Wednesday, July 27, 2011

Quality and Excellence

Still enjoying summer but with a lot of projects and proposals on the go.  Hopefully they will all be ready by September.  Will talk more about them later. 

But today I received another email from the American Society of Quality (ASQ) with concern that the US government has put the congressional financial support of the Baldrige Performance Excellence Program on the chopping block.  The ASQ is asking its members (presumably just the American members) to write letters of support demanding the cuts can be prevented.

I understand that every organization needs financial resources to exist, and that the Baldrige Program is a P3 program (Public Private Partnership) which implies public support, but I certainly hope that along with this rally-the-troops email solicitation program, there is also a Plan B abrewing. 

In my opinion smart, forward-looking organizations make the decision that their operation will be enhanced by a Quality program and implementation is based on internal decisions.  Being seen as a best-in-class organization creates huge goodwill and creates a significant competitive advantage.  Given the choice between mandated quality and internal (volunteer) quality, the latter has a much greater chance of impact.  There clearly is a role for regulated Quality through mandated accreditation but Quality-by-force is a constant battle.   

When an organization sees benefit in Quality and implements because it wants to, the level of enthusiasm is higher and the level of activity is greater.  That is why I strongly see advantage in the US Baldrige or the Canadian National Quality Award programs.  Whether the program is funded or not, I suspect there always will be US organizations that will be prepared to implement some version of improved Quality and Excellence on a volunteer basis. 

But there are a number of key issues of which folks should be aware.  The Malcolm Baldrige program has been in place near 25 years as a public-private partnership.  The major private partner is the Malcolm Baldrige Foundation (MBF).  After 25 years if a foundation can not survive without government handouts then I would argue either the foundation is inept or the idea is not one worth supporting.  Second, the amount of money that is going to be withdrawn after 25 years is about nine million dollars ($9M), which again I would argue for a foundation the size and maturity of the MBF should be small potatoes, especially with all its very high 
 profile and the additional support it gets from professional organizations, including the ASQ.  

These days, if they still really need the $9M, there are tons of ways to raise that kind of money.  Remember that the Baldrige Foundation is supposed to be about organizational performance excellence through innovation and improvement. 

They could have a lottery for a Malcolm Mercedes or a Baldrige Buick.  They could have bake sales for Baldrige Bagels.  ASQ and all the other organizations could a 5% fee on memberships and book sales (Buy a book for Baldrige).  How about Malcolm mugs or Baldrige buttons? 

For a country with a 15 million-million dollar debt ($15T), another $9M represents the pocket lint found on the penny in the jacket pocket, but cutbacks are an inevitable political reality. Instead of having 600 assessment staff, could they get along with 540?   A drop of 10 percent could easily have a cost reduction worth millions.  A little LEAN thinking may be in order for the MBF.

So from my perspective, it is time to stop whining and time to start showing some of that innovation and improvement that the organization so strongly endorses and supports.  Put me down for two Malcolm mugs.

Sunday, July 17, 2011

Keeping Busy

Ah, summertime; time to lay back and relax.  Well, kind of.  Actually for both CMPT and the Program Office, this is our big time for Acting and Planning.  Summer is when our PDSA cycle tends to end and start.

For example, our CMPT business cycle starts in May and ends in April.  Our last send-out for the year is in February, and our first is in May.  So the summer is our time for Management Review and for making our go-forward plans, keeping in mind that our reporting time comes around with our regular Annual Meeting in October.  For the Program Office, our course runs from January to June, which means that we have June and July and maybe August to do our evaluations and planning so that we can start to implement change in September so that we will be ready to go in January.

For CMPT we have some significant considerations on the table, but clearly the biggest one is our decision to join the international collaboration of EQA providers under the banner of Health Metrix.  This has been a long time in coming. We first started discussions with the group nearly 10 years ago.  Today there are too many good reasons to join and no good reasons to hold back.  First off, CMPT has already worked with many of the programs that participate in the collaboration in Asia, Africa, the Middle East, so this is not a situation where we (or they) are working with unknown entities.  Second, for a long time CMPT has worked as a stand-alone organization, which provides both benefits and risks.  Being part of a collaboration of like-interested programs provides some opportunities for common purchasing and research and development programs that can impact on revenues, on expenses, and academic pursuit.     

