Really great points, Aaron!

Joe,

Expanding on what Niki wrote, this is an important topic that seems to lead to a lot of confusion and flawed methodology. The P1, P2 probabilities are part of the ISO 14971 risk model but that doesn’t mean they should be explicit columns in a risk table. My recommendation is to make sure that everyone involved in risk assessments…

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Great topic!

I think of Pharm as the overall probability (P1 x P2). This is the same as P value – so in the instances where you don’t see P1 and P2 separately, that’s likely the approach. So, if you mitigate P1 to near 0, pharm will be reduced to the same. But they are not equal.

In my experience, technical mitigations can lower P1 – probably…

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Does anyone want to talk about P1/P2 values as part of the risk management process?

Some FMEAs include them, some do not, and Im looking to expand/broaden my knowledge on how to interpret risk management files that dont specifically call them out.

Note (Per ISO 14971): Risk = Severity x (P1xP2)

I think the explaination is that:

If you can mitigate…

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