Background....
Ours is a very relatively-new function of ""QA in R&D"".(pharma domain)
Typically, people are recruited from manufacturing background. and they are seasoned to the 'verification'&'accuracy' - 'compliance' type of work.
But what is required is án mindset oriented towards establishing 'adequacy' & 'requirements'.
Management is expecting the process&results in establishing robustness of manufacturing process and drive towards current trends...
Problem/Situation
But the Sr.QM team is caught up in the web of constraints-
1 driving the R&D teams towards accepting the newer concepts (R&D is avoiding them in the name of no-time for new processes )
2) orienting/leading the QA-team towards the ""change in mindset"".(accuracy --> adequacy)
3) essentially not having appropriate targets to demonstrate the progress/incentivise the change. (metrics)
ANS PLZ
what would you try/recommend for a person who is lower level of team.
Esp. for a person who is trying out couple of alternatives...
1) establishing expectations/requirements along with relevant-processes
2) demonstrating the ideas & value/pilots of those ideas in bringing awareness/examples to team
(consensus is what is missing among QM group...remember ppl from mfg. background...resistance to change... )
thanks for your thoughts.
:
Ours is a very relatively-new function of ""QA in R&D"".(pharma domain)
Typically, people are recruited from manufacturing background. and they are seasoned to the 'verification'&'accuracy' - 'compliance' type of work.
But what is required is án mindset oriented towards establishing 'adequacy' & 'requirements'.
Management is expecting the process&results in establishing robustness of manufacturing process and drive towards current trends...
Problem/Situation
But the Sr.QM team is caught up in the web of constraints-
1 driving the R&D teams towards accepting the newer concepts (R&D is avoiding them in the name of no-time for new processes )
2) orienting/leading the QA-team towards the ""change in mindset"".(accuracy --> adequacy)
3) essentially not having appropriate targets to demonstrate the progress/incentivise the change. (metrics)
ANS PLZ
what would you try/recommend for a person who is lower level of team.
Esp. for a person who is trying out couple of alternatives...
1) establishing expectations/requirements along with relevant-processes
2) demonstrating the ideas & value/pilots of those ideas in bringing awareness/examples to team
(consensus is what is missing among QM group...remember ppl from mfg. background...resistance to change... )
thanks for your thoughts.
