FOOD SAFETY AUDIT EXPECTATIONS - WHOLESALE - LAST UPDATED: JUNE 1, 2018 - TraQtion

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FOOD SAFETY AUDIT EXPECTATIONS - WHOLESALE - LAST UPDATED: JUNE 1, 2018 - TraQtion
WHOLESALE

FOOD SAFETY AUDIT EXPECTATIONS

                                          LAST UPDATED: JUNE 1, 2018

© Copyright 2014. Costco Wholesale Corporation.

This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco
COSTCO       Wt4THF
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RE-AUDITS                                                                                                                                                                 11

      AUTOMATIC RE-AUDITS                                                                                                                                                 11

SHADOW AUDITS                                                                                                                                                             12

COSTCO HACCP/ PREVENTIVE CONTROLS REQUIREMENTS                                                                                                                            13

                           DEFINITION OF HACCP / PREVENTIVE CONTROLS                                                                                                      13

                           HACCP/ PREVENTIVE CONTROL TRAINING REQUIREMENTS                                                                                                13

                           HACCP/ PREVENTIVE CONTROL TRAINING RESOURCES                                                                                                   14

MICROBIOLOGICAL TESTING                                                                                                                                                   14

                           ENVIRONMENTAL SAMPLING PROGRAM REQUIREMENTS                                                                                                    14

                           SANITATION VERIFICATION - FRESH PRODUCE PACKINGHOUSE AND LOW AND MEDIUM RISK
                           PROCESSING FACILITIES                                                        15

                           FINISHED GOODS TEST AND HOLD REQUIREMENTS FOR PRODUCTS OTHER THAN FRESH
                           PRODUCE                                                                                                                                        15

                           SPECIFIC FRESH PRODUCE TEST AND HOLD REQUIREMENTS                                                                                              15

                           WATER TESTING REQUIREMENTS                                                                                                                     17

ALLERGENS                                                                                                                                                                 17

FOREIGN MATERIAL DETECTION                                                                                                                                                18

PEST CONTROL                                                                                                                                                              19

GENERAL GOOD MANUFACTURING PRACTICE REQUIREMENTS (ALL FACILITIES)                                                                                                         19

                           BARE HANDS CONTACT                                                                                                                             19

                           HAND SINKS                                                                                                                                     20

                           HAIR RESTRAINTS                                                                                                                                20

                           PRODUCE SPECIFIC GOOD MANUFACTURING PRACTICE REQUIREMENTS                                                                                      20

PRODUCT TRACEABILITY                                                                                                                                                      21

                           TRACEABILITY EXERCISE                                                                                                                          21

                           PRODUCT IDENTIFICATION                                                                                                                         21

COSTCO VENDOR REQUIREMENTS FOR SUPPLIERS                                                                                                                                  21

COSTCO APPROVED AUDIT COMPANIES                                                                                                                                           22

GLOSSARY                                                                                                                                                                  23

COSTCO FOOD SAFETY CONTACTS                                                                                                                                               25

Revised as of 6/1/18 and replaces all previous versions.                          3
© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
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AUDITS

AUDIT PURPOSE

The purpose of an audit is to gather accurate information concerning the overall food safety status of
current and potential vendors. This information is to be shared with appropriate members of Costco
Wholesale ONLY (Food Safety Vendor Audit Team and the buying staff).
The Food Safety Vendor Audit Team will use a vendor ’s audit( s) to determine what areas are in need of
improvement to meet Costco Standards. The buying staff will use the information as an aid in making
sound, intelligent purchases for our members. The results of this audit will not be used as a punitive
measure; rather, this audit will provide both the vendor and Costco Wholesale the opportunity for
continued improvement and enrichment.

AUDIT CONSIDERATIONS

All facilities that manufacture consumable products (e.g. food, beverages, supplements) or supply
consumable products or food contact packaging materials to Costco are required to have an annual food
safety Costco GMP, GAP Audit, or GFSI certification audit. All food-producing and primary packaging
facilities located in China are required to have a Costco GMP Audit or GAP Audit every six months and/or
a combination of a GFSI certification and a Costco GMP or GAP audit (two audits per year).
New suppliers to Costco with a food safety audit conducted in the past year may submit the
audit/certification document to Costco for review. A Corrective Action Plan (CAP ) must be included for
each deficiency. Upon review, Costco will determine if the vendor ’s audit/certification is acceptable or if a
new audit must be conducted. If the audit / certification is accepted, and it is from an audit company or
certification body not on Costco’s approved list, the supplier must choose one of the Costco approved
audit companies / certification bodies for their next anniversary audit (listed on page 22 ).

                                                                                                   -
Costco will only accept audits /certifications (including re audits) performed while the audit site is fully
operational, i.e. actively cultivating crops, harvesting crops, packing, processing, manufacturing, etc. If the
growing season is finished or if the facility is non-operational, an audit must take place within the first 30
days of the next growing season or facility production season. It is not required for suppliers to be
processing Costco items at the time of the audit. Flowever, the same process flow and equipment used to
produce Costco items must be in use. This information should be confirmed by the vendor and the audit
company during the scheduling phase, eliminating the error of an auditor arriving on site and these
processing conditions not being met. Vendors must schedule their audits during their normal production
season. Costco considers a facility that is not processing on the scheduled day of the audit to be “ dark ”
and therefore the audit cannot take place.

