SAFE Food Safety Audit Checklist

7/31/2019 SAFE Food Safety Audit Checklist

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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.


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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 ASSOCIATIONSUPPLIER 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 aredescribed in five categories. The auditor shall assess the site's performance, relative to the checklist criteria. The auditchecklist is available to the supplier on the web site at www.fpa-safe.org. It is recommended that the supplier utilize theaudit checklist to perform a self-assessment prior to the scheduled audit. The audit is not scored, as are most traditionalaudits (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 providesdescriptive observations and a summary for each section to guide the recipient (customer) to an understanding of howthe facility manages their Food Safety, Security and Quality Systems. The audit report is based on the objective evidenceprovided to the auditor and observations of how the items in the checklist are deployed on the facility's factory floor. Thecustomer 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 inthe written report.

Facilities have 30 days after receiving the draft audit report to respond to all judgments rated "Substantially Meets" orbelow. 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 correctiveactions be placed in the "Facility's Responses to the Auditors Observations" for any identified critical failure. Should thefacility choose not to respond to any judgment rated "Substantially Meets" and below, FPA-SAFE will check with theauditee one time to verify that this is the condition the auditee wants the report to be posted to the Internet. Afterverification, 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 theintent of the checklist indesign and execution.

Meets or exceeds the intent of the checklist in designand execution. Evidence indicates system is effective.An effective, well-developed and executed system. Allchecklist criteria for the section have been addressed,

as applicable to this facilitys programs. Procedures areestablished, maintained and documented where sonoted in the checklist, and can be corroborated bymultiple parties and verified by objective evidence.

SubstantiallyMeets

Most of the elementsestablished by the SAFEAudit Checklist were inplace. (Almost FullyMeets)

Evidence indicates a good, functional system is inplace. However, 1) a few applicable, minor auditchecklist elements are not followed, 2) minorinconsistencies exist between implementation versusdocumented procedure, 3) minor examples are evidentof flawed record keeping, and / or 4) informal practicescannot be corroborated by multiple parties or objectiveevidence. (The term "minor" as used in this definitionmeans that the observation is one that, if leftuncorrected, could not adversely impact productquality, safety or security.)

Partially Meets Most of the elementsestablished by the SAFEAudit Checklist were notin place (Almost a DoesNot Meet)

Evidence indicates a semi-functional system is inplace. However, 1) most applicable, minor auditchecklist elements are not followed, 2) implementationhas little resemblance to documented procedure, and /or 3) record keeping is misleading, inaccurate ornonexistent. (The term "minor" as used in thisdefinition means that the observation is one that, if leftuncorrected, could not adversely impact product

quality, safety or security.)


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Does Not Meet Key system elements ofchecklist missing and / orpoorly designed and / orpoorly executed.

Evidence indicates system is not effectively developedor implemented. System is poorly designed or notfollowed. Multiple applicable checklist criteria for thesection are missing or not performed. Multiple orrepetitive deviations observed in execution or key

records.Critical Failure Clear evidence or direct

observation of conditionsthat would allowadulterated product to beplaced into commerce and/ ora clearregulatoryfailure likely to result inproduct recall, facilityclosure or furtherregulatory action.

Critical violation of GMPs with practices or conditionsleading to confirmed or highly probable adulteration ofproduct, or significant deficiencies in requiredregulatory programs, likely to result in product recall orfacility closure; and deficiencies likely would have goneundetected in the absence of the auditor.

Not Applicable /Auditable

A system that is notneededormajor portionsare not controlled at thisfacility.

Systems described in this section are not neededbecause of the nature of products or processes at thisfacility, or systems are controlled somewhere otherthan by the facility, e.g., corporate, and there is

insufficient direct evidence for the auditor to verifyactual practices of the key criteria in the section orjudge their consistency or effectiveness.

The auditor may provide verbal or off-line recommendations or guidance to the facility being audited, but shallnot include such comments in the written audit report. Specific information, such as identifying customers, isgenerally 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 thereport.


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Executive Summary

FullyMeets

SubstantiallyMeets

PartiallyMeets

DoesNotMeet

CriticalFailure

NotApplicable/Auditable

1-Management Responsibility1.1-Management Commitment and Review2-Fundamentals

2.1-Infrastructure

2.2-Sanitation

2.3-Pest Control

2.4-Chemical Control

2.5-Personnel Practices2.6-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 Management2.14-Food Defense (Security)

2.15-Calibration Measuring and Test Equipment

2.16-Traffic Control

2.17-Maintenance3-Food Safety & HACCP Systems

3.1-HACCP / Food Safety

3.2-Microbiological Testing3.3-Analytical Testing for Food Safety and / orRegulatory Compliance

3.4-Food Allergens and Chemical Sensitivities

3.5-Foreign Material Control4-Manufacturing Quality Systems

4.1-Conformance to Customer Specifications

4.2-Process Control

4.3-Inspection & Test4.4-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


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5-Regulatory Considerations

5.1-Labeling Approval

5.2-Regulatory & Industry Compliance

5.3-Management of the Regulatory InspectionProcess


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Date of Issue Supersedes Date Version Approval Page Number

08/17/06 06/06/06 4 KPW 8 of 54

Copyright 2006 by the Food Products Association. All rights reserved.

Item # Audit Item Auditor Instruction

1.1 MANAGEMENT COMMITMENT AND REVIEW

1.1.1 A Quality Policy isdocumented andcommunicated to all levels

of the organization.

DESCRIBE the Quality Policy, verbatim if possible.


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G id St t t f iti d t t lt


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08/17/06 06/06/06 4 KPW 19 of 54

Copyright

2006 by the Food Products Association. All rights reserved.


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5.3.4 Duplicate copies ofdocuments given toregulatory authoritiesconcerning a customer's

d t d

Does the facility notify customers when a regulator is given copies of written documents pertaining to its products?

Documents

SAFE Food Safety Audit Checklist