ISO 14971 Figure E.1 that starts with Hazard and ends with Risk

A

ariannas

Figure E.1 in ISO 14971 has a very handy diagram that covers the flow that starts with Hazard and ends with Risk. ( props to respondents of thread 60587 who helped me get to this point )

In this diagram, "Sequence of Events" is shown off to the side relative to the flow from Hazard to Hazardous Situation.

In the case of software, would it be correct (and possibly better) to say that there is a direct flow from Hazard to Sequence Of Events to Hazardous Situation, rather than having Sequence Of Events off to to the side?

If this not a correct interpretation in light of software, please enlighten me!

I am happy to post partial images of diagram (and my theoretical version) if those who know copyright better than I give me the thumbs up to do so...
 
M

Marcelo

Inactive Registered Visitor
Re: ISO 14971 Figure E.1

When analyzing risk in fault conditions, a software failure (in fact, any failure) is a part of the sequence of events that leads to a hazardous situation (exposition of the patient/user to the hazard).

The software itself does no harm (unless you are bombarded by code and disintegrates or something like that), but can lead to something that can create harm.
 
Last edited:
A

ariannas

Re: ISO 14971 Figure E.1

Gotcha (and agree) that software itself cannot do harm (except to my sanity, maybe..).

To me, putting the Sequence of Events off to the side creates the impression that it is optional.

But if a sequence of events must occur, (as must be the case for software), wouldn't diagram something like the attached be more appropriate? (again, only if we are considering software only).

Thanks for bearing with me.
 

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M

Marcelo

Inactive Registered Visitor
It?s sure not "totally" optional as 4.4 says:

Reasonably foreseeable sequences or combinations of events that can result in a hazardous situation shall be considered and the resulting hazardous situation(s) shall be recorded.
Click to expand...

And the explanation in E.1

According to the definitions, a hazard cannot result in harm until such time as a sequence of events or other circumstances (including normal use) lead to a hazardous situation.
Click to expand...

However, there are some cases in which you probably do not need to use it, for example, in the case of hazards in normal use in normal use, as mentioned.
 
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