TYPES OF AUDITS ACCEPTED

                    o      GFSI Certification
                                         Group/Multi-Site
                                         Costco Addendum - although not a formal audit this document MUST accompany
                                         ALL GFSI audits.

Revised as of 6/1/18 and replaces all previous versions.                          4
© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
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All Group/Multi-Site Audits for Field-Packed product and Processing facilities must include the appropriate
Costco Produce Addendum at the same sampling rate as the certification program requirements.

COSTCO ADDENDUM

All GFSI Certification Programs are required to be accompanied by the applicable Costco Addendum.
The Addendum is completed to address items of concern to Costco that are not covered in the GFSI
Certification Programs. This document is for informational purposes only and has no impact on the GFSI
Certification Program outcome. Costco will expect that all addendum non conformances be addressed
with Corrective Action within 14 calendar days, and shall be posted to the appropriate Costco audit
database. Certification bodies are required to complete both the Certification Audit and the Costco
Addendum. If the Addendum is not completed, Costco will expect the CB to return to the site and
complete the Addendum at the CB’s expense. If a supplier cancels the addendum when one is required,
the CB will return to the site at the supplier ’s expense to have one completed.

COSTCO GMP AUDITS

Costco will only accept GMP Audits from Costco approved audit companies ( see page 22 ). The only
exception is for new suppliers who want to submit a current GMP audit for review by Costco Food Safety
Staff.

FOOD GMP AUDITS

All Costco GMP audits are required to be unannounced. The unannounced audit must be conducted 45
days on either side of their anniversary date. For example : An anniversary date of May 1 will have an
audit between March 15, and June 15 - a 90 day window. The March - June window becomes the
anniversary date range and audits will be performed during that time period each year.
Audit companies will contact suppliers to schedule audits within the 90 day timeframe and gather info on
any blackout dates. The purpose of requesting blackout dates is to eliminate an auditor arriving at a site
and not being able to conduct an audit. Costco views a blackout date as a date the plant will not be
operational or producing Costco product or like product on the same lines and equipment that is or will be
used to produce Costco items. Costco expects all other dates that the plant is operational as “ audit ready”
dates. Should the auditor arrive on a non-blackout date and your facility cannot complete an audit, the
audit will need to be rescheduled prior to the end of your 90 day time frame and you will charged the full
price of the audit. It is advisable to check with your audit company regarding their late cancellation policy.

Generally when a Costco GMP audit is conducted, it should be scheduled for one 8-10 hour day.
Depending on the size and scope of the facility though, the audit can take up to 1.5 to 2 days to complete.

COSTCO SMALL SUPPLIER AUDITS

Suppliers that have less than 25 employees and have never had a third party food safety audit are eligible
for a Costco Small Supplier audit. These audits are used as an introduction to the auditing process and
are to be performed on a one time basis. These audits will NOT be unannounced. After successful
completion of a small supplier audit , the vendor will be expected to conduct the unannounced standard
Costco GMP or a GFSI audit with Costco Addendum on their anniversary audit.

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© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
COSTCO
All GMP and Small Supplier GMP audits must be current (within the past calendar year). Costco requires
the Audit Company performing your audit to post the results in the appropriate Costco audit database
within 7 calendar days.

PRODUCE GAP AND GMP AUDITS

Costco will only accept GAP /GMP Audits from Costco approved audit companies with the Costco
Produce Addendum.
Produce audits are comprised of three different operational areas :
                     o     Grower Audit - A food safety assessment of a Ranch or Greenhouse environment. When
                           product is Field Packed it must follow the Field Pack Audit protocol- see below.
                     o     Flarvest Crew Audit - A food safety assessment of the Flarvest Crew practices and
                           environment. When product is Field Packed it must follow the Field Pack Audit protocol -
                           see below.
                     o     Facility Audits - Costco defines a “ facility audit ” as processing that takes place in one of
                           the following environments: Packinghouse, Processor, Coolers/Cold Storage and
                           Distribution Centers.

      FIELD PACK AUDIT

      All suppliers packing product in the field that are using final packaging with no further handling
      involved and shipping product directly to Costco from the field will be required to conduct an annual
      Grower and Harvest Crew Audit. If the operation grows multiple crops with different harvesting
      practices separate audits will be required. Field pack audits will be managed by Costco.

      FACILITY AUDIT

      As part of the Facility Audit, suppliers will be required to provide confirmation that the facility is
      monitoring all applicable Grower and Harvest Crew Audits for commodities being supplied to Costco.
      These audits must meet minimum passing score /grade per the Certification Program/audit
      requirement. Oversight of the corrective actions and re-audits, if necessary, is the responsibility of the
      facility. Vendors should have evidence they are monitoring their suppliers in order to keep them
      approved, as well as their methods for suspending and re-approving suppliers. Vendors should also
      show they have evidence there are supplier verification documents onsite to demonstrate that the
      ongoing approval requirements are being met (e.g., third party audits, certificates of analysis, reviews
      of supplier records, etc.). Any Certification Program or C.B. may be used as long as agreed with the
      facility.

