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2. COMPLAINT FILEBenefits If you receive a complaint, it is important to record the complaint information, complete an investigation at your distribution centre, and refer it to the CFIA. Early action on your part may enable you to stop selling the product until it is determined that the product is safe. Description There are three main parts to the complaint file:
Recording of the Initial Complaint Information Complaints should be recorded by a designated individual(s). The information should include the following: 1. Complainant details
2. What is the problem with the product, e.g. chemical taste, allergic reaction, illness, object in the food 3. Product details
4. Retail Details
5. Has the complaint been referred to anyone else?, e.g. the Canadian Food Inspection Agency or Public Health Investigation at the Distribution Centre It is important when you receive a complaint to make sure that the problem with the product did not result from activities at your distribution centre. If you determine that the problem was caused by activities in your storage facility, contact the CFIA immediately. Record in your complaint file:
Complaint Referral If you determine that the problem was not caused at your distribution centre, refer the complaint immediately to the manufacturer who produced the product or the importer, as appropriate. Record in your complaint file:
Action Taken If you distributed/sold an unsafe or violative product, you are responsible for ensuring that your accounts are notified immediately and that the CFIA is contacted. Once you have been notified of a recall or product action by a manufacturer or importer, you should record:
3. RECALL CONTACT LIST - CANADIAN FOOD INSPECTION AGENCY (CFIA) NOTIFICATIONBenefit If you suspect that you have distributed an unsafe food product, contact the CFIA immediately. The CFIA staff can assist you with your investigations and should be notified of all corrective action decisions. Each area in the CFIA has a Recall Coordinator who will assist you in contacting CFIA staff to help you with your investigation and collecting the information necessary to make the right decision. Also, they can refer the complaint and coordinate the investigation at the appropriate manufacturing or importing firm. A list of CFIA Area Recall Coordinators is provided below. Since the list may change, it should be reviewed frequently. This list is available on the CFIA website: www.inspection.gc.ca. Description Your CFIA notification contact list should contain the following information:
The current CFIA Area Recall Coordinators can be reached at these telephone numbers from 8h00 to 23h00:
4. TRACING OF PRODUCTSBenefits Being able to identify which product(s) have to be recalled is a great benefit to your firm. It allows you to limit the scope of the recall and remove the product(s) from distribution quickly and accurately. To do this, you must be able to trace the products that you have received and distributed. If you cannot identify a specific product(s) you may have to recall more product than is necessary. Furthermore, incorrect identification of all of the product during the first recall, may lead to other recalls. Description To limit your recall to a specific product(s) you must:
Receiving Records All products that you receive, should be identified with a specific lot code. You should have a system in place which identifies and records the lot codes of each product you have received from each supplier. For each supplier you should document:
5. DISTRIBUTION RECORDS AND DISTRIBUTION RECORD SYSTEMBenefit When the product is being shipped out of the distribution system, the lot codes should be linked to the accounts receiving that product. This completes the link of the product from supplier to distribution centre to the accounts. Keeping this link is important; it enables you to limit your recall to the specific accounts that received the product being recalled. Your firm should have a record system which can generate these records accurately and quickly. Description Your firm should be able to create a distribution list which is product and lot code specific.. This distribution list should include:
These distribution records should be kept for a period of time that exceeds the shelf life of the product. In some instances the period of time is specified in CFIA inspection manuals or by regulations. Check with the CFIA to ensure that you are maintaining your distribution records for the correct period of time. 6. RECALLED PRODUCT RECORDSBenefit For your own protection, keep records of products that you have recalled from your accounts. Description Your recalled product records should contain:
7. RECALL PROCEDURESBenefit There are several activities which happen simultaneously during a recall. Having a step-by-step recall procedure will ensure that all of the activities are completed. This is the plan that you will action during a recall. A brief description of each of the recommended steps is included below. Further details on the parts of each step and how to action your plan are described in Tab 3 of this guide. Description The recommended step by step procedure is illustrated on the following page.
