line recommendations or guidance to the facility being audited, but shall not include such comments in the written audit report. Specific information, such as identifying customers, is generally considered proprietary and inappropriate to include in the report. Auditors will be told to remove such proprietary information unless specifically instructed by the Auditee to include the information in the report.
Executive Summary Fully Substantially Meets Meets 1-Management Responsibility 1.1-Management Commitment and Review 2-Fundamentals 2.1-Infrastructure 2.2-Sanitation 2.3-Pest Control 2.4-Chemical Control 2.5-Personnel Practices 2.6-Training & Education 2.7-Handling Storage & Delivery 2.8-Vendor Approval 2.9-Packaging Approval for Use 2.10-Control of Materials 2.11-Sanitary Design 2.12-Traceability and Recall Management 2.13-Crisis Management 2.14-Food Defense (Security) 2.15-Calibration Measuring and Test Equipment 2.16-Traffic Control 2.17-Maintenance 3-Food Safety & HACCP Systems 3.1-HACCP / Food Safety 3.2-Microbiological Testing 3.3-Analytical Testing for Food Safety and / or Regulatory Compliance 3.4-Food Allergens and Chemical Sensitivities 3.5-Foreign Material Control 4-Manufacturing Quality Systems 4.1-Conformance to Customer Specifications 4.2-Process Control 4.3-Inspection & Test 4.4-Control of Non-conforming Materials 4.5-Good Laboratory Practices 4.6-Document Control and Record Keeping 4.7-Corrective and Preventive Action 4.8-Continuous Improvement 4.9-Customer / Consumer Complaints 4.10-Internal Auditing
Partially Meets
Does Critical Not Failure Meet
Not Applicable / Auditable
5-Regulatory Considerations 5.1-Labeling Approval 5.2-Regulatory & Industry Compliance 5.3-Management of the Regulatory Inspection Process
Item # 1.1
Audit Item MANAGEMENT COMMITMENT AND REVIEW
Auditor Instruction DESCRIBE the Quality Policy, verbatim if possible. <<Guidance: If unwritten, provide basic elements as understood by employees. DESCRIBE who (title/position) authorized the policy. DESCRIBE evidence that the Quality Policy is effectively communicated to all levels of the organization. <<Guidance: "Evidence" may be in the form of manuals, placards, bulletin boards, incentive programs, company intranet, etc. Interview personnel to determine if they understand what the policy is and what it means to them. <<Guidance: State specifically that personnel were interviewed. Explain what employees said and whether they demonstrated an understanding of the Quality Policy.
1.1.1 A Quality Policy is documented and communicated to all levels of the organization.
1.1.2 A Quality Manual is documented. 1.1.3 An organizational chart indicates which positions are responsible for compliance to the Quality System. 1.1.4 Quality System Effectiveness Reviews are conducted routinely.
** Is there a documented Quality Manual? DESCRIBE the scope and structure (primary contents) of the Quality Manual. DESCRIBE whether the facility has an organizational chart and whether it is current. DESCRIBE how the facility is organized around food safety and quality. <<Guidance: Explain to whom (QA manager, Technical Services, Plant Manager, R&D, etc.) the quality function reports. DESCRIBE whether authority and accountability for food safety and quality are defined and delegated. When you asked people what their authority and accountability are, what did they say? Are proper Quality System Effectiveness Reviews conducted by management? <<Guidance: DESCRIBE any deficiencies, if any, from the criteria below. A "proper" review is conducted by top management at regular intervals to ensure the system's continuing suitability, adequacy and effectiveness. It will consider opportunities for improvement and determine the need for changes to the Quality Management System, including the general Quality Policy and quality objectives. DESCRIBE the process, including frequency, for conducting the review.
2.1
INFRASTRUCTURE
Supersedes Date 06/06/06
Version Approval Page Number 4 KPW 8 of 54 Copyright 2006 by the Food Products Association. All rights reserved.
2.1.1 Facility site and buildings are of suitable size, construction and design to facilitate maintenance and sanitary operations.
Are floors, walls and ceilings (overheads) in good condition? <<Guidance: DESCRIBE the nature of structural issues, if any. This could include pitted floors, missing ceiling tiles, unsanitizable construction materials on walls, etc. DESCRIBE drain design and condition. <<Guidance: Indicate type or style of drainage system, potential for contaminating product, cleanability, and current condition. ** Is there a risk of foreign material (e.g., condensate, dust, rust, peeling paint) from overhead equipment, pipes or structures, which may contaminate the product? <<Guidance: DESCRIBE nature of potential or actual contamination, if any, including location and severity of threat relative to exposed product, food-contact surfaces and packaging materials. Does equipment placement or positioning permit proper cleaning and sanitation? <<Guidance: DESCRIBE issues, if any, such as equipment proximity to ceilings or walls, accessibility for cleaning, etc.
2.1.2 Exterior grounds are maintained in a condition that protects against the contamination of food or facility. 2.1.3 There are appropriate environmental controls (controlled temperature, air filtration, humidity, lighting, etc.).
Does the inspection of exterior grounds and structures indicate they are maintained to protect against contamination of food or facilities? <<Guidance: DESCRIBE issues, if any, such as proximity to key operations and potential impact. Are exterior grounds graded to drain water away from the building? <<Guidance: DESCRIBE issues found, if any, during the audit regarding drainage. DESCRIBE procedures for controlling facility air, if any. <<Guidance: Should include environmental heating/cooling, humidity control, ventilation, ammonia control, etc. Are effective product protection controls documented and verified? <<Guidance: If ineffective, provide details. Is filtered air used? <<Guidance: DESCRIBE air filtration systems used (HEPA, electrostatic, dust traps, etc.) and their efficiency in terms of air volume (sufficient to cover the intended space?) and particle-size removed. CONFIRM through record reviews that air filters are cleaned and/or changed. Are key areas of the facility well lit, according to the particular application? <<Guidance: DESCRIBE 1) facility's requirements for lighting levels and 2) locations of any under-illuminated areas.
2.1.4 All food-contact surfaces are made of materials appropriate to the application (i.e., stainless steel vs. aluminum).
Is there a policy regarding types of materials used for food-contact surfaces? <<Guidance: Provide details of the policy; i.e., what materials are required by the policy. If N/A, provide rationale; i.e., type of product and/or process. IDENTIFY the materials used for food-contact surfaces. <<Guidance: What materials did you actually observe being used? Indicate any inconsistencies from the policy.
2.1.5 The quality of water, ice, steam and gases used in food applications is suitable for intended use. All food-contact water is determined to be from a potable source and is controlled for its use.
DESCRIBE all sources of water used at the facility. <<Guidance: This may include potable and non-potable water from municipal systems, on-site wells, cisterns, shipped-in water, "cow water", etc. If more than one source, identify all sources and their intended use. Is on-site treatment of potable or food-contact water conducted at this facility? <<Guidance: DESCRIBE any on-site water treatment provided, if any, including filtration, chlorination, dechlorination, deionization, demineralization, etc. This does not include waste water treatment. Is food-contact steam used? <<Guidance: DESCRIBE what food-contact steam is used for. If water is softened (carbonate removal), describe method. Is food-contact ice used? <<Guidance: DESCRIBE sanitation procedures followed for ice-making equipment, if any. DESCRIBE water testing performed and frequency. Is the testing performed in-house, by a third party, and/or by the municipality? <<Guidance: For both in-house and off-site water testing, indicate 1) types of analyses performed by each entity (microorganism, chemical, pesticide, other tests), 2) frequency and 3) whether testing is supported by documentation. Review and discuss water testing results. <<Guidance: IDENTIFY specifically what records were reviewed, AND provide a summary of testing results. Is compressed air used for food-contact purposes? <<Guidance: DESCRIBE purposes and filtration methods, if any. Are other food-contact gases used? <<Guidance: DESCRIBE which food-contact gases are used, for what purposes, and if purchased, their purity levels. (This does not include compressed air generated on-site.) How are food-contact gases/compressed air monitored? <<Guidance: DESCRIBE any testing and/or monitoring procedures followed by the facility to ensure suitability of food-contact gases and food-contact compressed air.
2.1.6 All water systems are protected against backflow.
** Are water systems protected against backflow? Is the functionality of backflow prevention tested and documented? <<Guidance: DESCRIBE frequency. Indicate who (title/position/contractor) performs inspections. Were improper employee practices observed that may contribute to potential backflow contamination? <<Guidance: DESCRIBE negative practices observed (e.g., water hoses submerged in sinks or drains, faucets with no air gaps, etc), locations found and potential for contamination.
2.1.7 Employee welfare areas and production hand-wash stations are equipped and functional.
DESCRIBE sanitary condition of restrooms, locker rooms and dining/break areas. <<Guidance: This can include whether restroom structures were clean and orderly, fixtures appeared to be regularly cleaned and sanitized, trash was not overflowing, etc. Do restrooms and locker rooms open directly into processing or packaging areas? <<Guidance: Explain circumstances, if any, which may compensate for lack of compliance. Are restroom doors self-closing? <<Guidance: Provide details (location, potential for contamination) of issues uncovered, if any. Explain circumstances, if any, that may compensate for lack of compliance. Is ventilation present and functional in restrooms and locker rooms? <<Guidance: DESCRIBE details of issues observed, if any. ** Are employee welfare systems functional; e.g., drains, commodes, sinks, hot water? <<Guidance: If issues were observed, provide further details (what, where, potential for contamination, etc.) Are hand washing/hand sanitizing stations readily available where needed (production, entrance, restrooms, etc.)? <<Guidance: DESCRIBE any issues. Are appropriate hand washing signs posted? <<Guidance: DESCRIBE signage (e.g., whether present or missing, language, size, location, etc.) and any issues observed. Indicate whether hand washing stations are properly equipped. <<Guidance: DESCRIBE specifically whether stations are equipped with: 1) hands-free faucets, 2) antimicrobial soap, 3) warm or hot wash water, 4) type of hand-towel, 5) waste disposal container, and 6. other items deemed necessary by the auditor.
2.2
SANITATION ** Does the facility follow a general cleaning and sanitation program? Provide a description of the cleaning and sanitation program. <<Guidance: DESCRIBE whether it includes all items and areas that are cleaned; e.g., overheads, drains, walls, dock pits, etc. Is a specified frequency followed? <<Guidance: DESCRIBE frequency of principal sanitation efforts AND any deficiencies regarding the actual execution of stated frequencies. Are cleaning and sanitation programs effective? <<Guidance: DESCRIBE issues, if any. From personal observations, provide your assessment regarding the effectiveness of the sanitation program followed by this facility.
2.2.1 There is a written, comprehensive plant and equipment sanitation program.
2.2.2 Maintenance of the facility and its equipment ensures safe manufacture of wholesome foods.
Is equipment easily cleanable? <<Guidance: DESCRIBE issues, if any. DESCRIBE current condition of processing equipment, particularly any issues. <<Guidance: From personal observations, provide your assessment describing any cleanliness issues. NOTE: ** Cleaning issues that impact quality and food safety shall not receive a "Fully Meets". Are welds and seams of food-grade quality; e.g., no tack welds, no welding slag, smooth? <<Guidance: DESCRIBE any issues (pitting, hard-to-sanitize, defects, gaps, etc.) observed regarding food-contact, welds and seams. Are there dead-end sections of pipes? <<Guidance: DESCRIBE issues and locations, if any. Look for open, unmaintained pipes, rails, plumbing, bollards, etc.
2.2.3 The facility follows written standard operating procedures (SOP) or work instructions.
Do they have documented work instructions for cleaning and sanitation? <<Guidance: DESCRIBE issues, if any. Provide details of work instructions for cleaning and sanitation (CIP/COP/manual). <<Guidance: DESCRIBE issues, if any, and identify whether work instructions include 1) specific chemicals to be used, 2) concentrations, 3) contact time, 4) temperatures, 5) frequencies, 6) rinsing procedures, 7) recleaning procedures, 8) etc. DESCRIBE how the facility determines that work instruction criteria are sufficient for sanitation tasks involved. Does this facility utilize clean-in-place (CIP) systems? <<Guidance: IDENTIFY locations.
2.2.4 Brushes and other utensils used for cleaning foodcontact surfaces are clearly identified and properly controlled.
Does the facility follow a system for the control of brushes and other utensils used for cleaning food-contact surfaces? <<Guidance: DESCRIBE what cleaning tools are included in the program (e.g., brushes, brooms, scoops, buckets, scrapers, pails, etc.), and any issues discovered during the physical audit. DESCRIBE how brushes and other utensils are identified for their purpose. <<Guidance: May include color-coding, signage, shape, printing directly on utensil, etc. DESCRIBE how procedures to identify and control utensils are communicated to appropriate personnel. <<Guidance: Explain what is done to make employees aware of details of the utensil identification program, e.g., through placards and/or training. Are specific locations designated for controlled utensil storage? <<Guidance: DESCRIBE whether utensils were misused, misidentified or improperly stored. DESCRIBE usage of brushes and utensils during the audit, and indicate any exceptions from established procedures.
2.2.5 Measures are in place to verify and monitor the effectiveness of cleaning methods.
Does the facility monitor the effectiveness of cleaning methods? DESCRIBE inspections and/or tests performed to monitor and verify that cleaning and sanitization activities are effective. <<Guidance: Explain what, if anything, the facility does to test the effectiveness of cleaning activities; e.g., audits, bioluminescence, checklists, visual inspection, micro analyses, etc. Are personnel who perform pre-operational testing trained? <<Guidance: DESCRIBE the scope of training given, who (title/position) conducts the training, and how trainers become qualified. If N/A, provide rationale. Are inspections and test results reviewed? <<Guidance: DESCRIBE who in management (title/position) reviews test results, and how often. Are documented corrective actions determined when cleaning/sanitation standards are not met? <<Guidance: DESCRIBE corrective actions that would be taken. Are individuals designated to manage the cleaning/sanitation program? <<Guidance: DESCRIBE who (title/position) has this responsibility. Interview persons charged with verifying the cleanliness of equipment, and indicate their understanding of procedures, reporting results, etc. <<Guidance: DESCRIBE titles/positions of personnel interviewed, and findings.
