Critical Tracking Events and Key Data Elements

Event-Based Traceability

FSMA requires manufacturers to maintain Key Data Elements (KDEs) that correlate to these Critical Tracking Events (CTEs) in the supply chain. This is the basis of event-based traceability.

To learn more about FSMA and new FDA requirements, click here.

Critical Tracking Events (CTEs)

CTEs are the events throughout the supply chain when a manufacturer is responsible to log associated data.

Wholechain encompasses all necessary CTEs through our “Events”, which include a commission, receive, ship, observe, aggregate, disaggregate, transform, or decommission event.

To learn more about what each of these events mean, click here *link to help doc on Wholechain Events Overview

To explore the FDA-published list of Critical Tracking Events, click here

Key Data Elements (KDEs)

KDEs are the specific pieces of information that a person/organization who manufactures, processes, packs, or holds foods on the Food Traceability List (FTL) to maintain and provide to their supply chain partners.

KDEs are dependent on the Critical Tracking Event that is taking place, so the data that needs to be collected will change based on the event occurring.

To explore the FDA-published list of Key Data Elements for each CTE, click here

Seafood KDEs

Seafood Key Data Elements are more specifically outlined by an international platform, The Global Dialogue on Seafood Traceability (GDST). The GDST created the global industry standards for seafood traceability. The GDST’s global framework for seafood traceability based on four pillars:

Internationally agreed key data elements (KDEs) to be routinely associated with seafood products
Technical specifications for interoperable traceability systems, along with standard legal and business formats facilitating business-to-business information exchange
Internationally agreed on benchmarks for verifying data validity
Harmonization of business-smart national regulations to help reduce compliance burdens

To learn more about the specifics of GDST and how to comply with GDST standards, read Wholechain’s GDST Standards and Compliance Help Doc

For more general information on the GDST, click here.

To learn more about the specific FDA Events and Data Elements that pertain to you, click here