Guest Blog Post – Melanie Neumann, Neumann Risk Services
With the FSMA compliance date right around the corner for the first companies impacted by this paradigm-shifting food regulation, what should companies be focusing on in this 11th hour race to the finish line?
First, let’s establish what the “finish line” looks like. September 19th is the first “finish line” for many businesses who must comply with the Preventive Controls Human Food (PCHF) Rule. This first deadline applies to large businesses (over 500 full time employees)—other businesses have another year or two depending on their size and/or revenue. Small businesses (companies with fewer than 500 full time employees) have until September 2017 and very small businesses (less than $1M in average annual sales) have two years or until September 2018.
Question: Is your company still racing to the finish line? More concerning, are you worried you may not break the tape in time? Let’s face it—some companies may be facing a ‘photo finish’ to make it to the finish line in time to comply with all of the required components of the PCHF Rule that are due by September 17th. Others may not quite make it and still need a few more yards of track to finish the race. So what should companies be focusing on now in the 11th hour sprint to the finish line?
Here are the top 5 tips for the race to the FSMA Finish Line from NRS:
1. Have a Plan. If you aren’t FSMA ready yet, have a written action plan to be FSMA compliant as soon as possible, as well as after the compliance date. List milestones with target completion dates and the roles responsible for execution. This will show the FDA that you know what you need to do and you have a plan to do it by a certain date. Target completion dates within 90 days after the Rule’s effective date—using the 90-day process validation window as a guide. This said, the best position to be in is compliance by the deadline and try to have the required process validations conducted by this date or within the 90-day process validation window granted under the Rule.
2. Focus on CAPA. The PCHF Rule requires a formal Corrective Action Preventive Action (CAPA) Program for the first time by regulation. Further, it will be accessible and reviewable by the FDA. Additionally, FDA investigators who inspect pharmaceutical companies are used to a much higher level of rigor and documentation standard for CAPA’s and may begin to expect to see that in food companies post PCHF Rule effective date. While there is much that goes into a best in class CAPA Program, a key component is that it is a closed loop process and is well documented. Each incident rising to the level of investigation is indeed properly escalated, investigated, resolved (root cause identified whenever possible) and documented—hence coming full circle which closes the loop. The best thing food companies can start to do now is start modeling its CAPA Program more along the lines of pharma and drug CAPA Programs. This will greatly increase the odds of standing up to the new types of FDA investigations.
3. Understanding the New Forms of Preventive Controls. Supply Chain, Sanitation, and Allergen Preventive Controls are the new ways the PCHF Rule asks us to manage hazards. Conceptually, some are grappling with how to include them in their food safety plans and use them from a day-to-day operational perspective. I think the key to understanding these “new” preventive controls are to first realize that we have been using them the whole time to manage risks in our facilities—we just called them something else! Maybe they were part of a prerequisite program, GMP program, or an operational prerequisite program. Now, the Rule simply asks us “Do you need to evaluate a part of that program to a preventive control because it’s SO important to control a hazard that requires a preventive control?” If the answer is yes, then a part of your allergen prerequisite program now becomes an Allergen Preventive Control.
Other ways to understand these new preventive controls is to consider the following:
For Supply Chain Preventive Controls:
- If you establish a Supply Chain PC, you need a way of ensuring you have approved suppliers and necessary controls (e.g. spot /emergency purchase protocols).
- Understanding who controls each food safety risk—if you as the manufacturer do, then you do not need a supply chain preventive control. If you do not, then you either need a supply chain preventive control on your supplier or a downstream customer needs to control the hazard. You need a written assurance to that affect evaluating adequacy and compliance. Lastly, be sure to document it!
- If you use co-manufacturers, you should understand their controls and their readiness for FSMA.
For Sanitation Preventive Controls:
- Determine how you will link your environmental control program to your food safety plan.
- Identifying the need for sanitation controls post-processing prior to packaging of ready to eat (RTE) where product is exposed—this is required!
