Thursday, June 20, 2013

Who should be Writing Standards?

Who should be Writing Standards

For some of us who spend time being involved in writing standards with various organizations, it starts to take on a certain repetitive rhythm and routine.  For the most part we work our way through even the most complex of subjects and end up with  credible documents in anywhere from 9 to 12 months.  For more contentious areas or new areas, the time may be a little longer, but it would be a very rare situation where it would take more than 18 months.

I contrast that with the initial writing of ISO 15189:2003 (Medical Laboratories – Particular requirements for quality and competence).  I am mind boggled when I think back and realize that the initial creation phase of that document took from 1995 through 2002, a stunning seven years.  Now I know that ISO is supposed to be like the Canadian Senate, the house of “sober [in this context meaning knowledgeable, objective and unbiased] second thought” and that the point of the exercise is not to do it fast, but to do it right; but the reality was that at the end of that seven year journey, we had an interesting and useful, but very flawed document.  It may have been second thought, but I am less sure about the sober part.

Today the need and demand for standards is growing rapidly and the need for a more realistic turnaround time is both required and essential.  

There is however a compounding factor, and that is that many of the people who have learned through the process are starting to be of the “greying” set.  I suspect the median age of standard developers is something close to 55 years with 20 years of experience.  That group is slowly becoming less reliable for a number of reasons.  Many are starting to think about retirement and may want to continue on in standards writing more as a hobby or past-time which is not a good idea.  The problem is that often even though they (we) are still involved in work they may be less involved in innovation and change.  There is a sense that the way we used to it, is still the way it should be done, and that through standards we can perpetuate that approach, even though it is no longer practical or effective (dare I say obsolete).  Worse, as they leave work, their connection with new technologies grows more distant, and their efforts become ever more marginal. 

Respect for age and wisdom can and should have both a “best before” and an “expiry” date.
On the other hand, attracting young people (“kids”?)  early on is not much help either.  Sure they have age (youth) and imagination and maybe idealism on their side, but rarely is it tempered with knowledge or experience or insight.     Standards development requires knowledge, and an understanding of how the world and its sub-sets works.  Standards development requires, indeed demands experience and expertise.  Period.

So where do you find the best of both worlds, young enough to be enthusiastic and open to innovation, but old enough to have knowledge and insight; someone who knows what standards are and how they can and should be used.  Someone who is in a position to likely grow into standards development over a couple of decades.  

And here is the answer: look to the students like those in my UBC Certificate Course for Laboratory Quality Management.  

These are all people with a minimum of 5 years of on-the-job work experience who know what they are supposed to be doing.  Importantly they have been around enough not only to know the right way to get things done, they also have pretty good insights as to what are the wrong ways.  More importantly these are people who self-selected themselves to be interested in the domain of Quality and Standards and Management.  Not every employee becomes interested in those aspects of work; lots of very good employees are “just in it for the money”.  But folks taking extra continuing education programs in the domain of Quality, often on their own time, are much more likely to have the requisite passion to want to do things better, and to be “in it to win it”.  

And these are the ideal folks to be getting engaged in standards development; young enough to be keen, experienced enough to be knowledgeable, and motivated enough to be engaged. 
You can call that the winning combination.

Saturday, June 15, 2013

Think Strategic and Global but Act Pragmatic and Local

Think Strategic and Global but Act Pragmatic and “Local”
This month Paul Borawski, the CEO of the American Society for Quality (ASQ) asks leading questions in his blog A View from the Q [see ]
  • What is the most important challenge the quality community faces in ensuring that the value of quality is fully realized for the benefit of society
  • And, what question does the quality community most need answered in order to advance the state of quality practice in the world?
Good questions, but from my perspective unanswerable.  That is not to denigrate either Paul or the Questions; but the reality is that the “quality community” is so diffuse and so complex that no single answer is going to address the needs for the whole community. There are too many variables that include geography, resources, sector, culture, and on and on…  So I won’t even try.

What I can do is talk about my own little world of Quality for the Medical laboratory. 
In many respects Medical Laboratory Quality is still very much in its infancy.  We can date the current advances back to 2003.   Most laboratorians if they think of Quality at all, view it as far too fuzzy and anything but evidence-based.  For most practitioners Quality means doing Quality Control or maybe gathering information for some a Quality Indicator that usually has nothing to do with Quality or being an Indicator.  For others it means begrudgingly expending time and money on Accreditation and maybe Proficiency Testing.  For a very few it means having the satisfaction of being in compliance with international standards, especially ISO15189:2012.

What Quality doesn’t yet mean is saving tangible money through reducing Error, and reducing Costs of Poor Quality.

Medical laboratorians perceive themselves as pretty much fact-based folks, and that is a very challenging measure, because while we can say with confidence that adherence to Quality requirements will improve laboratory performance and outcome, what we are still lacking is the evidence to prove it.  

