FSMA Compliance: 4 Steps to Move Forward with Confidence

August 30, 2016 Sarah Geisert



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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During my 32-year career in Food Safety, Quality, and Regulatory Affairs at General Mills, I led numerous strategic initiatives to help insure consumer safety and brand stewardship, including their compliance protocols for the Preventive Controls for Human Food rule. I know firsthand how daunting regulatory changes as sweeping and comprehensive as FSMA can seem. Even today I hear of companies that are closing in on their first compliance deadline, but are fearful they may have gaps in programs and systems that could trigger a non-compliance. I also hear of companies in the second and third compliance waves who are just getting started and are uncertain as to how to begin, or they have started but are unsure if they are on-track, have the right resources in place, or will meet the deadlines.

Stop. Take a deep breath. Here are 4 steps you can take now that will help you move forward with confidence.

1. Know Where You’re Headed and Map the Journey.

It may seem obvious, and I’m sure by now most organizations have done so, but the first step is to educate yourself and your company on the final rules. Fact Sheets and links to the complete rules can be found at FDA.gov. From my perspective, the complete rules document of each regulation is a "must read." In the case of Preventive Controls for Human Food, the actual regulation is only about 30 pages long. You’ll find it at the end of the Federal Register document. The preamble, which provides insights into FDA thinking in the development of the regulations is over 230 pages – save this for later. Next, create a simple regulations map of each sub-part and break each sub-part into its sections and key elements. For example, there are 7 sub-parts to the PC Human Food regulation. Sub-part C, titled Hazard Analysis and Risk-based Preventive Controls, has 2 major sections, Food Safety Plans and Records. In the Food Safety Plan section, there are 6 key elements. You get the idea. For each sub-part, section, and element, write down all the "must" statements. A good outline and list of "musts" generates a clear road map for evaluating your current programs, whether you do it in-house or via a third party service. Take a look at each “must” item and conduct a self-assessment. For example, do your internal food safety policies and procedures need to be updated? This is likely the case. Are you confident you have “qualified individuals” to deliver your training and/or review your food safety plans, or do you need to bolster this area? When the assessment is complete, you’ll have confidence in many of your existing programs as well as a list of areas that need attention. You can now prioritize your improvement activities based on knowledge of your current systems and where the greatest deviations from the “musts” exist. From this simple exercise, you can create a master plan that will guide your journey to compliance.

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2. Build Your Information Infrastructure.

Documentation and the ability to retrieve documents quickly is a pervasive requirement across all the FSMA rules. For companies with centrally managed programs such as supplier management, give thought to where and how important information will be stored and retrieved. Validation data that supports your product safety evaluations has even more rigorous requirements. An internal library to house scientific justifications could be useful as your R&D teams update product safety evaluations. Since there are many new requirements, frequent and consistent internal communication saves time and can facilitate the process. In addition, numerous software platforms are available to help integrate and manage the documentation and access requirements unique to food safety and FSMA requirements.

3. Don’t Go It Alone.

FSMA implementation requires understanding and interpretation of the regulations, conducting assessments, planning for and closing compliance gaps, writing plans, setting up documentation systems, linking with suppliers and customers, and more. To get the job done, you’ll need knowledge, expertise, people, systems, project management and other resources that you may not have (or have enough of) in-house. FDA has created an excellent website devoted to FSMA, including archived webinars and a Technical Assistance Q&A Tool. These are great resources to help advance your knowledge and understanding. Make frequent visits to these sites as new information is routinely added. Think both outside and inside the box as you work towards compliance. For example, at General Mills, we collaborated externally in the area of training since suppliers and co-manufacturers are common with many others in the industry. Internally, various FSMA teams provided a venue for challenging assumptions and plans, gaining critical internal alignment and support. We also reviewed our FSMA policies, programs, procedures and master plan with external experts seeking their insights and suggestions for improvement. If you find your strategic and/or executional expertise and capacity is lacking, consider leveraging the experience, wisdom, and sheer manpower available through flexible resourcing solutions, such as YourEncore.

4. Remember – It’s a Journey, Not a Destination.

Expect continuous improvement. As the FDA and the States, on behalf of FDA, begin inspections, I anticipate all companies will find some gaps between their interpretation of the regulations and that of the regulators. FDA has clearly stated that their goal is to educate before they regulate. Assuming this to be true, inspections and audits will provide the opportunity for dialogue. Regulators will also be in the learning mode as these are transformational changes for them as well. That said, it is in your best interest to be prepared to demonstrate what has been accomplished, what remains to be accomplished, and your plans to get there. In the FDA Strategic Program Plan for FSMA, improvements to data collection and management have occurred, allowing for more targeted inspections by federal and state agencies. A firm’s history, results for test data, recalls, passed inspections, and other structured data will be used to create an inspection-scoring algorithm. Therefore, you should consider creating something similar. As a start, it is more critical than ever to obtain your “Establishment Inspection Report” when one of your facilities has been audited by the FDA. This is your right. Thirty-sixty days after an inspection, a report should be issued to “the most responsible person” at your facility. If this has not occurred, contact your FDA District Office and request a copy. It is a comprehensive report, not the “483” report issued for violations. Correct any mistakes or seek clarification, where needed. This is an important piece of data and it remains in the FDA files for many years. And, keep your report readily accessible to review the next time an inspector shows up.

FSMA represents a paradigm shift from responding to outbreaks of foodborne illness to preventing in them in the first place. There are many roads and approaches to FSMA implementation; detours, set-backs and roadblocks will emerge. But in the course of getting through them, your food safety systems will become more robust. Your employees will be more knowledgeable and better internal and external advocates. Innovation and collaboration will improve and roll over to future work. Consumer trust and confidence in your products and brands will grow. This is your time to lead. Your company and your consumers are counting on you. Need help getting started or breaking through a current roadblock? Contact me and let's talk about what help might look like for your food safety program. Watch the webinar below covering other areas of FSMA Compliance.

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About Sarah Geisert: Sarah has 32 years of global food safety, quality, regulatory affairs, and risk & incident management experience at General Mills, where her leadership in the areas of microbiology, toxicology, biotechnology, sanitation, auditing and data analysis helped assure consumer safety and brand stewardship. She was intimately involved in advancing changes to the US FDA regulations associated with the Food Safety Modernization Act (FSMA). A YourEncore expert since 2015, Sarah helps clients design and implement comprehensive food safety programs that will help them achieve compliance with the new FSMA requirements as well as other global food safety and quality standards.



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