Experimental research vs. Actual design of product - ISO 9001 Clause 7.3

[al40]

Looking for advice.

My current employer (Pure research no prodcution facilities) is gearing up for ISO certification in July 2005.

We're currently developing a New Product Development manual and we're trying to make distinct mark between Experimental research and actual design of product concerning section 7.3 of ISO.

Quick overview.

1) The experimental prototypes are only delivered to the military for lab and field experiments. ( I can't elaborate any further)

2) The prototypes are based on an DOD SBIR "Small business innovation research grant" and no contract involved.

3) They have agreed that any product that is deliverable under a commercial contract or that will be comerically reproduced will fall into our NPD manual and follow ISO requirements.

4) All deliverable prototypes that are pure experimental are addressed per the DOD SBIR.

5) Management will not include their SBIR experimental research projects and lab, and eqipment under ISO and have stated that if this not acceptable they will not pursue ISO certification.


Is this acceptable per ISO? I can't find any ISO references that addresses this type of situation.

As far as I can tell only the products that Senior managment say are pursuable either by contract or RFQ should fall under the ISO requirements.

Is my thinking correct?

[qualitytrec]

Why are you pursuing ISO registration? Is it a customer requirement, business inhancement, marketing ploy, or something else?

For your grant are you required to provide something to prove that the grant is being used properly? This might be a "product" that requires ISO. The grantor in this case could be a customer.

You can limit your scope to a degree but it sounds like your business is to "play" until you find or create something useful (like silly putty, or post its ), then give it over to the DOD to find something to do with it. I am not sure how your experimental side is not a key process to your contract side, so I can not give much help beyond the above.

I would need more info than has been provided to answer more clearly.

Anyone else have input on this?

Mark

[Al Rosen]

In Reply to Parent Post by Allen M.

Looking for advice.

My current employer (Pure research no prodcution facilities) is gearing up for ISO certification in July 2005.

We're currently developing a New Product Development manual and we're trying to make distinct mark between Experimental research and actual design of product concerning section 7.3 of ISO.

Quick overview.

1) The experimental prototypes are only delivered to the military for lab and field experiments. ( I can't elaborate any further)

2) The prototypes are based on an DOD SBIR "Small business innovation research grant" and no contract involved.

3) They have agreed that any product that is deliverable under a commercial contract or that will be comerically reproduced will fall into our NPD manual and follow ISO requirements.

4) All deliverable prototypes that are pure experimental are addressed per the DOD SBIR.

5) Management will not include their SBIR experimental research projects and lab, and eqipment under ISO and have stated that if this not acceptable they will not pursue ISO certification.


Is this acceptable per ISO? I can't find any ISO references that addresses this type of situation.

As far as I can tell only the products that Senior managment say are pursuable either by contract or RFQ should fall under the ISO requirements.

Is my thinking correct?

Hi and welcome to the cove.

I think you will be able to limit the scope of your registration to include only products deliverable under a commercial contract. This will be stated on your certificate and in your Quality Manual. You need to discuss this with your registrar. Before going much further, find one that has experience with the type of operation and products you have and discuss your plan. They also have different financial arangements for registration, so this will also be a consideration. We have discussed the merits and cost of various registrars in other threads in the cove, so you might want to do a search here. For starters look at this thread.

[al40]

My company does SBIR research with acoustics for the DOD.

We have developed some patents that we would like to have commerically reproduce by a subteir contactor and our primary customer is requiring us to have ISO9001:2000 prior to the contract signing.

So we will only put those items that fall into our NPD under the scope of ISO.

Again management has made the commitment to become ISO certified and hopefully a new company they are starting will also be ISO certified that most likely will be the sub-teir contactor for their pre-production prototypes.

[al40]

Again,
I have been hired to implement the system and get them ready for certification, I have the full support of the executive committe, they even set in the four hour long ISO training with the workers and they have voiced their commitment to ISO.

Again we do not produce any products other than the future pre-production prototypes.

All other activiteis in the past has been research done on SBIR's. The only deliverables were either a DOD prototype or a report that had to meet the SBIR requirements.

The problem I'm having is where do I draw the line?

Right now I had to basically tag all their research equipment with "reference only" tags. Since they are not in the calibration system and management has decieded that the research equipment doesn't have to be

Their development side only has 5 pieces of equipment in calibration and they only have 10 suppliers that would affect quality of the final product.

So I have a very simple system the only problem for me is the research vs. design issue.

