Addendum ISO 23412: Indirect temperature-controlled refrigerated delivery services

FSSC 22000 ADDENDUMCOSTCO SPECIFIC FOOD SAFETYREQUIREMENTS MODULE

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COPYRIGHT
Copyright © 2024, Foundation FSSC
All rights reserved. No part of this publication may be reproduced and/or published in any form,by means of printed matters, photocopy, microfilm, recording, or any other method or technology,
without written approval by the Foundation FSSC.

Foundation FSSC
P.O. Box 2047
4200 BA Gorinchem, The Netherlands
Phone +31 183 645028
Website: www.fssc.com
Email: questions@fssc.com

TRANSLATIONS
Please note that in the case of translations of this Module, the English version is the valid andbinding version.

REVISION HISTORY
Date Published

Issue

Changes

July 2022

1

First publication

April 2023

2

Updates made to align with Costco Wholesale: Food Safety &Quality Audit Expectations for Costco Suppliers Version 2.0. The
main changes include Section 4.5 and Section 6 (Updated CSAR 1
to 6; and added CSAR 7 to 12)

May 2023

2.1

Updated the requirements for Section 4.5, Section 4.6, Section 4.9,
and Annex A

February 2024

3

Updated in line with Version 6 of the FSSC 22000 Scheme,
including but not limited to:•••

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Updates made to Section 2, 4.3, 4.7, 5.1 and 5.1.1
Reduced the requirements included under Section 6, CSAR 2
Added COID into Annex A

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CONTENTS
1.

Purpose ...........................................................................................................................................32.

Introduction ...................................................................................................................................3

3.

Scope................................................................................................................................................3

4.

Requirements for the Certification Process .............................................................................4

5.

Requirements for Certification Bodies......................................................................................6

6.

Costco Specific Audit Requirements ..........................................................................................7

7.

References ................................................................................................................................... 12

Annex A: Costco Module Checklist Template ............................................................................... 13

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1. PURPOSE
This document describes the additional requirements for organizations certified to FSSC 22000 tomeet those specified in the Costco Wholesale Food Safety Audit Expectations document, as wellas the process for Certification Bodies to follow when conducting audits to this Module. This
Module can only be delivered when combined with an FSSC 22000 audit. It is necessary for the
supplier to fully meet the requirements of both FSSC 22000 and the specific requirements within
this document.

2. INTRODUCTION
It is required that all FSSC 22000 certified sites have a customer focus process in place to maintainknowledge of customer expectations and to meet those expectations wherever possible.
Previously Costco Wholesale has required FSSC 22000 certified suppliers to have the Costco GFSI
Addendum completed during their FSSC 22000 certification audit. The additional Costco Specificrequirements within the Costco GFSI Addendum were recorded separately from the FSSC 22000
report.
Costco, in collaboration with FSSC 22000 stakeholders, has decided that a Module to show where
Costco Specific requirements differ from those of FSSC 22000 could replace the need for the fullCostco GFSI Addendum and would be of value to show how the Costco - Specific requirements
should be verified during an FSSC 22000 Assessment.
Depending on the product and technology, an adjustment of audit duration can be agreed upon
between the certified/to be certified organization and the responsible Certification Body.

3. SCOPE
This module is a voluntary document that applies to organizations wishing to meet therequirements of the Costco Wholesale Food Safety Audit Expectations document.
This module is applicable to:
1. All sites that manufacture, process, and pack food for Costco Wholesale,
2. Processed foods, both own-brand and customer-branded,
3. Raw materials or ingredients for use by food service companies, catering companies
and/or food manufacturers, and
4. Primary products such as fruit and vegetables.
Scope exclusions: Where the Costco module is requested, the scope shall include all the applicableproducts and processes on site. It is not possible to select Costco products or processes to be
excluded from the scope of certification.

