Thursday, September 18, 2014
It has been a while since I have felt the need to vent in this space, but the events of today lead to exasperation and venting here in public/private seems like a good way of dealing with it.
I will tell you that I have spent nearly my whole career in and around standards development, some at the very local level, some provincial, and some national, and a lot international. In the beginning, I think my major motivating driver was ego, that I was in a space where I could “impose” my ideas on a larger professional group. After a short while this wears off, and the driver gets replaced by being motivated to have your profession steered by sound principles that come in large part from understanding customer needs. By listening to what other laboratorians tell me, I am told that I am competent at translating those needs into requirements that work well in standards at all levels.
For example, when working with laboratories in developing countries it was pretty obvious that the best way to introduce quality management principles was to break a sophisticated document like ISO 15189 (medical laboratories – requirements for quality and competence) into bite size pieces and introduce them on chunk at a time, along with mentorship assistance until they have worked through a series of implementation and gap analyses until they are ready for international accreditation.
That is now a very common and popular model for success.
I have had my successes and I have had my failures, perhaps the largest being my inability to get the measurement of uncertainty removed as a requirement from biology based laboratories. From what I can see, after 20 years of experimenting with uncertainty, few laboratories get it, and the consequence is that they throw some numbers into a formula and get a number which they then ignore, as quite rightly they should.
I will say that from the laboratorians that I talk with, and increasingly the number of accreditation bodies that have to work with the standard, I see that the tide is slowly turning, and in time I will be vindicated. Sooner or later, the customer is always right.
But today was not about MU, it was about a clearly and shining arrogance displayed when some standards developers are intent on pointing out how smart they are and how dumb are the people that are going to be required to use the documents they are creating.
One person actually relayed a story about how he went to talk with a significant user and asked why he was concerned about a new standard version being created and was told that the new version was not going to work well with his peers. He felt the new version deviated substantially from the existing version.
As he recounted his story his response was along the lines of “this fellow is a nice guy and I consider him a friend, but in this case he was dead wrong and his opinion was garbage.” Good way of listening to the document users.
Then he went on to say that the document that was being created was complicated by including definitions of terms when they could be equally found in another document. The solution was simple. Take them out of the new document and require users to buy two documents, one with the standard, and another with the definitions. “When you buy a book, if you don’t understand the words then you go out a buy a dictionary.” Good attitude towards addressing customer needs.
What was interesting that this group also thought it was be a good idea to go through a document validation process before making a decision on next steps. For those unfamiliar with the concept, document validation means going to a group of users and asking them if they understand the document and discover if their understanding is consistent and compatible with what the crafters intend. It actually is a good idea, but can be a lengthy and complex process, and requires an open mind and the ability to accept criticism. It is the Check step of PDCA.
With what I heard today I think we have all the makings of a new PDCA – Plan, Do, Check, and Argue that the customer is a jerk and just doesn’t appreciate how much smarter we are than they.
Deming would be livid.
So am I.
Monday, September 1, 2014
Over the last decade I have become a firm believer in the use of ISO 9001 as a guide to implement and maintain a Quality Management System for my organization. Our proficiency testing program has been strongly enhanced as a direct consequence of our commitment along with the annual review by our certification body. While our Program Office is not similarly certified, for practical and pragmatic reasons, we follow many of the same processes, which has enabled us to be accredited within our university system.
As anyone who knows ISO9001, customer satisfaction is a central component. For our programs, seeking and listening to the Voice of the Customer is critical to understanding where the organization is and where it is going
[see: http://www.medicallaboratoryquality.com/2012/11/voc-voice-of-complainer.html]. In my experience, even though we work in a public sector university environment, in the absence of VoC, the laboratories that participate in our proficiency testing program would gradually fall away and the program would lose its raison d’etre. In the absence of listening closely to the voice of our course participants, new participants would cease to register and the course would end. We may be academics working in an academic environment, but it is all business all the time, and Quality is essential.
But in the last while I have had three experiences that have given me some pause about the universality of the place of Quality, especially in the public sector. I am less convinced of how much of what we do and study really works in the public sector and when it does, why.
