Product Recall and Product Withdrawal

Product Recall and Product Withdrawal

Food businesses 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 people ill or injure them, or is possibly in violation of food manufacture legislation. When an unsafe or unsuitable 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 Product Recall or Product Withdrawal. If your business has made a product that is a risk to public health or unsuitable for consumption and you have sold the product to someone else, you are legally obliged to recall or withdraw the product. This applies to all manufacturers that have sold unsafe food products.

The goal of a recall or withdrawal policy should be able to allow a food business to answer ‘Yes’ to the following 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 the entire 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 and remove it from the market?

The following information aims to provide a food business with an overview of how to develop a recall and withdrawal plan and how to action the plan in the event of a recall or withdrawal. It will assist in identifying products that are unsafe and enable the business to recall or withdraw the product from the marketplace.

Product Recall and Product Withdrawal Protocols

Managers should ensure effective procedures are in place to deal with any food safety hazard and to enable the complete, rapid recall or withdrawal of any implicated lot of the finished food from the marketplace. Where a product has been recalled or withdrawn because of an immediate health hazard, other products which are produced under similar conditions, and which may present a similar hazard to public health, should be evaluated for safety and may need to be recalled or withdrawn. The need for public warnings should be considered. Recalled or withdrawn products should be held under supervision until they are destroyed, used for purposes other than human consumption, determined to be safe for human consumption, or reprocessed in a manner to ensure their safety. Through the implementation and verified monitoring of all the above, results such as the production of safe and suitable food or foods that are free from potential hazards and of prescribed quality, and maintained custom can be easily obtained.

The documented recall and withdrawal procedures outline the anticipated actions to be taken in the event of a product being recalled for whatever reason. The nominated strategies for such an event will ensure that all relevant steps are followed to remove the food from causing potential harm. Product recall and withdrawal requirements include a documented product recall program; outlining specifically what is required in a recall situation.

The following examples show the types of Product Recall and Product Withdrawal classifications that can be used to define risk or severity in the event of an incident:

• High: A situation in which there is a reasonable probability that the use of, or exposure to, a volatile product will cause serious adverse health consequences or even death to consumers.
• Medium: A situation in which the use of, or exposure to, a volatile product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
• Low: A situation in which the use of, or exposure to, a volatile product is not likely to cause any adverse health consequences.

Steps to an Effective Recall

The documented elements of a recall and withdrawal plan form the basis for:

• Identifying health and safety concerns in your existing food safety systems;
• Contacting and working with Health Authority staff and other relevant parties;
• Assigning recall and withdrawal duties to specific individuals in your food business to ensure that all parts of the recall and withdrawal are covered;
• Tracing and identifying products that are affected by the problem;
• Tracing product shipments;
• Controlling returned product;
• Checking the effectiveness of your recall or withdrawal;
• Testing your written recall and withdrawal plan to ensure that it is efficient and effective.

All of these elements should be developed and documented before conducting a recall or withdrawal.

The goal of a recall and withdrawal plan is to describe in detail each of the key steps your food business should take once it has been decided that a recall or withdrawal will be conducted. These recommended steps include the preparation of a recall or withdrawal notice, and in some circumstances, a press release. Your business should review these sections before conducting a recall or withdrawal so that you are familiar with the nominated recall and withdrawal requirements. It would be beneficial for your firm to maintain ‘templates’ or to prepare sample documents that can be used as examples during a recall or withdrawal. This will speed up the process and ensure that all of the necessary information is included.

Formatting a Product Recall and Product Withdrawal Plan

Once the decision to conduct a Product Recall or Product Withdrawal, a structured approach must be implemented to ensure appropriate outcomes are achieved. Recalling or withdrawing a product is a planned action that will help you remove an unsafe or unsuitable product from the market rapidly and efficiently. The following information provides example elements that should be included in your recall and withdrawal plan. All of these elements must be considered as each provides a different benefit to your business operation. Some of these elements will link to other food safety program elements that may already be in place within your food business.
It is important to consider that the Product Recall or Product Withdrawal process can often be initiated out of a Customer Complaint. In such instances, the Product Recall or Product Withdrawal plans must include relevant customer contacts and notifications.
The following elements should be considered as components of your recall and withdrawal plan:

• Recall and withdrawal team;
• Complaint file;
• Recall and withdrawal contact list;
• Traceability of raw materials, packaging materials, finished products, and other process inputs;
• Product volumes;
• Distribution records;
• Recalled or withdrawn product records;
• Recall and withdrawal procedures;
• Recall and withdrawal effectiveness verification procedures;
• Testing the recall and withdrawal plan.

