Monday, October 5, 2026

 Quality in the First Person

 

Let me say from the get-go that I am an admirer of  ISO standards, but not a fan.  The ISO process is one of bringing a group of well-informed participants and experts together with the point being to develop a document of principles that are supposed to serve the greater good in a given and specific practice arena.  When they reach the collective point where they all generally agree, at least in principle, a document is crafted and approved and published.  

The cornerstone of the document is a series of statements that define the principles using the term "shall " a gentle and polite substitute for "must".  If the organization can demonstrate that they meet all the "shall" requirements, they can and usually will be recognized, publicly, nationally (often) and internationally as meeting the requirements of the standard, and everyone is happy... congratulations and well done.

The problem of course is that this is an exercise  performed largely on paper or as an observed study, all too often in the abstract.  

The recognition is rarely, if ever, done as an actual hands-on, sitting in the office watching people work experience.  It doesn't look at what actually happens on Tuesday when the key person came in late and distracted with a really bad headache.  

The real challenge, if you really want consistent performance is to allow the folks to work to ensure that they personally and deeply understand the consequences of their less-than-perfect performance on the reputation of each individual and the organization at large, and sometimes on the real outcome of the customers....  Sometimes the outcome is annoyance and inconvenience, sometimes it is out-of-pocket expanses, and sometimes it is actually illness and death.  

A new standard, ISO 7101:2023 (ISO 7101:2023   Healthcare organization management — Management systems for quality in healthcare organizations — Requirements) which works on the principles of Just Culture as expressed by Sidney Dekker.  It is an approach that kinds of leans towards no blame - no fault.

Recently I have been introducing into my Quality Management teaching a variation on this.  I think of it more as taking charge.

I start with a scenario.   You are working in your laboratory, minding your own business focused on your work and a friend/colleague interrupts your train of thought.  You have your chat and then go back to work, but you pause....  "was that 3 drops or 5 drops?... probably 5... but maybe not!"  Is this a “near miss” or a real miss and error?

What's the consequence of being right?... everything is good.  What's the consequence of being wrong?  If it is a test like a rapid-COVID test, the difference can be a false negative... maybe a family cluster? maybe a family harm.  Would I want to be responsible? 

Maybe the better approach is to see if I can do it over?  Yeh, that's a better idea.  I probably should tell someone.

This approach introduces the sense of my personal responsibility for my practices including my errors, even if they are not always exactly “my fault”. It rewards me by making me more focused on my work.   It rewards me by eliminating excuses and may some deceit.  If reminds me of the principles that Phillip Crosby said best “Do it Right the First Time”.   Be Focused and be aware and take ownership. 

More on this later.