QUALITY MANAGEMENT

CAPA-2026-0006

CAPA-2026-0006

HighIn Progress
Packaging seal strength below specification
CONTROLLED APPROVAL WORKFLOW
Electronic Approval & Rework
Segregation of duties is enforced: a CAPA owner or creator cannot approve the same CAPA.
Action Not Submitted
No approval request has been submitted.Submit the CAPA when the problem definition and ownership are ready for independent quality review.
Current gate Action · Not Submitted
CAPA Details
Problem definition and evidence base
Problem Statement
Seal strength failures were observed during final inspection on the packaging line.
Containment
Quarantined the affected production window and increased seal-strength sampling to every 30 minutes.
Root Cause
Seal contamination and inconsistent sealing temperature were identified as the primary contributors.
Corrective Action
Cleaned the sealing jaws, standardized temperature settings and replaced a worn thermocouple.
Preventive Action
Introduced preventive cleaning frequency, thermocouple verification and SPC monitoring of seal temperature.
Effectiveness Check
Not documented
Corrective & Preventive Action Plan
Actions feed the operational side of the CAPA workflow.
TypeDescriptionOwnerDueStatusUpdate
No actions added.

Linked Analyses
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Fishbone / Root Cause1 linked analysisOpen latest →
Pareto Analysis1 linked analysisOpen latest →
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CAPA Summary
SourceInspection
OwnerProcess Engineer
Detected2026-08-05
Target2026-08-25
Verification-
Submitted-
Final Approval-
Closed-
Workflow Timeline
Traceability of the CAPA improvement cycle
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