FMEA RPN Recalculation after Actions are (or are not) Taken

[medalex]

Hello!
I'm analyzing risks of health care information system. Risks are connected with new functionality which must be added to existing information system. As I have understood it is called Design FMEA. There are Action Results columns in FMEA table examples I have found with RPN recalculated. The second RPN shows how taken actions are effective. So the question is how can I calculate these numbers if there is no actions taken yet? Maybe these columns are filled later?
I am looking forward to your answers.

 

[qusys]

Re: FMEA RPN Recalculation after Actions are Taken

You should recalculate RPN after the recommended actions have been put in place for that specific item, looking at the effectiveness of the implemented action.
This only for the potential failures that have RPN of a certain threshold or a severity that could impact safety

Hello!
I'm analyzing risks of health care information system. Risks are connected with new functionality which must be added to existing information system. As I have understood it is called Design FMEA. There are Action Results columns in FMEA table examples I have found with RPN recalculated. The second RPN shows how taken actions are effective. So the question is how can I calculate these numbers if there is no actions taken yet? Maybe these columns are filled later?
I am looking forward to your answers.

 

[Jim Wynne]

Re: FMEA RPN Recalculation after Actions are Taken

You should recalculate RPN after the recommended actions have been put in place for that specific item, looking at the effectiveness of the implemented action.
This only for the potential failures that have RPN of a certain threshold or a severity that could impact safety

Threshold values are not a good idea, and a given modification doesn't have to affect safety in order to be worthwhile.

 

[medalex]

Thank you for your answers. So if it is the first time FMEA table is prepared I do not need to recalculate RPN because recommended actions are only mentioned not realized yet?

 

[Jim Wynne]

Thank you for your answers. So if it is the first time FMEA table is prepared I do not need to recalculate RPN because recommended actions are only mentioned not realized yet?

That's correct. You shouldn't do a recalculation until the recommended action(s) has/have been implemented and verified.

 

[medalex]

Thanks for the answer, before it I had some doubts, now it is clear.

 

[qusys]

Re: FMEA RPN Recalculation after Actions are Taken

Threshold values are not a good idea, and a given modification doesn't have to affect safety in order to be worthwhile.

I meant that even a low RPN in comparison to the other but its severity is 10, the organization could decide to mitigate , working at controls to detect, for example.
I agree with you that PRN threshold is not a good idea, but in my working experience I have had some questions of this type from customer audits and so I wanted to share my experience.
However in some technical literature this criteria is present, but the organization should address with a pareto analysis, i think.
Thks for your input