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  • merzkrashed replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices 8 years, 1 month ago

    As we have learned, Risk Management is done on multiple areas of a project, not just one:The product, The product design, and The manufacturing process.
    A method to analyze risk
    Looks at:
    HOW something can fail
    SEVERITY of the consequences
    PROBABILITY that it will fail
    you also can apply DFMEA – Design Failure Mode and Effect Analysis
    Apply APQP= Advanced Product Quality Planning and Control