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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,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. 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 Potential Hazard Inform Management. Assessment Exists and Violative, Management believes Management believes Management believes there.
there is no risk there is minimal risk is SIGNIFICANT risk. handled Assemble Recall,internally Committee,Withdrawal. Recall Committee believes Recall Committee believes. there is minimal risk a recall is warranted,Determine Level of. Product not in Commerce Product in Commerce,Quarantine Stock Recall Initiated by. Disposition,Recovery Recall Committee,Page 5 of 15. Recall Initiated by,Recall Flow Chart,Recall Committee.
Identify and locate All Products,subject to Recall. Quarantine Product Remaining Product not Under Company. and Under Company Control Control Only,Disposition. Implement Recall Strategy,Provide Distribution List Prepare. to appropriate regulatory Distribution,agency List. Prepare and Prepare and,Distribute Distribute Press.
Notice of Recall Release if,Determine what to do Remove Products from. with Recalled Product Commerce,Verify Recall,Effectiveness. Termination Recall Effective Recall not,of Recall Effective. Page 6 of 15,Recall Procedures, The recall procedure outlines the activities that OUR COMPANY will take to manage the recall. of our product s which has have been determined to be unsafe and or subject to regulatory. action The procedure contains the major recall elements below. Assignment of Roles and Responsibilities,Evaluation of the Complaint or Condition.
Identification of Implicated Products,Notification of Affected Parties. Removal of Affected Products,Assignment of Roles and Responsibilities. The roles and responsibilities of every individual on the Recall Committee should be clearly. defined in the recall plan Oversight of the following recall elements should be assigned to a. member of the Recall team Note that individuals may be responsible for more that one recall. Recall Coordinator, The recall co coordinator has been given authority by the management of OUR COMPANY to. execute the activities of the recall Responsibilities of the Recall Coordinator include but are not. limited to, Assure the documentation of all recall decisions and actions in a master recall file. Initiate the formation of the recall committee, Activate various components within the company for priority assistance.
Make recall decisions on behalf of OUR COMPANY, Manage and coordinate the implementation of the company s product recall. Keep management informed at all stages of the recall. Recall Committee, OUR COMPANY S Product Recall Committee is composed of the various components of the. company s organization The following functions should be represented on the committee an. individual may be responsible for more than one function. Management Administration Operations,Recall Coordinator Production. Accounting Purchasing,Consumer Affairs Public Quality Assurance. Relations Sales,Customer Service Maintenance,Distribution and Supply Records Management.
Information Technology Regulatory Affairs,Legal Counsel Sanitation. Note Outside resources may need to be obtained for some of the functions. Page 7 of 15,Responsibilities, Individual recall activities should be assigned prior to a recall event to avoid confusion during a. recall Assignment of the recall responsibilities are found in Appendix D assign an individual to. each activity,Evaluation of the Complaint or Condition. Complaint receipt processing and evaluation are the first steps in the recall process The steps. involved in the evaluation process are, Receive the complaint A file should be maintained containing any product. complaints the company receives Information that should be maintained in the. product complaint file is,i Complainant contact information.
ii Reported problem with the product,iii Product Identification. iv Product Storage,v Product purchase date and location. vi Illness and Injury details, Provide the complaint to knowledgeable staff for initial evaluation If an initial. assessment indicates a recall may be necessary the Recall Coordinator assembles. the Recall Committee for a full evaluation, Determine the hazard and evaluate the safety concerns with the product. Determine the product removal strategy appropriate to the threat and location in. Contact the appropriate regulatory authorities,Alert legal counsel insurance etc as appropriate.
Maintain a log of the events of the recall including information such as dates actions. communications and decisions,Identification of Implicated Products. It is OUR COMPANY S responsibility to ensure the identification of all products and quantities of. products implicated in the recall In addition determination should be made if any other codes. brands or sizes of product handled by the company are affected. A distribution list should be prepared as part of the Identification process The distribution list. should at minimum identify, Account name consignees that received the recalled product s. Account addresses,Contact names,Contact telephone numbers. Type of account e g manufacturer distributor retailer. Additional information relating to product information may include. Amount of product received shipped,Product ship date s. Amount of product returned,Amount of product consumed.
A link to the FDB Distribution Template can be found in Appendix B. Page 8 of 15,Notification of Affected Parties, Notifications during a recall must be done in a timely manner and should include the appropriate. regulatory agencies the product distribution chain and consumers when necessary Recall. notices are typically used to notify regulatory agencies and those businesses in the distribution. chain Press releases are generally oriented to consumers but may be used to notify any. affected party, Regulatory Agencies should be notified at the earliest opportunity after the decision has. been made to conduct a recall Regulatory guidance may be found online. Subsequent to the initial notification the regulatory authority should be updated. throughout the recall process, Distribution Chain contacts will be notified by appropriate means telephone fax email. letter etc It is recommended that a written recall notice be provided to all consignees. The Recall Notice must include all relevant recall information see Appendix B section. Confirm receipt of the Notice of Recall with all accounts A record of all account. communications should be maintained, Consumers should be notified by the most effective method available If appropriate a. press release can be used to notify consumers Considerations for preparing a press. release include, Issuance of a press release should be the highest priority and should be issued.
The local FDA District Recall Coordinator should be consulted before issuance of. a press release whenever possible, All relevant information should be included in the press release see sample. templates in Appendix B,Removal of Affected Product. The procedure for product removal can be divided into five components including removal. control and disposition of affected product recall effectiveness and recall termination. All reasonable efforts must be made to remove affected products from commerce. Products in commerce should be detained segregated and handled in a manner. determined by the recalling firm, Products that are still in the recalling firm s control e g inventory located onsite in. transit in off site storage and in offsite distribution should be detained and. segregated, All quantities and identification codes shall be documented to assist in the. reconciliation of product amounts,Control of Recalled Product.
When OUR COMPANY chooses to retain recalled product control must be regained to prevent. reentry of the product into commerce, All affected product returned will be clearly marked not for sale or distribution and. stored in an area that is separated from any other food products. Page 9 of 15, All quantities and identification codes shall be documented to assist in the reconciliation of. product amounts,Product Disposition, The final disposition of the recovered product must be determined The final disposition must be. reviewed and approved by the regulatory agency Options include. Redirection Products may be redirected for uses other than human consumption. Destruction Products determined to be unsafe for human consumption may be. destroyed or denatured and disposed by appropriate means. Recondition Products may be reworked to remove the safety risk For example. would be relabeling a product to declare an allergen originally omitted from the label. 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

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