Manufacturing Case StudyTrack & Trace

Complete Material Lineage

Reconstructing the full history of any product — from raw material lot to customer shipment — in seconds rather than days, and answering every recall, compliance, and quality question before it becomes a crisis

60–90%
Recall Scope Reduction
Surgical vs. blanket recalls
<1%
Inventory Variance
Down from 3–5% with ERP alone
Hours
Compliance Audit Time
From weeks of manual review
15–30%
Scrap Reduction
Early detection via genealogy
The Three Capabilities

Track, Trace, and Genealogy

Traceability is not a single query. It is the ability to navigate material history in both directions — and to see the entire transformation graph between them.

Forward Trace

Where did it go?

Given a raw material lot or production batch, the system instantly identifies every downstream product it contributed to and every customer shipment it reached. A contaminated ingredient is contained — not guessed at.

Backward Trace

Where did it come from?

Given a finished product or field complaint, the system reconstructs every upstream input: which raw material lots, which production batches, which processing conditions, which operators. The complete history in seconds.

Genealogy

The complete lineage graph

The full directed graph linking every material input to every output across every split, merge, rework, and transformation — maintained automatically as production progresses, queryable at any point in time.

The Recall Time Problem

When a contaminated raw material lot is discovered, two questions demand immediate answers: which supplier lots contributed to affected products, and which customers received them. Paper records take days. ERP takes hours — if the data was captured at all. Real-time genealogy answers in seconds.

Days
Paper Records

Manual search through batch records, dispatch notes, and supplier documentation

Hours
ERP Only

Aggregate lot balances visible but individual container lineage must be reconstructed manually

Seconds
Real-Time Genealogy

Full forward and backward trace executed instantly — surgical recall scope identified before a crisis escalates

Why ERP Cannot Provide Traceability

ERP systems were architected for financial transactions — tracking balances, not transformations. Manufacturing is a process of continuous material transformation, and this is a structural mismatch.

Batch Updates, Not Real Time

ERP inventory transactions execute hourly or at shift end. The system records what happened and when — but not which specific lots were consumed, which operator performed the operation, which equipment was used, or under what conditions.

Aggregate Balances, Not Individual Identity

ERP models inventory as a pool — a quantity with a value. Track and trace requires every container, pallet, and lot to carry its own unique identity and maintain its lineage links as it moves through the plant.

One-Level BOM, Not a Genealogy Graph

ERP can record that a finished product consumes certain raw materials. It cannot reconstruct which specific lot of each material was consumed in which batch, on which machine, by which operator — the multi-level parent-child graph that a recall requires.

No Process Conditions Captured

Temperature, pressure, humidity, mixing time, processing speed — the conditions under which material was transformed are invisible to ERP. If quality depends on process conditions, those conditions must be captured alongside the material record.

No Data Integrity Guarantee

Regulatory frameworks mandate that records be attributable, contemporaneous, and unalterable after the fact. ERP was not designed for electronic signatures, immutable audit trails, or prevention of retrospective data entry.

Blind to What Is Happening Now

ERP reflects the state of the plant as of the last batch upload. It cannot answer where a specific lot is right now — on which work centre, in which container, awaiting which operation — in real time.

What Gets Captured

Every event. Every container. Every condition.

Traceability is only as complete as the events recorded. At every production step — receiving, dispensing, processing, testing, packing, shipping — the system captures the full context of what happened, not just the quantity.

The result is a genealogy graph that can answer any question about any product at any point in its history — instantly, without manual investigation.

Recorded at Each Production Event

Material identityLot number, supplier, certificate of analysis
Container identityUnique serial / licence plate number per physical unit
Process parametersTemperature, pressure, time, speed — at the moment of production
Equipment usedWhich machine, vessel, or line performed each operation
Operator identityWho performed the operation, with what authorisation
Quantity and yieldInputs consumed, outputs produced, variance from standard
Quality resultsIn-process checks, test results, accept / reject decisions
Time and locationPrecise timestamps and physical location at every step

Where Traceability Is Critical

Serialization mandates are expanding. What started in pharmaceuticals is now required across food, medical devices, and automotive supply chains.

Pharmaceuticals & Life Sciences

Serialization mandates require item-level unique identification traceable from API through finished dose to patient. Recall obligations, cold chain integrity, and 21 CFR Part 11 data integrity demands make real-time genealogy a regulatory requirement, not an option.

Serialization21 CFR Part 11Cold ChainDSCSA

Food & Beverage

Ingredient traceability from farm to shelf — recording supplier lots, processing conditions, allergen exposure, and distribution destinations. A contamination event that previously required a nationwide recall can be contained to a specific production window.

Allergen ControlSupplier LotsFSMAGS1 EPCIS

Industrial & Process Manufacturing

Raw material certification tracking, in-process quality linkage, and customer-facing material traceability certificates. As-built records for engineered products and full process condition history for warranty and liability defence.

Material CertsAs-Built RecordsQuality LinkageISO 9001

Automotive & Discrete Manufacturing

Component serialization, sub-assembly genealogy, and supplier lot tracking across multi-level BOMs. IATF 16949 requirements for full traceability of safety-critical components and rapid field campaign scope identification.

Component SerialIATF 16949Field CampaignsSupplier Tracing

Compliance Automation

Regulatory audits that previously required 2–4 weeks of quality staff manually assembling batch records are answered by querying the genealogy system. Every data point is attributable to an operator, timestamped at collection, and protected against retrospective modification — meeting ALCOA+ requirements without manual effort.

FDA 21 CFR Part 11

Electronic records and signatures: attributability, audit trails, access controls, and data integrity for US-regulated products.

GS1 EPCIS 2.0

Standardised event exchange for multi-party supply chain traceability — interoperable with customers, regulators, and supply chain partners globally.

ISA-95 Alignment

Operations event model capturing what, when, where, and who for every production activity — consistent with enterprise-control integration standards.

The Fluxentra Difference

What distinguishes traceability that holds up under audit and recall pressure

Real-Time, Not End-of-Shift

Events are recorded as they happen — not batched at shift end and uploaded to ERP. The genealogy graph reflects what is on the floor right now, enabling forward trace of material in active production.

Connected to Your ERP

Production orders, material definitions, and inventory positions flow from your ERP system. Actual production events, genealogy links, and quality results flow back. The two systems complement each other — traceability fills the gap ERP was never designed to cover.

Surgical Recall Capability

When a quality issue is identified, the system identifies affected products immediately — down to the specific lots, batches, and shipments. The scope of a recall is defined by data, not by conservative assumption.

On-Premise Data Sovereignty

Genealogy data — which materials went into which products, for which customers — is commercially sensitive. All data resides on your infrastructure. No production history leaves the facility.

Operator-Centric Collection

Scan-based collection at each production step replaces manual paper records. Data is captured at the point of action — contemporaneously, by the operator performing the work, with their authenticated identity.

Genealogy as a Quality Intelligence Layer

The genealogy graph contains patterns invisible to ERP: certain material combinations, supplier lots, or processing sequences that correlate with quality outcomes. This data becomes the foundation for predictive quality as the system matures.

Ready to answer any traceability question in seconds?

We begin with a traceability assessment — mapping your current material flow, identifying the genealogy gaps your ERP leaves open, and defining what a recall would look like today versus what it should look like.

Real-time genealogy · On-premise data sovereignty · Works alongside your existing ERP