CAPA-2026-0020

HighUnder Verification

Foreign particle contamination in assembly

INTEGRATED CAPA WORKFLOW

Problem → Root Cause → Action → Effectiveness → Closure

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

3/11workflow steps

1 Problem Identified Completed 2 Containment Completed 3 Root Cause Current focus 4 Pareto Pending 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.

Effectiveness Review 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 Effectiveness Review · Not Submitted

CAPA Details

Problem definition and evidence base

Problem Statement

Quality event requiring investigation, corrective action and preventive controls for: Foreign particle contamination in assembly.

Containment

Quarantined affected units and performed controlled cleaning.

Root Cause

Not documented

Corrective Action

Introduced particle-count verification after cleaning.

Preventive Action

Added environmental monitoring and weekly housekeeping audits.

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-2026-0020: Introduced particle-count verification after cleaning.	Quality Manager	2026-07-08	In Progress
Preventive	Implement preventive control for CAPA-2026-0020: Added environmental monitoring and weekly housekeeping audits.	Quality Manager	2026-07-15	Planned

Linked Analyses

One-click access to every analytical layer

Fishbone / Root Cause1 linked analysisOpen latest →

Pareto AnalysisNot startedStart analysis →

Markov Lifecycle ForecastNot startedGenerate lifecycle →

CAPA Summary

SourceCustomer Complaint

OwnerQuality Manager

Detected2026-06-18

Target2026-07-08

Verification-

Submitted-

Final Approval-

Closed-

Workflow Timeline

Traceability of the CAPA improvement cycle

Fishbone cause removed21 Aug 2026 08:37

Compressed-air line introduced particlesSystem

Fishbone cause removed21 Aug 2026 08:36

Cleaning acceptance criteria were visual onlySystem

Fishbone cause removed21 Aug 2026 08:36

Cleaning checklist was not consistently completedSystem

Fishbone cause removed21 Aug 2026 08:36

Open-door airflow introduced dustSystem

Fishbone cause removed21 Aug 2026 08:35

Particle count was not routinely measuredSystem

Fishbone cause removed21 Aug 2026 08:35

Protective packaging generated fibersSystem