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Material Batch / Lot

vr.wm-mat-004 · wm-mat-004-material-batch-lot

Batches and lots of material produced under uniform conditions, for quality and traceability.

World Models Physical world and living systems PHY.MAT.SAM

Bundle → Layer → Finding → Questions Filled

3 bundles · 3 layers · 6 findings · 13 questions

Batch identity Which quantity of material forms the batch.

Definition

The material, quantity and production run that make up the batch.

Batch reference

The batch number with the producer and the material it belongs to.

  1. Which batch number identifies the lot, and who assigned it?
  2. Which material or product does the batch consist of?

Quantity and units

The quantity in the batch and how it is divided into containers.

  1. What quantity does the batch contain, and in which unit?
  2. Into how many containers or packages was the batch divided?
Genealogy Where the batch came from and where it went.

Inputs and outputs

Input lots consumed and downstream lots or shipments produced.

Input lots

The input lots and materials used to make the batch.

  1. Which input lots were used, and in which quantities?
  2. Can each input lot be traced back to its supplier?

Distribution

The shipments and customers that received parts of the batch.

  1. Which shipments carried material from this batch, and to whom?
  2. How much of the batch remains in stock?
Quality and status Whether the batch may be used.

Testing and release

Test results, release decision and later status changes.

Release status

Whether the batch is quarantined, released, rejected or recalled.

  1. What is the current status of the batch?
  2. Who released the batch, and on which test results?
  3. Has a recall or hold been issued for the batch?

Expiry

The manufacturing date, expiry or retest date of the batch.

  1. When was the batch made, and when does it expire or need retesting?
  2. Under which storage conditions does the expiry date hold?

Classifiers Filled

Family
World Models
Category
Physical world and living systems
Entry kind
entity
Navigation path
NAV.PHY.MAT.SAM
Domain
PHY.MAT.SAM
Industry
Cross-industry
Tags
materialbatchlotphy.mat.sam

What it is Filled

A material batch or lot is a defined quantity of material produced or processed under uniform conditions and identified as one unit for quality and traceability. It links a quantity of material to its production run, inputs, tests and release status; a single serialised item or the material type itself is not a batch.

In scope

  • Qualified lot identity, material reference, boundary rule and aliases
  • Lot-specific quantity assertions, packaging membership, production and genealogy references
  • Sampling and test evidence links, disposition assertions, storage history, expiry/retest and trace coverage
  • Local revision, access, retention and interoperability requirements

Out of scope

  • Substance, formulation and engineered-material master definitions; recipe design and production control
  • Sample, laboratory test, measurement, shipment, container and custody-event master lifecycles
  • Executing physical operations, issuing release or recall decisions, certifying safety or operating an inventory ledger
  • Hazardous or controlled material operating instructions; only policy and authorized profile references are allowed

Why it exists Filled

Batches and lots of material produced under uniform conditions, for quality and traceability.

Distinguishing features Filled

  • A batch is a quantity of material treated as one unit; a serialised item is identified individually.
  • It is an instance of production, unlike the material or product type it belongs to.
  • Batch release and recall decisions are made on the batch, so the quality status belongs to it.
  • Shipments carry parts of batches; the shipment and the batch are separate records.

What robots and AI may and may not do Filled

Must not

  • Change a batch status to released without the authorised release decision.
  • Alter test results or batch genealogy after release.
  • Merge or split batches without recording the new identifiers and links.
  • Hide a recall or hold from parties who received the batch.
  • Extend an expiry date without an approved retest.

Only with a human decision

  • Releasing or rejecting a batch.
  • Issuing a recall or hold.
  • Approving rework or reprocessing of a batch.

May

  • Record batch numbers, quantities, inputs and test results.
  • Trace a batch forward to shipments and backward to input lots.
  • Report batch status, expiry and storage conditions.
  • Flag a batch whose tests are missing or out of specification.

Moral aspects Filled

  • Accurate batch traceability is what makes fast and targeted recalls possible.
  • Falsified batch records can put patients, consumers and workers at risk.
  • Over-broad recalls waste material when genealogy is incomplete.

Who is affected

  • Consumers and patients
  • Manufacturers and quality staff
  • Customers and distributors
  • Regulators

Owners Filled

Steward

The manufacturer's quality function, which assigns batch numbers and decides release.

Roles

Lot custodian
Maintain lot identity, boundary, evidence links and reconciliation.
Quality authority
Review applicability and authorize scoped disposition in the external decision system.
Production or receiving recorder
Supply evidenced origin and quantity assertions within delegation.
Laboratory evidence reviewer
Assess sample and test relevance without altering laboratory masters.
Records and access officer
Govern retention, recipient access, exports and disposal.