2.2.6 For water-free (dry) processing zones effective procedures are in place to clean equipment and structures.
Does the facility follow procedures for cleaning water-free processing zones, equipment and structures? <<Guidance: For any wet cleaning that may be conducted in a water-free zone, explain in 2.2.6.4, not here. Are cleaning procedures for water-free processing zones documented? IDENTIFY the water-free processing zones. DESCRIBE procedures and frequency for cleaning water-free processing zones. <<Guidance: Examples may include air blasts, scraping, brushes, vacuum, etc. Is water ever used for cleaning in these zones? <<Guidance: DESCRIBE where, why and how, if true. Some waterfree zones call for periodic use of water as a cleaning agent; e.g., weekly sanitation of dry-ingredient blenders, monthly warehouse cleaning, annual wash-downs of flour silos, etc. CONFIRM whether cleaning records indicate that water-free cleaning procedures are followed correctly? CONFIRM through interviews the understanding of non-management personnel regarding dry cleaning programs and procedures. <<Guidance: State specifically who (position/title) was interviewed. Provide description of conversations and your assessment of the program based upon these conversations.
2.3
PEST CONTROL ** Is there a documented pest control program? Is the program managed in-house, by a contractor, or both? <<Guidance: If an outside contractor is used, provide company name. DESCRIBE pest control activities performed by plant personnel, if any. <<Guidance: Whether pest control is split between the company and the contracted service or whether it is performed solely by the company, explain the duties of in-house personnel. Does the facility identify target pests? <<Guidance: IDENTIFY all pests officially targeted by the program. Was evidence of current, uncontrolled pest activity observed during the audit? <<Guidance: IDENTIFY evidence and location of any, of current, uncontrolled activity; e.g., feces, feathers, webbing, live insects or rodents, urine tracks, chewing damage, rodent prints or trails, etc.
2.3.1 A documented pest control program is in place.
2.3.2 Building exterior is protected from rodent and pest entry.
Is the building exterior protected against rodent and pest entry? <<Guidance: DESCRIBE areas examined during the audit (including roofs, doors, holes in walls, drains, docks, flash plates, windows, ventilation, screens, pipe entries, etc.) and any concerns uncovered during this physical inspection. Does the facility use pest exclusion devices, such as air curtains, strip curtains, etc. to exclude pests? <<Guidance: IDENTIFY exclusion devices in use and locations. DESCRIBE any issues. Is a clear, vegetation-free perimeter (e.g., asphalt, river rock, etc.) maintained adjacent to production or storage buildings? <<Guidance: DESCRIBE the width and composition of the vegetation-free zone. If coverage around facilities is not complete or non-existent, describe exceptions (return growth, landscape shrubbery, etc.), location, and whether they pose a significant threat of pest harborage. Are building exteriors free of pest harborage sites; e.g., obsolete equipment storage, construction materials, uncapped piping, pallets, etc? <<Guidance: DESCRIBE type, cause, location and potential for contamination of all likely harborage sites found during the audit. Indicate the location and condition of the system for trash handling and disposal. <<Guidance: DESCRIBE whether location and condition (cleanliness, covered or open, off odors, attraction to pests, etc.) pose a potential risk of contamination to product or facility.
2.3.3 The pest control program addresses devices and
IDENTIFY the types/kinds of pest control devices utilized at this facility. <<Guidance: DESCRIBE whether Bait Stations, Mechanical Traps, Glue Boards, Insect Light Traps (ILTs), Pheromone/Monitoring Devices, Bird Netting, etc.
inspections.
are used AND whether they are appropriate for the targeted pest, and effectively deployed. Are PCOs required to examine the insides of all traps/bait stations during inspection? <<Guidance: DESCRIBE how this is verified (e.g., sign off cards or bar code located inside devices, etc.). DESCRIBE the inspection frequency of the various pest control devices. <<Guidance: Include inspection frequency for each type of device mentioned previously, and indicate whether inspection is performed by facility personnel or contracted technicians. Does the facility have a current schematic (map) of pest control device locations? <<Guidance: DESCRIBE date of map, and 1) location, 2) type and 3) significance of any device that is missing or that does not correspond with the map. DESCRIBE the types AND placement of bait stations utilized by the facility; e.g., number of units, general location and approximate spacing. <<Guidance: This question is regarding devices that utilize pesticides, rodenticides or other poisons. Examples of locations include fence lines, warehouse exteriors, production facilities, etc. If the facility manages the program in a different way, explain. DESCRIBE the types AND placement of curiosity traps utilized by the facility; e.g., glue boards, snap traps, mechanical devices, etc. <<Guidance: This question is regarding devices that do NOT employ poisons. State the number of devices, location and approximate spacing, whether along the side entrances, receiving doors, and entire interior perimeter. If the facility manages the program in a different way, explain. DESCRIBE the types (electrocutors, glue board traps, etc.) AND placement of Insect Light Traps (ILTs) utilized by the facility. <<Guidance: If used, indicate number, type (electrocutors, light & glue board, etc.) and location of devices. If traps can create problems (draw insects into the facility, contaminate product, etc.), provide details. DESCRIBE type AND placement of pheromone traps used at the facility. <<Guidance: If used, list target species.
2.3.4 Deficiencies are documented and corrective action taken.
Are issues revealed through the pest control program documented? <<Guidance: DESCRIBE any issues that were observed during the inspection. Are documented corrective actions taken when deficiencies are identified? DESCRIBE through a review of inspection reports whether they include observed activities, trend reports and corrective actions taken. <<Guidance: State specifically that records were reviewed, and provide findings. Explain whether records indicate that areas with repetitive activity are identified and corrected as part of the on-going program.
2.3.5 Pesticide applications are performed by certified applicators, a licensed pest control contractor or under direct supervision of the same.
Who is responsible for applying pesticides? <<Guidance: Explain whether the applicator/technician is employed by the contracted pest control company or is an in-house employee (title/position). Is the contracted pest control company's business license current? <<Guidance: Provide expiration dates of the pest control company's business licenses. (This does not refer to individual applicator licenses.) Are pest control company insurance certificates up-to-date? <<Guidance: Provide expiration date on certificate of insurance. Are individual applicator licenses current? <<Guidance: Provide expiration dates. (This does not refer to the pest control company's license.) CONFIRM the training of any non-licensed applicator and/or in-house personnel involved in executing or managing the program. IDENTIFY any pesticides documented as being used within the past 12 months. <<Guidance: Include rodenticides, herbicides, avicides, and insecticides. If Restricted Use Pesticides (RUP) are used, do individual applicator licenses specifically permit the application of RUPs? <<Guidance: IDENTIFY which pesticides in use are RUPs.
2.3.6 The facility maintains and enforces written procedures for the application of pesticides.
DESCRIBE through a review of pesticide (not rodenticide) application records the procedures followed to apply pesticides. <<Guidance: State specifically that application records were reviewed. State methods used on-site for the application of pesticides; e.g. crack and crevice spraying, fogging, bait placement, bird abatement, lawn spreaders, aerosol canisters, etc. ** Explain whether pesticide applications are documented in accordance with regulatory requirements. <<Guidance: DESCRIBE the key information missing, if any, from the pesticide information records: i.e., 1) Government registration number (e.g., EPA registration number), 2) targeted pests, 3) name of pesticide, 4) method of application, 5) concentration, 6) rate of application, and 7) the date of treatment. Are pesticide application records correctly retained according to regulatory requirements? <<Guidance: Explain, if not met.
2.3.7 All chemicals used in pest control are accurately labeled and securely stored.
Are pest control chemicals stored at this facility? <<Guidance: DESCRIBE, if stored on-site, the areas used to store such chemicals AND measures taken to prevent contamination from pesticides; e.g. ventilation, drainage, spill control, control of water, etc. ** If pesticides are stored on-site, are storage areas secure, and restricted from unauthorized access? <<Guidance: DESCRIBE measures to secure the area (locks, partitions, fencing, etc.), AND describe who (title/position) is given
access to the storage area. If not secured, provide details (no locks, left unlocked, no partitions whatsoever, etc.) ** Are old and obsolete pesticides stored at this facility destroyed/disposed in accordance with regulatory requirements? <<Guidance: DESCRIBE problems, if any, found during the audit. 2.3.8 The facility formally audits contracted Pest Control Operator performance. 2.4 CHEMICAL CONTROL ** Is there a documented chemical control program? <<Guidance: If not, explain further what, if anything, the facility does have. Does the non-food chemical control program verify that such chemicals are approved prior to use? <<Guidance: DESCRIBE how this is accomplished, if the program exists. ** Were unapproved non-food chemicals found in the facility? <<Guidance: DESCRIBE, if present, where these chemicals were found (relative to processing and packaging areas), their purpose and whether they pose a potential for contamination. Does the facility follow procedures that control the purchase of non-food chemicals? <<Guidance: DESCRIBE procedures, if any. DESCRIBE observations of storage areas for non-food chemicals. <<Guidance: Examples of what to describe: use of flame-proof cabinets, distribution (centralized secured storage areas, maintenance shops, labs, parts storage, etc.), controlled access, ventilation, drainage, spill control, etc. Are primary and secondary containers for non-food chemicals accurately and legibly labeled? <<Guidance: DESCRIBE 1) quantity, 2) location, 3) possible contents and 4) potential for contamination of inaccurate or illegible primary or secondary containers found during the audit. 2.4.2 Material Safety Data Sheets (MSDS) or non-USA equivalent are available for all non-food chemicals. Are current Material Safety Data Sheets (MSDS) or non-USA equivalent available for all non-food chemicals used at this facility; e.g., pesticides, cleaning, maintenance, etc.? <<Guidance: IDENTIFY which non-food chemicals were sought during the audit AND the amount of time required locating them. (During the audit, write down the names of several chemicals in current use. Later, see if each chemical has a corresponding MSDS (or non-USA equivalent) or applicable chemical documentation. Examples of chemicals to trace include pesticides, solvents, cleaning chemicals, lubricants, coolants, hygienics, etc.) Explain retrieval system for Material Safety Data Sheets (or non-USA equivalent) or applicable chemical
Date of Issue 08/17/06 Supersedes Date 06/06/06 Version Approval Page Number 4 KPW 17 of 54 Copyright 2006 by the Food Products Association. All rights reserved.
Does the facility audit contracted Pest Control Company's performance? <<Guidance: DESCRIBE procedures, if any, to audit/monitor the PCOs performance.
2.4.1 A chemical control program manages the use, storage, and handling of non-food chemicals.
documentation. <<Guidance: Describe, if on paper, where information is kept, or if not paper, describe whether the facility uses a toll-free phone system, FAX program, internet, etc. Do Material Safety Data Sheets (or non-USA equivalent) include both pesticides and food-contact sanitation chemicals? <<Guidance: DESCRIBE any omissions. Do employees understand how to access Material Safety Data Sheets (or non-USA equivalent) or applicable chemical documentation? 2.5 PERSONNEL PRACTICES ** Is there a policy that addresses hair restraints where food, product, packaging or ingredients are exposed? <<Guidance: DESCRIBE types of hair restraints observed during the audit; e.g., hairnets, beard covers, arm sleeves, surgical masks, etc. Do employees, visitors and contractors in relevant areas adhere to the hair restraint policy? <<Guidance: DESCRIBE nature and location of violations, if any, observed during the audit regarding the hair restraint policy. Is there a policy that addresses the wearing of jewelry, including body piercings, false fingernails, fingernail polish, watches, medical alert identification, etc., where food, products, packaging or ingredients are exposed? <<Guidance: DESCRIBE any other deficiencies indicated in the written policy. List any listed items not included in their policy. Do employees, visitors and contractors in relevant areas adhere to the jewelry policy? <<Guidance: DESCRIBE nature and location of violations, if any, observed during the audit regarding the jewelry policy. 2.5.3 Employees follow proper hygiene practices to prevent contamination. ** Is there a hygiene policy that includes hand washing, hand dips, and prevention of cross-contamination? <<Guidance: DESCRIBE the formal or informal personal hygiene policy. Indicate whether employees were observed washing their hands thoroughly, using soap and warm/hot water, before starting work, after breaks, and after using the restroom. <<Guidance: DESCRIBE nature and location of violations, if any, observed during the audit regarding the hand washing policy. Are hand dips and/or hand sanitizers used? <<Guidance: DESCRIBE the types of devices, if any, and where they are located. If no devices are available, describe the company rationale for not providing them. DESCRIBE whether hand sanitizer concentrations are properly monitored? <<Guidance: DESCRIBE discrepancies uncovered during the audit (weak solutions, hand sanitizers not tested, etc.), if any. CONFIRM sanitizer concentration complies with specifications by spot-checking hand sanitizer. DESCRIBE findings.
2.5.1 All employees wear in an effective manner hairnets and beard covers while in areas where food, products, packaging and ingredients are exposed. 2.5.2 The wearing of jewelry is controlled to prevent contamination.
<<Guidance: State type of sanitizer, and test results.
2.5.4 Employee gloves used for food safety related purposes are maintained intact, clean and sanitary.
Is there an employee glove policy, including procedures for glove control? <<Guidance: DESCRIBE policy details. This applies to gloves used for food safety related purposes. DESCRIBE types of gloves permitted for food safety related purposes. <<Guidance: Indicate glove material permitted; e.g., latex, nitrile, cotton, etc. Is there a procedure to ensure that gloves are intact, clean and sanitary? Do employees in relevant areas adhere to the employee glove policy? <<Guidance: DESCRIBE nature and location of violations, if any, observed during the audit regarding the employee glove policy.
2.5.5 Eating, drinking, gum chewing, snacks and tobacco products are prohibited in processing and packaging areas.
