Hi All,
This is my first posting so please bear with me :)

We have our TS re-registration coming up in early 2008 and are considering excluding design responsibility in our scope. I have been asked what the definition of "Design Responsibility" is to see if in fact we are responsible, by definition (ie. ISO definition). We offer full R&D and CAE capability if our customers need assistance, our customers always perform final validation.

Can anyone help me with an official definition? I have looked on IATF/IAOB websites and was unable to find a definition.

Thanks!

If you can be more specific about what your company actually does, it would be easier for Cove members to evaluate. Providing an all-encompassing definition is difficult, since there are many nuances involved in some situations. For example, it's not unusual for customer to do final validation even if you do the design, since they may have the final product into which what you produce goes/works ... in effect, the customer has the environment required for validation.

Another easy way is simply ask your registrar.

I have always used the simple criterion of 'Do you have the (direct) authority to change a product design?'

If not, you're not design responsible, even if you have CAE and R & D capabilities.

Thanks for the responses. We make iron castings (manifolds, turbo housings etc..). For 98% of our work we get handed a conceptual or fully defined design (CAD) and we may alter it slightly for our manufacturing process. There have been a few cases (1-2) where we have been contracted as design responsible. So, we could go for years without a design responsible contract and simply make what we are provided. When we propose changes to the product design (to fit our manufacturing process, or best practices) they are always approved by the customer first, so I don't even think we have direct authority, changes are proposed and accepted/declined by the customer.

Our organization is thinking there is no benefit to having design responsibility in the scope of our registration as it adds cost (audit days) and opens up more 'shalls' that we need to comply with.

I have talked to our registrar and they pointed me to IATF/IAOB, which turned out nothing so far. I was hoping to find something in the sanctioned interpretations or FAQ's that I can take back to our management for some decision making.

Thanks again

Check out the Guidance document called ISO 9001:2000 Sub-clause 1.2 'Application' at the following website. This document may or may not help.

http://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/755901/1069636/customview.html?func=ll&objId=1069636&objAction=browse&sort=name

And check out RFI (Request for Interpretation) #49 at this website...


http://www.tc176.org/Interpre.asp

I asked SMMT Do the interpretations of ISO/TC 176 as published here http://www.tc176.org/Interpre.asp apply to audits according to ISO/TS 16949:2002 ?

Thanking you in advance



The answer regarding ISO/TC 176 is No.

Thanks for the responses. We make iron castings (manifolds, turbo housings etc..). For 98% of our work we get handed a conceptual or fully defined design (CAD) and we may alter it slightly for our manufacturing process.

This is exactly the meaning of process design

What does your order say?
What are you paid for?
The definition should be there

Interpretations for ISO 9001 don't apply to TS? Do you mean from a conformity assessment stand point or from a general knowledge stand point?

I say they apply to both. It is my understanding that TS includes all of the text and intent of ISO 9001.

Also, if you will only accept those things that are officially approved by the IATF, then you might as well cancel this thread and send the IATF an e mail or call them or go to their website.

Don't ask us for reference material and ideas if you only want sactioned responses.


Regards,

Dirk

Hey Dirk,
Yes, for sure TS includes all of ISO 9001.

I think there is a mis-understanding here...I don't believe I stated anywhere I am only looking for sanctioned responses.:truce:

IATF/IAOB has a "Sanctioned Interpretations" area on their website, which is what I referenced earlier in my posting. This is where I was "hoping" to find some answers, but to no avail.

I am looking for help from the users of this forum and have received some excellent responses and material so far.:applause:

As far as I am concerned this posting will not be canceled as there is lots of good information coming out.

:thanx:

I overlooked the fact you are TS registered. You cannot exclude 7.3 since it is applied to process design as well as product design.

I have always used the simple criterion of 'Do you have the (direct) authority to change a product design?'

If not, you're not design responsible, even if you have CAE and R & D capabilities.


That is correct, but remember, the exclusion requires a justification. And usually, the only justification is that the customer does the product design. That would leave the organization responsible for only process design.

Our organization is thinking there is no benefit to having design responsibility in the scope of our registration as it adds cost (audit days) and opens up more 'shalls' that we need to comply with.It is not a matter of deciding whether you could simply remove the design aspect from your scope of certification. For TS, you either have product-design responsibility or you don't. It is an attribute. If you have design responsibility for the automotive products, then design must be a part of your QMS and the system audited against 7.3.