      All GAP/GMP audits must be current ( within the past calendar year). Costco requires the Audit
      Company performing your audit to post the results in the appropriate Costco audit database within 7
      calendar days.

Revised as of 6/1/18 and replaces all previous versions.                          7
© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
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GFSI GLOBAL MARKETS PROGRAM ASSESSMENT

Costco will now accept the GFSI Global Markets Program Assessments under the following criteria:

PRIMARY PRODUCTION
Costco will accept the GFSI Global Markets Program Assessment for Primary Production as follows:
       o     Initial Assessment must meet Basic Level at 90% or above
       o     Second Year Assessment must meet Intermediate Level at 75% or above
       o     Third Year Facility must obtain full GFSI Certification or complete Costco requirements for
             GAP/GMP Audits.

MANUFACTURING

Costco will accept the GFSI Global Markets Program Assessment for Manufacturing as follows:

       o     Initial Assessment must meet Intermediate Level at 80% or above
       o     Second Year Assessment Facility must obtain full GFSI Certification or complete Costco
             requirement for GMP Audit.

Costco prefers the Assessments be conducted by a Costco recognized Certification Body/Audit
Company. In the event that one of these recognized organizations are not available to the supplier
Costco will require the Assessment Certification Body be accredited against ISO 65 and/or ISO 17021.
The Certification Body shall be accredited by an IAF member Accreditation Body which can be found on
the IAF website: www.iaf.nu. If this is the case, the supplier must notify Costco in advance to verify that
the Certification Body meets these requirements.

ADDITIONAL AUDIT TYPES

ANIMAL WELFARE AUDIT

A facility that is converting animals into food or has an on-farm environment (i.e. laying hens, dairy cattle)
is required to have an annual animal welfare or certification audit. Please refer to the Costco Animal
Welfare Audit Expectations Document for further information.

DISTRIBUTION CENTER / WAREHOUSE AUDIT

Costco will accept a Distribution Center / Warehouse Audit from a Costco approved Certification
Body/Audit Company. Costco will accept either a GFSI Certification or the Audit Company’s unique
Distribution Center / Warehouse Audit form.
Packaging Audits (primary packaging ie. bag film, clam shell containers)
Costco will accept a Packaging Audit from a Costco approved Certification Body/Audit Company. Costco
will accept either a GFSI Certification or the Audit Company’s unique Packaging Audit form.

Revised as of 6/1/18 and replaces all previous versions.                          8
© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
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cGMP AUDIT

(for supplements/pharmaceutical industry )
Costco will accept either a cGMP Audit from a Costco approved Certification Body/Audit Company or the
Audit Company ’s unique cGMP Audit form.

AUDIT DATABASES

EFA

                                                                                                -
Beginning in 2018, Costco is transitioning into its own in house database management system known as
EFA ( Enterprise Facility Audit ). This database will be used to manage audits and corrective actions for all
food suppliers except for Fresh Produce. All such facilities supplying Costco are required to register on
the Costco EFA System. Suppliers will be sent invitations to be credentialed in the EFA System. Once
credentialed please use the below link to access the system.
 https://bpm.costco.com/ProcessPortal/login.jsp
Suppliers should be directed to the online form to request a food safety audit.
https: //docs.google.eom/forms/d/ e /1FAIpQLScUisdLuClbndUiyFkmgeMM2CNQN2 YsFAXPhG_MZF1RQIz
NrA /viewform?usp=sf_link

Facility information should be filled out completely. As audits are completed, CB’s are required to upload
the detailed audit (GMP, Small Supplier, Distribution/ Warehouse and Packaging audits) and summary
results of certification ( GFSI) to EFA within 7 calendar days. Each facility is to post their CAP (corrective
action plan) within 14 calendar days of the audit report being posted to EFA. For Certifications, the
complete audit and the certificate will be posted to EFA upon issuance of the certificate. GFSI audits will
follow the Certification Program owners’ timetable for posting.
The most current Costco Food Safety Audit Expectations and Addendum documents can be obtained by
contacting fsa@costco.com.

TRAQTION

Although Costco is currently transitioning to our privately managed EFA (Enterprise Facility Audit)
database, those suppliers who have not been directly contacted by Costco will continue to register in
TraQtion as they have in the past. If you are a new Costco supplier or are uncertain of which database
you should register your facility under, please email fsa @costco.com.

Costco is using TraQtion to manage audits and corrective actions for all food suppliers except for Fresh
Produce. All such facilities supplying Costco are required to register on the TraQtion Costco Food Safety
Portal at www.TraQtion.com /costcofood. Each facility should renew the registration on an annual basis
before their food safety audit. For information about TraQtion, email to support@traqtion.com.
Facility registration should be filled out completely to include all products sold to Costco. As audits are
completed, CB’s/Audit companies are required to upload the detailed audit (GMP, Small Supplier,
Distribution/Warehouse and Packaging audits) and summary results of certification ( GFSI) to TraQtion

Revised as of 6/1/18 and replaces all previous versions.                          9
© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
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within 7 calendar days. Each facility is to post their CAR (corrective action report) within 14 calendar days
of the audit report being posted to TraQtion. For Certifications , the complete audit and the certificate will
be posted to TraQtion upon issuance of the certificate.
GFSI audits will follow the Certification Program owners’ timetable for posting.

