Design and Development Procedure

[Chickenlips]

I was wondering if anybody could send me a sample of their design and development procedure, or lead me to a place where I can find one. We are working on documenting ours, and I have an idea that we are doing everything that we need to do, I'm just having a terrible time trying to write this procedure!! I was just hoping to get some ideas of the wording that other companies used, to hopefully remove the writer's block. Thanks in advance for any help I can get! Becky

This is one of those requests that will be very difficult to get a reference to. You will get the text book example, but very few real life examples. Reason? Nobody is sure that what they have is suitable for others. They probably feel like they are whistling past the Graveyard. Especially with the new standard. Our Engineering VP says that we meet all the requirements. I asked about the recommended records required from ISO regarding the 6 sections of design. "Well, we don't have them, per say, but I can produce anything they want". Somehow, I do not get that warm and fuzzy feeling that all is well. So, I can't help you, either.
Good luck! I'll be watching with you.

[florin pirvulescu]

I have faced the same problem in our company. There is no universal procedure suitable for everybody. Instead I can tell you from my experience. The problem is that the procedure has to fulfill two main condition: 1. compliance with the reqiurements of standard; and 2. suitability with the your own practice and needs. So:
a. at the beginning you don't know how detailed should document your activity. So try to organise your procedure according with the subclause of the standard (for instance "7.3.1 Planning of design and deveolpment" - define the document which state the stages of your design (Project Development Cycle or Desing Planning or however you name it) and don't forget to state also the review, verification and validation of each design stage, records and responsabilities.
b. define what are the inputs of you design and how you document them. Some of them are already documented so you need only the identify them (see the thread refering to the term "determination")
c. the same for outputs and so on.
Concluding try to adapt the standard requirements to your particular situation. Document what you do following the standard. Later on running your procedure, auditing it you will need to improve it and maybe to detail deeper.
Good luck!
Florin P.

florin pirvulescu said:

Concluding try to adapt the standard requirements to your particular situation. Document what you do following the standard. Later on running your procedure, auditing it you will need to improve it and maybe to detail deeper.
Good luck!
Florin P.

Absolutely. You can be sure that when this section is audited, the VP Engineering Director will have the honors of explaining all to the Auditors. We have a very extensive flow chart that shows all the design activities and records. They just don't match my vision of what the standard wants. The is no mention of "inputs" and "outputs". But they are there, according to the Director, just not broken down as the standard shows. But, hey, that's why he is the Director with the MBA. There is no doubt in my mind that we will have to do some modifications, down the road.

[Chickenlips]

Can I use my process map to show some of the major steps in the design process? I started with a written procedure, and I'm having such a difficult time trying to cover the requirements of the standard, so I decided to go with the Process Map first. Does everything in the Process Map need to be in the written design control procedure?

Another question: With inputs to the design process, do we have to state those inputs in the procedure/map? There are a few inputs that would be standard for each design, such as Product Specifications, but some of the inputs listed as examples in the standard would be subjective according to the type of product that you are going to be designing. Can I just state in the procedure that design inputs are on a form that is filled out during the Conceptual phase?

Can you tell that I am new to the ISO9K2K? It's a very confusing standard. Thanks for the help!

Chicken,

Your process map should show inputs and outputs by the direction of the arrows. At least, that's what I'm being told by Engineering and our Steering Committee also sees it that way, I guess. Our Engineering Quotation and Order Processing Flowcharts are huge. Somewhere in there, nestled in process blocks with different terminology is supposed to be 7.3.1 thru 7.3.7 of the standard. I had them open the standard and look at the requirements. "Well, it's all there, just not identified as such." We'll see.

Use your chart with an eye on identifying the clauses above for the average intelligent viewer and you may be good to go. JMHO

[Mike S.]

Chickenlips,

Don't feel bad, this is not the easiest thing in the world to do IMO -- making it suit the standard (and worse, suit the auditor!)and internal needs. Do a search -- I know there was a lengthy thread covering process maps, etc. recently, as I was one of those who was confused by all the opinions! If I have time I'll look and post the link -- if not do a search for something in the last few months. Good luck!

[Mike S.]

See if this helps -- lots of reading here!

ISO 9001 Quality Manual Organization and Structure including Numbering