SAFE Food Safety Audit Checklist PDF

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 Supersedes Date Version Approval Page Number

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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:

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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.

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There are six Auditor Judgments used for summarizing the various Sections to the checklist:
Fully Meets Meets or exceeds the Meets or exceeds the intent of the checklist in design
intent of the checklist in and execution. Evidence indicates system is effective.
design and execution. 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.
Substantially Most of the elements Evidence indicates a good, functional system is in
Meets established by the SAFE place. However, 1) a few applicable, minor audit
Audit Checklist were in checklist elements are not followed, 2) minor
place. (Almost Fully inconsistencies exist between implementation versus
Meets) 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.)
Partially Meets Most of the elements Evidence indicates a semi-functional system is in
established by the SAFE place. However, 1) most applicable, minor audit
Audit Checklist were not checklist elements are not followed, 2) implementation
in place (Almost a Does has little resemblance to documented procedure, and /
Not Meet) 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.)

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Does Not Meet Key system elements of Evidence indicates system is not effectively developed
checklist missing and / or or implemented. System is poorly designed or not
poorly designed and / or followed. Multiple applicable checklist criteria for the
poorly executed. section are missing or not performed. Multiple or
repetitive deviations observed in execution or key
records.
Critical Failure 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.
Not Applicable / A system that is not Systems described in this section are not needed
Auditable 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.

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Executive Summary
Fully Substantially Partially Does Critical Not
Meets Meets Meets Not Failure Applicable
Meet /
Auditable
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

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5-Regulatory Considerations
5.1-Labeling Approval
5.2-Regulatory & Industry Compliance
5.3-Management of the Regulatory Inspection
Process

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Item # Audit Item Auditor Instruction
1.1 MANAGEMENT COMMITMENT AND REVIEW
1.1.1 A Quality Policy is DESCRIBE the Quality Policy, verbatim if possible. <<Guidance: If unwritten, provide basic elements as understood
documented and by employees.
communicated to all levels DESCRIBE who (title/position) authorized the policy.
of the organization.
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.
1.1.2 A Quality Manual is ** Is there a documented Quality Manual?
documented. DESCRIBE the scope and structure (primary contents) of the Quality Manual.
1.1.3 An organizational chart DESCRIBE whether the facility has an organizational chart and whether it is current.
indicates which positions DESCRIBE how the facility is organized around food safety and quality. <<Guidance: Explain to whom (QA manager,
are responsible for Technical Services, Plant Manager, R&D, etc.) the quality function reports.
compliance to the Quality
System. 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?
1.1.4 Quality System Are proper Quality System Effectiveness Reviews conducted by management? <<Guidance: DESCRIBE any
Effectiveness Reviews are deficiencies, if any, from the criteria below. A "proper" review is conducted by top management at regular intervals to
conducted routinely. 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

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2.1.1 Facility site and buildings Are floors, walls and ceilings (overheads) in good condition? <<Guidance: DESCRIBE the nature of structural issues,
are of suitable size, if any. This could include pitted floors, missing ceiling tiles, unsanitizable construction materials on walls, etc.
construction and design to DESCRIBE drain design and condition. <<Guidance: Indicate type or style of drainage system, potential for
facilitate maintenance and contaminating product, cleanability, and current condition.
sanitary operations.
** 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 Does the inspection of exterior grounds and structures indicate they are maintained to protect against contamination of
maintained in a condition food or facilities? <<Guidance: DESCRIBE issues, if any, such as proximity to key operations and potential impact.
that protects against the Are exterior grounds graded to drain water away from the building? <<Guidance: DESCRIBE issues found, if any,
contamination of food or during the audit regarding drainage.
facility.
2.1.3 There are appropriate DESCRIBE procedures for controlling facility air, if any. <<Guidance: Should include environmental heating/cooling,
environmental controls humidity control, ventilation, ammonia control, etc.
(controlled temperature, air Are effective product protection controls documented and verified? <<Guidance: If ineffective, provide details.
filtration, humidity, lighting,
etc.). 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 Is there a policy regarding types of materials used for food-contact surfaces? <<Guidance: Provide details of the
are made of materials policy; i.e., what materials are required by the policy. If N/A, provide rationale; i.e., type of product and/or process.
appropriate to the IDENTIFY the materials used for food-contact surfaces. <<Guidance: What materials did you actually observe being
application (i.e., stainless used? Indicate any inconsistencies from the policy.
steel vs. aluminum).

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2.1.5 The quality of water, ice, DESCRIBE all sources of water used at the facility. <<Guidance: This may include potable and non-potable water
steam and gases used in from municipal systems, on-site wells, cisterns, shipped-in water, "cow water", etc. If more than one source, identify all
food applications is suitable sources and their intended use.
for 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.
All food-contact water is
determined to be from a Is food-contact steam used? <<Guidance: DESCRIBE what food-contact steam is used for. If water is softened
potable source and is (carbonate removal), describe method.
controlled for its use. 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 ** Are water systems protected against backflow?
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.