Recently I have been with my one son and also my daughter-in-law as the applied for visas associated with travel and work requirements. In both cases we had to go to the border security office at an international boarding crossing. I am sure that you think you know how this story goes, but you would be wrong. The office was set up as “customer friendly” with many fast moving lanes. The personnel were clearly all business, but not in a demeaning or officious way… courteous, but definitely to the point. In both cases the outcomes were positive, and the business was completely. What impressed me was that these officers had nothing to gain by making the process so efficient and effective, other than for their own professionalism and making their own work day more relaxed and enjoyable. They were never going to see us again, and there was absolutely nothing in it them if I told others that they were jerks or good guys. Their job is not dependent of good will. There will always be an endless supply of people needing travel documents.
Recently I have been a patient in our public health care system, requiring for my first time, seeing doctors and having tests and procedures performed. To date everyone has been very pleasant, indeed very similar to the story above. But the system stumbles so frequently, one wonders how anything gets done. An example: I received a phone message that I have an appointment coming up on a specific day and time to have a test done. Two days before the procedure I get another message as a reminder, but I was told to come at a different time. I got to the office and was told by the receptionist that there was a mistake because there is no appointment, but I when she checks she finds out that I have, but the paperwork was never created and now she has to do that. As that is being completed, the technologist comes and says that I have missed my scheduled appointment. Eventually we worked things out, but here we have a typical situation where nobody knows what is going on. If that was the only episode, I would write it off to a bad day, but it seems that with this group every day is a bad day. Once again everyone was friendly, but chaos ensued. The system was neither efficient nor effective, and for a moment, no one was very happy. There seems to be a real lack of learning from the past, and no improving the process, and I suspect that on my next visit I will go through the exact same exercise. Being friendly may be a small part of customer satisfaction, but only a small part.
The third story has to do with a colossal mess in my home province with a public sector teacher union on strike for months with little chance for resolution. Without going into any detail what this has in common with the other stories is that the sector has an endless capture of students (one customer) and the process has not only faltered, but failed. But in this situation, the union has made it all too clear that not only do they choose to not listen to their customer, they don’t even know who their major customers are. Hint: it is not the kindergarten kids.
What ties these stories together is that they all involve public sector workers with an endless capture of customers independent of word of mouth; one succeeds, one falters, and one fails.
So to me, here is the bottom line, ISO 9001 can work in a public sector environment, but only if conditions are right and if people are committed to a culture for Quality.
Monday, August 18, 2014
Bill Troy raises an interesting discussion on the future of Quality on ASQ’s blog “A view from the Q”. Will Quality change arise by Revolution (leaps and bounds) or Evolution (inch by inch). It is an important question as the world’s premier Quality organization plans and prepares for the steps forward into the next era of Quality advancement.
Discussion on the progress of Quality reminds me of a discussion with my mentor almost 40 years ago. We were talking about the creation, rise, and fall of new antibiotics. As new drugs come along they go through a certain predictable path; first they are the newest and hottest silver bullet, better than sliced bread. With the first few treatment failures or complications, they almost immediately reverse direction and are viewed as terrible and trash, even worse than poison. But over time we learn to recognize that these agents are neither perfect nor poison, and fall into their own individual niche within the armamentarium of treatment agents. He called it the sine wave of medical progress.
In my experience this is a commentary not only relevant to chemotherapy, but applies generally. We have seen Six Sigma touted both high and low in our own Quality Progress, but it continues on as a valuable tool in the Quality Tool Box. We have seen ISO 9001 declared as “broken”, yet it too remains as a valuable standard for implementing Quality. And in 2010 writers in the Wall Street Journal wrote “What do weight-loss plans and process-improvement programs such as Six Sigma and "lean manufacturing" have in common? They typically start off well, generating excitement and great progress, but all too often fail to have a lasting impact as participants gradually lose motivation and fall back into old habits.” But Lean is not dead, and many see great value.
Attitudes come and go as people jump on and off the bandwagon of what’s hot and what’s not. But the Quality movement continues on because society sees inherent value in confidence and competence and understands the true importance and security and safety that the Quality process brings.
