← Template Library
RISK ASSESSMENTREFERENCE OUTLINE
Quality Risk Assessment (QRA) — Type 1
Standard QRA template for process and change control risk assessment using FMEA methodology. Maps directly to ICH Q9(R1) formality guidance.
REGULATIONS MAPPED
ICH Q9(R1)ICH Q10
DOCUMENT TYPE
Risk AssessmentLAST UPDATED
June 2024PURPOSE
A standard quality risk assessment for processes and changes using FMEA, sized to the formality expected by ICH Q9(R1).
What's Inside
✓Risk question and scope definition
✓Process/step breakdown
✓Severity, occurrence, and detectability scoring
✓RPN calculation and risk ranking
✓Risk control and residual-risk sections
How to Use It
1Define the risk question precisely
2Assemble a cross-functional team
3Score each failure mode consistently against your scales
4Prioritise by RPN and criticality
5Document controls and re-evaluate residual risk
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
1Risk Question and Scope
2Team, Method, and Scoring Scales
› Assessment team› Severity (S) scale› Occurrence (O) scale› Detectability (D) scale
3Process / Step Breakdown
4Failure Mode Identification
5Severity, Occurrence, Detectability Scoring
6RPN Calculation and Risk Ranking
7Risk Controls and Residual-Risk Assessment
8Conclusions and Risk-Acceptance Sign-off
REGULATORY CONTEXT
ICH Q9(R1) emphasises formality proportionate to risk. This template provides a defensible, right-sized FMEA structure.