What is a food recall?
Food manufacturers use many controls to make sure that the products they produce are safe. Sometimes, for many different reasons, a product may be manufactured and sold which may make some people ill or injure them, or is in violation of the legislation. When an unsafe or violative food product has left the control of the manufacturer, it must be removed from the market. This process of removing the product is called a "recall". If your company has made a product which is unsafe or violative and you have sold the product to someone else, you must recall the product. If you choose not to conduct a recall, the Minister of Agriculture may order you to conduct the recall under Section 19 of the Canadian Food Inspection Act. This applies to all manufacturers which have sold an unsafe food product.
What is the goal of this guide?
Ask yourself these questions.
"If you needed to remove a product from the market right now, would you be able to do it?"
"Would you be able to remove the product quickly?"
"Would you be able to remove all of the product?"
"If a supplier advised you that an ingredient or package they have sold you is unsafe, and you have used the ingredient or package to make a
product, would you be able to identify that product(s) and remove it from the market?"
The goal of this guide is to provide you with an overview of how to develop a recall plan and how to action that plan in the event of a recall. It will assist you in identifying products which are unsafe and enable you to recall the product(s) from the market place.
Recalling a product is a planned action. This section of the guide describes how your firm can develop a written recall plan prior to having a recall. This will help you remove unsafe or violative product(s) which your firm has manufactured, from the market quickly and efficiently.
There are ten basic elements which should be included in your recall plan. All of these elements must be included, each element plays a specific role and provides a different benefit to your firm. Some of these elements will link to other food safety systems which may already be in place at your firm.
Benefits
When a food product has been identified as unsafe, it must be removed from the market quickly. Identifying persons in your firm and assigning recall duties to each person will allow you to action your recall plan smoothly. You can be assured that all of the procedures are covered. Also, many recalls happen after regular work hours so you must be prepared to contact people outside of the office/plant. The list of people who make up your team should be reviewed and updated on a regular basis.
Description
Your team should include people responsible for:
Your recall management team document should contain the following:
NAME | ALTERNATE PERSON | BUSINESS PHONE | AFTER HOURS PHONE | RESPONSIBILITIES DURING RECALL |
---|---|---|---|---|
Person's name and position in the firm | a replacement individual in the event that the person is not available | the duties of the person during a recall |
Benefits
When your firm receives a complaint, it is important to record the details and conduct an investigation. This enables your firm to identify unsafe products and correct problems in your food safety systems.
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:
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. How the complainant stored and handled the product after purchase
6. Illness and Injury Details
7. Has the complaint been referred to anyone else?, e.g. the Canadian Food Inspection Agency or Public Health
Complaint Investigation and Results
The complaint should be investigated immediately by a trained person in your firm. The investigation should answer the following questions:
"How did the problem happen?"
"Did the problem happen in your manufacturing plant or was it caused by a raw ingredient or package received from a supplier?"
"Could the problem affect other products?"
All products that may have been affected by the problem should be investigated.
Record in your complaint file:
Action Taken
When you have all of the investigation findings, a decision of the action to be taken must be made. Contact the Canadian Food Inspection Agency to ensure that your action / decision is correct. This decision includes:
Record:
Benefit
If you suspect that you have sold an unsafe or violative food product to another manufacturer, distributor, and/or retailer, contact the CFIA immediately. The CFIA staff can assist you with your investigations and should be notified of all food-related health and safety 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 the collection of the information necessary to make the right decision. 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:
Benefits
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 your raw ingredients, packaging materials and finished products.
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:
Raw Ingredient Tracing
In some instances your firm may be required to recall a product because of the use of a raw ingredient or packaging material which has been determined to be unsafe. By linking raw ingredient lot codes to the finished product code, your firm will be able to identify which of your finished products need to be recalled.
Premixing of Ingredients Ahead of Use
Where raw ingredients are premixed for future use, a coding system should be devised to allow tracing of the raw ingredients to the finished product. The code used, its interpretation, and linkage to the finished product should be recorded.
Rework
Limiting the use of rework to the same lot reduces traceability problems. If rework is used, a system should be devised to ensure that the ingredients of the rework can be traced to the finished product.