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2.1.7 Employee welfare areas DESCRIBE sanitary condition of restrooms, locker rooms and dining/break areas. <<Guidance: This can include
and production hand-wash whether restroom structures were clean and orderly, fixtures appeared to be regularly cleaned and sanitized, trash
stations are equipped and was not overflowing, etc.
functional. 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
2.2.1 There is a written, ** Does the facility follow a general cleaning and sanitation program?
comprehensive plant and Provide a description of the cleaning and sanitation program. <<Guidance: DESCRIBE whether it includes all items
equipment sanitation and areas that are cleaned; e.g., overheads, drains, walls, dock pits, etc.
program.
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.

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2.2.2 Maintenance of the facility Is equipment easily cleanable? <<Guidance: DESCRIBE issues, if any.
and its equipment ensures DESCRIBE current condition of processing equipment, particularly any issues. <<Guidance: From personal
safe manufacture of observations, provide your assessment describing any cleanliness issues. NOTE: ** Cleaning issues that impact
wholesome foods. 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, un-
maintained pipes, rails, plumbing, bollards, etc.
2.2.3 The facility follows written Do they have documented work instructions for cleaning and sanitation? <<Guidance: DESCRIBE issues, if any.
standard operating Provide details of work instructions for cleaning and sanitation (CIP/COP/manual). <<Guidance: DESCRIBE issues, if
procedures (SOP) or work any, and identify whether work instructions include 1) specific chemicals to be used, 2) concentrations, 3) contact time,
instructions. 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 Does the facility follow a system for the control of brushes and other utensils used for cleaning food-contact surfaces?
used for cleaning food- <<Guidance: DESCRIBE what cleaning tools are included in the program (e.g., brushes, brooms, scoops, buckets,
contact surfaces are clearly scrapers, pails, etc.), and any issues discovered during the physical audit.
identified and properly DESCRIBE how brushes and other utensils are identified for their purpose. <<Guidance: May include color-coding,
controlled. 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.

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2.2.5 Measures are in place to Does the facility monitor the effectiveness of cleaning methods?
verify and monitor the DESCRIBE inspections and/or tests performed to monitor and verify that cleaning and sanitization activities are
effectiveness of cleaning effective. <<Guidance: Explain what, if anything, the facility does to test the effectiveness of cleaning activities; e.g.,
methods. 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) Does the facility follow procedures for cleaning water-free processing zones, equipment and structures? <<Guidance:
processing zones effective For any wet cleaning that may be conducted in a water-free zone, explain in 2.2.6.4, not here.
procedures are in place to Are cleaning procedures for water-free processing zones documented?
clean equipment and
structures. 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 water-
free 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.

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2.3 PEST CONTROL
2.3.1 A documented pest control ** Is there a documented pest control program?
program is in place.
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.
2.3.2 Building exterior is Is the building exterior protected against rodent and pest entry? <<Guidance: DESCRIBE areas examined during the
protected from rodent and audit (including roofs, doors, holes in walls, drains, docks, flash plates, windows, ventilation, screens, pipe entries,
pest entry. 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, un-
capped 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 IDENTIFY the types/kinds of pest control devices utilized at this facility. <<Guidance: DESCRIBE whether Bait
addresses devices and Stations, Mechanical Traps, Glue Boards, Insect Light Traps (ILTs), Pheromone/Monitoring Devices, Bird Netting, etc.

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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 Are issues revealed through the pest control program documented? <<Guidance: DESCRIBE any issues that were
documented and corrective observed during the inspection.
action taken. 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.

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2.3.5 Pesticide applications are Who is responsible for applying pesticides? <<Guidance: Explain whether the applicator/technician is employed by
performed by certified the contracted pest control company or is an in-house employee (title/position).
applicators, a licensed pest Is the contracted pest control company's business license current? <<Guidance: Provide expiration dates of the pest
control contractor or under control company's business licenses. (This does not refer to individual applicator licenses.)
direct supervision of the
same. 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 DESCRIBE through a review of pesticide (not rodenticide) application records the procedures followed to apply
enforces written procedures pesticides. <<Guidance: State specifically that application records were reviewed. State methods used on-site for the
for the application of application of pesticides; e.g. crack and crevice spraying, fogging, bait placement, bird abatement, lawn spreaders,
pesticides. 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 Are pest control chemicals stored at this facility? <<Guidance: DESCRIBE, if stored on-site, the areas used to store
control are accurately such chemicals AND measures taken to prevent contamination from pesticides; e.g. ventilation, drainage, spill control,
labeled and securely control of water, etc.
stored.
** 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

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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 Does the facility audit contracted Pest Control Company's performance? <<Guidance: DESCRIBE procedures, if any,
contracted Pest Control to audit/monitor the PCOs performance.
Operator performance.
2.4 CHEMICAL CONTROL
2.4.1 A chemical control program ** Is there a documented chemical control program? <<Guidance: If not, explain further what, if anything, the facility
does have.
manages the use, storage,
and handling of non-food Does the non-food chemical control program verify that such chemicals are approved prior to use? <<Guidance:
chemicals. 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 Are current Material Safety Data Sheets (MSDS) or non-USA equivalent available for all non-food chemicals used at
(MSDS) or non-USA this facility; e.g., pesticides, cleaning, maintenance, etc.? <<Guidance: IDENTIFY which non-food chemicals were
equivalent are available for sought during the audit AND the amount of time required locating them. (During the audit, write down the names of
all non-food chemicals. 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

