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Different kinds of Risk Analysis for various Hazards

#1
Dear all,

when I started with risk management many years ago there was one single product risk analyis. We defined all possible hazards and started to find causes. Each cause was refined into more and more different root causes. That was a big amount of work and then we recognized that this is even not always necessary.
One example: There might be a mechanic part of the medical device that can shear off and a user may be injured by the sharp edge. In this case the cause of the shearing off could have several reasons: mistakes in handling by user, mistake by wrong transport conditions and so on.
In the end we decided to stop the root cause analysis at the moment where we found a good mitigating measure that covers all possible causes, e.g. a material that can not shear off.
Or another approach: we never go deeper than 3-5 levels of roots, just as a thumb rule.

That worked for us for many years.

Now a new discussion started in the company: Some people asked for seperate risk analysis covering special departments: purchasing, transportation/logistics, production, service, ...

We discussed about it and the proponents of that approach have the argument that 14971 tells us to cover ALL aspects of the medical product' life cycle.

On the other hand - and that is also my opinion - we have a single product risk analysis that covers all possible causes for each hazard and by that we already cover purchasing, service or other impacts implicitly.

What is your opinion or your way to deal with that question? Do you have an own dedicated risk analysis for each different field like production, service, purchasing and so on?

Just a remark: I am not talking about FMEAs for economic reasons or product/service quality. I am just talking about the patient/user risks adressed by 14971.

Thanks for your answers in advance!
Chris
 

yodon

Staff member
Super Moderator
#2
We've often found it helpful to have separate analyses for 'focus' areas. It's quite typical that we do separate FMEAs for design, use, software, and process (manufacturing).

We typically have a core set of people on the analysis team and then bring in discipline-specific folks for these focus areas. It broadens the participation, enables a deeper dive into the specific discipline, and results in better controls.
 
#3
I agree completely with your approach where 14971 covers all aspects of the medical device life cycle and I would respond by telling them and showing them how it's already covered.
 
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