- Disruption of key services such as utilities, labor disputes, and communications
- Natural disasters, such as fire, flood, tornados, etc.
- Malicious or intentional sabotage or tampering
- Undeclared allergens or illegal weights
- Microbiological contamination
The Food, Drug & Cosmetics Act administered by the Food and Drug Administration (FDA) classifies recalls into three classes:
- Class I: Involves a life-threatening situation. FDA now has the authority to mandate a recall, a 100 percent effectiveness check and appropriate public announcements.
- Class II: Involves a potentially hazardous situation, but not a life-threatening condition. FDA will usually mandate a recall to the retail outlets and will not require a 100 percent effectiveness check. A press release may be required, depending on the reasons for the recall.
- Class III: Involves no serious hazard. It is usually limited to the wholesale level with no effectiveness checks and no press release requirements.
A market withdrawal is the voluntary removal of distributed product that has a minor violation such as improper labels or packaging. Products included in voluntary market withdrawals are generally the result of a minor quality issue or regulatory program infraction that would not cause the product to be adulterated or misbranded. In most cases, this sort of defect is not subject to regulatory action by the FDA. While still a possible safety concern, the violation does not pose an immediate safety threat to consumers.
Preparing for these incidents will help you if you ever have to deal with one of these issues.
First, the scenario: your notified by a regulatory body, the news media runs a story on a possible problem with a type of product you produce (e.g. peanut butter) or your internal QC results or customers alert you to an issue.
The recall action plan might look like this:
Recall Action Plan
- Notify the Recall Team and initiate the crisis management plan
- Assign tasks per the pre-assignments
- Gather evidence
– Naturally occurring contamination or adulteration
– Purposeful act – call FBI
- Analyze evidence, notify FDA and work with them on classification
- Identify and trace the product
- Get word out to end users
- Monitor recall
- Dispose of product
- Apply for termination of recall
- Assemble recall team and debrief
- Prepare for legal eventualities
The next question is: Where do I begin? Here are some steps to take.
Have a product recall plan ready to execute at a moments notice. Test the recall plan at least annually in a real world scenario. Evaluate the test to find any “bumps in the road” to a successful execution.
The crisis management and recall plan should have the following elements:
- A list of key personnel and their back up. It may be necessary to have one team at a corporate level to direct recall activities overall, and individual teams more focused on the operational aspects of product recall at the sales/marketing and/or manufacturing levels. Assume that some recall-related lead personnel will not be available when you need them. Assume that the computer system where you maintain your stakeholder contact lists has crashed. Assume other similar worst-case scenarios and make your back-up plans accordingly.
- Identify team members. These can include but are not limited to:
– Quality Control
– Product Safety
– Legal Counsel
– Third-party consultants
– Outside counsel
- A defined list of responsibilities, i.e. who will handle the media, customers, regulatory bodies.
- A communication plan to inform the public and other stakeholders
- A list of support companies and their contacts such as legal advice, laboratories, transport companies, etc.
- Product withdrawal or recall procedures; who will initiate, who will deem recall complete.
- A training plan for all your employees including your receptionist. Very often, this person will be the first point of contact for customer, media and regulators. This person needs to know how to deflect and direct inquiries.
- Proper documentation is the single most important factor affecting the potential success or failure of a product recall. A document control system should be based on company policy and hazard analysis.
- The success of a product recall will largely depend on how accurately the company’s records can identify specific products (by batch, production or date codes) in question as well as tracing the customers who purchased these products. Such a system also enables the company to isolate specific causes of defects and thereby limit the number of products subject to recall.
- Product traceability should start with raw material suppliers and progress through the production and distribution system to the end users. Shipping documents and invoices should contain the records of batch/date codes.
- In the absence of adequate traceability, the company may actually end up recalling many more products through a blanket recall. Therefore, a practical and efficient lot or batch numbering, product or package identification, and shipment records system must be established before the fact.
- The traceability system should be tested at least annually and should be conducted raw material forward to end user, end user to raw material and should also include traceability data for any rework, ingredients, processing aids and primary packaging.
Recalls are procedures used to identify and recover potentially adulterated, misbranded, and/or hazardous foods in order to prevent potential food safety problems or economic fraud. The recall procedures outlined in this article are based on traditional industry practices that have proven to be effective for all foods, in all levels of commerce. The procedures comply with the expectations of both the state and federal regulatory authorities in the United States and GFSI (BRCGS, SQF, etc.) standards
In the real world, you cannot rely on “winging” it. Only a properly prepared crisis management plan and trained staff will allow you to get through a product recall successfully