Is there a consumption policy that restricts eating, drinking and tobacco use in processing and packaging areas? DESCRIBE any specific exceptions that may apply. <<Guidance: Examples: water bottles, medication, eating product from production line, etc. Are specific areas designated in the plant for the storage of personal effects and consumption? Do employees, visitors and contractors in relevant areas adhere to the consumption policy? <<Guidance: DESCRIBE nature and location of violations observed regarding the consumption policy. DESCRIBE any personal items stored in production or warehouse areas; e.g., sweaters, coats, radios, etc. <<Guidance: Explain presence and location of non-company-issued apparel, electronic devices (radios, cellular phones, etc.), medicine containers, purses, backpacks, sunglasses, etc.
2.5.6 Employees with symptoms of illness or open cuts/lesions are excluded from sensitive food handling jobs.
** Do personnel health policies and procedures exist to ensure employees afflicted by illnesses or open wounds have adequate protection or are reassigned? Are individuals trained to manage employee health issues? Do employees, visitors and contractors in food safety sensitive areas adhere to the health policy? <<Guidance: DESCRIBE nature and location of violations observed regarding the personnel health policy, if any.
2.5.7 Uniforms and outer apparel are designed or controlled in a manner to prevent risk from foreign materials.
Does the facility have an apparel policy prohibiting the use of top pockets in uniforms or other outer apparel? Is there an apparel policy prohibiting pens, pencils, or other objects from being carried anywhere above the waist? Does the facility apparel policy include restrictions against clothing materials that may cause foreign material contamination? <<Guidance: DESCRIBE any findings made during the audit where potential for contamination was observed; e.g., outer garments made of materials that shed fibers, glitter, rhinestones, etc. Do employees, visitors and contractors in food safety sensitive areas adhere to the apparel policy? <<Guidance: DESCRIBE nature and location of violations observed regarding the apparel policy, if any.
2.5.8 Uniforms and outer apparel are maintained in a clean manner.
Is there a company policy regarding cleanliness of uniforms, shoes and outer apparel? <<Guidance: DESCRIBE apparel cleanliness policy as it exists for this facility. Do employees working in highly sensitive food areas wear a different uniform than others? <<Guidance: DESCRIBE methods to distinguish between employees working in different areas; e.g. uniform color, badges, etc. Does the uniform cleanliness policy include restrictions on wearing uniforms, shoes or other specialized clothing when exiting the work area? <<Guidance: DESCRIBE any restrictions imposed by the uniform cleanliness policy. Do all facility employees (full time, part time or seasonal), contractors and visitors follow the uniform cleanliness policy by wearing clean outer garments where required and by restricting types of clothing in highly sensitive areas? <<Guidance: DESCRIBE nature and location of violations observed regarding the use of appropriate, clean uniforms or outer apparel.
2.6
TRAINING & EDUCATION ** Is there a documented training program? IDENTIFY food safety related training programs. <<Guidance: Indicate any food safety specific training conducted by this facility. Examples include chemical controls, MSDS (or equivalent), HACCP, hygiene, cleaning, microbiology/swabbing, GMPs, GLPs, etc. Provide information on the key elements of the training program. <<Guidance: Describe: 1) frequency of training, 2) approximate training time per employee per year, 3) new hire training, 4) refresher training, make-up training, 5) who (department/title/position) oversees training process, and 6) whether training is individualized, classroom, or computerbased. DESCRIBE how records for in-house and/or outsourced employee training are maintained. <<Guidance: Are records kept for each employee, signed by whom, stored where, etc?
2.6.1 Training needs are assessed and training is conducted and documented accordingly.
DESCRIBE methods used to verify training is effective. <<Guidance: For example, on-the-job observations, proficiency reviews, written exams, etc. Is training provided in the language of ALL employees working at the facility? <<Guidance: If not, explain further. 2.6.2 Authorized personnel conduct food safety related training. 2.7 Indicate who (titles/positions) performs training. <<Guidance: Provide titles/positions of individuals performing each type of training mentioned in 2.6.1.2. DESCRIBE the trainer's qualifications. <<Guidance: Examples include "Train the Trainer" courses, HACCP certification classes, food safety workshops, related college degree, number of years of experience, etc. ** Does the facility food safety program include the protection and inspection of stored goods? Does the food safety program for the protection of stored goods provide for inspection of both on- and off-site locations? <<Guidance: Additionally, provide information of the following five elements, where applicable: 1) type of storage (ambient, humidity or temperature controlled atmosphere, etc.), 2) site location, 3) type of goods kept at each off-site location, 4-the type of audit (housekeeping, GMP, pest control, etc.), and 5-who conducts the audit (department/title/position). DESCRIBE inspection frequency of storage sites. <<Guidance: Provide scheduling information for each on- and offsite location included in the food safety program. DESCRIBE record keeping regarding inspection and corrective action. <<Guidance: What records are kept regarding inspection of on- and off-site storage locations? How often and by whom (title/position) are they reviewed by the facility? DESCRIBE whether records reviewed demonstrate effective implementation of the inspection program? <<Guidance: State specifically that inspection records were reviewed, and provide findings. Inspect storage areas and describe findings. <<Guidance: Comment on observations made during physical inspection of storage areas; i.e., cleanliness, orderliness, housekeeping, protection from damage, potential contaminants, pest issues, etc. Report whether finished product packaging is used for anything other than its intended purpose. <<Guidance: DESCRIBE deficiencies, if any, involving the use of consumer containers to hold machine parts, chemicals, etc., or using finished product cases as stools, door stops, step ladders, or any other intended purpose.
HANDLING, STORAGE & DELIVERY
2.7.1 Stored goods are protected from damage, contamination and deterioration.
2.7.2 Temperature- or humiditysensitive items are maintained at proper temperatures to ensure proper food safety and maintain quality.
Are temperature or humidity sensitive items stored at the facility? DESCRIBE storage temperature and humidity requirements for ingredients and finished products regarding food safety/quality. <<Guidance: List general categories of products. Provide specific temperature/humidity ranges, not just "frozen", "refrigerated", "wet", "dry", etc. ** CONFIRM through inspection of storage areas whether items are stored within specified ranges. <<Guidance: Report any violation found during the audit. Explain procedures to control material risks caused by temperature or humidity differentials during receiving, storage, manufacturing, and shipping. <<Guidance: DESCRIBE what controls, if any, are in place, which products are involved, and why. Examples include unwanted freezing, mold growth, clumping, bridging, thawing, etc.
2.7.3 Carriers are routinely inspected for acceptability.
Are there inspection procedures for all inbound carriers? <<Guidance: DESCRIBE what issues are addressed by inbound inspection procedures; e.g., temperature, infestation, foreign material/toxins, product damage, odor, carrier damage, etc. Are there inspection procedures for all outbound carriers? <<Guidance: DESCRIBE what issues are addressed by outbound inspection procedures; e.g., temperature, infestation, foreign material/toxins, product damage, odor, carrier damage, etc. ** CONFIRM through a review of receiving and shipping records that inbound and outbound goods are inspected according to established procedures. <<Guidance: State specifically that receiving and shipping records were reviewed, and what they revealed. Are there policies and procedures regarding the use of seals or locks on inbound and outbound carriers? <<Guidance: If no formalized policies or procedures are followed, report on actual practices observed during interviews and inspection. DESCRIBE how "Less than Truck Load" (LTL) carriers are handled and secured. <<Guidance: This question refers to both inbound and outbound carriers. ** Are all inbound seal numbers cross-checked and verified against receiving documents (including top and bottom bulk carrier ports, hatches, doors, etc.)? <<Guidance: DESCRIBE through observation or record review (state which), whether the facility actually determines that seal numbers match the numbers on transport documentation. Does the facility have procedures for handling inbound carriers and goods when seals are missing or broken? <<Guidance: DESCRIBE required procedures, and whether they are properly executed. Explain any issues. Does the facility have a carrier back-haul policy; e.g., food product on return shipments with non-food products,
allergens, raw food ingredients, etc?
2.7.4 Pallets are managed for contamination, sanitary and physical conditions. 2.7.5 Bulk raw materials are protected against contamination during unloading and loading.
Report on whether the facility has a pallet management program. <<Guidance: DESCRIBE whether the facility inspects pallets prior to use for contamination, unsanitary conditions and physical damage. Also report on whether they have on-site pallet repair, a pallet identification program (e.g. CHEP), and a system to clean and recycle pallets. Are bulk carriers received at or shipped from this facility? <<Guidance: IDENTIFY all bulk goods received at or shipped from this facility. For the purposes of the SAFE audit, bulk carriers include rail tanks, tanker trucks, belly dumps, etc. where the entire transport container is a vessel. Totes, pallet-sized loads, super sacks, Gaylords, etc. are not included. Does the facility have documented procedures for unloading and loading bulk carriers? Indicate whether bulk unloading and loading conform to sanitary practices; e.g., screen or bag on hatch, filters on blowers or vents. <<Guidance: DESCRIBE any issues observed during bulk loading or unloading. Explain what food-safety related documentation accompanies inbound and outbound bulk carriers. <<Guidance: Could include wash tags, COAs, etc. DESCRIBE how bulk transfer lines/hoses and ports are handled when not in use. <<Guidance: Explain whether ports and openings are sealed and securely locked (not with key-ring-type clasps)? Are caps properly hung and kept off unsanitary surfaces? How are O-rings protected? Are hose ends kept off the floor and sealed? Etc. CONFIRM through a review of records that conformance to bulk handling procedures is achieved. <<Guidance: State specifically that bulk receiving/shipping records were reviewed, and what they revealed.
2.7.6 A schedule of inbound materials includes condition of storage and expiration date.
Does the facility have product receiving procedures that track expiration dates of raw materials? CONFIRM understanding of acceptance procedures by interviewing receiving/warehouse personnel. <<Guidance: DESCRIBE specifically who (title/position) was interviewed, and what was learned. ** DESCRIBE procedures to ensure raw materials are protected from deterioration and adulteration while awaiting final storage. <<Guidance: If no procedures exist, report observations (negative and/or positive) from the physical inspection. ** DESCRIBE procedures to ensure finished goods are protected from deterioration and adulteration while awaiting shipment. <<Guidance: If no procedures exist, report observations (negative and/or positive) from the physical inspection.
2.7.7 Materials are used and shipped with suitable rotation to prevent degradation.
Does the facility have procedures and requirements regarding shelf life and release status of finished goods? <<Guidance: Provide a brief description. If applicable, does the facility have a procedure that specifies the minimum remaining shelf life for domestic and exported goods? <<Guidance: If applicable, provide a brief description. Is there a stock rotation program; e.g., FIFO, Oldest First, etc? CONFIRM conformance to stock rotation procedures through a review of recent shipment records. <<Guidance: State specifically that shipping records were reviewed, and what they revealed. Does the facility have a verifiable stock rotation exception policy?
2.7.8 Returned goods are handled in such a manner as to protect against contamination or the contamination of other goods. 2.8 VENDOR APPROVAL
Does the facility accept returned goods? <<Guidance: DESCRIBE conditions, if any, which would prompt the acceptance of returned goods. DESCRIBE how returned goods are handled to prevent contamination to themselves, the facility and other products. <<Guidance: Include all criteria, designated area or room, next steps, potential dispositions, approvals, etc. CONFIRM conformance to returned goods receiving procedures through a record review of recently returned goods. <<Guidance: State specifically that returned-goods records were reviewed, and what they revealed. ** Does the facility have a vendor approval program? <<Guidance: DESCRIBE what is included in the vendor approval program. Does the facility only accept products/ingredients from specific manufacturing locations of approved vendor? <<Guidance: This question refers to vendor approval on a plant-by-plant basis. Does the facility maintain an up-to-date Approved Vendor List? ** CONFIRM that a recent ingredient shipment was received from a supplier on the Approved Vendor List. <<Guidance: State specifically that a recent shipment was reviewed, and what was revealed. Does the facility follow a program to evaluate vendor performance? <<Guidance: DESCRIBE issues, if not fully implemented. DESCRIBE the procedure to handle "out of compliance" situations with the vendors and explain whether vendor nonVersion Approval Page Number 4 KPW 24 of 54 Copyright 2006 by the Food Products Association. All rights reserved.
2.8.1 There is a Vendor Approval Process for ingredients, food-contact packaging, and services affecting food safety and quality. 2.8.2 An "Approved Vendor List" is utilized for ingredients, food-contact packaging, and services affecting food safety and quality. 2.8.3 A system for evaluation of vendor performance is in place.
Date of Issue 08/17/06 Supersedes Date 06/06/06