Part of the problem is that generating the fact-based evidence requires specific well-designed study and that means having access to grant-based revenue and graduate students and these are hard to come by.  Across North America and Europe the number of graduate studies programs that focus on laboratory quality issues are few and far between.  In the competition for funding, granting agencies tend to favor the traditional laboratory sciences based on molecular techniques.  I am aware of only one person who has been able to capture the revenues required to look at testing standardization and its potential impact on patient care and poor quality costs.
We have talked about our own data on TEEM costs in which we observed that the average laboratory error consumed an average of 140 minutes to repair (range 20 -1000 minutes) with external failure errors that involve having to contact physicians and patients being the most costly.  That is not a surprise and is consistent with all cost of poor quality data going back to Juran.  That is a start, but we need a lot more to create and provide a platform of data that supports the Quality benefit.  That will take time.

In the past, and even in the present, most laboratories are not creating a position for a Quality manager.  That is a problem, but I can also see their reluctance.  Healthcare is costly and budgets are becoming increasingly limited.  The Quality community is going to need to demonstrate that having a Quality manager will result in savings greater than the costs incurred.  That will not work as an article of faith; it will take hard data.  In the early days of antibiotic resistance, and indiscriminate ordering of antibiotics, hospitals were able to save often double the costs of the clinical pharmacist programs.  That was clearly a measurable success (We will see if the modern “Antibiotic Stewardship” programs are as successful). 
It will not be sufficient to say that having a Quality Manager is a good thing to do.  We will have to have measurable success.    We are starting to develop the metrics to answer this. 

PS:  Our October Quality Conference for Medical Laboratories is coming along well.  A great line-up of speakers and topics:

  • The impact of Stress on Quality and Error.
  • The Sources of Error in the Pathology Laboratory
  • Competency Testing
  • Quality for the Rural Laboratory
  • Measurement Uncertainty
  • The Science of Sample Collection
  • A 20/20 view of Medical Laboratory Quality
  • Canadian Standards in Transfusion Medicine.
  • And many more

For more information and registration visit:

Tuesday, June 11, 2013

Authority and Responsibility

I had a conversation the other day with a colleague of mine in the standards development arena talking about Authority and Responsibility.  The essence of the discussion (argument?) was my propensity to use the phrase “the quality manager has the authority and responsibility…” and her position that the phrase sounds nice but is both pedantic and redundant.  Her view was that Authority and Responsibility are two parts of the same thing.

I disagree.

Having authority is something that is granted by another.  In the Quality sense an organization can be authorized to provide certain services such as doing accreditation audits or certification audits.   On a corporate level an employer or supervisor can include within a job description the authority to make certain decisions about hazards and risk management or decisions about hiring or firing people at a certain level.  On  a professional level, authority to perform is usually based on have been granted to licence to practice.  On a personal level a person who goes out and gets a drivers licence has the authority to drive a car. 

On the other hand being given a responsibility is the same as being charged with a duty or task.  There is an expectation that when an if there is a task to be done,  the person given responsibility is the person who is expected to make sure it is done, either by themselves or somebody else. 

You can ask a direct question, “Who was responsible to get that done?” and you should be able to get a finger point at “him”. 

Having authority is about being given the licence to perform.  Having responsibility is about being charged with the duty to perform.

And to complete the argument, being given both the authority and the responsibility says that the person has both the permission to perform in general but also is charged with the duty to perform certain specific tasks or duties. 

Think about James Bond who was authorized as a MI-6 agent with “licence to kill”.  In the different situations he had the responsibility of stopping or killing Dr. No, Goldfinger, Blofeld, and on and on and on.  And as M pointed out in Casino Royale, if he killed someone that was not on his responsibility list, while he might have a licence to kill, he could lose his licence and be charged with a crime.  Having a licence to kill doesn't mean he could kill willy-nilly. 

Now to be fair to my colleague, in many situations, the basis of granting authority can be pretty tenuous.  In the best of circumstances it is based upon competency and achievement, like being accredited to 17011, or receiving a licence to practice a profession.  Other times it is an appointed authority by government or an employer.  Sometimes it is really unclear upon what criteria someone was given authority.  And unfortunately, there are lots of employers who are really ambiguous about what responsibilities are being granted and under what conditions. 

In my mind, one of the key differences between a Quality based organization and another based on “gut and intuition”, is that in the former people know who has authority and who does not and more importantly what each person is responsible for, while the latter, those roles are often left ambiguous or unstated.  In the long run, one has an increased likelihood for success, while the other, not so much.
So to my friend, let me say I may be pedantic, but I am not redundant.   
Being granted Authority and being given Responsibility are different.

PS:  Not to belabor the point, but if an organization offers to perform cut-rate certification or accreditation, be very suspicious.  Anybody can do an assessment, but not necessarily well.  And more to the point, they probably do not have the authority to provide a valid ISO certificate that would be recognized by anyone as an achievement.  Unfortunately, even in Quality we still have to follow “buyer beware”.

Registrations for our October Quality Conference in Vancouver are starting to pour in.  This week we have lined up three new topics:
  • Sources of Error in Pathology
  • Assessing Competency in the Medical Laboratory
  • Workplace stress and its impact on Quality.
Register at: