PRODUCT RECALL & RECOVERY POLICY & PROCEDURES · 2020-02-15 · 3 3 Product Recall & Recovery...

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POLICY & PROCEDURES 2018 CONFIDENTIAL & PROPRIETARY – FOR US FOODS ® USE ONLY 2018 US Foods, Inc. PRODUCT RECALL & RECOVERY

Transcript of PRODUCT RECALL & RECOVERY POLICY & PROCEDURES · 2020-02-15 · 3 3 Product Recall & Recovery...

Page 1: PRODUCT RECALL & RECOVERY POLICY & PROCEDURES · 2020-02-15 · 3 3 Product Recall & Recovery Policy and Procedures • ®At US Foods , our priority is providing safe, quality products

POLICY &PROCEDURES

2018

CONFIDENTIAL & PROPRIETARY – FOR US FOODS® USE ONLY 2018 US Foods, Inc.

PRODUCT RECALL & RECOVERY

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2 Table of Contents

Product Recall & Recovery Policy and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Recall & Recovery Corporate Contact List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Classifying Recalls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Definitions of Product Recall & Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

General Information on Product Recall & Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

BellTower and DC Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Instant Recall – Key Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Initiation of a Recall or Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Notification of Recall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Request for Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

DC Action and Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Response Times for Product Recall and Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Notifying Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Disposition of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Recall Contact Lists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Post-Recall Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Billing for Recall Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Billing for Product Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Follow-Up with Compliance Checks on Recall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Training on Product Recall and Recovery Policy and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Mock Recalls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

Mock Recall Summary Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Instant Recall Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Product Recall and Recovery Flow Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

CRT Action on Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

DC Action and Response on Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Multi-Unit Customer-Initiated Recalls & Product Recoveries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Customer-Controlled Brands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Centralized Cost Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Regulatory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

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33Product Recall & Recovery Policy and Procedures

• At US Foods®, our priority is providing safe, quality products at a fair price with excellent customer service . Occasionally, products that we sell and distribute may pose a health risk if consumed or may not be of the intended quality . If this type of situation occurs, US Foods will react quickly to ensure that any product not meeting our safety and quality standards is removed from distribution .

• Conducting a Class I or II Recall is a top priority in this company and takes precedence over all other company business . All other classifications of product recovery are important, but not as critical as a Class I or II Recall .

• Once notified by a vendor, US Foods will conduct all product recall and recovery activities in an expedient and efficient manner . Recalled or recovered products will be rapidly identified, segregated, placed on hold and either destroyed by or retrieved from US Foods locations as needed . Disposition of recalled products will be determined by considering not only the vendor’s direction but also the impact on our operations .

• Recalls and recoveries are normally classified by vendors based on the food safety or quality risk they present . However, the Corporate Recall Team (CRT) will occasionally make the determination that a recall should be handled with greater urgency than indicated by the vendor . The recall and recovery procedures contained herein reflect the urgency of the risk associated with the recall or product recovery .

• The vendor initiating the recall or product recovery is required to assume payment for all expenses associated with any level of product recall and recovery activities . Vendors are expected to pick up recalled and retrieved product at US Foods warehouses within two weeks of receiving a pick-up request .

• All DCs will provide and maintain a DC recall team in the instant recall system . The DC recall team will ensure that all DC team members are aware of the Product Recall & Recovery Policy and Procedures and how their jobs are affected by them .

• Refresher training by the CRT on Product Recall & Recovery Policy and Procedures to all applicable DC associates is required annually .

• While Customer Service Teams no longer contact customers on behalf of a recall, they are required to know that a recovery is happening and to direct the customer to the appropriate website . They will not report for the customer, though they can report inventory or email a link containing the recall or recovery information directly to the customer .

• DCs are responsible for complying with specific customer recall requirements (national or government accounts) and may need to vary their recall activities to accommodate these specific procedures .

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Group: [email protected] Recall Cell Phone: 847.226.0584

Recall and Recovery Corporate Contact List

Classifying RecallsDepending on the severity of the problem, classification of the product recall and recovery will vary. The United States Food & Drug Administration (FDA) and United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) have defined recalls based on health risks. Generally, the vendor or manufacturer makes the decision to initiate recovery of product from the market or pull the product back from distribution. The vendor or manufacturer must classify the recall and recovery.

