Incident, Non-Conformity & CAPA Record

GeNext MedEd Foundation — Incident, Non-Conformity & CAPA Record

Document code: GMEF-QA-003
Version: 1.0
Status: Controlled record template

Record ID: ______
Date identified: ______
Programme/activity/site/resource/research/document reference: ______
Reported by / source: ______

Classification
Academic quality / Assessment / Certificate / Attendance / Safety / Ethics / Research integrity / Privacy-data / Rights-IP / Documentation / Collaboration-role / Site / Other

Severity: Low / Moderate / High / Critical
Immediate restriction required: Yes / No

Description and evidence
What occurred or failed to conform: ______
Expected standard/requirement: ______
Evidence references: ______
Immediate containment: ______

Review
Root/contributing cause: ______
Impact assessment: ______
Affected records/people/processes: ______
Notification/escalation required: ______

Corrective and preventive action (CAPA)
| Action | Type | Responsible role | Due date | Completion evidence | Effectiveness verified |
|---|---|---|---|---|---|
| | Corrective / Preventive | | | | |

Closure
Residual risk: ______
Closed / Remains open / Escalated
Authorised reviewer: ______
Closure date: ______

Principle
A record is not closed merely because an action was performed. Closure requires evidence that the action addressed the issue and, where appropriate, that effectiveness was verified.