about Risk and Prevention through Continual Improvement
Yesterday we had our 12th
external audit by our ISO certification body in 12 years. You would think that by this time we would
have the process down pat. It should be
a walk in the park. Well this is sort
of true. In the early days we would look
at audit day with a certain degree of anxiety and distress. These days those negative concerns are gone,
and in fact we look forward to the exercise because we still find opportunities
for learning and opportunities for improvement.
would say that now that ISO 17043 (Conformity assessment — General requirements
for proficiency testing) exists there is no longer a place for assessment of
proficiency testing programs to ISO 9001.
I can see the argument since ’43 is more specific, but to my mind there
is no document more specific and exacting to quality management than 9001. So while we will likely seek an external
auditor that we have confidence can do a competent assessment to ’43, we will
continue to stick with 9001. Indeed, to
my way of thinking, I suspect that when the smoke clears, we will likely find a
way to do both.
thing that I appreciate about our current ISO 9001 assessment body (SAI Global)
is that they provide us with a knowledgeable and experienced auditor with a lot
of knowledge and skill in the laboratory area.
Several of his clients are in the laboratory arena. He is knowledgeable about calibration and
equipment and quality control, and our assessment covers these areas thoroughly. In addition to our regular close look at our
quality system and management review and customer satisfaction plus plus, we
also get a solid review of critical laboratory expectations. So in a sense we feel we currently are
getting the best of both worlds right now.
how did we do. We were found to have no
non-conformities. We continue to meet
all the requirements. But we are not
perfect. Although we do two major
internal audits each year, (one in February-March and one in July-August) and
had the documentation available, when I wrote up my Management Review report, I
forgot to add in an “Internal Audit” section.
We probably could have gotten away with that except we publish the MR
review in our Annual Report (available on-line at www.CMPT.ca) and so the absence of an IA section was pretty
obvious. This was written as an “OFI-Opportunity
For Improvement” rather than as a non-conformity. I could go back and edit the MR review, but
we agreed that the more appropriate approach would be to include the section in
our next MR in our next Annual Report.
other thing that came up is a common problem, but I think we have found a good
solution. Like most organizations we are
weak when it comes to having a documented list of Preventive Actions in our
report. It looks like we continue to be
only re-active to problems rather than pro-active through prevention. But in fact that is not true. Our problem is one of recognition and
make changes and improvements all the time.
We changed our glass slide labels to a better material so that they
would not fall off and not get covered with stain. We changed our packaging to reduce the risks
of leakage to a level beyond requirements.
We implemented our earthquake preparedness safety kit, and revised the
labelling on some of our reagent bottles.
There have been probably 15-20 of these types of changes going on over
the last year or two, and while we have thought of them as products
improvements and safety requirements (which they are) they are also true Preventive
Actions because each of them reduces a Risk of inconvenience to ourselves or our
So now as we continue along our path of
innovation and continual improvement we can also look at ourselves from a Risk
and Preventive Action perspective. And
if that was all we learned from this year’s audit, it was well worth the cost.
a PS note, some explanation may be necessary. If we are so satisfied with our current
assessment process, why would be even be thinking about including additional
assessments? The answer is that for some
of our customers (clients) seeing the words “Accredited to ISO 17043” is becoming
more important, and so I suspect our move to accommodate their concerns will come to fruition fairly quickly.
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