Sample Recall Plan
Sample Recall Plan Table of Contents
Version Verification
2
Introduction
3
Definitions
3
Statement of Recall Plan
4
Recall Plan Flow Chart
4
Complaint Evaluation Flow Chart
5
Recall Flow Chart
6
Recall Procedures
7
? Assignment of Roles and Responsibilities
7
o Recall Coordinator
o Recall Committee
o Responsibilities
? Evaluation of the Complaint or Condition
8
? Identification of Implicated Products
8
? Notification of Affected Parties
9
? Removal of Affected Products
9
o Removal
o Control of Affected Product
o Product Disposition
o Recall Effectiveness
o Recall Termination
Mock Recall
10
Appendix A ? Contact Information
11
Appendix B ? Templates
12
Appendix C ? Additional Information
13
Appendix D ? Assigned Responsibilities
14
Page 1 of 15
OUR COMPANY'S Recall Plan
Version Verification
OUR COMPANY'S Recall Plan shall be reviewed annually and revised as necessary when personnel, procedures, processes, suppliers, or as other factors change. The Plan will also be reviewed after any company recall.
Version _(mmddyy)_ Approved by _____________________
Name of Approver _________________________
Title
Date Approved __________
Page 2 of 15
Introduction
The primary goal of a food recall is to protect public health by removing products from commerce that have been determined to be unsafe. A recall plan can aid in the execution of a recall by apportioning duties, centralizing current contact information, and providing prewritten templates for communications. Key Individuals that will be participating in a company recall should review the recall plan and be familiar with the execution of the plan.
Definitions
? Class I Recall ? 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.
? Class II Recall - 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.
? Class III Recall - A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
? Depth of Recall: The level of product distribution for the recall (consumer, retail, institutional, wholesale).
? Distribution List - A product specific distribution list which identifies accounts that received the recalled product. Requested information includes type of business, account name, addresses, and contact information.
? FDB ? California Department of Public Health, Food and Drug Branch ? Market Withdrawal - A firm's removal or correction of a distributed product which
involves a minor violation that would not be subject to legal action by the regulatory agency or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. ? Press Release - A notice that alerts the public (including regulators, retailers, consignees, other distributors, processors, and consumers) that a product presents a serious hazard to health. Not all recalls require a press release; the regulatory agency will advise the firm when a press release is necessary. ? Recall - A firm's removal or correction of a marketed product that the regulatory agency considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery. ? Recall Committee ? The group comprised of key staff with the expertise, authority, and responsibility to manage the recall. ? Recall Plan - A written contingency plan for use in initiating and implementing a recall in accordance with 21 CFR Sec. 7.40 through 7.49, 7.53, and 7.55. The Recall Plan should be reviewed annually and revised as necessary when personnel, procedures, processes, suppliers, or as other factors change. ? Recall Strategy - A planned specific course of action to be taken in conducting a specific recall, which addresses the depth and scope of recall, need for public warnings, and extent of effectiveness checks for the recall. ? Scope of Recall: Defines the amount and kind of product in question.
Page 3 of 15
? Stock Recovery - A firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use.
Statement of Recall Plan
OUR COMPANY maintains a recall plan which provides specific procedures, defines terms, and assigns roles and responsibilities when a food safety issue arises with any of our products. The plan will be activated whenever a potential recall requirement arises and includes the following elements:
1. Recall committee member designations 2. Recall responsibility assignments 3. Key personnel and external contact information 4. Recall procedures 5. Communication templates Success of the plan relies on the proper execution of plan elements and up-to-date information.
Recall Plan Flow Charts
The following two diagrams are graphical representations of the various steps of a recall. Figure 1, illustrates the typical evaluation of complaints or conditions which may lead to a recall. Figure 2, outlines the various steps of a recall.
Page 4 of 15
Figure 1: Complaint/Condition Evaluation Flow Chart
Consumer Complaint
Regulator Notification
Internal Discovery
Laboratory Report
Initial Complaint Assessment
Potential Hazard Exists and Violative
Inform Management
No Risk
Management believes there is no risk
Management believes there is minimal risk
Management believes there is SIGNIFICANT risk
Complaint handled internally
Market Withdrawal
Assemble Recall Committee
Detain/ Quarantine
and Disposition
Recall Committee believes there is minimal risk
Recall Committee believes a recall is warranted
Determine Level of Removal
Product not in Commerce
Product in Commerce
Stock Recovery
Page 5 of 15
Recall Initiated by Recall Committee
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