How long should genealogy be retained?

Follow your product's regulatory and safety profile. Use your Record Retention policy; many life-science products require retention for years beyond expiry, while some food categories align to shelf-life plus a safety margin.

Can traceability improve quality, not just recalls?

Yes. By tying defects to specific inputs, shifts, equipment, or supplier lots, genealogy accelerates root cause analysis, informs CAPA, and supports smarter dynamic lot allocation and CPV decisions.

Traceability – End-to-End Lot Genealogy

Q: What’s the difference between traceability and genealogy?

Genealogy is the parent-child structure of how lots/serials were consumed and produced; traceability adds movement, status, and partner handoffs so you can follow the product through storage and distribution.

Q: Do we need serialization to be traceable?

No. Lot-level identity is sufficient for many processes. Serialization is required where unit-level tracking is mandated or risk justifies it (e.g., patient-level packs, UDI devices). Aggregation links serials to cases/pallets via SSCC.

Glossary

Traceability – End‑to‑End Lot Genealogy

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Supply Chain Identity, Status & Transformation History • WMS, MES, QA, Regulatory

Traceability (end‑to‑end lot genealogy) is the disciplined ability to identify every material, component, and finished good; to reconstruct where it came from, how it was processed, with what it was combined, where it moved, and to whom it was shipped. In practice, this means linking identity (e.g., GTIN, lot/batch, serial), status (e.g., Quarantine, Released), and events (receipt, consume, transform, pack, ship, return) across WMS, MES, and partner systems. Robust genealogy underpins Recall Readiness, targeted holds, supplier quality feedback, and regulatory compliance (e.g., FSMA 204 KDE/CTE and GS1 EPCIS).

“Traceability turns every scan into a breadcrumb—together they form the auditable story of your product’s life.”

TL;DR: Lot genealogy connects who, what, when, where, why across receiving, storage, manufacturing, packaging, and distribution. Use global identifiers (GTIN, lots, serials), logistic unit labels (SSCC), scan‑verified movements in WMS, consumption/transform links in MES, and publish events via EPCIS. Govern with Data Integrity, audit trails, and Record Retention. The payoff: seconds‑to‑minutes recall and precise impact scoping rather than plant‑wide shutdowns.

1) What Traceability Covers—and What It Does Not

Covers: identity assignment and verification at receive (Goods Receipt, Dock‑to‑Stock), storage and moves (Bin Location Management, bin/zone topology), shop‑floor consumption and transformation (weigh/dispense, blend, assemble), splits/merges, rework, packaging and aggregation, labeling and label verification, shipment (Pack & Ship), distribution handoffs (ASN/EDI), field returns (RMA), and targeted holds/disposition via Release Status and Lot Release.

Does not cover: demand planning, costing, or generic ERP postings in isolation; nor is traceability merely printing labels or storing PDFs. It is a living event network tied to controlled identities and statuses, governed by your quality system and verified by scanners, devices, and signatures.

2) Laws, Standards & Identifiers That Make It Work

Traceability is anchored by sector rules and global data standards. Food manufacturers face FDA FSMA 204 Key Data Elements (KDEs) and Critical Tracking Events (CTEs). Pharma and regulated cosmetics follow GDP, GMP, and labeling/serialization rules (Serialization). Devices operate under UDI within QMSR/ISO 13485. Across industries, GS1 identifiers—product (GTIN), logistics unit (SSCC), and event sharing via EPCIS—enable interoperable 1‑up/1‑down visibility across partners.

3) The Evidence Pack for Lot Genealogy

A defendable genealogy compiles machine‑readable identities and time‑stamped events. Expect to see purchase orders, supplier CoAs, inbound ASNs, receiving scans with putaway locations, sampling and Incoming Inspection results, status changes (Quarantine→Released), MES weigh/dispense and consumption records tied to the effective MBR/eBMR, split/merge transforms, rework entries, packaging with label versions and verification, aggregation trees (unit→case→pallet with SSCC), outbound staging (dock loading & handover), ship confirmations with transport IDs, and any returns/reconciliations. Every link should be attributable and audit‑trailed under Data Integrity.