Now, if you are unsure if the automotive products you manufacture are done under your design or the customer's design, in other words, if there is uncertainty of whom is designing the product, there is a fundamental flaw in the business relationship. And, in the unlikely event of a product failure, leading to injuries or worse, and the ensuing legal actions, that uncertainty would be a mine field for your defense lawyers.

Hi All,
This is my first posting so please bear with me :)

We have our TS re-registration coming up in early 2008 and are considering excluding design responsibility in our scope. I have been asked what the definition of "Design Responsibility" is to see if in fact we are responsible, by definition (ie. ISO definition). We offer full R&D and CAE capability if our customers need assistance, our customers always perform final validation.

Can anyone help me with an official definition? I have looked on IATF/IAOB websites and was unable to find a definition.

Thanks!

No definition but you are NOT design responsible.

I have talked to our registrar and they pointed me to IATF/IAOB, which turned out nothing so far.

Hello CE2JD2,

You may want to take this issue up with your Registar/CB. They should be able to verify whether you are design responsible or not. Referring you to IATF/IAOB seems like an easy way out for them....

Based on what you described, you are not design responsible. Having said this, why was this issue not addressed during your initial certification audit?

Stijloor.

Hi All,
This question has had great responses and I appreciate everyone helping. Here is what I have learned since the original post:

What can be excluded if we are not Design Responsible:
- Anything related to “product design” can be excluded. Anything related to “process design” cannot be excluded (as Duke mentioned).
- therefore, 7.3.2.1 and 7.3.3.1 are the only two clauses that can be excluded.
- so as you can see most of 7.3 still applies, as "Manufacturing Process Design and Development"
- even if an organization is registered with 7.3 as an exclusion, then you get one contract as Design Responsible, the organization needs to re-register with all of 7.3 included asap.

Design Responsible Clarification:
There are only 2 options regarding “design responsible”.
(1) The client or supplier is responsible to design and manufacture the widget for a customer.
(2) The customer retains responsibility for the design and only contracts the supplier to manufacture the widget.

So, currently we do have one contract as design responsible, with one customer, so by default that means the scope of our registration needs to include all of 7.3. In other words 99% of our business is awarded as customer is DR, 1% is we are DR.

As Sidney mentions this is a go/no-go (or attribute) decision; and...we are DR. I have since talked with our registrar and they have helped clear all of this up for us too.

Initially, we had lots of DR work with our customers/OEM's and included 7.3 in our scope (before my time in this role) but since 2004 our business has changed drastically as has the entire North American automotive market. We were thinking there would be an advantage to exclude 7.3 "Product Design and Development" but now, based on all of this information, it seems like too much of a hassle to exclude being you only need one job as DR and you need to re-register again....a waste of everyone's time and money.

Thanks again all, I appreciate your great feedback.:applause:

Dave:agree1:

...What can be excluded if we are not Design Responsible:
- Anything related to “product design” can be excluded. Anything related to “process design” cannot be excluded (as Duke mentioned).
- therefore, 7.3.2.1 and 7.3.3.1 are the only two clauses that can be excluded.
- so as you can see most of 7.3 still applies, as "Manufacturing Process Design and Development"



You have done a very good job of summarizing, better than some of the posters who tried to help.

I did want to clarify one point -

therefore, 7.3.2.1 and 7.3.3.1 are the only two clauses that can be excluded.

In ISO 9001, the process and product design are so interwoven throughout 7.3, we generally don't attempt to exclude clauses. In your case, you were trying to exclude the process "Product Design." So, you wouldn't have excluded those two subclauses, you would have excluded product design form the whole clause 7.3.

But, if you have "some" Product design responsibility, then you have all of 7.3. But, you will only apply the product design requirements in those limited circumstances where you are doing product design.

Good Morning Helmut,

I think this still needs to be worked out with our 3rd party as to how we are going to handle (identify etc...). They have suggested what you mention but I am still not 100% clear on how we are going to segregate the DR vs. NDR programs, and further, how we are going to audit internally.

I will follow up in a few weeks once I have more information again.

Thanks for all of your help,
Dave