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Lot Tracking Basics – A Primer to Clear Up Confusion
Lot tracking can sometimes seem a bit like tax code. Everyone is aware of it. Few really understand it. Most avoid delving into it until faced with a recall or violation.
It won’t take long to learn some lot tracking basics. Find out why lot tracking only keeps getting more important. After that, decide whether manually tracking is worth the risk.
You can take small steps to mitigate large risk. Why wait for bad news that could inflict both financial and commercial pain?
New Times, New Rules
The first thing to recognize about lot tracking is that regulations have changed, and the number of new regulations is piling up.
You likely know the FDA now has authority to mandate recalls and shut down mill operations. All it takes is lack of proof on the part of the mill. A mill that can’t prove it is collecting and managing lot tracking data – or can’t prove product integrity and safety – can be shuttered.
The Food Safety Modernization Act (FSMA) gives the FDA sweeping powers.
Do you also know FSMA places the manufacturing of animal feed on par with human ingredients and production? Regulatory statutes for both are predominantly the same. No longer can animal feed be viewed as less important in terms of safety, quality and a mill’s ability to track shipments in and out of its facility.
Two Types of Lot Tracking
Lot tracking has two fundamental goals:
- Look forward – track inbound ingredients through the manufacturing process to the finished product that was produced from it.
- Look backward – track backwards from a finished product lot number and identify all ingredients, amounts and lot numbers used when producing the finished product.
When you possess these lot tracking capabilities, you can determine the exact impact or exposure of recalls and know which customers might be affected.
Here’s a key point about that: The FDA sees things in black and white. They must do whatever it takes to ensure all bases are covered. For this reason, you could end up seeing excessive red.
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, with the FDA levying a penalty across the industry. It’s a matter of time before a single plant shoulders a similar cost burden all by itself.
Lot tracking to mitigate risk can make the difference between staying in – and going out of – business.
A Small Step to Getting the Upper Hand
The logical place to start with lot tracking is where commercial and financial risks are most concentrated. You can reduce risk substantially without tracking everything coming in and going out of your plant.
Where do big opportunities lie? In your preparation and inclusion of drugs or high-value ingredients. Medications, which can easily cost several thousand dollars for small volumes, must meet exacting inclusion standards. Tackle these areas first, and start reducing the biggest financial risks.
Consider 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.
Lot tracking requirements are real, and risk is already hovering over feed mills. If you’re not tracking properly, your business is exposed.
Need some help understanding lot tracking requirements and how to be prepared? Let’s Talk.