Saturday, December 21, 2013

Reflections on achieving organizational Quality

In a previous post, I commented on a “Notable Quote” printed in the ASQ’s November 2013  Quality Progress magazine.  It was reportedly a quote ascribed to Deming. 

Not entirely by coincidence, I was going through a number of books for our Certificate Course in Laboratory Quality Management and I came across a little book first published in 1996 entitled “Philip Crosby’s Reflections on Quality”.  It is basically a book of 295 quotations written and authored by Crosby.  I suspect by the very design of the book it was intended to be both a compilation of Crosby’s most influential comments on Quality and an homage to the book genre of the 1966 The Little Red Book: Quotations for Chairman Mao Tse-tung.  I mention this second point because while the two are in vastly different spheres, one can see common seeds between the Cultural Revolution and the Quality Revolution.  But that is a topic for a future posting.

What I want to focus on is Crosby’s absolutes, in particular his first “the definition of Quality is conformance to requirements”, his second “the system of Quality is prevention”, his third “the performance standard is zero defects” his fourth “the measurement of Quality is the price of non-conformance”.  

I was in a conversation with a colleague last week and the question came up about, at what point can you say that you truly run a Quality laboratory?  It is a fair question because we all tend to be goal oriented and labels are important.  

If I read Crosby as I think he intended, Crosby had a rather strict view on Quality and was that a Quality organization meets all requirements and has no defects or no nonconformities.  If that is a correct reading, I think that Crosby was of the opinion that the state of Quality is aspirational and a valued ideal, but is not truly or sustainably unachievable.  Quality is the ethereal end to the journey that begins with a single first step (homage to Confucius). 

I know that Crosby and Deming knew each other, but I don’t know if he had met James Reason, the expert on organizational error.  Current risk management is predicated on the concept that bad things happen, most often as the consequence of simple mistakes or distractions.  Many of these will be invisible or benign or seemingly innocuous but some of them will lead to very bad outcomes.  They are for all intents and purposes inevitable.  As long as we have working humans or machines, we will have defects.

But in today’s world recognition and public relations are important to organizations, especially in healthcare.  Top management needs to be able to point to evidence that their efforts to improve the organization are working.  Top management needs to be able to have some markers along the path to which they can honestly refer, and be able to say that the organization is moving well along the path to Quality and success.

So I present some markers that indicate they your organization is moving in the right direction, and at a certain point deserve to call yourself a Quality organization

1: A good start.
Perform your first Gap Analysis against your measureable goal, and develop a process by which you can and will close the gaps.

2: You are Making Progress.
Your first accreditation is always an achievement of which you can be pleased, but it is far more important what you do next.  The first is an achievement, the second is an accomplishment. The third is a demonstrated record.

3: Quality is your middle name.
You still have errors and defects, but now you have a system that detects them quickly and remediates their impact on your customers.  More importantly your system allows you to learn from your errors and put in corrective actions that make it unlikely that you will repeat that error.

4: Your name is Quality.
Your system works.  You know it works, your staff knows it works, your customers know it works, your colleagues know it works, your competition knows it works.  But you are still looking for continuous tweaks for improvement.

Sunday, December 8, 2013

Allowing your staff to do their best

I was perusing my November 2013 copy of ASQ’s Quality Progress magazine and the article “Words to Work By” caught my eye.  Not so much an article, it was a collection of Quality quotes submitted by other readers.  Some were predictable (“Quality is never an accident…”) and some were pretty iffy (“There is more than one way to skin a cat … but it matters to the cat”).  

But there was one that caught my eye.  It was ascribed to Deming, and maybe that is true: ”It’s not enough to do your best.  You must first know what to do, and then do your best”.  

First off let me say that in a quick peruse of the internet, many ascribe the words to Deming, so I guess I will have to believe it.  But I also will say it is pretty inconsistent with his own 14 points, specifically the one about “eliminate slogans, exhortations and targets for the workforce” and the other about “remove barriers that rob people of pride of workmanship”.  Somehow I have my doubts.  What Deming probably said was something more like “if your worker’s best doesn’t measure up to what you expected or wanted, perhaps it is because you didn’t tell them what you wanted.”  Don’t blame the worker, look more closely at yourself.  

All my career I have seen folks write job descriptions which gets read, signed off, and then put in a file where is sits forever, provided that it doesn’t get lost.  The job changes over and over, but the document remains written in stone which progressively becomes as immutable as granite.  As new tasks come on stream, there may be efforts to train workers, but in many situations the process of learning is one of self-discovery.  

It seems to me that if our organizations wants people to know what they are supposed to be doing, so that they can then “do their best”, what we have to do is start seeing their job descriptions as living documents that documents each change that gets implemented.  

There are many advantages in ensuring that job descriptions remain current.  First, the description becomes the foundation for ensuring that appropriate training and confirmation and follow-up competency assessment occur.   Second, it becomes a foundation for task ownership.  Third it becomes the foundation for management to know what exactly they are expecting their staff to be responsible for.  Fourth it provides a foundation for ensuring that when the job becomes vacant, the next person in can be made aware of all the tasks they will be expected to address.   
Let me focus on one of the above foundation statements, specifically management awareness.  

