CAPA-2026-0001

HighIn Progress

Repeated packaging seal failure

INTEGRATED CAPA WORKFLOW

Problem → Root Cause → Action → Effectiveness → Closure

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

2/11workflow steps

1 Problem Identified Completed 2 Containment Completed 3 Root Cause Current focus 4 Pareto Pending 5 Quality Review Pending 6 Action Pending 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

Seal failures were observed during final inspection, causing product rejection.

Containment

Not documented

Root Cause

Not documented

Corrective Action

Not documented

Preventive Action

Not documented

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
Containment	Quarantine all cartons produced during the affected production window.	Quality Manager	2026-08-06	Completed
Corrective	Clean sealing jaws and standardize sealing temperature setting.	Process Engineer	2026-08-10	Completed
Preventive	Introduce weekly seal-temperature trend review and thermocouple verification.	Quality Manager	2026-08-20	In Progress

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

SourceInspection

OwnerSystem Administrator

Detected2026-08-05

Target2026-08-25

Verification-

Submitted-

Final Approval-

Closed-

Workflow Timeline

Traceability of the CAPA improvement cycle

Corrective/action item completed16 Aug 2026 21:18

Quarantine all cartons produced during the affected production window.System Administrator

Integrated workflow enabled16 Aug 2026 21:01

Fishbone, Pareto, actions, Markov and closure tracking are now connected to this CAPA.System Administrator

CAPA record is active16 Aug 2026 21:00

Demo CAPA is ready for the integrated quality workflow.System Administrator