Tag Archives: Iso 17025

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

Promoting Quality In the Lab

I ran across this discussion on one of the LinkedIn groups that I partake in occasionally.  I’ve seen, andhttp://www.flickr.com/photos/ransomtech/5811447011/ on the question previously, but today, it triggered something greater in me.   Perhaps my current mood is a contributing factor, or the fact that I’m still recovering from a pretty long short week.  But the question got to me…

I’ve been irksome this week anyway, so I have to accept that my angst is probably attributed more to my personal challenge with this type of question.  In my bubble, I desire nothing more than to walk into the lab knowing that every single person in the building has an intimate knowledge of the “Standard” (ISO 17025, TNI, DoD QSM, whichever it may be).  Okay, maybe I also desire them to be as passionate about the various clauses that define our Systems as I am.  Such a passion for Quality would make our jobs darn near joyful, wouldn’t it?

The truth is, more often than not, the laboratory analyst’s working knowledge of  the standards that dictate quality is that of acquaintance.   I accepted this fact long ago.  So much so, that if I find an analyst that shows more interest than a slug when I step onto my QA Soap Box…  *Tag*  Start grooming him for the QA Department!

That’s a rare occurrence.  Not unheard of, but for the most part, I’m the Quality Assurance Manager for a reason…  My colleagues are more interested in doing science, than memorizing the ISO clause on the Management Review requirement (Admission:  I don’t have the citation memorized either, but I could turn to it in less than 2 minutes).  The sooner I can accept that, the better.  As such, the idea that a QA Manager would put much serious effort in training and evaluating the working knowledge of the technical staff puts a wrinkle in my forehead.

Broad stroke understandings… Yes I expect that from even the greenest analyst.  Understanding that every requirement is there for a reason.  We don’t do things in a willy nilly fashion.  There has to be consistency.  There has to be control.  I monitor, investigate, and stress out over “out-of-controlness.” That’s my job.  It is not so much their functional in destiny of the requirements that dictate our systems.  It’s about their big picture understanding, and their implementation of the systems.

Of course, my expectations of the leadership team are a bit more involved, but I still do not expect them to have the geektastic knowledge and understanding of the Standards.  These concepts do not excite the Supervisors, Technical Directors, and Lab Managers they way they do the QA Manager.   And that’s okay.

Albert Einstein once said:

“If you can’t explain it simply, you don’t understand it well enough.”

I believe this whole heartedly.  I am an advocate for Quality in the Lab.  If my colleagues get one thing from me, I hope it is consistency in my message.

My advocacy of quality has, over the years, boiled down to a few mantras that address key concepts like documentation, traceability, and integrity.  Those concepts that I have not yet been able to distill into a Haiku, I explain using real world applications, rather than abstract concepts.  Annual ethics and integrity training is supplemented by “case studies.” Real world examples are used in cautionary discussions.  Anything I can do to increase the knowledge of the purpose and application of the Quality System.

In short Quality in the Lab means one thing on my team – To provide data of known and documented quality.  And in my world, known and documented quality means reconstructable.  If I can’t look at your records and be able to understand exactly what you did, then we’ve got some work to do.

What are some of the ways you promote Quality in the Lab?





In the beginning…

…  there was no content.





But there was a vision, it was simple.  Find a sounding board for all of those thoughts, ideas, and philosophies that live inside of my head.  Maybe, just maybe, we can trigger a discussion.

My craft resides in the world of Quality Assurance, within the realm of Analytical Testing.  It is a very niche market.  There aren’t a lot of resources out there for the QA Manager for a testing laboratory (think ISO 17025 and the like).

Sure, ASQ has plenty of resources.   And the Voice of Quality features some individuals that have a lot to say on general topics in Qualimedium_3346906435ty.  There are few outlets, however, for those of us who manage the quality systems of testing laboratories.   While the general topics of Quality can, and do, apply to the testing laboratory, my job involves so much more than being the local thought leader on all topics of quality.


Continue reading In the beginning…