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Defining Quality Assurance's Role in R&D (Product and Process Development)

v9991

Trusted Information Resource
#1
I would expect that QA to play the role of harmonizing/integrating the "standards/requirements & learnings" into SOPs and monitoring the compliance.
while doing so, there is a tug of war of simplifying the documentation&processes as per the relevance to R&D.
That is fine....the clarity would evolve in due course, as per the experience/maturity of processes & people...

But real question is, to what extend does QA gets involved in development processes.
1) i am just trying to find equivalent activities of mfg.QA vs dev.QA
viz., what is equivalent of process control (is it dev.control through processes like FMEA)
what is equivalent of batch release (is it design/product.release through certain development reports)
of course, audits, document-control etc., would be same.

AND
2) to what extend does QA has say/influence in risks taken at different stages of development.
This is of significance because, often the assumptions made at later stage are complicating certain basic errors/gaps induced into design/product affecting robustness of mfg.process

thanks for your thoughts.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
I would expect that QA to play the role of harmonizing/integrating the "standards/requirements & learnings" into SOPs and monitoring the compliance.
while doing so, there is a tug of war of simplifying the documentation&processes as per the relevance to R&D.
That is fine....the clarity would evolve in due course, as per the experience/maturity of processes & people...

But real question is, to what extend does QA gets involved in development processes.
1) i am just trying to find equivalent activities of mfg.QA vs dev.QA
viz., what is equivalent of process control (is it dev.control through processes like FMEA)
what is equivalent of batch release (is it design/product.release through certain development reports)
of course, audits, document-control etc., would be same.

AND
2) to what extend does QA has say/influence in risks taken at different stages of development.
This is of significance because, often the assumptions made at later stage are complicating certain basic errors/gaps induced into design/product affecting robustness of mfg.process

thanks for your thoughts.
Hi,

I guess some parts of your concerns are generic to most regulated industries, however, every specific industry has it's own little practices, conventions and highlights. I'm not sure what industry you come from; I will try to answer from a medical devices perspective, as I have intimate knowledge of R&D processes in this industry (and also a broader perspective as a QA/RA professional in it).

In my opinion, QA'a role in R&D resembles its role in manufacturing, though it's not exactly the same.

I'd say the equivalent of process control is design control (risk management, of which FMEA could be a part, is an important part of design control processes, though it shouldn't be unique to the R&D stage). This is a very broad and general statement.

The equivalent of batch release comprises several types of design-control-related activities, in my opinion. It may include formal design reviews at critical milestones; design verification; various validation activities and finally the design transfer process. All of these are expected to be formal & controlled processes, documented in formally approved reports and other design output documents, that eventually lead to a "release" of a design to production (analogous to a batch being released for sale).

As a general statement, I think that QA staff should not act as process rangers in the R&D domain, but rather focus on "educating" R&D staff about design control best practices, and the importance / significance of doing it right. Educated R&D personnel that really care about quality (and from my experience - most of them do) can become the best R&D QA personnel.

To address the explicit concern about identifying risks upstream - I think it's a true concern, and there are at least 3 important issues in handling it well:
1. Make R&D people very aware of their power (for better or for worse) in that sense;
2. Make sure a comprehensive & thorough risk management process is established and properly implemented from the earliest stages of R&D (I think this is an important role for the QA member in the R&D team); and
3. Get all downstream stakeholders - manufacturing, logistics, purchasing, marketing, customer support, service etc. - involved in that process together with R&D staff FROM THE VERY BEGINNING.

Cheers,
Ronen.
 

michellemmm

Quest For Quality
#3
I would expect that QA to play the role of harmonizing/integrating the "standards/requirements & learnings" into SOPs and monitoring the compliance.
while doing so, there is a tug of war of simplifying the documentation&processes as per the relevance to R&D.
That is fine....the clarity would evolve in due course, as per the experience/maturity of processes & people...

But real question is, to what extend does QA gets involved in development processes.
1) i am just trying to find equivalent activities of mfg.QA vs dev.QA
viz., what is equivalent of process control (is it dev.control through processes like FMEA)
what is equivalent of batch release (is it design/product.release through certain development reports)
of course, audits, document-control etc., would be same.

AND
2) to what extend does QA has say/influence in risks taken at different stages of development.
This is of significance because, often the assumptions made at later stage are complicating certain basic errors/gaps induced into design/product affecting robustness of mfg.process

thanks for your thoughts.
I am not sure if you are dealing with hardware or software... In any case, QA 's role is:

1- To assure developers/designers/ Configuration managers are doing the "right" things.
2- They are doing it right (per plan and standards).

