Reverse Supply Chain Improvement Project
Recalled Products Work Group
“Do it once, right and fast”
Speakers:
Cathy LeRoux, Kellogg Company
Gary Spinazze, Nash Finch Company
Amy Fanale, GS1 US
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Recalled Products Work Group
Gary Spinazze (Lead), Nash Finch Company
Leon Elcock, Campbell Soup Company
Pete Bannochie, General Mills, Inc.
Jeff Pepperworth, Inmar
Ellen Harvath, Kellogg Company
Dave Jones, Kellogg Company
Daniel Triot, Procter & Gamble
Mike Rozenbajgier, Stericycle
Laura Trappe, Unilever US
Steve Henig, Wakefern Food Corp.
Becky Bly, Walgreen Company
2
Definitions of Recalls
Class I: A situation in which there is a reasonable probability that the
use of or exposure to a violative product will cause serious adverse
health consequences or death. For example, salmonella in peanuts.
Class II: A situation in which use of or exposure to a violative product
may cause temporary or medically reversible adverse health
consequences or where the probability of serious adverse health
consequences is remote. For example, foreign material found in food
products.
Class III: A situation in which use of or exposure to a violative
product is not likely to cause adverse health consequences.
For example, minor labeling violations.
Source: Recall Execution Effectiveness: Collaborative Approaches to Improving
Consumer Safety and Confidence, 2010 Deloitte
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Recall Mania
Real Examples
Class I
II, III & WD
Info
Rx
Total
Rtlr/Wlsr A 2010 total
17
75
47
181
320
Rtlr/Wlsr A 1/1/11 – 5/18/11
6
32
14
92
144
Perish
Non-Perish
GM/HBC
Rx
Total
136
214
60
43
453
Rtlr/Wlsr B 2010 total
UPC in First
Notice?
Received from
4%
Vendor 17%
Internal
58%
FDA
53%
No
21%
USDA
47%
Yes
Source: Rtlr/Wlsr B
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The Five Stages of a Recall
Prenotification
Manufacturer
Notifies
Customer
Customer
DCs Notify
Stores
Returns
and
Disposal
Regulatory
Close out/
Reconciliation
5
Communications Multiplicity
Communications need to follow the same path as products
“Growers”
Ingredient/
Packaging
Supplier
Plant
Plant
Manufacturers
A
Customer
DCs
Stores
Retailer
B
Wholesaler
C
Recalled
Good
Wholesaler
6
Communications Multiplicity
Communications need to follow the same path as products
“Growers”
Ingredient/
Packaging
Supplier
Plant
Plant
Manufacturers
A
Customer
DCs
Stores
Retailer
B
Wholesaler
C
Recalled
Wholesaler
7
Background
Recalled Products Work Group recognizes that every company has a
documented process – protocol – to follow for a recall/withdrawal
event.
Goal: Increase speed and accuracy of recall communication and
product removal from supply chain.
Suggestion: Read “Recall Execution Effectiveness: Collaborative
Approaches to Improving Consumer Safety and Confidence,” 2010,
GMA, FMI, GS1 and Deloitte*
Thought for Today: Simplify
*Available for download at: http://www.deloitte.com/assets/DcomUnitedStates/Local%20Assets/Documents/Consumer%20Business/US_CP_Joint%20Industry%20Rec
all%20Execution%20Effectiveness%20Report_052810.pdf
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Protocol Example
Potential Issue
is Identified
•Supplier
•Plant
•Consumer
•Customer
•Govt.
One Manufacturer’s Protocol
Regulatory
Status Letter
Issued
PRODUCT RECALL / RECOVERY FLOW
Convene Recall
Crisis
Management
Team
Required:
•QRO-Business/Regulatory
•Sales
•Legal
•Finance
•Corporate Communications
•Supply Chain
•Marketing
Situation Dependent
•Health & Safety
•Investor Relations
Recall
Yes
No
Manage As
Market
Withdrawal
or Locally
Customer
Communication by
ICS
•Returns
•Replenishment
Initiate
Recall
Authorization
•CEO & VP QRO
Recall Coordinator
•QRO
•Inform Senior
Leadership
Customer Communication
•Sales
Media/Consumer
Communication
•Corporate
Communications
•Rapid Recall Exchange
Portal is also used to
Communicate to
Customers
Recall Follow-up
/ Effectiveness
Check
Sales
•Customer Information
•Returns
•Replenishment
QRO
•Collects and maintains
documents
3rd Party
•Used to Visit Retail
Stores for Recall
Effectiveness Checks
Close Out
Recall with
Regulatory
Agency
QRO *
•ICS Reports / Tracking
•Collects supporting
materials
•Issues letter
•Maintains Master
Recall File
•Retains records for 7
years
•Review with Legal
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Protocol Example
One Wholesaler’s Protocol
10
Protocol Example
One Retailer’s Protocol
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Major Issue #1
Determining the problem and whether a recall is warranted by the
manufacturer.
