QUALITY MANAGEMENT
Edit CAPA-2026-0019
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Record the issue and the complete improvement cycle.
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CAPA No.
Title *
Problem Statement *
Quality event requiring investigation, corrective action and preventive controls for: Operator training expired for critical process.
Source
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Customer Complaint
Internal Audit
External Audit
Inspection
Incident
Process KPI
Supplier
Other
Source Reference
Owner
Unassigned
Process Engineer
Production Manager
Quality Manager
System Administrator
Severity *
Critical
Major
Minor
Priority *
Critical
High
Medium
Low
Operational Status
Status is controlled by the CAPA approval workflow.
Detected Date *
Target Date
Workflow Stage
Verification Date
Approval Status
Analysis & Actions
Containment Action
Removed unqualified operators from the process until retraining.
Root Cause
Training matrix did not trigger escalation before expiry.
Corrective Action
Updated training matrix and completed refresher training.
Preventive Action
Added automated expiry alerts at 30, 15 and 7 days.
Effectiveness Check
100% of critical-process operators are currently qualified.
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