SBS - The best value in QMS software

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

J
#1
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
 
Elsmar Forum Sponsor
S

SSwanson

#2
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.
 
J
#3
Thanks SSwanson, :thanx:
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. :confused:

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


Jaco
 

Wes Bucey

Quite Involved in Discussions
#4
Jaco said:
Thanks SSwanson, :thanx:
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. :confused:

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


Jaco
:topic: 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.
 
S

sal881vw

#6
Hello Jaco,
I agree with what SSwanson has told you already :agree1: , 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
http://isotc176sc2.elysium-ltd.net/1.2Application.doc

I hope to have been of help
 

Attachments

Last edited:
J
#7
Thanks for all of your reply

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

sal881vw said:
: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! :applause:


Wes Bucey said:
:

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

Quite Involved in Discussions
#8
Jaco said:
Hi all, :thanx:
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! :applause:



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.
 
Thread starter Similar threads Forum Replies Date
A What To Clauses Exclude - AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
qualprod ISO 9001:2015 Clause 8.3 - Is it possible to exclude one product but include it in other? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
a_bardi Is it possible to exclude internal audit from qms scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Not Design Responsible - Can we exclude all or parts of AS9100 clause 8.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
D Can we exclude purchasing and supplier evaluation - ISO9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
I Can we exclude 7.3 Clause of TS 16949 Design and Development of Products and Processes 5
S Can we exclude our subsidiary company from our ISO 9001 certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
S PFMEA Assumption to Exclude Latent Failures FMEA and Control Plans 6
Q Can we exclude design if we do not physically design our product? 7.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Developing Technology and Equipment to Manufacture Clients Product - Can exclude 7.3? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Fender1 Management Wants to Exclude a Customer Product Line from Registration Scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
N To Exclude Or Not - ISO 13485 7.5.3.2.2 and 8.2.4.2 - Plastic Pellets ISO 13485:2016 - Medical Device Quality Management Systems 11
E Is it Possible to Exclude Top Management (CEO, Chairman) in the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A ISO 9001 Clause 7.5.5 Preservation of Product - Apply or exclude? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
H Planning of Product Realization - AS9100 Clause 7.1 - Can we exclude 7.1f? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Design Review: Can I exclude Custom Products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Can this Contract Manufacturer exclude Clause 7.3? Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Can we neglect (exclude) the ISO 9001 Calibration clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Can I exclude Customer Property? ISO 9001 Clause 7.5.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
G Can a testing laboratory exclude section 7.3 of ISO 9001? Quality Management System (QMS) Manuals 2
P Which aspects of section 7 can I justifiably exclude? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Can I exclude 7.5.1 & 7.5.2 (Control of Production & Validation) from our QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J Can I exclude Service even though we do some service? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
N Scope of Certification - Can we exclude Distribution? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Z Can we Exclude the Validation of Process Clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Contract Review Question - China manufacturing site to exclude 7.2.2? Contract Review Process 6
L Can you exclude ISO 9001 Clause 7.3 completely from QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Audit Nonconformance - NCR because we exclude Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Can we Exclude Design and Development clause in ?Industrial Design? Company? Design and Development of Products and Processes 12
J New TL 9000 Released - Can Exclude more than Clause 7 Various Other Specifications, Standards, and related Requirements 0
Casana Auditor changing ISO 9001 AUDIT scope midstream - Cannot exclude all of 7.3 anymore General Auditing Discussions 26
I AS9100 - Would like to know if I can exclude the design Design and Development of Products and Processes 6
Q In ISO 9001:2000 Can We Exclude Some Customers and Products from our registration? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
D Design of Services - Can a Heat Treating service exclude parts of 7.3? Design and Development of Products and Processes 7
C Service - Must we exclude in the Scope? Service Industry Specific Topics 5
B My company makes product to order - Are we design responsible? Exclude 7.3? Design and Development of Products and Processes 17
C ISO9000 and CWF (Certified Welding Fabricator) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L Innovation in Quality as applied to ISO9000 ISO14000 or TS16949 Service Industry Specific Topics 1
L Vertical vs Horizontal Integration ISO9000 QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Explain to me the differences between ISO9000 and TQM ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M ISO9000.3:2004 vs. AS9100 - What are the Differences? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
ScottK Which ISO9000 Registrar would you pick? (Hypothetical Situation) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Certification of a Group Corporation - ISO9000/14000 vs. SONY GP certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
B The new Terms and Definitions in ISO9000:2005 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Randy ISO9000:2005 vs. ISO9000:2000 - Differences and Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
E Franchise of ISO9000 certified organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
M ISO9000 presentation help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M ISO9000 Training Presentation - Seeking introductory presentation on ISO9000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A How much objective evidence is required for ISO9000 certification? Records and Data - Quality, Legal and Other Evidence 8
N Signature for CAD / Engineering Drawings and ISO9000 requirements Quality Assurance and Compliance Software Tools and Solutions 3

Similar threads

Top Bottom