The FDA is proposing to establish additional traceability record keeping requirements, beyond what is already required in existing regulations, for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability list. The FDA website has more information on this rule.
At the core of the proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products. The FDA would encourage the voluntary adoption of these practices industry-wide.
The proposed rule identifies growing, receiving, transforming, creating, and shipping as the Critical Tracking Events. Firms executing these activities need to maintain records that link the traceability lot code of the food to the CTE along with additional information.
The Traceability Program Records include:
- A description of relevant reference records
- A list of foods on the FTL that are shipped
- A description of how traceability lot codes are assigned
- Other information needed to understand data provided within the required records
Upon request, the FDA requires a response within 24 hours of specific traceability data and you must be able to provide a sortable spreadsheet of relevant traceability information. Firms must provide relevant lot codes to customers as part of the shipping records and the product must be labeled with the lot code. If your firm does not transform a food on the FTL but receives and distributes the food on the FTL, then you must maintain the lot code provided by your supplier and pass that lot code on to your customers.
To implement the FDA’s proposed Food Traceability Rule your ERP system must provide:
- A perpetual inventory capability with lot codes and associated lot attributes
- An ability to capture the supplier lot code at receiving ideally with electronic integration via ASNs from your supplier
- The system should use the supplier lot code as the primary lot code for the raw inventory to enable easy traceback to the supplier. New lots should be assigned when first receiver, from a farm for example, or when transforming the item into a new SKU.
- Defined formulas/BOM and supporting work orders
- An ability to direct issue item lot codes to a work order
- Backflush transactions are not acceptable.
- An ability to automatically generate new lot codes with a logical method that can be described to the FDA
- Traceback functionality to identify source lot and then trace forward functionality to identify affected shipments
- The traceback and trace forward data must be able to be exported to a sortable spreadsheet.
- Formal recall letter generations enabled via an integrated CRM
Many food supply chain companies have capable ERP systems yet continue to perpetuate the lot traceability outside of the system because of the work and discipline required to drive an accurate and real time perpetual inventory. Adroit North America specializes in assisting companies to implement real time lot tracking through their systems. If your system is not capable of the above required functionality, then consider Aptean’s Food and Beverage ERP Solution which does a great job supporting food traceability and recall requirements.