I have a question of whether I can exclude 7.3. My company makes product to order.

Customers send me 2 types of drawings: TypeI dwgs are very specific, give exact dimensions. I specify suitable materials, I determine the appropriate mfg. processes etc.

Type II dwgs from my customers provide overall dimensions. Our engineering dept. calculates internal part size, specifies suitable materials and determines appropriate mfg methods.

My question is: Do we design our product, or not?

If you were simply making to print I'd say not. But you mention that you "specify suitable materials". From a metallurgical point of view, materials selection is generally part of the design process. Just one opinion.

Your use of the word "specify" leads me to think that you are design responsible.

What do your customers think?

ASD...

[This message has been edited by Al Dyer (edited 17 April 2001).]

Quote :
'Type II dwgs from my customers provide overall dimensions. Our engineering dept. calculates internal part size, specifies suitable materials and determines appropriate mfg methods.'

Keywords :calculate / specifies.

It's like your customer said : I want a box for shipping easter eggs - he gives you the overall dimensions, but it does not specify how to and from which type of material you must manuf. that box - so it seems like design.

This is an old thread, but there is some new information from one of my registrar contacts (NSF)

Accreditation bodies are scrutinizing registrations with exclusions. The most common exclusion is 7.3 Design and Development. A widespread practice for organizations was to exclude design when the company provided a service or had not designed a product for a long period of time. These are no longer permissible exclusions and the auditor must verify the justification during site visit…

In the pas, it was acceptable to simply state “no design activities” in your quality manual. The guideline [4.2.2 Quality manual] requires registered clients to provide an explanation of the exclusion. ISO/TC 176 has issued several documents to help organizations determine if their justification and documentation is appropriate. The documents are available on the web at http://www.iso.ch/iso/en/ISOOnline.frontpage



Just thought you would like to know.

Brian,

Brian B said:

... TypeI dwgs are very specific, give exact dimensions. I specify suitable materials, I determine the appropriate mfg. processes etc.

Type II dwgs from my customers provide overall dimensions. Our engineering dept. calculates internal part size, specifies suitable materials and determines appropriate mfg methods.

My question is: Do we design our product, or not?


Type I: customers provide you with design out output, you can use as one of inputs to manufacture beside materials, equipment etc. (If we consider design as a process previous to manufacture)

Type II: customers provide you with design input, you can use together with other inputs like engineering skills and knowledge, CAD, PC's etc. to design and develop products (read to produce design output, you shall be able to use as one of the inputs of manufacture... and so on.

That is with type II drawings you definitely are responsible for design.

IMHO,

regards,

Anton
:smokin:

If you can make a change to the product without customer approval (no deviation), then you design.

hi there i am new here and i am also making an effort to REALLY understand the requirements after reading the standard a couple of times.

anyway, in my opinion i think if you just produce direct from your customer request than there's no design involved, but if there is some input form you into the customer request than that would surely involve design.

and the next question here is up to what extend? this is where you explain how deep are you involved in the deisgn activities of the product.

comments from anyone on the above are most welcomed.

In my opinion there are very few companies who can say that they don't (according 7.3) design.
"Design" is very broad scope and covers a multitude of activities performed in the workplace.

John

:bigwave: Welcome to the Cove msrazak and John! Reading the information from the registrar, I think you are both pretty close. It will be much harder to exclude design than previously. I think one of the keys will be whether the organization is involved with the different aspects of design (planning, design input/output, review, verification, validation and the organization's input in changes. I think there will be a significant number of companies that are not going to be happy.

Maybe...just maybe...

If you are a supplier and your customer requires that you procure 100% of the component parts once THEY have completed the design (all parts lists, drawings etc are signed off, all pigs primed and ready to fly), then your procurement guys find an "alternative" widget that is to spec and cheaper (obviously passing the savings onto the customer), then you would, in effect have an input into the original design as per 7.3.3. b)..

At my previous company (100% turnkey supply), we were in at the design stage from a design for manufacture viewpoint and it was a handholding excercise.

Just a couple of thoughts over lunch.

Regards,

Chris

We are a job shop and manufacture to customer specifications. but we also make suggestions for design changes. Do we do design work, technically yes. Do we hold design authority over the product, no we do not. So my view is that our "design" work falls under our customers design program and we are excluded.

