Dear Sirs

If a company design a product and sell it to the customers. Here each product is unique and each product's specification also different. The company does not do prototype or prelaunch or production part, they design a product and produce a single product and sell it to the customers.

In this how we address the ISO 9001, 7.3 - Design and Development.

Whether design verification is just verification of drawings, specifications etc (i,e in tangible?)

and validation is same as the final inspection (8.2.4)

If the design product is single product, how we different the validation and final inspection.

Please clarify sir

Regards

Karthi

...my replies are in black...

If a company design a product and sell it to the customers. ...OK, Here each product is unique and each product's specification also different. ...Go on… The company does not do prototype or prelaunch or production part, they design a product and produce a single product and sell it to the customers. Well, if your customer requirement does not include a prototype for their approval and prior to your mass production, I don’t think you’ll have problem with that…

In this how we address the ISO 9001, 7.3 - Design and Development. ... the entire design & development process? No…

Whether design verification is just verification of drawings, specifications etc (i,e in tangible?)… of course, it should be… let’s put it on this way, how do you verify your design if your parameters for verification are unknown or simply cannot be measured?

and validation is same as the final inspection (8.2.4)… I’m afraid not… if you are referring to the design & development validation (7.3.6) with the monitoring & measurement of the product (8.2.4)… they are somehow associated, but not the same…

If the design product is single product, how we different the validation and final inspection… again, if you are referring to the design & development validation (as stated in 7.3.6), it is done to ensure that the resulting product is capable of meeting the requirements for the specified application of intended use – meaning it is more on the functional aspect of the product rather than physical (specification) as being done during final inspection, where you monitor & measure the characteristics of the product to verify that requirements have been met (8.2.4)…

Again as I mentioned, they are somehow associated, but it should not be the same… however, there are organizations that treat them exactly in the same manner and this is a not against ISO, as long as you satisfy both requirements... anyway, in some organization, there are products that cannot be validated until they are installed, but somehow they have to perform final inspection on these products prior to delivery…

...hope that helps...

I was taught

Verification - did we actually make what we set out to make?

Validation - did it actually do what we (or the customer) wanted it to do?

Verify - is it to prints and specs?

Validate - does it pass peformance testing?

Does that help?

Attached is a slide show I put together a while ago for Development.
Couple of points to note:

This is a visual aid as part of the discussion... in other words you needed to talk to the points the PPoint is showing.

It is a slide show, you need to run it as a show and click the mouse to move on, some animation is automatic (be patient and click when animation finishes)

I hope this helps with difference between Verification & Validation

I can't believe that your design process is so efficient that you never do any prototype or pre-launch product. You are saying that your organizaiton goes directly from a theoritical design to realized product with no intermediate step? How do you do verification and validation wiothout a few pre-lauch or prototype parts?

You also say that you do not make any produciton parts which really confuses me. Are you selling designs?

I bet all of 7.3 applies and that the confusion is rooted in an incomplete understanding of the standard.

Caster gave you a very simply and accurate explanation of the difference between verification and validation. 7.5.1 applies to the planning of product realization after all of the design work is done.

Dear Sirs

If a company design a product and sell it to the customers. Here each product is unique and each product's specification also different. The company does not do prototype or prelaunch or production part, they design a product and produce a single product and sell it to the customers.

In this how we address the ISO 9001, 7.3 - Design and Development.

Whether design verification is just verification of drawings, specifications etc (i,e in tangible?)

and validation is same as the final inspection (8.2.4)

If the design product is single product, how we different the validation and final inspection.

Please clarify sir

Regards

Karthi

What type of product are we dealing with here?

What does this "final inspection" entail?

Dear Sir

The product is designed based on the customer inputs. The manufacturing and design is done based on the inputs from the customers, product requirements etc. The manufacturing part is only one. And no additional product or reproduction,

It one time developement and one time manufacturing.

In this case hoe we differentiate the 7.3 Vs 7.2.1 Vs 8.2.4 (Final Inspection)

Regards

Karthi.T

may be you mean that you make the product and design upon sample from customer ? or what

because i have the same problem

I am also interested in how to best address quality system requirements as they apply in an "R&D" environment, particularly where the end result (unique design) may well end up delivered to the customer as a one-off special. This may then repeat for other customers or the same customer numerous times. Quite alot of the time the design is not well documented due to the rapid development it might have undergone to reach it's "deliverable state". I am new to the firm and this is quite an interesting setup. We do not have ISO/AS , hence the challenge. Is it possible to separate "R&D" operations (a prime driver of the business) from manufacturing and still maintain a workable QA system?