- Develop a plan to manage microbiological and allergen risks of cross-contamination through a sanitation preventive control.
For Allergen Preventive Controls:
- Do I need a sanitation preventive control to combine with an allergen preventive control to control for cross contact risk?
- Do I have allergens in my facility?
- How will I control for cross contact of those allergens? Where will I control for the cross contact risk? Earlier or later in my process or both?
- How do I control my labels to ensure the label declares the correct allergens according to regulations (both in the country I manufacture and where I export to)? Where in my process will I insert a label verification check?
4. Training enough Preventive Controls Qualified Individuals (PCQI’s). PCQI’s are needed to prepare or oversee the preparation of food safety plans, validate preventive controls, review records, and re-analyze/change food safety plans. It is vitally important that companies have enough of these critical roles. The rule of thumb many companies are using is to start with is two PCQI’s per production facility.
This said, self-certification is possible through training and experience. However, there is some level of risk in the unknown with respect to what is required with proving up to these credentials. What we do know is that HACCP training alone will likely not suffice. A question was posed in the April 2016 FDA Town Hall Meeting in Chicago and the FDA stated that HACCP alone will not likely be sufficient because the employee must also “be exposed to risk based preventive controls thinking”. Thus, unless the individual has participated in a focused training specifically on the Preventive Controls Rule for Human Food, I would be skittish to put him/her in the race. If they have had this kind of training, (just not the full PCQI curriculum) AND they are an experienced person in the industry through education and experience, the PCHF Rule clearly states that one could qualify as a PCQI trained individual. The key is demonstrating understanding of what the new preventive control requirements are.
5. Make Sure Management is in the Game and Ensure Management Commitment. We just witnessed the Summer Olympics. Almost every athlete we saw had their coach with them right? The same should hold true in our race to the FSMA finish line. Management should be running the race alongside food safety & quality. I almost hate to say it, but not all companies are taking the most significant regulatory change in the food industry since the Food, Drug & Cosmetic Act of 1938 very seriously—at least at the top levels. Management needs to be in the race—if for no better reason than they have a bigger stake than ever in the outcome. The owner, operator, or agent in charge of a facility is responsible for the food safety plan and its execution. Further, the legal principles of strict liability will hold owners and senior officials of food companies liable for distributing adulterated food even if there is no knowledge or negligence (witness the Jensen Farms case). There are other potential implications of non-compliance with the FD&C Act and amendments such as FSMA as well, known as prohibited acts. So it really does behoove management to play the role of a coach and commit to the food safety initiative, including the implementation of the food safety plans and PCHF Rule compliance.
I have had several athletic coaches in my life give very salient advice which I feel also applies here. While ideal to be fast and finish first, not at the cost of form. Applied here, if your food safety plans are sloppy, or if your hazard analysis, application of preventive controls, or your justifications do not make sense, the FDA will probe deeper into training and other records—thus opening the proverbial Pandora’s Box. I personally feel it is better to take a more thoughtful approach to the hazard analysis and establishment of preventive controls, monitoring, verification, and validation, and corrective actions. If steps are not complete by September 19th, develop that written action plan listing what is remaining with clear milestones, roles and responsibilities, and target completion dates. This will show your clear dedication to completing the race and getting to the finish line as fast as you can, but with good form which has a higher likelihood of achieving the main objective of the PCHF Rule—protecting consumer health and safety.
One last thing. Don’t stop running! You are not “done” with FSMA or the PCHF Rule as of September 19th. The race has just begun—the monitoring, verification, validations (where required) and ensuring corrective actions are conducted when needed. Pace yourself!
Thank you Melanie for providing to SafetyChain this informative post. To learn more about Neumann Risk Services, please visit: http://neumannriskservices.com/About-NRS/
To learn more about how SafetyChain can help you ensure ongoing FSMA compliance – please visit: https://www.safetychain.com/compliance-audit-readiness/