I am looking to improve the effectiveness of our internal audit program and would like to migrate to a QMS Maturity Model approach that would fulfill the Audit program while driving continual improvement at our sites to strengthen their system year over year. Is anyone aware of any existing Maturity Model Templates for ISO 13485 or FDA QMS Regulations that I could benchmark?
ISO 13485/FDA QMS Maturity Model Template
- Thread starter dstearns
- Start date
Elsmar Forum Sponsor
I'm not aware of any specific templates, but it should be straightforward to adapt the CMMI approach. I can't recall specifics, but I want to say that some of the CMU past (i.e. non-current) materials were made available, and while not their "latest" I think they'd be fine for your purpose.
It has been my personal experience that medical device manufacturers struggle to maintain or move beyond level 3 ("Defined") in the CMMI model. That is to say... a QMS can (rather trivially) be 'defined', but when certain issues crop up (or reoccur) the org can't really claim to have moved past this level... even if they are being 'discovered' during audits as part of a nominal level 4 "quantitatively measured". Furthermore...
... it is human nature to be reactive; many folks can't help(*1) but want to apply ad hocery to what they perceive as problems.
To get past level 3 (again, CMMI model) it is my opinion that the organization(*2) has to almost take human judgement calls out of the equation. This is not to say that critical thinking is replaced with some robotic algorithm, its just that a mature QMS should be executing planned activities on a regular schedule with known requirements, and if issues are found (ideally they are discovered outside of audits, because some control point triggered them) there is a known method of triage and they are tackled in a prescribed way without somebody throwing a flag and demanding that the issue be handled in some ad hoc way... because then you are back at level 2. If the process has to get revised because someone doesn't like the way it works, you are basically back at level 1.
(*1) I've seen a wide spectrum of personalities get in the way of maturizing an organization. Sometimes it's simple stubbornness coupled with a lack of critical thinking skills. Sometimes it's ego; "I know what I see". Sometimes it's people who enjoy living in crisis mode...
(*2) ...and the key to maturing is to taking these sorts of human issues out of the process as much as possible, and to trust the organization's QMS.
It has been my personal experience that medical device manufacturers struggle to maintain or move beyond level 3 ("Defined") in the CMMI model. That is to say... a QMS can (rather trivially) be 'defined', but when certain issues crop up (or reoccur) the org can't really claim to have moved past this level... even if they are being 'discovered' during audits as part of a nominal level 4 "quantitatively measured". Furthermore...
... it is human nature to be reactive; many folks can't help(*1) but want to apply ad hocery to what they perceive as problems.
To get past level 3 (again, CMMI model) it is my opinion that the organization(*2) has to almost take human judgement calls out of the equation. This is not to say that critical thinking is replaced with some robotic algorithm, its just that a mature QMS should be executing planned activities on a regular schedule with known requirements, and if issues are found (ideally they are discovered outside of audits, because some control point triggered them) there is a known method of triage and they are tackled in a prescribed way without somebody throwing a flag and demanding that the issue be handled in some ad hoc way... because then you are back at level 2. If the process has to get revised because someone doesn't like the way it works, you are basically back at level 1.
(*1) I've seen a wide spectrum of personalities get in the way of maturizing an organization. Sometimes it's simple stubbornness coupled with a lack of critical thinking skills. Sometimes it's ego; "I know what I see". Sometimes it's people who enjoy living in crisis mode...
(*2) ...and the key to maturing is to taking these sorts of human issues out of the process as much as possible, and to trust the organization's QMS.
Similar threads