AZZULE

Costco is using Azzule Systems to manage Fresh Produce audit documents, including corrective actions.
Suppliers must contact their Certification Body/Audit Company to have the required information uploaded
to Azzule. As audits are completed, they will be uploaded by the Certification Body/Audit Company to
Azzule and from there will be transferred by the suppliers using the SCP (Supply Chain Program) to the
dedicated Costco section within Azzule. As always , suppliers are responsible to maintain complete
transparency on Azzule, for their entire supply chain of products sold to Costco.
The most current Costco Food Safety Audit Expectations and Addendum documents can be found
through this link on the Azzule website:
http: //www.azzule.cQm /services/costcoaddendumsandexpectations.aspx
The contact email and telephone number for Azzule is: support@azzule.com and +1 805-354-7127.

AUDIT SCORING

Acceptable audits for Costco must meet the below scoring criteria:
Costco GMP Audits - a minimum score of 85 in each of the 10 categories. No critical findings                                                                 .
Costco Small Supplier Audits - a minimum score of 75 in each of the 9 categories. No critical findings.
GFSI Certifications - Total score of 85 for SQF, IFS and Canada Gap.
                                       Total grade of B or above for BRC.
                                       Total minimum score of 90 PrimusGFS.
                                       Successful certification FSSC 22000 and GlobalGap (documents are not currently
                                       scored).

The table below pertains to Costco GMP and Small Supplier audits only.

  Score                                                                Rating                                              Action
  98 - 100%                                                            Excellent                                            No Corrective Actions required

  85 - 97%                                                             Good                                                Corrective Actions required

  < 85% in any category for GMP                                        Needs Improvement /Failed                           Corrective Action and Re-Audit
  < 75% in any category Small Supplier                                                                                     Required

Revised as of 6/1/18 and replaces all previous versions.                          10
© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
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All Countries
         o      Failure to take corrective actions when critical limits are not met.
         o      Employees with obvious sores, infected wounds or other infectious illnesses are allowed to have
                direct contact with exposed food, primary packaging products or production / storage areas.
         o      Product contamination is observed, (e.g. condensate dripping on exposed product )
         o      Food allergens are present and an allergen control program has not been developed.
         o      A documented SSOP (Standard Sanitation Operating Procedures) Program has not been
                established and implemented.
         o      A documented Food Safety Plan ( GMP) has not been established .
         o      A written pest control program has not been established, including a designated pest control
                operator, frequency of service and a current map showing the location and type of all pest
                control devices; internal and external.
         o      Facility water is not from a potable source.
         o      Water potability is not tested by a certified laboratory annually for municipal water sources and
                quarterly for well water. Samples are to be drawn from various sites throughout the facility and
                records are maintained.
         o      Finished products not properly coded for traceability.
         o      Evidence of decomposed pests anywhere in the interior of the facility, including in pest control
                devices.
         o      Evidence of pests to include but not limited to insects, spiders, rodents, amphibians, mammals
                or birds, or any pest excreta on or in any food ingredient , food contact surfaces, product or
                packaging material.

U-S- Only

         o      The required registration for the Bioterrorism Regulation cannot be verified. (This applies to
                vendors that manufacture and import to the U.S. only )
         o      A Hazard Analysis has not been established per FDA - Preventive Controls requirements. (This
                applies to vendors that manufacture in, and import to the U.S. A. only )

SHADOW AUDITS

Auditor evaluations are a key component of Costco’s Food Safety Auditing Program because they enable
us to gauge auditor competency. This process, known in the industry as a Shadow Audit, takes place
during audits at our suppliers’ facilities. During a shadow audit, a member of the Costco Food Safety staff
will accompany the auditor for the entire audit day (s). The Costco employee will complete a written
auditor evaluation, which will be submitted to the CB (Certification Body ) after the audit is concluded .

The Costco evaluator will also take notes during the audit on any observations may have been
overlooked in the audit , though these are not discussed until after the auditor is finished with the closing
meeting. At no time are the Costco observations used for audit purposes. Any non-conformances
observed by Costco staff will not be included in the audit report but will require a corrective action
response. Vendor cooperation in this process is greatly appreciated.

