Data Collection: Systematic gathering of quality data from all sources
Root Cause Analysis: Thorough investigation using structured methods (5 Whys, Fishbone, FMEA)
Action Implementation: Corrective actions address existing problems; Preventive actions prevent potential issues
Effectiveness Verification (ICH Q10 3.2.2): Mandatory verification that actions eliminated root causes
Continuous Monitoring: Ongoing surveillance to detect reoccurrence and systemic issues
| CAPA # | Title | Source | Type | Severity | Status | Target Date | Actions |
|---|---|---|---|---|---|---|---|
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Verify that corrective and preventive actions have eliminated root causes and prevented reoccurrence
Timing: Typically 30-90 days after CAPA implementation, or one complete cycle
Methods: Data review, trend analysis, re-audit, process monitoring, customer feedback
Criteria: Pre-defined success metrics aligned with root cause elimination
Results: Effective (close), Partially Effective (additional actions), Not Effective (reopen)
Effectiveness check tracking interface (Coming Soon)
Key Performance Indicators for continuous improvement and management review
Volume Trends: CAPAs by source, department, severity over time
Cycle Time: Average time from initiation to closure (target: <90 days for standard)
Effectiveness Rate: % of CAPAs verified as effective (target: >95%)
Overdue CAPAs: % of CAPAs past target completion date (target: <5%)
Recurring Issues: Identification of repeat root causes requiring systemic solutions
Generate compliance reports, management review summaries, and effectiveness analytics.