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Monday, November 18, 2013

An ISO Quality Moment



Hi Paul

So let’s talk about Quality moments.  It was last year (November 8, 2012) when ASQ announced its engagement with World Quality Month that I balked [see http://www.medicallaboratoryquality.com/2012/11/world-quality-month-right-boat-but.html ]  I was concerned about World Quality Month competing with or worse diluting the impact of related events such as World Standards Day (October 14th)  and World Standards Cooperation Day (variable) , and World Accreditation Day (June 9th) or  Customer Appreciation Days.  (So far I have found many designated Customer Appreciation Days, but no formal “World Customer Appreciation Day”  I wonder if it  is just a matter of time before ISO POCOLPO makes an announcement?
But let me tell you about my Quality moment.  

Currently I am sitting at an annual plenary meeting for the International Organization for Standardization (ISO) Technical Committee 212.  This is my 20th time participating in the meeting.  This meeting has representative from thirty different  countries with some countries sending only a single delegate, others sending as many as 20.  

I enjoy attending because it is a meeting it produces a world wide variety of opinions on the topic of laboratory Quality.  I used to think after many years the group would come to a point of generally acceptable view.  We have still not reached that point.
Because of this broad diversity of opinion, ISO is, by necessity an organization that works on a basis of consensus.  As a concept consensus means general agreement, which does not imply 51 or even 95 percent.  ISO states it this way;   Achievement of consensus entails recognizing the wider interest and sometimes making certain compromises. Arguments for and against the existence of an ISO project should be pursued at the stage where the project proposal is considered and action is taken on it. However, once an ISO project has been approved, all national standards bodies and stakeholders involved in the process should be committed to advancing the global relevance of International Standard(s) within the agreed-upon scope, and they should not seek to hinder its further development.  Where a member sustains a fundamental objection and supports it with sound arguments, these concerns will be taken seriously.  

So let me bring out the key points.  

…recognizing the wider interest and sometimes making certain compromises.  There are two key points here.  The first is that the wider interest has to be considered as the first requirement of a standard.  If a document, guideline or standard is written by the “great minds” it will not have standing unless it is generally accepted.  Sometimes to reach that point of general acceptance,  certain compromises have to be accepted.

I will give you an example.  One of the documents that I have been involved with involves a specific issue of the thickness of plastic that are used in a product.  One person strongly believes that the thickness must provide 20 Newtons of force protection.  Many others disagree with equal strength and feel the right answer is 15 Newtons. It doesn’t matter if one side or the other is right or wrong; the point is that neither side is prepared to move, and as such we continue in a state of absence of consensus, ie  impasse.  And to date there has been no movement towards compromise.

The second point creates important balance.  The ISO statement says that (in the example above) if in the spirit of compromise, if everyone on the 15 Newtons side decides to move to 15 or 17.5, but the same one person deeply and truly believes that he is right and everyone else is wrong, and he can demonstrate the soundness of his argument, then that person cannot be forced to change.

Rightly or wrongly the impasse will remain, until a different approach can be found. 
It sounds complicated, and in a sense it is, but the very depth of ISO is that every voice is equal and every voice must be heard.  It is astounding to me how often the process actually works.

ISO meetings are challenging and every one comes ready meet their own needs.  As they used to say in the old Western movies, “Please leave your guns with the Sheriff before entering the hall”.




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