FSMA Food Safety Plan

Continuing with our Tip of the Week series about FSMA, today we would like to share some thoughts about the Food Safety Plan that registered facilities must develop, implement, manage and document. So, what is a Food Safety Plan, what does it contain, and who is responsible? Let’s take a look.

The Food Safety Plan is the result of the risk assessment undertaken by the facility. Such assessment contains two parts. The first one deals with the hazard analysis related to “known or reasonable foreseeable hazards” associated with incoming raw materials, ingredients and food contact packaging, the process itself, and lastly the manufacturing environment. The second part reviews the food safety compliance history of US suppliers with federal, state, local laws and regulations, as well as foreign suppliers’ compliance histories with US laws, as well as their local food safety laws and regulations.

The Preventive Controls Rule requires that the Food Safety Plan have at least the following components:

  • The risk evaluation
  • Hazard analysis methodology and results
  • Supplier evaluation
  • Identification of the Preventive Controls
  • The supply-chain control program, as required
  • A recall plan

The management elements of the plan, including written procedures to undertake 1) monitoring, 2) corrective action (has 4 elements), 3) verification, and 4) validation.
The Food Safety Plan must be written and consists of two sections, namely the components mentioned above, plus the “written” procedures for the management elements and the records to capture the implementation of the management elements and the results.

The rule also requires that the Food Safety Plan “must be prepared or overseen by one or more Preventive Controls Qualified Individuals” (PCQI). Also, the “the owner, operator, or agent in charge of the facility must sign and date the food safety plan, upon initial completion and upon any modification”.

The written Food Safety Plan must always be at the facility and must be re-evaluated every 3 years or when a significant change occurs, new information comes to light regarding relevant hazards, or a failure occurs that makes the PCQI question the effectiveness of a specific Preventive Control, a combination of them, or the plan itself.

We are sure most of you already have a similar plan at your facilities. But, just to be sure, we will issue additional tips in the coming weeks to review the different requirements of the Food Safety Plan in more depth.

In the meantime, if you have any questions, please send us an email.

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