Defining Quality

Paul Borawski, the CEO of the American Society for Quality and the writer of the blog A View from the Q has written a very interesting entry on the Definition of Quality.  It is worth a read [see: http://asq.org/blog/2013/01/how-do-you-define-quality/].

There are lots of definitions around that Paul was able to document in a Future of Quality report in 2011.

As I look at this list, I will tell you that in my opinion many, perhaps most, of the definitions presented are very unhelpful (The pursuit of perfect that never ends;  Quality is conscience, Excellence, Quality is the degree of feeling happiness, Quality is the intangible that makes a better world tangible,.).  These are phrases that contain nice but meaningless words. 

Then there were a few suggestions that were equally unhelpful, but didn’t even bother to include some feel good intention (Quality is what the customer says it is, I know it when I experience it, My total experience of the provider.)

The problem with all these phrases is that none of them express any sense of objective measurability, and as such don’t provide any support for progress for the science or discipline of Qualitology [see: They do nothing to advance study or progress in Qualitology [ see: http://www.medicallaboratoryquality.com/2010/12/science-of-qualitology.html ].

In 1979, Phillip Crosby created a pretty good working (excellent) definition that has by-and-large stood the test of time.  His Quality is the Conformance to Requirements has been reworked in a variety of ways, that all express the same concept (Quality is compliance to a specification, or Conformance to requirements, or Meeting customer requirements) 

This has proven to be a helpful place to start.  In my field, it starts to break down, for several reasons.  First, it implies that there is a uniform customer  or a common customer need.  It assumes that organizations has the flexibility to provide a unique service for each customer.  Second, it implies that customer requirements can always be met, and third it implies that we can capture and analyze the degree to which we have met the requirement (think customer satisfaction surveys).  I don’t think any of those are generally true statements.

I am not suggesting that the Crosby definition is wrong, or that it should be discard, or even denigrated, but I think in some fields it needs to be adjusted to fit the circumstance better.

With that in mind let me suggest: 

Quality is meeting the requirements and expectations in service or product that were committed to. 

Hold me responsible to what I commit to do.  If I do that then I can say I have Quality performance.  If I miss due to over-commitment  or under-performance I have detracted from my Quality.  

If I told you that I would get your dry-cleaning done by 10:00 AM, then Quality service requires me to have the job done without fault or damage and ready to go by 10:00 AM.  You can count on it. 

And if I told you it would be ready at 10:00 AM and you come at 09:00 AM and are angry because it is not ready yet, that may be a disappointment, but is not a reflection on the Quality of my service. 

If I told you that I would have that urine culture completed by Tuesday morning before 7:00 AM, that means that you can expect to have an accurate quality-controlled and quality-assured interpretable culture report with the appropriate antimicrobial susceptibility results on your computer screen for 07:00 hr rounds.

And if I told you that I would build a bridge for 3.3 Billion dollars that people can drive across safely, and what I provide within time, and under budget a bridge that nearly kills people in a predictable period of poor weather, that is called the Opposite of Quality. 

The value of my extension to Crosby’s definition is that it is predicated on to what I made a commitment.  If my commitment is not close to meeting customer needs  then we have a second issue (more on this later), but I can and should be held to what I commit to do.   If I have completed as committed then I can say I have performed a Quality task.  If I get it done well, but late, I can measure the degree of lateness (in the laboratory we call that turn-around time) and I can define the amount of Quality lost.  I can measure amount of conformance to commitment, and I can study the deviation and develop a specific strategy for improvement. 

So in summary my definition for quality is tied to the customer need, but is further refined based on my ability to perform based upon what I promised; it is stateable, and it is measureable, and it is studyable.  Mission accomplished.

Not bad, eh?

PS:  The planning for the UBC POLQM Quality Conference (October 16-18, 2013)  is coming along nicely.  The themes of World Standards in Health and Improving medical laboratory services for better consumer care are coming together are established.

Ranting on a Rant.