Coding System Documentation
For some products the coding system requirements are legislated; for others your firm may create its own coding system. In either instance, you should document: the definition of a lot for each product how to interpret the lot number on each raw ingredient how to interpret the lot number on each finished products how ingredient lot numbers are linked to finished product lot numbers
Where premixing and/or rework is used, document:
A "lot number" is defined as:
"Any combination of letters, figures or both, by which any food can be traced in manufacture and identified in distribution"
Benefit
It is your responsibility to ensure that as much of the product as possible is removed from the market. In the event of a recall you will need to know how much of the product is in your firm's control and how much has been sold. Using these amounts you can determine if you have notified all of the necessary accounts during the recall. This is called "Product Reconciliation".
Description
Record the amount of each lot code of each product produced.
Benefit
Keeping accurate distribution records allows 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 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.
Benefit
For your own protection, it is important that products which have been recalled are recorded so that you know that the product has been controlled and has not reentered the market.
Description
Your recalled product records should contain:
Benefit
Your recall plan must contain a step-by-step description of what to do when you have to recall a product. This is the plan that you will action during a recall. A brief description 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 as follows:
Benefits
Your firm is responsible for ensuring that all of the accounts which you shipped the recalled product to are notified. 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:
Benefit
During a recall, your firm's 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, pick a lot code of a product which you know has reached the consumer market. Then test your system and record:
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, in detail, 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 conducting a recall are as follows:
PROBLEM IDENTIFICATION / DECISION TO RECALL PRODUCT(S)
Problems resulting in a recall may be identified by the manufacturer, consumers or the CFIA. Once a product has been identified as being unsafe or violative, it is your firm's responsibility to determine the nature and extent of the problem in a timely manner and to take prompt and appropriate action to protect the health of consumers. Where the problem is of a health and safety concern, you must consult with the Canadian Food Inspection Agency to ensure that your action decision is correct.
At the very beginning of the recall your firm must:
Notify the CFIA immediately when you suspect that your firm has manufactured 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.
It is your firm's responsibility to ensure that all products which need to be recalled are identified. In addition to those products directly affected by the problem, your firm must:
It is your firm's responsibility to ensure that all products to be recalled that are in your firm's control are not distributed. Your firm must:
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:
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.
Your firm is responsible for immediately notifying all of the accounts that received the recalled product.
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.
Your firm is responsible to ensure that recalled products do not re-enter the market.
The action to be taken on the recalled product should be approved by the CFIA.
As the manufacturing firm that produced the unsafe product, it is your responsibility for ensuring that all reasonable steps are taken to prevent similar recalls in the future.
Listed 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 Solutions:
5. NOTIFICATION OF CUSTOMERS
Problem:
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:
FOR 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:
(DESCRIBE THE PRODUCT INCLUDING BRAND NAME, PRODUCT NAME, PACKAGING, SIZE(S). LOT #, UPC CODE)
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).
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For more information, media please contact:
(COMPANY CONTACT NAME)
(COMPANY NAME)
(CITY, PROVINCE/STATE, COUNTRY)
(DAYTIME PHONE)
(AFTER-HOURS PHONE)
URGENT - RECALL OF (Name of Product)
(NAME AND ADDRESS OF YOUR COMPANY)
(DATE)
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).
Product Name | Brand | Size | Code, Best Before date, UPC |
---|---|---|---|
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 "RECALLED"and (YOUR COMPANY NAME) staff will call you to arrange pick up.
IMPORTANT
Please record the time and date you received this Recall Notice and acknowledge receipt by signing and faxing this document to (YOUR COMPANY NAME) at
(YOUR COMPANY FAX NUMBER).
Date / Time Received: Signature:
Name of store / Distributor:
Thank you for your cooperation.
(Signature)
(YOUR COMPANY'S CONTACT, THEIR POSITION, YOUR COMPANY NAME)
"Mandatory recall" means a recall as per Section 19 of the Canadian Food Inspection Agency Act.
19.(1) Where the Minister believes on reasonable grounds that a product regulated under an Act or provisions that the Agency enforces or administers by virtue of Section 11 poses a risk to public, animal or plant health, the Minister may, by notice served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister."
"Product Withdrawal" means a firm's 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 firm's 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.
"Class I" is 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" is a situation in which the use of, or exposure to, a violative product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
"Class III" is a situation in which the use of, or exposure to, a violative product is not likely to cause any adverse health consequences.