compliance situations result in documented corrective actions. DESCRIBE through a record review whether corrective action files/records for issues are complete. <<Guidance: State specifically that corrective action records were reviewed, and what they revealed. DESCRIBE whether the vendor performance procedure includes routine feedback, or whether feedback is given only when there is a problem. DESCRIBE through a review of recent records whether feedback on an issue was provided to a vendor and whether subsequent improvement was seen. <<Guidance: State specifically that corrective action records were reviewed, and what they revealed regarding feedback on an issue. 2.8.4 There are provisions for buying from "non-approved" sources, in the case of emergency situations. Does the facility have procedures regarding emergency purchases from non-approved vendors? <<Guidance: If a procedure exists, describe it. Under what circumstances would this facility purchase from a non-approved vendor? Who (title/position) would authorize the purchase? Would the facility follow up with the purchase to determine if the goods met its expectations? Has a recent purchase (within the past 12 months) from non-approved vendors complied with facility policies? <<Guidance: If the facility did not follow its guidelines, provide details. 2.9 PACKAGING APPROVAL FOR USE Does the facility purchase packaging materials based upon written, approved specifications? Does the facility have a system to track and manage the Pure Food Guaranty program (or recognized program equivalent)? <<Guidance: A Pure Food Guaranty is the formal and signed agreement between buyers and sellers in which the latter promises the goods he sells are not in violation of the Food Drug and Cosmetic Act when shipped. Does the facility have procedures to inspect and release packaging into inventory? <<Guidance: Briefly describe procedures, if any. 2.10 CONTROL OF MATERIALS Do specifications and procedures identify acceptance criteria for incoming ingredients, including processing aids? DESCRIBE how employees responsible for approving incoming ingredients have access to specifications. <<Guidance: Explain whether the information is readily available to the responsible employee, and where it is kept (at work station, in QA, on floor computer, etc.) Are Certificates of Analysis (or equivalent) required and checked against the ingredient specifications? 2.10.1 Incoming materials are verified as conforming to written specifications. 2.9.1 Packaging materials are purchased according to written, approved specifications.
DESCRIBE the release procedures for incoming ingredients and verify whether they are followed.
2.10.2 A process to change or modify incoming material specifications is documented.
Does the facility have procedures that coordinate and confirm specification changes with vendors? Do vendors approve in writing all of their specification changes? <<Guidance: If not all, explain. Does the facility have records of specification changes that were made within the last twelve months? DESCRIBE through a review of specification change records whether written procedures were followed correctly. <<Guidance: State specifically that records about changes in specification were reviewed, and what they revealed.
2.10.3 There are control procedures for rework products.
Does the facility have policies and procedures that address the use of materials intended for rework? Does the facility have procedures that address the storage condition of rework materials? Does the facility have procedures that address the identification and coding of materials intended for rework? Does the facility have procedures that address percent of rework that can be added back to the regular formula? <<Guidance: DESCRIBE what percentage, if any, is allowed, or how the facility determines the appropriate amount of add-back. Does the facility maintain batch formulation records that identify the addition of reworked product? Does the facility enforce periodic breaks in the rework cycle? <<Guidance: IDENTIFY the time period between breaks, if any. (The purpose of the break is to minimize the time that reworked materials are commingled with later production lots, and thereby reduce the amount of product subject to recall.) DESCRIBE through a review of rework records whether rework control activities follow the written program. <<Guidance: State specifically that rework control records were reviewed, and what they revealed.
2.11
SANITARY DESIGN Does the facility have specific policies and procedures for the approval of equipment design before purchase? <<Guidance: This question deals with procedures regarding the selection of equipment PRIOR TO purchase. Does the facility have a documented procedure to review sanitary design considerations prior to purchase? Do sanitary design procedures utilize and/or reference industry standards. <<Guidance: IDENTIFY standards that are
2.11.1 The design of new equipment is approved following sanitary considerations.
followed; e.g., 3A, NSF, etc. CONFIRM through a review of purchasing records (new or used) from the past 12 months that approval procedures were followed. 2.11.2 Equipment installation is approved to ensure sanitary operating conditions. 2.11.3 Newly installed equipment is challenged to verify proper sanitary design prior to use. Does the facility have specific policies and procedures regarding the sanitary installation of equipment? <<Guidance: This question deals with sanitary procedures that should be followed DURING the installation of newly purchased equipment. CONFIRM through a review of recent records that approval procedures were followed for new equipment installation. Does the facility have specific policies and procedures to qualify or verify the sanitary design and installation of newly purchased equipment before it is placed into service? <<Guidance: This question deals with procedures that verify the proper sanitary design and installation of equipment AFTER installation and PRIOR TO being placed into service. For example, does the facility put new equipment through a test run to determine whether it is cleanable? If sanitary operating criteria are not met, do procedures require corrective actions prior to the final approval of newly installed equipment? CONFIRM through a review of recent corrective action records that established procedures are followed when less than acceptable results are found. 2.11.4 Modifications to existing structure and equipment do not compromise sanitary design. ** Do change control procedures for EXISTING equipment or structures require verification of sanitary design; and who in management is responsible? <<Guidance: DESCRIBE who (title/position) is responsible for this program. ** When changes are made to existing equipment and structure, are obsolete items removed? <<Guidance: If issues are observed during the audit, indicate location, what was found and potential for contamination. When equipment or structural changes are made, are all remnants of older, obsolete systems removed? <<Guidance: DESCRIBE the types and locations of issues, if any, observed during the audit AND their potential for contamination. 2.12 2.12.1 TRACEABILITY AND RECALL MANAGEMENT
An effective recall management program is documented.
Does recall management documentation describe the scope of the program? Does recall management documentation include procedures to be followed? Does the recall management program include emergency contact information? Does the recall management program include individual responsibilities? <<Guidance: DESCRIBE who (title/position) is in charge of the recall management program.
Does the facility keep activity records regarding the recall management program? <<Guidance: If not, explain what, if anything, the facility does have.
2.12.2 Vendors provide a means of traceability for incoming goods and materials.
Does the facility require all incoming goods, including bulk, to be coded by vendors? <<Guidance: This question is asking about what the facility asks its vendors to do. Was a recently received material shipment handled according to the procedure which permits traceability? <<Guidance: DESCRIBE issues found, if any. Does the facility have a policy regarding multiple lot codes on incoming pallets or shipments? <<Guidance: DESCRIBE policy, if it exists.
2.12.3 Inbound materials are coded by the facility when received.
Does the facility assign its own internal identification code for received materials? <<Guidance: Even if the vendor has coded its product, does this facility apply further coding?
2.12.4 Raw materials are traceable into finished products. Finished goods are traceable through distribution to the first customer.
DESCRIBE finished product control and tracking systems and the basic techniques used. <<Guidance: Include information regarding the use of unique bar codes or pallet tag numbers applied to finished product, whether tracked by computerized inventory system from production to the first level of distribution, etc. ** CONFIRM and provide observations that the facility has the ability to trace raw materials into finished product. Does the facility have the capability to maintain full traceability where one lot is commingled with others; e.g., bulk storage, common fields and/or collection sites, etc? <<Guidance: DESCRIBE situation, how much and type of product that may be at risk, and whether there are any mitigating factors. Is the process for traceability of reworked and/or repacked products documented and practiced? Can rework/repack be traced back to the original production lot? DESCRIBE the finished product lot-coding scheme. <<Guidance: If relatively easy to describe, explain how to interpret the code. Otherwise, explain the type of code used (Julian, open dating, encrypted, etc.) How are codes applied (video jet, stamp, sticker, embossed/debossed, laser imprint, etc.) Are codes for raw materials and finished products correct, accurate and legible? <<Guidance: DESCRIBE issues, if any.
2.12.5 The effectiveness of product traceability is tested regularly.
** Does the facility conduct routine in-house mock recalls for RAW MATERIAL FORWARD? <<Guidance: This can also include primary packaging. Does the facility conduct routine internal mock recalls for LOT CODE BACKWARD? Does the facility conduct routine internal mock recalls for LOT CODE FORWARD? What are the facility's expectations for percent recovery AND elapsed time? <<Guidance: If none, say so. DESCRIBE the results of at least two trace exercises performed within the past year or two. <<Guidance: Include type of exercise (see 2.12.4.1 - 2.12.4.3), dates, materials traced, percent recovery and elapsed time. ** Are trace exercise results documented and are self-assessments performed?
2.12.6 Traceability performance is challenged during the audit report.
DESCRIBE the product/ingredient trace exercise performed during the audit; e.g., one lot code of a raw material traced through to its finished product and to first level of distribution. <<Guidance: State specifically that a trace exercise was conducted during the audit. Preferably, a raw ingredient or raw material was tracked through the first level of distribution. Description should include name and type of product, original quantity, final quantity (pounds, cases, gallons, etc.) of product containing targeted item, and disposition of product that was traced (warehoused onsite, shipped, destroyed, on-hold, etc.) Report the percentage of product or ingredients traced and accounted for, and the total elapsed time to complete the exercise.
2.13
CRISIS MANAGEMENT ** Does the facility have a documented crisis management program in addition to product recalls? DESCRIBE crises for which the facility has contingency programs. <<Guidance: Examples may include labor disputes, power interruption, fire, natural disaster, ammonia leak, interruption of raw material supply, intentional disruptions, etc. Give title/position of persons accountable for crisis management at the facility. Does the crisis management program include emergency contact information? Has the crisis management program been tested or activated within the past 12 months? <<Guidance: If yes, provide details regarding what happened, what was done, whether the handling of the event was considered successful, and any findings. Does the facility have a contingency plan to continue product supply to customers in the event of a prolonged interruption? <<Guidance: DESCRIBE procedures, if they exist, for the continuation of supply; e.g., sister facilities,
2.13.1 The facility has a crisis management program in addition to product recalls.
large inventories, pre-arrangements with similar manufacturers, etc. Does the facility have procedures to inform customers that a crisis has occurred that may affect the supply chain? 2.14 FOOD DEFENSE (SECURITY) ** Has a Food Defense assessment been conducted for the facility? ** Is a Food Defense policy/plan documented? DESCRIBE which guidelines were used to perform the assessment. <<Guidance: Examples include ORM, CARVER, TEAM, Corporate sources, in-house assessment, etc. Was a Food Defense checklist used in the assessment; e.g., internally developed, governmental, trade association, etc? <<Guidance: Provide source of the checklist. Give titles/positions that are accountable for coordinating Food Defense at the facility. Does the Food Defense policy or plan require the investigation and reporting of security breaches to the leader of the program? 2.14.2 The Food Defense policy/plan is fully implemented. Has the Food Defense policy or plan been fully implemented at this facility? <<Guidance: If not, explain what portions are yet to be implemented AND when the facility expects to see full implementation. DESCRIBE procedures that restrict EMPLOYEE access to the facility in general (including warehouses), and/or to individual departments inside the facility/warehouse. <<Guidance: Explain how the plant makes sure EMPLOYEES do not go into unauthorized areas. This may include special badge designations, locked doors, signage, specialized apparel or markings, heightened supervision, staffed entrances, etc. DESCRIBE procedures that restrict NON-employee access to the facility; e.g., visitors, service providers, truck drivers, contractors, etc. <<Guidance: In addition to employee examples given above, restrictive measures for NON-employee may include sign-in instructions, escorts, withholding of badges, etc. DESCRIBE Food Defense tools used at the facility. <<Guidance: Explain what tools or devices are used to control access to the facility; e.g., electronic access control, picture IDs, guard service, fencing or restrictions to property, selfclosing doors to plant, levels of security clearances, cameras, or other monitoring devices, etc. Are background checks performed on all types of employees? <<Guidance: Indicate which types of employees do NOT receive a background check; e.g., full-time, part-time, temporary, seasonal, etc. During the audit, were observations of Food Defense activities consistent with the current policy/plan? <<Guidance: Provide assessment based upon observations, conversations and record reviews how well the facility carries out its
2.14.1 A documented policy/plan manages Food Defense (security) at the facility.
Food Defense policies. 2.14.3 The Food Defense plan is communicated and training is conducted. Has the facility Food Defense coordinator and/or team received specialized Food Defense related training? <<Guidance: DESCRIBE the source of any specialized training. Does the facility have a program to communicate/train its employees regarding Food Defense? Has the Food Defense communication/training program been fully implemented? DESCRIBE the frequency of employee Food Defense communication and training. <<Guidance: How often is training undertaken? Between training, how often are issues relating to Food Defense communicated to employees? DESCRIBE how plant policies regarding Food Defense procedures and GMPs are communicated to visitors and contractors. <<Guidance: Examples may include signed instruction sheets, verbal instructions, video instructions, etc. Were Food Defense instructions provided to the auditor before access to the facility? Were GMP instructions provided to the auditor before access to the facility? 2.14.4 The Food Defense plan is periodically assessed, reviewed and updated. Is the Food Defense policy/program periodically assessed by management for areas of vulnerability, including premises, products and raw materials that may be at risk? <<Guidance: DESCRIBE by whom (titles/positions), if applicable. At what frequency are management assessments of the Food Defense policy/plan performed? <<Guidance: DESCRIBE the frequency of management assessments of the Food Defense policy/plan. Indicate whether the facility implements corrective actions for Food Defense vulnerabilities when revealed through management assessments. <<Guidance: Determine this from record reviews and/or interviews. State source of information here. 2.15 CALIBRATION, MEASURING AND TEST EQUIPMENT Does the facility have a documented calibration program for processing equipment? Does the processing equipment calibration program include a list of equipment requiring calibration? <<Guidance: Itemize any CRITICAL processing equipment that appear on the list. Does the processing equipment calibration program include calibration frequencies for all equipment on the list? Does the processing equipment calibration program describe persons/positions responsible for calibrations? Does the facility have an identification system for processing equipment? <<Guidance: If yes, provide a brief