In other instances, the US Foods® Food Safety and Quality Assurance (FSQA) department may make the determination to recover the product from the market based on food safety or regulatory reasons. When FSQA dictates recovering product from the market, the recovery is referred to as a Directive.

Definitions of Product Recall & RecoveryType Definition Examples

Class I Recall A Class I recall involves a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death.

Product is or potentially is contaminated with a pathogen or may be undercooked (if it is a Ready to Eat item).

Class II Recall A Class II recall involves a potential health hazard situation in which there is a remote probability of adverse health consequences from eating the food.

Undeclared Yellow #5 and #6.

Class III Recall A Class III recall involves a situation in which eating the food will not cause adverse health consequences.

Product was placed in the wrong box or case.

Directive A product recovery initiated by US Foods FSQA that may or may not be a health hazard and occurs if vendor is unwilling to take action, or a product has been identified but the source is unknown.

Fish item is found to be a different species than what is labeled on the case, or the government issues an alert advising consumers to avoid a product.

Market Withdrawal

A situation where the product is not a health hazard but needs to be removed from sale for quality issues. Customers may or may not be contacted to retrieve product.

Product (biscuit dough) doesn’t rise (i.e., doesn’t meet the vendor’s specifications).

Product Hold Vendor suspends sale of product until further notice. No health threat is associated with this product.

Product is on hold until test results are returned.

Multi-unit, Customer-initiated Product Recovery

This is a product recovery initiated by a multi-unit customer for its labeled item.

Perkins initiates a Market Withdrawal on Perkins-branded pancake mix that is too yellow.

Unclassified A situation when the vendor refuses to classify the recall, so FSQA will direct to execute a Class I, II or III Recall depending on health risk.

Product has an undeclared milk allergen, and the vendor is refusing to classify the recall.

Additional information: http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-summaries http://www.fda.gov/Safety/Recalls/default.htm

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55General Information on Product Recall & Recovery

• All recalls, withdrawals and quality related product removals are tracked centrally by the Corporate Recall Team . • All US Foods® employees will submit any information received from outside US Foods related to a recall, withdrawal or quality-related

removal to recallteam@usfoods .com . • All affected product is segregated until disposition is determined and cannot be released unless advised by the Corporate Recall Team . • US Foods does not continue buying, receiving or distributing products subject to recall . This includes DC to DC transfers .• Our product recovery and customer notification process is managed by BellTower’s Instant Recall system .

BELLTOWER AND DC WORKFLOW• BellTower will provide support to the DC recall teams in three ways:

- Contacting customers with recall details - Providing documentation of customer responses - Documenting the administrative costs of the recall• DC recall teams are responsible for:

- Reporting all recall/recovery case counts - Reporting product and non-product costs - Completing customer credits - Advising all sales of ongoing recall activity - Guiding customers on how to complete the recall

NOTE: Customers who contact US Foods about a recall or product issues should NOT be given phone numbers for BellTower or the USF Corporate office for any reason . All pertinent contact information is provided at the time of the recall .

INSTANT RECALL – KEY TERMINOLOGY

Project • Contains recall/withdrawal details, affected products, vendor information, disposition instructions . • Unique Project ID and PR # . • Campaigns are part of a Project . A campaign is an organized, controlled effort to execute a specific communication

to the area recall teams or customers . • There can be multiple campaigns per Project, if the vendor is expanding a recall, upgrading a recall or any new

communication is released .

DC Communications Campaign • Notification of DCs, collection of information from DCs . • Deadlines: Acknowledge Notification, provide Response .

Customer Communications Campaign • Notification of customers, collection of information from customers . • Group Calls (voice, email, SMS/text), Hotlines, myinstantrecall .com portal . • Human follow-up .

DC Cost Recovery Campaign • Cost Submission, Review and Approval .

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General Information on Product Recall & Recovery

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INITIATION OF A RECALL OR RECOVERY • When all required information is assembled, an official Recall and Recovery Notification will be

blasted through the Instant Recall system to affected DC recall teams . • A recall notification will not be delayed waiting for a letter from the vendor authorizing product

bill-back . Vendors are contractually obligated to assume costs for recalls or recoveries of their products .

DC ACTION AND RESPONSEFor Class I, Class II and Class III Recalls, there are several actions required from the affected DCs 1 . Acknowledge the Instant Recall system email blast by clicking on the link in the notification email .