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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
2.5.1 All employees wear in an ** Is there a policy that addresses hair restraints where food, product, packaging or ingredients are exposed?
effective manner hairnets <<Guidance: DESCRIBE types of hair restraints observed during the audit; e.g., hairnets, beard covers, arm sleeves,
and beard covers while in surgical masks, etc.
areas where food, products, Do employees, visitors and contractors in relevant areas adhere to the hair restraint policy? <<Guidance: DESCRIBE
packaging and ingredients nature and location of violations, if any, observed during the audit regarding the hair restraint policy.
are exposed.
2.5.2 The wearing of jewelry is Is there a policy that addresses the wearing of jewelry, including body piercings, false fingernails, fingernail polish,
controlled to prevent watches, medical alert identification, etc., where food, products, packaging or ingredients are exposed? <<Guidance:
contamination. 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 ** Is there a hygiene policy that includes hand washing, hand dips, and prevention of cross-contamination?
hygiene practices to <<Guidance: DESCRIBE the formal or informal personal hygiene policy.
prevent contamination. 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.

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<<Guidance: State type of sanitizer, and test results.
2.5.4 Employee gloves used for Is there an employee glove policy, including procedures for glove control? <<Guidance: DESCRIBE policy details.
food safety related This applies to gloves used for food safety related purposes.
purposes are maintained DESCRIBE types of gloves permitted for food safety related purposes. <<Guidance: Indicate glove material
intact, clean and sanitary.
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 Is there a consumption policy that restricts eating, drinking and tobacco use in processing and packaging areas?
chewing, snacks and DESCRIBE any specific exceptions that may apply. <<Guidance: Examples: water bottles, medication, eating
tobacco products are
product from production line, etc.
prohibited in processing
and packaging areas. 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 ** Do personnel health policies and procedures exist to ensure employees afflicted by illnesses or open wounds have
of illness or open adequate protection or are reassigned?
cuts/lesions are excluded Are individuals trained to manage employee health issues?
from sensitive food handling
jobs. 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.

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2.5.7 Uniforms and outer apparel Does the facility have an apparel policy prohibiting the use of top pockets in uniforms or other outer apparel?
are designed or controlled Is there an apparel policy prohibiting pens, pencils, or other objects from being carried anywhere above the waist?
in a manner to prevent risk
from foreign materials. 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 Is there a company policy regarding cleanliness of uniforms, shoes and outer apparel? <<Guidance: DESCRIBE
are maintained in a clean apparel cleanliness policy as it exists for this facility.
manner. 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
2.6.1 Training needs are ** Is there a documented training program?
assessed and training is IDENTIFY food safety related training programs. <<Guidance: Indicate any food safety specific training conducted by
conducted and documented this facility. Examples include chemical controls, MSDS (or equivalent), HACCP, hygiene, cleaning,
accordingly. 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 computer-
based.
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?

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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 Indicate who (titles/positions) performs training. <<Guidance: Provide titles/positions of individuals performing each
conduct food safety related type of training mentioned in 2.6.1.2.
training. 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.
2.7 HANDLING, STORAGE & DELIVERY
2.7.1 Stored goods are protected ** Does the facility food safety program include the protection and inspection of stored goods?
from damage, Does the food safety program for the protection of stored goods provide for inspection of both on- and off-site
contamination and locations? <<Guidance: Additionally, provide information of the following five elements, where applicable: 1) type of
deterioration. 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 off-
site 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.

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2.7.2 Temperature- or humidity- Are temperature or humidity sensitive items stored at the facility?
sensitive items are DESCRIBE storage temperature and humidity requirements for ingredients and finished products regarding food
maintained at proper safety/quality. <<Guidance: List general categories of products. Provide specific temperature/humidity ranges, not
temperatures to ensure just "frozen", "refrigerated", "wet", "dry", etc.
proper food safety and
maintain quality. ** 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 Are there inspection procedures for all inbound carriers? <<Guidance: DESCRIBE what issues are addressed by
inspected for acceptability. 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,

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allergens, raw food ingredients, etc?
2.7.4 Pallets are managed for Report on whether the facility has a pallet management program. <<Guidance: DESCRIBE whether the facility
contamination, sanitary and inspects pallets prior to use for contamination, unsanitary conditions and physical damage. Also report on whether
physical conditions. they have on-site pallet repair, a pallet identification program (e.g. CHEP), and a system to clean and recycle pallets.
2.7.5 Bulk raw materials are Are bulk carriers received at or shipped from this facility? <<Guidance: IDENTIFY all bulk goods received at or
protected against shipped from this facility. For the purposes of the SAFE audit, bulk carriers include rail tanks, tanker trucks, belly
contamination during dumps, etc. where the entire transport container is a vessel. Totes, pallet-sized loads, super sacks, Gaylords, etc. are
unloading and loading. 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 Does the facility have product receiving procedures that track expiration dates of raw materials?
materials includes condition CONFIRM understanding of acceptance procedures by interviewing receiving/warehouse personnel. <<Guidance:
of storage and expiration DESCRIBE specifically who (title/position) was interviewed, and what was learned.
date.
** 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.

