CAPA-2026-0024

HighClosed

Incorrect software parameter loaded to test station

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 software parameter loaded to test station.

Containment

Locked the test station and revalidated affected test results.

Root Cause

Manual parameter selection allowed obsolete test files to be loaded.

Corrective Action

Implemented controlled parameter library with revision lock.

Preventive Action

Added software checksum verification before test release.

Effectiveness Check

All test stations passed parameter verification.

Verified 29 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-2026-0024: Implemented controlled parameter library with revision lock.	Process Engineer	2026-07-22	Completed
Preventive	Implement preventive control for CAPA-2026-0024: Added software checksum verification before test release.	Quality Manager	2026-07-29	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

SourceFinal Test

OwnerProcess Engineer

Detected2026-07-10

Target2026-07-22

Verification2026-07-29

Submitted-

Final Approval-

Closed2026-07-21

Workflow Timeline

Traceability of the CAPA improvement cycle

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