When is a standard NOT a standard?

There are a bunch of words that get thrown around a lot in the Quality community; words like “continual” or “continuing” or “improvement”  or “risk”.  But I would argue that the most significant word in the Quality arena is the word “Standard”.

In the Quality arena “Standards” is a powerful word.  It describes a document that indicates either “the right and thoughtful thing to do” or “the only and absolute thing to do”.   

A standard has a higher value than “guidance” which is something you can take or leave.  The general public understands this; David Letterman used to say “Traffic signals in New York are just rough guidelines” or there was the pirate in the movie Pirates of the Caribbean who said “the code of the brethren is more what you'd call guidelines than actual rules”.  Think of standards as similar to, but more righteous than regulations or laws and certainly more dignified than “rules”, which can be arbitrary, and more real than guidelines, which all too often are not much more than a punchline.

The word “standard” must be viewed as special and be safeguarded from abuse.

Standards deserve that special prominence because there are specifics about how standards must be properly designed and properly constructed.   Simply put, a standard is a respected document of requirement, not because of its content but more so because how those words were selected for proper use.  

The ultimate source of standards is the International Organization for Standardization (ISO) which points to a process of both objectivity and consensus.  ISO as the premier standards development body has established the importance of standards development objectivity.  ISO does not decide what standards it is going to write.  Instead member bodies have to make a solid proposal which is circulated through member committees to get approved.  

ISO committees that are given approval to develop the standard are made of individuals from a variety of jurisdictions, each with their own vested opinions.  To get through this process a document has to achieve agreement from at least two thirds of committee members with less than 25 percent of votes cast to the negative.  That is called committee consensus.  

But that alone does not assure the path to publication.  After committee consensus, the document has to be circulated broadly throughout the world to interested parties to get a broad sense of opinion.  All issues and differences raised through this process have to be addressed.  Only after the process has been repeated several times, to ensure as broad an agreement as possible,  a document can be published and referred to as a “standard”.  

And importantly, in order to ensure that any error that slip by are addressed and to ensure that the standard remains relevant to the times, it must be revisited every 5 years.

If a document does not succeed in going through this arduous process, often the result of differing opinions, it can still be published, but the term “standard” cannot be used.  The meaning of the term “standard” is, as it must be, protected from abuse or trivialization. 

There are solid reasons for this arduous process.  First off, when a small group of people decides to get together and write something, there is always a great risk for bias and for exclusion.  Not asking for broad opinion almost guarantees that none will be found.  The product generated, whatever its intent and purpose, is tainted because of the lack of broad consideration.  

Tainted standards are not the product solely of small organizations who strive a little too hard.  They all too often finds itself in the products of large “august” national bodies, who should know better.  They result because of the innate arrogance of august bodies.  “We must be right because we are so damn important”.

This last while, I have been dealing with one such organization with a disturbing track record.  An organization that makes up rules without working through objectivity or wide consensus, but who stills calls its products "standards".  An organization who wraps itself in a cocoon of self-import of its own making, either oblivious or indifferent to the flaws in their own “standards”.   I can’t go into specific detail here for obvious reason, but the battle ground is now set.

So let me just end (for now) with the following thought, if an organization is not prepared to put its work through a process of objectivity and the scrutiny of consensus through transparency, then it is just a bunch of guys and women hanging out making up its own rules.  Hardly august, and hardly dignified; more about pretense and self-serving rules than actually writing standards.

Just another herd of Pirates. 

Standards People

Standards People

So we have just gone through another very successful conference and Annual General Meeting for the Canadian Standard Association (CSA).  Canada is a very large geography with a very small population, but CSA continues to demonstrate its commitment to being a national (and international) organization by ensuring that the AGM travels across the country, touching every province through its cycle.   

In my short connection with CSA AGMs I have been to 3 different provinces and with the now established plans there will be 5 different provinces over a 6 year period.  

The AGM is an interesting mix of organizational information, standards oriented presentations, and working committees, and a broad array of expert presenters, all put together to bring together a very eclectic group of folks with interest or passion for national and international standardization.  