On the other side CMPT brings a lot to the collaboration, including our commitments to innovation and clinical relevancy and education.  Even within a collaboration where individual programs have choice, I think that we can put forward a compelling argument for our style of clinically oriented proficiency testing. 
So we are looking forward to participating as our linkages within the Health Metrix collaboration matures.

With respect to the Program Office, we completed another very successful year.  This has been a very eventful year with having our eighth year of the course, plus the creation of our first research collaboration, plus the Quality Weekend Workshop.  That has kept us very busy.

As usual, the comments and critiques from the course participants are available at  There are two going forward messages to us.  First, it has been pointed out again that the course in very intensive.  It has been strongly suggested that we recommend participants to begin reading some of the background materials before the course actually starts. 
I think this is an excellent idea, and I will introduce that idea at our faculty meeting this week.  The second one may be a little harder.  During the progress of the course some minor changes got introduced which resulted in a necessity for purposes of fairness to make some minor changes to the grading formula.  Some of the participants saw this less in terms of accommodation, and more as a breach of commitment.  I can see that the truth lies somewhere in the middle.  As much as I am a strong supporter of Phillip Crosby and DIRFT (do it right the first time) a commitment to quality understand that sometimes deviations happen and when they do, there is a requirement for review of the events that lead to the problem, and an open and transparent speedy solution, and a process to avoid repetition.  That is what we have implemented. 

Finally, I have some key changes that I will propose at our annual faculty meeting which will create even more value in the course.      More on this next week.  So much for the lazy hazy days of summer.   

Sunday, July 10, 2011

OFIs for ISO9004:2009

For the last few presentations I made the argument that ISO 9004: 2009 provides a valuable second look at its parent document ISO9001:2008 and suggests a way that Quality Management can be used  not only as a way to improve policy and procedure, but also to lead to a level of sustained success in meeting long term objectives.    

Learning through preventive action, and evidence-finding and focussing on the people in the organization not only makes sense, it also has a track record of success, at least from my personal experience within a small R&D compact Quality oriented organization.
Even if it is not an accreditation or certification document, I suggest that it is worth a look at by medical laboratory qualitologists and management.

But clearly, as much as many or maybe even most ISO documents come from a solid basis of consensus, there is always room for improvement. 

The first sentence of the introduction in 9004 says that the document provides guidance to support the achievement of sustained success for any organization by a quality management approach.  I think that sentence is supposed to mean that organizations can achieve sustained success by doing the right things. 

But sustained success is not something that any organization can have total control over. 

Consider Research in Motion (RIM) the pioneer in the smart phone environment; the creator of the BlackBerry.  For the longest period of time, there was only one smart phone, of at least a few models, but they all were variations of the BlackBerry.  BlackBerry defined the gadget market.    Life at RIM was good.   
But RIM got caught with its “pants down” when all of a sudden Apple decided to enter the market with a better smart phone, the iPhone (is the “I” in iPhone for  “innovation”), and then pulled off “innovation-squared” (I2) with the iPad.  S
hort of industrial espionage, I don’t think that there was anything that RIM could have done to quickly respond to this undeniable stroke of marketing genius. 

Today RIM stock is down about 70% from its highs.  Profits are still being made, but nothing like they were like before.  Shareholders are trying to force out the co-CEOs.  Rumors abound about RIM becoming a target of take-over.

All the study and adherence to 9001 and 9004 in the world would not have protected or prevented another company deciding to take a run at the Blackberry market and win.     
So in regard to ignoring the impact of competition on long term success, ISO 9004:2008 leaves a pretty big gap.

So as to not confuse the issue about the role and impact of competition as a success determinant for our Canadian publically funded medical laboratories, I also recognize the reality is that there is no competition in the medical laboratory field.  What we have instead is a Mafia-like carving up of communities which results in Medical laboratories have locked-in clientele without any form of competition.  Even if the laboratory was completely unresponsive to the needs of clinicians and patients, it would take almost divine intervention to have a competing laboratory allowed to provide testing in competition.  Personally I see this as a real weakness to our laboratory system.  The issues that prevail against competition are essentially the same as those that make it difficult for medical laboratories to define and measure success.  And absence of measures of success contributes to lacklustre activity.  Think about the problems as manifested at its most egregious level in Eastern Health in Newfoundland.