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2.7.7 Materials are used and Does the facility have procedures and requirements regarding shelf life and release status of finished goods?
shipped with suitable <<Guidance: Provide a brief description.
rotation to prevent If applicable, does the facility have a procedure that specifies the minimum remaining shelf life for domestic and
degradation. 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 Does the facility accept returned goods? <<Guidance: DESCRIBE conditions, if any, which would prompt the
handled in such a manner acceptance of returned goods.
as to protect against DESCRIBE how returned goods are handled to prevent contamination to themselves, the facility and other products.
contamination or the <<Guidance: Include all criteria, designated area or room, next steps, potential dispositions, approvals, etc.
contamination of other
goods. 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.
2.8 VENDOR APPROVAL
2.8.1 There is a Vendor Approval ** Does the facility have a vendor approval program? <<Guidance: DESCRIBE what is included in the vendor
Process for ingredients, approval program.
food-contact packaging, Does the facility only accept products/ingredients from specific manufacturing locations of approved vendor?
and services affecting food <<Guidance: This question refers to vendor approval on a plant-by-plant basis.
safety and quality.
2.8.2 An "Approved Vendor List" Does the facility maintain an up-to-date Approved Vendor List?
is utilized for ingredients, ** CONFIRM that a recent ingredient shipment was received from a supplier on the Approved Vendor List.
food-contact packaging, <<Guidance: State specifically that a recent shipment was reviewed, and what was revealed.
and services affecting food
safety and quality.
2.8.3 A system for evaluation of Does the facility follow a program to evaluate vendor performance? <<Guidance: DESCRIBE issues, if not fully
vendor performance is in implemented.
place. DESCRIBE the procedure to handle "out of compliance" situations with the vendors and explain whether vendor non-

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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 Does the facility have procedures regarding emergency purchases from non-approved vendors? <<Guidance: If a
buying from "non-approved" procedure exists, describe it. Under what circumstances would this facility purchase from a non-approved vendor?
sources, in the case of Who (title/position) would authorize the purchase? Would the facility follow up with the purchase to determine if the
emergency situations. 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
2.9.1 Packaging materials are Does the facility purchase packaging materials based upon written, approved specifications?
purchased according to Does the facility have a system to track and manage the Pure Food Guaranty program (or recognized program
written, approved equivalent)? <<Guidance: A Pure Food Guaranty is the formal and signed agreement between buyers and sellers in
specifications. 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
2.10.1 Incoming materials are Do specifications and procedures identify acceptance criteria for incoming ingredients, including processing aids?
verified as conforming to DESCRIBE how employees responsible for approving incoming ingredients have access to specifications.
written 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?

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DESCRIBE the release procedures for incoming ingredients and verify whether they are followed.
2.10.2 A process to change or Does the facility have procedures that coordinate and confirm specification changes with vendors?
modify incoming material
Do vendors approve in writing all of their specification changes? <<Guidance: If not all, explain.
specifications is
documented. 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 Does the facility have policies and procedures that address the use of materials intended for rework?
procedures for rework Does the facility have procedures that address the storage condition of rework materials?
products.
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
2.11.1 The design of new Does the facility have specific policies and procedures for the approval of equipment design before purchase?
equipment is approved <<Guidance: This question deals with procedures regarding the selection of equipment PRIOR TO purchase.
following sanitary Does the facility have a documented procedure to review sanitary design considerations prior to purchase?
considerations.
Do sanitary design procedures utilize and/or reference industry standards. <<Guidance: IDENTIFY standards that are

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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 Does the facility have specific policies and procedures regarding the sanitary installation of equipment? <<Guidance:
approved to ensure sanitary This question deals with sanitary procedures that should be followed DURING the installation of newly purchased
operating conditions. equipment.
CONFIRM through a review of recent records that approval procedures were followed for new equipment installation.
2.11.3 Newly installed equipment Does the facility have specific policies and procedures to qualify or verify the sanitary design and installation of newly
is challenged to verify purchased equipment before it is placed into service? <<Guidance: This question deals with procedures that verify
proper sanitary design prior the proper sanitary design and installation of equipment AFTER installation and PRIOR TO being placed into service.
to use. 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 ** Do change control procedures for EXISTING equipment or structures require verification of sanitary design; and
structure and equipment do who in management is responsible? <<Guidance: DESCRIBE who (title/position) is responsible for this program.
not compromise sanitary ** When changes are made to existing equipment and structure, are obsolete items removed? <<Guidance: If issues
design. 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 TRACEABILITY AND RECALL MANAGEMENT
2.12.1 An effective recall Does recall management documentation describe the scope of the program?
management program is
documented. 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.

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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 Does the facility require all incoming goods, including bulk, to be coded by vendors? <<Guidance: This question is
of traceability for incoming asking about what the facility asks its vendors to do.
goods and materials. 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 Does the facility assign its own internal identification code for received materials? <<Guidance: Even if the vendor has
coded by the facility when coded its product, does this facility apply further coding?
received.
2.12.4 Raw materials are traceable DESCRIBE finished product control and tracking systems and the basic techniques used. <<Guidance: Include
into finished products. information regarding the use of unique bar codes or pallet tag numbers applied to finished product, whether tracked
Finished goods are by computerized inventory system from production to the first level of distribution, etc.
traceable through ** CONFIRM and provide observations that the facility has the ability to trace raw materials into finished product.
distribution to the first
customer. 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.

