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  • gsharma replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices 6 years, 5 months ago

    Failure Modes and Effects Analysis identifies the opportunities for failure in each step of the process. Each failure mode gets a numeric score that quantifies (a) likelihood that the failure will occur, (b) likelihood that the failure will not be detected, and (c) the amount of harm or damage the failure mode may cause to a person or to equipment. As an organization works to improve a process, it can anticipate and compare the effects of proposed changes by calculating hypothetical Risk Priority Numbers of different scenarios.