Last week I had the opportunity to make a presentation to
a group of laboratory sciences graduate students. My topic was on Quality, a topic that I
suspect was pretty marginal in their sphere of knowledge or interest.
I had two agendas; first that they should be aware that
Quality can be viewed both only as a subjective characteristic based on market
influenced notions of value and craftsmanship, and specialness, and at the same
time as an objective measurable based on specifications, and requirements, and
commitment. The second was to introduce
to them not only that Quality in the objective sense has a role to play in
every research laboratory, but to go further, the absence of Quality awareness
makes everything that they think and do, null and void.
I started with the notion that there are tiers of
Quality, starting from the base of Quality Control, then Quality Assessment,
and finally Quality Management.
To be fair, I acknowledge that not all laboratories will
attain a level of achievement that includes a full Quality Management
System. Many clinical laboratories have
at best a perfunctory Quality Manual and a pretty iffy Document Control system
or Process Control and unfortunately most clinical laboratory directors do
little Management Review. But I am also
aware that these are by-and-large completely absent in research laboratories
unless their funding agency demands that they demonstrate they follow Good
Manufacturing Practices (GMP).
Many researchers scoff at the notion that they should
participate in any form of Quality Assessment, thinking that exclusively means
some form of proficiency testing or inter-laboratory comparison, and they
forget about the simple basics of internal audit, and competency assessment,
that let them know whether anything is being done the way that they think it is
supposed to be done.
But the sad reality is that even the most basic Quality
Control is by-and-large absent. All too
often basic assessment of equipment and reagents and supplies through use of
control materials barely occurs, and when it is done, it rarely is used
critically. There is little use of
control charts (sometimes referred to as Levey-Jennings) and a near complete
absence on its interpretation.
I was not alone in the room being knowledgeable on the
subject. One of the seminar leaders
lobbed be a really good softball question.
Is there not value in reproducibility as a reflection of accuracy? If a value is tested multiple times and the
same value is achieved, doesn't that give credibility to the value? Tempting, but sadly, not. What it did was open up the conversation on
accuracy versus precision and bias. It
reminds me of an age-old description of surgeons, confident, quick, adept and
wrong.
Research is a critical part of health progress, and to be
fair there has been great progress of the last couple hundred years. But investigation is slow and erratic, and
expensive beyond expensive. For every
step forward, there are dozens of steps back.
That is the nature of unraveling new knowledge. But we make the situation worse and not
better when graduate students don’t know of understand about the roles of
Quality Control and Competency. I would
argue that for every laboratory that uses a standard piece of analytic
equipment, there should be availability of programs that provide materials to
ensure that the equipment is being used properly. You could call that a variation of
proficiency testing or competency assessment.
I would also call it common sense.
I would further argue that an aware funding agency would require the
regular use of such challenges, perhaps even tying funding continuity to
performance.
Our universities and training centres have an obligation
to teach and guide graduate students to mold them into being excellent
investigators. When we leave the very
basics of Quality out of the experience and equation, we are just perpetuating
our folly, not fulfilling our obligations for investigation improvement.
We have another session with the group next week.
