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  • jp582 started the topic Risk management methods in the forum Risk Analysis for Medical Devices 8 years, 5 months ago

    As Dr. Simon has mentioned in this week video lecture, method to analyze risks and one of the method he talked about is Failure Mode, Effects, and Criticality Analysis (FMECA). FMECA is potentially utilized for failure and risks associated with manufacturing processes. It is used to analyze the probability of failure against the severity of their consequences. I would like to discuss some other methods such as
    Quality risk management methods and tools
    •Basic Risk Management Facilitation Method- organizing data and facilitating decision making such as flowchart, check sheets, process mapping, and cause and effect diagram.
    •Fault Tree Analysis (FTA) – a pathway to evaluate system failures one at a time. It is a function as a diagnostic tool to identify and fully solve the issue so it would not cause other issues later on.
    •Hazard Analysis and Critical Control Points (HACCP)-a tool for assuring product quality, reliability, and safety. It applies scientific principles to analyze, evaluate, prevent, and control the risk. It is use to identify and manage risks associated with physical, chemical, and biological hazards.
    •Risk Ranking and Filtering- evaluate qualitative and quantitative factors for each risk. The potential use is to prioritize manufacturing sites for inspection/audit by regulators or industry.
    •Supporting Statistical Tools- support and facilitate quality risk management. They can enable effective data assessment, aid in determining the significance of the data set, and facilitate more reliable decision making.
    What are the other risk management methods?