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Roles for QA

Posted Oct 23 2008 1:43pm

I was scanning through my email subscriptions today and noted an interesting item in my FDA News Drug Daily Bulletin (from the company “FDA News”) advertising one of their publications. Now, most of the time these “industry best practice” white papers are information that is common-sensical or freely available from another source (e.g., compilations of FDA Warning Letters that are available on the www.fda.gov website ) so I typically ignore them. However, the tone and posturing of this one caught my eye:

 

Lower Your Site Risk Potential (SRP) Score
Lower Your Site Risk Potential (SRP) Score zeroes in on what this risk-ranking model is and how FDA is using it to classify manufacturing plants and prioritize enforcement. This new management report also goes a vital extra step, showing you how to implement practical strategies that can reduce your score, limit inspections and unlock a host of valuable new business benefits.
To order, go to http://www.fdanews.com/store/product/detail?productId=23141.

 

To me, that is marketing to the worst of us. It doesn’t offer help to actually improve one’s processes, systems, or products so as to have more successful inspections. It implies that by doing certain things, a manufacturer can place themselves “below FDA’s radar” and thereby reduce the number of inspections to which one is subject. That is not to say that the advertisement is selling a lousy or unethical document. I wouldn’t know since I haven’t read it.

The ad did get me thinking about the various roles I play as a QA Auditor though. I was born an optimist, but through my work in QA, I’ve become somewhat of a reluctant realist. There are always those who will seek out “the quick and easy path” rather than the high road. That being said, my role varies depending upon with what I’m dealing:

 

1) In my opinion, most people I meet and with whom I’ve worked are genuinely interested in doing a good job, the right thing, etc.; and for that I am thankful. And as a QA professional, my primary job is to help them do just that. By serving as a fresh pair of eyes, as an uninvolved outsider, I can help those who may be by necessity focused on the trees, see the forest. This is the role I like best, that of an internal consultant.

 

2) In other instances, there are those who are very ready to make what a former mentor of mine liked to call “overly pragmatic decisions”. For situations like this, my role tends to be more akin to that of a traffic cop. Almost everybody slows down when they see a parked patrol car. My presence lets people know that “someone is looking”.

 

3) In the worst cases, I’m there to catch the most aggregious offenders, those who totally disregard ethical or moral considerations; or who are just so sloppy in their practice that they pose a major risk to their subjects, the public, or the research itself. I play the role of the enforcer in these cases. I like this role the least. However, I try to remember that it is because of this minority situation that there will always be a role for Quality Assurance.

 

~TJK

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