New FSMA Regulations — And What to Do About Them

New FSMA Regulations


Late last year, the FDA Food Safety Modernization Act completed the final release of new standards and rules for food safety compliance that have shaken the modern food and beverage manufacturing industry and completely changed the way the FDA will view food safety compliance going forward. Although the act was signed into law in 2011, it took over 4 years for all of the requisite rules to be formulated, finalized and approved. The rules finalized in the last months of 2015 include,

Science based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption, the process and certification of third party auditors, and a turn towards risk-prevention rather than risk-repairing. Food manufacturing facilities must now implement a food safety system that focuses not on eliminating food safety risks as they are found within a manufacturing facility, but preventing those risks entirely. This should happen through a comprehensive strategy of hazard analysis and preventative controls throughout the supply chain that take into account allergens, sanitation, all potential sources and sites of contamination along with a thorough recall plan. Documentation of records, to prove that preventive controls are being implemented constantly are actively working toward hazard reduction within the facility, and should be available in any event of a recall or FDA event within 24 hours. Does it sound like your business is ready for the new FSMA regulations, or do you have some shaping up to do? Most food and beverage businesses find that some key things need to change within their business when faced with the challenge.

The final roll-out of new FSMA regulation changes certainly comes at a pertinent time; recent recalls of Blue Bell ice cream products due to a listeria outbreak and the dive in stock of fast-casual behemoth Chipotle due to a rash of different outbreaks in various locations across the country have been taking over the news cycles and have customers more worried than ever about their food and what’s in it. Even minor food safety violations can have a devastating effect on your business and its processes, and FDA audits will be no doubt be costly and time-consuming, hitting your company’s bottom line even harder.

Clearly, the time is now for your food and beverage manufacturing business to get proactive about falling in line with new FSMA regulations. Read on for a few quick tips on getting started.

Leverage Information Technology

ERP software is one of the best systems currently on the market that businesses can leverage to monitor and manage hazard reduction and prevention within their facilities—it has also been outlined by the FDA itself as a smart food safety practice. Enterprise resource planning allows you end-to-end food traceability within your production plant, you will know where every single ingredient has come from and where it should be going. The FSMA requires that food manufacturers only use approved suppliers for their raw materials, or temporarily use unapproved suppliers as they concurrently determine the safety compliance of the product. ERP can help you juggle these tasks, receiving information from each supplier on temperature, pH and quality of the materials coming into your warehouse, and place notes on outgoing products if further checks are needed at the next stage of manufacturing.

What’s more, ERP can enforce risk-aware supply chain practices that include mandatory scanning and product analysis at certain checkpoints on your shop floor. If something isn’t right, that production line can be shut down immediately. You’ll be on the road from putting out fires to strong risk-prevention practices in your business in no time—exactly what the new FSMA regulations are asking your business for.

Informational Requirements

The finalized regulations from the Food Safety Modernization Act aren’t just focused on the quality of the processes that go into your food manufacturing, they also require a certain level of informational and reporting capability should you ever encounter a document food hazard or require an audit. You could be expected to produce a full report on a certain production line in mere hours—or face a costly recall.

Because ERP can process data from all of your production points and machinery in real-time, creating reports from a specified time on a certain product is practically a no-brainer. A press of the button (from a mobile device, no less, if you are operating within the cloud) will give you all the information you need in order to meet the FDA with the information they need. And this information won’t only be valuable to outside parties. Shared amongst your business and employees, every user will be able to understand their role in the food safety processes and keeping your company’s output at the high standard you expect of it. That way, every employee can be held accountable and potential areas of risk identified before they ever become a revenue-affected problem, and the new FSMA regulations will turn into a non-issue for your business.

Maintain Continuous Improvement

Because ERP software is such an expansive system, it will be able to handle the hazard prevention processes required by the FDA while also maintaining growth within your business. After all, continuous process improvement is one of the main goals ERP users should strive for, and supply chain management and inventory control are some key ERP features that allow manufacturers of any kind to lean out their processes and reduce waste in key areas like materials requirement planning and scheduling. Just because you need to fall in line with the new FSMA regulations doesn’t mean that you need to sacrifice the process improvements that you originally implemented ERP for in the first place. In fact, getting a greater hand on your supply chain and inventory will not only allow you to keep an eye on food safety, it will also allow you more control to streamline them and make sure everything going through your shop floor and onto your customers is cost-effective and totally safe.

REGISTER NOW For Our Upcoming Food Safety Webinar!

For even more valuable information on how to keep your business in line with the new standard, register for our upcoming webinar with Plex Systems to learn more and ensure your business stays compliant as you also grow revenue and reduce manufacturing waste and costs.

Run in partnership with both Plex ERP Systems and Bill Bremer of Kestrel Management, an expert in food safety consulting, the webinar will undoubtedly give you the foundation you need to make your food or beverage manufacturing business great—and totally compliant too!

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