CTE KDE Recordkeeping

This glossary term is part of the SG Systems Global regulatory & operations guide library.

Updated January 2026 • FSMA 204 traceability rule, Critical Tracking Events (CTEs), Key Data Elements (KDEs), event-based records, lot linkage, transformation/receiving/shipping datasets, 24-hour response, EPCIS alignment, data integrity controls • Primarily Food Supply Chain Traceability (FTL foods, compliance-ready traceability systems)

CTE KDE Recordkeeping is the operational discipline of capturing, validating, retaining, and retrieving the required Key Data Elements (KDEs) for each Critical Tracking Event (CTE) under FSMA 204 (and closely aligned customer/GFSI traceability programs). It is not “keep some shipping paperwork.” It is an event-based record system that makes trace investigations fast: for any lot, you can produce a consistent dataset of what was received, what was transformed, what was shipped, and which trading partners were involved—without reconstructing the story from scattered artifacts.

FSMA 204 pressures companies to move from document-based traceability (“we have POs and BOLs somewhere”) to event-based traceability (“we have a structured receive/transform/ship event chain with lot linkage”). CTE KDE recordkeeping is the mechanism that makes that shift real. It defines what must be captured at each event, how it must be validated and protected, and how it must be packaged when the regulator or customer asks for a traceability dataset—often on a tight timeline.

Tell it like it is: companies don’t fail FSMA traceability because they have no data. They fail because data is inconsistent, not lot-linked, captured late, editable without controls, or scattered across systems. CTE KDE recordkeeping fixes that by standardizing the “minimum viable event record” and enforcing it at the points where traceability breaks: receiving, transformation, aggregation/commingling, and shipping.

“CTE KDE recordkeeping is traceability you can export—not traceability you have to reconstruct.”

1) What CTE KDE recordkeeping actually is

CTE KDE recordkeeping is the “event ledger” of your traceability system. For each critical tracking event, you create a record that captures:

• event type (receive, transform, ship, etc.),
• event time and event location,
• trading partner(s) involved where applicable,
• product identity and quantities,
• lot identity (and container/case/pallet identities where used),
• linkage to prior and subsequent events via lot genealogy,
• exceptions, holds, and disposition evidence where applicable.

The records must be consistent and exportable. If each department records events differently, your trace dataset will be incomplete and slow to assemble.

2) Why FSMA 204 forces event-based recordkeeping

Document-based traceability is too slow. In outbreaks, regulators need to move quickly. Document sets (POs, invoices, BOLs) often lack lot linkage or are stored in incompatible formats. Event-based recordkeeping solves that by standardizing what is captured at each boundary moment.

Event-based recordkeeping also aligns with how supply chains actually move product: custody changes at receiving and shipping; identity changes at transformation and repack; scope changes in commingling and aggregation. Those are exactly the places trace breaks when recordkeeping is informal.

3) CTEs: the events that must be captured consistently

CTEs are “critical tracking events”—defined moments where the trace chain must be captured. Operationally, the most common CTE classes include:

• Receiving: material enters your custody.
• Transformation: input lots become output lots (manufacturing, processing, repack).
• Shipping: product leaves your custody.
• Aggregation/commingling: identity is grouped or mixed (mixed pallets, consolidation).

Not every facility performs every CTE type, but every facility handling FTL foods will have at least some boundary events that must be captured cleanly.

4) KDEs: the minimum viable data fields for each event

KDEs are the required fields for each event. The same KDE categories show up repeatedly:

• Who: ship-from/ship-to identifiers, carrier where applicable.
• What: product identity (item/SKU/GTIN).
• Which: lot code(s) and container/case/pallet identities (SSCC) where used.
• How much: quantity and UOM.
• When/Where: event time and location.

CTE KDE recordkeeping means those categories are always present and always lot-linked, regardless of department.

5) Lot identity spine: the single most important recordkeeping rule

Lot identity is the primary key that connects events. Recordkeeping fails when lot identity is:

• not captured at receipt (supplier lot missing),
• not linked through transformation (input-to-output mapping missing),
• not captured at ship confirm (outbound lots not linked to customers),
• lost in mixed pallets or repack operations.

So the first recordkeeping rule is: lot identity must be captured and preserved through every event. Everything else is secondary.