8. RECALL EFFECTIVENESS PROCEDURESBenefits Your firm is responsible for ensuring that all of the accounts which you shipped the recalled product to are notified about the recall. You must assess the effectiveness of your notification. The actual process of how to notify accounts is described in Tab 3 of this guide. Description The recall effectiveness procedure includes a plan to assess the effectiveness of the recall. Elements of the plan should include:
9. TESTING YOUR RECALL PLANBenefit During a recall, your firms recall management team will be busy putting your recall plan into action. This is not the time to find out that your recall plan is not working or that the plan does not provide the information you need to remove the unsafe product from the market completely and quickly. Testing your recall plan before you have to do a recall, enables you to identify and correct problems in your plan. Description Your recall plan should be tested on a regular basis. When you test your recall plan, ask a supplier to identify several products, some of which have been shipped to your firm. Use these products and corresponding lot codes to test your recall plan and record:
3.0 Action Your Recall Plan - Steps to an Effective RecallIntroduction:Tab 2 of this guide described how your firm can develop a written recall plan prior to having to conduct a recall. These written elements form the basis for:
All of these elements should be developed and documented prior to conducting a recall. The goal of this section of the guide is to describe each of the key steps your firm should take once it has been decided that a recall will be conducted. These recommended steps include the preparation of a Notice of Recall, and in some circumstances, a press release. Your firm should review these sections prior to conducting a recall so that you will be familiar with the document requirements and their purpose. It would be beneficial for your firm to maintain templates or to prepare sample documents that can be used as examples during a recall. This will speed up the process and ensure that all of the necessary information is included. As illustrated on the following page, you will recall from Tab 2, page 10, Recall Procedures, that the recommended steps of a conducting a recall are as follows:
PROBLEM IDENTIFICATION / DECISION TO RECALL PRODUCT(S) Problems resulting in a recall may be identified by the manufacturer, importer, consumers or the CFIA. Once a product has been identified as being unsafe or violative by a manufacturer or importer, and you have purchased and sold the affected product, it is your firms responsibility to take prompt and appropriate action to protect the health of consumers. STEP 1: ASSEMBLE YOUR RECALL MANAGEMENT TEAM (refer to Tab 2, page 1)At the very beginning of the recall your firm must:
STEP 2: NOTIFY THE CFIA (refer to Tab 2, page 5)Notify the CFIA immediately when you suspect that your firm has purchased and sold a product that may pose a serious risk to consumers. Provide the CFIA with the following information:
This information is pertinent for the CFIA to develop an accurate and complete risk management strategy. STEP 3: IDENTIFY ALL PRODUCTS TO BE RECALLEDIt is your firms responsibility to ensure that all products which need to be recalled are identified. STEP 4: DETAIN AND SEGREGATE PRODUCTS TO BE RECALLED WHICH ARE IN YOUR FIRM'S CONTROLIt is your firms responsibility to ensure that all products to be recalled that are in your firms control are not distributed. Your firm must:
STEP 5: PREPARE THE PRESS RELEASE (if required)This step may not apply to your firm. Consult with your CFIA contact to see if you are required to issue a press release. The purpose of a press release is to alert the public that a product presents a serious hazard to health. Not all recalls require a press release; the CFIA will advise you when a press release is necessary. Where the CFIA is not in agreement with a press release prepared by your firm, the CFIA may issue a separate press release. An example template is provided in Appendix A. In addition, examples of press releases are available on the CFIA website at: www.inspection.gc.ca. During this step, your firm must:
STEP 6: PREPARE THE DISTRIBUTION LIST (refer to Tab 2, page 7)Using your distribution record system, produce a product and lot code specific distribution list which:
Provide the distribution list to your CFIA contact within 24 hours. STEP 7: PREPARE AND DISTRIBUTE THE NOTICE OF RECALLYour firm is responsible for immediately notifying all of the accounts that received the recalled product. Usually the manufacturer or importer will prepare the Notice of Recall which your firm can then provide to your accounts.
STEP 8: VERIFY THE EFFECTIVENESS OF THE RECALL (refer to Tab 2, page 11)verify that your accounts have stopped distributing and selling the recalled product(s) verify that the recalled product(s) has been returned to the designated place(s) as stated in your Notice of Recall It is the responsibility of the CFIA to follow up with some of your accounts to verify the effectiveness of the recall. Where it is determined that the recall was ineffective, your firm may be required to repeat the recall process. STEP 9: CONTROL OF THE RECALLED PRODUCT(S) (refer to Tab 2, page 8)If you have returned the recalled product(s) to your supplier, this step does not apply to you. Your firm is responsible to ensure that recalled products do not re-enter the market.
STEP 10: DECIDE WHAT TO DO WITH THE RETURNED PRODUCTIf you have returned the recalled product(s) to your supplier, this step does not apply to you. The action to be taken on the recalled product should be approved by the CFIA.
STEP 11: FIX THE CAUSE OF THE RECALLThis step only applies if the cause of the problem originated at your firm.
