Early Research & Development - ISO 13485:2003 requirements Clarification

  • Thread starter TempusVernumProcella
  • Start date
T

TempusVernumProcella

#11
Re: R&D 13485:2003 Clarification...

Tempus,

I've highlighted your words that indicate to me that you are trying to impose your will on your R&D team instead of listening to them.

I agree with Laura's advice on this in #7 and Somashekar's in #8.

To whom does the QMS belong? How is the QMS fulfilling the needs of the R&D team. To paraphrase Edision, many R&D failures may be necessary for their eventual success.

They may already realize the importance recording what does not work but see the recording methods mandated by your QMS as unhelpful.

Lastly, periodic multidisciplinary design reviews for resulting in effective design output may not be appropriate to the sand-box or skunk works activities at the front-end of truly innovative R&D.

John


All excellent points, to be sure. Here's where I'm getting confused, though- ISO 13485:2003, 7.3 Design and Development states that "the organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification, validation and design transfer activities that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Planning output shall be documented, and updated as appropriate, as the design and development progresses (see ISO 13485:2003, 4.2.3 Control of Documents)."


So... having regulated documents IS necessary... :frust:
 
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Marcelo

Inactive Registered Visitor
#13
All excellent points, to be sure. Here's where I'm getting confused, though- ISO 13485:2003, 7.3 Design and Development states that "the organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification, validation and design transfer activities that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Planning output shall be documented, and updated as appropriate, as the design and development progresses (see ISO 13485:2003, 4.2.3 Control of Documents)."


So... having regulated documents IS necessary...
And that?s the problem qith most of the comments.

The thing is, the standard has not defined WAY to control research. But it does not mean that it expects that research is done in a total chaotic way.

If you go to the first "control", it is for design inputs. Those are the product requirements (so you already has decided in which product to develop). After that, there?s no specific way to control developt itself (besides design review at stages), and then design output.

So, there?s a little step-by-step control scheme after design input.

There?s no step-by-step control scheme prior to that (research), which means that you can control the way you want. There?s no specific requiremet, such as "resarch input" or "research output".

But that does not mean that you should not include some, even as a way to manage how thngs are done.

That?s why I mentioned in the comment before, if you defined that research has to follow some steps, those would became part of your QMS (even if the standard does not require specific controls).
 

Marcelo

Inactive Registered Visitor
#14
Also, you should take care because, a lot of times people THINK they are doing only research, they already are doing some development (which should follow the mentioned step-by-step controls). One examle is when people create prototypes, a lot of times people create initial prototypes then use then further down the development process..so, since the beginning, those would need some control.
 
T

TempusVernumProcella

#15
Also, you should take care because, a lot of times people THINK they are doing only research, they already are doing some development (which should follow the mentioned step-by-step controls). One examle is when people create prototypes, a lot of times people create initial prototypes then use then further down the development process..so, since the beginning, those would need some control.


Marcelo,
Thank you for your feedback. :agree1: I know for fact that initial design phases for prototype's are indeed cataloged/recorded as soon as an idea becomes a physical manifestation. The grand issue, unfortunately, is the bureaucratic paperwork... Our QMS, that was written by a previous QMS manager, states that R&D starts with an idea and then must be logged; which is, in my opinion, highly unrealistic. Because of this current process, R&D is 'falling out of compliance'. So, yes, restructuring our current system and working with R&D to effectively generate a functional process is most necessary.
 

John Broomfield

Staff member
Super Moderator
#16
Last edited:
M

MIREGMGR

#18
I read the thread from the beginning, and my initial impression was that the "R&D" people were product creators/developers who just wanted to avoid having to do any documentation work, or as little as possible.

The last few posts seem to have gone in that direction.

My view is that, except maybe in academic labs and a few pure-science organizations, "R&D" is just early stage product development.
 

Ronen E

Problem Solver
Staff member
Moderator
#19
Also, you should take care because, a lot of times people THINK they are doing only research, they already are doing some development (which should follow the mentioned step-by-step controls). One examle is when people create prototypes, a lot of times people create initial prototypes then use then further down the development process..so, since the beginning, those would need some control.
There should be a clear product development project kick-off. At that point anything brought forward from the Fuzzy Front End (FFE) phase should be documented. This can be done retroactively. Sometimes prototypes are even rebuilt, in a more orderly way, so that a good documented and controled basis exists for the next phases. This is not necessarily a bad thing.
 
Last edited:

somashekar

Staff member
Super Moderator
#20
Marcelo,
Thank you for your feedback. :agree1: I know for fact that initial design phases for prototype's are indeed cataloged/recorded as soon as an idea becomes a physical manifestation. The grand issue, unfortunately, is the bureaucratic paperwork... Our QMS, that was written by a previous QMS manager, states that R&D starts with an idea and then must be logged; which is, in my opinion, highly unrealistic. Because of this current process, R&D is 'falling out of compliance'. So, yes, restructuring our current system and working with R&D to effectively generate a functional process is most necessary.
You have such a good point here...
Research feeds design and development. Design and development feeds the Purchasing and the product & service provision.
There is no fine line dividing the Research and D&D. It is how you set up your QMS and how you want it to work for you effectively.
All you need are :
A Design plan, updated as appropriate, as the design and development progress.
Approved design inputs, which are complete and unambiguous. (Do not miss the risk management)
The Design outputs (As in note of 7.3.3 of the ISO 13485)
Records of the results of the design reviews, and necessary actions thereof
Records of the results of the design verification and necessary actions thereof
Records of the results of the design validation and necessary actions thereof
 
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