Standards do make the world go round –WSD 14 Oct

This year’s World Standards Day on 14 October 2011 is themed ‘International Standards – creating confidence globally’.  The international community recognized WSD2011 with a poster contest which was won by Caterina Fiorani  apparently a young architect working in Rome who has been quoted as saying that the graphic displays two open hands which are composed from the world’s continents, and represents honesty, helpfulness, and  cooperation for a common purpose (See below).

I congratulate the artist for her excellent design that well warrants the award and recognition. 

Although Canada is a very active member in the international arena of standards development, and I am a very active member of the Canadian standards community, I find that there is near nothing of recognition of WSD in my country.  I know it is so, but I don’t know why. 

Now I know and understand that WSD is not quite on the same level as Canada Day or Christmas.  But it must rank somewhere above Ground Hog Day.  I don’t really expect it to be a national holiday, but it is an opportunity for standards development bodies to create some buzz and awareness about what we do, and why it is actually pretty important to Canadian society. 

Imagine a world without electrical standards, construction standards, nuclear standards, and no medical standards.  Imagine a world without a Canadian Standards Association.  Shoddy and dangerous construction with ladders and bracings built out of sticks and twine.  Totally unstable electricity and dangerous wiring. Two or more people to a hospital bed.  Hygiene by and large non-existent.  And nuclear melt downs from incompetent workmanship (No, this does not describe Fukushema). 

Without standards we would all be huddled in a corner like some Eastern ba***rd freezing in the dark (ask any Canadian over the age of 50 for the reference to this phrase!)  

Standards Council of Canada is recognizing WSD2011 in a very small way, with a breakfast meeting in Ottawa.  That may be good for folks in Ottawa, and maybe as far away as Montreal, but it does not work well for us folks in British Columbia.  For the briefest of moments I thought about attending, but 3000 Km (and back) is a pretty long hike for a networking coffee and muffin. 

Maybe for next year I will be able to convince them that networking in Canada is better achieved through having linked events held in Halifax, Montreal, Ottawa, Toronto, Winnipeg, Edmonton and Vancouver perhaps with a video-linked presentation.  Such is the reality of living in a country that spans about 5000 Km west to east. 

I would like to say that at least we are doing something out here to recognize Friday as a special event day, but alas, I have been pretty silent here too. In part my absence of activity was a matter of problematic timing.  My colleague who is a graphic artist was on world travel during the month prior to the competition, so we did not get a poster done in time.  Again, it would have been very appropriate for us to have our Quality Weekend Workshop not in June, but in October.  We could have done that, but there are already a wack of conferences being held around this time and getting folks to travel would have been a challenge.  We also could have held our CMPT Annual General Meeting a few weeks later, but timing was not going to work out for that either.  

Bottom line was it did not work out.  As they say “Woulda, Coulda, Shoulda; but I didn’t”.  But if we want to be a part of the process then we have to stake our claim. 

No more excuses for WSD2012.  Written in stone.

M

PS:

In the meantime, lots happening next week including our annual meeting of ISO Technical Committee 212.  Will give a summary of the meeting.

Measuring ISO Objectives

In the world of standards development there are folks that participate at every level, from institutional, to regional, to provincial to national to international.  At each level the documents developed become more generalizable, more applicable in a greater cross-section of environments.  That doesn’t necessarily make them better, but it does create a closer connection to international truth.  

At the top of the pyramid is the International Organization for Standardization.  
The ISO has been the crown of the standards development structure since 1946 (or 1926, depending on when you start counting).  It has as one of its mandates to create voluntary consensus standards that once applied assist the World Trade Organization promote international trade in the absence of non-tariff barriers.   I have been a volunteer Canadian representative on ISO technical committees since 1995 and am currently a member of ISO TC 212 (the committee responsible for 15189) and ISO TC 176 (the committee responsible for 9001).  Over the years I have seen both the positives and challenges of developing high level documents.  

Which brings me to the recent publication of the official ISO magazine known as ISO Focus+. This is a great magazine that I suspect most of you have never seen or heard of, much less read.  It is available at www.ISO.org, or is available through your national standards body.  In Canada that is the Standards Council of Canada (SCC); in the US it is the American National Standards Institute (ANSI).  The January 2011 issue is all about the ISO Strategic Plan for 2011-2015.  Within it are the defined strategic objectives that ISO has set for itself over the next 4 years.  

If you are interested in Quality, you need to read this magazine.  

ISO has defined the following objectives.

1: ISO deliverables meet customer needs
2: Promote innovation and provide solutions to address global challenges
3: Enhance capacity and participation of developing countries in international standardization.
4: Reach out to and engage with stakeholders.
5: Foster partnerships that increase the value of international standards
6: Improve ISO processes
7: Improve understanding of the general public, stakeholders and customers of value of voluntary international standards.

