A prescriptive approach to FSMA 204
Now is the time to make a plan for your business to meet the upcoming FSMA 204 requirements. Achieve faster end-to-end traceability with the proven processes, industry expertise and flexible tech from SPS Commerce.
Roadblocks to traceability
In order to achieve FSMA compliance, members of the supply chain need to work together to share information about items, inventory, orders, shipments and sales. But when everyone communicates differently, traceability becomes extremely challenging.
FSMA 204 requires that many key data elements (KDEs) need to be accounted for, such as:
Transformation lot codes
Transformation dates and locations
Product descriptions
Quantities and units of measure
These KDEs, along with several other data points, must be kept and maintained for two years.
Retail organizations may attempt compliance in the following ways:
Manual methods like spreadsheets or emailed reports
Since these processes involve manual data entry, they take considerable resources to manage, update and maintain. In addition, manual processes like these are more prone to human error, which can be costly to resolve.
Traceability software with a portal for data entry
As a one-off, unique solution, traceability software requires significant buy-in from every supplier in order to collect the necessary data. Retailers are usually required to use their own resources to onboard each of their suppliers into the system.
Standardized electronic methods such as EDI
This option has great potential for success, but is underutilized. If EDI is managed in-house, retailers may struggle to get their suppliers to adopt an ASN that is compatible with the KDEs established by the FDA. This costs time and can result in errors, distracting from core business functions.
A better way to achieve and maintain FSMA compliance
Instead of manual methods or resource-heavy onboarding, trust the 20+ years of expertise from SPS Commerce. Our services bring together expert advice, the largest network of pre-built connections in the industry, cloud technology (including EDI) and effective change management methods. SPS Commerce offers:
Decades of industry expertise
Leverage our consultative expertise on the FSMA 204 requirements to achieve KDEs using pre-existing, proven EDI standards.
Flexible tech capabilities
Meet the needs of your organization, as well as those of your suppliers, with the ability to operate whether or not a system is already in place.
Best-in-class supplier onboarding and adoption
Increase the speed to FSMA compliance with proven change management approaches that expand use of EDI or data automation across a community of suppliers.
SPS has brought a high level of professionalism and expertise. You guys know the space well and we learned a lot about FSMA and how to approach it from you.
– Brian Porritt, master data manager at Gordon Food Service
The basics of FSMA 204
Section 204 of the Food Safety Modernization Act mandates that, by 2026, all organizations in the supply chain who manufacture, process, pack or hold foods (those included on the Food Traceability List, or FTL), must be able to present traceability records of products in the event of a recall. This requires extensive documentation and reporting capabilities, as records must be accessible within 24 hours per FDA guidelines.
The FDA has established critical tracking events (CTEs) and key data elements (KDEs) where compliance is needed. A few of the CTEs that supply chain members must record include:
Shipping of goods
Receiving of goods via an organization other than the end customer
Transformation of goods, involving a change to the food items like repackaging or relabeling
Along with these, each organization must have a traceability plan they can present to show their procedures for record-keeping, including how they identify foods on the FTL, how lot codes are assigned, the point of contact for traceability and the point of origination (e.g., a farm) for grown or raised foods.
To adequately address these areas, organizations must have capabilities around traceability that gives them quick and easy access to this data. They are also required to keep and maintain these data points for two years.
