7.3.2.1 Product Design Input
7.3.3.1 Product Design Output

Are these points from Design Responsibility exclusively?

This is because other ones (7.3.1, 7.3.1.1, 7.3.2, 7.3.2.2, 7.3.2.3, 7.3.3, 7.3.3.2, 7.3.4, 7.3.4.1, 7.3.5, 7.3.6, 7.3.6.1, 7.3.6.2, 7.3.6.3 & 7.3.7) have part of Design and Development Process of the Product.
If some company hasn’t a Design Responsibility but they need to introduce new products according ISO/TS 16949:2K terms on 7.3 “Design and Development” Element.
Will they need to comply with (7.3.1, 7.3.1.1, 7.3.2, 7.3.2.2, 7.3.2.3, 7.3.3, 7.3.3.2, 7.3.4, 7.3.4.1, 7.3.5, 7.3.6, 7.3.6.1, 7.3.6.2, 7.3.6.3 & 7.3.7) points only without 7.3.2.1 & 7.3.3.1 points without any non-conformance about it?
Or Which points from 7.3.1 “Design And Development” are necessary to comply If some company doesn’t have Design Responsibility?

I hope you can understand the situation.

Thanks in advance for your help.


Smile is good for your health!

:bigwave: :bigwave:

Taking advatnage of this new threat, I´ve another question I hope you can help me to fully understand.

We don´t design a thing not even the manufacturing process, so do I still have to deal with other points regarding design such as competence 6.2.2.1?

Thanks in advance:bigwave:

Tattva,

It is hard to digest for me that You don't design(Moderate & Regulate) the manufacturing processes or the elements of it.

May I know what is your product and How do you make it?

Manoj Mathur

Internet,
This is a difficult element to take exceptions since it applies to both the "Design and Development" of the product. At what point do you separate the design from the development? You may not be designing a product, but you may be developing a product. What is meant by development? Only you can determine that point.
IMO all of 7.3 requirenments would apply, except those explicitly related to the design of the product,i.e., design review.

Tattva,
7.3 Design and development applies to "products" and "processes". You may not design a process, but you may develop one.
As stated above, IMO all of 7.3 would apply, except those explicitly related to the deisgn of the product.

Thank You all VERY MUCH!

I was talking to quality manager yesterday, and told me we can not make aside point 7.3, ´cause we do develop de manufacturing process.

We pour polyurethane, and what I meant by " not designing a thing " is that all technology and equipment is designed by coorporate engineering. But as you say, developing the process is another thing,we do that.
:biglaugh:

I have been pondering this problem and after some resarch including the thread at

http://Elsmar.com/Forums/showthread.php?s=&threadid=4602
I have to agree with Sam:
From ISO 9000:2000

3.4.4
design and development
set of processes (3.4.1) that transforms requirements (3.1.2) into specified characteristics (3.5.1) or into the
specification (3.7.3) of a product (3.4.2), process (3.4.1) or system (3.2.1)
NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define different
stages of the overall design and development process.
NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product design and
development or process design and development).




3.4.1
process

set of interrelated or interacting activities which transforms inputs into outputs
NOTE 1 Inputs to a process are generally outputs of other processes.
NOTE 2 Processes in an organization (3.3.1) are generally planned and carried out under controlled conditions to add value.
NOTE 3 A process where the conformity (3.6.1) of the resulting product (3.4.2) cannot be readily or economically verified is
frequently referred to as a “special process”.


3.4.2
product
result of a process (3.4.1)
NOTE 1 There are four generic product categories, as follows:

— services (e.g. transport);
— software (e.g. computer program, dictionary);
— hardware (e.g. engine mechanical part);
— processed materials (e.g. lubricant).



7.3.1 must be in.

We are an electronics remanufacturing company. We did not develop or design the product that we remanufacture. We obtained a waiver from our customer stating that we did not have to comply to this requirement of the standard of QS9000. I am hoping to do the same for 16949 since we do not design the product or the MANUFACTURING process.

Mike, I would imagine that you do design/develop the remanufacturing processes. I believe you would need to include these design and development of these processes to meet 16949 requirements. From TS 16949 1.2:The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.
Permitted exclusions do not include manufacturing process design.

This brings up a good point. It also states in 1.2 "Where any requirement of this international standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion". Later in 1.2 it states "the only permitted exclusions for this TS relate to 7.3 where the organization is not responsible for product design and development". Does this contradict itself? First it states any requirement and then only requirement. Anyone?

Mike S.
This is not a contradiction.
"Considered for exclusion" means you can ask for a waiver.
"Permitted exclusions", IATF permitted, means you do not have to ask for a waiver, only that you provide evidence to your CB that you do not design or develop product.

as far as i am aware all design activities where you have an input or output are applicable to you. also note that as you have to design processes you have to include design in your scope. thats what i have been told by assessors anyway

Originally posted by Mike Smith
This brings up a good point. It also states in 1.2 "Where any requirement of this international standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion". Later in 1.2 it states "the only permitted exclusions for this TS relate to 7.3 where the organization is not responsible for product design and development". Does this contradict itself? First it states any requirement and then only requirement. Anyone?
The first part you quoted is taken from the ISO 9001 part of TS. The IATF chose to not allow all of the exclusions permitted for organizations certified only to ISO 9001. There are other cases of this "contradiction" elsewhere in TS 16949, such as 7.5.2 where ALL processes must be validated, not just special processes. The title of TS is "Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations." Basically what it boils down to is this: if you want to get the automotive certification, you've got to live with their more restrictive (and greatly expanded) rules.