A recent article in Quality Digest Daily (www.qualitydigest.com) posed the question “Internal Quality Audits – Valuable or False Security?”  The question was written within The QA Pharm, an anonymous blog focused mainly on issues in the Pharma industry.  

An interesting question, with an even more interesting answer.  QA Pharm contends that internal audits are not helpful because they tend to be done by auditors who have been working too long and who are too politically aware and avoid sensitive concerns, and senior management doesn’t support them anyways.  And they never get to the root cause because company culture gets in the way.  

In a way I am not too surprised by the rant.  My experience with folks who have transitioned from pharma to health care is that the pharma culture is hyper reactive to the point of absolute risk aversion, which tends to either paralyze or drive folks in the opposite direction.   People who care for pharma quality tend to get extremely passionate.  The rest get bashed to indifference.

Pharma does have certain problems.  Most drug release decisions are made through a series of graduated studies, on pharmaceutical effect, and then controlled safety studies, and then “larger” population studies, and then after-the-fact post-market analysis.  In their world even 6 sigma (3 defects per million) can be enough to sink the ship.  But they are not unique.  It only takes one airplane to fall out of the sky or one bridge to fall down to create industry chaos.  

In contrast the health care may be a little more tolerant, maybe too tolerant.

My biggest problem with QA Pharm is not on his opinions with respect to the frustrations of practicing qualitology in the pharmaceutical industry.  It is more with the folks who read the rant, and interpret the opinion as generalizable.  

Health care laboratories are just at the beginning part of the quality process and the introduction of internal quality audits is just being introduced in a significant way.  That is not only true in Vancouver, but it is my personal experience that this is the case across Canada, across the United States, and in many countries worldwide.  This is not the time for health care laboratorians to be thinking that internal quality audits are a waste of time, or too political. 

Internal quality audits can and should be an important component of technologist training, quality manager training, pathologist training.  They can and must (shall) be a component of quality monitoring infrastructure, and the foundation of quality research and outreach.

So QA Pharm can have his(?) point of view, and that is fine, if it is intended to apply only to the pharma industry.  That internal audits are a WOT, is not my point of view and it has no place in health care laboratories.

Memo to self: Ranting is a good thing, but don't expect everybody to agree with you.

m

PS:  Some of you may be in the receiving group for a POLQM Weekend Workshop blast out. next week.

PPS:  Some of you might consider sending the link to to friends and colleagues who might be interested.  All a part of being within an interest network.  Twitter works well as well.

Communicating Quality

About 15 years ago I decided that if CMPT was going to progress we had to develop an electronic presence, so with the assistance of my son, we created www.CMPT.ca.  I was so pleased that I had made this huge jump into the future, or at least the very current present.   I had a web site.  It took about a month for me to realize that a website had to be fed new material on a regular basis, and gradually it started to take over as a major preoccupation.  Gradually, what started as a hobby became the full time work of a number of people.  The problem, of course, was that we had never budgeted for the expenses.  The message to self was that you need to make sure that your organization gets benefit from electronic presence because it is going to become time (and money) expensive.  

Well the world has changed since the early times.  Web presence has become common.  Today, folks can spend their whole work day and their social life in the web world.  Communication outreach is world wide and immediate.  But the old messages continue to be true.  To be effective, the electronic world consumes TEEM (time, effort, energy and money).

I state the obvious because progress in Quality in every organization, regardless of size needs communication.  In an earlier time, Deming, Crosby, Juran were committed to quality communication by way of books and lectures.  They were prolific communicators.  If they were working today, they would have been within the first wave to embrace the Internet because it would have expanded their outreach.  
Evidence this by the myriad of sites that promote and communicate quality; www.darkdaily.com. www.iso.org, www.csa.ca, www.qualitydigest.com, www.westgard.com, www.asq.org, and medlab-eqas.blogspot.com, just to name just the ones that I get to follow on some sort of regular basis.

