Traceability in Regulated Manufacturing — End-to-End Lot Genealogy Across Plants, Warehouses and Customers

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

Updated November 2025 • traceability in manufacturing, lot genealogy, one-up / one-down, batch-to-bin, GS1-128, EPCIS, DSCSA, UDI, CFIA / FSMA / BRCGS / SQF traceability • Food & Beverage, Sausage & Meat, Bakery, Produce, Dietary Supplements, Pharma, Medical Devices, Cosmetics, Chemicals, Plastic & Resin

Traceability in manufacturing is the ability to follow materials, intermediates and finished goods forwards and backwards through every step of production and the supply chain. In practice that means connecting raw-material lots, tanks, silos, batches, WIP, warehouse bins, pallets, labels and shipments into one coherent story. For regulated plants, that story must survive scrutiny under frameworks like 21 CFR 117, Part 111, Part 211, ISO 13485, BRCGS, SQF, CFIA SFCR and others.

Different sectors use different labels—end-to-end lot genealogy, lot traceability, batch genealogy, one-up / one-down traceability, serialisation, EPCIS—but the pattern is the same: identify everything that matters, track how it moves and how it changes, and make that history queryable when you need it most.

“Traceability is not just ‘knowing where things are’. It’s being able to explain, in minutes, how every lot got to where it is, what happened to it, and who is affected when something goes wrong.”

1) Core concepts — what “traceability in manufacturing” actually means

Three ideas underpin every serious traceability programme, no matter what you make:

• Identification. Every meaningful entity—raw-material lot, WIP batch, tank, bin, pallet, case, serialised unit—has a unique identifier. Think internal lot numbers, GS1-128 case labels, GTINs, SSCC, serial numbers and device IDs.
• Genealogy (lot and batch relationships). As materials are combined, split, reworked or packaged, the system records relationships between IDs. This is what your batch genealogy and lot genealogy models capture.
• Context. Every genealogy link sits in a context: the recipe, step, equipment, line, CPPs, test results, QA status and routing decisions involved. Without that, you know where things went—but not why.

Traceability in manufacturing is simply the art of designing IDs, genealogy and context so that you can answer hard questions under pressure.

2) Regulatory expectations — food, pharma, devices & cosmetics

Most regulated traceability rules boil down to two simple obligations:

• Know where each lot came from (inputs, suppliers, previous stages).
• Know where each lot went (outputs, customers, markets).

Different frameworks express this in different languages:

• Food & beverages. HACCP, HACCP-based rules, 21 CFR 117, SFCR, and private schemes like BRCGS and SQF all require lot-level traceability and mock recalls with mass balance.
• Meat & poultry. USDA/FSIS expects documented HACCP, 9 CFR 417, Appendix A, Appendix B and one-up / one-down traceability across combos, smokehouses and finished packs.
• Pharma & biologics. 21 CFR 211 and EU GMP expect full batch records and genealogy across API, intermediates and finished dosage, with serialisation regimes like DSCSA adding a distribution layer.
• Medical devices. QMSR, EU MDR and UDI require traceability through the DMR and DHR lifecycle and into the field.
• Cosmetics. EU/UK PIF requirements and US MoCRA need traceability between INCI ingredients, batches, labels, CPSR and complaints.

In each case, traceability in manufacturing is where legal requirements meet your actual plant reality. That’s where V5 lives.

3) Building blocks — IDs, GS1-128, EPCIS and batch-to-bin

The mechanics of traceability are mostly about “IDs + events”. A few key building blocks show up again and again:

3.1 GS1 identifiers and barcodes

• GTINs. Global Trade Item Numbers (GTIN) provide product identity at unit/case/pallet levels.
• GS1-128 case labels. GS1-128 encodes item, lot, expiry, weight and more via Application Identifiers.
• SSCC pallets. The SSCC number uniquely identifies pallets and logistic units for shipping and warehousing.

3.2 EPCIS and event-based traceability

Modern traceability often uses the EPCIS traceability standard to represent “what happened to which IDs, where and when”. Typical events include:

• Commission. Creating new IDs (e.g. serialised units, new pallets).
• Aggregation / disaggregation. Linking units to cases, cases to pallets and vice versa.
• Shipping / receiving. Moving IDs between organisations and sites.
• Transformation. Turning incoming lots into new lots (e.g. batching, rework, repacking).

3.3 Batch-to-bin and warehouse topology

Traceability breaks if you lose track of where lots actually are. Batch-to-bin traceability ties each lot and pallet to a specific warehouse location (rack, bin, zone, room). This is crucial in mock recalls and allergen investigations: you need to know not just “how much” but also “exactly where”.

4) Process and quality context — where MES, LIMS and QMS fit

IDs and genealogy tell you what went where. To understand why, you need context from:

• MES (Manufacturing Execution System). Executes routes, applies recipe & parameter enforcement, maintains batch records and logs CPPs, IPCs, IPV, weighing and deviations.
• LIMS. The Laboratory Information Management System stores test results, specs, COA checks and review decisions that drive lot status.
• QMS. The Quality Management System manages deviations/NCs, CAPA, risk management, complaints and recall readiness.

When traceability in manufacturing is done well, IDs and genealogy form a spine that these systems hang their data from. You can pull a lot, batch or pallet and see not only where it went, but also what happened to it and what decisions were made about it, with full audit trails and data integrity.

5) Industry examples — what traceability looks like on the floor

5.1 Sausage & meat processing

Meat plants have some of the most demanding traceability patterns: variable-weight combos, complex grind/mix, smokehouses and strict FSIS and retailer programmes.