Initiating a Product Recall or Product Withdrawal

Your recall plan must contain a logical step-by-step description of what to do when you have to recall or withdraw a product. This is the plan that you will initiate during a recall or withdrawal.

The recommended step by step procedure is as follows in a logical sequence:

• Assemble the recall and withdrawal, management team;
• Notify the appropriate health authority and other relevant parties;
• Identify all products to be recalled or withdrawn;
• Detain and segregate all products to be recalled or withdrawn which are in your business’ control;
• Prepare a press release if required;
• Prepare the distribution list;
• Prepare and distribute the notice of recall or withdrawal;
• Verify the effectiveness of the recall or withdrawal;
• Control the recalled or withdrawn product;
• Decide what to do with the recalled or withdrawn product;
• Rectify the cause of the recall or withdrawal if the problem occurred within your business operation.

Assemble the Product Recall and Product Withdrawal Team – Step 1

When a food product has been identified as unsafe, it must be removed from the market quickly. Assigning recall and withdrawal duties to each will allow you to action your recall and withdrawal plan smoothly. You can be assured that all of the procedures are covered. Recalls and withdrawals often occur after regular work hours so you must be prepared to contact people outside of the business. The list of people who make up your team should be reviewed and updated regularly.

Your recall and withdrawal team should include people responsible for:

• Decision making;
• Quality assurance and technical advisory;
• Media communication;
• Complaint investigation;
• Contacting accounts;
• Relevant and appropriate government, customer, and food industry contacts;
• Legal Representation.

Your recall and withdrawal team listing should contain the following:

• Names of team members;
• Alternate replacement people;
• Business phone numbers;
• After hours phone numbers;
• Recall responsibilities;
• Recall authority nominations.

At the very beginning of the recall or withdrawal your business must:

• Make sure all members of the recall and withdrawal management team are informed of the decision to conduct a recall or withdrawal; and
• Ensure that each member knows their responsibilities during the recall or withdrawal.

Notify the Relevant Health Authority and Other Relevant Parties – Step 2

Notify the appropriate health authority and other Relevant Parties immediately when you suspect that your business has manufactured and sold a product that may pose a serious risk to consumers.

It is important to consider that if you are manufacturing a product on behalf of a customer, they may hold legal responsibility for contacting the relevant health authority.

Provide the health authority with the following information:

• A detailed description of the nature of the problem;
• Details of the affected product, including name, brand, size, lot code, and packaging type;
• Details of complaints received and any reported illnesses;
• The distribution scope of the product: local, national, or international;
• Specific dates for when was the product distributed;
• Labels of the product to be recalled or withdrawn;
• The total quantity of product manufactured and distributed;
• The name of your food business’ contact with the appropriate authority;
• The name and telephone number for your business’ after-hours recall or withdrawal contact.

This information is essential for the appropriate health authority to develop an accurate and complete risk management strategy.

Identify Product to be Recalled or Withdrawn – Step 3

Keeping accurate distribution records allows you to limit your recall to the specific accounts that received the product being recalled or withdrawn. Your business should have a record system that can generate these records accurately and quickly. Your business should be able to create a distribution list that is product and code-specific.

This distribution list should include:

• Name of the account, street address, city, state/province, country;
• The type of account, for example: manufacturer, distributor, and retailer;
• Product name and lot code;
• Who to contact at the account;
• Telephone number and other contact numbers consistent with the documented methods of contact during a recall, including fax number, e-mail, and postal address;
• Amount of product shipped to each account.