This tells the CRT that your DC is aware of and has begun reacting to the recall . This should happen as soon as you receive the email from https://dashboard .belltowertech .com/login . Note that multiple persons from a DC may receive notification . Only one reply per DC is necessary .

2 . DC communication: the DC Recall Team must disseminate any relevant recall and recovery information to appropriate DC associates, including product buyers and CSRs .

3 . All pallets of held product shall be marked with a completed Recalled Product HOLD tag . 4 . To prevent accidental shipment of the product, the product on hold is immediately put on “Suspend

Status” in Tandem . Once product is placed on hold, it cannot be taken off hold, for any reason, without the written permission of the Director, Food Regulatory Compliance or designee .

5 . Transfers and shipments in progress to other DCs must be communicated to the receiving DC . 6 . Recalled and Withdrawn product must be watched by inventory to make sure product in transit is

accounted for . 7 . The DC recall team must go back into the instant recall system with a case count . The product tracking

form must be submitted with the number of cases on hold, unaffected cases and additional comments by the DC .

Communications• If DC associates are notified directly by a vendor, they are to refer the vendor to the CRT . Once

DCs are notified by a vendor regarding a recall and recovery, they should identify the product in their warehouse, segregate it and place it on hold . Further direction on recall and recovery will come from the CRT .

• Recall notifications for all Class I Recalls affecting more than one DC are CC’d to all DC recall teams (whether affected or not) as a precautionary measure . DCs that are marked unaffected must notify the CRT if they discover that they have affected product .

• Only the DCs identified by the vendor to have received the affected product are emailed Recall and Recovery Notifications (excluding Class I as stated above) .

Notification of RecallThe CRT receives notice about recall from a vendor or a vendor-notified DC .

Request for Information (RFI)

The following information is needed from the Vendor before a notification is sent to the DCs: • Vendor • Classification • Contact name and phone • DCs affected • Product affected

and description • Lot # • ASYS and PSYS # • Brand name • Reason for recovery • Health Hazard • Mfg # • Numbers and dates if Recall • Disposition • Assumption of all product

recovery costs • Should customers be

contacted? If yes, earliest sales date

• Disposition for end users • ICSR when appropriate

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77General Information on Product Recall & Recovery

NOTIFYING CUSTOMERS • Automated phone calls: Affected customer locations will be contacted via Instant Recall if our records indicate that the location was

shipped affected product based on Merlin shipping data and phone numbers provided by SOUS . Customers will receive calls from 800 .919 .5439, and can call that number to listen to the recall details and report product counts .

• Emails and Text: If the email address and cell phone are provided in SOUS, the customer will receive a notification email/text, which will include a link to https://myinstantrecall com/portal . The customer can then review the notification details, confirm receipt and report affected product quantities .

• In the event the customer needs the link sent to them again, the DC Recall Team can send a direct link via email or mobile number .• Instant Recall Agents will contact customers after no response from three waves of voicemail, emails and texts .• Customer service cannot do this for the customer – they will direct the customer to the customer portal ONLY . If the person

responsible for recalls and recoveries isn’t reached through these methods, a certified letter will be sent to the customer, providing them with the details of the issue and how to report inventory for credit .

Response Times for Product Recall & Recovery

a Time from when recall and recovery notice is emailed to DC recall team.b Completion includes time to place affected product in stock on hold, enter case count into the instant recall system. This time does not include returning product to the warehouse or to the vendor.

Type Time to Acknowledge to the CRT a Recall and Recovery Completion Time b

Class I 1 hour within 12 hours (allows for weekend or after-hours recalls)

Class II 1 hourat within 12 hours (allows for weekend or after-hours recalls)

Class III 2 hourshat within 12 hours (allows for weekend or after-hours recalls)

Market Withdrawal 3 hoursat within 12 hours (allows for weekend or after-hours recalls)

Product Hold 3 hoursat within 12 hours (allows for weekend or after-hours recalls)

Directive 1 houra varies according to situation

Customer-initiated Recall and Recovery

Use guidelines for recalls, Market Withdrawal and Stock Recoveries

within 12 hours (allows for weekend or after-hours recalls)

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8General Information on Product Recall & Recovery8

DISPOSITION OF PRODUCT • If vendor indicates that recalled product is to be returned to them, the vendor listed on the recall notification should be contacted to

make arrangements to pick up all recalled product . • All recalled product must be picked up within two weeks . If, after two weeks, the product is not picked up, the vendor should be

contacted by the DC and told that their product will be destroyed if not picked up within 48 hours . - All conversations between DC and vendor about the pickup of recalled product should be documented and kept in the recall

file . Documentation should be kept on individuals spoken to, date and time of the call and a brief summary of the discussion . - If the vendor chooses to destroy the recalled product: > Arrangements should be made to destroy the affected product using appropriate product destruction methods

(e .g ., taking the product to a local landfill and getting a receipt for the deposit; making product unfit for consumption by pouring bleach or dye on the product when it is in the dumpster) .