2.15.1 A system for processing equipment calibration is in place.
description. DESCRIBE whether calibrations are performed in-house or by a contract service. <<Guidance: If outside contractors are used, list names of companies and which plant equipment they calibrate. Does the in-house processing equipment calibration program include documented calibration instructions? CONFIRM whether records for processing equipment calibration appear to be complete. <<Guidance: State specifically that calibration records were reviewed and whether they appear to be complete. Is the processing equipment calibrated against certified or other acceptable industry standards? <<Guidance: If yes, identify standards used. Do facility personnel responsible for calibrating the processing equipment receive specialized training? Does the facility have documented corrective action procedures when processing equipment is found to be out-ofcalibration? <<Guidance: Provide an example. CONFIRM that procedures for corrective actions are followed when processing equipment is found to be out-ofcalibration? <<Guidance: Provide an example. DESCRIBE procedures followed to control product affected by out-of-calibration processing equipment. 2.15.2 A system for laboratory equipment calibration is in place. Does the facility have a documented calibration program for laboratory equipment? Does the laboratory equipment calibration program include a list of equipment requiring calibration? <<Guidance: Itemize any CRITICAL laboratory equipment that appears on the list. Does the laboratory equipment calibration program include calibration frequencies for all equipment on the list? Does the laboratory equipment calibration program describe persons/positions responsible for calibrations? Does the facility have an identification system for laboratory equipment? <<Guidance: If yes, provide a brief description. DESCRIBE whether calibrations are performed in-house or by a contract service. <<Guidance: If outside contractors are used, list names of companies and which plant equipment they calibrate. Does the in-house laboratory equipment calibration program include documented calibration instructions? CONFIRM whether records for laboratory equipment calibration appear to be complete. <<Guidance: State specifically that calibration records were reviewed and whether they appear to be complete.
Is the laboratory equipment calibrated against certified or other acceptable industry standards? <<Guidance: If yes, identify standards used. Do facility personnel responsible for calibrating the laboratory equipment receive specialized training? Does the facility have documented corrective action procedures when laboratory equipment is found to be out-ofcalibration? <<Guidance: Provide an example. CONFIRM that procedures for corrective actions are followed when laboratory equipment is found to be out-ofcalibration. <<Guidance: Provide an example. DESCRIBE procedures followed to control product affected by out-of-calibration laboratory equipment. 2.16 TRAFFIC CONTROL Does the facility physically segregate raw from processed/finished product to prevent cross-contamination between items? <<Guidance: NOTE: "Cross-contamination" is not only microbial; it also may be physical and/or microbiological. ALSO, this Audit Item is not only for raw vs. cooked/RTE product. It can also include segregation of raw from packaged goods, ready-to-cook finished products, etc. Does the facility use dedicated equipment to prevent contamination of processing areas? <<Guidance: Examples may include separate lift trucks, pallets, etc. 2.16.2 Control measures are in place to reduce the potential of crosscontamination. Are control measures in place to minimize cross-contamination? <<Guidance: IDENTIFY measures taken, if any. They may include (but should not be limited to) restricted traffic patterns, physical partitions, separate restrooms, uniform policies, floor scrubbers, use of foot baths/sprays, airflow, UV sterilizers, etc. Are procedures for the control of cross-contamination documented? Report on the management of foot baths, if used. Does the facility have areas controlled by positive or negative air pressure? <<Guidance: If yes, describe location and rationale. Verify by inspection that control measures to reduce potential cross-contamination are being followed. <<Guidance: DESCRIBE any deficiencies found during the audit. DESCRIBE what environmental and traffic control measures are in place to prevent cross-contamination (e.g., segregation, containment, etc.) DURING CONSTRUCTION PROJECTS, if any. 2.17 MAINTENANCE
2.16.1 Segregation of raw from processed/finished product is sufficient to prevent cross-contamination.
2.17.1 A corrective and preventive maintenance program is in place and is effective.
Does the facility have a documented corrective and preventive maintenance program? Is the corrective and preventive maintenance program computerized or manually operated? <<Guidance: If manual, provide details of the system; e.g., printed work orders, verbal assignments, etc. If partially computerized, explain what is handled by computer and what is handled manually. Does the corrective and preventive maintenance program include procedures to address and track overdue/open work orders? Does the program include a list of food handling equipment? <<Guidance: DESCRIBE any discrepancies, if the list is incomplete. Does the corrective and preventive maintenance program include a schedule of maintenance frequencies? <<Guidance: DESCRIBE any discrepancies, if coverage is incomplete or frequencies seem unrealistic. Does the corrective and preventive maintenance program provide for the training of maintenance personnel? <<Guidance: This question pertains to job related responsibilities only. If the maintenance program doesn't include training, how does the facility determine that maintenance personnel are capable? Does the corrective and preventive maintenance program include parts inventory management? <<Guidance: If the maintenance program doesn't mention parts reordering, explain how parts are reordered and indicate whether it appears to be effective. DESCRIBE titles/positions accountable for the corrective and preventive maintenance program. Are priorities established for the repair of critical equipment regarding safety related issues; i.e., personnel and food? DESCRIBE maintenance workers' understanding of the corrective and preventive maintenance program, based upon INTERVIEWS with employees. <<Guidance: State specifically that maintenance personnel were interviewed, and what was learned.
2.17.2 The maintenance program includes maintenance records. 2.17.3 The maintenance program is structured to prevent contamination from maintenance activities.
** Does the facility keep records of maintenance activities performed; e.g., preventive, predictive, routine, emergency, etc? <<Guidance: State which records were missing, if any. CONFIRM and describe the record retention policy for maintenance documents. ** Does the maintenance program require reconciliation of all TOOLS after repairs and prior to start-up? Does the maintenance program require reconciliation of MACHINE PARTS after repairs and prior to start-up? <<Guidance: If not, provide further explanation. Does the corrective and preventive maintenance program require post-maintenance sanitation inspection of
equipment? <<Guidance: Explain who (titles/positions) is responsible for post-maintenance equipment inspection. Are post-maintenance equipment inspections documented? Are tools and/or part carts cleaned and/or dedicated to prevent contamination of the processing area? Is a purge process performed after emergency maintenance repairs? 2.17.4 The maintenance program includes a policy for temporary repairs. Does the corrective and preventive maintenance program include a Temporary Repairs policy? <<Guidance: DESCRIBE program, if any. For example, what types of temporary repairs are allowed, when are such repairs permitted, are they documented, are time limits for corrections listed, are work orders generated, etc? Is the Temporary Repairs policy documented? Indicate whether any temporary repairs were observed during the audit of the facility; e.g., duct tape, cardboard, string, plastic film, etc. <<Guidance: DESCRIBE temporary repairs, if present, whether they conform to facility policy, and whether they pose a potential for contamination. 3.1 HACCP / FOOD SAFETY Does the facility have a Hazard Prevention program? Is the facility Hazard Prevention program HACCP based? <<Guidance: DESCRIBE program here in full, if not HACCP based. Does the facility operate under a government regulated HACCP or Hazard Prevention program? <<Guidance: DESCRIBE which, if any, regulatory bodies are involved and, if possible, provide a reference to the actual regulation. IDENTIFY all individual Hazard Prevention plans and the product groupings associated with these plans; e.g., soup, parbaked bread, cereal, etc. Are all products or processes covered under the HACCP/Hazard Prevention program? <<Guidance: If not, describe the exceptions and the rationale for not including them in the program. 3.1.2 A team is in place and responsible for developing, modifying the Hazard Prevention program and implementing and maintaining the Hazard Is there a multidisciplinary HACCP/Hazard Prevention team that is assigned overall responsibility for the Hazard Prevention program? <<Guidance: A multidisciplinary team would be one where recruited members represent different departments (maintenance, QA, packaging, warehousing, etc.) within the plant and/or who have differing technical expertise. Does the HACCP/Hazard Prevention team meet on a regular basis? <<Guidance: DESCRIBE frequency of team meetings.
3.1.1 A HACCP/Hazard Prevention plan is documented for each product/process.
Prevention system.
DESCRIBE the members of the Hazard Prevention team and their qualifications. <<Guidance: Mention related educational backgrounds, whether they have HACCP specific training, management and/or QA experience, etc. Has at least one member of the Hazard Prevention team completed a HACCP/Hazard Prevention training session? <<Guidance: State the title/position of these individuals and the source of the training.
3.1.3 HACCP/Hazard Prevention preliminary steps and hazard analyses were conducted prior to developing the HACCP/Hazard Prevention plan.
Do the facility HACCP/Hazard Prevention plans comply with CODEX and/or NACMCF? <<Guidance: IDENTIFY which plan is followed. Do the HACCP/Hazard Prevention plans include product descriptions, distribution, intended uses, and target consumers (channels of trade)? <<Guidance: DESCRIBE which aspects are not included in the plan, if any. Also, explain here who the target customer is. Are process flow diagrams current for all HACCP/Hazard Prevention plans? <<Guidance: DESCRIBE any issues. Are HACCP/Hazard Prevention plans reviewed during the audit supported by a written Hazard Analysis? <<Guidance: If not all, explain further. Does the Hazard Analysis consider the severity and likelihood of occurrence?
3.1.4 The HACCP/Hazard Prevention plans include: CCPs, critical limits, monitoring activities, corrective actions, verification procedures and record keeping procedures.
Explain which HACCP/Hazard Prevention plan(s) were reviewed during the audit. Describe the key HACCP elements reviewed for the plans. If not HACCP, describe key elements of the Hazard Prevention program. <<Guidance: Attach plan if possible. The key elements of HACCP are: A-CCPs that control the hazards, B-Critical Limits, C-Monitoring Procedures and Frequency, D-Corrective Actions taken if Critical Limits are violated, E-plan Verification Procedures (what is done to make sure the plan is followed), and F-Record Keeping and Documentation Procedures for each CCP. Provide specific information for all six elements for each HACCP plan reviewed. Are audits or reviews of HACCP/Hazard Prevention procedures conducted to ensure they are executed according to the facility's plan? <<Guidance: DESCRIBE frequency of such audits or reviews. Has the facility validated all critical limits or key elements? <<Guidance: DESCRIBE exceptions, if any. State how validations are made; e.g., cite number and dates of in-house study, scientific reference, regulatory requirements, etc. DESCRIBE procedures to periodically reassess HACCP/Hazard Prevention plans. <<Guidance: DESCRIBE frequency (annual, or in response to changes or new information that could affect the validity of the Hazard Prevention or HACCP plan), who (title/position) is involved, and records kept.
3.1.5 Hazard prevention systems are correctly implemented, according to facility HACCP/Hazard Prevention plans.
Were copies of the HACCP/Hazard Prevention plan in use during the audit current and up-to-date? <<Guidance: Provide the date of the last reassessment. Are all copies of HACCP/Hazard Prevention plans signed by authorized individuals? <<Guidance: DESCRIBE exceptions and who (title/position) signed the HACCP/Hazard Prevention plans. CONFIRM that monitoring procedures are conducted and recorded as specified in HACCP/Hazard Prevention plans. <<Guidance: Explain any issues observed during the records review at the facility. CONFIRM that corrective action procedures are conducted and recorded as specified in HACCP/Hazard Prevention plans. <<Guidance: Explain any issues observed during the records review at the facility. CONFIRM that the verification procedures are conducted and recorded as specified in HACCP/Hazard Prevention plans. <<Guidance: Explain any issues observed during the records review at the facility. Are reviews of CCP monitoring, corrective actions and records verification conducted by personnel trained in HACCP/Hazard Prevention? Are reviews of CCP monitoring, corrective actions and record verification documented as specified by HACCP/Hazard Prevention plans? <<Guidance: DESCRIBE any issues observed during the records review at the facility. Are HACCP/Hazard Prevention records readily available? Are there recurring deficiencies noted in the HACCP/Hazard Prevention system? <<Guidance: If yes, describe. An example may be an incident when the HACCP/Hazard Prevention plans were not followed as written.
3.1.6 Personnel demonstrate knowledge and take specified actions regarding procedures identified in the HACCP/Hazard Prevention plan that are under their area of responsibility.
DESCRIBE interviews with non-management personnel regarding their areas of responsibility with HACCP/Hazard Prevention programs. <<Guidance: State specifically what non-management personnel were interviewed, and whether they were knowledgeable of procedures, how to handle out-of-control situations, who is responsible for the facility Hazard Prevention program, etc. Is specialized training provided for HACCP/Hazard Prevention operators? <<Guidance: DESCRIBE any special training required and provided for HACCP/Hazard Prevention operators. During the audit, were apparent deficiencies identified in training, knowledge or execution of HACCP/Hazard Prevention plans? <<Guidance: DESCRIBE concerns observed during the physical inspection of the facility. Does the facility have a microbiological testing program for sanitation? <<Guidance: DESCRIBE 1) non-product and product contact surfaces, 2) surface swabs, 3) items tested, 4) target microorganisms, 5) testing frequency, 6)
3.2
MICROBIOLOGICAL TESTING
3.2.1 Microbiological testing is in place, where applicable.

