CAPA-2026-0026

HighUnder Verification

Cracks found in molded housing

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 Current focus 4 Pareto Completed 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.

Effectiveness Review 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 Effectiveness Review · Not Submitted

CAPA Details

Problem definition and evidence base

Problem Statement

Quality event requiring investigation, corrective action and preventive controls for: Cracks found in molded housing.

Containment

Quarantined the affected lot and completed 100% visual inspection.

Root Cause

Not documented

Corrective Action

Balanced cooling channels and standardized cycle time.

Preventive Action

Added mold temperature trend monitoring.

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-2026-0026: Balanced cooling channels and standardized cycle time.	Process Engineer	2026-08-12	In Progress
Preventive	Implement preventive control for CAPA-2026-0026: Added mold temperature trend monitoring.	Quality Manager	2026-08-19	Planned

Linked Analyses

One-click access to every analytical layer

Fishbone / Root Cause1 linked analysisOpen latest →

Pareto Analysis1 linked analysisOpen latest →

Markov Lifecycle ForecastNot startedGenerate lifecycle →

CAPA Summary

SourceFinal Inspection

OwnerProcess Engineer

Detected2026-07-20

Target2026-08-12

Verification-

Submitted-

Final Approval-

Closed-

Workflow Timeline

Traceability of the CAPA improvement cycle

Fishbone cause removed21 Aug 2026 09:53

Cooling channels were unevenSystem

Fishbone cause removed21 Aug 2026 09:24

Cycle-time limits were not enforcedSystem

Fishbone cause removed21 Aug 2026 09:23

Setup verification was incomplete after mold changeSystem

Fishbone cause removed21 Aug 2026 09:22

Material moisture was above preferred process rangeSystem

Fishbone cause removed21 Aug 2026 09:21

Cooling-water temperature fluctuated during shiftSystem

Fishbone cause removed21 Aug 2026 09:21

Mold temperature sampling was infrequentSystem