Recall Management Driven by Risks and Regulations

USDA Food Safety Inspection Service (FSIS). Different from FDA’s mandatory recall authority, under USDA/FSIS regulation, it is a firm’s decision to voluntarily recall a product. However, FSIS coordinates with the firm to ensure it has properly identified and removed the recalled product from commerce by verifying the effectiveness of the firm’s recall activities. Companies under FSIS jurisdiction who find themselves in a recall are required to notify their local FSIS District Office personnel within 24 hours when they learn or determine that adulterated or misbranded product has entered commerce. FSIS also requires firms to prepare and maintain recall procedures detailing how to conduct and execute a recall, and affords FSIS the right to review and copy records that may relate to a recall.

USDA provides guidance on how to manage a USDA recall in its Directive 8080.1 Rev. 7 document, which can be found on its website.

Both agencies notify the public about product recalls through public press release announcements, and email alerts sent by each agency to subscribers, such as the FDA Recalls, Market Withdrawals, and Safety Alerts.

Preparation is Key

Understanding the regulations and expectations by the agency that governs you isn’t enough to truly be “ready” to successfully handle a recall. Companies must focus on preparation rather than reaction. By focusing on the following best-in-class preparation tactics, companies can better prepare themselves to tackle a recall and come out on top. The suggested tactics are as follows.

Create a Written Recall Plan. Both FDA and FSIS require written recall plans with specific elements, but what additional content should be in an effective recall plan? In my years of experience, the following elements are the keys of a robust recall plan that possesses a high probability of executing a successful recall:

• Corporate policy statement commitment to food safety and quality and placing consumer health and safety at the forefront of all decisions;
• Cleary defined roles and responsibilities;
• Incident identification, investigation, and escalation process;
• Health hazard evaluation process;
• Communications plan and procedures; and
• Training and testing through simulations.

Develop a Toolbox. Time is of the essence in a recall or other food related crisis. Sitting down in the midst of an actual crisis is not the time to start putting pen to paper for the very first time. Avoid the rush of writing content for a press release or researching appropriate health risk statements by planning in advance. Take the time now—in a time of calm not chaos—to prepare as much of this information in advance to save precious time during an actual incident. Good “tools” to develop and have in your toolbox include:

• Templates—press releases, FAQs for your call center and website, customer letters, and agency communications;
• Checklists—recall action items and meeting logs; and
• Contact Lists—internal recall team and backups and external expert resources.

Test Your Plan Through Simulations. The importance of training and testing your recall plan cannot be emphasized enough. The most effective way adults learn today is by practical, hands-on learning. So kick the tires of your plan, test your systems, and challenge your people! Do not make these simulation scenarios easy just to check the box. Your organization will not grow and improve unless you challenge the people, process, and technology that you rely on to successfully execute a recall.

Thus, companies should conduct both announced and unannounced recalls. Consider including your customers in the simulation by selecting a finished product of one of your major customers. This shows your commitment to food safety and the protection of your customer’s brand, and often your customer requires you to conduct a simulation using one of their products anyways.