More Reflections on Philip Crosby’s Reflections on Quality.

The quality improvement process is progressive.  One doesn’t just go from awful to wonderful in a single bound 

Crosby’s book on reflections contains a spectrum of trite such as “Anything that tastes good is bound to be bad for you (110)”, which is the all too common moan of the perpetual dieter, or inane “Once you put on a suit, no one tells you the truth anymore (83)” – I’m sure there is a grumbling story behind this.   

And there there are some very insightful, such as “The quality improvement process is progressive.  One doesn’t just go from awful to wonderful in a single bound.”  (234).  

I am intrigued by this reflection, not because it is so insightful (which it is) but that it comes from the mind of Philip Crosby.  

I never got to meet Crosby, but I have read his books.  He seems in writing to be a pretty black-and-white sort of guy.  “Do it right the first time” or “Anything caused can be prevented” or “The Performance Standard is Zero Defects” and “Zero Defects means doing what we agreed to do when we agreed to do it.  It means clear requirements, training, a positive attitude, and a plan.”   

This is all pretty absolute and without any wiggle room.  And none of that sounds even remotely aspirational.  You either did it Right or you did it Wrong.  

And it is a terrible message.

There have been few messages that have had so much resonance as DIRFT, or has spawned more corollaries.  “Why is there so little time available to do it right the first time, and so much time allocated to repeat it”.  “You can’t do it right the first time, unless you know what right is”  “You can’t do it right the first time, unless you know what it is”, “if you don’t have the time to do it right, when will you have the time to do it over”, and my personal favorite “it takes less time to do a thing right, than it takes to explain why you it wrong”.   

Almost all of these have the ring of bon mots; tone without substance.

In the medical laboratory and I suspect in a lot of other jobs and positions, nobody wants error, and nobody wants to make mistakes, and given a choice we “always” avoid error. But most error is human derived, some systemic, but a huge amount personal, and mostly silent or subtle;  distractions, slips, mis-interpretations, mis-understandings, errant keystrokes.  And while these still lead to errors and consequences, finger wagging about zero defects, does not make things better, it makes thing worse.  

It’s like when you mom or teacher or coach berated you with “you have to try harder”.

The quality challenge is to aspire to no errors, but to be vigilant in looking out, and diligent in catching as soon as possible.  In some situations, we can reduce error through inserting  some effective poke yokes (error blocking) tools and techniques such as required daily and in-run (real-time) quality controls, preventative maintenance, and error-reducing software and providing sufficient time-outs to allow reducing focus and stress.  More diligent attention to internal audits and proficiency testing can definitely help. 

But not always.

So that is why I was so pleased to see that Crosby also had a progressive side which acknowledged that nothing in reality is so cut and dry as zero defects, and that an organization needs to have enough tolerance and patience to accept a planned process of little steps, that allow time to reach a point approaching fewer mistakes and maybe even “zero defects” at least for a little while. 

⧫

On a related but different topic, work on our October Quality Conference is coming together nicely.  We have a working group that has come up with a number of very good topics, and some potential speakers.  One topic of special interest is a debate (Is Patient Centered Care in the Medical Laboratory Even Possible?),

We have our location, and assurances from a number of sponsors.  I expect that we will be able to post our first advert on time.  In the meantime,

Save the Date

POLQM October Quality Conference.

October 1-3, 2017

Vancouver BC Canada

Validation Verification and Vindication

Validation Verification and Vindication

We live in an era that loves to believe in logic and discipline as the basis of progress.  In near every discipline the clarion call to quality is that decisions must be evidence-based.  Evidence-based medicine is touted as the foundation for all diagnosis, investigation and treatment, based on the assumption that the overwhelming mass of studies performed and published provides us with all the information that we need.  

But it is pretty clear that many (most ?) of those studies are too small, too uncontrolled, and too biased and essentially not reliable, but we can do our best by combining studies and through meta-analysis can make the proverbial silk purse.  Despite this we generate tons of confusing and contradictory guidance in most things that are important, such as nutrition, vitamin usage, cardiac risk and anti-lipid therapy, and exercise, and on and on.  

For an interesting read on this subject, today I found an editorial in the Saudi Gazette written by Gary Taubes of the New York Times in which he talks about the “field of sort-of-science” in which “hypothesis is treated as facts”.   

The problem is not that we suffer from insufficient data or insufficient tools; indeed we live in the era of Big Data Analysis where thousands of databases with billions (and trillions) of points are available for picking and mining.  No it is not a problem of insufficient data; rather it is a problem of dirty data, poorly defined, incomplete, improperly gathered, and all too often inappropriately or insufficiently analyzed. 

