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REPORTREFERENCE OUTLINE
Deviation & Nonconformance Report
Structured deviation/nonconformance record with risk classification, product impact assessment, root-cause analysis, and CAPA linkage. Built for a defensible quality-event system.
REGULATIONS MAPPED
21 CFR Part 211ICH Q10EU GMP Chapter 1
DOCUMENT TYPE
ReportLAST UPDATED
January 2025PURPOSE
A structured deviation / nonconformance record that captures what happened, contains the impact, and drives a risk-based investigation to root cause — the backbone of a defensible quality event system.
What's Inside
✓Event description and immediate containment
✓Classification (minor / major / critical) with rationale
✓Product and batch impact assessment
✓Root cause analysis section
✓CAPA linkage and closure approval
How to Use It
1Record the event and immediate actions contemporaneously
2Classify by risk to product quality and patient safety
3Assess impact on affected and concurrent batches
4Investigate to true root cause, not just the symptom
5Link corrective/preventive actions and route for QA closure
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Event Identification and Description
› Event description
2Immediate Actions and Containment
3Risk Classification and Rationale
4Product / Batch Impact Assessment
5Investigation and Root Cause Analysis
› Investigation summary› Root-cause methodology
6Corrective and Preventive Actions
7Effectiveness and Closure
8QA Review and Approval
REGULATORY CONTEXT
21 CFR 211.192 requires investigation of any unexplained discrepancy, and EU GMP Chapter 1 / ICH Q10 expect a managed deviation system. This template enforces classification, impact assessment, and root-cause rigour.