The Food Safety Modernization Act (FSMA) was designed to move food safety from a reactive process to a proactive one, identifying and controlling hazards before they cause harm to consumers.

The FSMA also acknowledges that even the best food safety plans aren’t a 100% guarantee against a product becoming tainted with a pathogen or allergen. So it also outlines how manufacturers should be prepared to pull them from the marketplace if deemed necessary.

In early March 2022, the Food and Drug Administration issued its final guidance on how companies can be “recall ready.” This blog from ImEPIK the steps food manufacturers should take to be ready for a recall and how to implement them as part of their facility’s food safety plan.

Why the FDA Wants You to Be Recall Ready

Simply put, it’s in a manufacturer’s best interest to be able to remove a product from the market as soon as possible upon confirmation that it poses a health risk. That confirmation might come from within the company, from a supplier, or from the FDA if a traceback investigation implicates a product during an outbreak of foodborne illness.

In announcing the recall ready final guidance, Judith McMeekin, FDA associate commissioner of regulatory affairs, said a voluntary recall is the fastest and most effective way for a company to correct or remove potentially harmful products from the marketplace.

“It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain,” McMeekin said in a news release.

The FDA’s guidance centers on three questions that a manufacturer’s food safety team should ask during the process to establish a voluntary recall plan. The questions are:

  • How should a firm in a product distribution chain prepare to facilitate the timely initiation of a voluntary recall?
  • What should a firm do if there is an indication of a problem with a distributed product?
  • How should a firm initiate a voluntary recall?

How Should You Prepare for Voluntary Recalls?

Produce Food RecallThe first steps in establishing a recall plan are basic: determine who is responsible for recall-related responsibilities and train them on those responsibilities. Consider assigning alternate staff to assume those roles in case the primary recall leader is unavailable — food safety events don’t plan around vacations or time off. Training could include mock recalls.

Communication is critical during recall events, whether with the FDA, downstream supply partners, or the media. A recall communications plan will eliminate confusion and should include draft templates to make the process faster.

Record-keeping is critical when faced with a recall. Adequate product coding needs to identify production and control data for each lot. Maintaining distribution records ensures the products can be found on retail shelves, a restaurant’s kitchen, or a distribution facility.

What Should You Do When There’s a Problem with a Product?

The FDA recommends that firms that face product problems – regardless of whether required by regulations – take several steps:

Identify the problem. Procedures should be in place to trigger warnings for potential issues with distributed products. That includes out-of-spec test results, consumer complaints, and internal reports of product deviation.

Investigate the problem. Companies should conduct a timely investigation of whether a manufacturing deviation occurred and if product safety was affected. Criteria should be written out to ensure risks are consistently assessed and investigated in an inquiry.

Make decisions and take action. Is a recall necessary, and if so, what’s the appropriate scope of the recall – a full production run, all products containing a suspect ingredient, or items shipped to a specific region?

How Do You Initiate a Voluntary Recall?

The FDA advises companies to issue voluntary recalls before completing an investigation into what caused the problem and develop procedures to inform the entire distribution chain to rapidly identify affected lots. In addition, direct accounts receiving the products should be notified, and those accounts should extend the recall if products were shipped to another customer.

Although electronic records are not mandatory, the FDA has advised companies to use technology to speed traceability.

The FDA posts recall notices provided by companies on its Recalls, Market Withdrawals & Safety Alerts webpage.

ImEPIK Training Helps Guide the Recall Process

ImEPIK’s courses help companies prepare for all aspects of food safety, including recall plans. One of the course’s modules focuses solely on recall plans, record-keeping requirements, and related supplier/audit actions. Plus, the PCQI course  is available in Spanish.

Contact ImEPIK for more information on how we can help you become “recall ready.”