paul van oppen
Registered
I would appreciate your comments and suggestions on the following topic: we have a robust CAPA system in place (we are a medical device company) and we use a rigorous issue assessment process that rates issues for severity and occurrence (modelled after ISO14971). This assessment then assigns a risk rating to the issue, which in its turn drives the CAPA process. All good so far.
As in any organisation there are many issues that continuously occur, most of which would never make it to the level of a CAPA, even if rated. In fact, most issues do not get rated and are handled by the professionals in who's area the issue occurs.
And this is the concern: once a decision has been taken that an issue is important enough the formal process kicks in, but what about all those cases where we make informal decisions not to initiate the CAPA assessment process?
In other words, I am considering if there would be a need to have an issue tracking system that would log a larger volume of issues and require a quick assessment to:
1) further assess the issue for CAPA
2) not assess the issue for CAPA and allow a local correction of the issue
In case of no CAPA assessment, a justification would be required.
The advantages of tracking issues would be, amongst others:
- better visibility of non-conformances within the organisation (in addition to e.g. existing MRB and concession systems)
- having a recorded justification to NOT start a CAPA for a larger amount of issues.
The main disadvantages are increased complexity and the resource claims that such a system would bring with it.
I would like to get feedback from those of you in either medical device or pharmaceutical industry who has gone through similar evaluations and learn from you.
Thanks!
Paul
As in any organisation there are many issues that continuously occur, most of which would never make it to the level of a CAPA, even if rated. In fact, most issues do not get rated and are handled by the professionals in who's area the issue occurs.
And this is the concern: once a decision has been taken that an issue is important enough the formal process kicks in, but what about all those cases where we make informal decisions not to initiate the CAPA assessment process?
In other words, I am considering if there would be a need to have an issue tracking system that would log a larger volume of issues and require a quick assessment to:
1) further assess the issue for CAPA
2) not assess the issue for CAPA and allow a local correction of the issue
In case of no CAPA assessment, a justification would be required.
The advantages of tracking issues would be, amongst others:
- better visibility of non-conformances within the organisation (in addition to e.g. existing MRB and concession systems)
- having a recorded justification to NOT start a CAPA for a larger amount of issues.
The main disadvantages are increased complexity and the resource claims that such a system would bring with it.
I would like to get feedback from those of you in either medical device or pharmaceutical industry who has gone through similar evaluations and learn from you.
Thanks!
Paul