4) From Supplier to Customer—A Standard Path

Traceability begins before the truck arrives. Suppliers transmit identifiers and quantities via ASN; receiving verifies labels and counts, captures lots and expiry, and creates SSCC for inbound pallets. Product is scanned into controlled storage, often under initial Quarantine until Component Release. In MES, operators weigh and dispense inputs against the BOM and formulas, scanning every lot consumed so the system draws parent‑child links. As material is blended, split, or assembled, the genealogy expands to reflect transformations. Packaging commissions item identifiers (and serials where applicable), verifies labels, and aggregates units to cases and pallets. QA executes Lot Release once evidence supports conformity; WMS flips status to shippable and creates outbound SSCCs, while EDI shares shipment details downstream. If product returns or a rework occurs, the system records it as another event branch, always preserving the original lineage.

5) Granularity: Serial‑Level vs. Lot‑Level

Most processes rely on lot‑level identity for bulk materials and intermediates; unit‑level serials are used where patient safety, device identification, or market rules require them (e.g., pharma packs, devices with UDI). Aggregation connects the two: a serialised unit rolls into a case and pallet hierarchy and is tracked using the pallet’s SSCC. The rule of thumb: serialize what you ship individually; lot‑track what you blend or consume; aggregate everything that moves as a logistics unit.

6) Data Model: Who, What, When, Where, Why

Sound genealogy uses the EPCIS pattern: What (GTIN, lot, serial, quantity), When (event time), Where (location/area/bin), Why (business step and disposition), and How (device/actor). Transformation links (consume → produce) capture recipe step context; aggregation links (unit ↔ case ↔ pallet) capture packaging context; observation links capture conditions (e.g., temperature from Temperature Mapping). These events form the “graph” you query during recalls or investigations.

7) Integrations: WMS, MES, LIMS, ERP, 3PL

Receiving and storage events originate in WMS; consumption and transforms live in MES; sampling results reside in LIMS; orders and partners flow from ERP and 3PL via EDI. Interfaces must be validated (CSV) and identity resolution enforced so the same GTIN/lot/SSCC means the same thing everywhere. Avoid “hand‑keyed” reconciliations—scan and system‑generate wherever possible.

8) Data Integrity & Governance

Genealogy is only as good as its evidence. Protect records with audit trails, e‑signatures (Part 11/Annex 11), controlled Document Control, and retention per Record Retention. Ensure label data and scan events are attributable to real users and devices, with time sync across systems. Where transforms fail, treat as Deviations and drive CAPA.

9) Status Discipline & Disposition

Traceability without status is a half‑story. Maintain strict inventory states (Quarantine/Hold/Released/Rejected) in WMS and synchronize with QA decisions in Lot Release. Enforce FEFO versus FIFO and block picks of non‑released lots. Status changes must be events in the genealogy, not silent field edits.

10) Rework, Returns & Recalls

Controlled Rework creates new transform links—always preserve the original history and mark new identifiers. RMA events must reconcile serials/lots and reset status to Quarantine until evaluation. For Recall Readiness, your system should answer “who received what?” and “what did this lot touch?” in minutes, generate pick‑lists and communications, and isolate only what is truly impacted.

11) Master Data & Packaging Hierarchy

Identity relies on clean masters: items with GTINs, units of measure, expiry rules, formulas/BOM, and packaging hierarchies (unit→case→pallet). Label templates and printing logic live under Labeling Control; variable data (lot, expiry, serial) must be verified at print and scan (Label Verification).

12) Exception Handling & Control Plan

Design a pragmatic Control Plan for common exceptions: missing barcode, mis‑print, partial pallet, cross‑dock bypass, 3PL blind ship, or offline network. Provide controlled reprint workflows, temporary identifiers linked to the “real” identity, and reconciliation steps so no material moves without a traceable event.

13) Metrics That Prove Traceability Works

Backward/forward trace time: median seconds to find all parents or children of a lot/serial.
Lineage completeness: % of consumption and transform steps with scanned evidence (no manual gaps).
Label/scan conformance: mismatch rate caught by Label Verification.
Recall scope accuracy: % of lots/serials correctly included/excluded in simulations.
Event latency: time from physical action to recorded event (scan discipline).
Partner coverage: % shipments/receipts with ASN/EPCIS correlation.

Trending these KPIs demonstrates not only that genealogy exists, but that it is complete, fast, and audit‑ready.

