7 Easy Ways to Navigate FSMA for Food Processing

In Part I of this series, we explored the 4 Things You Need to Know About FSMA. As we progress together through analyzing this new regulation, we will drill down into how you should approach each of the four main areas of FSMA. These are perspectives that hold great value to you and are goals we set to achieve when working with our food processing partners. As you continue through this article, I challenge you to ask yourself the following question, “Is the company I purchase from a Supplier or a Partner?” If it’s the former and not the latter, then you need to demand more or seek out a true strategic partner that has the capabilities and the desire to stand by your side as you trek through the arduous landscape of food production operations.

Whether you’re well prepared or scrambling, having a process and a strategic plan for new regulations will pay favorable dividends in the long-run. You’ll sleep better at night and your stress level will operate in the “manageable” range. As a pragmatist, I’m not going to make any claims that stress can be completely eliminated, but rather minimized through proactivity. We will first identify the specific requirements of the new law, and then we will

So, FSMA is happening and the ship is coming to port. Below are the individual requirements of FSMA and how they will affect your business:

1. Registration – you will need to complete an electronic registration biennially in even-numbered years. You also need to ensure that your supply chain is both, initially and continually under evaluation. If not, you could run the risk of raw material shortages, because moving forward, food from unregistered production facilities will not be able to be imported into the U.S.
2. Preventative Controls – this requirement is now final, and compliance will begin to take effect in September 2016. Most facilities I have worked with do a good job with “prevention”, as they understand the value of risk mitigation and the importance of this component of their food safety plan and how it impacts their overall operation and ultimately, their profitability,
3. Hazard Analysis – conducting a thorough hazard analysis of your operation and developing a written plan is most likely something you’ve already done. When was the last time you updated it? Even more important, when was the last time your supplier partner offered to help you with this?
4. Detailed records – the requirement is to maintain 2 years of detailed records which include copies of hazard analysis, preventative control plans, related records, and any additional records that would assist the FDA in tracking and tracing high-risk foods. The practice in which companies would respond to an FDA records request remains unchanged, as do the types of documents. The major revision here is that it expands to now include records relating to any food product that the FDA deems reasonably likely to be degraded. It is the responsibility of the owner, operator, or agent in charge of each facility to maintain a copy of its written preventative controls,
5. Inspections – the FDA is now required, through Sec. 201 of FSMA and through section 421 of the FD&C Act, to identify facilities as high-risk (HR) or non-high risk (NHR) and perform a 3 year or 5-year cycle inspection based off of determined risk classification.

The current count for domestic HR facilities is 22,325 and domestic NHR facilities is 60,000. So, approximately 37% of facilities in the U.S. are considered “High-Risk”. (FDA website)

For a lot of facilities, the above requirements are nothing new. I would say that 85% – 90% of the facilities I work with are in compliance with most of the items above. But FSMA has changed the dynamic of how they are enforced, frequencies in which they are verified, and the exposure of oversight into your operation. Below are some ideas for approaching the requirements to help you navigate landmines related to the new regulation.

1.  Develop a Supply Chain Analysis Program – this will keep you proactively managing your supply chain by setting evaluation frequencies and standards. With FSMA requiring all levels of the food supply chain to be compliant, having a program in place will make it much easier to verify your receipt of safe & wholesome ingredients, as raw material providers are held to the same standards as “receiving” of “finishing” production facilities. Another risk mitigating measure would be to actively consolidate your supply chain wherever possible. Partnering with suppliers that can provide a multitude of products and solutions through one channel allows you several benefits vs. having a different supplier for each individual need.
2. Utilizing Software for your Operations – this is a huge opportunity for food production facilities. The vast majority of plants I visit are using a paper method for tracking sanitation data, SSOPs, validation results from quality inspections, scheduling & productivity rates, cleaning frequencies, equipment shutdowns & maintenance, and several other critical operational processes. I have recommended and implemented technology solutions that have decrease preparation time for audits, helped to identify trends that lead to increased productivity, created a better and more efficient process for scheduling equipment maintenance, and safeguarded data in several food-processing plants. Just imagine, being able to click and run reports while preparing for your SQF, BRC, or Customer audits instead of having to go through file after file and track down inspections, SSOPs, HACCP plans, Food Safety Plans, Hazard Analysis, etc. You can reduce your administrative prep time by as much as 65%.
3. 2^nd Party Validation & Prevention Program – engage your supplier/partner to help you with validation & prevention. Challenge them to review your SSOPs, perform inspections of your facility at a pre-determined frequency, verify sanitation chemical concentrations, complete assessments of non-production areas, and review your overall operation to help identify gaps.
4. Training & Education Programs – did you know that the average retention period for training material is 90 days? Did you know that when surveyed, employees resoundingly identified training & education as a more important reason for satisfaction in their job vs. an increase in pay? Training, both internally & externally are an incredibly valuable tool. Externally, Spartan Chemical Co. has developed a world-class online training program called CleanCheck. FlexPAC utilizes their proprietary emPAC Training Program to offer solutions to their customers. You MUST challenge your supplier to help you with training, or find a new supplier…
5. Documentation – this rolls into the software piece discussed above, but some facilities just aren’t ready to migrate to a tech solution yet. For best practices in managing the vast amount of documentation required in food production, you need to centralize it to a person or person(s). Also, have a physical manual, which holds all of your important documents as they relate to each department. If you’re more inclined to centralize on a computer, which I recommend, ensure that you are utilizing proper filing techniques to make information easy to find and share. Using a service like Google Drive or Dropbox is a great solution.
6. Validation Tools – you do what you say, but how are you going to prove it? This is where you want to use ATP meters, Swab Testing, Bio-Active Neogen Tests, 2nd Party Unbiased Inspections, and Consultative Analysis are among the most valuable validation measures you can incorporate.
7. Delegate the Responsibility of Understanding & Navigating Compliance to a Person or Team – by centralizing the responsibility, it allows for the information to flow through 1 channel as it is received and distributed throughout the organization.

This wraps up or two-part series on FSMA. We have explored the 4 Things You Need to Know About FSMA and now we have dialed into the requirements, then providing ideas on how to address compliance. As the industry progresses and the world population grows, the demand for our food production will only continue to increase. In today’s business climate, it is IMPERATIVE that you have a partner that understands your business and is able to help you proactively navigate extrinsic factors which impact your overall business. With new regulation comes new responsibilities, which increases demand on your time as well as the potential addition of new employees, which costs money. However, time is more valuable than capital, as time can have the largest impact on your bottom-line. Don’t be comfortable with a vendor relationship, simply because “You’ve always done business with them.” Challenge them to be a true strategic partner, give them the opportunity to step-up, and if they fail to step-up, it’s time to find someone who will.