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CAPA plans essential to surviving a recall

When auditors visit food facilities, particularly when auditing for compliance with the Food Safety Modernization Act, one of the first things they want to see is the Corrective and Preventative Action (CAPA) plan.

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Noncompliance and recalls can have financial consequences — the average cost of a food recall is $10 million, according to Sage Food Safety Consultants in Cincinnati. Yet, less than half of companies say they are ready for a recall. Only a third have a standardized process in place.

One of the goals behind the Food Safety Modernization Act of 2011 (FSMA) is reducing risks, which should reduce recalls. Companies with strong, automated CAPA plans can more quickly and efficiently conduct recalls. A CAPA plan can also enhance customer service by speeding responses to questions or complaints by improving traceability and certifying compliance.

What should a CAPA plan inclulde?

“Auditors want to see what is done when different high risk scenarios take place or happen and how does an organization ensure that steps are followed for corrective, as well as preventative measures,” said Chris Williamson, general manager of the X3 division of NexTec Group in Orlando.

Williamson said if a customer calls in with a complaint a number of questions come up: What type of complaint is it? Is it related to food safety? Does it require an inspection of some sort (equipment, produced good, raw material, packaging, etc.)?

Other factors to consider are: Is a product affected? Is it still in inventory? Does a recall need to be initiated? What are the next steps? What is the audit process?

“Best practices usually involve leveraging technology or a system that can record the action or incident and then have it trigger the next course of action,” Williamson said. “The definition of workflow in many solutions is an engine that sits and monitors, waiting for a specific condition to happen. So when that condition does happen, it triggers either a notification or another action.”

FDA’s take on CAPA plans

The Food Safety Modernization Act enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur, according to the agency’s website.

Under FSMA the FDA has, for the first time, a legislative mandate to require comprehensive, science-based preventive controls across the food supply. The following are among FDA’s key new prevention authorities and mandates.

Mandatory preventive controls for food facilities require companies to implement a written preventive controls plan that includes:

  • evaluating the hazards that could affect food safety;
  • specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards;
  • specifying how the facility will monitor these controls to ensure they are working;
  • maintaining routine records of the monitoring; and
  • specifying what actions the facility will take to correct problems that arise.

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