Monday, November 17, 2014

A look at ISO through the prisms of Risk and Uncertainty




I have had the opportunity to work with the International Organization for Standardization now for 20 years.  I have seen some very significant and positive contributions, and I have seen some contributions that have proved to be invisible.  And with regret I have seen some that would have been much better if they had been invisible or better yet, never created at all.  Like anything else, every individual ISO product has a certain level of hit-or-miss.  Each product carries its own level of risk (and beyond).

The positive about ISO, is the message that “all voices are equal” as the name ISO implies.  It means that folks from large countries and small countries, rich and poor can hammer out a set of principles to which everyone can concede, if not necessarily agree (consensus) which can be developed into a standard.   That being said, it should surprise no one that, with regret, that is more myth than reality.  I sometimes wonder if Orwell was thinking about ISO when he wrote “all animals are equal, but some animals are more equal than others”.

One of the extreme annoyances that used to bother me hugely was when one or more of the “more equal” countries would drive their influence and impact on document content, knowing full well that the resultant product would never see the light of day in their own country.   This seemed to me to be a certain power imbalance and injustice.  But I have since come to realize that in the international arena, countries get what they want and work for, and that imbalance and injustice are consequences that lesser countries can accept or tolerate, or not.  It is truly up to them.  There is a reality that if there is profit to be made by sitting at the table, and exerting influence, then one is foolish to ignore the opportunity.  

On a similar theme, there is an illusion that countries that provide documents to ISO as seeds for future standards gain in stature.   It is in fact false ego.  The reality is fraught more with risk than with benefit.   A group of local thinkers can collaborate and develop a guiding principle that will work very well in their own region or country.  They know their setting, they know local practices, and they can provide guidance that is (as they say) strongly fit for purpose.  

But when that document gets put in the hands of a broader community, it can get changed, not necessarily for the better. Indeed sometimes nonsense can get introduced.  And so when the final document is generated, the originators can find themselves with a dilemma; stick with what works, or adopt the broader document, even with the nonsense incorporated.   

So it has taken me 20 years to learn a lesson.  Some ISO documents are gold (ISO9001 comes to mind) while others may be of a lesser grade.  Adopting a document may be a giant step forward, or it may prove to be more illusion and politic.  It would be great if you could predict the outcome before you join the writing team.  

It is indeed all about Risk

About 10 years ago the phrase “unknown unknowns” became part of common parlance.  Decision making will always be impacted by the influence of factors that we didn’t know that we didn’t know.  That is not a new concept; it is simply a reiteration of Frank Knight’s near hundred year (1921) concept of uncertainty  which included two classes - one measureable uncertainty, which he called Risk, and the other which was the immeasurable.  Risk is the impact of measurable uncertainty on outcome or objectives.  If only that was sufficient.  The rest is more about rolling dice with an indeterminate and random number of sides where an outcome can be a mystery or surprise, either good or bad.   

You can deal with Risk with Knightian foresight, by considering the potential rate of occurrence or degree of severity of outcome.   Nassim Nicholas Taleb refers to  inherently unpredictable outcomes from unknown uncertainty as Black Swans.   In hindsight, some of them may have been predictable, and might have been avoidable (“black swan robust society”).

Two choices: live with “doodoo happens” or develop an active strategy of observation and preventive action s than may tease out a little more measurable Risk from the sea of uncertain uncertainty.

Thursday, November 6, 2014

Quality and Leadership: one step too far



Bill Troy has written an excellent entry on the links between Quality and Leadership, which many (I for one) see clearly.  In my Certificate course I get to meet many who have decided to transition their career to one engaged in Quality Management, because they see that as a good entry to a leadership role within their profession. 

I just think that Bill has moved the dial a little bit more than is comfortable for some in the ASQ family.  

But before I get to that, let me say that Leadership may be aspirational, and may be transformative or transactional or indeed all three.  If only we could figure out what the heck it is.  There are so many active definitions at play from “A leader is someone who has followers”, to “leadership is the capacity to translate vision into reality,” to leaders will be those who empower others” or “leadership is influence – nothing more, nothing less” and even “leadership is a process of social influence, which maximizes the efforts of others, towards the achievement of a goal”.  

