19. Nonconformance and CAPA governance
Govern detection, immediate containment, root-cause investigation, any MRB-linked disposition, corrective action, independent effectiveness and closure without duplicating or bypassing Inventory custody controls.
Purpose
Govern detection, immediate containment, root-cause investigation, any MRB-linked disposition, corrective action, independent effectiveness and closure without duplicating or bypassing Inventory custody controls.
Quality Inspector, different Quality Engineer, independent QA Head, Auditor
NCR-E2E-001 — obsolete incoming-inspection instruction → contained → FIVE WHY root cause → no material disposition → corrective acknowledgement control → effective → closed.
Before you begin
- Quality Inspector, Quality Engineer, QA Head and Auditor are separate named users with one common site scope
- At least one ACTIVE, CLEAN controlled evidence version exists at the NCR site
- For an exact stock NCR, the selected identity already exists in BLOCKED or MRB_HOLD
- For material disposition, the existing matching MRB decision and any required Stores execution are complete
Quality authority boundaries
One NCR resolves to an exact process, supplier, item, document, physical instance, product unit or held-stock boundary. Site and classification scope are enforced by the API.
Quality can reference exact BLOCKED or MRB_HOLD identity and quantity, then revalidates it at containment. The NCR never creates the hold, moves material or releases it.
Immediate action, affected scope, correction, completion result and completion date require at least one exact ACTIVE/CLEAN controlled document version.
The originator cannot triage their NCR. The QA decision maker confirms severity and assigns a Quality Engineer who is different from both originator and triager.
The assigned engineer submits immutable investigation versions. A material disposition requires the same-site/item MRB case with the same decision and completed execution; NO MATERIAL DISPOSITION requires no MRB.
Approval opens CAPA planning. Verification begins only when every action is completed and at least one action is CORRECTIVE.
The NCR originator, investigation owner, action owner and action completer cannot verify effectiveness. EFFECTIVE cannot retain UNACCEPTABLE residual risk.
Closure requires the latest independent review to be EFFECTIVE, residual risk to be accepted and any required notification reference plus CLEAN closure evidence to exist.
Auditor has quality:read only. The register returns the complete actor/evidence chain but no Quality mutation permission.
Each assurance lifecycle remains separately governed and evidence-backed. Quality does not acquire Inventory custody, supplier-master, configuration-release, financial-posting or external-system authority.
Procedure
- 1
Raise a process NCR and record proven containment as Quality Inspector.
- 2
Have a different QA Head triage and assign a separate Quality Engineer; confirm originator triage fails.
- 3
Submit an evidence-backed investigation as the assigned engineer; confirm self-approval fails and QA Head decides it.
- 4
Plan and complete at least one corrective action with objective criteria and CLEAN evidence.
- 5
Have an independent QA Head verify sustained effectiveness and acceptable or monitored residual risk.
- 6
Close with evidence, then read the complete chain as Auditor and reconcile unchanged inventory.
Expected result
- Lifecycle follows OPEN → CONTAINED → INVESTIGATION → DISPOSITION_PENDING → ACTION_IN_PROGRESS → VERIFICATION → CLOSED
- Inspector, engineer, QA decision maker and Auditor permissions remain distinct
- Originator cannot triage; investigation author cannot approve; CAPA executor cannot verify
- Every containment, investigation, action completion, effectiveness decision and closure links exact CLEAN evidence
- Material disposition cannot bypass approved/executed MRB
- An ineffective review returns the case to action work
- Required external notification reference blocks closure until present
- Every transition is attributable in audit and outbox history
- Quality routes never create or mutate current stock or stock-ledger rows