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The additional requirements specified in this document are based on a GAP analysis between FSSC
22000 and the Costco Wholesale Food Safety Audit Expectations document. Meeting the additional
requirements in this Module, in addition to the FSSC 22000 requirements, results in compliancewith the Costco Wholesale Food Safety Audit Expectations document.
This document also sets out the auditing and certification process requirements for FSSC 22000
licensed Certification Bodies (CBs) wanting to audit this Module.

4. REQUIREMENTS FOR THE CERTIFICATION PROCESSThis section sets out the requirements for the certification process and applies to bothorganizations and FSSC 22000 licensed CBs as relevant.
The CB shall have procedures for including the Module in the FSSC 22000 audit process and apply
the Module under the same principles as FSSC 22000.
This module may only be delivered by certification bodies that are recognized by Costco Wholesale
and licensed with the Foundation to deliver FSSC 22000 audits. Costco suppliers must notify theircertification body that they need to undertake this Module audit going forward.
This Module may only be carried out together with an FSSC 22000 audit with a corresponding
scope and may not be delivered as a stand-alone module. The certified organization (supplier)must notify the certification body in advance that they want to undertake this Module so that
additional audit duration may be determined prior to the commencement of the audit.
The scope must include all Costco Wholesale products and production facilities. The certified
organization (supplier) and certification body must agree to the scope of certification prior to theaudit.

4.1 CONTRACT AND APPLICATION PROCESSThe organization shall inform the CB that they wish to include the Module as part of their FSSC
22000 audit prior to the start of the audit. The CBs application system shall allow for thisinformation to be captured, including the scope, and the contract with the organization shall be
updated to include the Module.

4.2 AUDIT DURATIONThe CB shall determine the additional audit duration needed to assess the Module requirements
based on the size and complexity of the organization.
The minimum audit duration shall not be less than 1 to 2 hours in all cases and does not include
planning, reporting, or travel activities, and only relates to effective time spent auditing theModule.

4.3 ALLOCATION OF THE AUDIT TEAM
The audit to the Module shall be conducted by an FSSC 22000 qualified auditor for the relevant(sub)category, in accordance with the Scheme, Part 4, Section 3.5, and additionally, the auditor
shall meet the requirements as defined under section 5 below.

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4.4 AUDIT PROCESSThe Module audit is always a full audit covering all the requirements listed in Part 6 of thisdocument and is to be assessed as an integrated part of the FSSC 22000 audit.
The audit program and audit plan shall clearly reference and include the Module requirements.
The combined audit shall be conducted annually as part of the FSSC 22000 audit. The first audit of
the Module can take place at any full FSSC 22000 audit during the cycle (initial, surveillance, or
recertification).
The audit delivery method (on-site, ICT Audit approach, or full remote) shall be aligned to that of
the FSSC 22000 audit and follow the same requirements.

4.5 UNANNOUNCED AUDITS
It is a mandatory requirement from Costco that all audits accepted by Costco shall be delivered
unannounced where allowed by the Scheme. Therefore, it is mandatory for FSSC 22000
surveillance and recertification audits to be delivered as unannounced where the FSSC Costco
Module is delivered, as the Scheme allows both surveillance audits and recertification audits to bedelivered as unannounced audits if agreed with the organization (refer to Part 3, Section 5.4 of the
Scheme). The initial audit (stage 1 and stage 2) shall not be delivered as unannounced. The Scheme
requirements still need to be met, and therefore, the certified organization needs to agree to all
surveillance and recertification audits being delivered as unannounced audits.
If the certified organizations do not agree to this requirement, then they cannot undertake the
FSSC Costco Module in conjunction with the FSSC 22000 audit and can only undertake FSSC 22000
certification. Standalone audits against the FSSC Costco Module are not allowed.
Certified organizations that do not want to undertake an unannounced FSSC 22000 and FSSC
Costco Module combined audit each year and intend to stay in compliance with Costco cancomplete a separate unannounced Costco Food Safety audit. The separate Costco Food Safety
audit shall be completed in the calendar year that the FSSC 22000 announced audit is delivered,and the audit duration for this separate Costco Food Safety audit is as per Costco requirements.
The separate Costco Food Safety audit does not need to be completed during the year that the
FSSC audit falls into the unannounced cycle if the FSSC Costco Module is audited together with the
FSSC unannounced audit.
Note that the separate Costco Food Safety audit is managed by Costco and not a module oraddendum offered by the Foundation. Please contact your Costco Food Safety
Contact/Representative if you require details on the separate Costco Food Safety audit.

