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.