Revised as of 6/1/18 and replaces all previous versions.                          12
© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
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HACCP/PREVENTIVE CONTROL TRAINING RESOURCES

             HACCP TRAINING

             NOAA HACCP
             https://www.fisheries. noaa .gov /natiQnal /seafQQd-CQmmerce -certificatiQn /seafQQd-inspectio
             n-haccp-training-course-details

             HACCP Alliance
             http://haccpalliance.org /

             HACCP Training
             http://www.haccptraining.org/

             Resources for Food Safety Program Development
             http://producesafetyalliance.cornell.edu/

             PREVENTIVE CONTROLS TRAINING

             Food Preventive Controls Alliance

             https://www.ifsh.iit.edu/fspca

             Safe Food Alliance

             https://safefoodaNiance.com

             Additional References and Resources can he found at:

             www.traqtion.com /costcofood

             www.azzule.com

 MICROBIOLOGICAL TESTING

ENVIRONMENTAL SAMPLING PROGRAM REQUIREMENTS

Costco vendors that are supplying Kirkland Signature products or high risk items must have a
documented Environmental Sampling Program designed to detect pathogens of concern for each facility
producing for Costco.
The Environmental Sampling Program should be robust and must include sample frequency, site
selection, test results and corrective actions. Sampling frequency and site selection must be based on a
risk assessment of the facility and product involved. If positive test results are obtained

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© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
COSTCO
(presence/indicator of target organism), full details of the cause analysis, corrective actions and retesting
results must be available for review by Costco Food Safety upon request.
The following items are an example of what are identified as high risk:
        o      Fresh produce vendors with production and storage facilities where water is introduced ( wash
               step , high humidity storage , wet cleaning processes, etc.)
        o      Vendors producing foods that are ready to eat, foods that don't need any further cooking, or
               foods that provide a place for bacteria to live, grow and thrive (i.e. sliced lunch meats, dairy
               products, cooked meat and fish, frozen fruits and vegetables, cut salad mixes, baby leaf salads ,
               cut fruit, prepared vegetable trays , and cantaloupe).

SANITATION VERIFICATION - FRESH PRODUCE PACKINGHOUSE AND LOW AND MEDIUM RISK
PROCESSING FACILITIES

There must be a written program in place to verify sanitation effectiveness for food contact surfaces . The
program should be based on a risk assessment of the operation and validated. Examples of acceptable
verification include ATP monitoring or swabbing for TPC (Total Plate Count).

FINISHED GOODS TEST AND HOLD REQUIREMENTS FOR PRODUCTS OTHER THAN FRESH
PRODUCE

Costco vendors that are supplying high risk items must have a documented Finished Goods Microbial
Test and Hold Program in place to detect pathogens of concern.
The following items are an example of what are identified as high risk:
                     o     Vendors producing foods that are ready to eat, foods that don't need any further cooking,
                           or foods that provide a place for bacteria to live , grow and thrive (i.e. sliced lunch meats,
                           dairy products, cooked meat and fish, and frozen fruits and vegetables).
The Finished Goods Microbial Test and Hold Program should include a robust sampling plan developed
by the food safety staff that is designed to detect the organisms of concern.
An example of an appropriate sampling plan in a high risk ready to eat food processing facility would
include at a minimum an N=60 sampling plan. The sampling plan should utilize a grab sample with hourly
composite sampling and have appropriate lot definition with hourly test results.
The following references may provide additional information and assistance in the development of an
appropriate microbiological sampling and testing program (These resources are not all inclusive):
                     o     ICMSF (International Commission on Microbiological Specifications for Foods)
                     o     (2005) Microorganisms in Foods , 6, Microbial Ecology of Food Commodities, Kluwer
                           Academic/Plenum Publishers, New York , USA
                     o     ICMSF (International Commission on Microbiological Specifications for Foods)
                     o     (2002 ) Microorganisms in Foods, 7, Microbiological Testing In Food Safety Management,
                           Springer, New York , USA MIL Standard 105

SPECIFIC FRESH PRODUCE TEST AND HOLD REQUIREMENTS

Costco has a test and hold policy in place for all ready-to-eat and at-risk produce. This includes items
such as, but not limited to, cut salad mixes , baby leaf salads , cut fruit, and prepared vegetable trays.

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© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
COSTCO
Costco considers cantaloupe, either cut or whole, at-risk produce. Costco does not consider whole fruit
ready-to-eat produce.

Costco specifications for ready-to-eat and at-risk produce are as follows:

  Bacteria of Concern                                                Target                                                Maximum Level

  Total Plate Count (TPC)                                            < 100,000 cfu/ gram                                   1,000,000 cfu/gram

  Generic E. coli
COSTCO       Wt4THF10mg/kg
                    o      Canada : Crustacean Shellfish, Egg, Fish, Milk , Peanut, Soy, Tree Nuts, Wheat or
                           Triticale, Sulfites ( great than or equal to 10mg/kg), Molluscan Shellfish, Mustard, Sesame
                    o      EU/UK/lceland: Crustacean Shellfish, Egg, Fish, Milk, Peanut, Soya, Tree Nuts, Sulfites
                           >10 mg/kg, Cereal Grains w/ Gluten, Molluscan Shellfish, Mustard, Sesame, Celery,
                           Lupin.
                    o       Mexico: Crustacean Shellfish, Egg, Fish, Milk, Peanut, Soy, Tree Nuts , Cereal Grains w/
                           Gluten, Sulfites (> 10mg/kg).
                    o      * Australia : Crustacean Shellfish, Egg, Fish, Milk, Peanut, Soy, Tree Nuts, Wheat,
                           Sulfites (great than or equal to 10mg/kg ) , Cereal Grains w /Gluten, Sesame, Lupin,
                    o      China : Crustacean Shellfish, Egg, Fish, Milk , Peanut, Soy, Tree Nuts, Wheat, Cereal
                           Grains w/Gluten
                    o      Japan : Crab, Shrimp/Prawn, Egg, Milk , Peanut, Wheat , Buckwheat
                    o      **Korea : Crab, Shrimp/Prawn, Egg , Mackerel, Milk , Peanut, Pine Nut , Soybean
                           (including oils) , Wheat, Buckwheat, Peach, Pork, Tomato, Sulfites (> 10mg/ kg), Walnuts,
                           Chicken, Beef , Squid, Molluscan Shellfish