These distribution records should be kept for a period that exceeds the shelf life of the product. In some instances, the time is specified by regulations. Check with the relevant health authority to ensure that you are maintaining your distribution records for the correct time.

It is your business’s responsibility to ensure that all products which need to be recalled or withdrawn are identified.

In addition to those products directly affected by the problem, your business should:

• Determine if any other codes, brands, or sizes of the same product are affected;
• Determine if any other products are affected.

Traceability of Products to be Recalled or Withdrawn

Being able to identify which products have to be recalled or withdrawn is a great benefit to your food business. It allows you to limit the scope of the recall or withdraw the products 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 you may have to recall more products than is necessary. Furthermore, incorrect identification of the product during the initial recall may lead to other recalls.

To limit your recall or withdrawal to a specific product you must:

• Link all raw materials to their suppliers;
• Link all raw material lot codes to finished product codes and code your finished products by lot;
• If your business uses rework, you must be able to link the ingredients of the rework to the finished product codes;
• If your firm premixes ingredients and stores them for use at another time, you must be able to link the ingredients in the premixes to the finished product codes;
• Distribution Records – link your finished product codes to the accounts receiving the product.

In some instances, your business may be required to recall or withdraw a product because of the use of a raw ingredient or packaging material that has been determined to be unsafe or unsuitable. By linking raw ingredient lot codes to the finished product code, your food business will be able to identify which of your finished products need to be recalled or withdrawn.

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.

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 or withdrawal, you will need to know how much of the product is in your business’ 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 or withdrawal. This process is commonly called ‘Product Reconciliation’. To document product reconciliation, it is necessary to record the amount of each lot code of each product produced.

Product Recall and Product Withdrawal Records

For your protection, products that have been recalled or withdrawn must be recorded so that you know that the product has been controlled and has not re-entered the market. Your recalled product records should contain a description of the product recalled or withdrawn including where appropriate:

• Brand name;
• Product name;
• Size;
• Identifying codes.
• The amount of product recalled;
• The date the product was recalled;
• Corrective action was taken for each product.

Detain and Segregate Products to be Recalled that Remain in your Business’ Control – Step 4

It is your business’s responsibility to ensure that all products to be recalled or withdrawn that are in your business’ control are not distributed.

Your business should:

• Determine the location of the recalled or withdrawn product, for example on-site, in-transit or at off-site storage;
• Determine the amounts at each location;
• Identify and segregate products to prevent distribution.

Prepare a Press Release if Required – Step 5

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 relevant health authority will advise you when a press release is necessary.

During this step, your business should:

• Decide who will prepare the press release, your food business, or the appropriate health authority;
• If your firm decides to prepare the press release, include all relevant information;
• Complete the press release within two hours after being notified of the recall or withdrawal;
• Submit a draft of the proposed press release to the relevant health authority for approval;
• Arrange for translation of the press release if required.

Prepare the Distribution List – Step 6

Using your distribution record system, produce a product and lot code specific distribution list which:

• Identifies the accounts that received the recalled or withdrawn product;
• Lists the names and addresses of the account, contact names, and telephone numbers;
• Identifies the type of account, for example, a manufacturer, distributor, or retailer;
• Is provided to the relevant health authority contact within 24 hours.

Prepare and Issue the Notice of Recall or Withdrawal – Step 7

Your business is responsible for immediately notifying all of the customers that have received the product to be recalled or withdrawn:

• Content of notice – prepare a written notice that includes all relevant information;
• Confirmation of receipt or action – ask customers to confirm that the notice has been received and action has been taken;
• Approval of notice – submit the draft notice to the relevant health authority for approval. Where a Notice of Recall contains inaccurate information and/or is incomplete, the relevant health authority may require your firm to revise the notice and reissue it;
• Method of transmission – Send your notice of recall or withdrawal to each account by the method stated in your distribution list system;
• Follow-up – Contact customers who have not responded to your request for confirmation of receipt of the notice of recall or withdrawal;
• Recordkeeping – Keep records of those accounts which your food business has contacted and which accounts have confirmed receipt of the Notice of Recall.

