Early Research & Development - ISO 13485:2003 requirements Clarification

[TempusVernumProcella]

This may appear idiotic to anyone else, and mayhaps it's because I'm thinking about it too hard. Regardless, I'm going to ask...


To set the stage- We are an ISO 13485:2003-compliant in-vitro medical device manufacturer; I am currently conducting an internal (first-person) audit of our Research & Design/Development Department. Our R&D department isn't exactly on top of filling/filing the appropriate transitional process of our QMS R&D bureaucracy.

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?

Welcome to suggestions!

Thank you

 

[Reg Morrison]

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

ISO 13485:2003 has ZERO requirements associated with the product research process, which is different and distinct from product design and development.

So, if you are conducting an internal audit which objective is to ascertain the level of compliance of the QMS against ISO 13485, if you are bugging the people performing pure research, you are auditing out of the scope of the standard.

 

[TempusVernumProcella]

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

Thank you. Sometimes it helps just bouncing ideas/thoughts around.

 

[John Broomfield]

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

Tempus,

A nonconformity is a failure to meet requirements. You've not provided any evidence of a failure to meet a requirement.

Once you have a nonconformity it is too late for a PAR.

Once you have a nonconformity it may not be worthy of a CAR to remove its root causes. It may simply need correction.

Lastly, when auditing try asking the person monitoring conformity of the process (per 8.2.3) what they plan to do to correct a nonconforming process instead of assuming the role of supervisor.

That way you can keep your independence while reinforcing the process monitoring which should happen long before your audit.

John

 

[TempusVernumProcella]

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

Tempus,

A nonconformity is a failure to meet requirements. You've not provided any evidence of a failure to meet a requirement.

We do have QMS-controlled documents/guides for the R&D team that oft are undone or not completed. They track accurate notes and retain appropriate information on their own but are, simply, not filling out the necessary documentation as it applies to our QMS process. They have received a 'ding' on this account before, last year in fact. The CA then was to retrain R&D team and implement the necessary QMS documents upon the next official R&D review meeting per that project... Only, an official review of the project in conversation has not since been conducted.
So, knowing this, it seems a PAR may be the best option here.

 

[Marcelo]

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

ISO 13485:2003 has ZERO requirements associated with the product research process, which is different and distinct from product design and development.

So, if you are conducting an internal audit which objective is to ascertain the level of compliance of the QMS against ISO 13485, if you are bugging the people performing pure research, you are auditing out of the scope of the standard.

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.

 

[Laura Halper]

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

Tempus,
As has been mentioned, from what your describe, these R&D activities fall into the "pure research" area and are not covered by ISO 13485. You said that the researchers track accurate notes and retain appropriate information. This tells me that they have their own system (outside of the QMS documentation) that works well for them.

My suggestion is to enlist their help to simply describe their current system in the QMS. That way they don't have to do anything differently and you will have captured their process on paper. They probably feel (and maybe rightly so) that filling out the QMS documentation is not adding value to their research activities. Since ISO 13485 doesn't require them to, and since their system apparently works for them, why try to force them to change?

Maybe this perspective will help.

 

[somashekar]

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

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.

...
Any QMS including the ISO 13485 does not curb or restrict the scientific and research process. This will rather channelize the hard work put into the research when it gets into design and development phase for trials and manufacturing. As an output from the research one certainly can have all design inputs and design outputs which then feeds the verification / validation activities. It can at best make the D&D process as smooth as possible.
Systematic approach must not be confused with restriction of innovative approach.
Tempus, you have asked a fantastic question, that many here will benefit from.
Leave them alone. Do not audit them. Let them know how their brainy work can give great leads to D&D process.

 

[John Broomfield]

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

We do have QMS-controlled documents/guides for the R&D team that oft are undone or not completed. They track accurate notes and retain appropriate information on their own but are, simply, not filling out the necessary documentation as it applies to our QMS process. They have received a 'ding' on this account before, last year in fact. The CA then was to retrain R&D team and implement the necessary QMS documents upon the next official R&D review meeting per that project... Only, an official review of the project in conversation has not since been conducted.
So, knowing this, it seems a PAR may be the best option here.

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

 

[TempusVernumProcella]

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

...
Any QMS including the ISO 13485 does not curb or restrict the scientific and research process. This will rather channelize the hard work put into the research when it gets into design and development phase for trials and manufacturing. As an output from the research one certainly can have all design inputs and design outputs which then feeds the verification / validation activities. It can at best make the D&D process as smooth as possible.
Systematic approach must not be confused with restriction of innovative approach.
Tempus, you have asked a fantastic question, that many here will benefit from.
Leave them alone. Do not audit them. Let them know how their brainy work can give great leads to D&D process.

Thank you, Somashekar! By no means does our QMS aim to enclose or bind the productivity of R&D and their incredibly hard work. We simply have it in our group of company processes to be audited annually and within those processes are QMS-regulated documents that ought be filled out by the R&D... but aren't. So, to remedy this, I will coordinate with them further on restructuring the process to better-suit their needs. :


EVERYONE, for your inputs!