Can this be a case for Design and Development Exclusion

[Paul Simpson]

Something that has not been explained is just what is your relationship with the entity that validates your design. Who are they? Without knowing how they fit into the equation you will continue to get differing opinions.

Pardon me but the relationship is an irrelevance if there is no design involved as per my previous posts.

Incidentally most third party conformity assessment bodies will clearly identify the scope of the work they do and my guess is you won't see 'design validation' anywhere.

I can't speak for South Africa but in the EU one of the defences in cases of product liability is that it has been manufactured in accordance with relevant European standards (where they exist).

 

[DrM2u]

Richard, we are in agreement on the design responsibility/authority.

Big Jim, I am still not clear as well, see my post #21, first paragraph.

Boris, see my post #24. Andre clearly stated in the original post that members/owners of the organization are designing the product so you cannot state that there is no design involved.

Andre, please provide the whole picture if you want a straight answer. Ambiguos infirmation leads to conflicting answers and unnecessary debates. Until then, I am out of this thread!

 

[Paul Simpson]

Boris, see my post #24. Andre clearly stated in the original post that members/owners of the organization are designing the product so you cannot state that there is no design involved.

If I say I am a world class sprinter does that make it so?

As has been mentioned here ad infinitum the understanding of what 'design' is not fantastic. I have tried to explain the difference between applications engineering where you provide a tailored solution but without any original design vs. design activity when some original work is done to satisfy a customer requirement.

Andre, please provide the whole picture if you want a straight answer. Ambiguos infirmation leads to conflicting answers and unnecessary debates. Until then, I am out of this thread!

Again Andre has been very forthcoming when asked specific questions or where he has been offered a couple of options based on scenarios.

I think my work here is done!

 

[glenn0004]

Having read all the post given to your original post – I think too much is being made of the wording you quote: to provide a product that meets customer and applicable statutory and regulatory requirements.
It looks clear that you don’t design to a customer’s specification BUT you do design to meet statutory and regulatory requirements - it would be my interpretation that you do have a design and development obligation.
Alternatively… look at it another way, would you benefit from documenting and controlling your design and approval processes???????????????

 

[Big Jim]

Pardon me but the relationship is an irrelevance if there is no design involved as per my previous posts.

Incidentally most third party conformity assessment bodies will clearly identify the scope of the work they do and my guess is you won't see 'design validation' anywhere.

I can't speak for South Africa but in the EU one of the defences in cases of product liability is that it has been manufactured in accordance with relevant European standards (where they exist).

Pardon me Boris, but how do you know that there is no design responsibility? Where do you fit in here? Do you know what the original poster hasn't told us? Please enlighten us.

 

[John Broomfield]

Good day all

I work for a manufacturing concern, and our products are inter alia flameproof alternators and lighting for the mining industry. We are currently upgrading into I/S intrinsically safe products. So we are being audited by Sira and IECex for exporting.

Products are designed,drawings done by my bosses, owners of business,design and drawings are send to ATL (test lab)and after approval we start production.

Question : Can I exclude Clause 7.3 Design and Development ?
I am not sure who does the development, prototype etc.

Andre,

Why would a company that designs and manufactures sparkproof/flameproof products intentionally exclude design from its management system?

Surely your company has liability for the performance of the product and would wish to show that it has taken all reasonable steps to prevent product failure and the consequentional losses?

In the event of catastrophic failure (perhaps even from the customer's misuse of the product) I would not want to even try to explain to the judge why my company had ignored the national standard for quality management systems when it comes to the design of the product.

John

 

[JaneB]

Thank you Parag, however I have done some more research and found the easy answer on the official ISO 9001:2008 website....
We can therefore exclude clause 7.3 from our scope in the manual.

Oh dear... yes, it's good to do research. But a little knowledge can be a dangerous thing.

No, you cannot exclude design. YOU (the company) design the products, yes? And no, you cannot exclude design therefore.

Yes, one can exclude certain clauses in section 7 only from scope BUT you must always - always! - have justification (ie, good reason) for exclusion and that justification MUST be acceptable to your external auditor/certifier. Nothing you've said so far sounds like a good reason.

Best and simplest way to know for sure: talk to some reputable CBs (certifiers). They will decide whether they can/cannot allow you to exclude design. My experience tells me they won't.

 

[JaneB]

Oops - I missed this post of yours earlier.

I myself is not sure about this, but my bosses and a previous auditor excluded it and they want to keep it that way.

But thanks for the answer

Based on this information (which I overlooked), there's some pertinent information somewhere (ie, why it's OK to exclude design) that the 'previous auditor' - who will have acted according to the requirements knows that I don't. So ignore what I said. I can think of a few scenarios in which it would apply.

But I still hold that a little knowledge is a dangerous thing. A lot of knowledge is better.

 

[Paul Simpson]

Pardon me Boris, but how do you know that there is no design responsibility? Where do you fit in here? Do you know what the original poster hasn't told us? Please enlighten us.

In the best spirit of enlightenment.

The OP stated that his boss 'designed' the product. Me being a little bit curious asked a few questions as to what the company actually does (it's the quality guy in me - I always ask questions I think I know the answer to! ) and I suggested in my post that this might be what I call 'applications engineering' without any new (conceptual) design.

Now forgive me if I have a look around for my own trumpet ... but the OP thought that this might be exactly what they are doing - here.

So in answer to your first question: I don't know the company doesn't design - I'd have to visit them to establish that (a nice trip to South Africa, I'll have to think about that!). I just suspect it. I fit in as a regular Cover with an interest in (in order): quality, management systems and ISO 9001 and part of that means I want to discuss these questions when they come up. FWIW I have also been involved in certification and for a CB that offered certification to standards in support of the ATEX Directive.

 

[Big Jim]

In the best spirit of enlightenment.

The OP stated that his boss 'designed' the product. Me being a little bit curious asked a few questions as to what the company actually does (it's the quality guy in me - I always ask questions I think I know the answer to! ) and I suggested in my post that this might be what I call 'applications engineering' without any new (conceptual) design.

Now forgive me if I have a look around for my own trumpet ... but the OP thought that this might be exactly what they are doing - here.

So in answer to your first question: I don't know the company doesn't design - I'd have to visit them to establish that (a nice trip to South Africa, I'll have to think about that!). I just suspect it. I fit in as a regular Cover with an interest in (in order): quality, management systems and ISO 9001 and part of that means I want to discuss these questions when they come up. FWIW I have also been involved in certification and for a CB that offered certification to standards in support of the ATEX Directive.

Application engineering certainly can be design. Figuring out how to make it to the customer's design is not design, but application engineering most certainly can be.

What is obvious here is that the OP needs to be more forthcoming with information. Until he does, all indications to me is that his company is heavily involved with design.