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Oct
09

FDA’s Recall Planning Guidance Offers Little New Insight

FDA started issuing draft industry guidance related to Hazard Analysis and Risk-Based Preventive Controls for Human Food (PCHF) in January 2018, but the 16 chapters are still a work in progress. Most recently, the FDA alerted the industry in the federal register that Chapter 14: Recall Plan is now available.

The PCHF guidance specifies that companies and organizations “must establish a written recall plan for food that requires a preventive control (21 CFR 117.139(a)).” Per the FDA’s requirements, the plan must include “procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform” several actions, including the following:

  • Notify direct consignees of the food being recalled, including how to return or dispose of the affected food (21 CFR 117.139(b)(1));
  • Notify the public about any hazard presented by the food when appropriate to protect public health (21 CFR 117.139(b)(2));
  • Conduct effectiveness checks to verify that the recall is carried out (21 CFR 117.139(b)(3)); and
  • Appropriately dispose of recalled food—e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food (21 CFR 117.139(b)(4)).

With this in mind, the chapter is intended to help companies establish and implement a recall plan. While the presentation of the material is formalized as official Guidance, there is little new within the recommendations offered. In fact, the Guidance references several resources that FDA has made available over the years, including template recall warning notifications, news releases, response forms and effectiveness check letters.

In our experience, many companies already have most, if not all, of these suggested elements in place. And what they might not have in their own formal documents, the FDA already provides (like template news releases and notification documents). But the fact of the matter is that the real learning comes with regular recall planning, auditing and exercising efforts. In other words, to really ensure you are ready when a recall strikes, make sure you:

Review existing plans, templates and resources (such as contact lists and supply chain details) no less than annually. If you experience significant changes between those reviews, take the time to update the plan immediately.

Train your employees. With the plan development and review complete, ensure all employees with assigned responsibilities receive adequate training. At a minimum, this includes a detailed review of roles and responsibilities. But that training should also incorporate any technical, legal, or communications briefings that help the team understand how the company may make decisions related to the overall recall strategy.

Conduct mock recall exercise. This type of training should also be completed no less than annually, but possibly as frequently as quarterly. In an ideal world, you are evaluating recall readiness across the entire company – from your internal quality, food safety, sales, marketing and legal teams.

Initiate recall planning efforts across organizations. When appropriate, loop in your supply chain to ensure you fully understand the steps they would take (and their timeline) during an actual recall event. Don’t forget to include both upstream suppliers and downstream retail partners. Your recall effectiveness depends on their cooperation.

Engage outside experts. It’s easy to think you are ready for a recall when you are intimately involved in the planning. It’s even easier when you have a tenured team with members who have helped manage recalls in the past. But having an outside perspective is invaluable, especially as consumer, supplier, and retailer expectations of manufacturers and suppliers evolve. It doesn’t need to be done for every plan review or recall exercise, but when you can loop them in, we encourage you to do so. The added benefit is that they have intimate knowledge of your plan and team, making their ability to offer strategic and technical support during a recall seamless.

The value of recall planning can never be overstated. But don’t forget that effective planning is about far more than the words on a page.

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