4.6 AUDIT REPORTThe CB shall provide a separate written report for each audit to the Module. The report may becustomized by the CB but shall include sufficient objective evidence to confirm that all therequirements in the Module have been assessed, including a summary of the nonconformities
raised (where relevant) and meeting the requirements of Annex A of this document. It shall bereferenced in the “Audit Details” section of the FSSC 22000 audit report that the Costco Module
was combined with the FSSC 22000 audit.

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In addition to meeting the requirements of Section 4.9 of this Module, relating to uploading the
FSSC Costco Module to the FSSC Assurance Platform, the CB shall also upload a copy of the FSSC
22000 audit report and related FSSC Costco Module report to the Costco audit platform.
The FSSC 22000 audit report and FSSC Costco Module report shall be placed in a ZIP folder before
uploading to the Costco audit platform.

4.7 NONCONFORMITY MANAGEMENT
The same criteria, as defined in the FSSC 22000 Scheme, applies to any nonconformities identified
against the specific requirements of the Costco Module, including grading, timelines, and followup actions. With the exception that:••

For minor and major nonconformities if the timelines are not met, then conformance tothe Module will not be recommended.
For critical nonconformities then conformance to the Module will not be recommended,as suspension does not apply to the Module.

Where a systemic failure to meet the customer requirements of this Module is identified, anonconformity shall also be raised against the relevant clause of FSSC 22000 in addition to therelevant Costco clause.

4.8 CERTIFICATION DECISION PROCESSThe CB shall conduct a technical review and undertake a certification decision for all audits against
the Module, in conjunction with the review of the FSSC 22000 audit, to agree with the audit reportcontent and outcome, NCs (objective evidence and grading), and effectiveness of corrections andcorrective action plans. A positive certification decision for the FSSC 22000 audit is a prerequisite
for achieving conformance to this Module.
It remains the responsibility of the CB to ensure a proper and robust audit and certification
process.

4.9 ASSURANCE PLATFORM DATA AND DOCUMENTATIONThe Module report shall be uploaded to the FSSC Assurance Platform, together with the FSSC
22000 related audit, within 2 months of the last day of the audit. In addition, the CB shall indicate
in the Assurance Platform, under the Addendum section of the relevant audit, that the Costco
module was included as part of the FSSC 22000 audit. The same requirements relating to Data
Quality, as set out in FSSC 22000, apply.

5. REQUIREMENTS FOR CERTIFICATION BODIES
5.1 COMPETENCEThe CB shall follow the same requirements described in Annex C of ISO 22003-1:2022 for defining
the competencies required to conduct the audit and certification activities.
In addition, Technical Reviewers and Certification Decision Makers, are required to undertake thesame specific training as the auditors as per 5.1.1 below.
Records of training shall be maintained by the CB.
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5.1.1

AUDITOR REQUIREMENTS

Only FSSC 22000 auditors with the relevant (sub)category approval may conduct audits to the
Module. The auditor shall receive specific training on the requirements of the Module prior to
conducting any audits. Records of the training shall be maintained and uploaded in the FSSC 22000
Auditor register, under the maintenance tab, prior to commencing with Module audits.
The CB may define additional competency requirements in line with their procedures or
accreditation requirements.
A specific witness audit to the Module is not required for approval to audit against the Module.
Where an auditor does have approval to audit the Module, it would be preferred if the CB can
assign a 3-yearly witness audit which includes the Module, however, it is not mandatory.
The CB shall include the Costco Module as a specific element in the 3-yearly auditor performance
review during requalification of the FSSC 22000 auditor.

