Re-analyzing Hazards & Assessing Risk

The dates are well past for all food facilities, except those defined as very small, to be in compliance with FSMA’s Preventive Controls rule. This means you have Food Safety Plan in place that, as detailed by FDA in its guidance, “includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards.” So, you can now get back to business as usual and focus on producing food rather than fulfilling rules, knowing that you’re done with that. Right?

“No,” said Melanie Neumann, president of Neumann Risk Services, and EVP and general counsel of Matrix Sciences. “The race has just started. There is an ongoing expectation to keep the plan updated.”

In addition to conducting a reanalysis of your Food Safety Plan (FSP) at least once every three years, FSMA requires that food facilities reanalyze the plan or portions thereof based on certain triggers, such as the incorporation of a new ingredient or process, the event of a recall, etc. “Ergo: when there is a new risk,” Neumann said. “The strategy, or high-level message is to always come back to the reanalysis trigger. Put the question into a CAPA (corrective and preventive action) analysis, asking, ‘Does this trigger a reanalysis of my Food Safety Plan?’”

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