FSMA 204 requires covered entities handling foods on the Food Traceability List to maintain records for specific Critical Tracking Events (CTEs) and associated Key Data Elements (KDEs). The FDA also requires firms to provide requested records in an electronic sortable spreadsheet within the required timeframe, although firms are not required to use the FDA’s sample template.
For food companies, that requirement has a direct systems implication. CTE-related records may be created or updated across ERP systems, warehouse workflows, 3PL systems, production records, and partner-facing document flows. FDA guidance states that KDEs may be linked in multiple ways, including within a spreadsheet row, within a database record, through an electronic message, or through a common identifier such as a traceability lot code.
You can read more background on the FSMA 204 Food Tracability Rule. Read on and we’ll focus on what counts as a CTE, what qualifies as a KDE, how those records can be organized for retrieval, and how that data often maps to ERP, WMS, and 3PL workflows.
What FSMA 204 means by CTEs and KDEs
A CTE is a supply chain event for which traceability records must be maintained under the rule. A KDE is a specific piece of information associated with that event. FDA materials consistently organize traceability requirements around this event-and-data structure. FSMA 204 recordkeeping is event-based.
The rule for KDEs to be maintained for specific CTEs, and it expects those records to be retrievable in a sortable electronic format.
Seven CTEs that Food Companies need to Identify
FDA identified a set of core CTEs across the food supply chain. Depending on the role a company plays, those events can include:
- Harvesting
- Cooling
- Initial packing
- First Land-Based Receiving
- Shipping
- Receiving
- Transformation
These are the points where traceability records need to be created and maintained. FDA guidance and examples repeatedly organize traceability obligations around these event types.
For many in the food and beverage industry the most important CTEs are often shipping, receiving, and transformation. Those are also the places where traceability data tends to become fragmented, especially when information is spread across ERP systems, warehouses, 3PL providers, and trading partner workflows.
What is a KDE and how does it relate to individual events?
KDEs are not the same at every CTE. They vary based on what happened and what must be documented for that event. In practice, the required KDEs often include:
- traceability lot code
- product description or identifier
- quantity and unit of measure
- date
- location description
- source or destination information
- shipment or receipt reference data where relevant
FDA materials tie required KDEs to individual event types rather than presenting them as a single flat list. The agency’s own sortable spreadsheet template reinforces that by organizing records by CTE and showing the KDEs associated with each one.
Practical CTE-to-KDE mapping
CTE
Example KDEs
Where the data often lives
Harvesting
Commodity and variety, quantity, unit of measure, harvest date, farm location, field or growing area, immediate subsequent recipient, reference document
farm records, harvest logs, grower systems, field records, ERP or traceability system
Cooling
commodity and variety, quantity and unit of measure, cooling location, cooling date, farm location, immediate subsequent recipient, reference document
cooling logs, plant records, ERP, production logs, traceability system
Initial Packing
traceability lot code, product description, packed quantity, unit of measure, initial packing date, packing location, harvest details, cooling details if applicable, reference document
ERP, packing records, WMS, production records, traceability system
First Land-Based Receiver
traceability lot code, species or market name, product description if packaged, quantity and unit of measure, harvest date range, harvest locations, landing date, receiver location, reference document
landing records, seafood receiving logs, vessel records, ERP, WMS, traceability system
Shipping
traceability lot code, product description, quantity and unit of measure, ship-from location, recipient location, shipping date, traceability lot code source, shipment reference
ERP, WMS, ASN workflow, TMS, EDI platform
Receiving
traceability lot code, product description, quantity and unit of measure, previous source, receiving location, receiving date, traceability lot code source, receiving reference
ERP, WMS, receiving logs, EDI platform
Transformation
input lot, output lot, new traceability lot code, product description, quantity and unit of measure, transformation date, transformation location, production reference
ERP, MES, production records, batch records, traceability system
How to structure data for the FDA’s electronic sortable spreadsheet
You must be able to make the records required by the proposed rule available in an electronic, sortable spreadsheet format. The underlying data must be formatted so it can be exported by event, with consistent field names, proper date and time stamps, correct lot IDs, accurate source and destination identifiers, and sufficient linking between relevant records to enable traceability. This is exactly the data that already needs to be aligned in your ERP system, your WMS (warehouse management system), and with your partners. And it all needs to be aligned before you ever export a single file.
