Can We Exclude ISO9000:2000 Clause 7.3.7 (Control Of Design And Development Changes)?

[Jaco]

Hi all,
I do not know if this topic has been discussed before, so pls feel free to move/cancel it if it was an old topic for you. The company I am working for is manufacture plant, and our design function performed by design center that located oversea. And we make a exclusion for whole Clause 7.3 of 9k2k in our manual, but the CB said we can not make the clause 7.3.7 out of our QMS, because "the control of design change" MUST be considered and involved in our QMS. On the other hand, there is the ECN system existing our current QMS.

But i always consider the ECN system as a part of document control system. So what do you think about this subject?


Thanks in advance, if anyone could help me out here!

Jaco

 

[SSwanson]

First let me say that I don't know what you mean by ECM.

One point to remember is this... You may exclude 7.3 from your documentation, but your company is still responsible for the design process. That means, you have to document how the design process works for you even though you outsource design activities. So this isn't really an exception.

This leads to what your CB said about "control of design change". If your company provides input to the design or if you provide input to design modifications, your CB is telling you that you need to document this process. Even if your company only provides design specifications to the external designer, you have design. In this case, you must control the design requirements. Someone is responsible for that.

I would venture to say that you need to document the complete design process, start to finish if you are a manufacturing company. It doesn't matter that the actual design is outsourced. You don't have to write the design procedure for the outsourced company. You only explain how your company controls the design activity from your perspective.

Eventually, your company will review and accept the design once it comes back from being outsourced. If there is a problem, you will tell the designer about the modifications you want. You will review it again and again, until it is accepted. Then you will validate the design under practical application of the designed thingy.

It seems that many companies hate paragraph 7.3 because they don't understand the requirement nor have they identified an easy way to control design. IMHO all manufacturing companies probably have design activities that must be documented in their procedures/handbook.

The only exception would be a service company. Even then, should the service company decide to develop other services, it would benefit the service company to place project management of new services under a control such as design control.

I hope this helps.

 

[Jaco]

Thanks SSwanson,
your clear explanation is really helpful!
but I am still wondering if we could escape from this hot spot, because the only thing we can do for 7.3Design is document control. Maybe first, I should say sorry fro the incompleted description in previous thread.
First of all, we have no input to the design in our plant at all, and activities for design development are performed in our headquarters. That means in our company, everthing start with the formal print(completed by our headquarters design center). Any validation or verification for design are in charged by design center. And anything we can do is ensure correct drawing been used. And we do that through ECN, which is an abbreviation refer to Engineering Change Notice.
But that obviously just the work as same as document control.

After all, there are awful works ahead if i get the clause involved in.


Jaco

 

[Wes Bucey]

Thanks SSwanson,
your clear explanation is really helpful!
but I am still wondering if we could escape from this hot spot, because the only thing we can do for 7.3Design is document control. Maybe first, I should say sorry fro the incompleted description in previous thread.
First of all, we have no input to the design in our plant at all, and activities for design development are performed in our headquarters. That means in our company, everthing start with the formal print(completed by our headquarters design center). Any validation or verification for design are in charged by design center. And anything we can do is ensure correct drawing been used. And we do that through ECN, which is an abbreviation refer to Engineering Change Notice.
But that obviously just the work as same as document control.

After all, there are awful works ahead if i get the clause involved in.


Jaco

Revisions to documents which describe a product or process have a "flow" which goes in order from

1. change request (by anyone - customer, employee, government regulator, casual passerby, etc.)
2. person or department in charge of product or process
3. author (original or assigned for the purpose by person in charge)
4. approval process (may include many people/departments, including purchasing, manufacturing, finance, regulators, customers) [this is where Configuration Management begins if your organization practices it]
5. distribution process (includes storage of originals, recall of obsolete, retention schedule)
6. use (by applicable people, companies, etc.)

The point to consider is where your organization fits in this chain of events.
The mere form title of ECN (engineering change notice) means different things in different organizations. Some organizations call the entire process an ECN. Some organizations reserve the term strictly for the memo that goes out, saying, "we changed part # ______ , Revision 1, to Revision 2. Stop making parts until we give you new drawings."

If your organization is strictly "make to order" from prints and associated documents (instructions, bills of material, etc.), then you are not design responsible. If, however, you take a design and convert it into "shop drawings" - you "may" be considered "design responsible" in terms of the fact you design the process used to manufacture a product. It all depends upon how independent your site is from HQ.

 

[Manoj Mathur]

It appears You are not design Responsible hence exclude the clause.

Manoj Mathur

 

[sal881vw]

Hello Jaco,
I agree with what SSwanson has told you already , and I'm attaching some useful information ( see attachment and link ) with regards to the application of clause 7.3 Design and development., as I have passed through the same experience a while ago.

See example 3 of attachment............Changing regulatory requirements may necessitate changes to the product design. Since XYZ company is the owner of the product the responsibility for the design change rests with us and therefore clause 7.3 must not be completely excluded. This is because we have to adjust our products specifications in accordance with regulatory requirements .

Further reading ( attachment) Annex 3 Guidance 2 clearly defines our case if the organization is NOT PROVIDED with product characteristics necessary to plan its product realization processes and has to define those characteristics based on customer and/or regulatory body requirements, this is, by definition, PRODUCT DESIGN AND DEVELOPMENT. This process shall be addressed in the QMS, according to the requirements of clause 7.3 of ISO 9001-2000.

You can also find some additional useful information at the following site
https://isotc176sc2.elysium-ltd.net/1.2Application.doc

I hope to have been of help

 

[Jaco]

Thanks for all of your reply

Hi all,
pls accept my late appreciation for all of your kind help, since it is too busy yestoday to do so!

:I hope to have been of help
Attached Files ISO 9001-2000 clause application guidance.doc (152.0 KB, 14 views)

Hi sal881vw,
I found my case in your attached file(524R3), which described in Annex A example 2 on page five. Thank you!

:

If your organization is strictly "make to order" from prints and associated documents (instructions, bills of material, etc.), then you are not design responsible. If, however, you take a design and convert it into "shop drawings" - you "may" be considered "design responsible" in terms of the fact you design the process used to manufacture a product. It all depends upon how independent your site is from HQ.

Hi Bucey,
Do you think clause7.3 of iso9k should include process design/development? But we can not find any exact words say that in the standard, just like the description in TS16949. Maybe it is a potential requirement, right?

Jaco

 

[Wes Bucey]

Hi all,
pls accept my late appreciation for all of your kind help, since it is too busy yestoday to do so!


Hi sal881vw,
I found my case in your attached file(524R3), which described in Annex A example 2 on page five. Thank you!



Hi Bucey,
Do you think clause7.3 of iso9k should include process design/development? But we can not find any exact words say that in the standard, just like the description in TS16949. Maybe it is a potential requirement, right?

Jaco

Thanks for your confidence, Jaco. Everything you have described your site does for process design/development (including any processes to bring HQ customer's specs to realization [making the actual product]) all seems to be covered under ISO9k2k Section 7.1 and 7.2, which includes process design and development [what tooling you'll use and what machines you will use.]

Even if you have conversation with the customer [HQ]

• about your site's capability and capacity to make the product,
• to the point of discussing which machines and personnel you might use to produce the product,
• the instruments and methods you'll use to inspect the product before shipping it to them,

you still are not engaging in activities covered under 7.3.

Look especially at ("organization" refers to YOUR site; customer is HQ):
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.

So, if the product contains environmentally hazardous substances, your site is responsible for all labeling, and work cautions. If you have a health-related product, you are required to have your site pass muster with authorities, and yet all of that still does not make you design-responsible.