But what is so interesting to me is that communicating quality has evolved so far from the organizational website.  Outside communication is now about the website and the vehicles that transport to the website, like the web-log (I have taken on an aversion to the “b” word) and social media like Twitter and Facebook, all of which have become destination sites with their own messages.  
Outside communication has on-line courses and on-line conferences, extending beyond information and on to knowledge.  And  Inside communication is about intranets, and organizational email blast outs.

This is not to say that the concept of holding a meeting so that people can meet is now obsolete.  Meeting in person has powerful effects that Skype or GotoMeeting or videoconferencing will never duplicate.  But many organizations are shying away because of obvious costs.

And that brings me to my message to self:

1: The laboratory cannot succeed without Quality and Quality cannot succeed without Communication.
 
2: Communication is critical valuable and at the same time can be hugely TEEM consumptive.
 
3: For Communication to be implemented it requires the same level of rigor of Quality implementation and management as every other laboratory essential.  It has to be planned, and be implemented with forethought.  The implementation requires study and opportunities for improvement acted upon.  Over and over.

4:Quality requires Communication and Communication requires Quality.

Quality and Laboratory Medicine - Who is in charge?

As I continue with the Resident and Graduate Student seminar series, I have a dilemma.  I did a pre-course survey, in part to develop an objective measure of the course effectiveness in transferring knowledge. 

 

One of the questions asked in the survey was “When implementing a Quality System in a medical laboratory the single most critical procedure is “. 

The responses provided included:

     Regular and Frequent Management Review

     Regular Internal Audits

     Document Control

     Developing and Maintaining a Procedure Manual

     Regular Accreditation Assessments

     Robust and Regular Quality Control

     All included.

Only one answer (Regular and frequent management review) was deemed as the correct answer.  Of interest of 26 responses to the question, the number selecting that answer was zero.  The most common response was “all included” which was probably a poor inclusion on my part, but that does not take away from the absence of recognition of management as arguably the most critical part of implementing a quality system.

I don’t have to reiterate Deming’s stories about the importance of management to quality, because everyone interested in Quality knows and understands that to Deming, the absence of interest by top management results in failure to establish quality.  It is relevant that in the book “Out of Crisis” he makes the point that Management is responsible for 94% of error.  

Feigenbaum also made the point in Total Quality Management  when he said that by using the slogan “quality is everybody’s responsibility” we ensure that quality is “nobody’s” responsibility.  Quality is somebody’s responsibility and that somebody is Top Management 

I should not be too surprised that a group of residents in pathology and laboratory medicine would fail to recognize the importance of management in quality,  because most training programs do not have a tradition of recognizing how much of the work they will be doing will be management.   This is an excellent example of systemic failure.

Not to overstate the case (well maybe to overstate a lot!) laboratory chairs who feel it is acceptable and  appropriate to “game” or ignore accreditation and proficiency testing are unlikely to see a value and purpose in establishing quality management as a key component of their own laboratory or as a component of resident training.   To them quality is solely an operational responsibility, somebody else’s job.  In those laboratories that may well be the case.   

Pathology and Laboratory Medicine may well be at a cross-roads.  I wonder which path we will take.

Quality Education

Today I started my Quality Management Seminar Series for residents and graduate students in Pathology and Laboratory Medicine.  It is the second time that we have done the series, the first time being in January 2009.  I know that in Canada this is the only Quality Management Seminar Series provided for residents.  I am sure that there are other centers around the world that provide this information, but I do not know where.  Such is the reality of the communication networks in Quality.

A few things of note.  This year I have applied a PDSA to the series by having a pre-course survey which will be compared and analyzed to a post-course survey.  The results of the pre-course survey are in themselves instructive.  The survey included 10 knowledge questions that were pretty basic.   All questions were answered as single right answer with the list of responses being randomly positioned to avoid answering bias (if you don't know the right answer, then answer the 2nd in the list).  The style of questions included "what is the international standard for medical laboratory quality and competence?" or "in which phase of the medical laboratory cycle do most errors occur?". 
Of the 10 questions, the best response was 91% of responders getting the right answer, and the poorest response was 0 getting the right answer.  The mean, median, and mode for correct response was all around 40%.   So as they say, there is room for knowledge improvement.  When we have the post-course results collected and analyzed, I think the information derived will be a useful contribution to the resident education literature. 
I was tempted to attach the quiz to MMLQR, but I learned from the last survey that is unlikely to get many responses.  If anyone is interested, if you contact me I will send you a link to the survey.

