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  • ap499 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices 6 years, 9 months ago

    All risk is valued by Failure Mode Effects and Criticality Analysis (FMECA). It is an approach to analyze risk. Certain factors that contribute to determining the risk values are how something can fail, the severity of the consequences, and the probability that it will fail. The severity, significant and minor is evaluated with high, intermediate, or low while occurrence is frequent, infrequent, or occasional. Based on the analysis, companies make a decision whether it is worth to take the risk or terminate the project.