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  • zmh4 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices 7 years, 7 months ago

    Other factors would also be the probability of the occurrence; degree of harm caused by the failure; number of individuals affected and how exactly the failure affects them. Also, I wanted to add that it really all comes down to objective judgement. Often, you can tell how severe a failure is just by looking at the nature of the harm it brings and how likely it is to occur without a deep analysis. From there, index numbers can be assigned or evaluated.