So I was browsing in this
month’s Quality Progress (January 2019) and found an interesting article
written by Ningning Jing about Quality Culture, a topic about which I have a
lot of interest. What caught my eye was
that in 2015 a new guideline was created and subsequently published by China
Standard Press entitled Chinese National Standard, GB/T32230-2015—Guidelines
for Quality Culture Development in Enterprises.
I was unable to find an ISO equivalent, so I am unsure where or how the Standardization
Administration of China (SAC) developed guideline. As it turns out it is available in English, but
it was fairly expensive.
The guideline
makes for some interesting reading. It
reminded me of how much medical laboratories have changed over the last 15
years, dating in my mind back to the original publication of ISO15189:2003
(Medical laboratories – the particular requirements
for quality and competence).
Laboratory life has
changed a lot since those early days.
Despite the awareness of some of the efforts of W Edwards Deming and
perhaps of Armand Feigenbaum and Total Quality Management in the 1980s, for the
most part, quality in the medical laboratory was largely mechanical and
technical. The concepts of quality were
mostly about accuracy and documentation, and very little about timeliness, or
appropriateness, or clinical relevancy.
The quality dynamic was the laboratory, the physician customer and the
specimen.
Quality principles as
expressed in ISO15189:2003 made a material change because it introduced
concepts of Quality Managers and patients and the needs and requirements of the
staff. In today’s medical laboratory, quality has expanded
to address satisfaction, and interested parties and stakeholders and service
excellence. Modern laboratory quality is
an essential component of every aspect of the total experience.
Today many almost every
laboratory conference and education program and continuous improvement
program for medical laboratorians will focus on some aspect of the essentialness
of a Culture for Quality.
What many may not
realize is that Quality Culture is not
a new concept. Joe Batten has been writing on the topic
going back to 1992. Back then Batten presented a definition of
Culture that I still rely upon today [Culture: The pervasive philosophy,
central values, beliefs, attitudes and practices of an organization, and the
micro-elements that make things happen.]
While I still have
my old copy of Building a Total Quality Culture, I see it is no longer
available even on Amazon, but I see there is a new edition (2014) available.
This new guideline
defines quality culture as the “total of quality concepts and values, habits and
behavior patterns, basic principles and systems as well as their material
performance recognized by the enterprise and its staffs”. With interest, ISO 9000:2015 provides a
similar definition: “a culture that results in the behaviour,
attitudes, activities and processes that deliver value through fulfilling the
needs and expectations of customers and other relevant interested parties” When either of these variation definitions is
combined with the one used by Batten, back in 1992 you capture a clear picture
of Quality Culture.
The new guideline makes
several points: (a) the culture must be
driven and directed from the top; (b) that without leadership, a quality
culture is unlikely to happen. And (c)
that leadership by itself is insufficient and if the staff are not engaged then
the process with fail. (I am reminded of
Feigenbaum who said that Management is responsible for 80 percent of Quality,
with the organization sharing the responsibility of the 20 percent). (d) the document reminds that Quality Culture
is NOT a cookie-cutter operation. Each
organization is unique and their culture must have the freedom to reflect that.
And importantly (e ) building a Quality
Culture is NOT a one-and-done activity; culture is a philosophy/attitude that must
mature and change with experience.
Importantly the new
guideline urges that to ensure that the organization has implemented a truly
effective program, it has to find a way to measure its impact, which begs the
question, can one really measure an attitude?
Well the important answer is “yes, you can!”
In our course on
Laboratory Quality Management we talk about Quality Culture, and provide some
ideas on how culture measurement can be done and more to the point, illustrate how it is possible to
assist culture realignment when the organization’s changing needs require.
I have not yet taken
the opportunity to read the guideline thoroughly, but so far I am pretty impressed. I suspect that when the crafters of GB/T32230-2015
were thinking about “enterprises”, medical laboratories were no where on their
list. But they have done us a valuable
service.
Do I think that the new version
of ISO 15189: 202(?) will incorporate some elements of quality culture? I would be pleasantly surprised if it
did.
But regardless, it is well worth
the read.
