CAPA-2026-0021

HighClosed

Incorrect dimensions after machine setup

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 dimensions after machine setup.

Containment

Stopped production and completed first-piece reinspection.

Root Cause

Setup sheet did not identify the critical dimensions requiring independent verification.

Corrective Action

Revised setup sheet and added first-piece sign-off.

Preventive Action

Introduced digital setup checklist with mandatory critical-dimension confirmation.

Effectiveness Check

First-piece compliance reached 100% over four weeks.

Verified 15 Jul 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-2026-0021: Revised setup sheet and added first-piece sign-off.	Process Engineer	2026-07-08	Completed
Preventive	Implement preventive control for CAPA-2026-0021: Introduced digital setup checklist with mandatory critical-dimension confirmation.	Quality Manager	2026-07-15	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

SourceFirst Article Inspection

OwnerProcess Engineer

Detected2026-06-24

Target2026-07-08

Verification2026-07-15

Submitted-

Final Approval-

Closed2026-07-07

Workflow Timeline

Traceability of the CAPA improvement cycle

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