6. COSTCO SPECIFIC AUDIT REQUIREMENTS
Costco Specific
Audit Requirement(CSAR)

Costco Specific Food Safety Requirements

CSAR 1

Pest Control
The program must be administered by a licensed pest control operator,
and include a scheduled frequency of services, as well as a map
showing the location and type of all pest control devices. The map must
be updated as needed but at least annually.

CSAR 2

Supplier Approval
Operations must have a Supplier Approval Program in place to monitor
and evaluate all raw material (including primary packaging) suppliers. In
addition to FSSC requirements, the Supplier Approval Program shall at aminimum include:• A current list of all raw material (including primary packaging)
suppliers, including growers and harvest crews where applicable.
• Requirements for raw material (excluding food contact packaging)
suppliers to be operating under a food safety management system.
The system shall meet all applicable regulatory requirements.
• Requirements for food contact packaging suppliers to be operating
under a quality management system and a risk-based control plan.
The system shall meet all applicable regulatory and customer
requirements.
• A requirement for raw materials suppliers, including primary
packaging to be audited by a third party to a standard that verifies
implementation of GMP/GDP/GAP, HACCP / Preventive Controls /HARA, a traceability system, and a recall management plan. The
requirements shall have pass/fail criteria defined for the supplier’s
audits to maintain approved status.

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Costco Specific
Audit Requirement(CSAR)

Costco Specific Food Safety Requirements•

CSAR 3

Annual verification of the supplier’s audit.

Hand Wash Stations
Hand wash stations are appropriately located in the processing areasand include the following:• Hands-free water and towel operations (single-use or similar
drying services),• Liquid soap,• Warm water (within 15 seconds), and• Signage in languages appropriate for employees to understand.

CSAR 4

Glove Use
Costco has a “No Bare Hands” policy i.e., gloves must be used where
there is direct hand contact with ready-to-eat products regardless of therisk level.
Below are the additional Costco requirements for glove use:
• The facility must have a written procedure for the proper
handling and usage of gloves and must include verification
documentation.
• Reusable food-safe gloves must be washed and sanitizedfrequently – at a minimum, at the start, after breaks, and after
handling potential contaminants.
• If fabric gloves are used when hands are in contact with food,they need to be covered with an outer non-latex, powder-free
disposable glove.
• All other types of gloves are to be latex-free and powder-free.
• All gloves should always be clean and in good condition.

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Costco Specific
Audit Requirement(CSAR)

Costco Specific Food Safety Requirements

CSAR 5

Traceability
•
•
•

•
•

CSAR 6

Costco requires that suppliers show that traceability exercises
were conducted independently at least twice during the year.
The system must be able to account for 100% of the product in
a 2-hour timeframe.
Site must show that they have conducted separate trace
exercises for two of the three areas defined in the Costco
requirements:o Finished goodso Raw material/ingredientso Primary packaging
The third area should be the subject of the onsite auditorinitiated trace exercise.
Each exercise must be completed within a 2-hour limit andaccount for 100% of the selected sample.

Foreign Material Control
Operations must have a comprehensive foreign material control plan inplace for known and reasonably foreseeable physical hazard. In
addition to FSSC requirements the foreign material control plan at aminimum must include:• A glass and brittle plastic policy which maintains a map of glass andbrittle plastic in product zones and areas, verified at a defined
frequency.
• A policy that restricts the use of materials in product zones andareas that are not easily cleanable or prone to creating foreignmaterial contamination. These materials include – but are notlimited to - foam rubber, any type of carpet, wood, non-food grade
plastic, cardboard, tape, etc. Clothes, towels, and other cleaningmaterials that pose a risk of contamination or adulteration shall not
be used to remove dirt and debris from products. Workers must nothandle products in a manner that results in contamination or
adulteration.
• A mechanism for employees to report concerns that includes
specific language for foreign material contamination.
• Annual training on foreign material hazards for all employees at thefacility, including instruction on the mechanism employees can use
to report concerns.

