Does a change in managing product design drawings affect the audit scope for a manufacturing plant?
Hello,
The company i work for manufactures plastic bottles for several industries: food, hygiene, cosmetic, laundry.
My role at corporate is quality management systems and lead auditor for the several plants' certification audits.
For as long as I've worked here (5.5 years), the scope the plant's QMS / FSMS has barely covered product design and development. The audit discussion always states that our customer owns the design and works closely with our company's design team (who go by a different name and are not located at any of our plants). We also explain product drawings / specs are managed in the design team's data base, and the plants are unable to modify the drawings and specs.
This has generally been acceptable with certification audits. The design team's processes have never been part of the QMS audit.
Recently, however, i heard the design team may be handing off the product drawings /specs to the plants who manufacture the product. I believe this means the files will longer be controlled in the design team's database.
Right away, i wondered about the plants' certification audit scope--in truth i have no idea if it impacts the scope, but now i have to know!
Does the change of managing product drawings/ specs also change the audit scope from what is was? Will the plants now have to answer product design drawing / spec control? Will this scope expand to the product design team?
Please advise!
Thank you for any help you can provide.
Hi R Suarez,
From what you are describing it seems that there is no change to responsibilities, so the design team isn’t moving to site? If so, isn’t this simply a case of you holding a controlled copy of product drawings /specs?
Also, I don’t understand why the design team are passing off the responsibility for holding master/controlled copies of their work? Who is agreeing the product drawings /specs with the customer?
Kind regards,
Tony
Hi, Tony,
Thank you for responding.
The design team will not be moving to any of the plants for whom they design the product to be manufactured--they will remain at their central location.
My understanding is the design team intends to handover the responsibility to the respective plants--removing from the design team's database and handing them to plants to manage. This is why my department began to ask (me) questions---whether or not the plants' management of drawings & specs will be included in QMS audits and, if so, what does this mean for the design team (since they are still involved with design changes). Is there a new line between what is audited and what is not? Hence the question about 'scope".
i hope I'm clarifying some things--I would really welcome advice/ feedback.
Thank you,
There is a similar topic here.
https://www.ifsqn.co...-control-in-rd/
For short, people should find a common definition of "design & development" first.