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                    o      Taiwan: Crustacean Shellfish, Conch, Eggs, Milk, Goats Milk , Peanuts, Mango, Kiwi,
                           Soy, Tree Nuts, Sulfites (> 10mg/ kg), Cereals containing Gluten, Sesame, Fish [salmon,
                           mackerel, codfish, Dissostichus eleginoides (Yuan xue), Reinhardtius hippoglossoides
                           (Bian xue)], Mollusks, Buckwheat, Celery, Lupin, Mustard, and Sunflower Seeds
                           (effective 7. 1.2019)

*Australian product: if a food is or includes as an ingredient royal jelly, the following warning statement is
required: This product contains royal jelly which has been reported to cause severe allergic reactions and
in rare cases, fatalities, especially in asthma and allergy sufferers ’.

**“ May  contain” statements are mandatory for Korean products that have a shared manufacturing
process (workers, utensils , production line, storage of ingredients, etc.) with allergens, regardless of
sanitation procedures.

FOREIGN MATERIAL DETECTION

Costco requires potential physical hazards to be controlled using a foreign material detection device. If
Processors do not have a foreign material device in place they must have completed a risk assessment to
show why the process is low risk and a device is not warranted. If foreign material controls are not in
place at the time of the audit and no risk assessment has been completed the auditor, in conjunction with
Costco personnel, will determine the risk of the process. If the risk is considered low, a device will not be
required. If the risk is considered medium to high, the site will be required to implement foreign material
controls or install a foreign material detection device- preferably x ray- as soon as possible. This will be
deemed a required corrective action. In the event you have been required to install a foreign material
detection device, Costco will expect photo documentation of your installed device and your Foreign
Material Control Plan to be uploaded to EFA, TraQtion, or Azzule within 120 days. An automatic audit
failure will occur if at the time of an anniversary audit or re-audit, for facilities operating without
foreign material detection (if this requirement had been previously communicated by Costco
during the initial site audit).
Costco requires facilities to document regular checks at no more than 2 hour intervals to confirm the
foreign material detection device is operating correctly. When checking metal detection devices, the
auditor will ask plant staff to demonstrate that all devices in the facility are working effectively at their
operating level of sensitivity using certified test pieces for all three contaminants: Ferrous (iron ) ,
Non-Ferrous (non-iron), and Stainless Steel. For facilities using X-ray devices, challenge contaminants
shall be in accordance with manufacturer's recommendations i.e. glass, plastic, wood and must be used
for each X -ray device.
Costco will expect all foreign material devices to be challenged by the auditor during the audit regardless
if they are being used for Costco product or not. On the rare occasion when the device count exceeds 5
units , Costco will expect all 5 devices be challenged and a minimum of 30% of remaining devices be
checked.
All foreign detection devices must have a proper rejection device i.e. belt stops, air-jet etc. A written
procedure must be in place to control product rejected by a foreign material detection device and to
segregate that product from general production. This action is to be documented.

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Certain industries may be exempt from the requirement to have foreign material devices ( i.e. shell eggs,
any fluid processing, whole muscle meat processors, whole raw agricultural commodities ( RACs) that are
not processed.)

When adding or replacing equipment for foreign material detection, Costco would like all suppliers to
                      -
consider an x ray device, as this technology can detect physical hazards that a metal detector cannot.

PEST CONTROL

Pest control programs must be developed and monitored by licensed and certified pest control personnel.
In the case of a country without a licensing requirement, pest control personnel must be trained and have
a written protocol to demonstrate their understanding of pest control (as it applies to food safety).

A written integrated pest management (IPM ) must be established. The IPM should include information
about the pest control operator (PCO*) and include the scheduled frequency of service. A current map
(updated at least annually ) showing the location and type of all pest control devices (internal and external)
is also required. The program should outline responsibilities for both in-house personnel and contractors
( *can be an internal PCO or a contracted PCO). The program is to cover the facility, inside and out, and
storage areas for product and packaging. Pest control devices, including Insect Light Traps, are located
away from exposed food products, packaging and raw materials. Bait stations are properly tethered to
the ground or building and randomly checked by auditors unless prohibited by regulation. All pest control
devices must be identified with placards.

Bait stations and other pesticides are limited to outside use unless country laws require otherwise. Interior
devices i.e. tin cat or ketchalls must be placed on both sides of all doors leading to exterior of the facility
and properly identified with placards unless country laws require otherwise. In the case of a country
without a licensing requirement , pest control personnel must be trained and have written protocol to
demonstrate their understanding of pest control as it applies to food safety. Monthly trend catch records
must be maintained if facility is operating in house pest control.