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Costco Specific
Audit Requirement(CSAR)

Costco Specific Food Safety Requirements

CSAR 7Detection of foreign objects
All manufacturing operations must have a properly installed andcalibrated X-ray detection device for finished product, except in thefollowing circumstances:• Product texture, density, or chemical composition is such that it
limits the performance of the X-ray technology to an unacceptablelevel. These operations will be required to have a metal detector
installed as well as a letter from a subject matter expert confirmingthat Xray is not applicable.
• Shell Eggs, whole raw agricultural commodities, whole roasted
coffee beans, whole muscle meats, and packaging products will be
exempt from the X-ray requirement. The operation will need tomaintain current good manufacturing practices and prerequisite
programs to mitigate foreign material contamination.
• Operations that utilize a physical barrier (e.g., screen, filter, sieve)that is appropriately sized and placed will be exempt from the X-ray
device requirement. The operation will need to conduct integrity
checks at a defined frequency and maintain current good
manufacturing practices and prerequisite programs to mitigate
foreign material contamination.
All X-ray and metal detection devices must have a proper rejection
mechanism to segregate rejected products. Rejected products must be
physically controlled and have access restricted until evaluation by
designated personnel can be completed.
Operations must perform documented X-ray and metal detector
challenges at a defined frequency, but at a minimum:• At the start and finish of daily production/shift.
• At ≤ 2 (two) hour intervals during the production run.
• When changes in production batches occur.
• When changes in machine settings occur.
• After downtime for repairs.
Challenge materials must conform to the manufacturer’s
recommendations (e.g., metal, glass, plastic, wood, etc.) and reflect the
known and likely contaminants of the product and production process.
Where metal detection is deployed, Ferrous, Non-Ferrous, andStainless-Steel test pieces must be used. Facilities that have notinstalled a detection device by the time of their Costco Module audit will
receive an automatic audit failure for the Costco Module.

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Costco Specific
Audit Requirement(CSAR)

Costco Specific Food Safety Requirements

CSAR 8

Handling of potentially unsafe products
For products subject to the Costco Test and Hold Program, all productlots must remain within the supplier's control until satisfactory test
results are obtained. Additionally, all finished product lots that undergo
pathogen testing voluntarily, at buyer’s request, as required in productspecifications, or due to regulatory requirements must remain within
the supplier's control until satisfactory test results are obtained.
If pathogen testing is done on food contact surfaces, all product lots
processed over the swabbed surface(s) since the last validated
sanitation cycle shall remain within the supplier's control until
satisfactory test results are obtained.

CSAR 9Mock recall
All operations must conduct an annual mock recall to verify current
contact information and that the quantities received and distributed
through the next step in the item’s supply chain match what was
produced/distributed. The exercise may count towards one of the
traceability exercises; however, there needs to be evidence that thenext step up was contacted to verify current contact information andthe quantities received/distributed match what was
produced/distributed. The current contact information for any next stepup that was not part of the exercise shall be verified on an annual basis.

CSAR 10

Cleaning and Sanitation
All operations must have a written program in place to verify sanitation
effectiveness for food contact surfaces. The program should be basedon a risk assessment of the operation and validated and shall not rely
solely on visual checks for sanitation verification. Examples of
acceptable verification include ATP monitoring or swabbing for TPC(Total Plate Count).

CSAR 11Workwear and Protective Clothing
All persons must wear single use hairnet/facial hair coverings whenaround exposed products, regardless of risk level.

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Costco Specific
Audit Requirement(CSAR)

Costco Specific Food Safety Requirements

CSAR 12Pet Food Manufacturing (applicable to Category C only)
With the exception of products that are extruded, chopped, formed,
and cooked to the appropriate temperature under a verified preventive
measures plan, as well as any of the formulated biscuit style treats thatare baked, Costco requires that all whole muscle dog treats (chicken
jerky, pig ears, pizzles, fish jerky, etc.) and imported dog treats (allstyles) shall be irradiated.
Per Australian Standards for pet food, if the product has been
irradiated, the label must include the statement – “Must not be fed tocats”.

