Diagnose
A proposed workflow
The sequence below is a starting design, not a claim about the current operation.
- 01Define the trace object and required evidenceDefine evidence and the exception path
- 02Capture inspection against approved specification versionDefine evidence and the exception path
- 03Create a linked non-conformance when criteria failDefine evidence and the exception path
- 04Route disposition and approval to authorized rolesDefine evidence and the exception path
- 05Link corrective action where requiredDefine evidence and the exception path
- 06Reconcile release status before downstream handoffConfirm ownership and handover
Design
Data inputs
Use the minimum information needed and define its source and retention.
| Reference | Input or decision to establish |
|---|---|
| 01 | Product, revision, batch, lot or serial |
| 02 | Specification and inspection plan version |
| 03 | Result, evidence, non-conformance and disposition |
| 04 | Approval, action, status and timestamps |
Design
Human responsibilities
Automation routes information; accountable people retain operational decisions.
01Quality owns specifications and release authority
Use a representative example to confirm the cause, owner, decision rule, and exception path.
02Operations records process and product context
Use a representative example to confirm the cause, owner, decision rule, and exception path.
03Data owners control identifiers
Use a representative example to confirm the cause, owner, decision rule, and exception path.
04System owners preserve access and audit behavior
Use a representative example to confirm the cause, owner, decision rule, and exception path.
Measure
Limitations
A connected record does not by itself demonstrate product conformity or regulatory compliance. Procedures, qualified judgment, and any required validation remain essential.