In my industry the QA Manager is some what of an enigma. The common vision includes mounds of paper, a clipboard, and somewhat socially awkward tendencies.
Sadly, I must admit to social awkwardness, but that’s not the point here. QA Managers in the laboratory tend to wear many different hats. My most frequent hats include staff technical writer, LIMS/IT specialist, general question-answerer, and control charter. This is not, of course, is not an intensive list. And I am obliged to mention my mastery of Excel, and the pivot table.
Historically, and by “historically,” I mean, back in the day, the Quality Assurance Manager in the Laboratory had a very focused purpose. Maintain the Quality Assurance Manual, and the systems it describes. In a world before real time, instantaneous data evaluation, this was a serious job, with not so enjoyable tasks. Author and edit, as necessary, Standard Operating Procedures. Evaluate Method Detection Limits. Compile trending data and evaluate control charts. And most importantly, make sure accreditations stay up to date. Did I mention Proficiency Testing? No I didn’t, I avoid that subject as much as humanly possible. These tasks are tedious. They are time consuming. And prior to the advent of automation, were literally a full-time job. *Enter the mad Excel skills*
As my career has developed, I’ve seen my activities morph… Sure I still maintain the Quality System and all of the trend, statistical, and QA reviews required in that. But with the advent of automated data exports, and the aforementioned Excel magic, I’ve been able to leverage – to a degree – the time required to complete those tasks. Granted, my laboratory has a somewhat limited scope of testing, but the premise stands… Six months worth of trend data is not a small feat when most of that evaluation is done in excel. *Hail to the Land of LIMS, that one tool that can change the role of QA, should the lab choose to harness it’s magical power!*
An aside – If you are a QA Manager, and have not harnessed the power of your LIMS system… start asking some questions. Learn some tricks, a few keyboard strokes… Become the LIMS expert… second only to the developer himself… you’ll thank me later.
Having done what I can to harness the power of LIMS, the traditional statistical and trend evaluations have become somewhat simple tasks. This frees me up to concentrate on, what I believe is the most valuable function of QA. And i’ve mentioned it before…. The Left Tackle.
I now find myself in a position to do that thing that energizes me from the boredom others assume deserves their pity… Risk identification, continuous improvement, and, in rare events, damage control.
Risk comes from not knowing what you’re doing.
QA Managers are independent from operations for a reason. That “independent” perspective allows us to perform consultancy on the most intimate level. The unique position that we are in, where we know how things work, allows us to evaluate laboratory systems at a level much greater that a traditional assessment.
In this role, we are continuous risk assessors, constantly scanning the operation for things that might lead to problems later.
We monitor regulations, news and trends, we are mentally noting that one question that has popped up in their inbox 6 times this week. They not only know the answer to the question, but they know the premise behind the question, as well as patient Zero… that one validator, or auditor, that has that question on their short list.
We are the Kings of Research. Google is our best friend. If there is ever uncertainty to the answer we think we have, we’re likely less than 4 degrees of separation from someone who can give us a definitive answer. We are the lifesaver when no one can find the answer to that question.
The time we spend chatting in the lab, is time spent building relationships, that will ultimately make us approachable to that one analyst who isn’t sure if she just saw what she thinks she saw. And while we’re in the lab, we are observing everything. If I had a checklist while I was talking to Billy about last week’s football game, I’d have met my annual internal audit requirement. But the mental notes I have will end up in a conversation with the management team, so the training needs I’ve seen can be addressed.
This constant information gathering ultimately helps the Lab. Those small observations allow me to identify specific course corrections that might be needed, before they actually become an iceberg. It has proven to be an effective technique. When we break free from the spreadsheets, we might actually be able to effect continual improvement, and that means innovation.
Okay, so maybe we don’t wear a cape… but it’s not far off.
What’s your take? What should QA’s focus be?