Hello Everyone,
Good day to you.
please help me in following issue.
"Is Product development dept. is under Quality Assurance? or it is fully independent dept. for example we know, QC is under QA. Is PD also under QA? "
“R & D dept is independent ? or under QA?”
“And which dept. are under QA? Compliance , validation dept. are under QA?”
Please help me with reference.
thank you in advance.
Qa will be must to each every department according to regulatory requirements, they know as DQA that the make the commond at Pdr and R&D department
Like issues of master documents and master MFr any chang in maste formula afte approved
Thes all thinks hold and contrived by QQA
There should be a separate and independent QA function/department responsible to oversee R & D and product development activities independently. This QA team should be separate from the QA team of the production (related to manufacturing).
Hi,
R&D QA is defined as all the planned and systematic actions to verify whether R&D processes are conducted in a proper manner and the results of R&D fully satisfy customers’ requirements . … It may be helpful for the institute that has an interest adopting R&D QA.
Sounds like QA in our organisation is the “local police force” and the source of all knowledge…
I’ve seen that approach in action in many organisations, and in my opinion it is detrimental to R&D staff’s self-perception, quality attitude and performance.
Why not give them more autonomy and responsibility, and leave QA with oversight / auditing, to ensure compliance?
I believe R&D and marketing are best positioned to set specifications, while QA supervise and provide the final formal authorization. The same would apply for product release - R&D should do all the groundwork up to the point where they think all requirements have been met; then QA can verify and formally sign-off. Of course real-time monitoring is always recommended, to avoid surprises later, but I honestly believe this should come as objective feedback rather than ongoing “law enforcement”.
I also believe functions such as training, document control, change control and qualifications (in R&D domain) can, and actually better, be carried out by R&D personnel, with QA’s necessary formal oversight (authorization etc.) and objective feedback, in cases where processes go off-tracks. It would help build a sense of ownership and caring in R&D, while the core-knowledge is there anyway.
Thanks,
Kamlesh