I am not a fan of rules, regulations and compliance. I am of the opinion that auditors are cleverly disguised zombies.
When I have traveled around the world talking to plant managers and plant floor engineers in differing manufacturing environments. My main goal is to find ways that technology can help them improve their processes. I will assess the plants on where they are in their smart manufacturing journey. When I hear them talk about collecting data in a particular process, I always ask them why they are collecting the data. Most of the time the answer is, “because it’s required”, or “we do it for compliance”.
Damn those regulations. Only causing us money and headaches.
Well, here we go again…
The FDA recently created an FTL (Food Traceability List). The FDA also loves acronyms. This is all about the FSMA (Food Safety Modernization Act). At the core of this rule is a requirement that persons subject to the rule who manufacture, process, pack, or hold foods on the FTL, maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed. Those producing an item on the FTL will need to comply by January 20th of 2026.
Are you tired of acronyms yet? Basically, they want production traceability and a genealogy of the products.
Between the government’s regulations and the acronyms, I want to bang my large bald head against a wall. This isn’t about right versus left or red versus blue. This is a call to unite!
So how do we fight back? I am not a martial artist, but I am a wannabe ninja. I know from the extensive YouTube research I have done on ninjas, the best way to beat a big bad opponent is to use their weight and momentum against them. In this scenario, the government is your opponent, and you know they are coming at you with these traceability regulations. Essentially, how do we use these inevitable traceability regulations that are coming at us to our benefit?
Several years ago, I had the opportunity to work with a manufacturer in Turkey who was looking at the feasibility of smart manufacturing (Industry 4.0). As we went through all the aspects of automation and concepts of smart manufacturing, we quickly realized the benefits of tracking every product through the manufacturing process. Many of the possible use cases we discussed depended on traceability. If we were able to track the raw goods coming into the door all the way through final assembly this opened the doors for many other automation and process improvements. For example, if we could start to tie process parameters to a particular product or process, we could start to more closely monitor quality control. We could then start to see trends for machines and when those machines start to misbehave. We could start predicting quality and start predicting when a machine needed maintenance. Then our eyes started to get wider, and we realized we could start seeing trends related to suppliers and we could start tracking those products in our warehouse.
I could continue with many more ideas that started to pop up related to track and trace. My hope is, if you have read this far, that you too can start to see some of the added benefits outside of simple compliance and regulations. My message is simple, don’t collect data just because it’s required. Let’s use the weight of those regulations to our benefit. Let’s collect that data, not only for potential recalls but lets look at how we can use that data to create value and actionable insights.
As I usually do, I will leave you with wisdom and insight from Artificial Intelligence:
In the rapidly evolving landscape of manufacturing, traceability has evolved from being a regulatory requirement to a strategic necessity. The benefits of traceability extend beyond ensuring compliance; they encompass enhanced quality, efficient recall management, improved supply chain visibility, and the ability to drive continuous improvement initiatives. As manufacturers embrace traceability as a cornerstone of their operations, they position themselves to deliver high-quality products, build customer trust, and remain agile in the face of evolving industry demands.
ABOUT THE AUTHOR: Isaac Bennett is an internationally recognized author and keynote speaker on manufacturing technology. He is a Solutions Architect at Flexware Innovation, providing digital transformation consulting for global manufacturers. Isaac most often writes and speaks on topics like 1) accelerating business through technology (ERP, MES, Artificial Intelligence), 2) breaking down traditional business silos through digital transformation 3) demonstrating how technology can bring value to the organization. To book Isaac for an upcoming podcast or keynote, contact us.