Design Control - Validation and Verification Dilemma

[RCW]

There has been much heated debate at my company regarding implementing Design Control. Someone here brought up that during a conversation with our registrar, the registrar mentioned that for small engineering jobs, some items like validation and verification did not even have to be performed. To me this seems incorrect. Even for small jobs, there should be some kind of minimalistic record to support that verification and validation has been performed. Also I'm wondering if the registrar actually made such a comment or if it was totally misconstrued.

Another topic mentioned was that the customer could waive the requirements of certain elements (ex. validation or verification). Somebody came up with the idea to present an "ala carte" menu to the customer so he could pick and choose what he wanted done, after seeing the prices associated with each task. To me, this doesn't sound entirely "ISO legal". I would compare this to going to buy a car and the car dealer offers to add a "differential torque converter" for another $2000. Not knowing what a "differential torque converter" is and being asked to pay another $2000, I would probably say no, don't add it. It's the same way with an engineering quote. The customer most likely will not have an idea of what design input is from design output. Also assuming he doesn't want to pay more than necessary, when he sees the extra charge he will most likely say no to it.

I feel the Design Control program is being warped in such a way as to make it less expensive for my company while at the same time watering down the intent of the ISO clause, that is to improve quality of the product and to protect the customer.

Does anybody have any comments on these scenarios?

 

[Marc]

Verification is always performed. Validation is a different animal and a different issue. Every company and their product has their own scheme.

> Another topic mentioned was that the customer could waive
> the requirements of certain elements (ex. validation or
> verification). Somebody came up with the idea to present
> an "ala carte" menu to the customer so he could pick and
> choose what he wanted done, after seeing the prices
> associated with each task. To me, this doesn't sound
> entirely "ISO legal".

Why not "ala carte"? That's what was behind the brouhaha of US$500 toilet seats and hammers in military procurement a few years back. If you only want a few and you want them tested (validated) out the yazoo you're gonna pay me more to do it. If you want it off the shelf with minimal or no validation I'll sell them to you cheap. ISO says nothing about this in so far as for your specific product with consideration to customer requirements. For some products validation is not done until its actually in use. Keep an open mind, look at your company and your product and your customer requiremetns and don't over do validation for the sake of ISO.

I suggest you go over your (and your fellow engineers) definitions of verification and validation. :thedeal:

 

[RCW]

Okay, then for the sake of argument can it be safely said that any or all of the requirements for Design Control can be waived by the customer?

This should make auditing real fun or at least real short. When looking for design inputs or design outputs or design review Mr. Engineer whips out his customer waiver and that gives him diplomatic immunity.

What's going on in my corner of the world is that Engineering is going full blown on every requirement. For design planning or design review, they are looking to have formal meetings in the conference room including multiple people from multiple functions. This is totally impractical for "quickie - get it out the door in a day or two" jobs and I agree that this is a waste of money.

I told them that the 10 or 15 minutes they spend at someones desk discussing the project consitutes review and/or planning and to just jot down a few notes from the conversation to show evidence of review. Keep it simple, make it as quick and painless as possible.

OBTW, my company was heavily into military sales. It still does some mil work but also a lot of industrial and commercial work. It's difficult to get people out of the mil job mindset when you don't have multiple months and huge bugets to get product out the door.

 

[CarolX]

another spin

Hello RCW,

OBTW, my company was heavily into military sales.

Is it safe to assume that you do not have design authority over the product, that you are manufacturing to customer drawings/specifications? If so, then design review really doesn't apply to what you do.

Let me share whith you what we do. Everything we do is mad to customer drawings and specifications. We have no input in the "design" phase of the products, we are just a job shop making one, two or three parts of a larger piece. We do engineering work in the way of developing machine programs to make the parts, we perform first article inspections to verify parts are to print, and we make recommendations to the customer on how to make parts better, or more effectively.

I don't know how musch this may help, but there it is.

I agree whith Marc's statement - "Why not a-la catre?" - ISO is all about giving the customer what they want.

Regards,

CarolX

P.S. - Marc, I like the new avatar! Just watch out for those guys from Wisconsin!!! LOL

 

[RCW]

Sorry CarolX,

My company has their feet in both worlds. While we have some jobs that are just "build to print" which envolve only manufacturing, we also do engineering design for products which we later build.

I don't really have anything against the "ala carte" method. The only thing that sticks in my mind is clause 7.2.1 b) "The organization shall determine requirements not stated by the customer but necessary for specified or intended use, where known." To me this means to use your own personal insight into the job and be aware of things that the customer might not be aware of or have no knowledge in.

It gets back to my car example. The customer will usually want the quickest and cheapest route to get his product (unless it's a military job ). Does quick and cheap delivery a quality product? Sometimes yes, probably most of the time, no.

I guess it's up to me to instill in the Engineering staff to not get bogged down to the letter of the ISO spec, just try to meet the spirit of it

OBTW, while my current title is Quality Manager, I used to work as a designer in the Engineering department. Talk about straddling a fence!

 

[Marc]

> I don't really have anything against the "ala carte"
> method. The only thing that sticks in my mind is clause
> 7.2.1 b) "The organization shall determine requirements
> not stated by the customer but necessary for specified or
> intended use, where known." To me this means to use your
> own personal insight into the job and be aware of things
> that the customer might not be aware of or have no
> knowledge in.

95 times out of 100 a company has already identified items which are a liability to it. The "ala carte" is just above and beyond your internal requirements. For example, if you made car seats for toddlers and babies I would hope that even though customers may not specify it, your company would go through a rigorous validation process so that any failure could be addressed in court through evidence of 'due dilligence' on the part of your company.

 

[M Greenaway]

Well said Marc.

Safety is probably the paramount issue when considering design validation.

A good design FMEA should highlight the need for validation.

 

[Rockanna]

Our company produces parts for the government as well as design parts. We have tried to get out of the thought process of what does ISO require and make a turn around to what does our business require us to have in place. Design review is an important element in the success of our company (not to mention legal matters). Documenting the entire process under one set of rules, whether the design is large or small, makes sense to us.
I hope this helps.

 

[Marc]

The Bottom Line

Originally posted by j lean
We have tried to get out of the thought process of what does ISO require and make a turn around to what does our business require us to have in place. Design review is an important element in the success of our company (not to mention legal matters). Documenting the entire process under one set of rules, whether the design is large or small, makes sense to us.

I agree completely. :thedeal:

 

[JodiB]

I agree with the posts so far, and just to add my two bits as far as ISO is concerned I'll point out that both 7.3.5 and 7.3.6 require that verification and validation are performed in accordance with planned arrangements which are required in 7.3.1.

If your company determines that small jobs, off-the-shelf type jobs, etc. do not require extensive (or even the existence of..) verification or validation - then you are not required to do them. It all depends on the design planning done at the outset.

For a small job you may determine (per 7.3.1) that there are only two stages: review of the specs and review of the product before shipping. And the verification that you determine are appropriate (per 7.3.1) is to look at the order form and drawing, and then to visually inspect the item before shipment. You further determine that there is no validation required by your company because the customer has performed this act by ordering your product to start with after being informed of the item specifications and capabilities. Voila.

As a side note:
We will maintain records of design review by using a whiteboard-like device that prints the screen (boy does that save time!) It can save the lovely scribbled drawings and notations electronically onto your laptop too. Has anyone else used this sort of thing?