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2.12.5 The effectiveness of ** Does the facility conduct routine in-house mock recalls for RAW MATERIAL FORWARD? <<Guidance: This can
product traceability is tested also include primary packaging.
regularly. 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 DESCRIBE the product/ingredient trace exercise performed during the audit; e.g., one lot code of a raw material
challenged during the audit traced through to its finished product and to first level of distribution. <<Guidance: State specifically that a trace
report. 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 on-
site, 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
2.13.1 The facility has a crisis ** Does the facility have a documented crisis management program in addition to product recalls?
management program in DESCRIBE crises for which the facility has contingency programs. <<Guidance: Examples may include labor
addition to product recalls. 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,

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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)
2.14.1 A documented policy/plan ** Has a Food Defense assessment been conducted for the facility?
manages Food Defense ** Is a Food Defense policy/plan documented?
(security) at the facility.
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 Has the Food Defense policy or plan been fully implemented at this facility? <<Guidance: If not, explain what portions
policy/plan is fully are yet to be implemented AND when the facility expects to see full implementation.
implemented. 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, self-
closing 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

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Food Defense policies.
2.14.3 The Food Defense plan is Has the facility Food Defense coordinator and/or team received specialized Food Defense related training?
communicated and training <<Guidance: DESCRIBE the source of any specialized training.
is conducted. 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 Is the Food Defense policy/program periodically assessed by management for areas of vulnerability, including
periodically assessed, premises, products and raw materials that may be at risk? <<Guidance: DESCRIBE by whom (titles/positions), if
reviewed and updated. 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
2.15.1 A system for processing Does the facility have a documented calibration program for processing equipment?
equipment calibration is in Does the processing equipment calibration program include a list of equipment requiring calibration? <<Guidance:
place. 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

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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-of-
calibration? <<Guidance: Provide an example.
CONFIRM that procedures for corrective actions are followed when processing equipment is found to be out-of-
DESCRIBE procedures followed to control product affected by out-of-calibration processing equipment.
2.15.2 A system for laboratory Does the facility have a documented calibration program for laboratory equipment?
equipment calibration is in Does the laboratory equipment calibration program include a list of equipment requiring calibration? <<Guidance:
place. 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.

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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-of-
CONFIRM that procedures for corrective actions are followed when laboratory equipment is found to be out-of-
calibration. <<Guidance: Provide an example.
DESCRIBE procedures followed to control product affected by out-of-calibration laboratory equipment.
2.16 TRAFFIC CONTROL
2.16.1 Segregation of raw from Does the facility physically segregate raw from processed/finished product to prevent cross-contamination between
processed/finished product items? <<Guidance: NOTE: "Cross-contamination" is not only microbial; it also may be physical and/or
is sufficient to prevent microbiological. ALSO, this Audit Item is not only for raw vs. cooked/RTE product. It can also include segregation of
cross-contamination. 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 Are control measures in place to minimize cross-contamination? <<Guidance: IDENTIFY measures taken, if any.
place to reduce the They may include (but should not be limited to) restricted traffic patterns, physical partitions, separate restrooms,
potential of cross- uniform policies, floor scrubbers, use of foot baths/sprays, airflow, UV sterilizers, etc.
contamination. 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

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2.17.1 A corrective and preventive Does the facility have a documented corrective and preventive maintenance program?
maintenance program is in Is the corrective and preventive maintenance program computerized or manually operated? <<Guidance: If manual,
place and is effective. 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 ** Does the facility keep records of maintenance activities performed; e.g., preventive, predictive, routine, emergency,
includes maintenance etc? <<Guidance: State which records were missing, if any.
records. CONFIRM and describe the record retention policy for maintenance documents.
2.17.3 The maintenance program ** Does the maintenance program require reconciliation of all TOOLS after repairs and prior to start-up?
is structured to prevent Does the maintenance program require reconciliation of MACHINE PARTS after repairs and prior to start-up?
contamination from <<Guidance: If not, provide further explanation.
maintenance activities.
Does the corrective and preventive maintenance program require post-maintenance sanitation inspection of

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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 Does the corrective and preventive maintenance program include a Temporary Repairs policy? <<Guidance:
includes a policy for DESCRIBE program, if any. For example, what types of temporary repairs are allowed, when are such repairs
temporary 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
3.1.1 A HACCP/Hazard Does the facility have a Hazard Prevention program?
Prevention plan is Is the facility Hazard Prevention program HACCP based? <<Guidance: DESCRIBE program here in full, if not
documented for each HACCP based.
product/process.
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 Is there a multidisciplinary HACCP/Hazard Prevention team that is assigned overall responsibility for the Hazard
responsible for developing, Prevention program? <<Guidance: A multidisciplinary team would be one where recruited members represent
modifying the Hazard different departments (maintenance, QA, packaging, warehousing, etc.) within the plant and/or who have differing
Prevention program and technical expertise.
implementing and Does the HACCP/Hazard Prevention team meet on a regular basis? <<Guidance: DESCRIBE frequency of team
maintaining the Hazard meetings.

