I am confused relative to the applicability of the 7.3 Design and Development requirements to my organization.
We are a manufacturer of value added aluminum extruded assemblies. We obtain the design documents from our customers, but we need to translated those requirements into documents that we can use in the shop.
Our customers use solid modeling to create their designs and send us the model. We need to create 2D drawings with dimensions. We also want to add features to the drawing that represent the finished part. (eg. we add radii to the cornors of a rectangle to mirror the path of the milling tool)
We also determine the allowable tolerances for the aluminum extrusion. However, the calculation of those tolerances is standardized in the Aluminum Extrusion Council's Manual and in ASTM documents. So we merely perform a standard calculation that the customer could perform but chooses not to.
We feel that we do not change the form, fit or function of the product and therefor do not meet the requirements of 7.3 Design and development.
However, our registrar has a different point of view. He feels that the selection of tooling enters into the design realm. He also feels that our calculation of tolerance is design. He also believes that we are responsible for design and development review.
With this point of view it seems that any manufacturer would be a designer.
We fall into a situation that is similar to yours. We are a contract manufacturer for printed circuit boards. We have some involvement in the design process, but ultimately the customer is responsible for the design. We provide manufacturability guidelines and provide our own inspection templates, but all of this is based upon industry standards.
We excluded design and development since we were able to show that we are not responsible for the design of the product. If your customers are responsible for the design of the product and own that design, you should make a pretty strong argument with your registrar. From what you said in your post I would see no problem with excluding design and development.
It seems to me from what is described that the company in question has significant impact into the design of the product, and should include design controls to assure the quality of the product, and protect its own potential liability.
I've got to agree with Richard. We are a die cast/machine house and we have input into the "final" design of a part but, ultimately, the customer is the owner of the "black box" and approves (or not) any tolerance we may set based on the model. Our registrar concurs that we are not "design responsible".
Don't quite understand how an auditor feels selection of tooling enters into design
I have to agree with Richard & Bill. I worked for a company with a similar scenario in which we had some input into the final design but ultimately it was customer owned. We excluded 7.3 and were (they still are!) certified with no problem. I would definitely revisit this with your registrar.