GENERAL GOOD MANUFACTURING PRACTICE REQUIREMENTS ( ALL FACILITIES )

BARE HANDS CONTACT

Costco has a “ No Bare Hands” policy- i.e. gloves must be used where there is direct hand contact with
ready-to-eat products (all risk levels). The facility must have a written procedure for the proper handling
and usage of gloves and must include verification documentation. Reusable rubber gloves must be
washed and sanitized frequently, after breaks, and/or 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. They should
always be clean and in good condition.
Where it can be demonstrated, through scientifically sound validation studies , that the wearing of gloves
is impractical or less hygienic than bare hands, Costco may grant an exception to the glove requirement.
These are rarely issued, and are only granted when the product , processes, risk-level, and validation
evidence support this.

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HAND SINKS

Hand sinks must be available inside restroom facilities for use after using the restroom and also near the
workers ’ entrance to the processing area for use prior to starting work , after a break, or any time hands
become contaminated.

Hand sinks must be convenient and allow employees to go directly to their work-station without
contamination. Processing area hand sinks must be hands free, including water and paper towels.

Hand wash stations must have warm water, soap, hands free towels or suitable drying devices, and a
waste container. Hand wash signage must be posted near the station and in languages appropriate for
workers to understand.

HAIR RESTRAINTS

All employees must wear a hairnet when working around exposed product. If workers have facial hair,
Costco requires that all facial hair be covered when processing Costco product. Beard nets are to be
worn and will cover both beard and moustache. Costco does not view a ball cap as a hair cover or hair
restraint. If a ball cap or other head covering is worn, it must be covered by a hair net. If head covering                                                        -
( i.e. sunhat ) is to large to be covered by a hair net, a hair net MUST be worn underneath the head
covering.

PRODUCE SPECIFIC GOOD MANUFACTURING PRACTICE REQUIREMENTS

A minimum of one working field sanitation unit for each 20 employees, to include a toilet and a hand wash
station, is required. Toilet and hand washing facilities must be within a 5 minute walking distance for all
employees. Driving distance will not be considered. Hand wash stations should be located outside
portable restroom facilities in order for hand washing activities to be observed by supervisors.
Cloths , towels and other cleaning materials that pose a risk of contamination and/or adulteration are not
used to remove dirt and debris from product. Workers should not handle product in any way that may
cause contamination or adulteration.

Picking bags, gloves, knives and aprons must be covered by equipment storage & control procedures and
should be on a documented cleaning schedule. The entity is responsible to see that cleanliness and good
repair of equipment is maintained. Harvesting equipment must be on a documented cleaning and
sanitizing program.
With the exception of commodities where using wood is the industry standard, product must not come in
contact with surfaces that cannot be cleaned properly or would lend themselves to potential foreign
material contamination. Such items include but not limited to the following: foam rubber, any type of
carpet, non-food grade plastic, cardboard, tape etc.

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Costco does not allow drinking water ( or any beverage) in any container, on the packing line or
processing floor ( U.S. and Canada Requirement Only ).

PRODUCT TRACEABILITY

TRACEABILITY EXERCISE

For year round operations, Costco will require that suppliers show that traceability exercises were
conducted twice during the year in two of the following three areas: finished good item, raw ingredient,
and primary packaging. For the area not covered during the two previous exercises, it will be the subject
of an onsite exercise initiated by the auditor. The on-site traceability exercise will be used to assess the
effectiveness of the product recall program. The traceability exercise program must include the
distribution of specific product lots, raw ingredients , and primary packaging. The exercise will be
conducted on a random item chosen at the auditor ’s discretion (the scope will include one step forward
one step back capability ). If the facility is not yet producing for Costco, an item similar to what would be
supplied to Costco should be chosen. The system must be able to account for 100% of the product in a 2
hour timeframe.

Companies with corporate generated recall systems in place need only provide the auditor with a copy of
their program and a sample mock recall or trace back exercise. For non year-round operations , Costco
requires a mock recall/traceability exercise once a year in addition to having one during their Food Safety
Audit.

PRODUCT IDENTIFICATION

At a minimum, all product sold to Costco must be marked with a use-by, sell by or best before date that
can be used for traceability / recall purposes. Produce items should also include a packed on date or
scannable barcode that can provide traceability recall information. Julian code dating is not acceptable.

COSTCO VENDOR REQUIREMENTS FOR SUPPLIERS

Processing facilities must have an Approved Supplier Program in place to approve and monitor their
suppliers for all raw materials, ingredients and primary packaging. Costco Vendors must have a current
(within one calendar year) third party food safety audit with HACCP Certification, traceability exercise and
a product specification sheet which includes product requirements, labeling and code dates for each
supplier. Raw material and ingredient suppliers must be operating under a HACCP/PREVENTIVE
CONTROLS program.

Packaging facilities producing primary packaging must have a documented monitoring program to
evaluate packaging compliance to specifications, including a method to identify specific lot numbers and a
third party audit.

