QUALITY MANAGEMENT

CAPA-2026-0031

CAPA-2026-0031

HighOpen
Incorrect sampling frequency in incoming inspection
CONTROLLED APPROVAL WORKFLOW
Electronic Approval & Rework
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Draft Not Submitted
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Current gate Draft · Not Submitted
CAPA Details
Problem definition and evidence base
Problem Statement
Quality event requiring investigation, corrective action and preventive controls for: Incorrect sampling frequency in incoming inspection.
Containment
Increased inspection frequency pending procedure revision.
Root Cause
Sampling plan was not updated after supplier risk classification changed.
Corrective Action
Revised sampling plan based on supplier risk.
Preventive Action
Added automatic review of sampling plans after supplier score changes.
Effectiveness Check
Not documented
Corrective & Preventive Action Plan
Actions feed the operational side of the CAPA workflow.
TypeDescriptionOwnerDueStatusUpdate
CorrectiveImplement corrective action for CAPA-2026-0031: Revised sampling plan based on supplier risk.Quality Manager2026-09-02In Progress
PreventiveImplement preventive control for CAPA-2026-0031: Added automatic review of sampling plans after supplier score changes.Quality Manager2026-09-09Planned

Linked Analyses
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CAPA Summary
SourceQuality System Audit
OwnerQuality Manager
Detected2026-08-15
Target2026-09-02
Verification-
Submitted-
Final Approval-
Closed-
Workflow Timeline
Traceability of the CAPA improvement cycle
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