I would expect that QA to play the role of harmonizing/integrating the "standards/requirements & learnings" into SOPs and monitoring the compliance.
while doing so, there is a tug of war of simplifying the documentation&processes as per the relevance to R&D.
That is fine....the clarity would evolve in due course, as per the experience/maturity of processes & people...
But real question is, to what extend does QA gets involved in development processes.
1) i am just trying to find equivalent activities of mfg.QA vs dev.QA
viz., what is equivalent of process control (is it dev.control through processes like FMEA)
what is equivalent of batch release (is it design/product.release through certain development reports)
of course, audits, document-control etc., would be same.
AND
2) to what extend does QA has say/influence in risks taken at different stages of development.
This is of significance because, often the assumptions made at later stage are complicating certain basic errors/gaps induced into design/product affecting robustness of mfg.process
thanks for your thoughts.
while doing so, there is a tug of war of simplifying the documentation&processes as per the relevance to R&D.
That is fine....the clarity would evolve in due course, as per the experience/maturity of processes & people...
But real question is, to what extend does QA gets involved in development processes.
1) i am just trying to find equivalent activities of mfg.QA vs dev.QA
viz., what is equivalent of process control (is it dev.control through processes like FMEA)
what is equivalent of batch release (is it design/product.release through certain development reports)
of course, audits, document-control etc., would be same.
AND
2) to what extend does QA has say/influence in risks taken at different stages of development.
This is of significance because, often the assumptions made at later stage are complicating certain basic errors/gaps induced into design/product affecting robustness of mfg.process
thanks for your thoughts.
