2012 – spring Issue

Mitigate Your Recall Footprint with Lot Tracking

With pending enactment of the Food Safety Modernization Act (FSMA), facilities are focused on Track and Trace requirements. After the Bioterrorism act of 2002, most facilities created methods to track lot codes for incoming regulated items and to track lot codes of finished products; the goal being able to meet "one up" and "one down" FDA requirements.

"One up" and "one down" meets regulatory needs, but does little to meet extended needs of the facility. In addition to recording lots as they enter the facility, lot tracking is needed throughout the production process to finished goods. Facilities need ability to prevent or stop the use of questionable ingredients throughout the process.

Here are a few methods for a facility to consider as they work to mitigate their recall footprint.

Accurate Inventory Control "" It is becoming necessary to record both the receipt of product and its movement throughout your facility. Your system should provide history including when the product arrived, where it was stored, and when it entered production. Throughout production, it should be tracked so you know which run, batch, and bin it entered. Once it becomes finished product, you should track it until it is delivered to the next customer.

Comprehensive Holds "" Once you know where every lot is, you should implement a system allowing you to place a hold on any questionable item. This should extend to your raw material warehouse to prevent a product from entering production. It should include ingredients in bins so you can stop production and it should extend to the finished product so that you can prevent potential issues from leaving your facility.

Lot Enforcement "" Lot Enforcement requires a lot to be consumed before switching to another lot. A process where lots are tracked and consumed on a first in/first out basis reduces the chance that multiple lots will be used in a batch or that expired product enters production. Knowing exactly when a lot enters production allows you to reduce your recall footprint, saving money in the event of a recall, and minimizing negative impact to your brand name.

Comprehensive Reporting "" Access to extensive ingredient usage data is great. However, each facility must move toward turning data into easily-acquired information. While government regulations may allow 24 hours to compile recall information, properly configured databases would allow information to be available within minutes. With comprehensive track and trace reports, facility managers can quickly move toward mitigating impact of a recall rather than compiling data.

The industry has not yet matured in the area of Track and Trace. Another area to prepare for is automated transfer of lot information as product moves between owners. The day is near that consumers demand ability to scan lot codes using their smart phone to find where the item was produced, grown, and expiration dates for each ingredient. We should prepare to track lots of all raw materials, not just medicated materials. These requirements are being implemented in Canada and Europe; it is not a stretch to expect them to be implemented in the United States. Prepare your systems to be scalable and allow for increased requirements as they surface.

For more information or to discuss your track & trace needs, contact Interstates Control Systems at 712.722.1663