INTEGRATED CAPA WORKFLOW
Problem → Root Cause → Action → Effectiveness → Closure
Every analysis and action below is linked to this CAPA record.7/11workflow steps
CONTROLLED APPROVAL WORKFLOW
Electronic Approval & Rework
Segregation of duties is enforced: a CAPA owner or creator cannot approve the same CAPA.
Draft Not Submitted
Quality ReviewQuality ManagerApproved 06 Aug 2026 14:00
Effectiveness ReviewQuality ManagerApproved 16 Aug 2026 09:00
Final Quality ApprovalQuality ManagerPending
Review CAPA Details
Problem definition and evidence baseProblem Statement
Torque verification records showed that one assembly station did not complete the required start-of-shift verification on two occasions.
Containment
Affected units were identified and 100% torque verification was performed.
Root Cause
The work instruction did not clearly identify the start-of-shift verification as a mandatory recorded activity.
Corrective Action
Revised the work instruction and introduced a mandatory digital verification checklist.
Preventive Action
Added weekly compliance review and escalation for missed torque verification.
Effectiveness Check
No missed verifications were recorded for 12 consecutive shifts after implementation.
Verified 15 Aug 2026
Root Cause
Corrective & Preventive Action Plan
Actions feed the operational side of the CAPA workflow.| Type | Description | Owner | Due | Status | Update |
|---|---|---|---|---|---|
| Corrective | Revise work instruction and introduce mandatory digital torque verification checklist. | Process Engineer | 2026-08-10 | Completed | |
| Preventive | Review torque verification compliance weekly and escalate missed records. | Quality Manager | 2026-08-15 | Completed | |
| Corrective | Implement corrective action for CAPA-2026-0010: Reset oven profile and verified calibration. | Process Engineer | 2026-04-03 | Completed | |
| Preventive | Implement preventive control for CAPA-2026-0010: Added automatic oven parameter alarm and weekly trend review. | Quality Manager | 2026-04-10 | Completed |
Linked Analyses
One-click access to every analytical layerFishbone / Root CauseNot startedStart analysis →
Pareto AnalysisNot startedStart analysis →
Markov Lifecycle ForecastNot startedGenerate lifecycle →
CAPA Summary
SourceProcess Audit
OwnerProcess Engineer
Detected2026-08-04
Target2026-08-20
Verification2026-08-15
Submitted05 Aug 2026 10:30System Administrator
Final Approval-
Closed-
Workflow Timeline
Traceability of the CAPA improvement cycleEffectiveness review approved16 Aug 2026 21:03
Sample effectiveness approval recorded; final quality approval is pending.Quality ManagerQuality review approved16 Aug 2026 21:03
Sample quality review approval recorded.Quality Manager