CHRISTINA BERNAL, AIB LATAM GMPs Quality Manager

The main objective of a food recall is to keep consumers safe and prevent health and safety concerns. Food manufacturers may decide to recall products from the market when certain hazards that represent a threat to customers take place. Since FSMA became a law in 2011, FDA does not have to wait for a company to initiate a voluntary recall. Rather, it now has the authority to require food manufacturers to recall products if there is credible evidence to believe that the food presents a threat of serious adverse health consequences or death to humans or animals.

Although manufacturers’ food safety systems have to comply with regulations and are striving to ensure consumer safety, there is always the risk of allergen cross-contact, unwanted foodborne microorganisms, or foreign matter contaminating the product. If this takes place and it is a significant food safety issue, a food recall will need to occur.

Most food manufacturers are required to have a recall plan readily available, but even if this were not a regulatory requirement, it is a necessity for the food safety plan. The recall plan should include the management strategy to take quick and effective action if there is a food safety failure at the facility. If needed, this plan will be an invaluable guide to walk the company through the steps to take during the recall.

Additionally, when a company goes through a recall — whether it is voluntary or FDA-mandated, it must then go into a recovery stage. Once product distribution has ceased; product is removed from retail shelves; and the government, clients, and consumers have been informed of the situation, there are still other activities to perform.

A recall can be a difficult situation for a food company as there is no formal or regulatory procedure to follow once the recall has taken place. As with any learning process, there will be many questions to answer after the recall that will drive the company into action. Let’s look into the aspects that have to be completed.

  1. Assimilate the recall process. Analyze the recall plan execution and modify it as appropriate. Meet with the recall team to review what was useful, what was slow, what could not be performed, and what had to be done — even things that had not been considered previously. The outcome will be a modified recall plan and a timeline of post-recall activities, as well as messages to share with employees, customers, suppliers, and the media, if needed.
  2. Determine the root cause. Reanalyze your hazard analysis and risk-based preventive controls and prerequisite programs. Depending on the nature of the recall (e.g., mislabeled allergens, Salmonella or Listeria outbreak, contaminated ingredients, etc.), some prerequisite programs will need to be reviewed more thoroughly than others. The basic aspects to include in this analysis are:
      1. Use a flow diagram to review the processes and the flows of personnel, raw materials, packaging, and transportation equipment.
      2. Review personnel, contractor, and visitor practices in different activities, e.g., arrival at the facility, in changing rooms, handwashing, equipment and utensil cleaning, breakrooms, and work areas.
      3. Inspect equipment and its infrastructure to evaluate the conditions, maintenance, accessibility, cleaning, and in surrounding areas, such as drainage, connections, electric cabinets. The main focus should be the equipment that maintains special conditions or is a kill step in the process, such as refrigeration and cooking.
      4. Review your: 
        • Cleaning procedures, tools and utensils used, and chemical usage and rotation.
        • Raw materials, packaging, and finished product testing.
        • Environmental monitoring program with its testing methods.
        • Supplier approval program.
  3. Establish corrective actions to eliminate the root cause of the problem. These should be based on a thorough investigation of the situation from receipt of ingredients and packaging materials. Identify the root cause of the problem, define when and where in the process the problem began and ended, establish corrective actions, and follow them.
  4. Transform opportunities into learning outcomes. After meeting with the recall team to assess the recall approach, you will need to integrate some new information into the current food safety system. This information should be added to specific procedures, and personnel trained on the modified procedures. Follow up is necessary until new procedures are fully implemented. A recall management strategy is necessary to establish actions to prevent recurrence of the situation(s) that caused the recall.

Company awareness — from top management to the line workers — of your processes, vulnerabilities, and procedures will strengthen your organization and help it emerge stronger after a recall.