How to confirm the ability of computer software to satisfy the intended application (clause 7.6) in“shoe-last” manufacturing or similar situations?

“Shoe last” is a foot model / mould made of (wood or) plastic having dimensions and shape similar to the anatomical foot. This provides a working surface to mount shoe components during shoe manufacture.

CAD / CAM is used to manufacture “shoe-last”.

The "shoe-last" manufacturing process involves (i)) digitalizing of an existing physical “shoe-last” using a 3-D scanner (ii)) Using the input from scanner,CAD to produce a computer model of “shoe-last” (iii)Using output data from CAD system to CAM (numerically controlled lathe/milling machine) to produce “shoe-last” from blocks of plastic.

A “shoe-last” is free form object and composed of free form surface rather than basic geometric shapes. The question is how to confirm the ability of computer software (digitalizing software, CAD software and CAM software) to satisfy such type of intended applications? I anticipate some issues in this area from auditors since the dimensions of final product are controlled by the software.

I am quite new to application of software in such manufacturing processes. I greatly appreciate your help.

Thanks.

I believe your reference to 7.6 might be incorrect, if i understand your description correctly. IMHO your software is part of the production process and is not used as a monitoring and measuring device. 6.3b might be more applicable. All it says there is that the required infrastructure needs to be decided on, be there and be in good shape.

If you want to have something on paper, i'd suggest you write down what the requirements are for the software you use (needs to be able to manufacture shoe-last by doing the following things... and then check your current software with these requirements.).

We use some homemade software ourselves, and we dont have any proof that it suits the requirements, other than the fact that it does what it's meant to do. I'm not planning on "creating proof" either.

I believe that an auditor will not ask for "proof that it fits the requirements". It seems a bit theoretical to me. He might ask better questions, like how do you make sure software updates do not mess up your production and things like that.

Thanks for your reply and correcting me.

Your reply from The Netherlands takes me backward several years when, as a tourist, I had visited your country and visited a wooden-shoe hand carving factory during a conducted tour.