Category Archives: Audits

Accreditation and Interpretations

assumptionWhether you are the quality manager of an accredited laboratory, or preparing your laboratory for accreditation, understanding the standard you will be accredited to can be daunting.

If you’re new to the game, accreditation requires that an independent “Accreditation Body” perform an audit (or assessment) of your laboratory to ensure that you meet the requirements of the standard that you are referencing.

Now, the challenge comes when the assessor’s interpretation of the standard requirements differ from the laboratory’s interpretation.  Prevention is the key to audit findings associated with differences in interpretation.  I was reminded of this recently during the annual meeting for our accreditation body.  I thought I’d share some of the tools I use to ensure that our interpretation of the standard aligns with assessors that come in to audit us.

1.  FAQs and Interpretations

Governing and accreditation bodies have gotten wise to the challenges facing laboratories in understanding what is expected of laboratory’s to meet requirements that can be vague. Most have provided interpretations to clauses that have been problematic.  This isn’t a new concept, but not often one used by laboratories.  Two of note:

These cover primarily the environmental and food testing industries, which have requirements that are additional to those in the ISO 17025:2005 standard.  Each accreditation body has a similar resource with interpretations as well.

2.  Training

If you are new to the quality role, or pursuing accreditation, a great way to understand how your accreditation body interprets the standard is to attend a training session, facilitated by the accreditation body, about the standard.

3.  Get Engaged

Most accreditation bodies, as well as some governing bodies, will have an annual meeting of their stakeholders.  These meetings are where policy for the accreditation body is set and standard interpretations are clarified.  I’ve made a point to be involved in these types of meetings from very early in my career.  It’s not only a great networking event, but there is added value to knowing what current issues are brewing within the industry.  These hot topics are always a point during subsequent audits, so its good to know about them in advance.

A note about these meetings.  I find that laboratories are almost always grossly under-represented.  This is unfortunate.  I mentioned that these meetings are where policy for the Accreditation Body is established, revised, and approved, by the stakeholders.  By not attending these meetings, laboratories are missing out on the opportunity to have their voice heard within the accreditation community!  That is why I’m such a big proponent of getting to those meetings.

If you have any questions about how to find additional resources for standard interpretations, please drop a comment below!





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… Communicates well.

Yesterday, I reflected on the challenges that many of us encounter while we are interacting lab personnel, particularly when it comes to communication.  The ability to bridge that gap between QA Speak and the lab is one of the fundamental soft skills that a strong QA Manager must embrace.

In keeping with this idea of soft skills, and in honor of the upcoming football season, I propose that there are certain traits that truly effective QA Managers carry that cannot be highlighted in a job description, or on a resume.  Instead, they can only be observed, in certain context, as displaying true potential.

This concept was recently cauterized for me while I was reading Blind Side: Evolution of the Game.  Aside from the story of Michael Oher, the book discusses at length the position of the Left Tackle, and its role in the game as we know it today.  Now, I am well aware that the there are opinions that counter the idea that the Left Tackle is the most valuable position in football.  But I’d like to play on this analogy for the purpose of this post, and a few to come.

Continue reading The ideal QA Manager… Communicates well.