Design of Services - Can a Heat Treating service exclude parts of 7.3?

[dbzman]

This has been discussed before but I wanted to address it one more time.

ISO9001:2000 allows exclusions for section in 7.0.

Can a Heat Treating service that provides Heat Treating to a customer exclude the following:

(A). 7.3.1 - Design and Devlopment Planning
(B). 7.3.1.1 - Multidisiplinary approach
(C). 7.3.2 - Design and development inputs
(D). 7.3.2.1 - Product design inputs
(E). 7.3.3 - Design and development outputs
(F). 7.3.3.1 - Product design outputs
(G). 7.3.4 - Design and development review
(H). 7.3.4.1 - Monitoring
(I). 7.3.5 - Design and development verification
(J). 7.3.6 - Design and development validation
(K). 7.3.6.1 - Design and development validation supplemental
(L). 7.3.6.2 - Prototype programme
(M). 7.3.7 - Control of design and development changes

Our corporate headquaters determined since we provide a service and do not sell a product then we can exclude these.

I disagree. Since the standard mentions that "wherever the term 'product occurs, it can mean 'service'", then there reasoning does not hold up.

What do you think?

dazed and Confused......

 

[Al Dyer]

Maybe lack of common sense on their part, does the process affect product quality???

If so______________________

Al...

 

[dbzman]

Heat Treating Process

Yes, the heat treating process is very improtant to the customer. If we did not heat treat the customers parts to their spec then the parts would not be of any use to them.

The heat treating process that we do for them (we sell our service to them) makes their product functional.

The customer sends the parts to us, we heat treat them, and send them back. We may not always know what the final product will be (usually we do) but if we do not meet the spec then the parts are useless to them.

 

[Claes Gefvenberg]

Our corporate headquaters determined since we provide a service and do not sell a product then we can exclude these.

I disagree. Since the standard mentions that "wherever the term 'product occurs, it can mean 'service'", then there reasoning does not hold up.

What do you think?

I agree with your interpretation. Just one question: Is this really ISO9001:2000 we're talking about? (B, D, F, H, K & L from your list)

/Claes

 

[dbzman]

Correct

You are right. I took the numbers from Corporate who are TS. The facility that it will be applied to will only be ISO and the TS additions will not be addressed.

Sorry for the confusion.....

 

[Tom W]

As a heat treat company that is TS2 certified I can tell you that we also had these concerns. We have spent many hours / days trying to get this answer. Through our audit we "learned" that most of those you listed (which we had tried to address) were not needed (according to our registrar). It obviously may not be correct. We addressed the following:

7.3.2.2 Manufacturing Process Design Input
7.3.2.3 Special Characteristics
7.3.3.2 Manufacturing Process Design Outputs
7.3.4 - Design and development review (as it applies to process design)
7.3.4.1 - Monitoring (again as it applies to the process design)
7.3.5 - Design and development verification (per NOTE 2)
7.3.6 - Design and development validation (per NOTE 2)
7.3.6.1 - Design and development validation supplemental
7.3.6.2 - Prototype programme
7.3.7 - Control of design and development changes

We ensured that we tailored these sections to process design and our responsibilities for that.

This is what we "streamlined" it down to. Right / wrong it is what we have and we got TS. One of the hard parts is the auditors do not even know what should apply and what should not apply. They all seem to have different opinions. We decided to determine what we could and should do to satisfy the customer and what would be value-added to our business.

We discuss this also in our APQP section:
7.3.1.1 - Multidisciplinary approach

Like I said, this is only what we did. However we are constantly looking at it and seeing if there is any benefit for us to revisit these requirements (7.3) and determine if we need further implementation.

 

[Ingeniero1]

IMHO, if the customer specifies the material preparation, heat rise time, hold temperature and time, cooling period, furnace atmoshere, quenching media, and all other parameters involved with heat treating, then you probably can be excluded.

However, if the customer simply specifies that a part be heat-treated to 58/60 RC, for example, and perhaps a couple of other parameters, but you still have to 'design/develop' the process, then I don't believe you can be excluded.

Again, IMO, what you are selling (your product) is the heat-treating process, and in most cases it will be 'per your specifications' to achieve certain characteristics.

Alex

 

[Wes Bucey]

IMHO, if the customer specifies the material preparation, heat rise time, hold temperature and time, cooling period, furnace atmoshere, quenching media, and all other parameters involved with heat treating, then you probably can be excluded.

However, if the customer simply specifies that a part be heat-treated to 58/60 RC, for example, and perhaps a couple of other parameters, but you still have to 'design/develop' the process, then I don't believe you can be excluded.

Again, IMO, what you are selling (your product) is the heat-treating process, and in most cases it will be 'per your specifications' to achieve certain characteristics.

Alex

I think my answer to Jaco in another thread https://elsmar.com/elsmarqualityforum/showpost.php?p=80824&postcount=8
also covers this operation and that you are NOT design responsible.
The key point being that the customer specifies the hardness he wants for the material, regardless whether he goes into specifics of autensite and martensite characteristics. Your operation seems to fall exactly into 7.2.1 (especially 7.2.1 b):
7.2.1 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organization.