Functions and Responsibilities of Quality Assurance in R&D

[v9991]

QA has fair amount of clarity-expectation-acceptance wrt to their role/authority; These three areas are supported by either regulations - industry practices...etc.,

I am working with QA in technical area; here it gets little tricky in one of the above three areas.

Some one accepts the QA role to the extent of "verification of protocol/results" alone; Other feel that it must take care of "completeness";


But then how do we make a difference if we do not contribute to "planning/adequacy" of protocols. AND the point is R&D keeps cutting corners (in the name of meeting timelines, etc.,) and does not always ends up having positive results. (QA gets caught up in the act for not having a robust process!!!)

thank you for you thoughts.

 

[Ralph Long]

I don't know your process, but if QA has a part, to the extent of being evaluated based on the results, then they should have input at the planning stage.

Another approach: If the results are not positive, then there is a system failure (cutting corners as a possible cause) - requiring Corrective Action. Again, I don't know your process - but during the corrective action/problem analysis stage would be a good time to re-evaluate QA's input. This can be easy to justify (corrective action) if R&D had some metric that they were not meeting. If the situation is more perception (no metrics), then you may have some trouble justifying re-evaluation.

Remember - system evaluation and continuous improvement.

 

[v9991]

actually you have almost read the situation...

but if QA has a part, ..., then they should have input at the planning stage.

We have some sort of clearance mechanism before a product.process is transferred to manufacturing; and role (right-now) is restricted to looking for correctness(traceability, compliance); (adequacy aspects are only to the extent of defined process/systems ) completeness is still prerogative of R&D and PM

If the results are not positive, then there is a system failure (cutting corners as a possible cause) - requiring Corrective Action. ... - but during the corrective action/problem analysis stage would be a good time to re-evaluate QA's input. This can be easy to justify (corrective action) if R&D had some metric that they were not meeting.

yes, we do have established this approach; but the point is, its becoming re-trospective/reactive approach. (i.e, problems would be controlled from future batches). + that is adding further steps to the existing the systems/processes --> complex/detailed ...

If the situation is more perception (no metrics), then you may have some trouble justifying re-evaluation.
Remember - system evaluation and continuous improvement.

but if QA has a part, ..., then they should have input at the planning stage.
.

i agree with the point that i have to figure out a way to capture/quantify the "inputs" provided by QA. also consider the open points of clearance.

 

[somashekar]

But then how do we make a difference if we do not contribute to "planning/adequacy" of protocols. AND the point is R&D keeps cutting corners (in the name of meeting timelines, etc.,) and does not always ends up having positive results. (QA gets caught up in the act for not having a robust process!!!)

Unless the total quality management is built in from this early stage at all levels, and the design function stops false pleasing the management., someone like QA (if weak and willing to take the blame) will be made the blacksheep....

 

[v9991]

Unless the total quality management is built in from this early stage at all levels, and the design function stops false pleasing the management., someone like QA (if weak and willing to take the blame) will be made the blacksheep....

TRUE, that is exactly the point...dilemma is two fold...
1)what extent QA(concepts) be overviewed in R&D function...(that is very delicate to find a middle way...wihtout hampering the innovation/creativity of scientist + at the same time ensuring the completeness/adequacy of development (read avoiding cutting corners!!!))
2) should this aspect of overview be actually played by "team of independent-technical-experts" who actually take care of adequacy & completeness? this would still take care of independent reviews..(right?)

in either of the case, how to define&track effectiveness...

 

[somashekar]

without hampering the innovation/creativity of scientist

lets get clear between research development and design development ....
The first find out a new thing or an enhanced version of an available thing. They can do all the stuff they dwell upon in the lab and burn the midnite candle and come out with a creative stuff.... hurrray .. I have found this, ... Great ... ......leave them alone.
Design development now is about making this to the market, to the outside world perhaps in great numbers and now we have to get so many other inputs apart from the research input and get realistic to design output that can help make and deliver. Here the same personnel may be performing. They have to get the design plan considering all activities to the extent best possible, (review, varification, validation) the cost things to control, the regulation to control, and likewise many other stuff. They may even have to get back and tweek the research a bit if need be. The more they are informed about these in the beginning phase of the research, the better, however research gives one input to the design development process and lot more have to be then integrated. The design development process resulting in the design development outputs just expects this.
Are your design people sensitive to this.....Is your management sensitive to this .... or each one is driving and fooling themselves and all others >>>>>> ?

 

[v9991]

lets get clear between research development and design development ....
The first find out a new thing or an enhanced version of an available thing. They can do all the stuff they dwell upon in the lab and burn the midnite candle and come out with a creative stuff.... hurrray .. I have found this, ... leave them alone.
Design development now is about making this to the market, ...Are your design people sensitive to this.....Is your management sensitive to this .... or each one is driving and fooling themselves and all other >>>>>> ?

Where/how do you categorize a typical pharmaceutical R&D setup. (lets say ANDAs)?
1) some part of it has to do with "Research or Design" (to know if/which things(equipment & material) will work); the approach would be differ based on category. the categorization depends on the expertize and strengths on tha particular work. this is where it gets little tricky!!!

2) and then develop/optimize it for other efficiencies or even transferring it to manufacturing. there is no argument in this case, that this ought to be subjected to completeness/adequacy criterias (be it from QA or from experts!!!)

btw Regulatory authorities as of today, are only seeking necessary reports during technical reviews,(in few cases backup data) from development/optimization areas, if and where requipred, but haven't heard about them auditing the R&D facilities!!!

i am trying to get more understanding... it better; thank you for bearing with me and clarifying.