ISO 9001 - Design Validation Record exemption

[Tyler C]

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?

 

[Coury Ferguson]

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?

In my opinion, if you didn't asked for the exemption you will be required to show records.

Question: Do you build to the design and submit to your customer, or does your customer(s) build to your design?

 

[howste]

Read the whole text of that requirement and see if the answer is there:

Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known.

Do you know how the product will be used? If yes, you should validate that it will work for that application. If not, you already have an "exclusion" built into the standard.

By the way, you should also look at what you're allowed to exclude:

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

The short story is if you design product and you know how it's used, you have to validate. You'd have a really tough time justifying an exclusion. My take is that if you design product and you don't validate it, and it doesn't meet requirements, then you're still on the hook. If it can only be validated in a higher assembly by the customer, then you should specify that in your agreement with them.

 

[Tyler C]

In my opinion, if you didn't asked for the exemption you will be required to show records.

Question: Do you build to the design and submit to your customer, or does your customer(s) build to your design?

Coury - to answer your question, sometimes the customer sends us a design specification sheet and we then create internal design sheets to be used in production. Other times, the customer simply tells us what they need (for example, we make heaters, and they may say they need a 5"x6" heater at 120 volts and 200 watts with 24" power leads) and we draw up a design specification sheet and send to them, they say yes or no, and we go from there.

 

[Ninja]

sometimes the customer sends us a design specification sheet and we then create internal design sheets to be used in production. Other times, the customer simply tells us what they need (for example, we make heaters, and they may say they need a 5"x6" heater at 120 volts and 200 watts with 24" power leads) and we draw up a design specification sheet and send to them, they say yes or no, and we go from there.

If it is documented anywhere (including a PO terms or order acceptance terms or simply in your design control procedures) that the customer approval on design IS the verification...then your record of "Yes" or "No" is your design verification.
If the customer supplied it...there's your design verification right there.

Depending on how you and your customer relate, you can also push first use at the customer to stand for design validation. The record of validation being the second order, or simply an email from them saying "Hey, it works nicely".

Those steps of verification and validation are there to make sure you are not just slapping stuff together and making promises. You seem to be working back and forth with your customer and sharing the design and validation steps back and forth...don't be afraid to simply call it that. It is a fully valid approach (mostly 'cause it works well).

 

[normzone]

I don't see any easy out from this, but you may already be doing this.

First I'll take liberties with your post, by removing some words.

" the customer sends us a design specification sheet and we then .... design .... Other times, the customer simply tells us what they need (for example, we make heaters, and they may say they need a 5"x6" heater at 120 volts and 200 watts with 24" power leads) and we ... design ... and send to them, they say yes or no, and we go from there.

So viewing verification as making sure you built what the customer wanted, and validation as making sure that it does what they wanted it to do, do you test the completed units you build for them?

Seems to me the test records would be validation records.

 

[Tyler C]

Read the whole text of that requirement and see if the answer is there:


Do you know how the product will be used? If yes, you should validate that it will work for that application. If not, you already have an "exclusion" built into the standard.

By the way, you should also look at what you're allowed to exclude:

The short story is if you design product and you know how it's used, you have to validate. You'd have a really tough time justifying an exclusion. My take is that if you design product and you don't validate it, and it doesn't meet requirements, then you're still on the hook. If it can only be validated in a higher assembly by the customer, then you should specify that in your agreement with them.

Howste - the standard is somewhat confusing to me, maybe I'm just having an off day, but here's an example. As I said above, we make application heaters. So, a customer calls and they need a heater to warm a table to keep a dog at the right temperature while they operate. So, we know the application.

How do we validate this application, simply show that the heater will get to the specified temperature they need? Or, do we have to build a table, apply a heater to it, perform surgery on a dog and see whether or not the dog was kept at the right temperature the whole time?

This is what I'm struggling with. Because we have thousands and thousands of customers, all with different applications, we can't re-create every single customer's application that we know to validate that the heater will meet the application requirements.

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?

 

[Tyler C]

Thank you Ninja. It works very well and I think this is the approach I am going to take.

 

[Tyler C]

I don't see any easy out from this, but you may already be doing this.

First I'll take liberties with your post, by removing some words.

" the customer sends us a design specification sheet and we then .... design .... Other times, the customer simply tells us what they need (for example, we make heaters, and they may say they need a 5"x6" heater at 120 volts and 200 watts with 24" power leads) and we ... design ... and send to them, they say yes or no, and we go from there.

So viewing verification as making sure you built what the customer wanted, and validation as making sure that it does what they wanted it to do, do you test the completed units you build for them?

Seems to me the test records would be validation records.

Thank you Normzone. We do perform 100% testing at final inspection when the product is complete. I do at times struggle with verification vs validation because it seems to be the same to me. I understand the difference in your definitions, but it seems building what the customer wants is the same as ensuring it does what the customer wanted it to do. The customer wants something that will do what they want it to do... But, I was considering the inspection records as verification records, not validation records. Maybe I am looking at it wrong.

 

[Ninja]

FWIW...you'll likely have to walk your CB auditor through it the first time...we had to.

There are so many applications where in-house validation is a total must, that many are used to it from everybody.

In cases like yours where such a thing just doesn't make sense...you may have to help them get out of the rut and think about it without bias or preconception.