Ultimately the problem is that we are left with the same lingering question “Who do you trust?”

To get on top of the solution we think in terms of Verification (is the analyzer capable of providing a repeatedly reproducible result within a narrow range of allowable error?) or Validation (do test results provide a result that is consistent with the gold standard and can they distinguish groups of subjects who are consistently “positive” from those that are consistently “negative” as measured by other parameters?).

But in addition I argue that we even more heavily rely on Vindication, which in this context I use to mean, “My approach must be right because I came to the same conclusion as noted in this other study”.  It’s a pretty soft measure, and a throwback to “evidence by authority” which predominated in the Dark Ages.  But it does have its compelling aspects.

 

I will give you an example.  In the Winter 2013 edition of Harvard Business Review Edward Hallowell wrote an article about a study published by Gilbert and Killingsworth in Science (Nov 2010) about people’s ability to focus on what they are doing and their sense of happiness.  What the study pointed out was that based on a pool of 2200 adults and over 250,000 observations, about 46 percent of people will commonly have their minds wander, even if they are enjoying what they are doing.  Hallowell, a psychiatrist and prolific writer on the subject of distraction writes, “Not only does such a lack of focus lead to unhappiness, it results in errors, wasted time, miscommunication, and misunderstanding, diminished productivity, and who knows how much global loss of income…”   

Now I am not a psychiatrist  (although I did a huge wack of training in psychiatry in my younger years), but in that sentence Hallowell summarizes the singular challenge for medical laboratory, and indeed all, Quality.  Recognizing that distraction occurs regularly is totally consistent with James Reason’s views on human error (slips and mistakes) and is consistent with Decker’s views on response to error, and is consistent with non-linearity of cause and effect in Chaos theory.   Lots of people (maybe most? maybe all?) lose concentration during work, and when that happens the opportunities for error and confusion arise.   Telling people to try harder is not an answer.  Telling people to Do it Right the First Time, is not an answer either.

Putting in systems to prevent the consequences of inattention and distraction (think Lean Poka Yoke) and putting in systems that will pick up on errors as early as possible, and putting in systems to reduce the repeating of error have a far more reasonable likelihood of success. 

I understand that my buying-in to this hypothesis is exactly what Taubes (sort-of-science) was concerned about (hypothesis becoming fact).  He would say that the linkage between distraction and error remains unproven.  But I have to say, without apology, that it works for me and I believe it.

Vindication.

Doing it Right or Doing it Wrong?

Doing it Right

Recently I was reading the recent (August 2013) edition of ASQ’s Quality Progress and came across an opinion article by Bob Kennedy who jumped into the fray between W. Edwards Deming and Philip Crosby and said that in his opinion that Crosby’s first essential, Do it Right the First Time (DIRFT) was wrong on every level.  The foundation of his argument was that Deming proscribed against slogans and therefore Crosby and DIRFT was wrong.

 I have to say that Crosby was NOT wrong, and that DIRFT was NOT wrong.  I am not sure that Deming’s concerns about sloganism was meant to include concepts like DIRFT, but if they were, then in all due respect, in this circumstance, I would have to side with Crosby.  Even a pioneering genius like Deming could not always be correct all the time. 

When is comes to concepts like DIRFT, Crosby was spot on, and Deming should have acknowledged it.

First off, let me put some context around my opinion.  I understand Deming’s point of view.  There are some slogans that I think are unhelpful.  “There is no such thing as an Accident” .  “Accidents poison to our organization”.  “Time is money – time loss kills growth and progress”.  These are not slogans, they are less than idle threats that lead people to hide slips and simple mistakes.  There is little place for threats in the workplace.

But DIRFT is not a threat, and indeed makes sense.  Given the alternative I would hope that a neurosurgeon makes triplely sure he does it right the first time.  And by the same token, the same goes for the airplane pilot.  Even the woodworker says, “Measure twice and cut once”. 

DIRFT is in fact a reiteration of a concept that Deming was so proud to adopt, even if he did not state it, “PLAN DO CHECK ACT”.  (For the origins of PDCA see Deming did not create PDCA.  [ http://www.medicallaboratoryquality.com/2012/06/deming-did-not-create-pdca.html ] .

What DIRFT was intended to mean was before you do something, make sure that you have organized your thoughts before you put a plan into action.  It is the essential corollary to PDCA.  Think before you do. 

In the medical laboratory we have tons of examples where things don’t work that way.  Tests get implemented without proper validation.  Tests are done and reported before checking the Quality Control results.  Reports are sent to the wrong person before confirming who was truly was the intended receiver.  These happen all the time and in every instance they result in external failures with potential false reports, misleading information, loss of confidentiality and huge cost of poor quality.  And most of them were pointless and preventable. 

