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

September 15, 2016 Jim Kamman, Ph.D.



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”.

I’ve found that prioritizing ingredient, finished product, and documentation requirements moves companies farther and faster towards compliance than trying to do everything all at once. I also take a “Break It Down, then Build It Up” approach, which helps prevent the paralysis that can occur when an organization becomes overwhelmed by a change of this magnitude. Finally, it’s important to recognize and plan for the fact that getting to compliance will take more, and often different, resources and skill sets than are typically available for ongoing operations.

Break It Down, then Build It Up.

Following a regulation map of the “musts” associated with each sub-part, section, and element of the final rule, compare your current status versus the new requirements. Once you’ve identified and prioritized your gaps, begin to build out the processes, procedures, etc. to close them. Based on my experience, here are some things in particular to look out for:

1. Ingredients: Food manufacturers are now liable for all food safety aspects of the finished product, including all supplier ingredients and components. Do you have a list of approved suppliers? Do your suppliers use multiple locations to source the ingredient? Do your ingredient specifications match what you are actually receiving? Do the specs include the critical parameters for acceptance or rejection? Do you receive “not ready to eat” materials?  If so, there is now a requirement that you acknowledge to your supplier that you understand this attribute and that you will further process the material. 

When your ingredient spec review is complete, make a list of those that need revision and prioritize them. Start with the most sensitive ingredients.  If you decide you no longer want to receive "not ready to eat" ingredients, a product reformulation may be required. Throughout this process, work closely with your suppliers to insure they are aligned with your specifications, requirements, and expectations.

register for free webinar september 202. Finished Products: Start with a review of the current food safety plan (FSP) at each facility. Many companies discover that their FSP’s haven’t been reviewed in over 3 years, and/or that they vary between facilities for the same product. You’ll need a multi-functional team to ensure you don’t miss potential hazards associated with processing, packaging or the product itself. Allergens are now required to be included in your hazard analysis, whereas you may have had them in a separate program in the past. And don’t forget that food contact packaging risks are just as real as ingredient or process related risks.  For example, reduced oxygen packaging (ROP) is used to prevent the growth of spoilage organisms.  The major concern with ROP is C. botulinum.  Have you ensured that there is a barrier present such as water activity below 0.93 or a pH below 4.6, etc.? Are you comfortable that appropriate judgment, experience, and/or technical reference has been used to ascertain risk and establish process controls? If you have a critical control point (CCP) where you are eliminating a hazard, do you have documentation that shows you have validated your process and verified that your controls work?  

3.  Documentation: New documentation and quick-access requirements are central to all of the FSMA rules. Key questions to consider include: does documentation exist, where is it, is the information accurate and up-to-date, and does it include all the required information and data for compliance? We frequently find critical documents are stored in different formats and locations … a Word document here, an Excel file there, on a local share drive, in a facility’s hard copy file, maybe in R&D. Typically, there is no common format or access, and often, key information on the same topic/issue is different at different locations. 

In developing your action plan to close documentation compliance gaps, include where and how future documentation will be maintained, in what (ideally standard) format, accessibility, and control procedures … who maintains what documentation, who can change or modify, and what approvals are required.  Does your system allow quick data retrieval and facilitate trend analysis? If you are moving to a new data management system, will your employees need training?

Resource it Right.

Achieving FSMA compliance is a major undertaking. To get the job done, you’ll need knowledge, expertise, people, systems, project management and other resources that you may not have in-house. Think outside the box. Benchmarking with a peer group is an excellent way to share best practices (and tough lessons). Share and review your FSMA policies, programs, procedures and master plan with external experts to get their insights and suggestions for improvement. And consider leveraging the experience, wisdom, and sheer manpower available through flexible resourcing solutions, such as YourEncore. Hands-on experience is vital to thoughtful decisions and approaches, as well as practical execution. 

Implementing the FSMA rules may seem daunting, but it is manageable with the right approach and experience. And remember that the goal is to develop a living system of food safety and risk management that focuses on prevention. There will be additional learning, interpretation, and adjustments along the way. But for now, it’s crucial that companies are actively moving towards compliance, with the ability to demonstrate where they are, what they’re doing, and, ultimately, what compliance will look like for their organization.

Need help jumpstarting your FSMA compliance plan or breaking through a roadblock? Contact me and let's talk about what help might look like for your food safety program. Watch the webinar below to learn more about FSMA Compliance in today's market.

About Jim Kamman, Ph.D.: Dr. Kamman has over 30 years of Quality and R&D experience in the food industry, including executive positions at ConAgra Foods, General Mills, and Quaker Oats. Since 2007, Jim has led a variety of Quality, R&D and Supply Chain initiatives for YourEncore clients. He holds a Ph.D. in Food Science from the University of Minnesota, with minors in Physical Chemistry and Marketing.

 register for free webinar september 20


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