Saturday, April 5, 2014

Learning about Risk and Prevention through Continual Improvement

Learning 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.  

Some 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.  


One 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.


So 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 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.  


The 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 value.  


We 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 customers.  


 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.


As 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. 



1 comment:

Comments, thoughts...