CAPA-2026-0028

HighIn Progress

Seal leak after environmental exposure

INTEGRATED CAPA WORKFLOW

Problem → Root Cause → Action → Effectiveness → Closure

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

4/11workflow 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 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.

Action 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 Action · Not Submitted

CAPA Details

Problem definition and evidence base

Problem Statement

Quality event requiring investigation, corrective action and preventive controls for: Seal leak after environmental exposure.

Containment

Stopped release of affected configuration pending testing.

Root Cause

Seal material compatibility was not evaluated for the revised chemical exposure condition.

Corrective Action

Qualified alternate seal material and updated specification.

Preventive Action

Added environmental compatibility review to engineering change process.

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-2026-0028: Qualified alternate seal material and updated specification.	Process Engineer	2026-08-22	In Progress
Preventive	Implement preventive control for CAPA-2026-0028: Added environmental compatibility review to engineering change process.	Quality Manager	2026-08-29	Planned

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

SourceReliability Test

OwnerProcess Engineer

Detected2026-08-01

Target2026-08-22

Verification-

Submitted-

Final Approval-

Closed-

Workflow Timeline

Traceability of the CAPA improvement cycle

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