Nonconformance Report
v1.0.0Capture the initial nonconformance with traceability and severity.
Required fields
- id
- detectedAt
- source
- severity
- affectedLots
- containmentPlan
- owner
Reviewed:
Module
CAPA & Nonconformance Management
Nonconformances contained, investigated, corrected and prevented with verified effectiveness.
Module details
ExpertStage: Cross-stage
Outcome: Nonconformances contained, investigated, corrected and prevented with verified effectiveness.
Roles
- Quality Head
- Compliance Manager
- Process Owner
Workflow
- 1.Log NCR with severity and containment plan
- 2.Investigate to occurrence, escape and systemic cause
- 3.Execute corrective and preventive actions
- 4.Verify effectiveness and horizontally deploy
Evidence
Common failures
- Closure without effectiveness evidence
- Same owner opening and approving closure
Escalation
Overdue or high-risk CAPAs escalate per the CAPA escalation rules to Quality Head and executive sponsor.
KPIs
- CAPA effectiveness rate
- Recurrence rate
Official sources
- ISO 9001 — Quality management systems (ISO 9001:2015)
International requirements for a quality management system covering leadership, planning, support, operation, performance evaluation and improvement.
International Organization for Standardization · Authority: ISO
Related on Sanjeewa.life
Learning
Technology
- QMS Software
CAPA lifecycle
- 1.Detection— Record the nonconformance with severity, source and initial impact.
- 2.Containment— Stop the escape and protect the customer while investigation runs.
- 3.Investigation Planning— Define scope, team, data needs and target dates for investigation.
- 4.Root Cause Analysis— Identify occurrence, escape and systemic causes with evidence, not opinion.
- 5.Risk Assessment— Evaluate likelihood and impact including regulatory and customer exposure.
- 6.Corrective Action— Eliminate the identified root cause of the specific nonconformance.
- 7.Preventive Action— Address systemic causes to stop the same class of problem elsewhere.
- 8.Effectiveness Verification— Prove with data that the actions worked over an agreed monitoring horizon.
- 9.Independent Closure Approval— Approver independent of the action owner reviews effectiveness before closure.
- 10.Horizontal Deployment— Extend the fix to other affected lines, sites, styles or suppliers.
- 11.Closure— Formally close the CAPA and archive with references.
Lifecycle statuses
- Open
- In Containment
- Investigating
- Action In Progress
- Verification Pending
- Awaiting Closure Approval
- Closed Effective
- Closed Ineffective
- Reopened
Cause categories
- Occurrence
- Escape
- Systemic
Effectiveness gate
Closure requires evidence over an agreed monitoring horizon that the corrective and preventive actions worked. The gate is passed only when acceptance rules are met.
Independent closure approval: an approver independent of the action owner reviews effectiveness evidence before the CAPA can be closed.
- Overdue Stage: Stage exceeds agreed due date by more than 3 working days — Escalate to CAPA owner's manager with revised due date (Quality Manager)
- High Risk: Risk rating high or customer / regulator visible — Escalate to Quality Head and executive sponsor within 24 hours of risk decision (Quality Head)
- Closure Ineffective: Effectiveness verification fails or CAPA reopened — Re-run investigation with independent chair and executive review of the reopen decision (Executive Sponsor)
Metrics
- CAPA Ageing
Distribution of open CAPAs by age band from open date, split by severity.
Target: No CAPA open beyond agreed maximum age for its severity
- Recurrence Rate
Share of closed CAPAs whose problem class recurs within the monitoring horizon.
Target: Downward trend quarter on quarter
- Effectiveness Rate
Share of closed CAPAs whose effectiveness evidence meets the acceptance rule.
Target: Rising trend, floor set by governance forum
- Reopened Rate
Share of closed CAPAs reopened within the monitoring horizon.
Target: Downward trend
- Horizontal Deployment Rate
Share of closed CAPAs where deployment scope has been executed against plan.
Target: At or above governance-set threshold
- COPQ Avoided
Estimated cost of poor quality avoided by CAPA actions.
Target: Tracked against annual improvement plan
Resource definitions
CAPA Record
v1.0.0Persist the CAPA lifecycle, stages, statuses and linked evidence.
Required fields
- id
- linkedNcrIds
- stage
- status
- causeCategories
- actions
- openedAt
- dueAt
- owner
Reviewed:
Containment Log
v1.0.0Record what was contained, where and by whom.
Required fields
- capaId
- scope
- quantity
- location
- actionAt
- owner
Reviewed:
Root Cause Worksheet
v1.0.0Structure root-cause analysis for occurrence, escape and systemic causes.
Required fields
- capaId
- problemStatement
- occurrenceCause
- escapeCause
- systemicCause
- evidenceRefs
Reviewed:
Corrective Action Plan
v1.0.0Define corrective and preventive actions with owners, dates and success criteria.
Required fields
- capaId
- actions
- owners
- dueDates
- successCriteria
Reviewed:
Effectiveness Verification
v1.0.0Record the evidence and decision that a CAPA has demonstrably worked.
Required fields
- capaId
- monitoringHorizon
- acceptanceRule
- evidenceRefs
- decision
- verifier
Reviewed:
CAPA Dashboard Specification
v1.0.0Define KPIs, refresh cadence and drilldowns for the CAPA governance dashboard.
Required fields
- metrics
- refreshCadence
- owners
- drilldowns
Reviewed:
Management Review Template
v1.0.0Template for periodic management review of CAPA performance, risks and decisions.
Required fields
- period
- kpiInputs
- risks
- decisions
- actions
Reviewed: