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
Finished cartons were found with an incorrect revision of the product label during final inspection.
Containment
Quarantined affected cartons and stopped dispatch until all labels were verified.
Root Cause
The label master file was not linked to the active production revision and the final inspection checklist did not require label revision verification.
Corrective Action
Updated the controlled label master and added mandatory revision verification at packing.
Preventive Action
Implemented electronic label issue control and quarterly review of controlled documents.
Effectiveness Check
No incorrect labels detected in the next 10 production lots and 100% checklist compliance.
Verified 14 Aug 2026
Root Cause
Corrective & Preventive Action Plan
Actions feed the operational side of the CAPA workflow.| Type | Description | Owner | Due | Status | Update |
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Linked Analyses
One-click access to every analytical layerFishbone / Root CauseNot startedStart analysis →
Pareto AnalysisNot startedStart analysis →
Markov Lifecycle ForecastNot startedGenerate lifecycle →
CAPA Summary
SourceFinal Inspection
OwnerQuality Manager
Detected2026-07-28
Target2026-08-08
Verification2026-08-14
Submitted-
Final Approval-
Closed2026-08-07
Workflow Timeline
Traceability of the CAPA improvement cycleNo workflow events yetEvents will appear as you create analyses and complete actions.