The rest is up to your organization.

I am attaching a QA process map that I constructed recently that shows QA role throughout software lifecycle. This map does not list the tools (FMEA, CP, etc...) Depending on the complexity of the program, you can select one.
 

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A

Al Dyer

#4
v9991,

I've started 3 responses to your post and deleted them all to come up with this:

What exactly is the defined role of QA in your organization? Departments do what they are told to do by management.

Great question that needs some input!

Al...
 

v9991

Trusted Information Resource
#5
v9991,

I've started 3 responses to your post and deleted them all to come up with this:

What exactly is the defined role of QA in your organization? Departments do what they are told to do by management.

Great question that needs some input!

Al...
With specific reference to R&D, QA is taking charge of
* compliance to development development protocol, (SOP + checklistssS)
* setting the specification,
* releasing the product to manufacturing;
Of course this is all in addition to the common aspects such as training, audits, documentation control, change control, qualifications etc.,
 

Ronen E

Problem Solver
Staff member
Moderator
#6
With specific reference to R&D, QA is taking charge of
* compliance to development development protocol, (SOP + checklistssS)
* setting the specification,
* releasing the product to manufacturing;
Of course this is all in addition to the common aspects such as training, audits, documentation control, change control, qualifications etc.,
Hi,

Sounds like QA in your organisation is the "local police force" and the source of all knowledge...:lol:

I've seen that approach in action in many organisations, and in my opinion it is detrimental to R&D staff's self-perception, quality attitude and performance.

Why not give them more autonomy and responsibility, and leave QA with oversight / auditing, to ensure compliance?

I believe R&D and marketing are best positioned to set specifications, while QA supervise and provide the final formal authorization. The same would apply for product release - R&D should do all the groundwork up to the point where they think all requirements have been met; then QA can verify and formally sign-off. Of course real-time monitoring is always recommended, to avoid surprises later, but I honestly believe this should come as objective feedback rather than ongoing "law enforcement".

I also believe functions such as training, document control, change control and qualifications (in R&D domain) can, and actually better, be carried out by R&D personnel, with QA's necessary formal oversight (authorization etc.) and objective feedback, in cases where processes go off-tracks. It would help build a sense of ownership and caring in R&D, while the core-knowledge is there anyway.

Cheers,
Ronen.
 
Last edited:

v9991

Trusted Information Resource
#7
Hi,
Sounds like QA in your organisation is the "local police force" and the source of all knowledge...:lol:
I almost agree with that...it is an interesting perception there..... for a moment lets imaging that its true...
Could you throw some practical/measurable/implementable thoughts to change that perception.!

In real world out-there, need to acknowledge that R&D (like manufacturing) is always in a rush to get the product to shop floor. (also need to understand the complexity of long product transfer life cycles..) Also remember that in real world, there very few R&D personnel who care for system/processes.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
I almost agree with that...it is an interesting perception there..... for a moment lets imaging that its true...
Could you throw some practical/measurable/implementable thoughts to change that perception.!

In real world out-there, need to acknowledge that R&D (like manufacturing) is always in a rush to get the product to shop floor. (also need to understand the complexity of long product transfer life cycles..) Also remember that in real world, there very few R&D personnel who care for system/processes.
Dear friend,

My thoughts are actually based on living and working "out there", "in the real world", both in R&D and in QA/RA capacities. I am very aware of the above notions, yet I know (from experience) it can be done differently. If you accept your current reality as a given you'll find it very hard to improve :(

Regarding changing perceptions / organisation mindsets / cultures - I'm no expert on that so I can't really give you any hard & fast tools that will show quick results; however, I noticed that some guys with such expertise attend the forums, so hopefully one of them will join the discussion with some insights... In my own capacity I would just back off a little (as QA) and see how R&D react. You might be surprised. I respectfully disagree with you that R&D personnel who care for system/processes are very few (in general), and if that's the case in your setting maybe that's part of the problem to begin with. At least in medical devices, the right QS background and approach are essential prerequisites for any decent R&D guy.

Regarding the pressure to show quick results - I wasn't comparing between a state of compliance and a state of being out-of-compliance. Even if we assume that working out of compliance yields faster results (which is debatable either way), that wasn't my point. I was merely comparing a situation were compliance is achieved by QA-policing, vs. letting R&D be big boys with just the necessary top-level monitoring by QA.

Cheers,
Ronen.
 
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