Recommendations for manufacturers
1. Focus on identifying products and batches affected.
2. Assemble all relevant data.
3. Set a reasonable goal for notification and work to it.
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Major Issue #2
Multiple notices over multiple days for same recall.
Recommendations for manufacturers
1. Include the maximum number of products in first notification.
2. Communicate all information in first notification including:
• All UPCs, sizes/pack counts, lot codes, expiration dates.
• Concise disposition instructions.
3. Include important system data such as:
• PO# (or copy of full PO)
• PO date, ship to/from locations
13
Major Issue #3
Not knowing where all of the recalled product has gone in the
supply chain.
Recommendations for supply chain
1. Communicate to customers who did not buy the recalled
product:
• Just in case they acquired it elsewhere.
• So they know which lots and SKUs are not recalled.
2. Wholesalers who carry the item in their DC and are not sure
which customers purchased recalled product, send recall
notification to all.
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Major Issue #4
Stores must accurately and quickly prevent consumer purchases.
Recommendations
1. Involve key store personnel in the recall process/protocol:
•
Store manager – first line of audit.
•
POS coordinator – block the item in scanning systems.
•
Service desk personnel – prevent restocking of consumer returns.
2. Lock out the recalled product UPC in the POS system as soon as
possible to disable scanning.
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Major Issue #5
Efficiently handling returned product and closing the recall.
Recommendations
1. Verify DCs have stopped shipping, stores have removed product.
Then start replenishment.
2. Contract with service providers to:
•
Remove recalled product.
•
Audit for compliance.
3. Involve corporate auditors to check compliance.
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A Little Help
Boiler plate communications templates from the Recalled
Products Work Group:
• Press release
• Letter to customers who received recalled product
• Letter to customers who did not receive product
• Frequently Asked Questions
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Conclusion
“Do it once, right and fast”
• Over-communication helps if you are unsure of product
locations.
• Over-communication hurts if you are making up for incomplete
or inaccurate information.
• Publish as soon as accurate and complete information is
available.
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Amy Fanale GS 1 US
• PRESENTATION FROM GS1
Food Safety Modernization Act
• Signed into Law on January 4, 2011
• Implementation phased in over 3 years – we are only half way
there!
• The focus is on Prevention
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–
–
–
–
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Prevention controls requirements
Expanded records access
New expectations in records maintenance
Increased inspections
FDA Mandatory recall authority
Traceability
Prevention and Documentation
Prevention Controls Requirements
HACCP (Hazard Analysis and Critical Control Points)
required for all foods*
Recall plans*
*MUST BE IN WRITING
Expanded Records Access to FDA
FDA access to all records related to manufacturing,
processing, packing, transportation, distribution, of any
food for which there is a reasonable probability that
exposure will cause serious adverse health consequences
or death AND all records relating any food that is likely to
be affected in a similar manner MUST BE PROVIDED UPON
REQUEST
Be Prepared to Act Quickly
New expectations in records maintenance
Then: FDA could only access records related to the food
product believed to be adulterated
Now: FDA can request access to records related to other
food handled by the facility, including consumer complaint
records
The FSMA requires companies to report to the FDA using
the Safety Reporting Portal within 24 hours of confirming
they have a reportable food
Increased inspections
Be prepared. FDA inspections likely to focus on high risk
products and ingredients
One Step Forward and One Step Back
FDA Mandatory Recall Authority
“History will be made when FDA changes its approach to
inspection to take full advantage of the preventive
controls framework and enhance our public health
focus. This means conducting more inspections …. that
better target the key elements of a company’s food safety
plan and are effective and efficient in determining
whether the company is meeting its prevention duty.”
Michael R. Taylor Deputy Commissioner for Foods Food and Drug Administration
FDLI Food Safety Conference
January 27, 2011
Traceability
Record Keeping – Are Supplier, Manufacturer, Distributor, Wholesaler and
Retail Customer records matching up?
The FSMA requires companies to track and trace product back from where it
was received and forward to where it was shipped
• “Do it once, right and fast”
• Let’s talk about it!