We just pass the certificate audit last week. Thank you very much for very good comment and resources from everyone.
I do have to provide corrective action for 3 NC anyway.
Need help from anyone about
1. How can we set the target of manufacturing process desing cost? Need some example or calculation method. We establish for target cost of product, but not process. So, this is one of NC.

2. When we implement ECN one item, we got the new drawing from the customer, but we don't completely change within two business weeks due to design change activity need more time to do the pre-launch and testing. We try to explain about but we got NC. Can anyone suggest how to due with this?

3. We had the customer approved on drawing after we start make tooling. This is the way we implement for a long time becuase some time customer approve only verbally. For this NC, how to due with the real world business and satisfy the requirement (or auditor)? What is the bottom line for auditor?

The 2nd and 3rd may not likely relate to design.

Thank you in advance for any comment.

QSMSO

qsmso,

Trying to figure out where the auditor came from, not is coming from. You received an NC for not having a method for determining a manufacturing design cost target? I ask, "What business is that of his?" As you often see here, "Where is the shall ?" Maybe I'm spouting off but it's a start for this discussion.

You received a NC because it takes 2 weeks for changes to be implemented paperworkwise? Well, how long would the auditor like? 2 hours? Again, the standard says you will develop the methods to control changes.

The third NC I may not understand, (Okay-the other two, too). You have a Customer's signature on a drawing. Some customers only give verbal approvals. So there may be changes to a drawing that a Customer gave a verbal approval of with the original signature on the drawing. maybe they are red-lined or marked up. But, if this is the only Customer that receives this component from you and you have an agreement with the Customer to operate this way....I would tell the Auditor to go back to the hole he/she crawled out of. If I didn't get the whole picture or misread your post, I apologize to that low hanging fruit filled auditor. ;) Just getting the discussion started. :vfunny:

These were my immediate thoughts exactly, energy - although I have not worked in the automotive industry for quite a while. I am looking forward to the responses from the covers who work with the TS standard regularly.

Hi qsmso - Does it state anywhere in your own procedures or other documentation that "ECN's are processed with in two weeks" or that you "can't proceed without written customer approval"? And - what clauses of the standard did the auditor cite in each of the minors? "What is the Shall?" :p

I certainly agree with what Energy has already said (I think) but let's not forget the old "obvious" kicker on this.

If YOUR PROCEDURES state you are going to do something one way and you do it differently, you have a NC. I would be looking at the internal procedures on items 1 and 3. Do they state how this will be handled?

NC #2 looks to me like a "timeliness" issue. I think I would look twice at "more than 2 weeks" myself.

Dave

We just pass the certificate audit last week. Thank you very much for very good comment and resources from everyone.
I do have to provide corrective action for 3 NC anyway.
Need help from anyone about
1. How can we set the target of manufacturing process desing cost? Need some example or calculation method. We establish for target cost of product, but not process. So, this is one of NC.

2. When we implement ECN one item, we got the new drawing from the customer, but we don't completely change within two business weeks due to design change activity need more time to do the pre-launch and testing. We try to explain about but we got NC. Can anyone suggest how to due with this?

3. We had the customer approved on drawing after we start make tooling. This is the way we implement for a long time becuase some time customer approve only verbally. For this NC, how to due with the real world business and satisfy the requirement (or auditor)? What is the bottom line for auditor?

The 2nd and 3rd may not likely relate to design.

Thank you in advance for any comment.

QSMSO

Not knowing the clause which is cited in your NC, I will just take a guess.

#1 - 7.3.4.1 - Monitoring; Normally this information is determined at the time you conduct the "Run@Rate". However, if you ate designing a new process then you would hve additional items such new equipment, additional manpower, etc.

#2 - 4.2.3.1 - Engineering Specifications, Read the clause carefully. . . .shall have a PROCESS for the timely review, distribution, and implementation . . .,
Timely review should be ASAP . . not to exceed two working weeks.

The "Timely review" should be completed in two weeks. Distribution and implementation will be determined during the review.

#3 - Not a clue. Its been my experience that customers do not approve drawings until sometime immediatly before PPAP submission. I would be curious as to what TS2 clause your auditor is citing.

NC #2 We just had this discussion with our auditor during our pre-assessment. 4.2.3.1 Engineering Specifications-shall have a process to assure timely review, distribution and implementation of engineering standards and changes based on customer required schedule. Timely review of the changes shall not exceed two working weeks. No where does it say that the changes shall be implemented in two weeks, only reviewed. The implementation of the change should be based on the customer required schedule.

NC #1 During our APQP process, which is used for process design, part of this is planning for any new equipment, additional labor and any other costs associated with the design of the new process. We do not measure it. I believe the standard states that you monitor and measure at specified stages of process design. It is up to you what you monitor and measure. We measure timeliness of the implementation. Are we meeting our dates for each step of the process design implementation.

Dear all,
Thank you for your comment.
To clarify the NC, here we are:
The 1st NC: against 7.3.2.2 "target for productivity, process capability and cost"
We did for productivity target and process cap as specify by the customer, but for process design and development cost, we don't.
The 2nd NC: against 4.3.2.1; auditor try to convince that ECN chage lead time not being established.
The 3rd NC: against 7.3.7 :Control of D&D change" In details we have desgin change for dimension. We has responsible to issue Drawing for customer approval. Customer use long time to review and sign for approval as usual. However, we try to show the PSW with cusotmer signature. But it's still the problem. In my opinion, I agree with the auditor, but I'd like to know how to due with this situation in case we lack evidence from customer.

Thank you,
QSMSO