YourEncore Insights - Consumer Goods

FSMA Implementation: Getting Past “What” to “How”

Posted by Jim Kamman, Ph.D. on 9/15/16 11:00 AM

After five years of listening sessions, draft rules, comment periods, discussion, analysis, planning, and compromising, the rules are final and the first compliance date for the Food Safety Modernization Act (FSMA)has arrived. It’s here, it’s now, and it’s real!

Many food companies began their move towards compliance when the preliminary rules were first published in late 2011. A lot of companies, however, waited until the final rules were issued last fall, leaving themselves only 1 or 2 years to comply with the Preventive Controls for Human Food rule, depending on their size. Regardless of when they started, much of the focus has been on "what" needs to be accomplished … understanding and interpreting the rules. Of course, this is crucial. There are a lot of excellent resources available to help companies, including those outlined in Sarah Geisert’s recent post. But as Llaine Groninger noted, based on her experience at The Hershey Company, and as I’ve seen as a YourEncore Consulting Partner helping our food clients in their FSMA journey, the real challenge is in “how” to achieve compliance. And nearly all companies, both large and small, have discovered that the “how” is more complex, time consuming and resource intensive than they anticipated.

So, how do you get started on the “how"? Here are 3 areas of focus and a process I follow to help clients get past “what” and on to “how”.

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Topics: Consumer, FSMA Compliance

FSMA Implementation: 3 Lessons Learned Along the Way

Posted by Llaine Groninger on 9/6/16 3:48 PM

Over the course of my 36 years with The Hershey Company, I helped lead and execute a number of global Quality, Regulatory, and Governance initiatives. Perhaps one of the most challenging, and yet rewarding, was implementation of the Food Safety Modernization Act (FSMA).

When the FDA published the proposed rules in 2011, we had a very robust food safety program in place. The first question senior management asked was, “how close are we to being compliant?” At the time, there were still a lot of unanswered questions. But, like many food companies, generally speaking we thought we were in pretty good shape – maybe 85% to 95% “there.” We initiated a FSMA working group within Hershey to identify potential gaps and develop associated action plans in preparation for the final FDA rules. Thus began a five-year marathon to move us to full compliance with FSMA.  There are three lessons we learned along the way that might prove helpful to others as they make this same journey.

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Topics: Quality & Safety, Food, Regulatory, FSMA Compliance

FSMA Compliance: 4 Steps to Move Forward with Confidence

Posted by Sarah Geisert on 8/30/16 10:00 AM

The time is now, yet the journey is still just beginning. Since January 2011, significant work has been underway by both food regulators and the regulated industries preparing for implementation of The Food Safety Modernization Act (FSMA). Seven new rules have been issued by the FDA, with Preventive Controls for Human Food now reaching the compliance date for large companies. Preventive Controls for Animal Food and Produce Safety compliance dates are only 12-15 months away. And all industries have to layer on the sanitary transport, foreign supplier, and food defense rules concurrent with, or closely on the heels of, their industry-specific rules. A training curriculum has been developed and deployed for both regulators and the regulated industries via the Food Safety Preventive Controls Alliance and Produce Safety Alliance. Companies have been adjusting existing plans and adding new plans to meet compliance expectations. It is a challenging, busy (and yes, stressful) time for everyone. But if you are a food safety and/or regulatory professional, this is your time to shine.

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Topics: Consumer, FSMA Compliance