Track & Trace

Why RMMs?

In addition to reducing your production cycle by several days, allowing you to further ensure the quality and safety of your products before they are released, RMMs also simplify and streamline your record-keeping process. These significant benefits also contribute to lean manufacturing practices, including reduced working capital requirements due to shortened cycle times, improved return on invested capital, and minimized warehouse space requirements.

If you are involved in a contamination event, the right RMM system can help you not only report the incident to the FDA quickly and accurately, but also physically recover from the event faster. The rapid results provided by RMMs mean you can detect contamination earlier in the process, while your product is still in your warehouse (see Figure 1). This allows you to identify the source of the contamination, take corrective action, pull the affected products before they are released into distribution, and get your production cycle back up and running, all at a much higher speed than traditional methods.

Planning for a potential contamination event keeps you ready for the unexpected. Whether you are new to the idea of RMMs or already have a rapid microbial detection system in place, take time today to make sure you are ready for that request for records from the FDA. Investigate the different features of RMMs and see how they could help you get your products to your customers quickly and safely—while reducing your chances of ever having to submit a report to the RFR.

Look at your record-keeping system and think about how a more secure, organized system could simplify your compliance with track-and-trace requirements. You can’t always predict when you might get that dreaded notice from the FDA, but RMMs can help you establish a strong program today that helps your company respond in the fastest and best way possible.

Scott Scdoris serves as director of food and beverage for Celsis Rapid Detection. Experienced in microbiological testing procedures for the dairy and beverage industry, he has been with Celsis for more than 10 years and works closely with Celsis’ business development managers and technical support representatives to help prospective customers successfully implement rapid methods. He can be contacted at [email protected].

Key Steps to Ensure Compliance and Avoid Contamination Events

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Dairy time to results with the traditional agar method, top, versus the Celsis ATP test method.

1. Do everything you can to ensure the safety of your products before they leave your facility. You probably feel pressure to get your products out the door as quickly as possible. This may mean you’re releasing lots from your facility before all quality testing is complete. Some people call this the “ship and pray” method. You ship your products and then test the lots that have already left your site, knowing that 99% of the time they will be clean and you won’t have a problem. But what happens when there is a problem? Although your products are clean most of the time, if there is a contamination event and your products have left your facility, they must be reported to the FDA and recalled—whether they are on trucks moving around the country or, even worse, on shelves and in the homes of your consumers.

While the FDA requires reporting on all contaminated products that leave your facility, it does not require contaminated products to be reported if they have not yet left the plant, because they do not pose a risk to consumers if they never leave your facility. This makes it all the more important to test your products before releasing them.