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© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
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CB - Certification Body or Audit Company. A provider of certification services, accredited to do so by an
authoritative body.

                                                                                    -
Current Good Manufacturing Practice (cGMP) cGMPs provide for systems that assure proper design,
monitoring, and control of manufacturing processes and facilities. Primarily used in drug and supplement
manufacturing.

                                         -
Cooling/Cold Storage This type of facility is where they are not only receiving and storing finished
goods but performing some kind of pre-cooling and/or cooling activities. In this type of facility, no packing
or processing activities are being performed, if so, a different type of facility operation shall be used. A
Cooling/Cold Storage facility covers the activities involved in the Storage & Distribution Center type.

                                  -
Corrective Action Action to eliminate the cause of a detected nonconformity or other undesirable
situation. Corrective action shall include:
a ) Determine / document any immediate action required / taken
         i. Determine the cause of the problem
         ii. Evaluate action needed on the identified cause
         iii. Determine if the problem exists elsewhere in the system and implement actions needed

b) Document the actions taken and the results of the action taken.
       i. Review/verify and document effectiveness of action taken with objective evidence.

Environmental Monitoring Program (EMP) - a program which includes pathogen or indicator swabbing
as appropriate to detect risk in the sanitary conditions in the processing environment. A verification of the
effectiveness of the pathogen controls that a management facility has in place for high risk foods.

              -
Facility The site’s premises at its street address. The production, manufacturing, or storage area where
product is produced, processed, packaged, and/or stored, and includes the processes , equipment,
environment, materials and personnel involved. The facility must be managed and supervised under the
same operational management. The facility is the site audited during an on site audit (refer to “ site” ).                    -
Field Packed Commodities                          - Product packed in the final packing unit in the field (i.e. clamshell, cartons
wrapped product etc.).

                            -
Food Allergen a protein or modified protein found in a food with the potential to cause an allergic
reaction in people as a result of consumption . See Allergen section for specific allergen by country list.

                           -
Food Defense As defined by the US Food and Drug administration, the efforts to prevent intentional
food contamination by biological, physical, chemical or radiological hazards that are not reasonably likely
to occur in the food supply.

Food Safety Modernization Act (FSMA) - U.S. Food Safety Act passed into law in 2011. The purpose
of the Act is to focus on prevention of foodborne illness rather than reacting to outbreaks of foodborne
illness. The Act contains 7 rules: Preventive Controls for Food for Humans; Preventive Controls for Food
for Animals; Sanitary Transport of Human and Animal Food; Produce Safety; Foreign Supplier
Verification; and Accredited Third-Party Certification (used for the Voluntary Qualified Importer Program
( VQIP)).

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                                                                -
Good Agricultural Practices ( GAP) Food safety practices for farm activities related to risk mitigation of
water, soil amendments , land use (previous and adjacent ), animal access (domestic/wild), equipment,
tools and buildings, worker health & hygiene practices

                                                                     -
Good Manufacturing Practices (GMP) The combination of management and manufacturing practices
designed to ensure food products are consistently produced to meet relevant legislative and customer
specifications.

              -
HACCP Hazard Analysis Critical Control Point , a system that identifies evaluates and controls hazards
which are significant for food safety.

                        -
Harvest crew A crew of harvest personnel under common management.
Hazard Analysis                - A system that identifies, evaluates and controls hazards which are significant for food
safety.
High Risk Product - Food or food product with known attributes for microbiological growth, physical or
chemical contamination, or which due to a process type may allow for the survival of pathogenic microbial
flora or other contamination which, if not controlled, may contribute to illness of the consumer. It may also
apply to a food that is deemed high risk by a customer, declared high risk by the relevant food regulation
or has caused a major foodborne illness outbreak.
PCQI       -a
            qualified individual (Ql) who has successfully completed training in the development and
application of risk -based preventive controls at least equivalent to that received under a standardized
curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop
and apply a food safety system.

                                                  -
Preventive Action/Controls Action or control to eliminate the fundamental, underlying root cause) of a
detected nonconformity and to prevent recurrence.
Produce Safety Rule                       -
                          rule establishes science-based minimum standards for the safe growing,
harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is part
of the FDA Food Safety Modernization Act.

                                -
Risk Assessment The identification, evaluation and estimation of the levels of risk involved in a process
to determine the appropriate controls

Supply Chain Program (SCP)                                  -
                                   Program operated by Azzule Systems to connect suppliers to
customers. Allows suppliers to manage food safety information, to include food safety audits, and share
with customers of their choosing.

COSTCO FOOD SAFETY CONTACTS

AUSTRALIA CONTACTS
Name                                          Title                                 Phone                                     Email
Ellie Parsa                                   FS/RD Manager                         011-61-2-9805-3808                        eparsa @costco.com.au
Puja Shrestha                                 Food Compliance                       011-61-2-9805-3838                        pshrestha@ costco.com.au
Nicole Hendieh                                Food Compliance                       011-61-2-9805-3824                        nhendieh@costco.com.au

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© Copyright 2014. Costco Wholesale Corporation. This document is proprietary to Costco Wholesale and should not be distributed without express permission from Costco .
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