6) Receiving event recordkeeping: one step back starts here

Receiving recordkeeping must capture ship-from/supplier, supplier lot and internal lot mapping, quantity, time/location, and disposition (quarantine/hold/release). This is where “one step back” becomes provable.

Common weaknesses that break recordkeeping at receiving:

• typed supplier lot numbers,
• mixed pallets recorded as one lot,
• put-away before disposition,
• CoAs stored but not linked to lot IDs.

Fixing receiving recordkeeping is the highest leverage traceability improvement because it prevents mystery inputs.

7) Transformation recordkeeping: input-to-output genealogy and mass balance

Transformation is the hardest record set because identity changes. A transformation record must link:

• input lots consumed (with quantities),
• output lots produced (with quantities),
• time/location of the transformation,
• business context (batch/run ID),
• scrap/rework/yield outcomes so mass balance reconciles.

Transformation recordkeeping fails when operators substitute lots without recording it, rework is added without identity, or WIP tanks are managed “by memory.”

8) Shipping event recordkeeping: one step forward and ship confirm truth

Shipping recordkeeping must capture ship-to, shipment identifiers, lots shipped, quantities shipped, time/location, and handover evidence (BOL/ASN/manifest). It is the one-step-forward proof.

Shipping recordkeeping fails when:

• shipments are confirmed without lot identity,
• mixed pallets are not tracked at case/pallet level,
• holds do not block shipments,
• exceptions (substitutions, short picks) are undocumented.

If you can’t prove who received which lot, your recall notifications will be broad and slow.

9) Aggregation/commingling: preserving identity through mixed operations

Aggregation and commingling are where many trace programs break because identity becomes layered:

• cases aggregated to pallets (SSCC),
• pallets mixed with multiple lots,
• partial pallets broken down and rebuilt,
• DC consolidation and cross-docking events.

Recordkeeping must preserve the relationships: what cases/lot codes are on each pallet, and what pallets went on which shipment. Without those relationships, forward trace is imprecise.

10) Documents vs events: how to use POs/BOLs/ASNs without losing lot linkage

FSMA 204 does not ban documents; it requires that the trace dataset be event-based and lot-linked. Documents like POs, BOLs, ASNs, packing lists, and CoAs are still valuable—if they are linked to event records.

Practical rule:

• documents provide commercial context,
• event records provide lot-linked trace context,
• both must be connected by shared IDs (shipment ID, receipt ID, lot IDs).

If documents exist without linkage, you have paperwork but not a trace dataset.

11) Data integrity controls: preventing silent edits and backfill

CTE KDE recordkeeping must be credible under audit. That means it must be protected from “quiet fixes” after the fact. Strong integrity controls include:

• unique user identities (no shared logins),
• audit trail for changes (see audit trail),
• reason-for-change for edits,
• event-time capture distinct from entry-time where relevant,
• controlled exception paths when scanning fails (not default manual entry),
• hold/release enforcement so records match physical control reality.

If the system allows backdating and silent edits, the trace dataset becomes legally fragile.

12) Retention and indexing: making records retrievable by lot and time window

Recordkeeping is not only capture; it’s retrieval. Your system should support:

• lot-centric search across receiving/transform/shipping,
• time-window search for suspect windows,
• trading partner search (ship-from/ship-to),
• export formats that can be delivered quickly,
• retention policies and backups so records remain available.

This aligns with the 24-hour response mindset: if you can’t retrieve the dataset quickly, you’re not ready.

13) 24-hour dataset response: building exportable trace packages

A mature CTE KDE recordkeeping program can export an FDA traceability dataset quickly. Practically, your export packages should include:

• receiving event dataset (supplier lot mapping, quantities, disposition),
• transformation event dataset (input-to-output linkages, quantities, yields),
• shipping event dataset (ship-to, lots shipped, quantities, shipment IDs),
• mass balance reconciliation summary,
• exceptions and holds tied to the time window/lot scope.

If you have to assemble these manually each time, you will miss deadlines and create errors. “Exportability” is a core design goal.

14) EPCIS alignment: representing CTE/KDE records as standardized events

EPCIS is a practical representation format for event recordkeeping. When your system already captures the core KDE categories, EPCIS mapping becomes natural:

• receive/ship events map to object events,
• transform events map to transformation events,
• event time and location map directly,
• business transaction references (PO/BOL/ASN) map to EPCIS businessTransactionList,
• SSCC/case IDs map to EPC identifiers,
• quantity lists map to quantityList structures.

