CAPA-2026-0015

HighClosed

Leak detected during pressure testing

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: Leak detected during pressure testing.

Containment

Quarantined affected assemblies and increased pressure-test sampling.

Root Cause

Seal installation torque was inconsistent.

Corrective Action

Standardized seal installation torque and retrained operators.

Preventive Action

Introduced torque traceability and layered process audits.

Effectiveness Check

Leak rate reduced to zero across 500 tested assemblies.

Verified 24 May 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-2026-0015: Standardized seal installation torque and retrained operators.	Process Engineer	2026-05-18	Completed
Preventive	Implement preventive control for CAPA-2026-0015: Introduced torque traceability and layered process audits.	Quality Manager	2026-05-25	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

Detected2026-05-03

Target2026-05-18

Verification2026-05-24

Submitted-

Final Approval-

Closed2026-05-17

Workflow Timeline

Traceability of the CAPA improvement cycle

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