The U.S. Food and Drug Administration (FDA) recently published its Food Traceability Final Rule, which introduces new recordkeeping requirements for all participants in the supply chain of certain foods. In our latest blog, we discuss what this means for food and beverage manufacturers.

Guide to Effective, FDA-Compliant Food Tracking and Traceability

A total of 48 million people in the U.S. get sick from food-borne diseases every year, according to alarming statistics by the Centers for Disease Control and Prevention. Systematic tracking of certain types of food along the supply chain can help significantly in reducing that number.

Effective traceability allows for quick removal of contaminated food from the market, thereby minimizing risk of illness and dramatically cutting business costs.

The U.S. Food and Drug Administration (FDA) recently published its Food Traceability Final Rule, which introduces new recordkeeping requirements for all participants in the supply chain of certain foods. Those include different types of fruit, vegetables, cheese, and fish, among others outlined on FDA’s Food Traceability List.

Food creators and processors have long been subject to regular FDA audits. But up until recently there was no such clearcut set of traceability rules for food shippers.

The lack of concrete guidelines inevitably resulted in gaps in distributors’ recordkeeping and therefore impacted the speed and effectiveness of potential recalls.

The FDA’S new rule has been introduced to fill those gaps and is expected to greatly improve the food tracking process.

What is Lot Tracking and Traceability?

A key requirement under the new FDA rules is the presence of a traceability code that is to be passed on to each link of the supply chain. The code should also tie back to all reference documents associated with the specific food shipment.

The traceability code typically used for such purposes is referred to as the lot number – a unique identification label assigned to a specific production batch.

Lot tracking is an increasingly popular practice in inventory management. It allows companies to scan and store information about any specific batch, including its location in the warehouse, the date it was received, and the supplier it was purchased from.

Prior to FDA’s latest set of traceability rules, certain food market participants were subject to the “one step forward, one step back” approach, meaning they had to be able to provide detailed information about the party they received a batch from and whoever they passed it on to.

This, however, would only give an auditor limited information and fail to achieve “cradle- to-grave” traceability, which is often needed for actions such as recalls to take place.

Lot tracking, on the other hand, makes it possible to access not only details about the lot’s journey through the supply chain, but also any relevant documentation such as invoices to certificates of approval (CoA).  

Below is a list of the key data elements (KDEs) that shippers of food are now required to provide in a case of an FDA inspection. Some of these may vary for other participants in the food supply chain.

• Entry number assigned to the food in case it was imported;
• Quantity and unit of measure of the food;
• Traceability product identifier and description;
• Location identifier and description of the traceability lot code generator;
• Location identifier and description of the immediate subsequent recipient of the food; and
• Location identifier and description of the location from which the food was shipped, as well as the date and time of the shipment.

How can software solutions help?

Effective lot tracking goes hand in hand with a reliable software solution.

It is best for the tracking program to be fully integrated with your Enterprise Resource Planning (ERP) system, thus avoiding duplicate number entries and any other unnecessary confusion.

Some of the main benefits of lot tracking for food and beverage companies include:

• FDA compliance: FDA’s tight timeframes mean it’s difficult to provide this data if it’s not electronically stored. Lot tracking software allows you to instantly pull customer information for any batch and generate lot-recall letters, helping you avoid costly compliance fees while keeping customers safe.
• Increased efficiency: Don’t waste time wandering around warehouses or searching through paperwork. Lot tracking gives you a snapshot of your entire inventory, updated in real time. This helps with manufacturing as well as inventory counts.
• Enhanced health and safety: Attaching important documentation such as COAs helps ensure safety in manufacturing and distribution, while enabling rapid response to product and ingredient recalls.
• Reduced waste: Lot tracking allows for the so called FIFO [first in, first out] and FEFO [first expired, first out] tracking, which ensures you sell your oldest and closest to expiring products first, so you don’t have products sitting in your warehouse too long.
• Better business decisions: Enhanced visibility of your inventory enables better business decisions, which in turn helps increase profitability. For example, it helps you better analyze customer demand and adjust your own order books to achieve the best possible margin.

If you want to learn more about how Datacor’s software can help you enhance your inventory management and tracking, get in touch or Sign up for a free demo with one of our industry experts.