sampling procedures, etc. Note: bioluminescence testing (ATP) belongs under 2.2.5. Does the facility have a microbiological testing program for environmental monitoring? <<Guidance: DESCRIBE 1) non-product and product contact surfaces, 2) surface swabs or air sampling, 3) items tested, 4) target microorganisms, 5) testing frequency, 6) sampling procedures, etc. Does the facility have a microbiological testing program for raw/rework materials? <<Guidance: DESCRIBE 1) items tested, 2) target microorganisms, 3) testing frequency, 4) sampling procedures, etc. Does the facility have a microbiological testing program for work-in-progress? <<Guidance: DESCRIBE 1) items tested, 2) target microorganisms, 3) testing frequency, 4) sampling procedures, etc. Does the facility have a microbiological testing program for finished products? <<Guidance: DESCRIBE 1) items tested, 2) target microorganisms, 3) testing frequency, 4) sampling procedures, etc. Explain whether rapid tests are used. If they are used, describe how rapid test procedures are validated. <<Guidance: Which analyses, if any, employ rapid tests? Are recognized and validated official methods used to confirm positive results? 3.2.2 Microbiological testing follows approved standards, procedures and methodologies. Does the microbiological testing program include acceptance limits/standards used to determine product acceptability? CONFIRM that results of microbiological testing conform to product specifications. <<Guidance: State specifically that micro testing records were consulted, and what was found. Does the microbiological testing program include actions to be taken when out-of-standard results are found for ingredients or product; e.g., re-sampling/re-testing protocols are defined and followed? <<Guidance: Explain procedures and resampling/re-testing protocols. Does the microbiological testing program document corrective actions when out-of-standard results are found for ingredients or product. <<Guidance: DESCRIBE an out-of-standard result, if any, that was tracked through the system to verify that the stated corrective actions were followed; e.g., re-sampling/re-testing, heighten vigilance, product isolated, etc. 3.2.3 The environmental testing program documents corrective actions taken in response to isolated positive results (to eliminate
Does the environmental testing program document corrective actions taken in response to isolated positive results (to eliminate harborage sites)? <<Guidance: DESCRIBE an environmental positive result, if any, that was tracked through the system to verify that the stated corrective actions were followed. Does the microbiological testing program require results to be recorded when isolated environmental testing limits are
harborage sites).
exceeded? Have trends or recurring environmental positives been identified through periodic in-house record reviews? Are follow-up environmental swabs or other tests taken to verify effectiveness of the corrective action? Were the corrective actions taken effective in eliminating recurring environmental positive results? Does the microbiological testing program require that finished product be tested in response to positive environmental results?
3.2.4 Appropriate decisions are made, based upon microbiological testing results.
Are microbiological results used to determine product disposition? Are environmental microbiological results used to determine product disposition? Does the microbiological testing program require products and/or raw materials to be held until testing is completed? CONFIRM through a review of microbiological testing records that product and/or raw materials are held as required by the microbiological testing program. <<Guidance: State specifically that micro testing records were reviewed, and what was revealed.
3.3
3.3 ANALYTICAL TESTING FOR FOOD SAFETY AND/OR REGULATORY COMPLIANCE Does the facility conduct analytical testing as part of its Food Safety program? <<Guidance: DESCRIBE (identify) all FOOD SAFETY RELATED tests performed, if any; e.g., pH, water activity, heavy metals, pesticides, mycotoxins, etc. Does the facility conduct any analytical tests required by a regulatory body? <<Guidance: IDENTIFY all tests, if any, if any, required by governmental regulation; e.g., USDA grading requirements, pH, Howard Mold, mycotoxins, water activity, Defect Action Levels, etc. Does the facility employ rapid test methodologies for any analytical testing? <<Guidance: DESCRIBE procedures, if any.
3.3.1 Analytical testing is conducted as part of the Food Safety program.
3.3.2 3.3.2 Appropriate decisions are made, based upon food safety related analytical testing results.
Does the facility have acceptance limits for analytical test results? <<Guidance: This pertains to analytical testing with regards to food safety. ** CONFIRM through a review of analytical testing records that results conform to specifications. <<Guidance: This pertains to analytical testing with regards to food safety. State specifically which analytical testing records were reviewed, and what was revealed. Does the analytical testing program include actions to be taken when out-of-standard results are found for ingredients or product; e.g., re-sampling/re-testing, heightened vigilance, product isolated, etc? <<Guidance: DESCRIBE
resampling/retesting protocols, if applicable. (This pertains to analytical testing with regards to food safety.) Does the analytical testing program document corrective actions taken in response to out-of-standard ingredients and/or product results? <<Guidance: DESCRIBE an "out-of-standard" result, if any, that the facility had tracked through the system to verify stated corrective actions were followed. (This pertains to analytical testing with regards to food safety.) Are analytical test results used to determine product and ingredient disposition? <<Guidance: DESCRIBE how products and/or ingredients are handled until testing is completed. This ONLY pertains to analytical testing related to food safety. DESCRIBE from a review of analytical data whether policies are followed regarding the disposition of products and ingredients. <<Guidance: State specifically that analytical data were reviewed, and what was revealed. (This pertains ONLY to analytical testing related to food safety.) 3.4 FOOD ALLERGENS AND CHEMICAL SENSITIVITIES Are any materials used or stored at this facility officially recognized as food allergens or sensitizing agents? <<Guidance: The eight major allergens recognized by the USFDA and Codex include: proteins from peanuts, tree nuts, egg, soy, milk, wheat, fin fish, and crustaceans.) Sensitizing chemicals include; sulfites, and some food colorings such as Yellow 5. If product is manufactured in or intended for a country that recognizes additional allergens (sulfites, celery, poppy seed, sesame seed, etc.), state the name of the country and also include these in the list. IDENTIFY all food allergens and sensitizing ingredients used by the facility, as recognized by the country receiving the product. ** Note whether the allergen control procedure lists allergens and sensitizing agents for ALL ingredients and materials used in the plant. <<Guidance: IDENTIFY all discrepancies, if any. "Ingredients and materials" should also include colorants, lubricants, processing aids, packaging, ingredient blends, etc. ** Does the allergen control procedure provide for updates to the allergen list when new allergens and allergenic sources are brought to the facility? Does the facility provide allergen-specific training to personnel working with or handling allergens? <<Guidance: DESCRIBE scope of training given. 3.4.2 Procedures are in place to prevent crosscontamination of products
3.4.1 Food allergens and sensitizing chemicals are identified and managed at the facility.
Are protective measures and corrective actions taken to protect other products from allergens/sensitizers during product changeover or equipment cleaning? <<Guidance: DESCRIBE protective measures and corrective actions, if any. Examples may include thorough cleaning, dedicated lines, strategic production scheduling, special solvent
by undeclared allergens and sensitizing agents.
applications, etc. ** Does the allergen program have documented procedures for the control of allergen/sensitizers used in the facility? Are special precautions followed to prevent inadvertent cross-contact by allergens and sensitizing agents through the entire process (i.e., from receiving to processing to warehousing to shipping)? <<Guidance: If so, provide examples. DESCRIBE whether ingredients and products containing allergens and sensitizing agents are managed differently than other items. <<Guidance: If so, provide examples. ** Does the facility dedicate people and equipment (utensils, scoops, buckets, clothing/uniform, etc.) to specific allergen/sensitizer related products or processes? <<Guidance: If not both people and equipment, describe potential risk. ** Does the facility comply with its production schedules, change-overs and cleaning regimens that prevent allergen/sensitizer cross-contact issues? <<Guidance: DESCRIBE any issues observed from the audit. Does the facility conduct post-cleaning tests of shared equipment to verify absence of allergens prior to processing product of a different formula? <<Guidance: This could include visual checks, ATP swabbing, allergen-specific testing, etc. DESCRIBE specific actions required when cross-contact with an undeclared allergen is suspected. Are corrective actions documented for suspected cross-contact with an undeclared allergen?
3.4.3 Labeling and packaging procedures exist to ensure that only correct labels are used. Labels are verified to be correct relative to the appropriate 3.4.4 Rework procedures are in place to prevent the cross contact of products with an undeclared allergen.
Are procedures in place that ensure all allergens and sensitizing agents are correctly displayed on product labels in accordance with regulatory requirements? <<Guidance: DESCRIBE if such a system is in place. CONFIRM that allergen labeling procedures are documented. Does the facility uses "May contain" or similar label statements? <<Guidance: DESCRIBE the policy of when to use such labeling. ** Does the allergen control program include provisions and controls for the rework of products and ingredients containing allergens or sensitizing agents? <<Guidance: DESCRIBE controls, if any. DESCRIBE whether the facility maintains designated locations for rework products and ingredients containing allergens or sensitizing agents. DESCRIBE whether the facility has identified specific re-entry points on each production line for reworked products and ingredients containing allergens or sensitizing agents.
Is rework product containing allergens/sensitizers clearly differentiated from regular rework? <<Guidance: DESCRIBE any discrepancies. 3.5 FOREIGN MATERIAL CONTROL ** Does the facility have documented procedures and work instructions governing foreign material control? IDENTIFY all classes of foreign material control devices intended for ingredients, bulk items, work-in-progress and finished goods. <<Guidance: Examples of such devices include optical sorters, destoners, screens, sieves, sifters, metal detectors, X-ray machines, magnets, gravity traps, etc. IDENTIFY the processes where material control devices are used. Does the facility regularly monitor its foreign material control devices? Does the facility provide specialized training to employees who monitor or handle foreign material control devices? Does the facility have metal detector or X-ray procedures that include test frequency, test piece specifications and requirements of an acceptable verification test? <<Guidance: DESCRIBE verification procedures AND testing frequencies, if any, for metal detectors and X-rays, including the types of metal AND size of test pieces. DESCRIBE observations and employee interviews at workstations near foreign material control devices. <<Guidance: Include position/title of persons interviewed. Verify correct operation of devices through a review of available documentation and monitoring results. <<Guidance: IDENTIFY concerns, if any, coming from the document review. Do facility inspections of foreign material control devices include equipment integrity and functionality? Does the facility conduct pre-operational and/or post-maintenance inspections to detect metal-to-metal contact points, equipment wear, and missing nuts or bolts that could result in foreign material contamination in, on or above product surfaces. Does the facility document results of pre-operational and post-maintenance inspections of foreign material control devices, including corrective actions? DESCRIBE any wood used in the facility AND any additional controls or devices intended to prevent wood contamination (slip sheets, vibratory screens etc.). <<Guidance: Wood examples could include pallets, building materials, handles, flooring, overhead structures, etc. Wood control programs may include pallet repair, inclusion in GMP inspection process, use of slip sheets, vibratory screens, wood replacements (plastic pallets & handles), etc. 3.5.1 Procedures or devices are in place for foreign material control.
3.5.2 Corrective action is taken if a foreign material control device (including metal detector/x-ray) is found to be nonfunctional.
Does the facility take corrective actions if any foreign material control device (including metal detectors/X-rays, screens, magnets, etc.) is found to be missing or nonfunctional? <<Guidance: If not, explain further. Does the facility have product hold procedures that define what leads to a "HOLD" decision and the scope/amount of product to be held? Do product hold procedures define acceptable methods for re-inspection and sensitivity of the equipment used to release product? CONFIRM product hold procedures are followed correctly through a review of documents and employee interviews. <<Guidance: State specifically that Hold records were reviewed, who (title/position) was interviewed, and what was revealed.
3.5.3 Effective procedures are in place for the prevention of glass/brittle plastic contamination, breakage, and handling.
