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![]() ISO 9001/4:2000
![]() Design verification vs validation
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| Author | Topic: Design verification vs validation |
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Andy Bassett Forum Contributor Posts: 284 |
I needed to double check this area again so i did a search and came up with an old thread. https://elsmar.com/ubb/Forum5/HTML/000015.html I distilled from the thread the following summaries posted by various helpful souls; Number 1 I could agree with that, but then i no longer understand the difference between a development output (which i thought was the checking of a drawing) and design verification. Number 2 I think this is saying more or less the same as above, (check the drawing and then physically test the product) so i am left with the same problem of understanding the difference between design output and verification. Number 3 And that is the one i will use. ie For Design validation i will present the actual physcial Test Reports relating to the physical testing of the product. Any comments, what do you think, is this realistic? BTW Having spent a couple of hours agonising over the meaning of ISO 9000:2000 in this area, i firmly beleive that the Standard deserves every criticism that it gets. Regards
[This message has been edited by Andy Bassett (edited 03 August 2001).] IP: Logged |
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Zanzi unregistered |
Andy, I completely understand your confusion at this greyest of grey areas of the standard. My understanding is as follows: Verification - Check in put meets output, in my mind the output of design and development reviews Validation - Check design is capable of doing the job for which it is intended - trials etc Hope this helps but I to am stuggling through this area as we speak. IP: Logged |
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Marc Smith Cheech Wizard Posts: 4367 |
The two words - Design and Development - are to some degree synonymous. Ehat I mean is we're reaching into the world of symantics. Many companies call their design function just that - design. However, we think of a 'Design and Development' process in which Design is a part of the larger system. -> For Design validation i will present the actual physcial Every company and industry is different. What does an equipment manufacturer do as 'validation' as opposed to an electric motor manufacturer? For an equipment manufacturer validation is typically performed at the customer's facility. Sometimes it is done at a 'turn-key' company. And yes - some do test their systems prior to shipping, but seldom is reliability an issue in such a 'validation'. On the other hand, if you're manufacturing electric motors and you make and sell 1M a year, you probably have a number of accellerated life tests you do and other validations. My point is to look at your design (and Development) process (read system) and determine where the appropriate 'key' points are and how you define each within your system / company. As per your statement you have done that. I'd want some more info on verification ("...please explain some more..." an auditor may ask). I think you have validation defined OK. IP: Logged |
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goose Forum Contributor Posts: 31 |
ISO 9000:2000 page 15 defines Verification as confirmation thru objective evidence that specified requirements have been met... Validation...that requirements for a specified intended use or application have been fulfilled. This is basically how our Registrar explains it. IP: Logged |
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Andy Bassett Forum Contributor Posts: 284 |
Hello Marc, just to flesh out my approach to Design Verification, the company i am working with produces right at the start a Design Target Brief which sets out how the final product should look and perform. I will ask them to go back to this Word Document and write on the right hand side the actual target reached ie Target weight 1100kg, weight reached 1150 Kg etc. This would be my way of doing Design Verification in what is basically a company producing complete small-run automobiles. Thanks for you help Goose with the comments below, unfortunately i cannot translate them in my particular environment Goose Said; This is basically how our Registrar explains it.
[This message has been edited by Andy Bassett (edited 04 August 2001).] IP: Logged |
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