BRCGS Clause 3.9 – Traceability RequirementsGlossary

BRCGS Clause 3.9 – Traceability Requirements

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

Updated October 2025 • Food Safety & Traceability • BRCGS, GFSI, Food, Manufacturing, Supply Chain

BRCGS Clause 3.9 requires sites to maintain a rapid, bi‑directional traceability system that links supplier lots, processing records, finished‑goods genealogy, and distribution details—including packaging. Expect auditors to test your system with a mock recall and a mass‑balance reconciliation. If you can’t produce a complete forward/backward trace with quantities inside your site’s target time (benchmark: ≤ 4 hours), you will get written up. Pack it, scan it, prove it—or don’t release it.

“If you can’t account for every unit in and out—raws, WIP, rework, packaging—you don’t have traceability. You have luck.”

TL;DR: Clause 3.9 demands end‑to‑end lot genealogy (back to supplier lots and forward to customers), mass‑balance proof, inclusion of all packaging, and a timed mock recall. Use GS1 identifiers (GTIN, AI (10) Lot, GS1‑128, SSCC), verify barcodes at line (label verification), capture events (EPCIS), and lock status in WMS. Test routinely. If it isn’t traceable, it isn’t shippable.

1) What Clause 3.9 Actually Demands

  • Lot identification everywhere. Use globally unique product/pack identifiers: GTIN + Lot AI (10) (+ dates/others via GS1 AIs).
  • Bi‑directional trace. Back to goods‑receipt supplier lots and forward to first customer/market. Include WIP, rework, and returns.
  • Packaging is in scope. Primary and secondary packaging must be traceable like ingredients; manage artwork and codes via Labeling Control.
  • Mass‑balance challenge. Reconcile quantities used vs. produced/scrapped per lot; explain losses—don’t hand‑wave (Mass Balance).
  • Timed mock recall. Perform and document a mock recall at defined frequency and within a defined time target (benchmark ≤ 4 hours). Record how long it took and what was missing.
  • Readable, durable labels. Print & verify GS1‑128/SSCC; stop the line if verification fails (Label Verification).
  • Controlled records. Keep evidence under Document Control, with secure audit trails and access control.

2) Scope That Trips Teams Up

  • Packaging lots. Films, cartons, labels, ink, adhesive are materials—trace them like ingredients.
  • Variable‑weight items. Manage catch‑weight lots so mass‑balance math still works.
  • Rework & by‑products. Link rework both ways; don’t bury it in yield variance.
  • External handlers. Include 3PLs and co‑packers in the chain via ASN/EPCIS events or you’ll lose visibility at the dock.

3) Identification & Coding That Works

Use GS1 everywhere: product GTIN, AI (10) for lot, date codes and others per AIs. Case/pallet labels use GS1‑128 with pallet SSCC. Print‑and‑verify at line; fail verification = fail the lot routing (Label Verification).

4) Records & Linkages You Must Show

5) Mass‑Balance & Mock Recall—How You’ll Be Graded

A mass‑balance test proves you can reconcile material in/out for a chosen window or lot, including scrap, rework, and yield loss. A mock recall proves you can list every affected lot shipped and every customer notified—fast. Keep the bar high: run quarterly per high‑risk SKU; challenge packaging‑only recalls too. If you need “all day” to finish, you’re not compliant—you’re lucky no one’s been hurt.

6) Digital Evidence & Data Integrity

Paper gets you in trouble. Use eBMR with audit trails, Part 11/Annex 11 e‑signatures, and standardized event capture (EPCIS). Lock product status in WMS; make barcode verification a hard gate. Tie this to your QMS for controlled documents and training.

7) Common Failure Modes (and How to Fix Them)

  • Packaging not linked to lots. Fix: require scans of case/pallet IDs during pack & ship.
  • Rework “disappears.” Fix: formal rework traceability lots and usage steps.
  • Offline spreadsheets. Fix: enforce MES/WMS entries; block hard‑gating if data are missing.
  • Variable weight chaos. Fix: treat catch‑weight as first‑class data; integrate scales.
  • 3PL blind spot. Fix: require ASN/scan events from partners or don’t ship.

8) Implementation Checklist (No Excuses)

  • Define product, component, and packaging IDs using GS1 standards.
  • Map end‑to‑end genealogy (supplier → process/WIP → FG → customer).
  • Enforce scan points at weigh, issue, mix, pack, and ship (MES/WMS).
  • Make label verification a hard stop.
  • Run quarterly mock recalls for top‑risk SKUs; time them.
  • Perform routine mass‑balance on bulk‑to‑pack conversions.
  • Integrate 3PLs/co‑packers with EPCIS or ASN.
  • Tie evidence to QMS training; no training, no access.
  • Trend mock‑recall duration and % completeness; drive to zero gaps.
  • Align with regulatory add‑ons where relevant (e.g., FSMA 204 KDE/CTE).

9) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform is built for traceability at line speed—IDs, scans, events, and status are enforced and reportable in real time.

V5 MES. The V5 MES captures usage genealogy in the eBMR, enforces IPC and label checks, and blocks release without complete lot links.

V5 WMS. The V5 WMS governs status, Directed Picking, SSCC, and Dynamic Lot Allocation so only the right lots ship.

V5 QMS. The V5 QMS controls SOPs, approvals, and training for trace processes; it houses mock‑recall reports and CAPAs when gaps appear.

Bottom line: With V5, Clause 3.9 becomes muscle memory. Scans are mandatory, genealogy is automatic, and mock‑recall reports are a click—not a fire drill.

10) FAQ

Q1. Do we have to include packaging in traceability?
Yes. Cartons, films, labels, inks, and adhesives are in scope. Link them at issue and verify at line with barcode checks and GS1‑128/SSCC.

Q2. How fast must we complete a traceability test?
Define a hard internal target and meet it—auditors commonly expect a full forward/backward trace with mass‑balance in ≤ 4 hours. Faster is better.

Q3. What counts as a “pass” on mass‑balance?
You reconcile inputs to outputs (including scrap/rework) with defensible tolerances. Unexplained gains/losses fail the test—fix your counting or your process.

Q4. How often should we run mock recalls?
Annually is the bare minimum. Best practice: quarterly for high‑risk SKUs and whenever you change codes, packaging, or systems (Mock Recall).

Q5. How do we handle variable (catch‑weight) items?
Treat weight as a controlled attribute per lot; integrate scales and capture pack weights to keep catch‑weight reconciled.

Q6. Does BRCGS traceability align with FSMA 204?
Yes—map your KDE/CTE events to EPCIS and ensure rapid retrieval. If you satisfy Clause 3.9 rigorously, FSMA 204 gets a lot easier.

Q7. How does this compare to SQF?
Similar fundamentals—bi‑directional trace, packaging in scope, and reconciliation. See SQF Edition 9: Traceability & Mass Balance for cross‑reference.


Related Reading
• Core Traceability: End‑to‑End Genealogy | Batch Genealogy | Mass Balance | Mock Recall | PTI
• GS1 & Codes: GTIN | AI (10) Lot | GS1 AIs | GS1‑128 | SSCC | Label Verification
• Execution Systems: MES | WMS | eBMR | EPCIS
• Compliance Context: FSMA 204 KDE | GFSI | QMS

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