Has this happened at your place?  It certainly has in mine.  Over time, the number of tasks required incrementally increases, commonly at a rate that is faster than revenue generation.  We can always hire more people, so we tack the new tasks on to existing personnel.  Research and development, or provision of new programs sometimes requires what seems to be just a few more hours per week to get a new service or program established; at least that is what you estimate.  But the task becomes a little bigger than you anticipated or takes longer than you thought.  Now your staff are incrementally busier than before.  Then another “small change” gets added in, and then another.  Nobody says anything, but after a while the signs of stress and distraction start to show up.  Mistakes start happening.  People seem angry, or worse, burned out.  All of a sudden, a key person quits.  Now you and your program are in trouble.  Unchecked persistent incremental change all too often leads to precipitous crisis.  

The problem wasn’t that people stopped doing their best; the problem was that you let the operation get out of control.  Management dropped the ball by not keeping an eye on what you were expecting of your staff.  

So here is the solution.  May sure that the job description is kept as a living document which is checked regularly and often.  If you know what you are asking people to be responsible for, and you monitor that list to ensure that it is feasible, then and only then can you count on your staff meeting expectations.
You hired your staff because you saw their strengths and merits.  Good management provides the opportunities that allow them prove your judgement and assessment was right. 

Sunday, November 24, 2013

Quality and Risk Management

Introducing Rational Risk

I was invited to give a presentation at the Biomedical Standards eXchange 2013 meeting sponsored by the Singapore Standards Council.  The meeting was held in conjunction with our International Organization for Standardization (ISO) meeting for Technical Committee 212.  As opposed to the ISO meeting, the eXchange was well organized, and provided a lot of interesting information that would likely form the basis of some future action.  [The ISO meeting was pretty much the opposite.] 
I was invited to give a presentation on the application of Risk Management for the medical laboratory.  The sub-title for my presentation was “Reducing Risk through Application of Standards”.  For those interested, the presentation slides will be available at by November 27, if not sooner.

The message from my presentation was not a traditional Risk Management message, but I think it was both realistic and appropriate, and therefore an effective message for medical laboratorians.  

I started with some basics from Frank Knight that Uncertainty is made of two components; measureable uncertainty (“risk”) and the unmeasurable component (the unknown unknowns).  I argued that in controlled situations, like manufacturing, one can expect to considerably reduce uncertainty variables (measureable>>unmeasureable), but when one thinks of all the variation associated with patient selection, test ordering, sample collection and transport, the unknown unknowns in medical laboratory testing are huge and the relationship is likely inverted.  

Then I introduced observations from medical laboratory error investigation which indicate the large impact and frequency of testing slips.  Game and Chaos theories say that all events have a cause and effect, but often the cause is unrecognized.  Causes may be unproportional, meaning that seemingly trivial causes are associated with major effects (downstreaming). 
My main argument was that while there is a role in using risk management tools to reduce bad outcomes, at the same time, we have to acknowledge that until many other control issues come to play in the medical laboratory, one needs to understand that the goal is to reduce risk of bad events rather than prevention. 

We are more likely to achieve success through the application of outcome oriented risk management tools (such as severity-occurrence grids) than we would with a static precision tools (like Failure Mode – Effects Analysis or FMEA).     

I demonstrated how to set up an S-O grid, and how to use one for setting priorities and further how an S-O grid helps in implementing risk mitigation strategies.  

I think that was a helpful message, and it seemed to be well appreciated.

I also pointed out a risk strategy flaw in ISO 15189:2012.  As good as this standard is it introduces risk management as a way to reduce error soley associated with patient safety.  That is a good message, but does not go far enough.  Risk in the medical laboratory has a much broader footprint than just patient safety.  We also have risks that impact clinical staff, laboratory staff, the community, the environment, and the institution.  Setting up risk reduction without taking these issues into consideration would likely leave the laboratory with all sorts of liability issues.  

One of the other speakers, coming from the cosmetic industry, also talked about risk, but from another perspective.  He introduced the following formula:


His point was extremely relevant to the microbiology laboratory.  Just because E. coli can produce exzymes and toxins and can cause infection (all examples of inherent hazard), this does not equate to risk level because exposure effects are moderated by handwashing, containment, packaging, laboratorization, antimicrobials, etc, etc, etc.  

The formula is critical in recognizing and understanding the differences between risk perception and risk reality.  It is the key issue that should distinguish the general public from what should be the knowledgeable public [politicians, regulators, biosafety officers].  

All too often, it seems that “knowledgeable public” see a microbial name and then based on that information alone make all sorts of inappropriate assumptions and judgements about risk to public, many of which are just wrong.   

Recently I tried to have a discussion on the subject with one of our Canadian transport regulators, who was clearly incapable in understanding the concept.  Too busy first protecting her right to write regulation to make sure that the regulations were rational or appropriate.  

  Write before being right.  

It was disappointing and sad comment on the ability and mindset of what should have been a responsible professional.  Tragic.

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 ]  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”.