This SOP describes the structured process for identifying, evaluating, mitigating, and monitoring risks within your Quality Management System (QMS).
 
It provides a clear and practical framework for applying risk-based thinking in accordance with ICH Q9, GxP, and EMA/FDA expectations.
 
The document is professionally written and pre-filled (≈ 99 % complete), requiring only your company name and QA reviewer to finalize.
It ensures that all risk evaluations—whether related to product quality, clinical operations, or suppliers—are performed consistently and traceably.
 
Includes:
• Methodology for qualitative and quantitative risk assessment
• Risk identification, scoring, and prioritization templates
• Mitigation planning and effectiveness review
• Responsibilities of QA and management
• Integration with CAPA and Change Control systems
 
Using this SOP helps your organization demonstrate that risks are managed proactively and transparently—supporting inspection readiness and regulatory confidence.