No Design - Which points from 7.3.1 'Design And Development' are necessary to comply

I

Internet-101

7.3.1 Design and Development

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:
 
T

tattva

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:
 

Manoj Mathur

Quite Involved in Discussions
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
 
S

Sam

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.
 
T

tattva

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:
 

Howard Atkins

Forum Administrator
Leader
Admin
I have been pondering this problem and after some resarch including the thread at

https://elsmar.com/elsmarqualityforum/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.
 
M

Mike Smith

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.
 

howste

Thaumaturge
Trusted Information Resource
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.
 
M

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?
 
S

Sam

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.
 
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