What are "Recall Plan Templates"

The "Recall Plan Templates" are worksheets used by Food Distributors and Manufacturers to track products and manage a food recall process. If you do not have a Recall Plan, every template provided will be useful. If you already have a Recall Plan, feel free to request the templates to compare your plan with ours and ensure you have everything you need.

CLICK HERE: INSTANT ACCESS TO FREE RECALL PLAN TEMPLATES 

What to Do In The Event Of A Product Recall?

Every Food Distributor and Food Manufacturer must track the products they manufacture and distribute. Since the "The Food Safety Modernization Act" was signed on January 4, 2011, it's the law. Food Decision Software Inc. (FDS) has taken all the applicable information regarding product recalls and recall planning and have summarized it into 10 easy steps so you can create your own Recall Plan. Not having a Plan to recall a product is like not having insurance. You hope you never need it, but when you do, you’re happy that you have it.

The information we have provided can be used by any Distributor or Manufacturer in the Food Industry. FDS has been granted permission to use and summarize the information that is provided below to help you create your own Food Recall Plan. To help speed up the process in developing your own Recall Plan, FDS has created Recall Plan templates for both a Manufacturer and Distributor.

As Recall Plans for Food Distributors and Food Manufacturers do have some differences, we have provided the applicable information for both. If information is specific, we have identified it as “Manufacturer” or “Distributor”.

What is a Food Recall?
What is a Recall Program?
Parts of a Recall Program
1. Recall team
2. Complaint file
3. Recall contact list
4. Traceability
5. Production amounts
6. Shipping and sales records
7. Recalled product records
8. Recall procedures
9. Recall effectiveness
10. Testing the recall program
Which Government Agencies Deal with Recalls?
Recall Decision
Recall Classification
References
Food Recall Plan Templates in Excel Format
Disclaimer

What is a Food Recall?

Food producers use many controls to ensure the safety of their products. Despite their best efforts, however, sometimes unsafe food products, or those that do not meet legislative requirements, make their way into the marketplace. When an unsafe or violative food product has left the control of the manufacturer/distributor, it must be removed from the market. This process of removing the product is called a recall.

Any food recall has the following aims:

• Stopping the delivery and sale of the product in question;
• Informing the appropriate regulatory agencies; and
• Proper and timely removal from the marketplace of the product in question.

What is a Recall Program?

The ability to remove products from the market quickly and effectively is vital to every food producer and distributor. A recall program is a written action plan that is carefully constructed, tested and evaluated to ensure efficiency. It is the safety net that can prevent consumers from buying or eating a potentially harmful food product.

Having an efficient recall program may reduce a company’s liability, while a non-existent or poor recall program can have serious economic and legal consequences. For a small processor or distributor, a recall can be a very traumatic experience. Being properly prepared for a recall can make the difference between a recall being a learning experience or a nightmare.

Parts of a Recall Program

A recall program can be broken into 10 parts. Each part plays a specific role and gives a different benefit to your company. These parts are often linked to other food safety programs that may be in place.

1. Recall Team

Identifying recall team members and assigning recall duties enables the recall procedures to be conducted quickly and smoothly. The recall program should also identify the person who will coordinate the recall. The recall coordinator should have the authority to call upon other recall team members as needed to address the issues at hand. Because many recalls happen outside of regular working hours, after-hours contact information should be included in any recall team list.

Your team should include people responsible for:

• Decision Making
• Quality Assurance/Technical Advisory
• Media Communication
• Complaint Investigation
• Contacting Customers
• Contacting your regulatory body (FDA, FSIS or CFIA)
• Legal Counsel

The list of people that make up your team should be reviewed and updated on a regular basis.

2. Complaint file

When a complaint is received, it is important to record the details and start an investigation either at your plant or your distribution facility. Early action on your part may enable you to identify potentially unsafe products and correct problems or enable you to stop selling the product until it is determined that it is safe.

A complaint file should consist of:

• Complainant Information – This should include information about the person who made the complaint (name, address, telephone numbers, any illness or injury)
• Problem Details - The problem with the product (allergic reaction, illness, object in the product, chemical taste, etc.)
• Product Details – The product name, lot code or production date, package type and size, other identifying codes, is there a sample of the product.
• Retail Details – name and address of the store purchased and the date of purchase
• How the Complainant stored and handled the product
• Detailed Illness Inquiry (Manufacturer) – Find out as much as possible regarding when the product was consumed, how many persons are ill, ages of people that are ill, etc.
• Complaint Referred? – Has the complaint been referred to anyone else? This could be Public Health, FDA, CFIA, FSIS, etc.
• Investigate the complaint and record the findings

- Ensure that all products that may have been affected are investigated by a trained person in your company

- Record the details of the investigation (persons name, date, findings, other products that might be effected)

- Take action based on investigation findings

- If you are a Distributor, contact the Manufacturer of your findings

- Once all findings are in place, contact the appropriate government agencies to discuss and ensure your actions are correct.

