CAPA-2026-0019

MediumClosed

Operator training expired for critical process

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: Operator training expired for critical process.

Containment

Removed unqualified operators from the process until retraining.

Root Cause

Training matrix did not trigger escalation before expiry.

Corrective Action

Updated training matrix and completed refresher training.

Preventive Action

Added automated expiry alerts at 30, 15 and 7 days.

Effectiveness Check

100% of critical-process operators are currently qualified.

Verified 30 Jun 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-2026-0019: Updated training matrix and completed refresher training.	Production Manager	2026-06-24	Completed
Preventive	Implement preventive control for CAPA-2026-0019: Added automated expiry alerts at 30, 15 and 7 days.	Quality Manager	2026-07-01	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

SourceInternal Audit

OwnerProduction Manager

Detected2026-06-10

Target2026-06-24

Verification2026-06-30

Submitted-

Final Approval-

Closed2026-06-23

Workflow Timeline

Traceability of the CAPA improvement cycle

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