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Unacceptable risk and information for safety

MrTetris

Involved In Discussions
#11
Hi,
I`m hopping on the re-design train, hope it didn`t leave already.... ;-)

We solved a similar problem (treatment planning) by having users sign off with their password, once they wanted to make a change. This was also stored in the audit trail.
We had different roles who could plan the treatment, and also a kind of busy use environment (nurses, doctors, techs..). But someone in charge had to sign off all changes.
Honestly, from a usability perspective: not cool. workflows were often interrupted by the password dialogue.
From a risk perspective: probably quite good.
Totally agree with your view about usability and risk... that is the reason why it is not an acceptable solution :)
 

MrTetris

Involved In Discussions
#12
Do you know how the Occurrence, Severity and Detectability levels were established?
Not properly, in my opinion, and for sure qualitatively. Considering the environment in which our sw are used, I believe that attributing 3 to the occurrence is far too conservative.
 
#15
Not in a position to have an opinion on occurrence. On severity, is it a certainty that an undetected (and therefore implemented, I think?) wrong surgical plan can't end up killing the patient? At the very least, I hope this isn't how the failure is detected...
 

MrTetris

Involved In Discussions
#16
Not in a position to have an opinion on occurrence. On severity, is it a certainty that an undetected (and therefore implemented, I think?) wrong surgical plan can't end up killing the patient? At the very least, I hope this isn't how the failure is detected...
No, no death or serious permanent impairment are possible.
 
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