R&D and Design Process. Where the borders are?

D

Daniele Italy

#1
Helloand happy new year.
Someone could suggest me where is the limit between Research and Design ( 7.3).
In our organization we have 100 people involved in Research and there are problem in trying to "chain" them in following the Standard since the very beginiing of the "product idea"( also not feasible and efficient for the research ). I'm trying to set the Research fase since the product is in prototype phase ( in this phase many times there are not any clear customer inputs because the customers don't know what they want to have, they are trying to define the product with our Research labs and many many different in configuration prototypes are tested). Till this stage we are using the "Stange and Gate" management of development approach.
When the prototype has a sufficient definition or an initial customer technical request, the Research project is transferred to the industrialization process and managed by the 7.3 of ISO 9001.
I would like to share my experiences and have the opnion of some of you working in organizations where the Research aspect is predominant on the production. Maybe better if someone working in Corporations having the HQ focussed on R&D and the production facilities spreaded in other countries or far from the HQ.
Thank in advance for the help
:agree1:::cool:
 
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S

selena15

#2
Hi daniele

A quick glance in the iso 9000, would give you a difinition of design and dev.

Design and development

Design and development is a set of processes which use resources to change requirements (inputs) into characteristics or specifications (outputs).

Research is one of the set of processes, and in this case treat it as this. there is no barrier, it is one f the step of design. I fund these definition above in the internet but this is what the ISO say anyway . all the step since the idea since your prototype , is one process that you can chain as what you suggest and i think the different product ideas that they product is their output that it submitted to test and of course can be accepted and in this case go to your industrialization process, otherwise come back to your dream team of research
I hope that i helped you

Btw, i have a question, what is the nature of your company and why your research dept is so huge as you said ?
 
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J

JaneB

#3
Daniele,

You don't have to chain people up. The various requirements specified by ISO need to be met, but you have flexibility in how you meet them.

Prototyping is a valid way of establishing customer requirements. If your 'design' process is too rigid to enable/allow this, make it more flexible so that it does!


Helloand happy new year.
Someone could suggest me where is the limit between Research and Design ( 7.3).
In our organization we have 100 people involved in Research and there are problem in trying to "chain" them in following the Standard since the very beginiing of the "product idea"( also not feasible and efficient for the research ). I'm trying to set the Research fase since the product is in prototype phase ( in this phase many times there are not any clear customer inputs because the customers don't know what they want to have, they are trying to define the product with our Research labs and many many different in configuration prototypes are tested). Till this stage we are using the "Stange and Gate" management of development approach.
When the prototype has a sufficient definition or an initial customer technical request, the Research project is transferred to the industrialization process and managed by the 7.3 of ISO 9001.
I would like to share my experiences and have the opnion of some of you working in organizations where the Research aspect is predominant on the production. Maybe better if someone working in Corporations having the HQ focussed on R&D and the production facilities spreaded in other countries or far from the HQ.
Thank in advance for the help
:agree1:::cool:
 
D

Daniele Italy

#4
Selena15
Thank you for the suggestions.You know how difficult is to give directions to the scientists, they live in their "dream" world and they don't like any costriction indeed.
I would not like to "cut" their wings during the first stage of the idea development but my problem is how and when I could ask them to start to follow a more defined design process as requested by the standard.

Now the more difficult part of your question: what we are producing?
We are expert of gas-surface interacions and in metallurgy and production of exhotic metal alloys. There is one of our products into the small lamps backlighting your LCD or PC display, we also develop metal alloys for industrial application and now we are entering into medical devices and equipment with some super elastic alloy ( also used for into the car industry)... in few words a big mess :magic:. There are 100 scientists working in our Head Quarter for studying the most strange and unusual alloys for future product ( I hope) applications.
Happy newyear :D
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Unless an organization's product is pure research, the typical research function falls outside of the scope of ISO 9001. 7.3 of ISO 9001 starts (IMO) when an organization engages with a product design phase.

Conceptual research, to determine viability of new technologies, material, features, etc... is not covered in 7.3.

Typically, as an output of research processes, an organization might make a determination to trigger a commercial development of a product. That is when 7.3 kicks in.

As mentioned several times in the past, just because pure research does not follow 7.3 requirements, it does not mean that some basic quality principles should not be applied.