Again: EPCIS won’t fix weak capture. It will only standardize what you already have.

15) Testing and drills: proving recordkeeping works under pressure

The best test is a mock recall that requires a complete event chain dataset. Pick a finished lot and produce:

• receiving KDEs for implicated inputs,
• transformation KDEs linking inputs to outputs,
• shipping KDEs showing where outputs went,
• mass balance reconciliation,
• export package within your target time window.

If any event is missing or not lot-linked, the drill will reveal it. That’s the value of testing: it finds the dead ends before a real investigation does.

16) KPIs: measuring completeness, drift, and exception rates

Useful KPIs for CTE/KDE recordkeeping:

If manual entry rates creep up, KDE integrity will drift. That’s an early warning signal you can act on before audits do.

17) Audit posture: what regulators and customers pressure-test

Pressure tests typically include:

• pick a lot and request the full event chain dataset,
• verify receiving supplier lot mapping,
• verify transformation linkage and mass balance,
• verify shipping consignee linkage and quantities,
• verify record integrity (no after-the-fact edits without audit trail),
• verify retrieval speed (timed response).

Auditors don’t care that you can generate a report eventually. They care that the dataset is complete, consistent, and fast.

18) Copy/paste readiness scorecard

Use this as a blunt internal test. If you can’t answer cleanly, fix capture discipline—not the report templates.

19) Failure patterns: how CTE/KDE compliance gets faked

• Document substitution. POs/BOLs provided without lot-linked event datasets.
• After-the-fact linkage. Lots “matched” later to make trace work; timelines don’t match reality.
• Transformation blind spot. Input-to-output linkage missing; genealogy is assumed.
• Typed lots. Manual entry dominates; error rates climb.
• Mixed pallet ambiguity. Aggregation not recorded; forward trace is broad.
• Holds not enforced. Records show control, but shipments prove otherwise.
• No audit trail. Records can be edited silently; integrity is questioned immediately.

The antidote is event-time capture with validation and enforcement, backed by routine drills.

20) How this maps to V5 by SG Systems Global

V5 supports CTE/KDE recordkeeping by making traceability events native to execution rather than add-on reporting. In practice, V5 can:

• capture scan-driven receiving KDEs and supplier lot mapping with disposition gating,
• capture transformation events linking input lots to output lots with quantities and mass balance support,
• capture scan-driven shipping KDEs tied to customers, shipments, SSCC/case identity, and documents,
• enforce hold/release and movement rules so records match physical control,
• protect integrity with audit trails and controlled access,
• export complete traceability datasets and EPCIS events where required.

These capabilities align across V5 WMS (receiving/shipping), V5 MES (transformations), and integrations via V5 Connect API to connect ERP, LIMS, and trading partners.

21) Extended FAQ

Q1. Are CTE/KDE recordkeeping requirements the same for every company?
No. Requirements depend on your role, the food category (FTL scope), and the event types you perform. But the operational categories (who/what/which/qty/when/where) remain consistent.

Q2. What is the hardest record set to maintain?
Transformations, because they require input-to-output linkage with reconciling quantities. Most trace programs fail here due to WIP and rework identity gaps.

Q3. Do we need EPCIS to comply?
Not necessarily. EPCIS is a common exchange standard, but compliance depends on your ability to capture and produce the required KDE datasets quickly and consistently.

Q4. How do we keep manual entry from ruining KDE integrity?
Make scanning the default, treat manual entry as a controlled exception with verification, and trend manual entry rate as a KPI. If manual entry is common, your system is drifting into error.

Q5. How do we prove we’re ready?
Run mock recalls and retrieval drills that require a full receive/transform/ship dataset for a randomly selected lot and time window, with mass balance. If you can export it quickly and it reconciles, your recordkeeping is real.

Related Reading (keep it practical)
CTE/KDE recordkeeping becomes durable when receiving, transformation, and shipping are scan-driven and lot-linked (receiving, transformation, and shipping), quantities reconcile (mass balance), and datasets are exportable within the 24-hour response window. Then prove readiness with mock recalls and structured drills that close gaps instead of repeating them.