7. REFERENCES•

Costco Wholesale – Food Safety & Quality Audit Expectations for Costco Suppliers. Version
2.0 of 2023.

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ANNEX A: COSTCO MODULE CHECKLIST TEMPLATE
The module only addresses areas not specifically covered or not covered to the same extent as in
FSSC 22000. The Costco Module Report Checklist should always be read in conjunction with the
FSSC 22000 Audit Report. The same general principles as set out in Annex 2 of the FSSC 22000
Scheme also apply to the completion of the Module Checklist.

1.1 AUDIT DETAILS
Registered legal nameName of organization to be certified.

Location/Address

Full address (or other unique identification of site locationi.e., GPS, GLN etc. where a postal address is not available).

COID
Contact person

Name and function – if different to the FSSC 22000 audit

General description ofactivities
Scope of certification

Specific to the Module, but in line with the FSSC 22000 scope

FSSC 22000 reportreference

Record the date and type of FSSC audit delivered in order for the
Module report to be linked to the FSSC 22000 report.

Module Audit duration

Time spent auditing the Module in hours

1.2 AUDIT TEAM
Name

Function

Audit delivery

Date(s)Time

Auditor nameIncludes lead auditor,
auditor, translators, TE,
witnessor, trainees,
observers

i.e., remote/onsite

DD/MM/YYYY

08h00-17h00

1.3 SUMMARY OF COSTCO MODULE AUDIT FINDINGS# Critical nonconformities# Major nonconformities# Minor nonconformities

1.4 COSTCO MODULE AUDIT RECOMMENDATION
Recommended
Not recommended

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1.5 COSTCO MODULE NONCONFORMITIES#

Requirement
Reference(std., clause)1

For example:
CSAR 1

Nonconformity
Grading(Minor,Major,
Critical)NC
statement(incl objective
evidence)

Root Cause
Analysis(determine
why it arose)

Corrective ActionPlan(action to prevent
repeat; person
responsible; due date
for completion)

Correction(to address theimmediateissue)

Objective
Evidence
Reviewed(relating to thecorrection)

Acceptance ofcorrection andCAP(auditor anddate)

For example:
Minor

Provide aclear
statement of
the deviationfrom therequirement.

Completed byclientCompleted by client

Completed byclientIndicate
evidence
reviewed for thecorrection i.e.,
document nameand number

Auditor nameand date ofacceptance ofRoot cause
analysis, CAP,
correction, andobjective
evidence

Providedetailed
objective
evidence.
2
3
4

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1.6 COSTCO MODULE CHECKLIST
Costco Specific Audit Requirements

Conform

ClauseRequirement

CSAR 1

Pest Control

CSAR 2

Supplier Approval

CSAR 3

Hand Wash Stations

CSAR 4

Glove Use

CSAR 5

Traceability

CSAR 6

Foreign Material Control

CSAR 7Detection of foreign objects

CSAR 8

Handling of potentially unsafe products

CSAR 9Mock recall

CSAR 10

Cleaning and Sanitation

CSAR 11Workwear and Protective Clothing

CSAR 12Pet Food Manufacturing (applicable to Category C only)

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Yes

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No

Grade
N/A

Minor/Major/Critical

If No – detail NC
If N/A – provide
justification

NC #Costco Specific Food Safety Requirements Module

Summary of Costco Specific Audit Requirements:
Pest Control:
Supplier Approval:
Hand Wash Stations:
Glove Use:
Traceability:
Foreign Material Control:
Detection of foreign objects:
Handling of potentially unsafe products:
Mock recall:
Cleaning and sanitation:
Workwear and protective clothing:
Pet food manufacturing (applicable to Category C only):

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