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Guest Post: Electronic Documentation Eases FSMA Compliance

January 28, 2013
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On the two-year anniversary of the passage of the Food Safety Modernization Act, or FSMA, the agency proposed its first two major FSMA rules – and the food industry finally got a glimpse into the FDA’s expectation of preventive controls.

A major part of compliance is documentation. According to the FSMA, if it isn’t recorded, it didn’t happen.

First, the requirements: Facilities need to have a comprehensive written plan that shows…

  • How hazards have been evaluated
  • How they are being controlled
  • How the facility knows the controls are working and are being implemented in the way specified by the plan
  • What specific steps are taken when any kinks in the system are observed
  • Documentation that these steps are in fact taken, and that the food safety plan is then re-evaluated

Many companies will have a difficult time tracking down the required paper documentation, and then they will have to order scores of filing cabinets to contain it. Others will adopt electronic recordkeeping and documentation systems that manage all of this for them. The FDA, in its new preventive controls rule, expressed its preference for continuous monitoring of preventive controls, and the agency expects firms to be looking for — and reacting to — trends in data.

Our suggestion: Go electronic. 

While it is important to begin preparing for FSMA compliance, it is also important to realize what the path forward looks like. The FDA is requesting public comment on a multitude of critical issues that will greatly influence what the final rules look like. Right now, we are in the “proposed rule” stage. It will be many months before FDA issues “final rules,” and companies will have one to three years to comply, based on their size.

But this does not mean firms should delay! The FDA is ramping up both the frequency and intensity of inspections, and it expects to see firms heading in the right direction, not keeping their heads in the sand.

FSMA rules have a long way to go before they are completely enforceable – but remember that, in the short term, a head in the sand does not protect the brand.

What is your company doing to not only comply with these new rules, but also look forward at industry trends?

About the Author

Dr. David A. Acheson Partner, Leavitt Partners

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