I am always amazed at how many processors avoid delving into lot tracking until faced with a recall or violation. Is this you? Why?
What I found was that there are a variety of reasons for procrastination typically. Reasons like perceived potential costs to implement and/or simply not understanding how to implement. Lot tracking, or knowing what raw material went into a particular batch of product, just keeps getting more important however. You can no longer ignore the need for a digital solution over risky manual tracking. You can, however, find yourself in a bad situation quickly especially with new regulations piling up regularly.
Lot tracking explained.
Tracking in its basic form has only two fundamental goals:
- Track inbound ingredients through the manufacturing process to the finished product that was produced from it.
- Track backwards from a finished product lot number and identify all ingredients, amounts and lot numbers used when producing the finished product.
Implementing these tracking capabilities, you can determine the exact impact or exposure of recalls and know which customers might be affected instantaneously. A very good thing.
The FDA sees things in black and white.
We all know the FDA has authority to mandate recalls and shut down operations. All it takes is lack of proof on the part of the processor. If they can’t prove they are collecting and managing lot tracking data, or can’t prove product integrity and safety, they can be shuttered. Not a good thing.
Why wait for bad news that could inflict both financial and commercial pain?
For example, let’s say there’s an ingredient recall. If the FDA finds you’re not tracking lots and you can’t prove that you didn’t receive the recalled ingredient, they’re going to force you to do the recall whether it’s deserved or not. Or, if you’re unable to track and trace with precise specificity, you could be subject to a degree of pain much greater than necessary. Plants today get fined regularly for improper lot tracking.
Ingredient traceability and where to start.
One of the areas to consider is Enterprise Resource Planning (ERP) systems. Many of these systems are now offering lot tracking capabilities as a part of their solutions. However, those capabilities are often considered theoretical as they do not have physical means to report exactly what was included. They typically rely on ingredient inclusion records and time stamps supplied manually or by a control system with the ability to report it.
Control systems can support lot tracking in many ways. Even a simple automated lot tracking system can enable you to look forward and look backward, and can be integrated with an ERP system.
Partnering with a vendor that “gets” tracking and ingredient traceability could save you large sums and maybe even your business. Start the conversation today on how this would work for you and your company.
Need some help understanding lot tracking requirements and how to be prepared? Let’s Talk.
National Sales Manager at Coolearth Software.
Chris is a syndicated author, digital marketer and experienced sales leader in the high tech sector.
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