ISO 9001 - Design Validation Record exemption

[normzone]

It's confusing because it's ... designed to be confusing ;-)

Sometimes a record will serve more than one purpose also.

For us, we build custom computers. Our verification is making sure that the product contains all the materials cited in the Bill of Materials (BOM), which is an input of customer communications with the Sales folks.

Our validation is our burn-in and test record - it performs as expected with all the widgets the customer asked for in it. Only if there are specific test requirements in the customer's P.O. do we go further. Most of our customers run factories or fight wars with our computers. We can't duplicate those conditions.

 

[Tyler C]

Thanks Ninja, that makes sense. We have a pretty good auditor and I think he will understand.

Normzone, they definitely succeeded in making it confusing! I think we have several instances where one record serves multiple purposes. Your next paragraph just gave me a Ah-ha moment.

Verification (making sure the customer is getting what they want) making sure the product physically has everything required.
Validation (making sure the product performs as intended) performing final inspection to ensure it does indeed perform.

I think this is the clearest explanation of validation vs verification I've ever heard. Thank you so much.

 

[howste]

From your post above it looks like you have a better idea of what the requirement means now.

If they tell us the heater needs to maintain the table to 98.6 degrees F, we can validate this in house very easily.
If they tell us it needs to maintain the normal body temperature of a dog while under anesthesia for 6 hours continuously in a room that maintains 71 degrees F with a 50% humidity, we cannot validate this for several reasons. If this were to happen, we would tell them we need specific temperatures to work with but we would now know exactly how the heater is going to be used, are we still expected to validate all of these requirements?

In your example, you get from your customer their requirements in terms you can understand and validate. You can validate the product can maintain temperature at 98.6±X°F for 6+ hours. I think that should be sufficient.

 

[Paul Simpson]

Quality Pros

I have been looking through the records required by ISO 9001:2008 and one of them is Design Validation records.

My company does do design, but we design to customer requirements. We have stated it is not our responsibility to perform design validation as that is the customer's responsibility because we are a custom shop.

Since I didn't ask for an exemption on this, will it be a finding that we don't have design validation records?

Interesting question and firstly I'd agree with a couple of other posters that the distinction between 'verification' and 'validation' is unhelpful for real world applications. The distinction primarily has been created by the quality community and has been lifted and is used in ISO standards.

If we work with the definitions, though, verification is the ability of the design to meet specification requirements and you can do this as described in your later posts through desktop reviews, prototype tests and final design testing. This activity should show the output meets the input (specification).

To show that the product is suitable for its intended use you are right: to cover the full range of possible use is difficult but you can test it with a range of intended uses - so a range of animal sizes (or dummies) to ensure that it both maintains temperature for a range of masses of 'patient' and a range of ambient temperatures / variation of temperature over time to see that the controls react and the temperature remains constant.

There may be other examples of 'real world' variation that you can build in to your test programme including use / abuse of controls / adequacy of packaging etc.

BTW if you choose you can lump all the testing into one programme and just talk to your CB about what is verification and what is validation - let them record which is which.

Good luck.

 

[Ninja]

FWIW: and agreeing with Paul about the squishy definitions of "verifications" and "validations" (sorta like verify vs calibrate)...

We define "Design Verification" as simply "Does Input = Output?"
We define Product verification the same way...basically "Does it meet (output) the measurable items we defined as necessary (input)?"

Validation we define as essentially "Fitness for use"...and we can't often test that...so it goes to the customer and they provide "validation".

 

[Tyler C]

Thank you everyone who responded. You have helped ease my concerns. I really appreciate it.