After years of reading and thinking I personally have decided that the Potter Stewart approach is probably the most practical.    

In 1964 while sitting on the bench of the US Supreme Court, Potter Stewart was commenting on a case about a certain movie and whether or not was appropriate for viewing.  The issue was should it be protected as free-speech and should it be excluded as hard-core pornography. Stewart said (paraphrased)…  “I shall not today attempt to define [pornography], and perhaps I never intelligibly can, but I know it when I see it.”   

That’s how I feel about Leadership.

Note:  For those whose jaws have just dropped thinking that I have maligned leaders and their leadership talents, I am not linking leadership with pornography, beyond to notion that the two concepts are both easy to recognize, but near impossible to define.

But to get back to Bill’s comment, he wrote: “we want, need, and expect every one of our members—and indeed, every person in the quality community—to grow and develop as leaders.  

And in that I have a problem.  

The other day I was in a conversation at a healthcare academia curriculum workshop about leadership.  One notion put forward is that as part of the professional curriculum we should always be including instruction on leadership because we all have a natural drive that aspires us to leadership, and a duty to lead, but we don’t know how.  It sounded so powerful and so fulfilling; how could you argue against.  

But I did.  I think it is nonsense.

 In my experience in laboratory management, I see two groups of workers, both excellent at what they do.  When given the opportunity to take on a special project, some jump at it. They love the opportunity, they love the recognition, and they love the opportunity to get ahead.  Given the distribution of age, and gender, and ethnicity it would be nice to say you can pinpoint this group because they are all young, or all women, but it doesn’t work out that way.  

But there are others who are quite happy to do their work diligently and accurately and (near) error free, and leave room for others.  It is not a matter of shyness or self-deprecation.  It is that they are very satisfied with what they are doing and are quite happy to continue grow within that framework, but they are not driven to new frontiers. They are happy to work hard and hone their talents and skills, but at the end of the day they prefer to go home to their family and friends.  Their lives are both fulfilling and complete and they do not feel the need to be team leaders.    

Both groups are equally excellent workers and both are essential as part of the staff.  One group clamours for new adventure, the other not.  Denying the one group leaves them frustrated.  Pushing the others can jeopardize their excellent work habits by adding in unwarranted distraction. 

The challenge to leadership is to figure out which group is which and how to make all of them happy to be on board and working with you.

So to Bill I say, “want and need…”, absolutely.  “Expect…” let’s not go there.

Monday, November 3, 2014

Multitasking in the Quality Arena



In 1977, on the television show M.A.S.H. a new character was introduced, an ill-place army surgeon named Charles Emerson Winchester lll.  Wanting to define the character as Bostonian, elitist, and arrogant, a brilliant (in my opinion) writer gave the character the line “I do one thing, I do it very well, and then I move on.”
 
Every time I make an error, or I see someone else around me trying to multitask and result in inconvenience, accident, or injury, my mind wanders back to “I do one thing…”  (Over the weekend I saw a young man riding his bicycle while talking on his cell phone, ride into the back of a parked car.)

Unfortunately “piling on” task over task has become for me a chronic and persistent bad habit, and I leave myself overly vulnerable to making too many distracted errors.  Over the last month we have held our CMPT Annual General Meeting, started our annual review of the POLQM Certificate Course in Laboratory Quality Management, attended the ISO Technical Committee 212 annual Plenary Meeting (this year in Toronto!!), attended the annual conference for the European Association for EQA providers, (EQALM), written a new manuscript, been a reviewer of 2 journals, signed a commitment for CMPT to seek accreditation to the ISO standard 17043:2010, and prepared a Competency Assessment for a laboratory physician renewing their licence.  I mention the list, not so much to impress, but to point out to myself that as continue along the path of excessive commitment, I create the increased opportunities for distracted error, the potential for dropping the ball or making errors that could have serious impact on my career and others in a major way is unacceptably high.  (Memo to self:  I need to focus one thing, to do it well, and then move on!!).

Knowing myself as I do, I know that I will never stop being a “piling-oner”,  it is therefore important to ensure that I incorporate some protections that should decrease my doing serious harm to the programs that are important. 