3. Recall Contact List

If you suspect that you have sold or distributed an unsafe or violative food product, it is your duty to contact your regulatory agency immediately, as they can assist with the investigation and the collection of information to help make the right decision. A recall program should contain a contact list with the names, phone and fax numbers of the appropriate regulatory agencies. As there are local contact numbers for regulatory agencies, we have provided the website links so you can find those applicable to you.

Food Safety and Inspection Service (FSIS) Index of local offices and Phone numbers

https://www.fsis.usda.gov/wps/portal/informational/contactus

Canadian Food Inspection Agency contact #’s in case of recall

https://www.inspection.gc.ca/food-safety-for-industry/cfia-notification/eng/1300377749580/1300378289195

The contact list should also contain the phone and fax numbers, after hours contact information, primary contact and email address of all your suppliers and customers. Every company you distribute to should be listed on this document.

WinFDS Built-in Functionality – Generating a list of all your suppliers and customers is part of the functionality built into WinFDS. Being able to generate a report that lists the supplier who delivered the product and all customers that have been shipped a specific product with specific lot number is also part of the functionality built into WinFDS.

4. Traceability

Being able to determine which products need to be recalled allows you to limit the scope of a recall. If the specific affected products cannot be identified, you will need to broaden the scope of the recall, often recalling more products than necessary, which results in more financial losses. If the products are incorrectly identified, another recall may be necessary.

As a Distributor, traceability of products involves record-keeping procedures that provide you with the information of products that have been received and distributed. If you are a Manufacturer, additional traceability procedures that show the route a raw material took from the supplier through production to the final product, and then on to customer/distributor are necessary.

To develop a traceability system:

• (Distributor and Manufacturer) – Link the products you receive from each Supplier.
• (Manufacturer) - Link all ingredient lot codes to finished product codes: If a raw material has caused a food safety issue, being able to trace it back to the supplier will increase the chances of correcting the problem and avoiding it happening again. When an ingredient enters production, record its lot number and link it to a formula or production information.
• (Manufacturer) - If you use rework, link the ingredients of the rework to the finished products. Carryover product from one lot to another can compound the traceability of a product. All rework should be assigned a lot number to be later linked to the final product it goes int
• (Manufacturer) - Lot code finished products: All products manufactured should be coded. This information will be used to inform customers what products are associated with any recall activities. Product lots can be determined by one day’s production or by the time span from one sanitation period to the next. Each plant’s volume and type of production will dictate how far processors may go in subdividing product lot size. The smaller the lot size, the more manageable the recall becomes. It is important to document the definition of a “lot” in your recall program.
• (Manufacturer) - Link finished product codes to customers/distributors: This can be achieved by including the lot codes sold to each customer on distribution records.
• (Distributor) – Link the products you have received to the accounts you have distributed the product to.

Each manufacturer and distributor should develop their own traceability policies. The more key information products can carry with them, the better the chances of finding and removing them swiftly from the marketplace.

WinFDS Built-in Functionality – Linking raw materials to finished goods and maintaining the traceability path from receiving goods to knowing what accounts they were shipped to is part of the functionality built into WinFDS.

5. Production amounts (Manufacturers)

In case of a recall, a company must ensure that as much of the affected product as possible is removed from the marketplace. Having an accurate record of how much product has been sold, and how much is still on the premises, helps ensure that all customers are notified of the recall. This means documenting the amount of each lot of each product manufactured.

WinFDS Built-in Functionality – Documenting exactly how much product was manufactured, how much was sold and how much is still in your warehouse is part of the functionality built into WinFDS.

6. Shipping and sales records

Maintaining accurate shipping and/or sales records is crucial because they can enable a company to limit the recall to only the customers who received the affected products.

Shipping and sales information should include:

• Customer name and contact information. In the case of a wholesale customer, the name of the person to contact and the contact information (e.g., telephone and fax numbers, email address) are needed. Some food processors sell their products from retail areas on their premises; it can be difficult to keep track of customers in this kind of operation. Should a recall be necessary in this event, a local media announcement would be considered.
• Product name and lot code.
• Amount of product shipped to each customer. If products are sold through a retail area, it is not necessary to know the amount sold to each individual customer. However, it is the plant’s responsibility to know the amount of product sold through the retail system.

The operator must keep all production, traceability and distribution records for at least one year after the expiry (best-before) date on the label or container. Check with your regulatory agency to ensure that you are maintaining your records for the correct period of time.

WinFDS Built-in Functionality – Tracking exactly how much product was sold/distributed and how much is still in your warehouse is part of the functionality built into WinFDS.

7. Recalled product records

It is beneficial to develop recall product records to ensure that recalled products are controlled and do not get into the hands of customers. Such records should include the name of the product being recalled, the amount, the date the product has been recalled and the corrective action taken for each product.

8. Recall procedures

Every recall plan should contain a step-by-step explanation of what to do when a product needs to be recalled. Following this plan will help food manufacturers and distributors ensure that important steps are not overlooked during this time of crisis. Recall procedures should be readily available and should explain product coding, product traceability, and production and distribution records. Develop all necessary forms to be used in case of a recall, as well as a media release form if necessary.

