QUALITY MANAGEMENT
Edit CAPA-2026-0002
New CAPA
Edit CAPA
Record the issue and the complete improvement cycle.
Back
CAPA No.
Title *
Problem Statement *
Finished cartons were found with an incorrect revision of the product label during final inspection.
Source
Select
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
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.
Cancel
Update CAPA