M
Hi All,
ISO14971 stongly suggests (to me at least) that steps 4.2, 4.3, 4.4, 6.2 to 6.7, and 7 would seem to be best structured as a chart (table E.3 on p53 is suggestive of this type of format) to organize it all. Is this how others are doing it? If so, how do you bridge the questions in Annex C with the first column of the DFMEA (and is a 'function' synonymous with a 'characterstic')?
It's almost like the ISO spec calls for one type of analysis (risk, along with the calculation of severity and occurence), then you go off to a parallel universe to do a DFMEA and figure out RPNs. The two don't seem to be well integrated at all.
On a side note, I get the impression that if you follow ISO14971 (and IEC62366 for good measure), that you will end up with a dozen or so cross referencing documents and a bit of a paperwork nightmare. Should this not all organize neatly into the 'Waterfall Design Control' process promoted by FDA in "Design Control for Medical Device Manufacturers"?
Pardon the frustration, but back in my automotive past the line from DFMEA to DVP&R, and DFMEA to PFMEA to Control Plan to Work Instructions was nice and clean. Ah, those were the days...
Here's the litmus test that will determine the correct methodology for me: a material change (a new/different plastic resin for an epi pen for example) should be covered and allow one to logically backtrack to all the risks that such a change would involve. Not all risks, characterisitics, and functions would be affected but a material change would touch a lot of them.
Any guidance from those that have gone to the school of hard knocks would be appreciated! I've read the post from gholland back in January 2009 and most of mmantunes replies elsewhere in this forum on this topic.
Cheers!
ISO14971 stongly suggests (to me at least) that steps 4.2, 4.3, 4.4, 6.2 to 6.7, and 7 would seem to be best structured as a chart (table E.3 on p53 is suggestive of this type of format) to organize it all. Is this how others are doing it? If so, how do you bridge the questions in Annex C with the first column of the DFMEA (and is a 'function' synonymous with a 'characterstic')?
It's almost like the ISO spec calls for one type of analysis (risk, along with the calculation of severity and occurence), then you go off to a parallel universe to do a DFMEA and figure out RPNs. The two don't seem to be well integrated at all.
On a side note, I get the impression that if you follow ISO14971 (and IEC62366 for good measure), that you will end up with a dozen or so cross referencing documents and a bit of a paperwork nightmare. Should this not all organize neatly into the 'Waterfall Design Control' process promoted by FDA in "Design Control for Medical Device Manufacturers"?
Pardon the frustration, but back in my automotive past the line from DFMEA to DVP&R, and DFMEA to PFMEA to Control Plan to Work Instructions was nice and clean. Ah, those were the days...
Here's the litmus test that will determine the correct methodology for me: a material change (a new/different plastic resin for an epi pen for example) should be covered and allow one to logically backtrack to all the risks that such a change would involve. Not all risks, characterisitics, and functions would be affected but a material change would touch a lot of them.
Any guidance from those that have gone to the school of hard knocks would be appreciated! I've read the post from gholland back in January 2009 and most of mmantunes replies elsewhere in this forum on this topic.
Cheers!