My other main concern about 9004, as well its parent (9001) and sister document (15189) is that they expect top management have control over resources and infrastructure.  Top management is expected to establish and provide sufficient resources, infrastructure and work environment to meet the needs of sustained success.  Well best of luck with that. 
I can’t imagine any organization being able to ensure sufficient money, personnel and resources to do all the things that think are necessary and lead to innovation, learning and sustained success.  Well maybe some provincial and federal ministers can do that for their personal offices can pull that off, but I don’t expect that as a realistic reasonable recommendation for any private sector organization (Microsoft or Google excluded) or the public sector, and certainly not a medical laboratory.

The reality is that throughout near the whole of the economy, budgeting is pretty much a wish-list exercise with too many variables and moving parts.  No one can ensure that appropriate money and resources are available.  The best we can do is try to focus something approximating real needs and then try to look at what has to be done to stop the bleeding of money that results from poor quality losses.

So what does all this mean? 

ISO 9004:2009 has some overly idealist points of view with respect to self-sufficiency and supply side resources.  It makes certain excessive assumptions on what top management can and cannot do.  It overstates what is achievable. 
Nonetheless I still see it as a valuable contribution.  It is not an accreditation requirement, and it is not a legal requirement, but it provides an interesting and valuable approach for organizations interested in adopting and working within a quality management approach.

Overall this is still a very good thing, even for the for the medical laboratory.

Wednesday, July 6, 2011

9004 - once more with passion

In 2009, Boiral and Amara published in Quality Management Journal (QMJ VOL. 16, 2009, ASQ: 36-60) that only about 25 percent of adoptions of ISO 9001 were effective, with the ineffective ones marred by internal or external barriers, or by little evidence of ongoing activity.  Those situations where there was little activity but few barriers to explain the failure were referred to as Managerial adoptions (the manager may care but no one else does).  Those with lots of activity but huge road blocks and pitfalls were referred to as Ceremonial (we adopted it, but we have no intention of allowing this to actually work).   Those where there was poor activity and huge barriers were called Ineffective (why did you even bother?), and the remainder showed ongoing success (Effective…Hooray!). 

I raise this because I suspect a similar pattern with ISO 9004:2009  Managing for the sustained success of an organization – A quality management approach.  There will be those (some) who become aware of ISO 9004:2009, and progress towards sustained success, but the majority will be unsuccessful.

ISO 9004 provides a useful approach to take the requirements of ISO 9001, but help enhance the view of shifting from just implementing because you have to in order to maintain your certification, to seeing value and purpose.  It promotes the use of factual evidence, awareness of changing environment, valuing employees, and monitoring customer satisfaction as tools to keep the organization moving forward towards success.  Success is enhanced not by creating a strategic plan and policies, but by communicating the strategic plan and policies, and setting forth to action and implement.  And succeed through success, meaning learning from your experiences and adopting  innovation for progress through positive change. 
One can see the influences behind 9004.  Focus on measurement (Six Sigma); focus on involvement and motivation of staff (Toyota) and focus on analysis and review (PDSA).  It completes the loop back to the beginnings of quality management.

9004 should be a roadmap to success. 

So why do I think that adoption and success will be small, especially in medical laboratories?  First and foremost, at least in Canada – and indeed probably most or all public sector funded organizations - there are no longer any traditional measures of success, because there is no incentive for success.  Medical laboratories will always “succeed” in the sense that patients will always come for care, and physicians will always send samples.  And the budget will always be there.  Closures don’t result from doing bad things, or bankruptcy; they come from higher level “efficiencies”.  And in a union shop environment, the concepts of personal pay-for-performance or bonus-for-excellence have been wiped off the table.  Laboratorians in institutional laboratories no longer know what success looks like.

The only real measure for effective success is, in my opinion, professional pride, and the sense that MY laboratory is the best, a concept much more of the ‘60s and ‘70s than of today.  Today the notion of organizational pride and the spark of competitive edge are all but completely wiped out.  That is not to say there are not still organizations committed to National Quality Awards and the Baldrige Award, but they are truly few and far between.

