My company makes product to order - Are we design responsible? Exclude 7.3?

[Brian B]

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?

 

[Dan Larsen]

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.

 

[Al Dyer]

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).]

 

[newbie]

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.

 

[db]

Design exclusions

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 https://www.iso.ch/iso/en/ISOOnline.frontpage

Just thought you would like to know.

 

[Anton Ovsianko]

Re: Design? Yes and NO

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

 

[gpainter]

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

 

[msrazak]

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.

 

[QHSE]

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

 

[db]

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.