Tag Archives: Laboratory

How to move a Lab and not go CRAZY!

the getaway2014 has been an interesting year in the life of this QA Manager. This time last year, we were in a full court pressto prepare the lab to move into our new facility. As we ushered in the year, the facial twitch caused by transferring equipment, personnel, and systems was deeply present. Of course, moving a lab is not a new concept. It was, in no small scale, a big deal for our team.

I was reminded of that this week while searching for an email that I sent at the beginning of the year. Plenty of labs have relocated, mostly successfully.   But that doesn’t negate the fact that the project was extremely challenging. Specifically, the instrumentation that we employ could not simply be loaded onto the back of a pick-up truck. It took no less than a full day to prepare each instrument to move, another day to crate, forklift, and haul each instrument to the new lab, followed by two days of installation. The coordination involved in moving all four of our instruments could be a full discussion of choreography and agility. 

As I scrolled through my email traffic early 2014, one thing was apparent. As a team, we were on fire.

When we entered into the project, we had a strategy.   We had a schedule. We had a punch list. Most importantly, we made a commitment to stay agile. We new from the start that through all of the planning, the schedules, the punch lists, there would be surprises. There would be crises. How we reacted would be the key to our success or failure.

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When Science and Regulations Collide

I stumbled upon an article a couple of weeks ago that gave me pause.  I must begin, however, with the statement that I have absolutely no detailed knowledge of the details of this article.  My opinion below is based solely on my initial reaction to the article.

Now, if you are unfamiliar with the nuances of the environmental testing industry within the US, there deserves a bit of explanation, however elementary, of the political climate in which we operate.  I considered including that in this post, but that would be comparable to explaining the genealogy of the Tudors.  So I’ve included a supplement here.

Now, there were a couple of things that struck me immediatelylarge__11747440176 about the circumstances leading up to the settlement, as described in the article.  To the average Joe, the most concerning issue may appear to be the fact that the laboratory was not using the correct procedure.  Doesn’t that, after all, put all of the laboratory’s results for that test in to question?  Maybe… maybe not.

I can’t say that I’m intimately familiar with the named state as a primary accreditation body, but I understand that there is a strong focus on ensuring that Method Modifications (changes to the EPA published procedure) are minimized, or at least thoroughly technically justified.   This can prove problematic, and a tad frustrating, to laboratories tasked with developing improvements that somehow improve the sustainability of the operation.   The dynamic of the laboratory defending a proposed modification to a regulator could also be a post in itself.  We’ll just say that modifications are scrutinized to ensure that data quality is not compromised.  (Any scientist that I have been lucky enough to work with would welcome such scrutiny, if only for the opportunity to say “I told you so”)

So without speaking to the modification itself, the one thing that struck me, as a QA Manager, was the fact that the regulator had cited this as an issue that needed to be corrected on three separate inspections.   Continue reading When Science and Regulations Collide

The Ideal QA Manager… Technically writes, technically

I love the wiki on editing.  There are so may different types of editors, each having a different specific task leading to the final product.

It has to be a thankless endeavor, that of an editor.  Much like the QA Manager, the only real attention likely comes when things go wrong.  I know I am quick to judge a professionally published copy that is poorly edited.

I can’t say that I’ve ever seen a laboratory with a staff technical writer, whose sole job it is to write highly technical policies and procedures that define the Quality System.  That said, in my experience, the role of author/editor/publisher often falls on the QA Manager.

As the keeper of all things written among the Quality System, I struggle with this role of author/editor/publisher.  I want to do it all perfectly, all the time.  I have this inkling that my colleagues that review those documents expect the same.  Self-torture, I believe they call it.  A glutton for punishment?  Perhaps.  Honestly, I dabbled in journalism a bit in college, but a career as a writer has never been something I’d envisioned for myself.

I have found, however, that I have a particular interest in doing my part to improve the written communication in the laboratory.  It may not be terribly exciting material, but my hope is that I can make reading those mandatory SOPs less painful.  And those documents can be painful.  It seems that every document I pull for review needs serious work.

In this vein, I recently had an epiphany.  After spending the weekend with my blind parents, I thought that I would use the “text-to-speech” function of Windows to “proof-read” a certain document I’m currently working on.  I was extremely excited about this idea for about a week.  I even mentioned it to a few of my colleagues on Friday.  And then I saw this.  Grrr…  it just goes to show, there is no unique problem, only solutions.

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