INTEGRATED CAPA WORKFLOW
Problem → Root Cause → Action → Effectiveness → Closure
Every analysis and action below is linked to this CAPA record.6/11workflow steps
CONTROLLED APPROVAL WORKFLOW
Electronic Approval & Rework
Segregation of duties is enforced: a CAPA owner or creator cannot approve the same CAPA.
Closed Approved
No approval request has been submitted.Submit the CAPA when the problem definition and ownership are ready for independent quality review.
CAPA Details
Problem definition and evidence baseProblem Statement
Quality event requiring investigation, corrective action and preventive controls for: Missing inspection records for batch release.
Containment
Batch release was temporarily held pending record reconstruction.
Root Cause
Manual filing allowed records to be misplaced.
Corrective Action
Introduced indexed electronic batch records.
Preventive Action
Added weekly record completeness audit.
Effectiveness Check
100% of sampled batch files were complete.
Verified 15 Apr 2026
Root Cause
Corrective & Preventive Action Plan
Actions feed the operational side of the CAPA workflow.| Type | Description | Owner | Due | Status | Update |
|---|---|---|---|---|---|
| Corrective | Implement corrective action for CAPA-2026-0011: Introduced indexed electronic batch records. | Quality Manager | 2026-04-08 | Completed | |
| Preventive | Implement preventive control for CAPA-2026-0011: Added weekly record completeness audit. | Quality Manager | 2026-04-15 | 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
SourceInternal Audit
OwnerQuality Manager
Detected2026-03-28
Target2026-04-08
Verification2026-04-15
Submitted-
Final Approval-
Closed2026-04-07
Workflow Timeline
Traceability of the CAPA improvement cycleNo workflow events yetEvents will appear as you create analyses and complete actions.