Verify the Effectiveness of the Product Recall or Product Withdrawal – Step 8

Your food business is responsible for ensuring that all of the customers to which you have supplied the product to be recalled or withdrawn have been notified. You must assess the effectiveness of your recall and withdrawal notification. The recall effectiveness procedure includes a plan to assess the effectiveness of the recall or withdrawal.

Elements of this plan should include:

• The number of customers that were notified of the recall or withdrawal;
• The number of customers that were contacted or confirm if they had received the recall or withdrawal notification;
• Method of confirming that the customers were notified;
• A statement describing how you determine if your recall and withdrawal notification was effective;
• A statement of the recall or withdrawal notification effectiveness;
• A statement of the corrective action to be taken where it is determined that the recall or withdrawal was not satisfactory;
• Verification that your customers have stopped distributing and selling the recalled or withdrawn product;
• Verification that the recalled or withdrawn product has been returned to the designated place as stated in your notice of recall or withdrawal.

It is generally the responsibility of the relevant health authorities to follow up with some of your customers to verify the effectiveness of the recall or withdrawal. Where it is determined that the recall or withdrawal was ineffective, your business may be required to repeat the recall or withdrawal process.

Control of the Recalled or Withdrawn Products – Step 9

It is your business’s responsibility to ensure that recalled or withdrawn products do not re-enter the market. This may include requirements to:

• Separate and identify recalled or withdrawn products;
• Reconcile quantities and monitor returned product;
• Record the recalled product in your recalled or withdrawn product records document.

Decide what to do with the Recalled or Withdrawn Products – Step 10

The action to be taken on the recalled or withdrawn product should be approved by the relevant health authority, and may include:

• Decide on the action to be taken on the recalled or withdrawn product, for example, rework or destruction;
• Find out if the relevant health authority is required to witness or verify that this action has been taken;
• Verify that the action has been effective;
• Record the action taken for each product in your recall and withdrawal records.

Rectify the Cause of the Recall or Withdrawal – Step 11

As the manufacturing business that produced the unsafe product, it is your responsibility to ensure that all reasonable steps are taken to prevent similar recalls or withdrawals in the future. You must endeavor to put controls into place or revise existing controls to prevent similar problems in the future.

Common Problems with Recalls and Withdrawals

Following are some common problems, potential impacts, and recommended solutions associated with some of the steps in the Product Recall and Product Withdrawal Procedures:

Press Release and Notice of Product Recall or Product Withdrawal

Problems:

• The hazard is not clearly described;
• The urgency of the recall is not clearly stated;
• The key message is obscured by other information, for example, advertising content;
• Instructions to customers are not clear.

Potential Impacts:

• Distributors, retailers, and consumers may not understand the seriousness of the hazard;
• Hazardous products may not be removed from sale or distribution promptly;
• Consumers may use the recalled product before they are aware of the hazard;
• The relevant health authority or the recalling or withdrawing food business may have to issue a second press release.

Recommended Prevention:

• State the hazard clearly to the product being recalled or withdrawn;
• Put the word ‘URGENT’ in the title of the notice;
• Be brief and to the point, do not include promotional information;
• Instruct customers what to do with the product, for example, to destroy it or return it to the store for a refund and controlled disposal

Preparation of the Recall or Withdrawal Distribution List

Problems:

• The list is not provided to the relevant health authority within 24 hours after the food business decides on the classification of the recall or withdrawal;
• Key information in the distribution list is missing or not current, for example, contact names, addresses, or phone numbers;
• The list is not legible; the print is too small or letters are not clear;
• The list includes customers who did not receive the product to be recalled or withdrawn.

Potential Impacts:

• Recalled or withdrawn product which has not been removed from the sale is not identified on time;
• Customers may purchase and consume the recalled or withdrawn product;
• Verification of the effectiveness of the recall or withdrawal may be significantly delayed.

Recommended Prevention:

• Develop the ability to identify customers who received specific codes of product quickly;
• Develop the ability to prepare an accurate, complete distribution list within a suitable time frame.

Informing the Relevant Health Authority

Problems:

• The relevant health authority is not notified of the recall or withdrawal;
• The relevant health authority is notified days or weeks after the problem is identified by the food business.

