⚠️SOP for Risk Management and Risk Assessment (FMEA, RPN, HAZOP, SWOT) This Standard Operating Procedure (SOP) describes a comprehensive risk management and risk assessment framework using FMEA, RPN, HAZOP, and SWOT methodologies. It supports pharmaceutical quality systems in accordance with ICH Q9 and ISO 31000 for effective identification, evaluation, mitigation, and monitoring of risks. 1. Introduction Risk Management is a structured approach to identify, assess, mitigate, and monitor risks in laboratory, R&D, QC, manufacturing, and quality systems. This SOP provides step-by-step instructions for multiple risk assessment techniques, including FMEA, RPN, HAZOP, and SWOT analysis, ensuring robust evaluation, prioritization, and mitigation of risks. 2. Purpose To establish a standardized framework for risk identification, analysis, evaluation, mitigation, monitoring, and continuous improvement using multiple validated risk assessment techniques, ens...
Comments
Post a Comment