> Any product destruction costs are to be included in the vendor billing .

RECORD KEEPING

DC recall teams must keep or be able to access electronic records (in the instant recall system) on each Recall and Recovery in which their DC is involved . Each electronic folder must contain all information pertaining to recall notifications from CRT, customer notification, amount of product returned, billing information, courier information and whether the product was destroyed (Certificate of Destruction) or returned to the vendor .

RECALL CONTACT LISTS Each Division Recall Coordinator (DRC) maintains the most up-to-date recall teams in the Instant Recall system .

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99 Post-Recall Activity

BILLING FOR RECALL COSTS• When every customer has been contacted directly or by certified letter, the DC recall team will be sent an email by the instant

recall system to pull reports for all inventory reported by the customers . The team can use these reports for customers or for any audits needed .

• DCs are responsible for billing vendors for all costs associated with product recoveries (non-product costs and costs associated with conducting the recall) . All costs and bills should be documented in the Instant Recall system within the recall designated timeframe given by the CRT .

• All costs will be submitted to the Instant Recall system, approved by the CRT and submitted to the National Service Center (NSC) for vendor billing . These costs include administrative costs, labor costs, disposal, return or donation fees and other miscellaneous fees, and are completed online by the DC recall team coordinator or designated responsible person for recall costs .

• The vendor should be billed for all expenses associated with conducting the recall, including product labor cost (i .e ., warehousing and delivery fees charged to customer, labor, courier, postage, temporary personnel, etc .) .

• The CRT will determine the time frame each DC will get to submit costs depending on the size of the recovery . • Recoveries based on Directives will be billed to the vendor unless otherwise directed by the CRT .

BILLING FOR PRODUCT COSTS • The DCs are responsible for billing the vendor for product costs associated with inventory and customer credits .• The NSC will complete the deductions per DC from one statement provided by the CRT .

FOLLOW-UP WITH COMPLIANCE CHECKS ON RECALLIt is very common for a regulatory agency representative to visit a DC, inquire about how we conducted our recall activities and contact our customers .

• If you are contacted by a regulatory agency, contact your Regional FSQA Manager and send notification to the shared legal mailbox: legal@usfoods .com .

• Information is to be released to a state or federal inspector ONLY after their identification has been verified . Government officials attempting to retrieve information by telephone should be referred immediately to the CRT . He or she will attempt to verify identity . Do not proceed until you have been instructed that it is ok to do so .

• US Foods® policy is to cooperate with all regulatory agencies and provide them with the list of customers and their contact information when requested .

• Having a complete set of records for each recall is essential for quickly and correctly answering all questions asked by the regulators . • If an inspector has an issue with a recall (e .g ., claiming that we did not contact a customer):

- Retrieve the information that is being challenged from the inspector . - Immediately contact Corporate Regulatory with details of the situation, including the inspector’s contact information . - The CRT will respond to the inspector .

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10Training on Product Recall and Recovery Policy and Procedures

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TRAINING ON PRODUCT RECALL AND RECOVERY POLICY AND PROCEDURES

• The DC recall coordinator is responsible for training its DC recall backup coordinator, DC recall team or other applicable operations associates, as well as making sure that DC management is aware of all procedures .

• Refresher training on Product Recall & Recovery Policy and Procedures will be conducted by the CRT on a yearly basis . However, it is recommended that buyers and marketing associates be reminded of recall and recovery procedures as needed .

• New-hire training protocols in the Procurement, Merchandising and Operations Departments must include how the Product Recall & Recovery Policy and Procedures affect each new employee’s job and responsibilities .

MOCK RECALLS

Every US Foods® location is required to have a mock recall initiated by the CRT each year . This requirement can be waived if the location has been affected by a Class 1 Recall with customer contact during the year . US Foods locations that do not meet this criterion will have to abide by the policy as written and conduct a mock recall .• Each mock recall will be for a Class I Recall, which will include contacting customers

via the instant recall system . • The purpose of contacting customers even though this is a mock recall is twofold:

- Making the customer aware of our recall procedure - Verifying contact information, including alternate phones, email, etc .

