FSMA 204 Traceability

This topic is part of the SG Systems Global traceability, food safety & regulated supply chain glossary.

Updated December 2025 • FSMA 204 traceability, FSMA 204 KDE, FSMA 204 CTE, food traceability, produce traceability, EPCIS, GS1-128, one-up/one-down, recall readiness, MES, WMS & QMS • Food & Beverage, Produce, Meat & Poultry, Ingredients & Dry Mixes, CPG, Cold Chain

FSMA 204 traceability is not “just more paperwork”. It’s the FDA’s way of forcing the US food chain to show, with data, how high-risk foods move through supply chains—using Key Data Elements (KDE) at every Critical Tracking Event (CTE). If FSMA 204 is about the law, FSMA 204 traceability is about your systems: do your intake scans, production records, WMS and recall drills actually line up with what the rule expects?

This hub page connects the SG Systems Global glossary topics needed to make FSMA 204 traceability real: KDEs and CTEs, GS1-128 labelling, PTI and EPCIS, lot genealogy, rework and mass balance, one-up/one-down traceability, mock recalls and recall readiness. It also shows how V5 MES, WMS and QMS can turn the regulation into a practical architecture instead of a once-a-year panic exercise.

“If your FSMA 204 traceability plan lives in a binder and your data lives in disconnected systems, you don’t have traceability. You have a story you hope nobody stress-tests.”

1) FSMA 204 traceability stack — how the pieces fit

The table below groups key topics into layers of an FSMA 204 traceability stack—from IDs and labelling through plant events, warehousing and recall-ready analytics:

2) Why FSMA 204 traceability matters now

FSMA 204 is about more than a new acronym. It tightens expectations around who must capture what data, when, and how fast it must be provided during an investigation. For manufacturers, the hard truths are:

• Lot codes and COAs are not enough. FSMA 204 traceability demands KDEs at each CTE—especially receiving, transformation and shipping—not just a lot number on a pallet.
• Excel-based traceability will not scale. The FDA expects responses in hours, not weeks. That requires integrated systems, not manual cross-checks.
• Rework, re-packing and partial lots are in scope. Unlogged rework streams or “partial pallet” practices quickly turn into blind spots when you try to reconstruct KDEs.
• Label quality suddenly matters more. If GS1-128 or SSCC labels are wrong, incomplete or optional, your FSMA 204 traceability chain breaks before it starts.
• Mock recalls will expose gaps. Running a realistic mock recall under FSMA 204 assumptions usually reveals missing KDEs, inconsistent IDs and untraceable rework.

3) KDE & CTE — the data backbone of FSMA 204 traceability

FSMA 204 traceability is built on two ideas:

• Critical Tracking Events (CTE). Points where food is changed in custody, form or location—e.g. receiving, transformation (mixing, cutting, cooking), packing, shipping.
• Key Data Elements (KDE). Specific data required at each CTE—e.g. product identifiers, lot IDs, quantities, dates/times, locations, linked shipments and source/destination.

The KDE layer is captured in the SG Systems glossary as KDE – Key Data Elements (FSMA 204). The goal is to ensure that every CTE your plant executes—whether at the dock, in batch execution, in WIP moves or at shipping—outputs a set of KDEs that can be stitched together into a coherent genealogy for each FSMA-relevant item.

From a system perspective, that means configuring MES, WMS and ERP so that:

• Every intake, yield, move, rework and shipment event has an associated product, lot, quantity, location, date/time and source/target.
• Those events are linked by consistent IDs (GTIN, lot codes, SSCC) and not by free text or spreadsheet keys.
• Audit trails and data integrity controls ensure KDEs are trustworthy.

4) IDs & labelling — getting FSMA 204 traceability off the ground

Without robust identifiers and barcodes, FSMA 204 traceability becomes manual detective work.

• Product identities. GTIN Item Identity ensures each commodity or SKU has a unique, structured ID.
• Raw intake labels. GS1-128 Raw Material Intake Labeling captures supplier, product, lot, quantity and dates at first receipt.
• Internal transfers. GS1-128 Lot Transfer Scanning tracks moves between silos, rooms and lines.
• Cases & pallets. GS1-128 Case Label and SSCC anchor case/pallet KDEs at packing and shipping.

These IDs are what let systems connect KDEs across CTEs. If intake, production and shipping each use different identifiers—or allow free-text—KDEs cannot be joined automatically and FSMA 204 traceability becomes a manual reconciliation exercise.

5) Plant-level genealogy, rework & mass balance

Once identifiers work, the next challenge is the messy reality of plant flows: partial lots, rework, re-packing and blending. FSMA 204 traceability expects that you can explain:

• Which intake lots contributed to which intermediate and finished lots.
• Where rework came from and where it went.
• How much of a lot remains in inventory or waste versus shipped product.

