Recently during our internal audit a question came up regarding ownership of verification and validation processes. According to ISO 13485 these caluses fall under Design and development. Should Design department take ownership of verification and validation activities before transerring the design to Production or is there a conflict of interest and Quality Assurance should take ownership of the process?

How is validation and verification being handled at other medical device manufacturers with in house design process? What are the best practices? Are these processes being outsourced to avoid this conflict?
Thanks

Amjad Rana

Our design & development (Engineering) department performs V&V activities, but Sales is a co-owner...particularly if we are Manufacturing but to the requirements of a particular major customer.

Particularly when we have major-customer involvement, the walls between our departments are intentionally kept very low, so a project isn't done in a particular department until all the stakeholders are satisfied.

Process Validation is part of V/V so in my opinion you can't completely have it in design and development.

We get the design to a point where it is verified and validated through the design group. At the same time the manufacturing/operations group is working to validate the equipment. When both sets of folks are finished we hold a design transfer and go to production. Quality has its hands in all of it, Sales/Marketing input is required as during the product validation phase we work with our customers to get volunteers to validate new stuff. It is very much a team effort.

Who 'owns' it? In the end Quality is responsible for succesful completion of V/V.


:2cents: