Hi. Our organisation uses FMEAs for evalulaton and control of risks. It works something like this, which I hope is similar to the way some of you might also do it. Firstly, we would identity Risk control measures to reduce the risk associated with a particular hazard. After implementation, we would then re-evaluate the risk (i.e., re-score it) and then determine whether this "residual risk" is considered acceptable or not. If acceptable, then we would be done and dusted --> move on to the next hazard.
So firstly, I want to get thoughts as to whether that sounds about right to any other folks using FMEA? Secondly, and the point of this post, is what then are we supposed to do about MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks". Like it or not, our FMEAs are often full of every possible, hypothetical risk we can think of - are we really supposed to discuss each one in the labelling? Sometimes the risk to start with is so low that we wouldn't even implement additional risk control measures. In this case, section 6 of 14971:2019 says to treat this initial risk estimate as the "Residual Risk". So every hazard that is risk assessed in the FMEA ends up with a "residual risk" estimate. And we could have a hundred of these (in a bad FMEA).
14971 says that "the manufacturer shall inform users of significant residual risks" which makes total sense, but that's not what the MDR is saying. I'm obviously missing something here so any direction would be appreciated.
PS - I know some may feel that FMEA is the root of many a problem, but it's what we've been using for ever and won't be switching. Old dogs, etc.
Thanks, Damien
So firstly, I want to get thoughts as to whether that sounds about right to any other folks using FMEA? Secondly, and the point of this post, is what then are we supposed to do about MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks". Like it or not, our FMEAs are often full of every possible, hypothetical risk we can think of - are we really supposed to discuss each one in the labelling? Sometimes the risk to start with is so low that we wouldn't even implement additional risk control measures. In this case, section 6 of 14971:2019 says to treat this initial risk estimate as the "Residual Risk". So every hazard that is risk assessed in the FMEA ends up with a "residual risk" estimate. And we could have a hundred of these (in a bad FMEA).
14971 says that "the manufacturer shall inform users of significant residual risks" which makes total sense, but that's not what the MDR is saying. I'm obviously missing something here so any direction would be appreciated.
PS - I know some may feel that FMEA is the root of many a problem, but it's what we've been using for ever and won't be switching. Old dogs, etc.
Thanks, Damien