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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 Do the facility HACCP/Hazard Prevention plans comply with CODEX and/or NACMCF? <<Guidance: IDENTIFY
preliminary steps and which plan is followed.
hazard analyses were Do the HACCP/Hazard Prevention plans include product descriptions, distribution, intended uses, and target
conducted prior to consumers (channels of trade)? <<Guidance: DESCRIBE which aspects are not included in the plan, if any. Also,
developing the explain here who the target customer is.
HACCP/Hazard Prevention
plan. 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 Explain which HACCP/Hazard Prevention plan(s) were reviewed during the audit.
Prevention plans include: Describe the key HACCP elements reviewed for the plans. If not HACCP, describe key elements of the Hazard
CCPs, critical limits, Prevention program. <<Guidance: Attach plan if possible. The key elements of HACCP are: A-CCPs that control the
monitoring activities, hazards, B-Critical Limits, C-Monitoring Procedures and Frequency, D-Corrective Actions taken if Critical Limits are
corrective actions, violated, E-plan Verification Procedures (what is done to make sure the plan is followed), and F-Record Keeping and
verification procedures and Documentation Procedures for each CCP. Provide specific information for all six elements for each HACCP plan
record keeping procedures. 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.

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3.1.5 Hazard prevention systems Were copies of the HACCP/Hazard Prevention plan in use during the audit current and up-to-date? <<Guidance:
are correctly implemented, Provide the date of the last reassessment.
according to facility Are all copies of HACCP/Hazard Prevention plans signed by authorized individuals? <<Guidance: DESCRIBE
HACCP/Hazard Prevention exceptions and who (title/position) signed the HACCP/Hazard Prevention plans.
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 DESCRIBE interviews with non-management personnel regarding their areas of responsibility with HACCP/Hazard
knowledge and take Prevention programs. <<Guidance: State specifically what non-management personnel were interviewed, and
specified actions regarding whether they were knowledgeable of procedures, how to handle out-of-control situations, who is responsible for the
procedures identified in the facility Hazard Prevention program, etc.
HACCP/Hazard Prevention Is specialized training provided for HACCP/Hazard Prevention operators? <<Guidance: DESCRIBE any special
plan that are under their training required and provided for HACCP/Hazard Prevention operators.
area of responsibility.
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.
3.2 MICROBIOLOGICAL TESTING
3.2.1 Microbiological testing is in Does the facility have a microbiological testing program for sanitation? <<Guidance: DESCRIBE 1) non-product and
place, where applicable. product contact surfaces, 2) surface swabs, 3) items tested, 4) target microorganisms, 5) testing frequency, 6)

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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
Does the facility have a microbiological testing program for finished products? <<Guidance: DESCRIBE 1) items
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 Does the microbiological testing program include acceptance limits/standards used to determine product
follows approved standards, acceptability?
procedures and CONFIRM that results of microbiological testing conform to product specifications. <<Guidance: State specifically that
methodologies. 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 Does the environmental testing program document corrective actions taken in response to isolated positive results (to
program documents eliminate harborage sites)? <<Guidance: DESCRIBE an environmental positive result, if any, that was tracked
corrective actions taken in through the system to verify that the stated corrective actions were followed.
response to isolated Does the microbiological testing program require results to be recorded when isolated environmental testing limits are
positive results (to eliminate

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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 Are microbiological results used to determine product disposition?
made, based upon Are environmental microbiological results used to determine product disposition?
microbiological testing
results. 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
3.3.1 Analytical testing is Does the facility conduct analytical testing as part of its Food Safety program? <<Guidance: DESCRIBE (identify) all
conducted as part of the FOOD SAFETY RELATED tests performed, if any; e.g., pH, water activity, heavy metals, pesticides, mycotoxins, etc.
Food Safety program. 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.
3.3.2 3.3.2 Appropriate decisions Does the facility have acceptance limits for analytical test results? <<Guidance: This pertains to analytical testing with
are made, based upon food regards to food safety.
safety related analytical ** CONFIRM through a review of analytical testing records that results conform to specifications. <<Guidance: This
testing results. 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

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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
3.4.1 Food allergens and Are any materials used or stored at this facility officially recognized as food allergens or sensitizing agents?
sensitizing chemicals are <<Guidance: The eight major allergens recognized by the USFDA and Codex include: proteins from peanuts, tree
identified and managed at nuts, egg, soy, milk, wheat, fin fish, and crustaceans.) Sensitizing chemicals include; sulfites, and some food
the facility. 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 Are protective measures and corrective actions taken to protect other products from allergens/sensitizers during
prevent cross- product changeover or equipment cleaning? <<Guidance: DESCRIBE protective measures and corrective actions, if
contamination of products any. Examples may include thorough cleaning, dedicated lines, strategic production scheduling, special solvent

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by undeclared allergens applications, etc.
and sensitizing agents. ** 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 Are procedures in place that ensure all allergens and sensitizing agents are correctly displayed on product labels in
procedures exist to ensure accordance with regulatory requirements? <<Guidance: DESCRIBE if such a system is in place.
that only correct labels are CONFIRM that allergen labeling procedures are documented.
used. Labels are verified to
be correct relative to the Does the facility uses "May contain" or similar label statements? <<Guidance: DESCRIBE the policy of when to use
appropriate such labeling.
3.4.4 Rework procedures are in ** Does the allergen control program include provisions and controls for the rework of products and ingredients
place to prevent the cross containing allergens or sensitizing agents? <<Guidance: DESCRIBE controls, if any.
contact of products with an DESCRIBE whether the facility maintains designated locations for rework products and ingredients containing
undeclared allergen. 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.

