CAPA-2026-0009

HighOpen

Supplier certificate does not match incoming batch

INTEGRATED CAPA WORKFLOW

Problem → Root Cause → Action → Effectiveness → Closure

Every analysis and action below is linked to this CAPA record.

4/11workflow steps

1 Problem Identified Completed 2 Containment Completed 3 Root Cause Completed 4 Pareto Current focus 5 Quality Review Pending 6 Action Completed 7 Effectiveness Pending 8 Effectiveness Review Pending 9 Lifecycle Forecast Pending 10 Quality Approval Pending 11 Closed Pending

CONTROLLED APPROVAL WORKFLOW

Electronic Approval & Rework

Segregation of duties is enforced: a CAPA owner or creator cannot approve the same CAPA.

Draft Not Submitted

Quality ReviewQuality ManagerPending

Review

Current gate Draft · Not Submitted

CAPA Details

Problem definition and evidence base

Problem Statement

The certificate of analysis supplied with an incoming material batch contained a specification revision different from the approved purchase specification.

Containment

Quarantined the material lot and suspended release until certificate and material identity were verified.

Root Cause

Supplier document control did not synchronize the approved specification revision with the certificate template.

Corrective Action

Updated supplier certificate review checklist and required revision verification before material release.

Preventive Action

Added supplier document revision control to the approved supplier audit checklist.

Effectiveness Check

Not documented

Root Cause

Root Cause Intelligence

Corrective & Preventive Action Plan

Actions feed the operational side of the CAPA workflow.

Type	Description	Owner	Due	Status	Update
Corrective	Implement corrective action for CAPA-2026-0009: Added enhanced incoming thickness sampling.	Quality Manager	2026-03-25	Completed
Preventive	Implement preventive control for CAPA-2026-0009: Added supplier KPI review and quarterly process audit.	Quality Manager	2026-04-01	Completed

Linked Analyses

One-click access to every analytical layer

Fishbone / Root CauseNot startedStart analysis →

Pareto AnalysisNot startedStart analysis →

Markov Lifecycle ForecastNot startedGenerate lifecycle →

CAPA Summary

SourceSupplier Inspection

OwnerProduction Manager

Detected2026-08-14

Target2026-08-28

Verification-

Submitted-

Final Approval-

Closed-

Workflow Timeline

Traceability of the CAPA improvement cycle

CAPA submitted for quality review16 Aug 2026 21:03

Sample CAPA is waiting for independent Quality Manager approval.System Administrator