Does the facility have a documented glass/brittle plastic control policy? DESCRIBE the glass/brittle plastic control procedures. <<Guidance: IDENTIFY in the description procedures for 1) line stoppage, 2) segregation of suspect product, 3) clean-up 4) re-inspection, 5) other. DESCRIBE what objects and equipment are included in the glass/brittle plastic control policy for the plant and production. <<Guidance: Examples may include facility lighting, forklift lenses, glass packaging, clock faces, windows, plastic signage, etc. Does the facility provide documented work instructions for managing glass/brittle plastic? Do glass/brittle plastic work instructions define inspection and approval procedures for line start-up following a breakage incident? Do glass/brittle plastic control procedures identify areas where usage of glass utensils (beakers, bowls, glass thermometers, etc.) is permitted? <<Guidance: Consider lab glassware, glass thermometers, dishware, etc. Does the facility maintain a highly audited "glass-free zone" in the processing area? DESCRIBE how lights are shielded and IDENTIFY any exceptions. Does the glass/brittle plastic procedure define accountabilities for line start-up following a breakage incident? <<Guidance: Explain who (title/position) is accountable to ensure these procedures are followed correctly. Report observations regarding compliance with glass/brittle plastic control procedures based upon the audit of processing areas and "glass-free" zones. <<Guidance: State specifically that your comments are based upon personal observations, and report findings. Report on observations from operator and supervisor INTERVIEWS (include title/position who was interviewed)
regarding their understanding of the glass/brittle plastic work instructions. <<Guidance: State specifically who (title/position) was interviewed, and report findings. Review glass/brittle plastic breakage records; indicate whether the facility correctly follows documented procedures. <<Guidance: State specifically that breakage records were reviewed, and report findings. 3.5.4 Lubricants used are food grade, where necessary. Does the facility have documented procedures regarding use and control of food grade lubricants? <<Guidance: DESCRIBE discrepancies, if not fully covered. Does the facility have documented evidence that lubricants used in its processes are food grade, and used according to labeled instructions? DESCRIBE how lubricants are labeled and stored to prevent improper use. During the audit, were incidents observed where non-food grade lubricants appeared to be inappropriately applied? <<Guidance: DESCRIBE issues, if any. Are exposed food or food-contact surfaces that are located below lubricated mechanisms protected from possible contamination? <<Guidance: DESCRIBE if actual contamination was observed, and whether the contamination was verified to be food-grade grease or not. 4.1 CONFORMANCE TO CUSTOMER SPECIFICATIONS Does the facility have documented procedures for reviewing and accepting customer orders/requests and specifications? After receiving a customer's order/specification, does the facility verify whether it has the capability, required test methods, equipment and trained analysts to produce product that will conform to customer specifications? Does the facility contact its customers whenever specifications cannot be met? <<Guidance: Explain who (department/title/position) makes the contact. DESCRIBE how customer specifications are communicated to the appropriate departments/areas within the facility. <<Guidance: NOTE: This question should be addressed even if Corporate has overall responsibility for the function. DESCRIBE how the facility controls copies of customer formulations, recipes, and specifications. <<Guidance: Are any protective measures employed? How are documents secured? How are they distributed to the floor? Are they openly displayed? How are copies recovered? Indicate whether specification versions used by the facility were current (not obsolete). <<Guidance: DESCRIBE details, if not current.
4.1.1 Customer-specific standards are evaluated and controlled.
4.1.2 Co-manufacturers are managed and steps are taken to ensure conformance to customer specifications. 4.2 PROCESS CONTROL 4.2.1 Process control procedures are in place to ensure conformance to specifications. 4.2.2 Current procedures are available for operators for all prescribed process and quality checks. 4.2.3 Statistical process controls are utilized.
Does the facility utilize co-manufacturers to make or produce part or all of a customer's product? <<Guidance: If yes, explain further. ** Does the facility inform customers when co-manufacturers are used? DESCRIBE how product made for a customer by a co-manufacturer is controlled, and how this ensures the quality? DESCRIBE process control activities used to monitor and adjust the production process in order to assure conformance to specifications. <<Guidance: Process control examples may include temperature, flow rate, viscosity, granulation, pH, in-line moisture, weight control, organoleptic checks, etc. ** Are up-to-date, documented processing and quality procedures readily accessible to key operators? CONFIRM through observations at workstations whether operators follow documented procedures provided by the facility. Does the facility utilize Statistical Process Control (SPC) techniques? <<Guidance: If yes, explain which production functions utilize SPC. Indicate whether a process review has been performed by qualified individuals to determine whether SPC would be beneficial. <<Guidance: In other words, has a study been made to determine whether SPC could be helpful? Report observations at workstations that 1) documented SPC procedures are available, 2) they are followed, and 3) process control is being achieved. Report observations from SPC documentation and results whether processes are operating to a pre-defined target. <<Guidance: State specifically that SPC records were reviewed, and report findings.
4.3
INSPECTION & TEST ** Does the facility have an inspection program to ensure product conformance to internal or customer specifications? Are results reviewed with respect to internal or customer specifications? <<Guidance: Ask to see examples of customer specifications. Then compare analytical results to customer requirements. IDENTIFY who (title/position) verifies whether product complies with specifications. Does the facility conduct organoleptic (sensory) evaluations on products? <<Guidance: If yes, list tests performed;
4.3.1 Finished products are inspected and tested to ensure conformance to internal and/or customer requirements.
e.g., flavor, visual color, mouth feel, aroma, brightness, etc. Verify that samples are set aside according to the retain sample program, and then provide details of the program. <<Guidance: DESCRIBE location of retain sample storage, storage time, temperature, etc. 4.3.2 Finished goods records are available to show evidence of inspection and test results. 4.3.3 Finished goods records are reviewed before product release to customers. 4.4 DESCRIBE which product inspection records are maintained by the facility. DESCRIBE through a review of product inspection records whether procedures are followed, AND whether results are reviewed and properly archived. <<Guidance: State specifically that finished goods inspection records were reviewed, and report findings. Does the facility execute a positive release system for products? <<Guidance: Describe criteria, if any. Indicate whether inspection records are reviewed before products are released for sale. <<Guidance: IDENTIFY who (title/position) is authorized to review and release products. ** Does the facility have product non-conformance ("Hold") procedures? <<Guidance: Provide a brief description of the facility's "Hold" procedures; i.e. who (title/position) can place product on hold, who (title/position) can release product back for sales, whether held product is isolated (physically or electronically), whether special tags or markings are applied to held product, etc. Are product non-conformance procedures documented? Do product non-conformance procedures apply to raw materials, work-in-progress, AND finished products? ** Do procedures exist to communicate information to customers regarding non-conforming finished goods prior to shipment? How does the facility communicate product non-conformance issues to appropriate personnel? Report observations from employee interviews regarding their understanding of product non-conformance procedures. <<Guidance: State specifically who (title/position) was interviewed, and report findings. DESCRIBE any observations from the audit regarding whether non-conforming materials are inadvertently released to production or shipped to customers/consumers. Indicate whether the disposition of product for release or destruction is done by only the employees who are authorized to perform this function. <<Guidance: IDENTIFY who (title/position) has this authority, if anyone.
CONTROL OF NONCONFORMING MATERIALS
4.4.1 Non-conforming product is segregated and controlled against inadvertent shipment.
DESCRIBE methods used to audit or challenge the product non-conformance program. <<Guidance: Explain how the facility and/or its Corporate counterpart determine that the Held Product program is carried out according to established guidelines. 4.5 GOOD LABORATORY PRACTICES Is analytical or microbiological testing performed at this facility? DESCRIBE controls that prevent facility in-house laboratories from becoming a source of contamination to production areas and products. <<Guidance: Controls could include physical isolation, negative air pressures, restricted access, special apparel, ventilation hoods, glassware control policies, locked cabinets for toxins and reagents, autoclaves, sample disposal, etc. Is any analytical or microbiological testing performed by contract laboratories? <<Guidance: IDENTIFY the names of the contract laboratories AND tests they perform, if applicable. Note the criteria used by the facility to select contract laboratories. How does the facility verify the contract lab is utilizing approved methods and procedures? 4.5.2 Laboratory procedures follow recognized and/or official methodology for all tests for which such standards exists. DESCRIBE the scope of in-house laboratory testing; e.g., quality, analytical, microbiological. <<Guidance: Only a general description is needed here. ** Do in-house laboratory procedures follow recognized and/or official methodology? <<Guidance: DESCRIBE source of methodologies; e.g., FDA, AOAC, NOM, BAM, USDA or customers' methods, etc. Indicate whether the facility has an up-to-date laboratory manual that includes testing methodologies. Does the facility verify internal and/or customer-specified methods are followed? CONFIRM through record review AND interviews whether internal and/or customers' requirements for test methods are identified and followed. <<Guidance: State specifically that records were reviewed, who (title/position) was interviewed, and report findings. DESCRIBE how the facility determines the receiving country's product testing requirements (if products are manufactured for export). <<Guidance: If no product is exported, state specifically that the facility is not engaged in product exportation. CONFIRM through a review of records and interviews whether appropriate test methods are used for exported products. <<Guidance: State specifically that records were reviewed, who (title/position) was interviewed, and report findings.
4.5.1 Analytical and microbiological testing are performed in a suitable laboratory.
4.5.3 Laboratory methods are validated for accuracy and analyst proficiency is periodically verified.
** Does the facility validate laboratory procedures for accuracy and reproducibility? Indicate whether the facility periodically confirms that 1) test methods are accurate at the stated limit of detection, 2) quantitative methods are accurate throughout the desired range and 3) established procedures are followed. DESCRIBE observations regarding the validity of stated detection capabilities and quantitative methods. <<Guidance: Review a random selection of in-house laboratory validation reports. State specifically that random records were examined, and report findings. DESCRIBE how the facility verifies ANALYSTS are capable of performing laboratory procedures with accuracy and precision. <<Guidance: Examples may include participation in internal and/or external check-sample programs, knowledge testing, etc. CONFIRM from a review of randomly selected proficiency reports that the facility actually does verify analyst proficiency. If contract laboratories are used, note whether the facility verifies that these laboratories also conduct self-validation procedures.
4.6
DOCUMENT CONTROL AND RECORD KEEPING ** Does the facility employ a document control system to manage food safety and quality related data and records? DESCRIBE the document control system relative to 1) document creation, 2) transmission, 3) changes and 4) removal of obsolete documents. <<Guidance: NOTE: the description calls for a four-part answer. IDENTIFY who (title/position) is authorized to issue quality and food safety documentation. DESCRIBE how document control procedures ensure customer confidentiality. DESCRIBE how the document control system protects physical and electronic documents against loss AND unauthorized access. <<Guidance: Examples should include methods to protect against fire, theft, damage, erasure, unauthorized access, theft, etc. DESCRIBE the record retention policy for food safety and quality related documentation, data and records. <<Guidance: What is retained, where, and for how long? CONFIRM through a review of work instructions, procedures, batch records, etc. whether documents used during the audit are current and up-to-date. <<Guidance: State specifically that records were reviewed, and describe findings. CONFIRM through a review of records that documents are signed, authorized and dated by the appropriate personnel.
4.6.1 Systems are in place for managing and controlling food safety and quality related documentation, data and records.