We standards people are indeed an interesting lot, who all approach the field from our own perspectives.  There are some who are truly entrepreneurs with a commodity perspective, some seeing income generating consultant opportunities.  There are some who focus on the production of standards with a purist point of view; create good standards for the sake of making good standards, while there are others, who are passionately involved in their work sector and approach documents as a way of improving service to their own field of interest.  Then there are the regulator types who like rules creation; they are balanced by the educator types who are mostly interested in standards mostly as valuable opportunities for research and outreach through academia.  And then there are the “just curious” and the the rest who just like being there for the sake of being there and having a good time.  Motives for attendance and participation are wide and varied, but it seems to me that there is something for everyone and solid reasons for being there.  

As for me, I see my motivation as being a combination of many of the above.  I am certainly committed to healthcare and see one of my roles as a Quality leader and educator and standard developer, and am not ashamed of finding opportunities to intermittently promote my knowledge as a consultant and public speaker.   but I can honestly say that I am also at these meetings because I get to meet interesting folks and have a good time.  

This range of views attitudes is actually very important for standards development.  If we were all of one point of view, the standards that get written would likely become very narrow, and very difficult to use.  Without diversity of opinion, there is little need to seek out consensus.  

I personally do not see standards as black-or-white precision documents; you might say I have a more nuanced, shades-of-grey perspective.  In most cases, at least in my area of interest, standards need to include a significant sense of flexibility that is, within a certain range, open to interpretation.  If they are going to be available on tablets, they have to be of the electronic kind and not Mount Sinai stone.  

But I also recognize that if all standard people approached documents my way, the products would be too fluffy to be of value.  On the other side, the precision-driver-obsessive-compulsive-kill every-loop-hole folks without my counterbalance would create tomes that best belong in tombs.  

So this is my point, folks interested in being engaged in standards are always enhanced by attending conferences with people with the broad range of views.  We get the opportunity to express our point of view and at the same time experience tempering through competing ideas. 

Working on standards in isolation of diversity of opinion makes for bad standards.  

Three cheers for AGMs

To learn more about Standards Development, visit www.polqm.ca and consider joining our Certificate Course in Laboratory Quality Management.

Innovation and Quality – Part 3

I have been pre-occupied recently with the concepts of innovation and quality.  Perhaps it has something to do with the recent media attention to Steve Jobs and his impact on manufacturing and design.  Or maybe it has to do with some things that are happening around CMPT and our Program Office course in Laboratory Quality Management.  Making progress through change. 

Today I saw an interview of James Dyson, another innovator perhaps not as well known as Mr. Jobs.  James Dyson is a British engineer with a interest in industrial design who has made among other things significant improvements to vacuum cleaners, room heaters, hand dryers.  Less flash than Apple, perhaps, but he has created a slew of brilliant product improvements, and has been knighted and amassed a ton of money in the process.  And he has established the James Dyson Foundation to support education and research at many levels.  

When asked about where he got his motivation for his innovations, he said it came from passionate anger when he found things that did not work properly.  Find something that doesn’t work and set out to fix it.  Innovation, according to this very successful innovator, starts off from the passion to make things better.

I think that is where the interface between innovation and quality resides: the passion to make things better.

As with many innovators, some of his commentary is pretty far out there, but still has resonance and connection.  Innovation is the product of failure.  In the process of creating the Dyson vacuum, he created some 5127 prototypes which meant that he missed his target 5126 times.  In addition he says that schools drive passion and the innovative spirit out of students.  Grades should be reversed with students being rewarded for error.  When there is no tolerance for error there is no opportunity for improvement and success.  

I kind of get what he is talking about.  All the way through the education process, even today we tend to reward the students who give back what we taught.  The "smart" students all to often figure out what we want to hear.  That being said, while I’m all for the notion of learning from trial and error in the sense of opportunities for improvement, it is a bit of a stretch to start there and go to rewarding for error.  

More on this education conundrum later. 

Many of the famous innovators of our time such as Jobs and Gates and Dyson had one thing in common with the famous innovators of yesterday including Edison, Ford, and Harland Sanders (Kentucky Fried Chicken) is that they were all inspired and succeeded but did it on their own initiative.  They saw flaws, or weaknesses, or absences in the present as inspiration to make the future better.  Their inspiration came from within and they carried out their risk-and-reward on their own terms.  I suspect that that sense of personal investment, drive, and vision are all important contributions to their success.   W. Edwards Deming who clearly belongs in this group deviates somewhat because for a substantial part of his career he was a government employee, not a position usually associated with taking initiative and risks, but perhaps he found  positions that gave him a sense of personal empowerment.

