Independence of DQA (Design Quality Assurance)

#1
Ussually the Design Quality Assurance is under the responsibility of the QM organization. Nevertheless I have heard about setups where DQA is under the R&D organization. Is there any larger Company structured like this? What are the measures to ensure Independence?

Any info would be highly appreciated

Thanks

Carsten
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
The setup I'm familiar with is R&D being directly responsible and QA having oversight and being involved hi-level (e.g. participating in SOP development and approving design control documents). Independence is guaranteed through design reviews (where at least one independent reviewer is mandated, many times it's someone from QA not connected to the specific project). I've seen this setup in >90% of the orgs I worked with/for, in all sizes of orgs.
 

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