Scope of Registration ? Design Responsible ? Outsource Design???

[jhaz420]

Scope of Registration – Design Responsible – Outsource Design???

Here is our situation…our parent company is in Japan, until last year we were both TS certified but Japan was Design Responsible as the design originated from there. Due to cost savings and other issues Design responsibility was moved to the US and Japan facility was dropped from our scope. Last year, we were re-certified with new scope and no mention of Japan. However we still utilize them as approved supplier and as outside lab/testing facility amongst others…after all they are our parent company.

Now we just got a new project approval from GM, this product line is not listed on our scope of registration. All the design was strictly done in Japan; we don’t have design standards or DFMEA for this product. The question is do we have to get recertified again to add the new product line to the scope…which would be very painful… or can Japan be utilized as an outsource design facility? What does TS say about outsourcing your designs? In the future there will be a lot more projects where Japan works with Japanese automotive companies and we try to sell the product to Ford and GM. We cannot keep adding the products to our scope as we don’t have the resources to design those products here. What options do we have?

Thanks in advance for all your help.

 

[DrM2u]

Re: Scope of Registration – Design Responsible – Outsource Design???

I am not sure if the interpretations have changed since the last time I read them, but here is what I remember: an organization is considered design-responsible if it has anything to do with the design process. This means that if you provide the littlest input to the design process (i.e. DFM, DFA, component standardization, a chamfer instead of a radius, etc) you are considered responsible for your inputs. If you outsource the design process you are also responsible because the design was originaly delegated to you by the customer. In your case, the only way around clause 7.3 is if GM contracted directly with Japan to do the design then GM gave you the finished designs to manufacture.

Regarding the scope, it will have to change to include Design if applicable. I suggest contacting the registrar about how to address the scope change. I am not sure if they will verify the new scope at the next audit, conduct a partial audit immediately just to verify the scope, or conduct an immediate full audit.

Someone else please verify my statement. Thanks!

 

[Big Jim]

Re: Scope of Registration – Design Responsible – Outsource Design???

I don't know if TS 16949 has anything additional to say about outsourcing design since I'm not overly familiar with the automotive standard.

I do know for ISO 9001 (which TS 16949 is based) forbids excluding things that you outsource.

Here is a link to TC 176, the committee within ISO that wrote ISO 9001.

http://isotc.iso.org/livelink/livelink/open/tc176SC2public#_4.__Interpretations

Look for "Guidance on ISO 9001 Sub-clause 1.2 Application". Example 4 in the appendix should help.

While you are there, you may also find "Guidance on Outsources Processes" useful too.