Feed – Risk Management – INDiE Med Tech

Jeff joined the group Risk Management 4 days ago

4 days ago

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Rebecca joined the group Risk Management 5 days ago

5 days ago

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Cullom joined the group Risk Management 4 weeks ago

4 weeks ago

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Niki replied to the discussion P1/P2 Values RIsk Management in the forum Risk Management 6 weeks ago

6 weeks ago

Reply to P1/P2 Values RIsk Management

Really great points, Aaron!

Aaron replied to the discussion P1/P2 Values RIsk Management in the forum Risk Management 8 weeks ago

8 weeks ago

Reply to P1/P2 Values RIsk Management

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…

Niki

Niki replied to the discussion P1/P2 Values RIsk Management in the forum Risk Management 8 weeks ago

8 weeks ago

Reply to P1/P2 Values RIsk Management

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…

Joe started the discussion P1/P2 Values RIsk Management in the forum Risk Management 8 weeks ago

8 weeks ago

P1/P2 Values RIsk Management

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…

Risk Management

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