Section 16 of 50
14. Production Identity and Traceability
Stable section ID: S05-CON-012-SECTION-16 · 44 content blocks
Every manufacturing object requiring control shall possess an identity appropriate to its consequence and lifecycle role.
Production identity may apply to:
- Individual serialized products.
- batches.
- lots.
- material heats.
- work-in-progress items.
- assemblies.
- tools.
- fixtures.
- machines.
- programs.
- inspection equipment.
- production orders.
- evidence packages.
Identity shall support traceability without requiring every low-consequence item to be individually serialized.
Identification methods may include:
- Human-readable markings.
- barcodes.
- QR codes.
- data matrices.
- RFID.
- embedded digital identifiers.
- durable stamped or engraved marks.
- protected electronic identity.
- Identity shall remain readable or recoverable for the required lifecycle period.
A product identifier shall link to applicable information such as:
- Manufacturer.
- facility.
- product type.
- version.
- date or production period.
- material genealogy.
- production route.
- inspection status.
- release status.
- certification.
- known limitations.
- recall status.
- Identity shall not be reused in a manner that creates ambiguity.
Replacement, remanufacture, rework, or repair shall not erase prior identity or history. Where a new identity is assigned, the predecessor relationship shall be preserved.
Traceability depth shall be based on criticality, failure consequence, process risk, regulatory obligation, and recall needs.
The identity system shall protect against duplication, counterfeiting, unauthorized relabeling, and separation of evidence from the physical product.
Loss or uncertainty of identity shall trigger quarantine or additional verification. A product shall not be released solely because it visually resembles the required item.