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Is rework product containing allergens/sensitizers clearly differentiated from regular rework? <<Guidance: DESCRIBE
any discrepancies.
3.5 FOREIGN MATERIAL CONTROL
3.5.1 Procedures or devices are ** Does the facility have documented procedures and work instructions governing foreign material control?
in place for foreign material IDENTIFY all classes of foreign material control devices intended for ingredients, bulk items, work-in-progress and
control. 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.

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3.5.2 Corrective action is taken if Does the facility take corrective actions if any foreign material control device (including metal detectors/X-rays,
a foreign material control screens, magnets, etc.) is found to be missing or nonfunctional? <<Guidance: If not, explain further.
device (including metal Does the facility have product hold procedures that define what leads to a "HOLD" decision and the scope/amount of
detector/x-ray) is found to product to be held?
be nonfunctional.
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 Does the facility have a documented glass/brittle plastic control policy?
place for the prevention of DESCRIBE the glass/brittle plastic control procedures. <<Guidance: IDENTIFY in the description procedures for 1)
glass/brittle plastic line stoppage, 2) segregation of suspect product, 3) clean-up 4) re-inspection, 5) other.
contamination, breakage,
and handling. 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)

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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 Does the facility have documented procedures regarding use and control of food grade lubricants? <<Guidance:
grade, where necessary. 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
4.1.1 Customer-specific Does the facility have documented procedures for reviewing and accepting customer orders/requests and
standards are evaluated specifications?
and controlled. 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.

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4.1.2 Co-manufacturers are Does the facility utilize co-manufacturers to make or produce part or all of a customer's product? <<Guidance: If yes,
managed and steps are explain further.
taken to ensure ** Does the facility inform customers when co-manufacturers are used?
conformance to customer
specifications. DESCRIBE how product made for a customer by a co-manufacturer is controlled, and how this ensures the quality?
4.2 PROCESS CONTROL
4.2.1 Process control procedures DESCRIBE process control activities used to monitor and adjust the production process in order to assure
are in place to ensure conformance to specifications. <<Guidance: Process control examples may include temperature, flow rate, viscosity,
conformance to granulation, pH, in-line moisture, weight control, organoleptic checks, etc.
specifications.
4.2.2 Current procedures are ** Are up-to-date, documented processing and quality procedures readily accessible to key operators?
available for operators for CONFIRM through observations at workstations whether operators follow documented procedures provided by the
all prescribed process and facility.
quality checks.
4.2.3 Statistical process controls Does the facility utilize Statistical Process Control (SPC) techniques? <<Guidance: If yes, explain which production
are utilized. 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
4.3.1 Finished products are ** Does the facility have an inspection program to ensure product conformance to internal or customer specifications?
inspected and tested to Are results reviewed with respect to internal or customer specifications? <<Guidance: Ask to see examples of
ensure conformance to customer specifications. Then compare analytical results to customer requirements.
internal and/or 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;

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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 DESCRIBE which product inspection records are maintained by the facility.
available to show evidence
DESCRIBE through a review of product inspection records whether procedures are followed, AND whether results are
of inspection and test
reviewed and properly archived. <<Guidance: State specifically that finished goods inspection records were reviewed,
results.
and report findings.
4.3.3 Finished goods records are Does the facility execute a positive release system for products? <<Guidance: Describe criteria, if any.
reviewed before product Indicate whether inspection records are reviewed before products are released for sale. <<Guidance: IDENTIFY who
release to customers. (title/position) is authorized to review and release products.
4.4 CONTROL OF NONCONFORMING MATERIALS
4.4.1 Non-conforming product is ** Does the facility have product non-conformance ("Hold") procedures? <<Guidance: Provide a brief description of
segregated and controlled the facility's "Hold" procedures; i.e. who (title/position) can place product on hold, who (title/position) can release
against inadvertent product back for sales, whether held product is isolated (physically or electronically), whether special tags or markings
shipment. 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.

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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
4.5.1 Analytical and Is analytical or microbiological testing performed at this facility?
microbiological testing are DESCRIBE controls that prevent facility in-house laboratories from becoming a source of contamination to production
performed in a suitable areas and products. <<Guidance: Controls could include physical isolation, negative air pressures, restricted access,
laboratory. 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 DESCRIBE the scope of in-house laboratory testing; e.g., quality, analytical, microbiological. <<Guidance: Only a
follow recognized and/or general description is needed here.
official methodology for all ** Do in-house laboratory procedures follow recognized and/or official methodology? <<Guidance: DESCRIBE source
tests for which such of methodologies; e.g., FDA, AOAC, NOM, BAM, USDA or customers' methods, etc.
standards exists.
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.

