Quality Risk Analysis: The Key to Failure Prevention
摘要
Risk is defined as a potential for hazards and failures. Risk analysis done proactively helps mitigate the possibility of failures well before they occur. We explore here a scientific methodology of risk identification and proactive actions on causes that lead to failures. The focus of risk analysis and management is on prevention of occurrence of hazards rather than acting on failures after they occur. Structured approach of quality risk management (QRM) as recommended by USFDA guidelines is taken as a baseline for discussions. Our discussions address scope of risk management and scientific principles of the approach. We explore the structure of risk through all its elements and enumerate the process that leads to risk management and minimizing potential failures in processes. Failure mode and effects analysis (FMEA) is widely recognized as the underlying method of risk analysis and is practiced widely in the industry. We delve in detail into FMEA methods and their workflow. Risk analysis tools of fault tree analysis and criticality matrix evaluation are touched upon.