Tip Sheet 15 - Product Identification, Traceability, and Withdraw and Recall

The ability to identify and trace product is an important aspect of any food business. Food regulators, retailers, insurance companies and food manufacturers require that product be traceable, and at a minimum have a process in place that enables them to trace product to the customer (one up) and back to the material supplier (one back).

However, even with your best efforts, there may be a breakdown in controls that can lead to a recall or withdrawal. Having an effective plan in place that includes the ability to effectively identify and trace product and respond to a recall will help in minimizing the impact of the event to your brand.

Learning Objectives

• Describe the requirements for identifying product within its process
• Describe the basic components of traceability
• List the top reasons for recalls
• Prepare for a recall
• Execute the basic steps of a recall

Applicable Code Elements

• 2.6.1
• 2.6.2
• 2.6.3

Key Terms

Effectiveness Checks

Investigations or follow up to assure that all stakeholders in the recall have been notified and appropriate action has been taken.

Market Withdrawal

Removal from the market of contaminated or below quality products not in violation of regulatory requirements.

Recall

A site’s action to protect the public from food products that and may cause health problems for possible death. A recall removes food product from the market when there is reason to believe that the product is contaminated, adulterated, and/or mis-branded. Recalls are often voluntary; however in some instances regulatory agencies may mandate a recall. In some countries, withdrawal is used as recall.

Traceability

The ability to track food through all stages of production, processing and distribution. Traceability movements should be traced one step backwards and one step forward at any point in the supply chain.

Process Steps

1. The first step in an effective traceability and recall program is to have the ability to label and identify product at all stages of its process within the operation.

a. Product must be labeled upon receipt and identified throughout the process through to finished product. This includes the identification of all major and minor ingredients, such as spices, additives, etc., as well as processing aids.

b. How the site designs the identification system is entirely their own choice as long as product can be identified and tracked at every stage of production from receiving, production, including rework and work in progress, to the finished product and delivery/dispatch.

c. The finished product label needs to contain information that accurately describes the product in accordance to customer specification and/or regulatory requirements in the country of origin and intended country of destination.

d. When shipping finished product, the site must ensure the product is clearly identified and that all product identification details are accurately described on dispatch documents or otherwise included with a shipment once it leaves the business.

e. Examples of how product is identified can include:

i. Bin tags

ii. Pallet tags

iii. Color coding

iv. Labels/stickers

f. Product identification records must be maintained.

2. The supplier must have a process in place that enables them to trace product to their customer (one up) and back to the material supplier (one back).

a. Traceability is a “one up, one back” requirement. The supplier’s procedure must include details of how all raw materials, packaging materials and processing aids are linked through to the finished product; and must outline how the supplier accounts for the reuse of reworked product. The product trace procedure must outline how the supplier traces product to a customer and who is responsible for implementing and maintaining the product trace system.

b. The documentation must assign responsibility for product dispatch and include the product name, when it was dispatched (sold), who was the customer (not including direct sales to consumers), the quantity and the production batch dates and details.

c. The supplier’s first customer is the first location where the product is delivered after it leaves direct control. This can be a distribution center, customer location, broker, etc. It is not the requirement of the site to be able to trace past the first customer. However the supplier should also check with the requirements of their buyers.

d. For example, if a site shells and roasts pecans and sells this as an ingredient to a granola bar manufacturer, the site must know the source of the pecan farmer (one back) and the granola bar manufacturer (one forward).

3. The best way to handle a recall is to prevent one from occurring. Having an SQF food safety system in place is one way to prevent a recall. However, despite all our best efforts and good intentions, recalls are still a fact of life. A recall is a crisis situation and like other crises must be handled in a calm, logical and methodical manner. Having an effective identification and labeling program in place will help improve your response time and minimize the overall impact to your product and brand.

a. The following are the most common recalls

i. Mislabeling of product and not including allergens in the ingredient statement.

ii. Biological contamination from environmental pathogens- specifically Listeria and Salmonella.

iii. Foreign material such as plastic, metal shavings, etc.

b. Summary of a recall

i. Remain calm

1. If you have a tested plan in place, you can have confidence that you will be able to live through this recall.

ii. Investigation

1. Gather the necessary information.

2. Locate the product.

3. Speed and accuracy are important.

iii. Evaluation

1. Decide to recall or withdrawal.

2. Develop the recall strategy.

iv. Coordination

1. One person should be assigned to coordinate all activities.

2. Send out recall notification.

v. Implementation

1. Notify the distribution chain.

2. Double check the notification.

vi. Document, review and evaluate

c. How to prepare for a recall

1. Establish a recall team and select a recall coordinator.

a. The team should be made up of responsible representatives from top management, the technical staff, distribution, public relations, and legal. Outside expertise such as an outside laboratory should also be considered.

b. The recall coordination will have the primary responsibility for coordinating and directing all recall related activities.

c. The recall team also includes the communication team and strategy.

2. Establish recall contacts

a. This includes all recall team members, suppliers, and buyers.

b. The CB and SQFI are to be included on the recall contact list.

c. Include business and emergency contact information.

3. Develop a process flow of the site

a. Identify the location of all food and non-food items.

b. Show the flow of product from receiving through distribution.

c. Include all storage facilities (on site and off).

d. Identify the segregated area for the returned product.

4. Develop an ingredient product identification program (see above)

a. Maintain a supplier register for all major and minor ingredients, processing aids, lubricants, chemicals, food packaging, etc.

i. Obtain product codes and lot identification information for each supplier.

b. Maintain invoices

i. Maintain invoices and bills of lading for all ingredients.

ii. Keep records orderly, such as in chronological order.

c. Develop and retain receiving records

i. Show the use of all the incoming ingredients and material.

ii. Maintain distribution records.

iii. Include invoices and bills of lading.

iv. Identify distributors, brokers, wholesalers and retailers.

v. Shipments should include name of the shipper.

d. Maintain records of lot codes and labels

i. Lot codes shall be legible.

ii. Records should include all finished product, the quality produced and where the product was shipped.

e. Establish a product rotation system i. Include raw materials, partially process items and finished goods. ii. Rotate the stock using the first-in first-out method.

f. Develop and implement your written food safety plan and SQF system

i. Conduct internal audits to determine effectiveness.

ii. Conduct initial and refresher training.

iii. Monitor the incoming supplies and suppliers.

g. Test the plan and conduct a mock recall

i. Test all elements of the recall plan at least one time annually.

1. Choose a mock incident either end of the process flow.

a. For example, you may test the system by choosing a finished product or an ingredient.

ii. Test the full process including the recall contacts, investigation process, communications, and actions taken during the recall and to the affected product.

iii. Keep records of all mock recalls and supporting documentation, including follow up or corrective actions.

iv. Be cautious in your test as not to trigger actual publicity.

d. Depth of a recall refers to the distribution level involved.

a. Consumer level: Typically the end user

b. Retail level: Level immediately preceding the consumer level, typically the retailer

c. Wholesale level: All levels between the manufacturer and the retailer.

e. Effectiveness checks: This is the action taken by the site to verify that everyone at the recall depth has been notified and appropriate action has been taken. The buyer often determines the level of effectiveness checks for the site.

Relevant Resources

• FDA - Recalls, Outbreaks & Emergencies
  https://www.fda.gov/Food/RecallsOutbreaksEmergencies/default.htm
• Food Marketing Institute - Crisis Communications Manual
  https://www.fmi.org/industry-topics/crisis-continuity
• SQF Food Safety Code Module 2 Guidance Document
  https://www.sqfi.com/wp-content/uploads/Module-2-Manufacturing-Guidance-with-cover.pdf