Blog,Food Safety,Undeclared Allergens

Food Recalls are Serious Business – Protect Your Company with Mock Recalls

6 Tips for Effective Mock Recalls

Mock recalls are routine exercises that are conducted to verify the effectiveness of a manufacturer’s traceability and recall procedures. They are an essential tool in every food manufacturer’s toolbox that are capable of limiting the scope of a recall, saving the company time and money and ultimately protecting its reputation.

Object of a Mock Recall

If you spend any time reviewing FDA Recalls, Market Withdrawals and Safety Alerts then you have noticed that a large number of recalls are occurring due to “Undeclared Allergens”.

The object of the mock recall is to periodically confirm that a company can trace product throughout the supply chain. Each time a mock recall is performed, it provides valuable information for the food company on fine-tuning their procedures to fill in gaps in traceability and highlight what further training may be needed for personnel.

What are potential causes for a food recall?

It is critical for a company that handles food to understand that food recalls can be attributed to many different possibilities. Some of the more recent recalls that have happened relate to:

• Undeclared food allergen recall
• Pathogen, such as Listeria or Salmonella, discovered
• Foreign object in food
• Packaging Defects
• Misbranding

Why is it important to document lot codes and traceability information?

It is critical to have complete information on incoming goods including ingredients, and any packaging materials that could potentially come into contact with food. If your procedure for documenting lot code and traceability information is lacking, you will find this out immediately when performing a mock recall. Without accurate and up-to-date information, you could end up recalling much more product than necessary in order to account for all potentially affected products.

Recall Plan

Prior to conducting your Mock Recall exercise, your company should have developed a Recall Plan. This plan should include, among other things, the forming of the Recall Team and the establishment of your company’s recall goals.

What is the Recall Team?

The recall team is a group of people that are designated in your Recall Plan. This team is identified by name, position and the responsibility they have on the recall team. Responsibilities for the Recall Team could include:

• Recall Coordinator – corresponds with FDA/FSIS/State/ERD/OPHS
• Alternate Recall Coordinator
• Public Relations – corresponds with media
• Legal Counsel Liaison
• Quality Assurance Manager
• Production Manager

What are company recall goals?

Each recall exercise should be done within the timeframe established by the company. With proper execution of a traceability system it is entirely possible to conduct a mock recall in less than 30 minutes. However, in more complicated situations, the mock recall could take several hours to perform. Each company should define a time limit to conduct the exercise and work to meet or exceed the goal.

The goal of any mock recall is 100% reconciliation of recalled product. However, each company should evaluate their program and determine minimum criteria for a successful mock recall. Depending on the type of operations being conducted it may be necessary to allow a certain percentage to account for normal waste or shrinkage. For example, a typical food manufacturing operation might use the following goals:

CATEGORY GOAL
Outgoing Finished Product 100%
Incoming Ingredients 98%
Packaging Materials 98%

Failure to meet these goal requirements should necessitate evaluation and repeat exercise.

Steps of an Effective Mock Recall

1. Determine Scope of Mock Recall

Choose the item to be used for the mock recall. Ideally someone other than the person performing the mock recall should determine the focus of the exercise. This person should define whether it is a single lot code, an entire production run or some other defining factor for the recall.

Developing a “real life” scenario for the recall is also an effective way of making the scenario more realistic. For example, you might conduct a recall that was initiated by your packaging material supplier that covers a specific lot of containers that have been found to crack under normal storage conditions.

Be sure to alternate between ingredients, packaging and finished product.

2. Track products/ingredients/packaging using traceability procedures

The starting point of this process will depend on the scope of the recall. If you are simulating a supplier recall then you will need to begin your recall at your receiving step and determine how many units of affected product you received and then trace it through your production process to determine how many lots of your finished product must be recalled. Supplier recalls are generally more complicated because they could potentially affect multiple lots of different finished products.

If you are conducting a mock recall on one of your finished products then you typically begin that process by evaluating your production records to determine how many units of finished product were produced. Then an evaluation of your current inventory should be performed to determine if any of the affected lot codes are still in house. If product is still in inventory then the quantity in stock should be deducted from the total units that must be recalled. (During an actual recall this inventory of affected product would be placed on hold and quarantined).

The next step in the process is a review of shipping records to determine where each container of recalled product was shipped so that you can generate a list of customers that would have to be notified during the recall.

3. Reconciliation

Once you have completed the review of receiving, production and shipping records you must then evaluate the effectiveness of the system by calculating the percentage of product that you were able to locate.

Recall Effectiveness Calculation

 
 
 
The goal of any mock recall is 100% reconciliation, however your recall may be deemed successful based on the parameters set in your Recall Plan.

4. Verify Communication

Contact information for affected suppliers and customers
Identify all companies/people that would have to be notified during an actual recall. It is important to verify that contact information is accurate. It is not necessary to actually contact those identified.

5. Assess Mock Recall

At the completion of your Mock Recall it is important to review the process and evaluate the effectiveness of your traceability and recall procedures. At this time the team should discuss the percent of product recovered, the time necessary to complete the mock recall and any issues that arose during the process. Any issues that were discovered during the exercise should be discussed with the entire Recall Team and corrective actions should be established.

6. Modify Plan if Necessary

It is very possible that the result of the audit will identify a weakness in your system. Use this experience to strengthen your Recall and Traceability systems either with additional technology, improved documentation or enhanced training for employees.

Frequency of Mock Recalls

It is up to each company to determine the frequency that mock recalls should be performed. You should consider the potential risk associated with the product produced, as well as, the success rate of the mock recalls performed. If you are consistently missing the established goals, more frequent recall simulations may be needed.

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John True
Director Regulatory Compliance