But for those of us that have set objectives for our own organizations in the past, we recognize that objectives need to meet a number of tests:
A: Are they appropriate? Are they consistent with the organization’s Quality Policy?
B: Are they measurable?  Can you by the end of the time period objectively document if you met the objective?
C: Are they achievable?  Does the organization have the resources and capabilities required to meet the objectives in the time frame that has been defined?

So how, in my opinion, do the new objectives measure up, and what will ISO need to do to meet the objectives successfully.

Objective	Quality Policy	Measurable	Achievable	CHANGE MANAGEMENT
Meet customer needs	YES	YES	YES	Process improvement
Promote innovation	YES	YES	YES	Process improvement
Developing Countries	YES	YES	NO	Communication
Engage stakeholders	YES	YES	YES	Communication
Foster partnerships	YES	YES	YES	Communication
Improve processes	YES	YES	YES	Process Improvement
Improve understanding	YES	YES	YES	Communication

Most of the work that ISO needs to do focuses on improved communication.  ISO certainly needs to do that.  The organization has become elite and presumes far  too often that the world will come banging on their door  Congratulations on recognizing that is not how it works any more.  

The other changes will come from acknowledging tat ISO has some internal work to do to tidy up its own processes.  Where there are rules, ISO needs to make sure that (A) they make sense, (B) the communicate them and (C ) they are applied consistently.

About the “NO”.  ISO can ask developing countries to be involved, but small countries don’t have the resources to attend and participate meetings. Fixing that is by-and-large outside the power of ISO.

So congratulations to the ISO.  This is a big step forward.

We will watch to see if this is "just words" or a "call to action".

m

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.

Implementing ISO 15189:2007

For folks interested in medical laboratory quality, it is not necessary to explain the number 15189.  In the area of medical laboratory quality it is probably the most significant harmonizing document ever created.  ISO 15189:2007 entitled "Medical laboratories - particular requirements for quality and competence" sets out a clear and comprehensive set of quality requirements for medical laboratories.  Initially published in 2003 and is in place both for laboratory and accreditation body usage in over 70 countries.  It is being used on every continent, with the possible exception of Antarctica. 

Unfortunately, ISO 15189 shares many characteristics with other documents created by the International Organization for Standardization, and lots of other standards development bodies; it can be a challenge to understand and interpret, even in English, because, as they say, the devil is in the details, and understanding the details may require a certain subtlety and appreciation for nuance. 

Enter the implementation guides.

There are a variety of implementation guides to assist with understanding this document.  Some are in the form of courses, both on-line and in-person.  Others are in the form of text books.  One of the first published was created by the Canadian Standards Association (CSA) and was known as ISO15189:2003 Essentials.  Written by members of the Canadian delegation that were actively involved in the creation of the standard, it was a small but extremely well received book, purchased and used around the world.  It suffered from some editing issues, but the content was reviewed and supported by folks in the US, UK, and Australia.

Well, time went by and in 2007, the standard was republished, with some minor text changes.  With passage of time and increasing usage of the standard, a lot of the content was open for revised interpretation and guidance and implementation advice. 

So now, the 2^nd edition is available through the Canadian Standards Association.  The full title is:  The ISO 15189:2007 essentials - A practical handbook for implementing the ISO 15189:2007 Standard for medical laboratories. 
Again written and supported by the Canadian delegation to ISO TC 212 Working Group 1, it still contains the content of the standard, interpretation and guidance and tips on implementing the requirements.  The guides and tips are designed for use in laboratories with a range of size and complexity.  It will be helpful and useful for medical laboratories in many countries

Most or all of the editing issues that needed addressing in the first edition have been much improved. The book contains both table of contents, and an index, and contains all the annexes. 

So the book is worth a read.  It is a good book and I will be using it as part of the UBC Certificate Course in Laboratory Quality Management (see www.POLQM.ca).

It is available through the Canadian Standards Association web-site (www.ShopCSA.ca) at a fair and reasonable cost.  

One of the themes that I have raised before is that in many countries, medical laboratory accreditation is NOT a requirement, and in some places where it is a requirement,  there are allowable options for accreditation to requirements other than ISO15189:2007.  But in many countries, medical laboratorians recognize the value of implementing this standard on a voluntary basis because of its superior quality management and its international application. 
Some who go through voluntary implementation go further by applying for voluntary accreditation. 
Both these steps provide great value to the laboratory that makes the commitment because ISO quality implementation and accreditation can be the basis of international recognition, business opportunity and all the benefits that accrue: higher satisfaction, lower costs, improved patient safety.  

I declare my personal connection with the book.  I was the co-author of the first edition and the principle author of the new edition.   It was written under a fixed contract though the University of British Columbia.  Neither I, nor the UBC Program Office for Laboratory Quality Management, or the university receives payment in the form of royalties for present or future sales.  

m

PS: A third iteration of 15189:XXXX is underway and may be available in 2013.