Design & Development Clause 7.3, Applicable or not, What is rule?

[AndyN]

Dear Sidney Vianna

Agreed ! but i want slight differnt view, actually design applicablity can be judge by understanding actual application onsite , that is why iso certification process of Two stages in the first stage ( pre audit) one has to check .

What is your opinion about foundry/ melter where organization changes material composition they mixup material and make the different application and Customer are not aware about chemistry then what?

what design applicability ?.

Mixing materials to get different characteristics/chemistry isn't 'design'! This is not new material or changed material. The customer may not be aware of the chemistry but they do order a grade or specification, (in even basic terms) and the blending of raw materials to achieve that grade isn't considered to be 'design' - sorry!

 

[vijaysonawane]

ISO 9001 clause 1.2

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.


Refer above , if chemical or chemistry changes in its effect the final products application or requirements and final products performance got effected then claim of exclusion not is acceptable and organization is responsible for design

Look at pharm /medical : where whole RD is on the base Formulation , in change in chemical composition by PPM whole performace of final medicine got changed

Sorry!!!! design is creativity / innovation can be done

 

[Sidney Vianna]

Refer above , if chemical or chemistry changes in its effect the final products application or requirements and final products performance got effected then claim of exclusion not is acceptable and organization is responsible for design

If a supplier changes the formulation/chemical composition/metallurgy of a product WITHOUT conferring with the customer, who has design authority, they should be penalized and subjected to criminal prosecution; not given design responsibility rights.

In some cultures, suppliers believe that they can adulterate products without customer formal consent. Not only that is unethical and possibly criminal, but exactly THE OPPOSITE of what ISO 9001 prescribes.

 

[AndyN]

ISO 9001 clause 1.2

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.


Refer above , if chemical or chemistry changes in its effect the final products application or requirements and final products performance got effected then claim of exclusion not is acceptable and organization is responsible for design

Look at pharm /medical : where whole RD is on the base Formulation , in change in chemical composition by PPM whole performace of final medicine got changed

Sorry!!!! design is creativity / innovation can be done

I'm well aware of what the standard says regarding exclusions! I'd appreciate you not doing that! Your premise is fundamentally incorrect. You're wrong to suggest that 'creativity/innovation can be done. Here in the USA consumers have seen the effects of producers in other countries who are 'creative' and 'innovative' in changing fundamental characteristics - often to save money - with disastrous effects. As Sidney says, it's illegal, immoral and just plain wrong!

Your suggestions won't work in the Western world and if we are in a global economy, you will have to revise your thoughts about this topic, since the precedents have already been set! No more arguements, please!

 

[Big Jim]

Mixing materials to get different characteristics/chemistry isn't 'design'! This is not new material or changed material. The customer may not be aware of the chemistry but they do order a grade or specification, (in even basic terms) and the blending of raw materials to achieve that grade isn't considered to be 'design' - sorry!

I think I see where you are coming from. Foundries check the composition of the melt before they pour. If the check shows that the material in the melt does not meet spec, they add ingredients as needed until it is in spec, checking as many times as needed. This activity would not be design as long as what they are doing is to make sure that they are meeting the customer requirement.

If, however, the foundry took it upon themselves to alter the formula just because they thought they could improve what the customer asked for, they have crossed the line in several ways. They may have moved into design. They have also viotlated their customer's trust to suppply what was specified.

 

[vijaysonawane]

Thanks for healty discussion,
I involved to puts my view as open forum , I have total respects of your views and defintley I got some insight about discussion.
But discussion is going to wards othe way,forum is not use to blame hence i drop my self ....



Thanks to all

 

[howste]

I've seen a copy of a registrar's confidential internal document (I've been asked to not disclose the name of the registrar) that has the exact interpretation that Big Jim has stated above. It states that if the organization gives input to customer design, even if they don't have the final authority, then they cannot exclude design from the scope of their system.

I don't believe that it's a correct interpretation. I think having design listed on such certificates would be misleading to customers of the organizations.

BTW, this is not a registrar that I audit for...

 

[ABUHASHIM]

please explain what you mean by partial design.

If you mean that the organization has some authority to change the design without customer approval, then they must include 7.3 in their scope. If they have no authority to change the design, even if they provide advice to their customer, then 7.3 should be excluded.

Howste,

your reply is convincing to me, but can I claim a case for Painting Manufacturing company with R&D department, which involve in inventing new types of products ( new colors, or new types of paints for different usage), at this case, they have authority to change in the contents without refering to customers, but, they should not exceed the Legal specifications.
how do you thing such case should be? I mean including 7.3 or NOT

 

[howste]

If you are designing different formulations of paint which are being sold as commercial off-the-shelf products, then I believe you must include 7.3.

 

[ABUHASHIM]

If you are designing different formulations of paint which are being sold as commercial off-the-shelf products, then I believe you must include 7.3.

I feel it should be excluded, as in any type of business, you can not go out beyond the limitation of specifications (legal.. local or International), and you have limitation of developments, or new invents in your products conditioning that you shouldn't deviate off these boundaries.

please, comments