Tag Archives: Corrective Action

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

Confession of the Week – We’re not perfect.

I have a confession.  I am an NPR Junkie.  Not your typical Morning Addition and All Things Considered Junkie, but a hard core Junkie.  This American Life.  Snap Judgement. The Moth.  Dinner Party Download.  I just can’t get enough.  It’s sad really.  And I should probably seek help or something.

But the one show I just cannot get enough of is TED Radio Hour.  I think the hook for that show is the back story.  I could watch TED talks for hours, but there is just something fascinating about the introspective provided as part of the Radio Hour.   The dialogue with the speakers during the show can be just as thought-provoking as the talks themselves.

That being said, occasionally, the theme of the show fits nicely with my current thought lines.  This week’s episode [08-22-14] did just that.  Three perspectives on mistakes.  Why they are not necessarily evil, and that while they often suck, a lot of good can come of them.

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In the office of Quality, we see a lot of mistakes. A lot of them.  Some might say that we search endlessly for them (however untrue that might be).

The truth is, the human element is the one factor that the Quality Manager can’t control.  Sure, we can automate the heck out of processes to reduce inconsistencies, but unless you’ve found the holy grail of lab automation,  you are unlikely to fully eliminate mistakes from the laboratory.

The reasoning is simple.  Even the most proficient and effective chemist is going to have a bad day every now and again.  None of us work inside a bubble.  We have distractions far from work that can distract even the best of us into a misstep.

Continue reading Confession of the Week – We’re not perfect.

It Doesn’t Make Sense

[I want to begin this, my third post, with a bit of gratitude.   In a perfect world this site would have been planned with structured, themed, cleverly-titled posts long before I started posting.  But what I’ve come to realize is that the vision of perfection is fleeting. So, I’m simply going to write, and we’ll see what form this takes.]

I don’t know why, but there are times when it seems that those of us who are cut from the QA cloth are incapable of a) getting to the point quickly, or b) keeping things simple.   This often leads to a communication gap between the QA Department and the Laboratory

We might be starved for human interaction.  We might have just fried our brains reviewing control charts.  Perhaps the fact that we are constantly surrounded with facts, figures, requirements, citations, regulations, standards, methods, statistics, has ruined us for any normal workplace interaction.

Regardless of the cause, there is a language, a secret handshake, if you will, that exists within the community of Quality Professionals that is incomprehensible to the folks in the lab.  As a QA Manager, I have to acknowledge this.   If I don’t, I risk being less than effective in the planning and implementation of the systems I’m charged to employ.

Honestly, I struggle with this constantly.

I catch myself all the time.  A simple question regarding the seeming absurd ban on correction tape can easily result in a 30 minute training session on the integrity of record keeping… If i let it.

Continue reading It Doesn’t Make Sense