For me, the most significant protection is the implementation of standards and backing that up with external assessment, in this case meaning on-site accreditation visits.  In my opinion, our adding in the requirements for ISO/IEC17043 (Conformity assessment - General requirements for proficiency testing) is an important step forward in our path towards improved Quality.  Our strict adherence to ISO9001:2008 (Quality Management systems – Requirements) has bought our program to an extremely effective management level.  Adding to this the more vertical (drill down) requirements for proficiency testing programs will ensure that our skills remain focused and sharp, to the betterment of our program and by extension the betterment of the laboratories that we serve and for the patients that use their services. 

I am not sure that a non-academic program would see particular value in putting expectations on themselves to meet two international standards (one more horizontal in nature, and the other more vertical).  It might seem to be abusive and inappropriately expensive.  But for me, I see sufficient clear benefit.  I find that during assessments, the folks responsible for ISO9001 are excellent in understanding and reviewing our activities with respect to organizational management, risk, personnel, quality improvement, error detection, quality improvement, customer satisfaction, management review.  They have a strong sense of these topics and review them well both in context of the standard, also in context of common best practice.  On the other hand, the laboratory assessors focus very well on the finer aspects of Quality Control, and aspects critical to PT users, like committee structure, instruction information, cautionary information,  and statistical analysis. It creates a healthy blend of practical and pragmatic, of ying and yang, of masculine and feminine.

If we can continue to afford to run both accreditation (17043) and certification (9001) we will continue to do so. 



Wednesday, October 8, 2014

The Pain and Glory of AGMs



For the last 2 days we have met, chatted, planned and ate our way through our CMPT Annual General Meeting.  Twelve months of awareness, 6 months of meeting planning, 1 month of getting details into place and 2 days of presentations and questions and answers and stress, and it is over… for another year. Would someone please pass the Advil.

The gist of the meeting with all the pretty graphs and Management Report is available on line for all to see at www.CMPT.ca check in the left hand margin and click on Annual Report. 
As much as I stress over this annual event, having now done it for many years, I have to say that I can’t envision running any operation without it.  I am a little surprised that ISO90001 talks about Management Review (which is a good thing) and setting Goals and Objectives (and that too is a good thing), but is silent on the importance and value of an AGM.  AGMs bring all the players into a single room and create a moment in time to discuss strengths and weakness, and the opportunities and threats (a SWOT conversation!).

CMPT is actually in pretty good shape; we have new digs – good clean and open space, and we have resources and interested partners.  I can’t think of any time in our 31 year history when things have been better, keeping in mind we are still working with governments determined to shave medical laboratories slowly out of existence.  But as long as patient safety is considered a priority, quality and quality assessment will be central to whatever laboratories do exist.  So we are likely to survive in some form or another, provided that we can keep one step ahead, and focus more on the future than on the past.   

This year we had for the first time some lessons to be learned which are displayed on our composite customer satisfaction score.  A visit to the Annual Report will show what I mean.  

 We have created a unique composite satisfaction score that is based on survey results, written comments, complaints, and contracts and consultations.  The score has an intentional negative bias.  Positive findings have positive multipliers of (+5) while negative findings have negative multipliers of (-10 or -25 or -100).  The point is to allow negative comments and complaints to dramatically drive our score downward.  For the first time since 2002 this downward pressure actually kicked in the current year.  

This was primarily due to a survey of users’ opinions of our web-site as a method for data entry.  As much as the site scored very high on Quality and Usefulness, Navigation was seen as problematic, and Ease of data entry was not very good; lots of not so positive comments.
I suspected this was going to happen, and my suspicions bore out.  I guess if we had wanted our satisfaction score to indicate that everyone was happy with everything that we did, we could have picked another topic for our survey, but what’s the point of the exercise.  At least this way we know and have documented that we have a problem that needs to be addressed.  And so now we will.  And that is a good outcome. 
For us the bottom line is that Quality Management is a risky process.  When we look for problems we find them and then we have to deal with them.  Better to bring this out to the open than to let them sit in the background and fester until the whole program falls apart in one inglorious cloud of smoke. 
We are a very small not-for-profit service provider that has impact on patient care and medical services across Canada.  If we are not prepared to focus on Quality, then it becomes pretty hollow for us to make demands and expectations on others. 
So the planning for next years’ meeting has already begun. 
I invite you to visit www.CMPT.ca