14) Common Pitfalls & How to Avoid Them

Identity drift. Multiple codes for the same item/lot. Solve with a master‑data strategy and scanner‑enforced mappings.
Manual “paper bridges.” Paper weigh sheets or pallet tallies later typed in. Replace with in‑line scanning and device feeds.
Orphan transforms. Consumption without output (or vice versa). Enforce MES step interlocks and reconciliation checks.
Aggregation gaps. Units packed but not linked to cases/pallets. Require pack‑by‑scan with SSCC creation.
3PL blind spots. Shipments outside your WMS. Integrate via EPCIS or EDI receipt confirmations.
Unverified labels. Print logic diverges from masters. Govern under Labeling Control with verification at point of use.

15) What Belongs in the Traceability Record

At minimum: product identity (GTIN, description), lot/serial, quantity/UoM, event type (receive, move, consume, transform, pack, aggregate, ship, return, status change), time, location, actor/device, business step and disposition, links to parents/children, label template/version, related quality records (sampling, NCR/NCMR, MRB), and governing eBMR or work order. Retain and protect per Record Retention.

16) How This Fits with V5 by SG Systems Global

Unified identity & scan discipline. The V5 platform enforces one source of truth for GTIN, lots, serials, and packaging hierarchies. Handhelds and fixed scanners validate labels at receive, move, consume, and pack, preventing “ghost” inventory and orphan events.

MES transformation graph. V5 MES links every consumed lot to outputs at each step (weigh/dispense, blend, fill, assemble), all tied to the effective MBR and captured in the eBMR. Splits, merges, and rework are modeled natively—no spreadsheets.

WMS aggregation & status control. V5 WMS commissions case/pallet identities, prints/verifies labels, creates SSCCs, and enforces Quarantine/Hold/Released states. FEFO and shelf‑life rules are automatic, and picks are blocked until QA disposition.

EPCIS/EDI connectivity. V5 publishes and consumes EPCIS events and correlates ASNs/ship notices, closing the loop with suppliers and 3PLs. You can query the full chain‑of‑custody across company boundaries with confidence.

Cold chain & condition evidence. Temperature and time‑out‑of‑refrigeration (TOR) from data loggers are bound to lots/SSCCs, complementing Temperature Mapping and proving that distribution conditions met product requirements.

Recall cockpit & simulations. With one search (lot or serial), V5 lists all parents/children, shipments, customers, and on‑hand locations. It generates targeted hold/release tasks and customer notifications, and supports “what‑if” recall simulations for readiness drills.

Governance & analytics. All events are attributable with audit trails, governed by Document Control and retained per policy. Dashboards expose trace time, lineage completeness, scan conformance, and partner coverage; alerts trigger when gaps appear so you can fix the process before an audit does.

Bottom line: V5 turns traceability into a living, queryable graph—identity, status, and events captured once at the point of work and reused everywhere for quality, service, and compliance.

17) FAQ

Q1. What’s the difference between traceability and genealogy?
Genealogy is the parent‑child structure of how lots/serials were consumed and produced; traceability adds movement, status, and partner handoffs so you can follow the product through storage and distribution.

Q2. How much scanning is “enough”?
Scan at every identity change (receive, pack, aggregate), every location change with loss risk, and every transformation where lots are consumed/created. If you could not reconstruct the story without asking an operator, add a scan.

Q3. Do we need serialization to be traceable?
No. Lot‑level identity is effective for many processes. Serialization is required where unit‑level tracking is mandated or risk justifies it (e.g., patient‑level packs, UDI devices).

Q4. How are rework and returns represented?
As additional events and links: a rework transforms an existing lot into a new lot (preserving history); a return creates a receive event tied to the shipment record and sets status to Quarantine until evaluated.

Q5. How long should we retain genealogy?
Follow your product’s regulatory and safety profile. Use your Record Retention policy; many life‑science products require years beyond expiry, whereas some food categories align to shelf‑life plus an additional safety margin.

Q6. Can traceability help quality improvement, not just recalls?
Yes. By tying defects to specific inputs, shifts, equipment, or supplier lots, genealogy accelerates RCA, informs CAPA, and supports smarter dynamic lot allocation and CPV decisions.