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.  

In this sense, “inspections” are audits, performed against a Quality Management Standard, and the applicable state specific regulations. The Environmental Testing Industry is often scrutinized in such manner, to ensure that Quality and Technical Integrity are maintained.  Periodic monitoring by the regulators is an integral part of the US industry.  personally, I view them as a key tool for improvement.  There is something extremely valuable about having a fresh set of eyes pour over the systems that I manage.  We are all constantly striving for areas of improvement, and these audits provide a great medium for identifying those areas.  The bi-annual audit cycles, similar to that implied in the article, ensures that the regulator is satisfied that the laboratory is continually operating in compliance with the applicable standards and regulations.

Fortunately, or maybe unfortunately, there is an expectation that the laboratory addresses issues identified during audits.  Corrective actions to audit findings are a big deal.  They are a condition of Accreditation, the key to performing work within the jurisdiction of the regulator.  In most cases, corrective actions are simple, and easily implemented.  The key is to define a strong corrective action that not only fixes the problem, but prevents the problem from happening in the future.   Band-aid fixes, superficial, running through the motions are rarely adequate to prevent the problem from rearing its ugly head.

This isn’t always easy, especially if the lab personnel do not agree with the finding, or the proposed corrective action…  As a QA Manager, we are tasked with finding that delicate balance…  Empower the laboratory to develop solutions that meet their needs, but are also acceptable to the regulator.  As the article indicates, failing to do so could mean a hefty price.

So, fellow QA Managers, what tools and tricks do you use to ensure that audit findings won’t be repeated two… four years down the road?

2 thoughts on “When Science and Regulations Collide

  1. reviewing past audits and checking that the corrective action is, number one, still in place, two check if it is working, and three take that deficiency and audit other areas in the lab it might apply to and make corrections there as a preventive action.
    I liked your article and have faced the same problems with modifications to methods, including ones we have sent them and they approved. It seems in the last couple of years they have been more and more strict.
    Would love to hear other comments.

  2. In reviewing the news article as well as the PDF from GE on the situation, if there is one thing, do not ignore a finding. And if you really want to get under an auditors skin, ignore them twice.

    Conversely, most State Agencies accrediting environmental labs, will work with labs to when there is a finding, and a lab is working through correcting. When you have a finding and are struggling with correcting the problem, a status email will go a long way to ameliorate the situation.

    And if you disagree with a finding, communicate that as well. There are instances where there are method and/or QA interpretation perspectives, the lab may disagree with the auditor. Communicate and make the argument. There is very little likelihood the point will somehow disappear.

    Generally when an auditor walks in, the first thing they do is start with the issues form the prior audit. So, you you have corrective actions, and can demonstrate that you’ve corrected the problem, you will be in a much better situation than if they find the same issue unaddressed.

    In a nutshell, communicate to your auditing agencies. Be proactive.

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