O
onin111
Hi,
We are the outsourced engineering services facility. Our Lead Design unit(same company) in another country is directly interfacing with OEM. So basically they identify the engineering changes, draw a mark-up of changes in the powerpoint, send us the CAD files & powerpoint, and simply change the CAD drawings on that data. Our output is the updated CAD files. The Lead Unit checks our output, does all the Verification & Validation processes (7.3.5, 7.3.6).
Now we are for conformance to TS16949, and the auditor keeps on looking for the D&D verification & validation process, but i keep on saying that it is done by the Lead Unit. She said that we should identify it in the scope of QMS, but excluding such clauses would contradict 1.2.
Our setup has really been a headache for CBs. Our previous CB already understood our setup. With the new CB, we have to orient them again.
So my question, how can we state in our quality manual that we are only catering some of the D&D processes in a way that we are not excluding them, unlike stating it under 1.2 ("The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is
not responsible for product design and development."
Thanks!
We are the outsourced engineering services facility. Our Lead Design unit(same company) in another country is directly interfacing with OEM. So basically they identify the engineering changes, draw a mark-up of changes in the powerpoint, send us the CAD files & powerpoint, and simply change the CAD drawings on that data. Our output is the updated CAD files. The Lead Unit checks our output, does all the Verification & Validation processes (7.3.5, 7.3.6).
Now we are for conformance to TS16949, and the auditor keeps on looking for the D&D verification & validation process, but i keep on saying that it is done by the Lead Unit. She said that we should identify it in the scope of QMS, but excluding such clauses would contradict 1.2.
Our setup has really been a headache for CBs. Our previous CB already understood our setup. With the new CB, we have to orient them again.
So my question, how can we state in our quality manual that we are only catering some of the D&D processes in a way that we are not excluding them, unlike stating it under 1.2 ("The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is
not responsible for product design and development."
Thanks!