TS 16949 6.2.2.1 Product Design Skills - Product Design is done overseas

[freberg2000]

Our facility does not perform Product Design. Product Design is done overseas, however, we do process design since there are some process design outputs we are responsible for (pFMEA, Work Instructions, Control Plan, etc.)

In 6.2.2.1 it states that "The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques."

Would this requirement include the process design aspect or strictly product design?

Thanks,

Todd Freberg

 

[D.Scott]

Good question Todd. Thanks for throwing it out there. I am sure it will prompt a number of responses. This is how I see it.

I understand your comment about product design being done at another facility. Your site has to be involved and aware of whatever product design is passed on to you regardless of the responsibility for the design itself. Put another way, someone there has to be able to interpret the design inputs, design a process and then verify the design (product and process) outputs.

TS has, to my knowledge, only 2 parts which can be excluded from your system; both deal specifically with product design and both are in 7.3. All other elements of TS have to be addressed.

I would interpret 6.2.2.1 as addressing any product design responsibilities associated with your contribution to the process or product. All skills needed to carry out your portion. It wouldn't make sense to me to exclude either product or process in the training needs as the two are so closely related and dependant on each other.

I will be interested in the opinion of others.

Dave

 

[Kevin H]

Excellent thread start - I'll be very interested in seeing how it progresses.

My interpretation of product design within the TS standard is that if your company owns/controls the design of the product, you are responsible for product design, and cannot exclude it from your TS scope. Thus even if you outsource the actual product design (whether to a different division or to an independent subcontractor) you still are responsible for product design and need to address it within you QMS & its scope.

I've had some major differences of opinion on this with our corporate management - they do design for us. I've argued we need to have design included in our scope. Corporate QA has argued & decreed that no, we don't need to include it, even though we control the design of our base products (we're a bulk material producer). Surprisingly, so far our registrar hasn't objected to our excluding design. We have been fairly upfront about our exclusion - stating to the registrar that product design of our products is done by our corporate design group based at our corporate headquarters.

Getting back more to subject, I'd agree with Dave that 6.2.2.1 needs to be addressed - I plan to check our system to insure that we adequately address it.

 

[freberg2000]

Let me clarify. We are a worldwide supplier of components to mainly Asian automakers, though we do supply GM, and product design is performed in Japan. It is still part of the same corporation, just a different location. In fact, the facility in Japan is in the scope of our audit and an off site audit will be performed before our audit.

Todd Freberg

 

[Sam]

As I interpret 6.2.2.1 it applies to the design of the product only.
However, products should be designed with manufacturability in mind, which means enlisting the aid of the process designer, quality engineer and buyer. All should be competent and skilled in their applicable tools and techniques.
IMO Para 6.2.2 was sufficient without adding the follow-on sub-para.

 

[freberg2000]

I spoke with our registrar yesterday and asked him the same question. He said that 6.2.2.1 addresses only product design and not process design.

 

[D.Scott]

Todd - just as an experiment for our forum, ask your registrar the following.

If a customer, who has design responsibility, requests that their design validation be done in your facility, on your equipment and process, should your company ensure the employees working on that validation have skills in the applicable tools and techniques?
Is he saying employees using those same tools and techniques for process design don't need to be competent?

There is, in my mind anyway, a distinction between "Design Responsible" as stated in the standard and "having design responsibilities" as indicated in 6.2.2.1

Just my opinion.

Dave

 

[Macjaney]

Product Design vs Process Design

I just finished being audited for TS and that was one question I asked our auditor. We don't do Product Design but she said that our engineers need to be able to work with the information we receive from our customers and that in order to complete the PROCESS, they need the same skill set, so we DO need to address this area.

 

[RoboElvis]

We don't do Product Design but she said that our engineers need to be able to work with the information we receive from our customers and that in order to complete the PROCESS, they need the same skill set, so we DO need to address this area.

Ouch. We're a Tier 2 (mostly) supplier of stamped panels. We farm out the customers designs to die shops. They 1) cut the dies 2) PPAP them 3) have us over to buy off on them 4) send them here for our initial run and PPAP. We don't have the technology or skill set to design or create these dies. The customer is the owner of the tools. Our in house die shop can make minor repairs and modifications. Even the modifications are customer designed engineering changes. This is what we told our auditor and he said that as long as we call out the exclusion from product design, we won't have to worry about it. of course, we are responsible for process design.