QUALITY MANAGEMENT
Edit CAPA-2026-0011
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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: Missing inspection records for batch release.
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
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.
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