COMMON PROBLEMS WITH RECALLS, POTENTIAL IMPACTS AND RECOMMENDED SOLUTIONSListed below are some common problems, potential impacts and recommended solutions associated with some of the steps in the Recall Procedures. 1. PRESS RELEASE AND NOTICE OF RECALL Problems:
Potential Impacts:
Recommended Solutions:
2. PREPARATION OF THE DISTRIBUTION LIST Problems:
Potential Impacts:
Recommended Solutions:
3. INFORMING THE CFIA OF A RECALL Problems:
Potential Impacts:
Recommended Solution:
4. IDENTIFICATION OF PRODUCT(S) TO BE RECALLED Problems:
Potential Impacts:
Recommended Solution:
5. NOTIFICATION OF CUSTOMERS Problems:
Potential Impacts:
Recommended Solution:
6. CONTROL OF THE RECALLED PRODUCT Problems:
Potential Impacts:
Recommended Solutions:
7. VERIFYING THE EFFECTIVENESS OF THE RECALL Problems:
Potential Impact:
Solution:
APPENDIX A: PRESS RELEASE - INDUSTRY TEMPLATE, ALLERGENSFOR IMMEDIATE RELEASE ALLERGY ALERT - UNDECLARED (Name of Allergen) IN (Name of Product) CITY), (DATE) -- (COMPANY NAME), (LOCATION) is warning consumers not to consume (BRAND NAME AND PRODUCT NAME) because it may contain (NAME THE ALLERGEN) which is not declared on the label. The product being recalled is: The product is distributed in (NAME THE PROVINCES) or across Canada. (NAME THE PRODUCT) may cause a serious or life-threatening reaction in persons with allergies to (NAME THE ALLERGEN). Consumers should (TELL CONSUMERS WHAT TO DO WITH THE RECALLED PRODUCT e.g., return to point of sale for a refund). There have been (NUMBER) of reported illnesses associated with this product. Consumers can contact (COMPANY NAME) by calling (PHONE NUMBER). - 30 - For more information, media please contact: (COMPANY CONTACT NAME) APPENDIX B: NOTICE OF RECALL - TEMPLATEURGENT - RECALL OF (Name of Product) (NAME AND ADDRESS OF YOUR COMPANY) Dear Customer, or Attention: (NAME OF CUSTOMER CONTACT) (YOUR COMPANY NAME) is recalling the products listed below because they may contain (NAME THE PROBLEM, e.g. an ingredient which may cause an allergic reaction and is not declared on the label, bacteria, foreign pieces of material).
Please discontinue selling these products IMMEDIATELY by removing them from display, counting the amount in your inventory and storing them in a secure place. Please contact all accounts to which you sell this product immediately and inform them of this recall. (YOUR COMPANY NAME) staff will credit you for the recalled product. Please mark the product RECALLEDand (YOUR COMPANY NAME) staff will call you to arrange pick up. IMPORTANT Date / Time Received:___________________ Signature:______________________ Name of store / Distributor:_______________________________________________ Thank you for your cooperation. 4.0 GENERAL REFERENCE INFORMATION ON RECALLSDefinitionsMandatory recall means a recall as per Section 19 of the Canadian Food Inspection Agency Act.
Product Withdrawal means a firms removal from further sale or use of a marketed product that does not violate legislation administered or enforced by the CFIA. It is not considered to be a recall. Public Warning is a news release that pertains to a specific food recall. The title of this form of communication is WARNING/MISE EN GARDE. The public warning is issued for those recalls requiring the recall of a product to the consumer level. Recall (verb tense) means for a firm to remove from further sale or use, or to correct, a marketed product that contravenes legislation administered and/or enforced by CFIA. Recall (noun tense) denotes the process of recalling the affected product and encompasses all tiers of the affected product distribution system. Recall Classification means the numerical designation, i.e. Class I, Class II or Class III, assigned by RAMU to a particular product recall to indicate the relative degree of health risk presented by the product being recalled. Recall Depth means the level to which a recall is conducted (consumer, retail, distribution). Recalling firm denotes a responsible firm which is accountable for the implementation of a recall. Stock Recovery means a firms removal or correction of a violative product that has not been marketed or that has not left the direct control of the firm. It is not considered to be a recall. Violative Product is product that violates legislation administered or enforced by the Canadian Food Inspection Agency. Voluntary Recall means a recall that is initiated and carried out by the recalling firm without ministerial order. Recall Classifications
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