• Combos and grind. Lots from raw-material intake (with GS1-128 raw labels) feed into grind batches; each grind carries its genealogy upstream.
• Mixer-to-smokehouse linkage. Mixer-to-smokehouse load validation and smokehouse load scanning ensure each load’s composition is known.
• Catch-weight packs. Catch-weight and chub ID and weight tracking tie variable-weight packs back to upstream lots.
• Foreign material control. Metal detector verification and X-ray bone detection validation events are linked to specific products and loads.

5.2 Bakery

Bakeries combine high-throughput WIP with complex allergen and freezer flows.

• Flour & ingredients. Flour silos and micro stations feed sponge, dough and line-scale systems.
• Sponge & dough genealogy. Sponge and Dough Systems link preferments and dough batches to final product lots.
• Freezer & par-bake. Dough ball freezer inventory and frozen slotting track partially processed WIP for later bakes.
• Route traceability. Trolley and route-level tracking maintain visibility through outbound logistics and returns.

5.3 Pharma and medical devices

In pharma and devices, traceability in manufacturing focuses on batch records and serialised distribution:

• End-to-end batch records. BMR/eBMR and DHR/eDHR keep manufacturing genealogy straight.
• Serialisation & UDI. DSCSA and UDI link units, cases and pallets to batch and distribution events.
• Complaints & field actions. Complaints and field alerts are tied back to serials, lots and batches via traceability records.

6) Mock recalls & mass balance — the only real test of traceability

The acid test of traceability in manufacturing is not how pretty your diagrams are; it is how your system behaves when you simulate a crisis. Two practical checks:

• Mock recall performance. Can you start from a suspect lot or batch and identify all affected finished products, shipments and customers—plus remaining stock—within your defined SLA? Your mock recall drills should be based on live data, not idealised exercises.
• Mass balance. Does material in (purchased/received) reconcile with material out (shipped, scrapped, reworked) at the scale your auditors expect? This is exactly what mass balance, BRCGS/SQF traceability clauses and CFIA/FSMA guidance are pushing towards.

Without a coherent traceability spine, mock recalls and mass-balance tests quickly turn into multi-day forensic exercises. With one, they become just another routine drill.

7) How V5 Traceability provides the spine for traceability in manufacturing

V5 Traceability is designed to be that spine—across MES, WMS and QMS:

• Identification. V5 manages internal lots, pallet IDs, case labels and integrations with GS1-128, GTINs, SSCC, serials and UDI where needed.
• Genealogy. MES and WMS events automatically create genealogy links—intake to batch, batch to WIP, WIP to finished, finished to pallet, pallet to shipment—under a consistent lot genealogy model.
• Context & decisions. V5 QMS and LIMS integrations bring in QA decisions, deviations, CAPA and test results, so traceability includes not just where lots went, but also what was learned and decided about them.
• Cross-industry models. The same spine supports food, meat, bakery, pharma, devices, cosmetics and chemicals—you don’t need a different traceability philosophy for each plant.

In short, V5 turns traceability in manufacturing from an Excel-and-effort problem into a system property.

FAQ — Traceability in Regulated Manufacturing

Q1. What is the difference between “traceability” and “batch genealogy”?
Traceability is the overall ability to follow a product or material through the supply chain, both upstream and downstream. Batch genealogy is the subset that deals with how lots and batches are related inside manufacturing—what lots fed which batches and what outputs they produced. Genealogy is a core component of traceability.

Q2. How does traceability help beyond recalls?
Once you have clean genealogy and movement history, you can also use it for yield analysis, supplier performance, cost-to-serve, process optimisation, allergen management, shelf-life studies and continuous improvement. Most of the ROI comes from everyday decisions, not rare recall events.

Q3. What’s the minimum traceability model a regulated plant should have?
At minimum: lot IDs for raw materials and finished goods; scan-based receiving, batching and shipping; batch-level genealogy for key products; and the ability to answer “where did this lot go?” and “what lots are in this product?” using system data alone. Schemes like BRCGS and SQF expect you to prove that with mock recalls and mass-balance checks.

Q4. How do GS1-128 and EPCIS fit into traceability in manufacturing?
GS1-128 provides standard barcodes for cases and pallets, encoding item, lot, dates and weights with GS1 Application Identifiers. EPCIS provides a standard way to describe events that happen to those IDs. Together, they make it much easier to exchange traceability data between plants, warehouses, 3PLs, customers and regulators.

Q5. Can small and mid-sized manufacturers achieve robust traceability without a huge ERP?
Yes. Many run finance and orders in QuickBooks or a light ERP, while using V5 for lot-based MES/WMS/QMS. The key is to let a dedicated traceability spine (like V5) manage IDs, genealogies and events, then feed summarised movements back to finance systems.

Q6. Where should we start if our current traceability is weak?
Start by mapping one high-risk product family end-to-end: suppliers, intake, batching, WIP, packaging, warehousing, shipping and returns. Identify where you lose identity or context, then plug those gaps with IDs, scanning and simple system changes. Once you can run a credible mock recall on that family, replicate the pattern across the portfolio.

Related Reading (Glossary)
• Foundations: Traceability (End-to-End Lot Genealogy) | Lot Traceability | Batch Genealogy | Batch-to-Bin Traceability
• Standards & IDs: GS1-128 Case Label | GTIN | SSCC | EPCIS
• Programmes & Regulations: BRCGS Traceability | SQF Mass Balance | CFIA SFCR Traceability | DSCSA | UDI
• V5 Solutions: V5 Solution Overview | V5 MES | V5 WMS | V5 QMS | V5 Connect API