Regards,
CarolX

Another way to view this is to look at what you actually do, not what you call it. Lay out the steps, and identify the starting point, decisions you are making, and the information you reference (documentation and/or experience) to do that, and how you know you have achieved what you want.

Then you can look at the standard and see if the elements help you better understand and improve your process.

If the extent and level of detail of this is driven by your business needs (work forward from your business, not backwards from the standard), you should also have nothing to fear from an audit according to the design element in ISO 9001(2000).

By experience all this can be done or referenced on a single sheet of paper, and it makes it easier for people to understand and improve on the results you get.

It has been my understanding that it doesn't matter what you do... you do some designing. Even if you are selling a service!

I'm not sure what type of industry Brian B is in, but it sounds similar to what we do. We only make custom parts... our customers send us a drawing and we make the parts. Most times we DESIGN tooling. But even if we didn't design the tooling I still think you design the process?

Anyway, the long and short of it is that I really don't think you can get out of the design stuff.

Just the opinion of one Fire Girl

Well said Fire Girl.

We certainly all design processes dont we, and if you look at the design clauses they are almost a micro version of the complete standard, and clearly based around the PDCA cycle.

Posted by M Greenaway - 9th August 2002 at 03:11 PM
Well said Fire Girl.

We certainly all design processes dont we, and if you look at the design clauses they are almost a micro version of the complete standard, and clearly based around the PDCA cycle.

Posted by Fire Girl - 9th August 2002 at 02:08 PM
It has been my understanding that it doesn't matter what you do... you do some designing. Even if you are selling a service!

I'm not sure what type of industry Brian B is in, but it sounds similar to what we do. We only make custom parts... our customers send us a drawing and we make the parts. Most times we DESIGN tooling. But even if we didn't design the tooling I still think you design the process?

Anyway, the long and short of it is that I really don't think you can get out of the design stuff.

Just the opinion of one Fire Girl

Help me understand 7.3 correctly. If I am a manufacturer with a "set of processes that transforms requirements into specified characteristics or into the specification of a product, process or system" 9000:2000 3.4.4 Design and Development, then 7.3 is to be in the scope of my QMS.

As a Job Shop that manufacturers perishable tooling, those jobs where the customer establishes the specification of the final product (Customer Specification and/or tool drawing) and our manufacturing/production controls (7.5.1) establish the manufacturing specification to comply with the product specification, then 7.3 is not in the scope. Is this right or wrong?

As a Job Shop that manufacturers perishable tooling, those jobs where we help establish the specification for the final product (involves submitting specifications and/or tool drawings for customer approval off the customer's tooling/part drawings), then 7.3 is involved in the scope. Is this right or wrong?

Is 7.3 involved in the scope if a customer's perishable tooling is resharpened to a specification controlled by the customer? If so, how?

Does the service of resharpening a customer's perishable tooling involve 7.3? I am trying to understand how the development of the process is different from the control of service provision.

Thanks for your input on these various issues!

Doug

Are there any support documents from ISO (or registrars) that (at least attempt to) help clarify the design requirements, what is and what is not design, etc.?

Regarding the quote below which was taken from a response above, I am either blind or the documents mentioned that provide guidance on design and development exclusion justifications are well-hidden. I looked at the two interpretations relating to 7.3 and they really don't shed much light. Can anyone provide a more specific address than http://www.iso.ch/iso/en/ISOOnline.frontpage as to where this advice can be found? Thanks much.

John


Quote: Accreditation bodies are scrutinizing registrations with exclusions. The most common exclusion is 7.3 Design and Development. A widespread practice for organizations was to exclude design when the company provided a service or had not designed a product for a long period of time. These are no longer permissible exclusions and the auditor must verify the justification during site visit…

In the pas, it was acceptable to simply state “no design activities” in your quality manual. The guideline [4.2.2 Quality manual] requires registered clients to provide an explanation of the exclusion. ISO/TC 176 has issued several documents to help organizations determine if their justification and documentation is appropriate. The documents are available on the web at http://www.iso.ch/iso/en/ISOOnline.frontpage