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hg93 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Risk index number = impact of risk event x probability of occurrence
The impact of the risk event is commonly assessed on a scale of 1 to 5, where 1 and 5 represent the minimum and maximum possible impact of an occurrence of a risk (usually in terms of financial losses).
The probability of occurrence is assessed on a scale from 1 to 5, where 1 represents a very low probability of the risk event actually occurring while 5 represents a very high probability of occurrence. This axis may be expressed in either mathematical terms (event occurs once a year, once in ten years, once in 100 years etc.) or may be expressed in “plain English” (event has occurred here very often; event has been known to occur here; event has been known to occur in the industry etc.)Risk factors can change in magnitude depending on the adequacy of risk avoidance and prevention measures taken and due to changes in the external business environment. Hence it is absolutely necessary to periodically re-assess risks and intensify/relax mitigation measures, or as necessary.