I am faced with a big confusion - we have Nonconforming material reports, Deviations (Planned and Unplanned) and Change Control in our system.
When all these were introduced, little did was realized to the enormous confusion that we are in now; so we plan to overhaul the system.
The confusion comes when there is a nonconfreming material - what do we raise - a NCMR or a Unplanned Deviaition and likewise in case of any prospective changes, do we raise a Planned Deviation or a Change Control ?
Could you pls advice on path forward from a medical device perspective ?
When all these were introduced, little did was realized to the enormous confusion that we are in now; so we plan to overhaul the system.
The confusion comes when there is a nonconfreming material - what do we raise - a NCMR or a Unplanned Deviaition and likewise in case of any prospective changes, do we raise a Planned Deviation or a Change Control ?
Could you pls advice on path forward from a medical device perspective ?