Key glossary anchors here are:

• Lot Traceability & End-to-End Genealogy — the core mapping logic across CTEs.
• Batch-to-Bin Traceability — linking bulk WIP in bins, totes or silos to specific batches and lots.
• Rework Traceability – Controlled Re-Use — ensuring rework streams remain traceable and within policy.
• Mass Balance — quantitatively reconciling inputs, outputs and losses.

When these controls are in place, you can explain not just where each lot went, but also how much of it is still on site, in rework, or scrapped—critical for defining recall scope under FSMA 204 traceability.

6) Produce & PTI — FSMA 204 traceability in case-level operations

FSMA 204 puts particular emphasis on certain high-risk foods, including many produce items. For these, case-level traceability is the norm rather than the exception. The SG Systems glossary anchors that world with:

• Produce Traceability Initiative (PTI) — case-label requirements for fresh produce.
• One-Up / One-Down Traceability — connecting inbound and outbound shipments via KDEs.
• Cold-chain and smart-factory concepts from Industry 4.0 & Connected Operations.

FSMA 204 traceability in produce typically means every case has a PTI or GS1-128 label, every pallet has an SSCC, and every movement (receiving, storage, consolidation, shipping) is scanned into WMS. V5 can enrich that with transformation events (washing, cutting, mixing) captured via MES and rolled into EPCIS-style events for customers and regulators.

7) EPCIS & data exchange — tracing beyond the four walls

FSMA 204 traceability won’t stop at plant boundaries. Many customers and retailers will expect event-level data in machine-readable form. That’s where:

• EPCIS Traceability Standard provides a framework for sharing “what, when, where, why” for each event.
• Electronic Data Interchange (EDI) for orders, ASNs and invoices intersects with KDEs and CTEs.

FSMA 204 does not mandate EPCIS, but EPCIS makes it easier for trading partners to exchange the KDEs associated with CTEs. V5 can generate EPCIS-ready event streams by combining MES events (production, transformation) with WMS events (receipts, picks, shipments) and exposing them via the V5 Connect API.

8) Warehouse & logistics — making WMS FSMA-aware

WMS is where much of FSMA 204 traceability lives day to day: receiving, put-away, moves, picks, staging and shipping. The SG Systems glossary anchors this with:

• Warehouse Management System (WMS) — the system of record for locations and moves.
• Dock-to-Stock and Goods Receipt — where intake KDEs are born.
• Directed Put-Away and Bin & Zone Topology — ensuring risk-based zoning and segregation are respected.
• Order Picking & Fulfilment — where outbound KDEs are set.

For FSMA 204 traceability, WMS must capture KDEs for each CTE it owns and expose them cleanly to MES, ERP and recall-response tooling. V5 WMS is designed to operate in that FSMA-aware mode: every receipt, move, pick and shipment becomes a traceable event with the right KDEs attached.

9) Mock recalls, recall readiness & FSMA 204 traceability

FSMA 204 traceability is ultimately judged in the heat of recalls and investigations. Two glossary entries capture the mindset:

• Mock Recall Performance — how quickly and accurately you can determine scope from a starting lot or complaint.
• Recall Readiness & Rapid Traceability Response — the culture and tooling around fast, defendable answers.

With FSMA 204 traceability in place, mock recalls should be able to answer questions like:

• “Which customers received product that includes any of lots X, Y or Z?”
• “Which intermediate batches used those lots, and what KDEs were recorded at each transformation?”
• “What is the minimum viable recall scope given mass balance and rework usage?”

V5 supports this by making recall queries a native function of the combined MES/WMS genealogy instead of an emergency IT project pulling logs from half a dozen systems.

10) How V5 implements FSMA 204 traceability

V5 turns FSMA 204 traceability from a policy into an execution pattern:

• V5 MES. The V5 MES layer:
  • Captures CTEs inside the plant: batch start/finish, transformation steps, rework additions and yields.
  • Applies product and batch identities consistently, feeding KDEs into the genealogy model.
  • Links production events with QA checks, holds and Nonconformance (NC) records for suspicious lots.
• V5 WMS. The V5 WMS layer:
  • Records KDEs at receiving, moves, picks, staging and shipping using GS1-128 and SSCC labels.
  • Implements zoning, segregation and FEFO/lot policies that lower cross-contamination and mis-ship risk.
  • Provides the “where is it now?” and “where did it go?” views needed for FSMA 204 traceability queries.
• V5 QMS. The V5 QMS layer:
  • Holds the FSMA 204-relevant procedures, risk assessments and FSMS / HACCP / GFSI framework.
  • Manages NCs, CAPA and management reviews driven by traceability gaps or recurring issues.
  • Ensures changes to labelling, processes or systems go through Change Control with traceability impact assessed.
• V5 Connect API. The V5 Connect API layer:
  • Integrates V5 with scales, scanners, label printers, PLCs and customer systems for end-to-end KDE capture.
  • Pushes EPCIS-style event data and FSMA 204 traceability reports to corporate BI, customers or regulators as needed.
• V5 Solution Overview. The end-to-end architecture is summarised in the V5 Solution Overview hub.