A typical question: should R&D instruments be calibrated? Well, when you consider that, many times, research is dealing with state of the art measurements and decisions to invest millions of dollars into a full fledged Design and Development phase are an outcome of the research results, wouldn't you like to have confidence that the research results are reliable?
Wouldn't you like to manage your risks, also during this critical phase?
 
D

Daniele Italy

#6
Sidney Vianna
You are right in fact, we are maintaining all the measuring instruments of the R&D lab under calibration.
It is a quite expencive job ( even if most of them are internally calibrated by masters) and also sometime very difficult... how is it possible to calibrate a Quadrupole Mass spectrometer or a DSC or Xray Auger ? No external master are available for these measurements than an internal calibration procedure has been settled.

But the R&D results are too important for having even a small doubt about the measuring system.
:bigwave:
 

Helmut Jilling

Auditor / Consultant
#7
Unless an organization's product is pure research, the typical research function falls outside of the scope of ISO 9001. 7.3 of ISO 9001 starts (IMO) when an organization engages with a product design phase.

Conceptual research, to determine viability of new technologies, material, features, etc... is not covered in 7.3.

Typically, as an output of research processes, an organization might make a determination to trigger a commercial development of a product. That is when 7.3 kicks in.

As mentioned several times in the past, just because pure research does not follow 7.3 requirements, it does not mean that some basic quality principles should not be applied.

A typical question: should R&D instruments be calibrated? Well, when you consider that, many times, research is dealing with state of the art measurements and decisions to invest millions of dollars into a full fledged Design and Development phase are an outcome of the research results, wouldn't you like to have confidence that the research results are reliable?
Wouldn't you like to manage your risks, also during this critical phase?
I kind of disagree. I think ISO 9001 discusses design in broad terms. I agree that ISO does not explicitly mention R&D, nor make the distinctions between Product and Process Design as TS does. However, I think it infers it in the discussion. Cl 4.1 says to define all the activities of the organization. In some companies, R&D is done in a secret black box environment, totally removed from the rest of the organization. In most, however, design and R&D overlap significantly. It should be recognized that the activities exist, and the QMS (or EMS) should deal with whatever is appropriate for that organization.

HOWEVER, let me hasten to add, that does not meanthat all the R&D activities and procedures have to be documented, or locked down tight. They can be very flexible. It is up to the organization to decide what should be documented. But, I would expect it to show up somewhere in the processes.
 
S

selena15

#8
hi all
welcome Daniele:)
When i asked daniele about what they are producting , i had in my mind the exclusions possibilities. and IMO, as she said " There are 100 scientists working in our Head Quarter for studying the most strange and unusual alloys for future product ( I hope) applications."

i asking if not under their scope :mg:. i'm quiet confused and surprise about what you said, Sydney. i'm agree that their goal is not the research itself, but this is the way the meet their target isn't ?

i'm agree with helmut, the D&C in ISO infer the research, otherwise how do you explain " Design and development is a process (or a set of processes).
This process uses resources to transform requirements (inputs)

into characteristics or specifications (outputs) for products,
processes, and systems. " Research is one of these "set processes
as said Daniele; it is huge process into their organization and it is costing as you said ?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
i'm quiet confused and surprise about what you said, Sydney.
Apparently I have this innate ability....:tg:. Fundamentally, the problem resides with the fact that some people erroneously believe that ISO 9001 is an all encompassing business management standard, which is not. Some people believe ISO 9001 touches and addresses all processes, functions, areas, etc. of an organization, which it does not.
ISO 9001 has a defined scope of application. In my view, it does not include the typical Research function many organizations have. If 7.3 of ISO 9001 was titled: Research, Design and Development, I would agree with you, but it isn't.

I am sure some would disagree with that perspective. That is life. And the beauty of living in a democratic, free society where people can express their opinions.
 
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S

selena15

#10
That is life. And the beauty of living in a democratic, free society where people can express their opinions.
:lmao: agreed

#the problem resides with the fact that some people erroneously believe that ISO 9001 is an all encompassing business management standard, which is not#
I can ensure to you sydney that i don't think like this, but i know something, the activity or process which have an impact in the quality of product have to get the awareness of the organization as said iso in chap 4.1a)&b) .....

but as you said above, once again agreed
 
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