Potential Impacts:

• Hazardous products may not be removed from distribution and sale on time;
• Customers who have purchased the product may use it before they are aware of the hazard.

Recommended Prevention:

• Notify the relevant health authority immediately if you suspect a product that your food business has manufactured and sold may pose a risk to the health of consumers.

Identification of Products to be Recalled

Problems:

• All of the sizes, lot codes, brands of the affected product are not identified;
• Other products affected by the recall or withdrawal are not identified.

Potential Impacts:

• Hazardous products may not be removed from distribution and sale on time;
• Customers who have purchased the product may use it before they are aware of the hazard;
• The relevant health authority or the recalling food business may have to issue a second press release;
• The food business may have to conduct a second recall or withdrawal.

Recommended Prevention:

• Determine and include all of the products manufactured from the time the problem started to the time the problem was resolved;
• Consider other products manufactured on the same line or using a similar process.

Product Recall and Product Withdrawal Notification to Customers

Problems:

• The food business decides to remove the product from the retail level without informing customers of the recall or withdrawal;
• The notice of recall or withdrawal is not written; the food business has no record of what was communicated to customers;
• The notice of recall or withdrawal is mailed to clients;
• Customers are not notified until days after the recall or withdrawal was classified;
• Customers are not notified.

Potential Impacts:

• Distributors, retailers, and customers may not be aware of the hazard;
• Distributors, retailers, and customers may not understand the seriousness of the hazard;
• Hazardous products may not be removed from sale or distribution on time;
• Customers may use the recalled or withdrawn product before they are aware of the hazard;
• The relevant health authority or the recalling or withdrawing food business may have to issue a second press release.

Recommended Prevention:

• Inform all customers of the recall or withdrawal immediately and in writing and through effective advertising media.

Control of the Recalled or Withdrawn Product

Problems:

• Recalled or withdrawn product is accidentally transported to customers;
• Recalled or withdrawn products are sold to customers.

Potential Impacts:

• Retailers may sell the recalled or withdrawn product;
• Consumers may purchase and use the recalled or withdrawn product.

Recommended Prevention:

• Segregate and identify recalled or withdrawn products;
• Take precautions to ensure that the recalled or withdrawn product is not accidentally released.

Verifying the Effectiveness of Product Recall and Product Withdrawal

Problems:

• The recalling food business does not verify that the notice of recall or withdrawal was received and action was taken;
• The recalling or withdrawing food business does not confirm if the recall or withdrawal was effective.

Potential Impact:

• Recalled or withdrawn products which have not been removed from the sale are not identified on time.

Recommended Prevention:

• Implement recall and withdrawal effectiveness verification procedures.

Testing Your Product Recall and Product Withdrawal Plan

Your recall and withdrawal plan should be tested regularly through a ‘Mock Recall’ activity. During a mock recall, your business’ recall and withdrawal team will put your recall plan into action. This is the perfect time to find out which elements of your recall and withdrawal plan are effective. You may also discover that the recall plan does not provide the information you need to remove the unsafe product from the market completely and quickly. Testing your recall and withdrawal plan before you have to do an actual recall or withdrawal enables you to identify opportunities for improvement that can be rectified. When you test your recall and withdrawal plan, pick a lot-code of a product that you know has reached the customer marketplace. This will ensure you can demonstrate an effective recall and withdrawal process.

The following example flow processes can be used to verify the effectiveness of your Product Recall and Product Withdrawal procedures in both backward and forwards traceability scenarios:

• Forward from the raw ingredient level, for example: “Our business received a phone call from Supplier ‘X’ who informed us that ingredient ‘Y’ was contaminated and that all products which have this ingredient should be removed from the market immediately”; or
• Backwards from the finished product on the marketplace, for example: “Our business investigated a consumer complaint and found that product ‘Z’ manufactured by our food business was unsafe and should be removed from the market immediately”.

Follow your established processes and record the outcomes as an example of the application of your Product Recall and Product Withdrawal procedures.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Product Recall and Product Withdrawal Development requirements in relation to their items.