Change will come because nothing remains static. Some will result as old guard folks retire and are replaced by newer, younger voices that emerge. Some will come as we attempt to fine-tune the subtleties within our standards. Some will lurch onto the scene with new technologies.
But let me argue that ultimately change will not be driven just from within the professional community because the real driver of change comes from public demand on one issue or another.
Want to know the future of Quality? Keep your ear close to the ground and listen to what your customers, your workers, and the public are talking and maybe even complaining about.
Quality change evokes better solutions.
Saturday, August 16, 2014
The world these days is struggling with another infectious disease outbreak. This time it is Ebola Fever. As of today there are over 1000 victims to a terrible and miserable death, for which there appears to be little that can be done, at least in its current home of West Africa. It is a major health problem, which cannot be diminished even when one takes into consideration the total population of west Africa being near 200 million. (1000 cases represents 5 cases per million population).
The challenge to the more developed countries that the outbreak poses are many and varied, but the one that came to front of mind over the last few days in Canada, is how should Canadians health programs prepare for the possibility of a case arriving at a local hospital emergency department.
This is a fair question to ask. Canada is a country that sends diplomats and missionaries and aid workers around the world, some actively in West Africa. And while there may not be a lot of tourists, there is a lot of business that goes on between the Canadian and Nigerian oil businesses. It is not impossible that a Canadian worker could be exposed in their line of duty and then get on an airplane, and later manifest illness back in Toronto, or Montreal or Vancouver or Winnipeg.
Regardless of how you look at the factors, the reality with respect to severity and occurrence is that the likelihood of occurrence is greater than one, and the severity of outcome would likely be considerable. Regardless of how the S/O grid is plotted, the level of risk is going to be considered as High or Serious. Some forward planning is clearly appropriate.
The challenge is what kind of risk strategy should be implemented; and that appears to not be a simple question. It depends on your starting point. If we start from the perspective of a business person who had recently visited Abuja on oil business who feels unwell, the probability of having a true case is not zero, but probably very very low, but if we start from a doctor working with Doctors Without Borders (MSF) in the epidemic zone, the probability is higher.
Further if one takes as the baseline the infection control and care delivery in a Canadian facility as opposed to West Africa, it would be fair to say that the risk of transmission in Canada is much much lower, but not zero. (As an anecdote, we once had a case of human rabies in a Canadian hospital where one healthcare worker shot spinal fluid in his eye, and another cut her hand on a microscope glass slide, so incredible things can always happen!).
But does the level of risk in Canada require setting up bunker mentality barriers of hazmat suits and hypervigilance, or can one depend upon our same level of cautions as we would use for influenza or rabies suffice? It is an interesting and important question.
The reality is that health care workers are humans and humans make mistakes. Many struggle with even basic precautions, but putting in complex procedures are rarely sustainable. The higher the degree of complexity, and the greater the level of stress, then the more likely errors is made. Recent readings of Sydney Dekker make that pretty clear. There are no perfect systems. The other reality is that hyper isolation creates less than perfect care for some patients, especially the elderly. Creating poor care for the “greater good” does not meet even the most basic oath of care: “Primum non nocere” or "first, do no harm."
To my mind, the crafters of Risk Management standards and S/O grids have a solution. High Risk or Serious Risk does not always necessitate extreme actions. What it does require is engagement of the highest level of decision making. In other words when the measures don’t contain the risk, the organization can say that the persons with the widest access to knowledge and information were engaged and the decisions had the highest degree of authority. The buck stops at the top.
That puts a lot of pressure on the folks at the top, but that is why they are there. In today’s world they have to take into consideration, not only the issues of risk and containment, they also need to consider the plague of 24 hour television news, public anxiety and hysteria, the politics of opposing voices, of workers refusing to work, and the general distrust of authority. And who can forget the lawyers just waiting to pounce. Sometimes, the loudest voice, not the best voice wins.
The reality is that this outbreak will come and go, just as did SARS, and Swine Flu. But there will always be another. And at some point we need to figure out how to implement risk management solutions that are truly fit for purpose.