We do not design anything brand new from scratch - Design Exclusion?

[amariepsu]

We are a small fabrication company that makes modifications to designs that were developed by a company the owner purchased over 10 years ago.

Technically, we own the original designs, and we constantly improve aspects of the design and incorporate these minor changes into products, but we do not design anything brand new from scratch at this time.

Can we take exclusion to this clause? Can anyone offer advice?

For example, we fabricate aluminum slide gates and use the original design for the frame, but the seal is constantly being improved and drawings are constantly changed to reflect these improvements. Hope this helps a little.


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[PaulJSmith]

Hi, amariepsu!

You may want to re-read 7.3.7 Control of Design and Development Changes. If you're making changes to the existing designs, I think this might spoil your quest for exclusion.

 

[Stijloor]

We are a small fabrication company that makes modifications to designs that were developed by a company the owner purchased over 10 years ago.

Technically, we own the original designs, and we constantly improve aspects of the design and incorporate these minor changes into products, but we do not design anything brand new from scratch at this time.

Can we take exclusion to this clause? Can anyone offer advice?

For example, we fabricate aluminum slide gates and use the original design for the frame, but the seal is constantly being improved and drawings are constantly changed to reflect these improvements. Hope this helps a little.


.

I agree with Paul.

If you make design changes you actually "own" the design. So, 7.3 can not be excluded. Some organizations are waaay to scared about this "design thing."

 

[qusys]

We are a small fabrication company that makes modifications to designs that were developed by a company the owner purchased over 10 years ago.

Technically, we own the original designs, and we constantly improve aspects of the design and incorporate these minor changes into products, but we do not design anything brand new from scratch at this time.

Can we take exclusion to this clause? Can anyone offer advice?

For example, we fabricate aluminum slide gates and use the original design for the frame, but the seal is constantly being improved and drawings are constantly changed to reflect these improvements. Hope this helps a little.


.

Agree with the other Covers. As a matter of fact , it could be interesting to understand what you mean for "minor changes".
The question could be : Does a certain amount of minor changes carry to a new product, different from the original ones related to a past project?
I see some risks in this, because you have implemented some changes from your side without having a process in place.

 

[MIREGMGR]

Your designer is making decisions as to what changes are good ideas and accomplish what the product needs. That design change evaluative process is design activity.

There is no distinction between design of a new product and design of a change to an existing product. If someone is making a determination of what the design should be, or should be changed to be, that's design activity.

 

[amariepsu]

Ok, thank you for all your help everyone. Now how do I convince management that we cannot take exclusion to this clause?

Oh my....

 

[somashekar]

Ok, thank you for all your help everyone. Now how do I convince management that we cannot take exclusion to this clause?

Oh my....

Tell them that you are not doing research and development.
You are doing design and development, where you take inputs and provide suitable outputs to meet the input requirements, consistently.
One of the main inputs that you have is the original design that you say you have.
You are the owner of several designs each of them slightly different from the other based on the inputs that you have received.
Is that not so simple now ~~~

 

[SalCoraccio]

Ok, thank you for all your help everyone. Now how do I convince management that we cannot take exclusion to this clause?

Oh my....

I'm assuming you're going to have what is called a "Stage 1" audit, a sort of pre-audit by your registrar. They'll certainly identify it as a gap.

You could just tell your management that you don't believe it is an allowable exclusion, "but let's see what the Registrar says".

Alternatively, you might hire "an expert" to say the same thing you said; cost you a grand or so and you'd likely get some other benefits.

They might even balk at that, so the Registrar option is pretty certain.

Good luck.
Sal

 

[Mikishots]

We are a small fabrication company that makes modifications to designs that were developed by a company the owner purchased over 10 years ago.

Technically, we own the original designs, and we constantly improve aspects of the design and incorporate these minor changes into products, but we do not design anything brand new from scratch at this time.

Can we take exclusion to this clause? Can anyone offer advice?

For example, we fabricate aluminum slide gates and use the original design for the frame, but the seal is constantly being improved and drawings are constantly changed to reflect these improvements. Hope this helps a little.


.

We also perform the same functions you do for our product: Designs are up to 70 years old, but we own the type designs. Our activities revolve around modifications of existing designs. Clause 7.3 is not solely reserved for brand-new designs. 7.3 cannot be excluded.

Because you own the original designs and are modifying original designs, you are responsible for providing product that meets customer and applicable stat/reg requirements. This is explicitly defined in Clause 1.2 Application, and therefore, no exclusion is allowed.

 

[qusys]

Ok, thank you for all your help everyone. Now how do I convince management that we cannot take exclusion to this clause?

Oh my....

Make them read this post and reflect together on the related chapter of ISO 9001.
In alternative, try to contact an external consultant to help them in that direction. This could be a good method to have support and involvement of the management.