I work at a tool and die shop. We make metal progressive stamping dies and run some production. My question(s)- are tool shops that are going after QS-9000 TE design responsible? We do not design car parts. We do layout our own tool designs but trying to apply APQP and design FMEA just doesn't seem to fit our type of business. Our consultant for QS is telling us we have to follow the APQP manual completely. While I am finding some of it to be useful other parts only apply to cars and not dies. Is our consultant right?
A supplier must follow QS-9000 Section 4.4 (Design Control) only if they have the authority to establish a new, or change an existing product specification.
I understand this to mean that if you have the authority to initiate or change customer design records (ie blueprints and specifications)you must follow section 4.4.
See page 23 of the QS-9000 3rd Edition also.
I'm not sure exactly what your consultant is advising you to do, but my understanding is you have to treat your design (the tool) and establish a process to ensure the design meets the intent. Yes, if you design the tool, 4.4 applies. APQP can be applicable to some extent. Unique designs (also called one-offs) may have less applicability than, say someone producing cutting tools or even, for example, larger equipment such as screw machines, where you can have the same checks being made on each production run. Your FMEA can look at previous builds of similar product and "things that didn't go right" for ways to improve lead time, etc.
So if you consider things like how you conduct design reviews of your tools, how do you verify incoming material, how do you verify your assembly (could be the same PCP for many tools) and what is your final inspection, you can apply some of the techniques of APQP. If you look at the intro to T/E, "implementation" section, it does say that "it is recognized that not all of these requirements are applicable to every organization" - (then uses the obvious example of Element 4.4). However, if you determine something is not applicable, be prepared to justify why. Make sure you think of all angles, because your auditor will.
Laura hit all the relavent points pretty well. I would add that the TE manual only requires some sort of advanced quality planning it does not say that the APQP model is the one that you are required to use.