Early Research & Development - ISO 13485:2003 requirements Clarification

  • Thread starter TempusVernumProcella
  • Start date

sagai

Quite Involved in Discussions
#21
Interesting discussion and there are plenty of valid points.

I have also encountered several times similar kind of cases, so I would reassure the original poster to look for some kind of certainties in the research field that assures that they are having some level of process awareness.
Not because of any standards rather of common sense and enhancing business benefits of increased process awareness.
Unless there is a planned approach how to transfer projects from research to let say “development” there is always a headache at the end.
Plenty of times research produces something that becomes palatable for sales and there is a very limited time to apply safety measures and to enhance product (prototype) maturity therefore there is a narrow and slippery slope only for “design”.

Being too lengthy here, so my recollection would be that it would be beneficial to look into product development as a whole that includes research, design, whatever and then see if it really fit for purpose (recall tendencies, level of customer satisfaction, etc.) to determine if the scrutiny applied to research activities are really the ones that help the business.

To be honest I am looking less and less into standards. I am tired of them and help more or less none for me. Reasoning with common sense however helps lot more whilst dealing with research/development engineers ... :)

Cheers!
 
Last edited:
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#22
<snip> My question is:IF R&D has projects that only exist on "scratch paper" (so to speak) that the status is investigatory and zero physical experimentation/prototypes have occurred, is it a CAR or PAR if their QMS-controlled documents are not filled out? <snip>
If it is on a napkin from a "luncheon", it's a non-issue. But, if the napkin is brought in and a "project" is formed from it, it is now a "company" property so it has to be entered into the company's system.

Typically, during Research and Development there is no such thing as a non-conformance. It's research. Unless it is determined that the researcher has falsified information (Not unheard of) there is no issue other than management determining how, why, etc. it happened and doing a standard Corrective Action, if that. Management may never know that napkin drawing ever existed. :notme:

HOWEVER - What do you mean by: "...their QMS-controlled documents are not filled out..."?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#24
Yup, but the point is - What are their R&D procedures, or - Are there any to begin with. QA should not be "forcing" anything. R&D should have their own procedures, documented or (worst case) "tribal knowledge".
 

Ronen E

Problem Solver
Staff member
Moderator
#25
Yup, but the point is - What are their R&D procedures, or - Are there any to begin with. QA should not be "forcing" anything. R&D should have their own procedures, documented or (worst case) "tribal knowledge".
It is well established by research that FFE activities are not procedural by nature and don't respond too well to "proceduarlization". The phase in which procedural thinking starts to be effective and efficient is the D&D phase which begins with Design Planning.
 

Marcelo

Inactive Registered Visitor
#27
Quote:
In Reply to Parent Post by Marc View Post

Yup, but the point is - What are their R&D procedures, or - Are there any to begin with. QA should not be "forcing" anything. R&D should have their own procedures, documented or (worst case) "tribal knowledge".

It is well established by research that FFE activities are not procedural by nature and don't respond too well to "proceduarlization". The phase in which procedural thinking starts to be effective and efficient is the D&D phase which begins with Design Planning.
However, the OP original question is related to NCs. And NCs are related to current, established requirements.

The discussion went to "research is not required to be controlled by standards" or research does not respond well to procedures, but this in fact does not answer the question.

What the OP stated,

he 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.
And as I mentioned

ISO 13485 does not have "explicit" requirements for R&D, but that does not mean that the organization can?t include their own set of requirements and thus this would be part of the ISO 13485 QMS anyway.
So, to the original question, I would say that, if the procedures in place do require that Research be recorded and follow a "procedure", and if it?s not being done, then it?s a NC related to current requirements of the QMS.

After the NC, one of the possible corrective actions may be to remove the constraints of research (but I would suggest keeping a general requirement for some recording), but this is a second step.
 
Last edited:
T

TempusVernumProcella

#28
Yup, but the point is - What are their R&D procedures, or - Are there any to begin with. QA should not be "forcing" anything. R&D should have their own procedures, documented or (worst case) "tribal knowledge".

