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Template · NCR + CAPA (ISO 9001)

Nonconformity capture, containment, root-cause, corrective + preventive actions, and an effectiveness-check gate. Linked to audits and customer complaints.

7 min read · 3 sections

What it looks like

NCR AddEdit — 38 fields, 7 workflow states

RCA — Five Whys + fishbone canvas

Sample records (pre-seeded)

NCR #SourceTitleSeverityState
NCR-1042Internal auditMissing sign-off on batch releaseMajorEffectiveness check
NCR-1051Customer complaintMislabelled SKU shippedMajorActions open
NCR-1059Supplier auditExpired calibration cert at supplierMinorContainment
NCR-1063InternalCAPA-0422 effectiveness not demonstratedMinorClosed

Typical configuration

  • Guard: state cannot advance to Closed until effectiveness-check result is recorded ≥ 90 days after the last corrective action.
  • Capability: Five-Whys + fishbone canvas — collaborative edit, exports a PNG snapshot into the record.
  • Permissions: Quality team owns; Owners of linked records (audit, complaint) get read-only; Operators see their containment tasks.
  • Effect: Major NCR triggers a Management-review agenda item for the next clause-9.3 review.
Tags: ISO 9001 · quality · CAPA · template