Are food safety and quality related records maintained electronically? <<Guidance: DESCRIBE how electronic records, if any, are accessed and controlled. Indicate whether the facility validates that data are accurately captured by electronic records. Explain whether the requirements for electronic records include security measures, signatures, and audit trails. <<Guidance: DESCRIBE any deficiencies in the facility's electronic record requirements. 4.6.2 Food safety and quality related records are legible and correct. Proper procedures are utilized for making corrections. From review of a random selection of facility records, are records accurate and legible? <<Guidance: Provide details of any deficiency. Does the facility follow proper procedures in making corrections to records? <<Guidance: DESCRIBE improper techniques observed (if any); e.g., use of pencil, "white-out", erasures, pre- or post-entering of data, false signatures, etc. Are food safety and quality related records signed and dated by the reviewer to verify the review? Does the facility PROMPTLY review quality and food safety records after production? <<Guidance: DESCRIBE timing of record reviews; i.e., how soon (minutes, hours, days) after the production of materials. 4.7 CORRECTIVE AND PREVENTIVE ACTION ** Does the facility have a systematic approach or program for corrective and preventive actions when problems occur? <<Guidance: This program is SEPARATE from corrective actions involving HACCP/Hazard Prevention or facility & equipment maintenance. It could include customer or consumer complaints, audit deviations, noncompliance issues, vendor issues, etc. Are procedures documented for managing corrective and preventive actions? Does the corrective and preventive action process include identification of the issue, investigation of root cause, timely corrective action, and follow-up to confirm implementation and effectiveness? <<Guidance: If incomplete, indicate discrepancies. DESCRIBE whether the supplier maintains a corrective and preventive actions log? Does the facility collect and analyze data that would help it prevent future product failures? CONFIRM through a record review whether corrective and preventive actions are periodically reviewed by the facility's management team. <<Guidance: State specifically that records were reviewed, and describe findings. CONFIRM through a review of randomly selected incidents from the corrective and preventive actions log whether established procedures are followed, appropriate investigations are conducted, corrective actions are taken, and
4.7.1 The corrective and preventive action process is defined and includes: identification of the issue, investigation of root cause, timely corrective action, and follow-up to confirm implementation and effectiveness.
timely follow-ups are done. <<Guidance: DESCRIBE one or two examples. The selected incidents should be food safety related.
4.8
CONTINUOUS IMPROVEMENT ** Does the facility have a continuous improvement program? <<Guidance: This audit Item does not refer to corrective actions aimed at resolving ONGOING problems. It is a systematic, proactive approach to examine and improve current practices BEFORE issues arise. DESCRIBE key performance indicators, the types of data reviewed or trended, and the types of issues targeted for improvement. <<Guidance: Include the underlying goals of the program. This may include "first time" quality, number of quality incidents, number of consumer complaints, internal and external audit results, elimination of risk, simplified work processes, reduction of waste, etc.). Does the facility assign people/teams to work on improvement projects in a designated time frame? <<Guidance: DESCRIBE types of teams and time frame. Does the facility conduct management reviews of improvement opportunities? <<Guidance: DESCRIBE from a review of records 1) who (title/position) performs continuous improvement reviews, 2) which improvement opportunities are reviewed and 3) which are not. DESCRIBE a "successful" continuous improvement project implemented by the facility.
4.8.1 A systematic, proactive approach examines and improves current practices before issues arise.
4.9
CUSTOMER / CONSUMER COMPLAINTS ** Does the facility have customer/consumer communication procedures for handling complaints, suggestions and inquiries? <<Guidance: For the purposes of the SAFE audit, the "customer" is the client to whom the supplier ships its products; the "customer/consumer" is the ultimate user of the product. For example, a PET jug manufacturer ships its containers to a fluid milk plant, its customer. Then the milk is purchased at a retail store by the consumer. Are facility customer/consumer communication procedures documented? <<Guidance: DESCRIBE mitigating circumstances, if any, and state reasons given. CONFIRM from record reviews whether the established customer/consumer complaint procedures are followed. <<Guidance: Note deficiencies found, if any. Do customer/consumer communication procedures assign responsibilities for managing customer/consumer complaints, suggestions and inquiries? <<Guidance: IDENTIFY facility personnel (titles/positions) responsible for
4.9.1 Procedures manage customer/consumer complaints, suggestions and inquiries in a timely manner.
handling and managing customer/consumer complaint issues. Does the facility train employees to properly handle customer/consumer communications? Does the facility maintain up-to-date customer contact lists? DESCRIBE the key measurements for success in handling and resolving customer/consumer issues. <<Guidance: Examples could include prompt closure (state time frame), customer/consumer satisfaction, steps taken to prevent recurrence, reduction or elimination of future complaints of a similar nature, etc. Does the facility promptly resolve issues regarding customer/consumer complaints, suggestions and inquiries? <<Guidance: State the number of communications reviewed, the nature of the communication and the time taken for the facility to completely resolve the issue. 4.10 INTERNAL AUDITING ** Does the facility have a documented internal auditing program? Does the work originate from an audit schedule and an up-to-date audit log? DESCRIBE the types of internal audits performed at the facility. <<Guidance: System-wide QA, GMP, completion of required documentation, PM, allergen-specific, Hazard Prevention, etc. Does the facility define accountability for managing the internal audit program? <<Guidance: State titles/positions of designated individuals. DESCRIBE the qualifications of these individuals. <<Guidance: For example, on-the-job training, experience, formal education, in-house or Corporate training, third-party training, etc. Has the facility documented qualifications and training requirements for internal auditors? <<Guidance: DESCRIBE the qualifications and training for internal auditors. Are the auditors independent of the areas they audit? <<Guidance: If not, provide further explanation. 4.10.3 The audit process is effectively implemented. DESCRIBE whether internal audits follow written procedures, standards and/or checklists. Are internal audit reports issued that detail findings of the audit? Are issues from internal audits PROMPTLY resolved? <<Guidance: Provide a general description of the time required to effect resolution of issues uncovered during internal audit. Are follow-up procedures established to verify corrective actions are promptly implemented?
4.10.1 A documented internal audit program ensures ongoing compliance with quality and food safety standards. 4.10.2. The audit process is managed and conducted by trained, qualified individuals.
Does the facility management team periodically review results and corrective actions resulting from the internal audit program? <<Guidance: DESCRIBE frequency of management reviews. CONFIRM and report on observations during the physical inspection AND reviews of the audit log, training records, etc. whether corrective actions and follow-ups are actually performed on findings uncovered by internal audits. <<Guidance: State whether evidence suggests the facility is making good use of its internal audit program. 5.1 LABELING APPROVAL Does the facility have a documented label approval process? Does the facility verify labels comply with regulatory requirements? Does the facility obtain and verify nutritional information for labels? <<Guidance: DESCRIBE further, if the facility does not obtain and verify nutritional information. Do labels include specific health, process or product claims? <<Guidance: DESCRIBE types of claims made; e.g., Kosher, Halal, organic, Carb-free, GMO, origin of materials, etc.) and whether all certificates are up-to-date. Indicate where labels are designed or developed; e.g., corporate, customers, etc. 5.1.2 Labels are verified before use as appropriate for the product being run. ** Do labels in use during the audit match the product and/or formula? Are labels checked prior to shipment using a UPC/bar code scanner or similar device? <<Guidance: Note devices used, if any. DESCRIBE the procedure used during changeover to ensure removal of incorrect labels from the line and surrounding areas. Indicate container coding procedures, if the facility packages finished goods into "Brite Stock". <<Guidance: DESCRIBE whether brite stock coding, if any, provides product description, facility identification, pack date, lot/line identification, etc. 5.2 REGULATORY & INDUSTRY COMPLIANCE IDENTIFY what food regulations govern production at this facility, if any. DESCRIBE how the facility ensures it complies with applicable state, local and federal regulations. IDENTIFY who (title/position) is responsible for ensuring the facility complies with applicable state, local and federal regulations. Does the facility use the services of a Process Authority? <<Guidance: Provide the name and/or organization serving
5.1.1 There is a documented process and procedure to develop, review and approve labels.
5.2.1 Facility products, processes, training, and records comply with applicable local, state and federal regulations.
as the Process Authority. CONFIRM from a review of training records whether employees are trained to understand and comply with the regulatory requirements related to their jobs. <<Guidance: State specifically that training records were reviewed, and describe findings. CONFIRM from a review of regulatory records whether regulatory non-compliance issues are corrected promptly; e.g., 483s or Noncompliance Reports. <<Guidance: State specifically that regulatory records were reviewed, and describe findings. 5.3 MANAGEMENT OF THE REGULATORY INSPECTION PROCESS Does the facility have documented procedures for handling regulatory inspections? **DESCRIBE the process for handling regulatory inspections. <<Guidance: For example, does the facility ask for and verify credentials? Notify Corporate? Accompany inspector? Take notes? Prohibit photography? Fix things immediately? Etc. Do procedures for handling regulatory inspections include an up-to-date list of personnel responsible for managing the regulatory process? <<Guidance: State the last revision date of the personnel list. Do procedures for handling regulatory inspections include 24-hour contact information for personnel responsible for managing the regulatory inspection process? Are personnel responsible for managing regulatory compliance and/or accompanying regulatory inspectors provided specific training for this purpose? <<Guidance: DESCRIBE scope of training, if any. 5.3.2 Customers are notified if their product is not in regulatory compliance. 5.3.3 Duplicate samples are retained when a regulatory sample is taken. Does the facility notify customers if a regulatory inspection determines the product to be out-of-compliance? 5.3.1 Management and training for the regulatory inspection process is in place.
Do regulatory inspection procedures require duplicate samples be collected when samples are taken by the regulator? Are production lots represented by the regulatory sample held pending results? Does the facility notify customers when a regulator evaluates that customer's product? <<Guidance: If notified, explain how and by whom (title/position). DESCRIBE examples from record reviews that verify regulatory inspection procedures are followed. <<Guidance: State specifically that records were reviewed, and describe findings.
5.3.4 Duplicate copies of documents given to regulatory authorities concerning a customer's product are made.
Does the facility notify customers when a regulator is given copies of written documents pertaining to its products? <<Guidance: If notified, explain how and by whom (title/position). DESCRIBE examples that verify procedures are followed. <<Guidance: State specifically that records were reviewed, and describe findings.

SAFE Food Safety Audit Checklist

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SAFE Food Safety Audit Checklist

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Supplier Audits for Food Excellence

Food Safety Audit Checklist

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Audit Item MANAGEMENT COMMITMENT AND REVIEW

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2.1.6 All water systems are protected against backflow.

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2.2.1 There is a written, comprehensive plant and equipment sanitation program.

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2.3.1 A documented pest control program is in place.

2.3.2 Building exterior is protected from rodent and pest entry.

2.3.3 The pest control program addresses devices and

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2.3.4 Deficiencies are documented and corrective action taken.

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<<Guidance: State type of sanitizer, and test results.

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2.5.8 Uniforms and outer apparel are maintained in a clean manner.

HANDLING, STORAGE & DELIVERY

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2.7.3 Carriers are routinely inspected for acceptability.

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allergens, raw food ingredients, etc?

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2.10.2 A process to change or modify incoming material specifications is documented.

2.10.3 There are control procedures for rework products.

2.11.1 The design of new equipment is approved following sanitary considerations.

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2.12.3 Inbound materials are coded by the facility when received.

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2.12.5 The effectiveness of product traceability is tested regularly.