• Records will be kept on mock recalls for two years and made available to third-party auditors and customers upon request .

• The DRC will email the CRT with information to complete the mock recall Information will include ASYS number, product description and a list of one to 10 customers with customer numbers and names for contact and one customer to follow up with .

• The CRT will schedule the mock recall with the DRC in advance with information and date .

• The CRT will initiate the mock recall on date specified with DC . Customers will be contacted by email and phone via the instant recall system .

• Each DC should meet following the completion of mock recall to discuss the DC’s performance nd to complete the Mock Recall Summary Sheet (see form on page 11) .

• Customer-initiated mock recalls can be initiated to assist customers with their recall systems . This is completed with the knowledge of the CRT and can be documented as a mock recall completed for the DC(s) involved . The process will be the same as a DC mock recall .

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1111 Mock Recall Summary Sheet

Form 775 Mock Recall Summary Sheet

US Foods Facility: Date:

Distribution Center Recall Coordinator:

Product Information:

Vendor: Date of Receipt and PO#:

Lot Number: Product ASYS Code:

Product Description:

Identified Product:

Amount of product received:

Amount of affected product in warehouse:

Amount of affected product shipped to customers:

Total amount of affected product identified:

Customer Contact:

Number of customers contacted:

Number of letters sent:

Amount of total product and cases identified by customers:

Number of product and cases consumed by customers:

Mock Recall Effectiveness:

Time recall started:

Amount of product identified:

Time recall completed:

Amount of product received:

Total time required:

(Identified and received) x 100 = %

Corrective Actions and Observations from Mock Recall:

Please email completed summary sheet to the CRT at recallteam@usfoods .com

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Instant Recall Workflow 12

Corporate Recall Team

Vendor Recall Notification

1. Launch a new Project

2. Enter details and disposition instructions

3. Identify affected DCs and schedule DC notifications

4. Import affected customers list

5. Approve customer notification details

Real-time view and export of notification status and reported product counts

Campaign reports and analytics

Notify when Multi-Unit Account’s (MUA) locations are affected

Filtered real-time view of the MUA’s locations’ status

Notify affected DCs (escalating from email to text message to phone)

Acknowledge notification. Respond with additional info

Real-time view of DC’s customers’ status

Notify affected customers (phone, email, text)

Respond to missed calls and report affected product counts by phone or via web

Handle exceptions, close the loop and mark as notified in real-time

Human follow-up to reach stragglers, certified mail to any not confirmed as notified

Regulatory Reporting

Instant Recall

Multi-UnitAccounts

Customers

Distribution Centers

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1313Product Recall and Recovery Flow Diagram

Vendor - Sends notice to US Foods® about product recovery or recall

CRT - Receives information about recall and recovery

- Sends out Recall and Recovery Notification to affected DC recall coordinator and Team

- Report to Regulatory Management about status of recall and recovery

DC and Area - Calls meeting of Recall Team- Operations checks inventory; segregates and pulls affected product to place on HOLD- Replies with cases on hand- Instant Recall contacts end users, DC recall teams follow up with customer

credits and maintenance of customer contact information- Arranges for product pick-up from customers and vendor, if applicable

- Bills vendor for all expenses associated with recall and recovery

- Completes the Certificate of Destruction (COD), if applicable, for product destroyed in a Recall and Recovery

Customer- Receives communication from US Foods about recall and recovery via phone call,

email blast, text or certified letter

- Checks product inventory and places it on hold

- Replies with cases on hand

- Returns product to US Foods or destroys for credit; TM uses credit code for return authorization

- Customers must reply to the site https://myinstantrecall.com/ for credit

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Directives14

CRT ACTION ON DIRECTIVES• Corporate FSQA management and (usually) Corporate Legal Department

determine when a Directive is necessary .• All necessary information needed by DCs to conduct the Directive is compiled by

the FSQA Department .• A Directive Notification email is sent to DCs along with any approved legal letters

or associated documents .• Corporate FSQA will determine on a case-by-case basis if customers need to

be contacted about actions associated with a Directive, or if product needs to be retrieved from customers .

• At the discretion of Corporate FSQA, the FDA or USDA may be notified about the action taken by US Foods® .