The steps in any recall are similar for all products. For each recall, the processor should:

• Identify the concern
• Assemble the recall team
• Notify your applicable regulatory agencies
• Identify all products to be recalled
• Segregate (put on hold) affected products that are in your control
• Prepare a distribution list
• Prepare a press release (if necessary)
• Notify customers (informing them what to do with the recall products)
• Control recalled products and decide what to do with them
• Dispose of recalled products
• Fix the cause of the recall

9. Recall effectiveness

A company recalling a product is responsible for notifying all customers who bought the affected products. They should also verify that all customers have stopped the distribution of the affected products, and that all recalled products have been returned to the processors’ or distributors’ control or other designated area as instructed in the recall notification.

10. Testing the recall program

Mock recalls test a company's ability to recall products without actually recalling them. Mock recalls are strongly suggested and should be tested on a regular basis. The goal is to be able to identify every affected lot, know exactly where it is at any point in the process, and know who to contact to bring it back. A mock recall can be an eye-opener: some processors discover that they are not as prepared as they thought.

Mock recalls should test both product-tracking and ingredient-tracking systems.

Results of the practice must show that a manufacturer/distributor is able to handle a recall situation (a 95-100% efficiency rating). If deficiencies are identified, correct the problems and retest the program with another mock recall.

Which Government Agencies Deal with Recalls?

Depending on if you are in the United States or Canada will depend on the Government Agency that will deal with product recalls.

In the United States – The United States Department of Agriculture Food Safety and Inspection Service (FSIS), deals with product recalls for meat and poultry in the United States. For egg products and all other products the U.S. Food and Drug Administration (FDA) deals with all other products. The FDA or FSIS may take the lead role in investigating and coordinating food recalls, or just require that the processor ensure they are kept informed.

In Canada - Under the Food and Drug Act and Regulations, the Canadian Food Inspection Agency (CFIA), with help from Health Canada (which provides health-risk assessments), deals with product recalls for all food processors/distributors in Canada. The CFIA may take the lead role in investigating and coordinating food recalls, or just require that the processor/distributor ensure the CFIA is kept informed.

All of these regulatory agencies are also available to help with investigations and recall activities.

Recall Decision

Recalls are usually initiated by the manufacturer or distributor of the unsafe product, sometimes at the request of the regulating agency. These are called voluntary recalls because they are initiated and carried out by the manufacturer or distributor without a regulatory agency order.

If a processor or distributor refuses or chooses not to conduct a recall, the regulating agency may order the processor or distributor to conduct the recall.

Recall Classification

There are three levels of food product recalls. The classifications identified by the US and Canada are the same and indicates the relative degree of health risk posed by the product being recalled:

Class I

A situation where serious adverse health consequences (possibly even fatal) may result if the product is consumed. A public alert is usually issued.

Class II

A situation where a health hazard might exist but the probability is remote. A public alert may be issued.

Class III

A situation where the consumption of the product is not likely to cause health problems. A public alert is not usually issued.

References

Food Safety and Inspection Service (FSIS) Index of local offices and Phone numbers: https://www.fsis.usda.gov/wps/portal/informational/contactus

FDA’s Regulatory procedures Manual (Chapter 7): http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074312.pdf

Recall for Provincial Meat and Poultry Processors:

The Canadian Food Inspection Agency - Food Recalls: Make a Plan and Action it! Manufacturers' Guide:

The Canadian Food Inspection Agency - Food Recalls: Make a Plan and Action it! Distributors' Guide:

Health Canada: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/proces-eng.php

Food Recall Plan Templates in Excel

Food Decision Software has also developed the Food Recall Plan Templates into Excel Worksheets.

What you get:

• 17 Excel worksheets to use as your own Recall Plan
• 3 Excel worksheets that help you manage your product movement
• Worksheets for both Manufacturer’s and Distributor’s
• Detailed guide on how to use the worksheets provided
• Ability to sell to Customers that require Product Traceability and a Recall Plan in place
• Piece of mind that you are ready in the event of a Food Recall  

If you are interested in acquiring the Food Recall Plan Excel Worksheets, send us an email to: sales@fooddecisionsoftware.com and we will provide you with the details of how to acquire the Food Recall Plan Excel Worksheets.

Disclaimer

The information provided on this page has been compiled from a number of reputable sources that have granted FDS permission to use all or part of their information. FDS has in its best effort compiled the information to provide a much needed process for producing Food Recall Plans. The following companies and Government Agencies shall not be held responsible for any information used from their sources to compile this procedure:

Food Decision Software Inc. (FDS)

United States Food and Drug Administration (FDA)

United States Department of Agriculture Food Safety and Inspection Service (FSIS)

Alberta Agriculture and Rural Development

The Canadian Food Inspection Agency (CFIA)

Articles Written about FDS Recall Plan

Read a Case Study on how WinFDS helped a Distributor perform a Product Recall. >>

"Recall Preparedness" in "Canadian Meat Business".

"Canadian software firm offers free recall plan templates" in "The Packer".

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