So does that mean that Qualitologists should write this document off as “interesting but not realistic”?  I don’t think so.   Read it, and think about it.  There are some pearls here.  Some of them may even be enough to help overcome some of the afore-mentioned barriers which could contribute to some of the ceremonial adoptions may shift over to being more effective.  Some of the practices may improve to the point where more than just the manager cares. 

Long term hopes and aspirations? Absolutely.  That is what we call strategic planning for long term success.

PS:       I am aware that few medical laboratories focus on 9001 as their source document for quality.  9004 is fully compatible with ISO 15189, and as far as I can tell, with CLIA.

Next time.  The two major holes in ISO 9004:2009.  

Monday, July 4, 2011

Innovation and Education and a new document

Our External Quality Assessment / Proficiency Testing program (CMPT) began in 1983 to fulfil some local needs.  As years progressed, CMPT changed, increasing in scope of geography, increasing the quality and variety and complexity of samples, improving the assessment scales, and providing better critiques, and expanding our education activities nationally and internationally. 
By 2003 when we made the decision to introduce our quality management system under ISO 9001, it was clear that the first two components of our Mission State would be Innovation and Education.  From my very narrow and personally biased perspective, I was pretty convinced that we had the concepts of innovation in proficiency testing down pat.

So it was with interest when we started to read about a new version of an old document, ISO 9004:2009, Managing for the sustained success of an organization – A quality management approach. 
(Note: for the sake of brevity, I will refer to this document simply as 9004.  Don’t tell the folks at ISO.  They hate it when their documents are abbreviated to a single number.)

9004 is a newly developed companion document to ISO 9001:2008 on Quality Management, but it is not itself a standard in the traditional sense: it is much more a guidance or advisory document. It is stripped of the directive, normative term “shall” and usually replaces it with “should”.  It describes how any organization can use their ISO 9001 quality management system to increase their opportunities for sustained success.

I spent the last few days looking closely at ISO 9004, in part to see how well it describes our the path over the past 28 years, and second to see if it could have anything more to contribute to CMPT.     

Actually I am pretty impressed.  9004 does not really add anything to 9001, but it reshapes it, and provides a focus on how to organize the requirements in a way that can lead an organization along a successful pathway.  For example, 9004 talks a lot about Learning. 
 Learning comes from knowledge, and knowledge comes from a myriad of directions: from the information that you collect from your own organization including opportunities for improvement, internal assessments, external assessment, your evaluations and experiences of your suppliers and partners, your KPIs and indicators, and importantly both your successes and failures.  And knowledge also comes from the experiences, past and present of your staff.  Organizational learning comes when that knowledge is integrated into the capabilities and thinking and behaviours and values of the people within your organization.  But for all that to happen, you have to be prepared to SHARE your organizational knowledge with your staff.  If you are very active in collecting the information, but fail in the sharing part, then don’t expect the organization to grow.  
9004 also talks about my favourite topic of innovation.  9004 suffers from a lack of definition for the term, but a short search describes innovation as “the act of introduction of change, creation, novelty with the connotations of “advance” and “leading-edge”.  With that in mind, 9004 talks about innovation not only being about new products, but also about introduction of quality management, or new organizational structure, or new technology, or new processes, the point being change with a positive point of view.  
But for those of us that focus on innovation, 9004 also makes the key points that change carries its own risks because not everyone is always comfortable or positive about change, and change may uncover some previously hidden conflicts.  Plans for introduction should address timing and resources as critical and ALWAYS follow with an impact study (PDSA)  and always have a contingency plan (Plan B).

So far, I am pretty impressed with the document in my setting and situation, and plan to spend a little more in depth coverage, for example where I see 9004 having traction, and where I see it likely not. 

PS: I got my copy of ISO 9004:2009  from the on-line ISO bookstore (  It cost 150 Swiss Francs (about $150 CAN)

On another completely different topic, the beginning of July is always a good time.  On the west coast, lots of Canadians spend Canada Day visiting malls in Bellingham Washington, and there are lots of Americans cars here in Vancouver.  Kind of like going to your neighbours for a holiday BBQ.