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The FDA is knocking; are you ready to answer the door?

In a recent Industry Today article, we advised manufacturers who are wrestling with Food Safety and Modernization Act compliance, that there is no denying one simple truth: once the regulatory genie is out of the bottle, there’s no turning back. Regulations rarely become less stringent, and inspections and audits rarely become simpler over time.

Too many organizations struggle to catch-up, leading to unnecessary costs and panic wrapped in bureaucratic red tape. Waiting until the FDA has fully codified the rules and begun enforcement is not the time to start implementing a compliance plan. But good planning and implementation of compliance programs will not only meet requirements but also, in this age of social media, control the market perception when it comes to food safety. As Dr. David Acheson, the former chief medical officer for the FDA and the USDA Food Safety and Inspection Service, cautions, “When things go badly with the FDA and USDA; that is a headache. When things go badly with our customers; that is the end.”

So how do manufacturers stay ahead of the curve when compliance rears its head? We hear consistently how critical documentation is; but documentation is not the means to the end. Sarah Geisert, Senior Director, Global Product Safety and Regulatory Affairs at General Mills states it clearly, “You have to have process.” She, and we at Kepner-Tregoe, define this as “the walk;” involving the right people, at the right time, in the right way, to ensure each person is doing the right thing. Clear, consistent thinking drives success – across different levels of the organization, across different functional areas, even across different locations.

Shawn Stevens, a Food Safety attorney, submits this theory: Access to records is needed for the FDA to determine if your product is a risk. Visible, transferable process can help you operate and perform. Further, the Agency may conclude from your records whether or not you are at risk.
You need good documentation and a good process. Facilities that have thought clearly about how to operate under the new rules and have executed rational processes in preparation, will be in better stead. With a solid corrective action mindset in place, audits and exceptions can be treated as individual, manageable episodes – not devastating and distracting sagas, wrought by an unreasonable watchdog.

In our next blog post, we’ll outline some basic steps that can help manufacturers to proactively address the Food Safety and Modernization Act and to use effective and efficient compliance for competitive advantage.

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