CAPA-2026-0012

HighClosed

Incorrect component orientation during assembly

INTEGRATED CAPA WORKFLOW

Problem → Root Cause → Action → Effectiveness → Closure

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

6/11workflow 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 Completed 8 Effectiveness Review Pending 9 Lifecycle Forecast Pending 10 Quality Approval Pending 11 Closed Completed

CONTROLLED APPROVAL WORKFLOW

Electronic Approval & Rework

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

Closed Approved

No approval request has been submitted.Submit the CAPA when the problem definition and ownership are ready for independent quality review.

Current gate Closed · Approved

CAPA Details

Problem definition and evidence base

Problem Statement

Quality event requiring investigation, corrective action and preventive controls for: Incorrect component orientation during assembly.

Containment

Stopped the assembly cell and inspected affected units.

Root Cause

Fixture allowed the component to be loaded in two orientations.

Corrective Action

Modified fixture with poka-yoke feature.

Preventive Action

Added fixture verification to start-up checklist.

Effectiveness Check

No orientation errors in 2,000 subsequent assemblies.

Verified 25 Apr 2026

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-2026-0012: Modified fixture with poka-yoke feature.	Production Manager	2026-04-20	Completed
Preventive	Implement preventive control for CAPA-2026-0012: Added fixture verification to start-up checklist.	Quality Manager	2026-04-27	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

SourceProcess Audit

OwnerProduction Manager

Detected2026-04-06

Target2026-04-20

Verification2026-04-25

Submitted-

Final Approval-

Closed2026-04-18

Workflow Timeline

Traceability of the CAPA improvement cycle

No workflow events yetEvents will appear as you create analyses and complete actions.