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”.

Monday, November 11, 2013

The Meaning of Quality

The Meaning of Quality

At our Quality Management Conference for Medical Laboratories last month, one of our speakers made a throw-away comment, that the word “Quality” is so overused these days that he was no longer sure what people meant by the term.  What intrigued me was that a similar comment was made by another speaker as well, and indeed the concept became an on-going recurrent theme throughout the meeting.
I understand where they are coming from, and I feel a certain empathy, but in all due respect, I think that the sentiment is wrong.  Quality does have meaning.

On the other hand, one of our speakers reached back into the past and made a relevant comment:  “Quality is not a word, it is a journey” [ note: a variant from Ralph Waldo Emerson (?) dated around 1854 – life is a journey not a destination.  The Quality variant has been used since the early 1990s] ,  As much as this sounds like an old truism, I think it is still valid and still an appropriate attitude and approach towards understanding the discipline in which we work.

Let me pull a few things together here.  

With regret we still see all too many laboratories with a track record of repeat  accreditation as far back as the early 1970s.  If you applied the Crosby definition of Quality being defined as meeting requirements, then you would call repeated accreditation meaning Quality.  But you could be wrong.  

Many repeat accreditations were a joke.  Laboratories doing nothing for 4 years and 9 months manifesting no evidence of improvement, and then spending 3 months to tidy up manuals and fill in QC charts.  An accreditation visit, lasting maybe 4 hours done haphazardly, which is then followed by an approval process, perhaps with some recommendations for improvement which don’t occur.  The laboratory then takes a post accreditation breather hiatus of about 4 years and 9 months, and then gets started again.  There is no evidence of a journey here.  It is Quality in name only.  That theme gets carried out in so many ways.  Quality Manuals are beautifully created, only to be locked up in an office more as a trophy on display than as a useful and usable document.  Quality in word only; no journey here. 

We see laboratories where management hands off the Quality portfolio to the senior staff (or worse the junior staff) expecting receive a report of quality indicators for signature once a month, but never actually doing anything with the information; and calling that Quality.

We see laboratories where management receives continuing education funds from institutional resources, but 90 percent or more is spent on management level travel, and 10 percent goes to technologist training.   Again, static words.

We see laboratories that bring in consultants to review and propose grandiose plans for leaning and implementing quality software or purchasing new bells and whistles, but little happens to justify the expenditure, with little consequence.  

We see evidence of static quality all the time; it is no wonder folks fatigue of hearing the word.  

Quality is about progress, about continual improvement, about setting goals for change and making the commitment to follow through.  Quality is about giving voice to both compliments  and critiques to discover what you are doing well and more importantly discovering what you can do better.  

So I agree there is lots of evidence that if action without meaning continues to be the norm, then the term Quality has lost its meaning.  So if you are fatigued by the “journey not a destination” homily, let me offer another more functional definition. 

Quality is the commitment to continuous positive change.  

PS:  If you are interested in viewing the presentations from our conference follow:
Go to the LEFT margin and click on SCHEDULE
Each presentation is linked to the author’s title.

Wednesday, November 6, 2013

Seeding Knowledge 2013

Seeding Knowledge 2013

I have been invited to speak at a conference in Jeddah Saudi Arabia November 16-17, 2013 with the most interesting title “Seeding Knowledge”.  I think this is a brilliant title and an even more brilliant concept.  For conference planners, I suggest that it is a title worth considering*.  

Seeding conjures up all sorts of horticultural sparks:  selecting the best seeds, sowing optimally, tender and vigilant care with selective cultivating and strategic weeding, and above all enjoying the benefits of later harvest.  The concept ties with medical laboratory Quality in the best of ways.  At its core it is an exemplar of Deming and Plan Do Study Act.

I will be talking about ISO Standards for Medical Laboratories, in particular, but not exclusively ISO 15189 as a foundational document upon which a laboratory can build a Quality culture, and also about Leadership issues (think the “Feigenbaum Rule” of 80:20 responsibility for Quality).  Other presentations will include (but are not limited to) Effective Delegation of Authority to Modern Approach, Driving Improved Patient Outcomes from the Clinical Laboratory, and The Era of Static Quality Is Vanishing , all of which constitute an impressive set of titles and subjects.  

 For those laboratorians with geographic access to Jeddah, the meeting coordinators have done a magnificent job.  

I will revisit this subject again after the meeting.

For those with interest in attending, please visit:

* Note: I hasten to add that the conference coordinators may have copyrighted the title. For those that see the excellence of "Seeding Knowledge" I suggest you contact the project lead (under Contact Us on the site) before just taking it for your own use.