Master systems

  • Manufacturing execution system
  • Enterprise resource planning batch records
  • Laboratory information management system

Links to other meta-models Filled

references

  • WM-MAT-001 Chemical Substance - Candidate optional material-definition binding when applicable; no substance master duplication. Profile binding and version require validation before integration.
  • WM-MAT-002 Engineered Material - Candidate optional engineered-material definition and specification reference. Profile binding and version require validation before integration.
  • WM-MAT-003 Mixture / Formulation - Candidate optional formulation version reference; no recipe execution. Profile binding and version require validation before integration.
  • WM-MAT-005 Lab Sample / Specimen - Sample identity and sampling lineage remain separately mastered. Profile binding and version require validation before integration.
  • WM-MAT-007 Laboratory Test / Analysis - Test master and method references, without operating a laboratory. Profile binding and version require validation before integration.
  • WM-MAT-008 Observation / Measurement Record - Measurement results and environmental observations remain external masters. Profile binding and version require validation before integration.
  • WM-FLW-013 Supply-chain Trace / Chain of Custody - Custody and shipment evidence links; no transfer execution or ownership inference. Profile binding and version require validation before integration.
  • Production event and quality decision masters - Reference actual occurrence and authorized disposition, without adopting their execution functions. Profile binding and version require validation before integration.
  • world-m1-material-and-substance - A batch is a quantity of a defined material.
  • wm-mat-007-laboratory-test-analysis - Batch release relies on laboratory tests.

aligned

  • EPCIS - Conceptual event and quantity alignment; implement and test a version-pinned mapping before claiming conformance.
  • SOSA/SSN and PROV-O - Conceptual sample, observation and provenance alignment; links do not certify truth or representativeness.

neighbor

  • WM-MAT-001 Chemical Substance; WM-MAT-002 Engineered Material; WM-MAT-003 Mixture / Formulation - Reference the applicable material definition and version. A lot may instantiate a substance, engineered material or mixture; none of these is the lot identity.
  • WM-MAT-005 Lab Sample / Specimen - A sample has its own identity and sampling lineage. Lot-level inference must cite representativeness assessment; sample lifecycle remains external.
  • WM-MAT-007 Laboratory Test / Analysis; WM-MAT-008 Observation / Measurement Record - Reference test and observation masters and their revisions. This model records relevance and decision support, not laboratory execution or raw-result replacement.
  • WM-FLW-013 Supply-chain Trace / Chain of Custody - Keep lot-specific links and known trace coverage. Custody events, shipments and title transfers have separate masters; a location observation proves none of them by itself.
  • Production event, logistics unit and quality decision - A persistent lot is neither the transformation that created it nor a container or decision. One lot may span containers and locations; one container may contain several lots.

related

  • wm-flw-013-supply-chain-trace-chain-of-custody - Batch genealogy supports supply chain traceability.

What else AI and robots need to interact with it Filled

Identity and identifiers required Filled

  • A batch is identified by its batch or lot number together with the producer and product identifier.
  • GS1 Application Identifier (10) carries the batch number in barcodes, with GTIN for the product.
  • Expiry and production dates are often encoded alongside the batch number.

Direct properties required Filled

  • Quantity of the batch in mass, volume or count with its unit.
  • Results of specified quality tests, each with method, unit and specification limits.
  • Manufacturing date and expiry or retest date.
  • Storage conditions such as temperature and humidity ranges required to keep the batch in specification.

Recognition required Filled

  • A batch is recognised by the batch number on its labels and containers, with product and dates.
  • Often confused with a shipment, a pallet or a single serialised item.

Capabilities and actions required Filled

  • Batches can be traced forward to customers and backward to input lots.
  • Batches can be held, released, rejected or recalled as one unit.
  • Batches can be split or merged with recorded genealogy.

Hazards and failure modes required Filled

  • Contaminated or out-of-specification batches reaching users.
  • Mix-ups of batches with similar labels.
  • Incomplete genealogy that slows recalls.

Standards and interfaces required Filled

  • GS1 General Specifications for batch numbers in barcodes and EPCIS events.
  • ISA-88 batch control and ISA-95 enterprise-control integration.
  • Good manufacturing practice batch records in regulated industries.

Context of use required Filled

  • Batch records are required by law in pharmaceuticals, food and many chemical industries.
  • Used in manufacturing, quality control, logistics and recalls.

Sources Filled

  1. EPCIS Standard - GS1
  2. EPCIS and CBV Implementation Guideline - GS1
  3. Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients - Food and Drug Administration
  4. Semantic Sensor Network Ontology - World Wide Web Consortium
  5. PROV-O: The PROV Ontology - World Wide Web Consortium
  6. NIST Guide to the SI, Chapter 7: Rules and Style Conventions for Expressing Values of Quantities - National Institute of Standards and Technology
  7. Date and Time on the Internet: Timestamps - Internet Engineering Task Force
  8. GS1 General Specifications, GS1
  9. ISA-88 Batch Control, International Society of Automation

Open questions

  • Resolve source version pins and direct reachability, especially the EPCIS URL/PDF mismatch, and obtain independent external review before canonical promotion.
  • Implement and test nested fields and mappings using collision, mixed-container, continuous-production, invalid-sample, concurrent-hold, partial-trace and correction-after-release fixtures.
  • Review material-sector and jurisdiction profiles, continuous-flow allocation, recycled-material accounting and controlled-material policy boundaries with qualified custodians.
  • Independent external provider review is absent; the local self-audit cannot replace it.
  • Direct HTTP checks were not attempted under the owner-declared sandbox block. Current reachability, response hashes and source revision reconciliation remain unverified.
  • EPCIS URL includes 2.0.1 but the retrieved PDF identifies Release 2.0, June 2022. Resolve this before any executable mapping claim.
  • Nested instance schemas, exact unit conversions, inventory balance rules and executable acceptance fixtures remain to be implemented.
  • Sector-specific continuous-flow allocation, recycled-material accounting, food and other regulatory profiles require additional research.
  • No complete identifier encoding, laboratory accreditation, safety certification or legal compliance assessment is provided.

Machine files

Provenance

world-models research · reviewable-draft

Built from: models/wm-mat-004-material-batch-lot/spec.yaml, ver-cy/world-models/card-supplements/wm-mat-004-material-batch-lot.json