DC ACTION AND RESPONSE ON DIRECTIVES• DC recall teams must respond with a case count within

one hour of receiving the Directive notification in the Instant Recall system .• If customers are to be contacted, follow procedures for a Class I Recall .• Remember that if product must be destroyed under a Directive, all costs may be

borne by US Foods . DCs must keep meticulous records of products destroyed for attempts to recover costs from the vendor .

• Directives are Product Recoveries determined to be necessary by the US Foods FSQA Department without authorization of the vendor .

• Even though vendors do not authorize Directives, all expenses associated with a Directive are to be billed to the vendors unless otherwise told .

• Directives are handled according to the perceived risk of the product, and they may range from a simple product hold to a Class I Recall .

• Notification of Directives are issued through the instant recall system in the same manner as other recalls and recoveries .

• When a DC recall team receives a Directive, a response in the Instant Recall system is required within one hour, indicating how much of the affected product the DC has on hand .

• In most cases, regulatory issues are the cause of Directives . Therefore, because there could be legal ramifications for mishandling recoveries, it is imperative that DC personnel only do what is asked of them in a Directive . DC recall teams are encouraged to call the CRT with questions, but they are not to conduct additional recovery activities or contact customers without express direction from the CRT .

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1515Multi-Unit Customer-Initiated Recalls and Product Recoveries

Customer-Controlled Brands • Only customer-controlled brands and labels may be recalled and recovered at the direction

of the customer rather than the vendor .

• The manufacturer and vendor must be notified of the customer-initiated recall and recovery by the CRT .

• Direction on contacting individual units and instructions for disposal of the affected product will be supplied by the multi-unit customer (corporate headquarters) or vendor .

• Customer and/or the vendor and manufacturer classifies the recall and recovery .

• Customer and vendor provides all notification materials to be sent to the individual units .

• Multi-unit customer-initiated recall will be handled using procedures for vendor-initiated Class I, Class II, Class III, Market Withdrawals or Product Holds with the following exception: the multi-unit customer (instead of vendor) can provide all information needed to conduct the recall if the vendor is resistant .

• Additional customer requirements addenda .

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16 Centralized Cost Recovery16

• Administrative costs and customer notification fees are calculated automatically with each recall .• Each DC adds product handling fees, labor, dumpster fees and other miscellaneous fees .• There are no actual DC or customer product costs .

The following form is available online, to be completed with the details of each recall . Invoices, the Certificate of Destruction (COD) and other relevant documentation can be attached at the bottom of the form .

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1717 Regulatory Requirements

REGULATORY REQUIREMENTS

FOR FDA CLASS I RECALLS INITIATED BY US FOODS® The CRT will report to the Reportable Food Registry (RFR) within 24 hours of the Recall Notification .

Access the report at: https://www .safetyreporting .hhs .gov/fpsr/WorkflowLoginIO .aspx?metinstance=BAE08D7E4CCA4F8E6FE00178D7139C0D024B8C76

• A username and password are required . • Fill out a new report with the PR# pertaining to the Class I Recall . • Fill in only the required (*) information . • For “Organization Type,” fill in the information for the

manufacturer, own label distributor or shipper, warehouse storage, warehouse frozen and warehouse refrigerated options .

• For “Are you located in the food facility for which you are reporting?” indicate the response, “No, I am the responsible party but not located at the food facility .”

• For the “discovery site FFRN number,” pick the DC that was affected and use its FFRN number since it (not corporate) is affected and ship product .

• For the “discovery site contact information,” enter your contact information as indicated above in the sender information section because you are filling out the form for the recall .

• For “problem details” put in the “ICSR number” that the vendor provided .

• For the “Full account of the Reportable Food issues,” fill in: “Vendor name” notified US Foods of recall on “date .” All affected US Foods DCs were notified, and all potentially affected US Foods customers were notified on “date .” Any affected DC and customers that have any affected product on hand have been instructed to “list disposition .”

• For “How did you determine which products or lots of product are affected?” fill in: The vendor gave US Foods all the affected product information, including lot codes .

• No attachments need to be added . • Submit the report .

Once the report is submitted, you will receive an email confirmation that the report was successfully submitted . Put in the PR# folder .

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18

For more information about US Foods, Inc ., please visit www .usfoods .com . © 2018 US Foods, Inc. 02-2018 SPE-2018010203