There are, I think, some careful lessons here for laboratory quality.  We work in a domain that requires a certain discipline and a can not tolerate being wrong 5126 times.  There are certain rules.  But these must be opportunities to learn and adapt.  

Within the framework described by standards such as ISO15189 or ISO9001 or CLIA there must be room for passion and design.  There are a number of ways that we can create and deliver quality that may on one level seem to be site specific, but have a certain generalisability.  Those may be the more positive aspects of Lean, or Six Sigma, or may be whole new directions.  There has to be the opportunity to stretch even if sometimes (most times?)  things may not pan out.  That is an essential part of risk and reward. 

And we have to be able to acknowledge that the standards framework itself can sometimes be wrong.  Improvement in standards comes from challenging the status quo.  When standards writers cannot or will not acknowledge that components of requirements have failed the tests of experience and time, they are lost opportunities.  Innovations can and must be allowed to flourish everywhere.

PS:  Our course in Laboratory Quality Management is filling up more quickly this year.  If there are some interested in the course for themselves or for people in their laboratories, it would be a good idea to get in touch a www.POLQM.ca soon.

Quality that drives folks crazy

The other day I was part of a meeting reviewing a document intended to standardize Quality Standards.  The point was that was being put forward was that all Quality standards should use the same words and use them to mean the same thing.  That way regardless which quality standard you use you will immediately understand the document and be able to implement the requirement.  That makes sense.

But as the document continued, the devil in the details started to appear. 

Is the word “document” a verb or a noun, or can it be both?  Is “documented” an acceptable adjective?  The same applies to the word “record”.  And what about the words “goals”, “objectives”, “aim”, and “target”; are they the same of different? Is the term “goals and objectives” meaningful or redundant. 

The terms “continuous” and “continual” are raised as well.  Is the correct term “continuous improvement” or “continual improvement”?  Apparently the word “continuous” means “ongoing without interruption”, while “continual” means “ongoing but at regular intervals”.  Both of these terms need to be differentiated from “continued” because that term means “ongoing but after having stopped”.  And should we refer to “continuous education” or “continual education” or “continuing education”?  Apparently the term “continuing” can mean one or the other.   So perhaps the correct term for improvement is “continuing improvement”.  And where might “continuity” fit in?

In my own technical committee, we have struggled with a truly pointless convention.  When a “sample” is being collected from a patient (or is that a customer or a client) then we can that this is an action (procedure) in the “pre-examination phase”.  And if someone wants to refer to this as collecting a “specimen” as part of the pre-analytic phase” then they are wrong.    This is truly the stuff that some Qualitologists and Standardization people love, but which really drives most people crazy.
This is the stuff that gives quality a bad name as being deeply involved in minutiae rather on issues that are really important to organizations.  And I agree with that too. 

There are lots of drawbacks with this sort of discussion.  First and foremost, there must be hundreds of words that would need to be examined and discussed, and thousands of people who would be affected (should we call them “stakeholders” or “interested parties” or “affected parties”).  It would take years to work through with the likelihood of some sense of “consensus” or “agreement” or “general agreement” being very limited.  And even if we could come to some “common understanding” in English, would the subtleties translate into French or Spanish or Mandarin or Russian?  And third, it drives the "big-picture" advocates crazy, and even more importantly away from trying to improve Quality.

My solution to all this is to reduce the number of jargon words in what we try to convey.  And further to the point, reduce the number of words period.  Pictures are good.  More importantly, we should quit worrying about the trivial issues. 

Quality is about big principles of making sure people understand what they are supposed to do, thinking about a project before jumping in, checking what went right and learning from what went wrong.  Whether you used a red pen, or a blue pen, or white-out is a side issue. 

As this standards year soon comes full circle (World Standards Day is October 14^th) we should resolve that next year our goal (objective) for Quality should be to keep it simple and effective.