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4.5.3 Laboratory methods are ** Does the facility validate laboratory procedures for accuracy and reproducibility?
validated for accuracy and Indicate whether the facility periodically confirms that 1) test methods are accurate at the stated limit of detection, 2)
analyst proficiency is quantitative methods are accurate throughout the desired range and 3) established procedures are followed.
periodically verified.
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
4.6.1 Systems are in place for ** Does the facility employ a document control system to manage food safety and quality related data and records?
managing and controlling DESCRIBE the document control system relative to 1) document creation, 2) transmission, 3) changes and 4) removal
food safety and quality of obsolete documents. <<Guidance: NOTE: the description calls for a four-part answer.
related documentation, data
and records. 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.

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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 From review of a random selection of facility records, are records accurate and legible? <<Guidance: Provide details
related records are legible of any deficiency.
and correct. Proper Does the facility follow proper procedures in making corrections to records? <<Guidance: DESCRIBE improper
procedures are utilized for techniques observed (if any); e.g., use of pencil, "white-out", erasures, pre- or post-entering of data, false signatures,
making corrections. 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
4.7.1 The corrective and ** Does the facility have a systematic approach or program for corrective and preventive actions when problems
preventive action process is occur? <<Guidance: This program is SEPARATE from corrective actions involving HACCP/Hazard Prevention or
defined and includes: facility & equipment maintenance. It could include customer or consumer complaints, audit deviations, non-
identification of the issue, compliance issues, vendor issues, etc.
investigation of root cause, Are procedures documented for managing corrective and preventive actions?
timely corrective action, and
follow-up to confirm Does the corrective and preventive action process include identification of the issue, investigation of root cause, timely
implementation and corrective action, and follow-up to confirm implementation and effectiveness? <<Guidance: If incomplete, indicate
effectiveness. 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

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timely follow-ups are done. <<Guidance: DESCRIBE one or two examples. The selected incidents should be food
safety related.
4.8 CONTINUOUS IMPROVEMENT

4.8.1 A systematic, proactive ** Does the facility have a continuous improvement program? <<Guidance: This audit Item does not refer to
approach examines and corrective actions aimed at resolving ONGOING problems. It is a systematic, proactive approach to examine and
improves current practices improve current practices BEFORE issues arise.
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.
4.9 CUSTOMER / CONSUMER COMPLAINTS
4.9.1 Procedures manage ** Does the facility have customer/consumer communication procedures for handling complaints, suggestions and
customer/consumer inquiries? <<Guidance: For the purposes of the SAFE audit, the "customer" is the client to whom the supplier ships its
complaints, suggestions products; the "customer/consumer" is the ultimate user of the product. For example, a PET jug manufacturer ships its
and inquiries in a timely containers to a fluid milk plant, its customer. Then the milk is purchased at a retail store by the consumer.
manner. 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

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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
4.10.1 A documented internal ** Does the facility have a documented internal auditing program?
audit program ensures Does the work originate from an audit schedule and an up-to-date audit log?
ongoing compliance with
quality and food safety DESCRIBE the types of internal audits performed at the facility. <<Guidance: System-wide QA, GMP, completion of
standards. required documentation, PM, allergen-specific, Hazard Prevention, etc.
4.10.2. The audit process is Does the facility define accountability for managing the internal audit program? <<Guidance: State titles/positions of
managed and conducted by designated individuals.
trained, qualified DESCRIBE the qualifications of these individuals. <<Guidance: For example, on-the-job training, experience, formal
individuals. 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 DESCRIBE whether internal audits follow written procedures, standards and/or checklists.
effectively implemented. 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?

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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
5.1.1 There is a documented Does the facility have a documented label approval process?
process and procedure to Does the facility verify labels comply with regulatory requirements?
develop, review and
approve labels. 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 ** Do labels in use during the audit match the product and/or formula?
use as appropriate for the Are labels checked prior to shipment using a UPC/bar code scanner or similar device? <<Guidance: Note devices
product being run. 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
5.2.1 Facility products, IDENTIFY what food regulations govern production at this facility, if any.
processes, training, and DESCRIBE how the facility ensures it complies with applicable state, local and federal regulations.
records comply with
applicable local, state and IDENTIFY who (title/position) is responsible for ensuring the facility complies with applicable state, local and federal
federal regulations. regulations.
Does the facility use the services of a Process Authority? <<Guidance: Provide the name and/or organization serving

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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
5.3.1 Management and training Does the facility have documented procedures for handling regulatory inspections?
for the regulatory inspection **DESCRIBE the process for handling regulatory inspections. <<Guidance: For example, does the facility ask for and
process is in place. 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 Does the facility notify customers if a regulatory inspection determines the product to be out-of-compliance?
their product is not in
regulatory compliance.
5.3.3 Duplicate samples are Do regulatory inspection procedures require duplicate samples be collected when samples are taken by the regulator?
retained when a regulatory Are production lots represented by the regulatory sample held pending results?
sample is taken.
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.

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5.3.4 Duplicate copies of Does the facility notify customers when a regulator is given copies of written documents pertaining to its products?
documents given to <<Guidance: If notified, explain how and by whom (title/position).
regulatory authorities DESCRIBE examples that verify procedures are followed. <<Guidance: State specifically that records were reviewed,
concerning a customer's and describe findings.
product are made.

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Guidance on the Application and Interpretation of the Audit Report:

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4.8 CONTINUOUS IMPROVEMENT

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