Where food companies usually struggle with KDE capture
Most food companies have a solid grasp of the traceability concept. The challenge that the food industry faces in implementing effective traceability is in collecting and maintaining data on a day-to-day basis as products move through various stages of processing, distribution and storage. There are several common pain points that occur in many processing and packaging environments including commingling, rework, repacking, lot reassignment, 3PL involvement and incomplete or inconsistent shipment documentation such as missing or incorrect product numbers, incomplete vendor names or incorrect weights.
Data inconsistencies occur at the most problematic moments for every organization: transformation, shipping, and receiving. These moments involve changes to a product’s identity, quantity, or direction of movement. The FDA provides numerous examples and guidance on these issues in the GMP Requirements for Pace Maker Parts and Leads Guidance Document.
Shipments and KDEs involving products are spread across data in multiple systems, including ERP order information, WMS shipment information, 3PL confirmation information, and carrier information such as tracking numbers and delivery signatures. This data exists but is not accessible, reportable, or reliable due to inconsistencies among related records.
Visualizing Relationship Paths Between KDE/CET Structures and Distribution Networks
Since KDEs are typically spread across many applications, as noted above, the ERP (Enterprise Resource Planning) system serves as the central hub for the data, containing order information as well as product and lot data.
The WMS (Warehouse Management System) houses information related to handling, picking, and shipping activities in the warehouse, as well as data regarding receiving, storage, and slotting. The 3PL portal will also include receiving and fulfillment details as seen by the customer.
The various KDE workflows that go out as part of the organization’s EDI processes will include data related to shipments and ASNs, as well as corresponding data received from trading partners. Ultimately, the connectivity of all of these systems and workflows is what will impact the organization’s readiness to meet the FSMA 204 food traceability rule requirements.
Shipment KDEs that are rekeyed manually from system to system always seem to introduce errors. Matching an ASN against a warehouse receipt in the reporting tool is not as fast as we’d like. The 3PL confirmations are posted outside the core process, making it harder to complete a traceability review quickly. We want to make sure that the correct KDEs are automatically moved between systems and between our company and our 3PL partners, and that the KDE record stays accurate throughout the process.
What better KDE capture helps prevent
Strong KDE capture can help reduce your company’s risk of non-compliance. Better KDE processes can go a long way toward preventing common problems such as incomplete or missing traceability records, slower recall response, variable lot assignment, shipments based on bad data, and delayed access to relevant records scattered across different organizations.
The FDA has stated that one purpose of the new rule is to allow for faster identification and removal from the market of potentially contaminated foods. Better KDE processes will also reduce the amount of manual investigation and processing that must take place in the event that something does go wrong.
Creating records based on KDEs (Key Data Elements) and CTEs (Critical Tracking Events) is crucial for FSMA 204 compliance. A CTE indicates when a record needs to be made, while a KDE outlines the data fields required for that event.
To meet FSMA 204 standards, food companies must identify relevant events, map out the necessary fields, integrate various systems, and ensure the data is accessible in an electronic, sortable format for review. TrueCommerce EDI answers these needs by linking ERP, WMS, 3PL and trading partner systems, automating the transfer of critical traceability data, and reducing manual work. With integrated EDI workflows, food companies can enhance the accuracy, reliability, visibility, and retrievability of FSMA 204 records throughout their supply chain.
Want to streamline FSMA 204 data exchange across your supply chain? Schedule a TrueCommerce demo to discover how our EDI platform can connect your systems, automate traceability data sharing, and support more reliable compliance processes