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: Barcode unreadable on finished product.
Containment
Reprinted affected labels and verified scanner readability.
Root Cause
Printer head contamination reduced print contrast.
Corrective Action
Cleaned printer head and replaced worn ribbon.
Preventive Action
Added daily printer verification and cleaning checklist.
Effectiveness Check
Barcode readability remained above 99.8%.
Verified 27 May 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-2026-0016: Cleaned printer head and replaced worn ribbon. | Production Manager | 2026-05-20 | Completed | |
| Preventive | Implement preventive control for CAPA-2026-0016: Added daily printer verification and cleaning checklist. | Quality Manager | 2026-05-27 | 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
SourcePackaging Inspection
OwnerProduction Manager
Detected2026-05-11
Target2026-05-20
Verification2026-05-27
Submitted-
Final Approval-
Closed2026-05-19
Workflow Timeline
Traceability of the CAPA improvement cycleNo workflow events yetEvents will appear as you create analyses and complete actions.