Today's presentation included an introduction on why residents in training need to be more aware of Quality issues.  I reinforced the message with a series of news releases from the Canadian press highlighting high-profile error in the medical laboratory.  The list was put together by Robert Michel (of the Dark Report) and shared at the Quality Confab in San Antonio, and I thank Robert for letting me use this as an instructional exercise.   I was able to expand this list with a few more events.  The point of the exercise was to point out that once the public starts shining the light that results in change, it tends to not turn the light off.  And further, shining light does not result in confidence building; indeed it points out that public trust and confidence are fragile.  It is fair to say that for many the era of "I am a doctor. You can trust me"  is over.

The seminar series will continue for 3 more weeks.

While not posted yet, the presentations will be available on www.POLQM.ca

m

PS:  I have not mentioned the POLQM Weekend Workshop for a while. 
We have put together a brilliant group of speakers on a variety of topics highly relevant to education and practice of medical laboratory Qualitology.   Plus we are inviting posters and podium presentations.
Please visit www.POLQMWeekendWorkshop.ca

Predictions in Qualitology - 2011

As the year slowly creeps to a close and the next year gallops forward, I start to wonder what 2011 will look like for medical laboratory quality.

1: Flavor of the decade?
It is unlikely that Quality is going off the agenda in the next while in health care.  Across Canada the media has decided to keep an eye on the laboratories, waiting for the bad thing to happen.  We are unlikely to disappoint. 
This will put increasing pressure on provincial governments and maybe (but unlikely) Ottawa. 
Organizations like the Royal College will have a hard time turning away.

The validity of Crosby will ring true in health: the costs of non-conformance, in NOT doing it right the first time, are too high.  I don't know if we will ever actually achieve zero tolerance for error, but 2011  will be a pressure point.

2: Jobs, Jobs, Jobs
As the world comes out of recession and folks again have money to spend, the jobs will return.  This will be true in both the private and the public sector.  Near the top of the list will be the positions postponed or sacrificed along the way.  People over machines.  Buying bigger and better analyzers is unlikely to be seen as the best way forward.  But institutions will still be cautious and a major priority will be effective use of money and more effective monitoring. 
And that will mean more interest for more quality team positions.
Add to this, increasing political pressures (as mentioned above) and there will be even more Quality positions.  Think of 2011 and 2012 as the equivalent of what SARS did for Infection Control.

3: Knowledge is King.
In Canada, we had our Royal College meeting and the importance of shared knowledge in Quality was seen as priority number ONE.  In the US the audience for quality is growing, as is the number of laboratories seeking supplemental accreditation.  The number of folks coming to our training programs is increasing from around the world.  So the message is clear in healthcare that more folks need more information, and we will see the sharers of the that knowledge in more demand.
Again as mentioned above, the wave of new positions will require a wave of new educational opportunities.
Universities and Colleges will become more actively engaged in Quality.

4: Conferences - maybe
Organizations are increasingly leery of  conferences as good vehicles for continuing education.  Airfares, hotels, meals are very expensive.  So how does this fit with Knowledge is King".

First the number of on-line courses and conferences and confabs will increase using a wider array of communication tools that will promote connectivity.  Video conferencing, collective conversation,creative use of networking software will be an increasing part of the on-line education experience.
Second, when conferences are held, they will attracting an audience will be tougher as folks get more selective.
The conferences that survive will be fewer but better.

Successful conferences will be the ones in the right place, and the right time, with the right information, and the right contacts. For example, Vancouver in June at the POLQM Quality Weekend Workshop (visit www.POLQMWeekendWorkshop.ca )


So I'm looking forward towards an exciting year coming up with lots to keep us all busy.
See you next year!

m