Design & Development - Exclusion of Clause 7.3.6 - Design and Development Validation

K

khetar

#1
Dear Friends,

I would like to have your views on exclusion of Clause 7.3.6 - Design and Development Validation of ISO 9001:2000 from our system. We are a consultancy organisation and our product is basically engineering designs, e.g. design of bridges, highways and drainage etc. Validation of design, if my interpretation is right is the process of checking that the physical product meets client's needs / intended use. We do not physically construct the product. Our designs are generally converted into physical products by contractors supervised by some other consultancy firm. Keeping this as the background, kindly give your views if we can exclude Clause 7.3.6 from our system under the provision of Clause 1.2 - Application.

Best regards,

Khetar
 
Elsmar Forum Sponsor
#2
Hello khetar, and welcome to the Cove :bigwave:

Considering the fact that your product is more or less what is described under 7.3.3 (Design and development outputs),one could consider 7.3.6 to be your customers concern. However, you are in fact acting as the customers design dep.

ISO 9004:2000, clause 7.3.3 expands a bit on validation of design output:

Validation of the output of the design and development processes is important for the successful reception and use by customers, suppliers, people in the organization and other interested parties.

Participation by the affected parties permits the actual users to evaluate the output by such means as

validation of engineering designs prior to construction, installation or application,

validation of software outputs prior to installation or use, and

validation of services prior to widespread introduction.

Partial validation of the design and development outputs may be necessary to provide confidence in their future application.

The distribution of responsibility must be the key here, and that is something you and your customer will have to agree on. You will have to look at ISO9001:2000, clause 7.2.

You may have a case for excluding 7.3.6, but that depends...

/Claes
 
#3
Good answer, Claes. While reading your post it occured to me that, if you really want to improve your product not just get a cert., you would take advantage of 7.3.6 and say something like:
"Whenever possible[i.e. when we can get the customer to agree], XYZ company includes a requirement for the customer to supply XYZ with their design validation data, as agreed in the contract." Etc., etc. The point being that this data would be very valuable to your design group when improving future product.
 
M

mirwan

#4
Re: Design & Development - Exclusion of Clause 7.3.6 - Design and Development Validat

Hello all,

I would like an opinion regarding the exclusion of Clause 7.3 Design and Development. Our company Subsidiaries plan to get ISO certification by end of this year. Their nature of business is property & house developer. My question is :

1) it's ok if we exclude this clause?
 

somashekar

Staff member
Super Moderator
#5
Re: Design & Development - Exclusion of Clause 7.3.6 - Design and Development Validat

Dear Friends,

I would like to have your views on exclusion of Clause 7.3.6 - Design and Development Validation of ISO 9001:2000 from our system. We are a consultancy organisation and our product is basically engineering designs, e.g. design of bridges, highways and drainage etc. Validation of design, if my interpretation is right is the process of checking that the physical product meets client's needs / intended use. We do not physically construct the product. Our designs are generally converted into physical products by contractors supervised by some other consultancy firm. Keeping this as the background, kindly give your views if we can exclude Clause 7.3.6 from our system under the provision of Clause 1.2 - Application.

Best regards,

Khetar
Hello dear Khetar.
Have you seen this line in the 7.3.6 of the ISO9001 .. ?
Wherever practicable, validation shall be completed prior to the delivery or
implementation of the product
.
Is it practicable to validate your design.
Well yes, if the contractor has an order to build several bridges of the same design. But unfortunately this does not happen like making cars to a design. So you validate post to the delivery or implementation of the product.
Your design validation begins to happens as the product is being put in place and is being used. You put a process in place to gather information and data from this and process it, such that you can provide any annex to your design back to customer for onward implementation., and your next design inputs will be more mature with learnings from the previous. The standard here has put in words which cannot justify your exclusion. So that is it. You do not exclude.
 
Last edited:
M

Moun10 gal

#6
Re: Design & Development - Exclusion of Clause 7.3.6 - Design and Development Validat

Hello,

My company is trying to get API Spec1/TS 29001 & ISO 9001 as dual registration from API and I am struggling a bit here with inclusion of D&D.

Can somebody who had gone through API Certification for the above standards help me out here with info pertaining to Design & Development. We are an industrial engineering company that does, machining & repairs of Engineering products and at times, manufacture according to customer spec.

The thing here is, it was excluded from ISO 9001 which we are certified already but with API it soemhow signals that we have to include 7.3.

Also, would like to understand the difference between designing a product and designing a process in API language.

Unfortunately for me, I have to resubmit the quality manual by today (20/07/2011) so desperately need help.

Waiting in anticipation...

Moun10 gal
 

harry

Super Moderator
#7
Re: Design & Development - Exclusion of Clause 7.3.6 - Design and Development Validat

Dear Friends,

I would like to have your views on exclusion of Clause 7.3.6 - Design and Development Validation of ISO 9001:2000 from our system. We are a consultancy organisation and our product is basically engineering designs, e.g. design of bridges, highways and drainage etc. Validation of design, if my interpretation is right is the process of checking that the physical product meets client's needs / intended use. We do not physically construct the product. Our designs are generally converted into physical products by contractors supervised by some other consultancy firm. Keeping this as the background, kindly give your views if we can exclude Clause 7.3.6 from our system under the provision of Clause 1.2 - Application.

Best regards,

Khetar
I know this is an old thread but there are issues to clarify.

A structure such as a bridge will normally be designed to a certain standard such as BS 5400. The design standard consist of requirements and 'Codes of Practice'. Codes of practice are practically good design and construction practices that had evolved over time. Thus, a structure designed strictly to particular standards/codes does not need validation - rather it is not practical to validate such massive structures and hence the 'codes'.

How do you know? Once a registered professional engineer certify so! Can one exclude validation? No. Often, there may be something out of normal such as slenderness dues to requirements or topography. In which case, validation such a wind tunnel test, mathematical and computer finite analysis, simulations, etc, etc may be carried out - these are methods to validate the design. At other times, the engineer may not have the resources and he can engage an 'expert' to certify the design - again another form of validation.
 
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