11) KPIs that show FSMA 204 traceability is under control

• Traceability query time. Minutes required to answer “which shipments include lot X?” from system data alone.
• KDE completeness. % of CTEs with all required KDE fields populated (by product family and site).
• Mock recall success rate. % of mock recalls completed within target time and without scope bloat.
• Rework visibility. % of rework routed through defined, traceable paths versus ad-hoc practices (target: 100 % defined paths).
• Label scan failure rate. Number of unreadable or non-compliant GS1-128/SSCC labels per 10,000 scans.
• “Unknown origin” incidents. Number of complaints or investigations where raw-material origin cannot be fully reconstructed.

12) Common pitfalls in FSMA 204 traceability programmes

• Policy without plumbing. Writing FSMA 204 traceability policies but leaving IDs, labels and systems unchanged.
• Spreadsheet genealogy. Relying on offline Excel models that cannot keep up with real-time operations or investigations.
• Partial coverage. Focusing on finished-goods KDEs while ignoring intake, rework and partial-lot use.
• Unstructured rework. Allowing rework to bypass standard WMS/MES paths and quietly break genealogy.
• Single-point labelling. Only applying compliant labels at shipping, leaving upstream containers and WIP anonymous.

13) Quick-start checklist for FSMA 204 traceability

• Identify which of your products and ingredients fall under FSMA 204 and map their current traceability flows.
• Standardise product, lot, case and pallet IDs using GTIN, lot codes, GS1-128 and SSCC where applicable.
• Define CTEs in your operations and map which KDEs are required at each one (KDE – FSMA 204).
• Configure WMS and MES to capture those KDEs automatically during normal work (no “FSMA mode” button).
• Run a realistic mock recall starting from an intake lot and from an outbound shipment; document gaps and fix them.
• Bring FSMA 204 traceability under your QMS and FSMS, with regular reviews and CAPA for traceability issues.

14) FSMA 204 Traceability FAQ

Q1. What is FSMA 204 traceability in practical terms?
In practice, FSMA 204 traceability means that for each FSMA-covered food, you can reconstruct a chain of KDEs across CTEs—from intake through internal transformations and rework to outbound shipments—using system data rather than manual investigation. It demands consistent IDs, structured events and recall-ready reporting.

Q2. Do we need a new system just for FSMA 204 traceability?
Not necessarily. Most organisations can meet FSMA 204 by tightening IDs, labels and processes and then integrating existing MES, WMS and ERP into a coherent genealogy model. The key is to close gaps and automate KDE capture, not to create a separate “FSMA system” that duplicates everything.

Q3. How does FSMA 204 traceability relate to our HACCP and GFSI programmes?
FSMA 204 traceability sits alongside HACCP and GFSI as part of your overall Food Safety Management System (FSMS). HACCP focuses on hazards and controls; FSMA 204 focuses on being able to reconstruct product paths and scopes quickly when hazards materialise or are suspected.

Q4. We already have one-up / one-down traceability. Is that enough?
One-up / one-down, as captured in One-Up / One-Down Traceability, is a good foundation, but FSMA 204 adds more specific KDE expectations and often requires finer granularity (e.g. case-level rather than batch-level), plus faster response times. You should validate that your current one-up/one-down model can produce the KDEs FSMA 204 expects.

Q5. How can we tell if our FSMA 204 traceability is “good enough”?
The most honest test is a time-boxed mock recall for one FSMA-covered item: can you identify all affected lots and shipments within the time expectations in your plan using only system data? If not, the gaps you encounter—missing KDEs, inconsistent IDs, unlogged rework, manual spreadsheets—show exactly where to improve.

Related Reading
• Traceability & FSMA: KDE – Key Data Elements (FSMA 204) | Lot Traceability & End-to-End Genealogy | One-Up / One-Down Traceability | Produce Traceability Initiative (PTI) | EPCIS Traceability Standard
• Warehouse & Labelling: Warehouse Management System (WMS) | GS1-128 Raw Intake | GS1-128 Lot Transfer | GS1-128 Case Label | SSCC
• Rework & Mass Balance: Rework Traceability | Batch-to-Bin Traceability | Mass Balance
• Governance & FSMS: Quality Management System (QMS) | Data Integrity | Audit Trail (GxP) | FSMS / HACCP / GFSI Hub
• V5 Products: V5 Solution Overview | V5 MES | V5 WMS | V5 QMS | V5 Connect API