Thanks,

[Graeme]

Allen,

I am working with an electronic calibration lab that is a very small department (10 people) of a very large (over 50,000 people) company. The calibration lab is registered to ISO 9001:2000 -- the rest of the company is not registered to anything.

We found that they key was to be able to very clearly define and enforce a "fence" around the lab. Everything inside the fence is part of the lab and under the QMS; everything outside the fence is either a supplier or a customer. (Yes, that means the entire rest of the company!)

That sort of idea may be able to work for you as well. Can you define research as a supplier to development? If ncessary, can you also define HR, finance, shipping & receiving, IT and so on as either a customer or a supplier (or both)? Can your definitions be made to stick? If so, it might be workable. You will certainly have to check with some registrars as well to see if they will accept it, but you are probably going to have to shop around anyway to find someone with a qualified auditor with the proper clearances.

In Reply to Parent Post by Allen M.

Right now I had to basically tag all their research equipment with "reference only" tags. Since they are not in the calibration system and management has decieded that the research equipment doesn't have to be

Their development side only has 5 pieces of equipment in calibration and they only have 10 suppliers that would affect quality of the final product.

Allen,

This is a side issue to your main question ...

I don't understand why the research people don't want their equipment calibrated. I recall that one key factor of research is reproducibility -- the researcher or anyone else should be able to repeat the work in the same manner and get the same results. If the test and measurement equipment is not calibrated, reproducibility might be impossible because, without calibration, they have no idea what the measurements really are! Yes, there are numbers on the screen, but are they valid?

Calibration with proper traceability provides the vital assurance to a reseacher that he or she is reading values that are actually meaningful. Even if the work can't be published in the open press they still have to do reports to the government sponsor ... and those reports have to be as truthful as possible. Calibration gives assurance that, if used properly, the instruments are telling the truth.

As a longtime friend of many of us said -- "does it matter if the measurement is wrong? If it does, calibrate the instrument. If it doesn't matter, then why are you making the measurement?"

[al40]

In Reply to Parent Post by Graeme

Allen,

I am working with an electronic calibration lab that is a very small department (10 people) of a very large (over 50,000 people) company. The calibration lab is registered to ISO 9001:2000 -- the rest of the company is not registered to anything.

We found that they key was to be able to very clearly define and enforce a "fence" around the lab. Everything inside the fence is part of the lab and under the QMS; everything outside the fence is either a supplier or a customer. (Yes, that means the entire rest of the company!)

That sort of idea may be able to work for you as well. Can you define research as a supplier to development? If ncessary, can you also define HR, finance, shipping & receiving, IT and so on as either a customer or a supplier (or both)? Can your definitions be made to stick? If so, it might be workable. You will certainly have to check with some registrars as well to see if they will accept it, but you are probably going to have to shop around anyway to find someone with a qualified auditor with the proper clearances.





Allen,

This is a side issue to your main question ...

I don't understand why the research people don't want their equipment calibrated. I recall that one key factor of research is reproducibility -- the researcher or anyone else should be able to repeat the work in the same manner and get the same results. If the test and measurement equipment is not calibrated, reproducibility might be impossible because, without calibration, they have no idea what the measurements really are! Yes, there are numbers on the screen, but are they valid?

Calibration with proper traceability provides the vital assurance to a reseacher that he or she is reading values that are actually meaningful. Even if the work can't be published in the open press they still have to do reports to the government sponsor ... and those reports have to be as truthful as possible. Calibration gives assurance that, if used properly, the instruments are telling the truth.

As a longtime friend of many of us said -- "does it matter if the measurement is wrong? If it does, calibrate the instrument. If it doesn't matter, then why are you making the measurement?"

I'm not sure if we can since our customer wants the company to be ISO certified.

I'm really stuck on this one,
I'm looking at having any military research out of our ISO scope, so we don't have to address research. As far as calibration of equipment goes, the equipment used is mostly signal generators, microphones, and a couple of multmeters, and micrometers.

Any equipment used in receiving or design will be in the calibration system.

Any help or documents I could benchmark against would be welcome.

[Al Rosen]

In Reply to Parent Post by Allen M.

As far as calibration of equipment goes, the equipment used is mostly signal generators, microphones, and a couple of multmeters, and micrometers.

Then it shouldn't cost very much to calibrate. From experience, that multimeter will invariably find its way into production, test or design. What is the objection to calibrating the development equipment, if there isn't much of it?

Look at this thread, as an example.