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IEEE defines the operational profile as a quantitative characterization of how a system will be used. Christian Kaestner uses examples in his descriptions of P1 and P2 starting at 2:37 in the webinar.Īnother software engineering tool to use when determining the probability of the sequence of events is to develop an operational profile. The combination of P1 and P2 create a more accurate probability of occurrence for the software risk. P2 is the probability of occurrence of harm. P1 is a combination of the probabilities of a hazard occurring and the sequence of events that lead to a hazardous situation. A link to the video is below.īasically, you divide the probability of occurrence into two parts P1 and P2.
#RISK PROBABILITY OF OCCURRENCE HOW TO#
Christian Kaestner, one of the authors of IEC 62304, hosted a webinar last year that further described how to develop the probability of occurrence for software risks. Luckily the authors of IEC 62304 created additional guidance around determining the probability of occurrence. It does not take into account how often the actions leading to the risk occur. According to IEC 62304 the probability of occurrence is assumed to be 100%. That is, reducing the probability of occurrence. Software risk management is all about reducing the software’s ability to contribute to a hazardous situation. Each risk is assigned a severity and probability of occurrence. Medical device software – whether it’s standalone (SaMD) or embedded in a device – begins with its risk assessment.