ISO 9001:2000 clause 7.3 Design & Development Exclusion - Collagen casing for sausage

Paul Simpson

Trusted Information Resource
#11
Around we go!

Now it sounds as if Design control is applicable to the scope. The problem will be in capturing what the customer wants.
Colleen said:
Customer requirements are changing. Examples of what the requirements are: The client says" we want your casing to be easily removable from the sausage we make" or "we want your casing to work on our type of filling machinery".
With the latter it is easier - once you understand the differences in this type of machine and how it interacts with your product you can put together a specification for the product to design against. With the first example the spec is more difficult to define. How do you define "easy to remove?"
Colleen said:
So we experiment with our original technology (adding components, changing technological conditions (time, etc) or adjusting our old existing machinery. And we make a sample product. If the customer is satisfied then we describe the technological process for the "new" type of casing (keeping the "old" for other types of casing as needed). After that we go ahead with a full production.
Sounds like a typical iterative design process. The verification activity will be any evaluation you carry out in house to test the "new" product against the original specification. The validation will probably be a trial run at your customer's premises.
Colleen said:
So this new exerimental production line of casing is done in parallel with what we have done according to the original technology. Perhaps we could exclude this new line from the scope of the quality system if it indeed requires D&D??
If this is something your customer pays for (even if it is amortised in the cost of product you supply) then my opinion is that it should not be excluded from your scope. There are plenty of others who may disagree.
 
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Craig H.

#12
Colleen, I have to agree with Paul here, and really do not have anything else to add. Good answer, Paul!
 
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Colleen

#13
Thanks a lot Paul - Round we go indeed! the customer doesn't pay for this - its our attempt to keep up with the market! But I see your point - sorry am still not quite convinced???
 

Al Rosen

Staff member
Super Moderator
#14
Colleen said:
"There is no original thought going in to the final product specification. If the customer comes to you with a requirement that is specified in general terms..".

Customer requirements are changing. Examples of what the requirements are: The client says" we want your casing to be easily removable from the sausage we make" or "we want your casing to work on our type of filling machinery". So we experiment with our original technology (adding components, changing technological conditions (time, etc) or adjusting our old existing machinery. And we make a sample product. If the customer is satisfied then we describe the technological process for the "new" type of casing (keeping the "old" for other types of casing as needed). After that we go ahead with a full production.
So this new exerimental production line of casing is done in parallel with what we have done according to the original technology. Perhaps we could exclude this new line from the scope of the quality system if it indeed requires D&D??
If you read the standard it is pretty clear
1.2 Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

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 organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
I may be wrong but, it seems that you are developing new casings based on your customer's requirements.
 

Paul Simpson

Trusted Information Resource
#15
"Internal" design control

Colleen said:
Thanks a lot Paul - Round we go indeed! the customer doesn't pay for this - its our attempt to keep up with the market! But I see your point - sorry am still not quite convinced???
It is a little like staring into a crystal ball - it's coming clearer, it's coming clearer, it's coming clearer ....

As I mentioned there are many who will say it needn't be covered by your system. My opinion is based on the principle of "If it's important - it's included in your QMS."

Even if it is an internal design control process that ensures you are in a position to compete in the marketplace the purpose of having a process is to ensure the organisation manages the process so that new product design requests are handled effectively. That involves:
  • statements of requirements,
  • allocation of responsibilities,
  • some sort of checking to see the product is what was asked for
  • product release to the market place
The nature of the controls are up to you and the type of design activity.
 
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Colleen

#16
Thanks Paul and Al,
Think the weight of the argument lies on keeping up with regulatory requirements! :bigwave:
 
V

vanputten

#17
How does the date of the original design activity affect whether an organization is responsible for design within the realm of ISO 9001? If I designed something 25 days ago, does that have a bearing as to whether or not I am responsible for the requirements of design? 25 months? 25 years? I don' think the fact that Colleen's organization designed the original casings 25 years ago has any bearing.

I have no experience with qms' in the food industry. But based on what Colleeen has reported, I would say her organization is responsible for design. Only an opinion.

Also, there is document N524 - Guidance on ISO 9001:2000 Sub-clause 1.2 'Application' that speaks to the application (exclusion) of design. This guidance document (and other guidance documents) can be found at the TC 176 website. Here is the loooong web address.

http://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/755901/1069636/customview.html

Regards, Dirk
 

Paul Simpson

Trusted Information Resource
#18
Is it core business?

Thanks for the link, Dirk. I have skimmed through the document. It doesn't materially change the thinking behind my post.

If original design is required of the organisation by its customers and / or the organisation chooses to design new products to satisfy changing market needs then design control should be included in the scope of the QMS.

If they manufacture product to existing designs (from 25 months or more ago, say) then design is not part of their core business and should be excluded from the scope.

Whether an organisation actually designs is a tricky question. I had a stand up row with my boss years ago when a company manufacturing house doors had an ISO 9001.1994 registration (years ago) because of one project they had carried out years before to design a piece of machinery (to make doors). Their logic was that 9001 was better than 9002. At the time I thought (and still think) it was a mistake as it wasn't a requirement of the customer and implied they were doing something (designing doors) that they weren't.
 
F

freelovefest

#19
Colleen said:
"There is no original thought going in to the final product specification. If the customer comes to you with a requirement that is specified in general terms..".

Customer requirements are changing. Examples of what the requirements are: The client says" we want your casing to be easily removable from the sausage we make" or "we want your casing to work on our type of filling machinery". So we experiment with our original technology (adding components, changing technological conditions (time, etc) or adjusting our old existing machinery. And we make a sample product. If the customer is satisfied then we describe the technological process for the "new" type of casing (keeping the "old" for other types of casing as needed). After that we go ahead with a full production.
So this new exerimental production line of casing is done in parallel with what we have done according to the original technology. Perhaps we could exclude this new line from the scope of the quality system if it indeed requires D&D??
This is without a doubt D&D. I have audited with several registrars and can say that you are certainly altering form, fit, and function and my guess is that your "recipes" are proprietary. If you develop it, and your end result is not public knowledge, it is design and development. D&D can also be applicalbe processes as some registrars interpret it. Each registrar has different requirements, but most would undoubtedly require you to follow 7.3, and in all honesty, just keep some records.

For iso 9001, it is pretty simple to meet, just show inputs(Customer Requirements), review them, outputs (Drawings, BOM) Review them and then test them, reviewthat, control your changes (ECO). You can do all of this on a cover sheet, one page doc showing dates things were done, on top of design notes or pictures or whatever you have. It is really simple. Good luck
 
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Colleen

#20
Lack of D&D can impact organization's ability to conform to customer requirements!

Paul Simpson said:
Thanks for the link, Dirk. I have skimmed through the document. It doesn't materially change the thinking behind my post.

If original design is required of the organisation by its customers and / or the organisation chooses to design new products to satisfy changing market needs then design control should be included in the scope of the QMS.

If they manufacture product to existing designs (from 25 months or more ago, say) then design is not part of their core business and should be excluded from the scope.
Whether an organisation actually designs is a tricky question.
:rolleyes: After all is said and done, D&D (internal or external) when rightly approached and implemented should be a usefull tool to the organization to meet customer and regulatory requirements!
Fulfilling the requirements of the standard is an extra bonus!!

So go for it all you responsible companies, and have fun!!:biglaugh:
Bye for now! Colleen
 
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