A few seconds or at most minutes of thought and planning could prevent most of these problems, and save the laboratory from embarrassment or potential liability, and save the patients from inconvenience or harm.

Perhaps in Deming’s time, folks were very aware and sensitive to threats in the form of slogans.  Labor protections, either under the umbrella union protection or workplace legislation either did not exist, or were in their infancy.

That is not the world in which we live today.  Today we live with 40 character headlines and 140 character tweets, and thirty second commercials.  We live in a slogan society, and we by-and-large put them into a more current context.  We may see slogans as jargon and trite or sophomoric, but we don’t see them as threats.

Personally I see DIRFT as rather aspirational.  I fatigue of avoidable errors, or repeated mistakes.  I embrace the notion that doing things RIGHT is better than doing things WRONG, and believe that many errors result from automaton-like behaviour.  I absolutely support “Plan before you do; Prevent the avoidable error”  and even more importantly, “Learn from mistakes; support continual improvement”.

So to Bob Kennedy I think with respect it is OK to relax on the absolute adherence to Deming’s word.  It is time to embrace context and circumstance, and to acknowledge that it is also possible to acknowledge that both Deming and Crosby were giant contributors to our current concepts of Quality. 

One size does not fit all.

When I am doing project and lecture preparation, I tend to go back to basics; more times than not that means Deming and Crosby, two men with a common goal, but different approaches.  One place where they differ 180 degrees is in the area of error reduction and prevention.  Crosby promoted the principle that setting a goal of zero tolerance for error was the most effective way to prevent costs and consequence.  Do it RIGHT the first time (DIRFT).    Deming thought this was not only nonsense, but indeed dangerous and destructive nonsense, that would be used as a stick to punish and blame workers when things went wrong. 
 Forty years after the two were busy establishing the fundamentals of business Quality, the truth still lies somewhere in between.  

But as I was preparing for a presentation, I came across an now interesting 2007 article entitled ``Trying to Do It Right the First Time Isn't Always Best``.  Hooray for Google (see http://www.chacocanyon.com/pointlookout/070314.shtml) .  The author, a Quality consultant Rick Brenner, is rather dismissive of the concept of DIRFT (``These slogans might make some sense in the operational context, where tasks are very repeatable.``) , and then makes the points that an important aspect of project management and learning in general is to have the opportunity to do it wrong the first time and that risk taking is about giving permission to allow doing things wrong at first, if the consequence is that you might by accident or intent find a  better solution.

Well I can see where he is coming from.  In the research and development setting, we are looking for new insights, new knowledge, and novel approaches.  That is why we call it ``search and re-search``.  But as much as the medical laboratory is about new information, it is about correct information.  The right information from the right patient sent to the right clinician at the right time.  Everytime.  While  Brenner describes this as being merely operational, but it is pretty narrow-minded when describing this as repeatable as a simple repeatable task. 
 Clearly while being a consultant in one very narrow field, he has little interest or experience or expertise in the broader laboratory world.  
And can we agree that might not be the strategy of choice when building nuclear reactors!

From my perspective, in the medical laboratory, establishing DIRFT is not so much an imperative, but more a target and  attainable  goal, and the only way that we can move towards error reduction and reduced clinical consequence.

I recognize that in the busy laboratory there are many distractions that contribute to slips, but if information is delayed or faulty, the clinician and patient are not  interested in our problems.  They want what they want and they want it when they want it.   Period.

In 1986 Briggs Phillips published in an article entitled "Human Factors in Microbiological Laboratory Accidents" in Laboratory Safety: Practices and Principles.  Laboratory accidents, injuries and infections do not occur randomly;  most happen around a small group of people with repeat problems.  By case-control comparison to accident-free peers, accident involved people were less aware of work environment risks, Less aware of work behaviour risks, and were more prone to working quickly, especially before lunch and breaks and days end.  Accident involved people were more likely to take risks.

There is reason to suspect that similar issues are at play when it comes to Quality slips.  Most slips and errors occur in the laboratory in a similar fashion, a small group of workers represent the largest group of repeaters slippers.  I am not aware of any study that has looked at behaviors of this group, but it would not surprise me if we found a pattern similar to one described above.   Wouldn’t it be great if that type of information was available!

When we don’t don’t have an policy or a mechanism to deal with the repeaters, then we are only apt to find ourselves in the same place over and over again.  That doesn’t mean trashing the person.  Maybe  some investigation into causation and responses to distractions is in order, or some  re-training assistance may be  required.  

Regardless, at some point management needs to have a solution, and it seems to me that having accepted a DIRFT policy and principle to aim towareds is not a bad place to start.