Currently our company doesn't have R&D "procedures", and to my knowledge the R&D department does not have any form of traceable paperwork other than notes on lined, college-ruled paper or within [confidential] lab notebooks or electronically stored. The QMS-regulated documents I reference is in regards to the documents our previous QMS Manager generated to better track R&D progression as it pertains to the company; since R&D operates on a slightly different level/flow of life and because sometimes projects go 'on-the-back-burner', these forms of data/time control and records are oft times forgotten and not updated with any inclination that a project is on hold or what-have-you; though a CA re-training/reminder of the process flow and importance of documentation was implemented earlier this year (NOTE: additional R&D per that project CA has not been conducted since, no new data accumulated)
SO...
Herein lies the question... Do we restructure the QMS to completely accommodate R&D and eliminate their bureaucratic trail/link into the company QMS until an actual prototype of some kind is in design (which would warrant begin-stages of Configuration Management) and have their processes be entirely their own? -OR- Do we issue a CA/PA to reinforce ISO's requirement for data tracking in Design and Development from its first stages of panning???
:deadhorse: :frust: :confused: :bonk:
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#29
Do we restructure the QMS to completely accommodate R&D and eliminate their bureaucratic trail/link into the company QMS until an actual prototype of some kind is in design (which would warrant begin-stages of Configuration Management) and have their processes be entirely their own?
Having been on both sides (R&D and QA) this is what I would recommend your general approach should be (refer to Marcelo's last post above for more detailed recommendations).

OR- Do we issue a CA/PA to reinforce ISO's requirement for data tracking in Design and Development from its first stages of panning???
Why do you need to "reinforce"? The standard represents best practices. IMO, if you try to do that all you will get is wasted energy on both sides. All you need to require is that by the time a D&D project kicks off all relevant documentation is formally made available (in whatever way). You could even conduct an annual review with R&D of what sort of information was missing (not documented) for each such project, and how much resources were consumed to close the gap. You could then trend the outcomes and initiate a CA based on solid information. Such CA would be proportional with the problem (if there is one) and the actual good of the company. Most important, keep the R&D team close in that improvement process.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#30
However, the OP original question is related to NCs. And NCs are related to current, established requirements.

The discussion went to "research is not required to be controlled by standards" or research does not respond well to procedures, but this in fact does not answer the question.

So, to the original question, I would say that, if the procedures in place do require that Research be recorded and follow a "procedure", and if it?s not being done, then it?s a NC related to current requirements of the QMS.

After the NC, one of the possible corrective actions may be to remove the constraints of research (but I would suggest keeping a general requirement for some recording), but this is a second step.
I agree. I went off-topic a bit. I read this:
<snip> My question is:IF R&D has projects that only exist on "scratch paper" (so to speak) that the status is investigatory and zero physical experimentation/prototypes have occurred, is it a CAR or PAR if their QMS-controlled documents are not filled out? <snip>
The "only on scratch paper" part got me because I have seen it a lot over the years. The old "we were thinking about things and did some "napkin" work. Essentially at that point there isn't even anything official and no system to follow. As soon as it is started in their system, then all system requirements apply.

It's kind of company dependent.

In one company a couple of people chatting about an idea and maybe doing a "napkin" sketch or figures isn't officially in the system. It's just them "thinking".

In another company it can be that the people in R&D are required to keep notebooks and even "chatter" about an idea between colleagues are required to be noted, so it's part of their system requirements and it's a non-conformance if they don't put <what ever it is> in their notebook.

In this case, my question would be what "only exists on "scratch paper"" means and whether their system/procedure(s) address what ever "scratch paper" is.
 
Thread starter Similar threads Forum Replies Date
J EDMS for Very Early Drug Development (Research/Drug Discovery) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
P IEC 62304:2006 A1:2015 - Software from the early 1990s IEC 62304 - Medical Device Software Life Cycle Processes 4
M Informational FDA Panel: Too early to pull textured breast implants over cancer risk, need more data Medical Device and FDA Regulations and Standards News 0
Sidney Vianna Interesting Discussion World wide energy demand will peak in the early 2030's Sustainability, Green Initiatives and Ecology 0
Q Is EN 55011:2009+A1:2010 is expiring in early 2019? Other ISO and International Standards and European Regulations 1
Marc Air Pollution in the Early 21st Century Coffee Break and Water Cooler Discussions 5
S Final FDA Guidance on IDEs for Early Feasibility Clinical Studies - 2013 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Best Attribute Data Sampling Plan - Early Production Containment Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K Tips 'n Tricks for getting a Job in the early 21st Century Career and Occupation Discussions 1
Q Reduced Device License Fee was rejected for being sent in too early Canada Medical Device Regulations 2
G ISO/DIS 14045 - Anyone have an early draft copy? Miscellaneous Environmental Standards and EMS Related Discussions 2
V Evidence for Preventive Action & Early Warning Vigilance procedure Preventive Action and Continuous Improvement 4
J Today it's 'Leave The Office Early' Day Career and Occupation Discussions 2
P Early versus Late delivery from suppliers - what's the acceptable ratio? Quality Tools, Improvement and Analysis 6
Stijloor ASQ Membership Renewal Request Comes Early - Will you renew?? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 35
M Risk Management - AS9100 revision C - Early advice please! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
A Juran is dead - Why the thread is closed so early? Philosophy, Gurus, Innovation and Evolution 2
Jim Wynne Never believe early news reports Coffee Break and Water Cooler Discussions 7
Marc When Flying, How early do you get to the airport? Travel - Hotels, Motels, Planes and Trains 25
Q Early Spring Cleaning - Finding Old Documents and Specifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Retiring Early or Never? Coffee Break and Water Cooler Discussions 65
T "Creative" ways to handle Early Production Containment Misc. Quality Assurance and Business Systems Related Topics 9
Marc GM in early talks to buy Chrysler World News 6
C Graph Choice For Monitoring DOA's (Dead On Arrival) and ELF's (Early Life Failures) Statistical Analysis Tools, Techniques and SPC 5
T AS9003 becoming obsolete as early as 2008??? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D An Early Brush with Design of Experiments Design and Development of Products and Processes 7
M Aspect Indentification? Early stages of ISO 14001 implementation ISO 14001:2015 Specific Discussions 4
C Reasons for early termination of an audit? General Auditing Discussions 23
J GM's GP-12 Early Production Containment applicable to Tier 2 Suppliers? Customer and Company Specific Requirements 14
Marc BP Meets ISO 14001 Targets 8 Years Early Miscellaneous Environmental Standards and EMS Related Discussions 5
Marc Containment FMEA and GP-12 (GM procedure for early production containment) FMEA and Control Plans 9
Marc The Future of Quality - An Early Discussion Philosophy, Gurus, Innovation and Evolution 11
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
A VDmax25 and cGMP requirements for "research use only" products Other Medical Device Related Standards 1
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
M Exemption Clauses for Research, Demonstration, etc. Other Medical Device Regulations World-Wide 2
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
S Medical Device Research Use Only (RUO) label Other Medical Device Regulations World-Wide 4
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
N Dataset for Academic Research - Infusion pump flow IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T Research Medical Device EU - Requirements and Regulations EU Medical Device Regulations 13
Y Change Management in a very complex Research Organization Misc. Quality Assurance and Business Systems Related Topics 3
L EU MDR CRO (Contract Research Organization) requirements for Clinical Investigations EU Medical Device Regulations 1
T Control of R&D (Research and Development) Parts and Equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
I AS9100D - Interview Request - I'm doing research Misc. Quality Assurance and Business Systems Related Topics 1
I Design & Development, Research and Innovation in the Medical Device framework ISO 13485:2016 - Medical Device Quality Management Systems 3
R University Research Project - Management Review Management Review Meetings and related Processes 17

Similar threads

Top Bottom