Join Now

P1/P2 Values RIsk Management

Disclaimer: Posts on IndieMedTech Forums are user-generated and do not reflect the views of IndieMedTech. Information shared here is for general discussion only and should not be considered professional or medical advice.
  • Risk Management

    P1/P2 Values RIsk Management

    Posted by Joe on December 6, 2025 at 6:51 pm

    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 P1 (Probability of a Hazardous Situation Occuring), then by default, you eliminate P2 (Proability of a Hazardous Situation Leading to Harm) ever occuring, and therefore P1 is approx = PHarm? But I can also see where there may be instances when P1 > P2 and so the minimum of the 2 values is used as an estimate of the Probability of Harm?

    Can anyone help!?

    Thanks!

    Joe replied 22 seconds ago 1 Member · 0 Replies
  • 0 Replies

Sorry, there were no replies found.

Log in to reply.

Start of Discussion
0 of 0 replies June 2018
Now
Profile Access Restricted
Viewing Member Profiles
is a Premium Feature.
Upgrade your membership to connect directly with fellow MedTech professionals, explore their backgrounds, and grow your network within the IndieMedTech community.
Become a Premium Member