Value of the ASQ

If I were to ask a hundred of my peers “How did you get into quality,” I would probably hear 100 different stories (with of course some commonalities). And yet, quality is definitely a distinct set of expertise and practice.

When I try to describe my job, I often find myself breaking down what I do into categories (I’m a project manager, a trainer, a problem solver, risk manager, a facilitator, a puzzle solver, a detective, etc). some of these are professional paths on their own, others not so much.

It is for this reason that I am a huge fan of the ASQ’s Quality Body of Knowledge, as it does a good job of uniting what we do. Sure, it’s not perfect but it is an excellent framework to build an understanding of just what a quality professional can bring to the table, as well as great development path.

One of the many things I love about this is the ability to learn from folks no matter what their industry. This cross-pollination is vital to innovation. And having the QBOK there gives a framework for common discussions.

With the QBOK goes a technical knowledge bolt-on. For example, in my case pharmaceuticals (strong) and medical devices (average).

The ASQ certification board I believe gets it wrong by calling these specific technical certifications “Leadership.” There is nothing leadership centric by getting the CPGP, for example.

I think we’re better breaking these certifications into QBOK core (e.g. quality improvement associate, quality process analyst, manager of quality), specific skills (e.g. six sigma, haccp, quality auditor, reliability and calibration) and then industry specific (e.g. CPGP, biomedical auditor)

As the ASQ goes through its current transformation, I hope the leadership and members remember the strength of the QBOK, work to enshrine it in everything the organization does, and continues to refine it. This is the value of my ASQ membership.

 

ASQ – Pharmaceutical GMP Professional Certification

The ASQ’s CPGP certification covers a very broad body of knowledge that covers regulatory agencies, to facilities and utilities, to testing, to release. In short, about every aspect of a GMP facility.

I am maybe the only person I know in the field who has this certification. I don’t know the details, but uptake does not seem as high as other certifications I am aware of. Yesterday at lunch I ended up discussing this with a few colleagues. We discussed a few options:

  1. The certification is not well known. Most of my colleagues were not aware of it.
  2. Many pharmaceutical GMP professionals are more directed at the PDA and ISPE. The ASQ is well known, but perhaps not as important when considering options.
  3. This certification is a generalist. There was a general opinion that many quality professionals tend to be specialized and night not feel comfortable stretching ther wings.

Is there value in this BoK? Definitely. I found this certification much harder than the CMQ/OE, and as a result I’m prouder of having it. The major question is how can we make this more valuable to the field. This is certainly a question I’ll be asking next week in Seattle.

 

The Journey Begins

Thanks for joining me!

Start with what is right rather than what is acceptable. — Franz Kafka

Let me introduce myself. I am a quality manager in the pharmaceutical industry who for the last year has been doing quality systems deployment, and previous to that spent 4 years running the change management/change control program at a site under a consent decree with the FDA. I’ve spent almost two decades developing, implementing, and maintaining quality systems in biopharma. I an a senior member of the American Society of Quality with my Certified Manager of Quality/Operational Excellence (CMQ/OE) and Pharmaceutical GMP Professional certifications. I’ve been known to haunt one or three other professional associations.

This blog is my attempt to explore what I’ve learned. It is a example of thinking out loud. Perhaps, in that, it will be valuable to others.

The views and opinions expressed in this blog are those of the individual blogger (Jeremiah Genest) and should not be attributed to any company with which the blogger is now or has been employed or affiliated.