ISO9000 and the Quality Management Principles

I was reviewing “The ISO9000 Essentials – 4th Edition” as I prepare to update my notes for our on-line course and the new Resident Training program, and I came across an interesting table that I had overlooked before, entitled “Quality Management Principles”.  I am not sure of the history of the table, but the information is readily available through a brochure that is available on the ISO website (www.iso.org).

As I reflected upon the list, I came to the conclusion that regardless if you seek 3rd party recognition through an accreditation program or a certification program, or if you plan to implement Quality without benefit of an external assessment, these principles are excellent and should be a part of every organization’s mission and vision.

Here is the list:
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships.

Most of these are self explanatory, even in the context of the medical laboratory.  If the laboratory does not keep patients and clinicians front of mind, then they do not deserve to stay in operation.  If leaders don’t take care of the present, and at the same time keep their eye on progress and future trends, then their organization will soon become obsolete and vulnerable.   If leaders don’t create opportunities for staff to become engaged, their staff can, and will and should leave.  Management should not need a certification body or an accreditation body to remind them of these realities. Incoming complaints and discontented and leaving staff are loud signals that the public sector hospital leadership or the private sector CEO can not and will not ignore.  

Continual improvement, in its traditional sense, should be a given.  If you don’t learn from errors and accidents then you are likely to repeat them over and over.  It should be inherently obvious that when the bad thing occurs, someone should think “well let’s make sure that doesn’t happen again”!  Any management group that does not understand that has lost before it starts.  This doesn’t have to be a formal process, although a formal process helps because it will likely pick up the conditions for error earlier and with less potential damage.  

With respect to making decisions based on actual information, I am reminded of the recent Dilbert cartoon from the other day where the manager says “From now on, I’m going to rely on my intuition rather than on market research”, to which Dilbert replies “If guessing can bring your success rate up to 50 percent, I am all for it.”  Not every decision needs a full scale investigation and report, but on the other hand, who needs a management team when flipping a coin works just as well.  Again this should be inherent management knowledge, and should not need an assessor’s view.

Systems approach and process improvement are another matter.  Maintaining a structured process in laboratory testing makes sense because it increases consistency, reduces the risk of error, and in both the long and short run saves time, effort, energy and money.  But by and large, most of the downside can be hidden from view for a long time.  Budgets can appear to be in control, and hospital executives tend to become aware of injuries and accidents and excessive sick time only when they become union issues or when the reports from the watchful eye of external assessment comes to the fore.  Mission and vision statements and Quality policies and adherence to programs of internal audits can all too often slip by the wayside unless management is diligent.  The watchful eye of a 3rd party assessor increases the likelihood of attention to detail.

Of the eight principles, probably the one on supplier relations is the weakest.  This is not because of less regard for suppliers (we include suppliers within the group of Quality Partners [ see http://www.medicallaboratoryquality.com/2011/06/more-musings-on-quality-partners.html]
) but rather because it is too specific to a principle.  There are all sorts of groups with whom the laboratory should be seeking out mutually beneficial relationships, including government, administration, clinicians, patients and education providers.  This principle probably needs restating using broader terminology and concepts.

My bottom line: The list of Quality Management Principles is essential information at every level.  I recommend that you visit www.ISO.org and look under ISO9000 Quality Management and find the Principles brochure.  You will be glad you did.

PS: ISO Technical Committee 176, the group responsible for ISO9000 has started the process of revision for the principles.  We will follow (and participate) with interest.

Report from Berlin: ISO TC 212

I have been in Berlin for our ISO Technical Committee 212 meeting.  This represents 19 consecutive years of direct involvement.

From my perspective it was a not-so-busy but in the long run a very successful meeting; but mostly it was a vocal meeting.  I talk a lot at meetings, usually with a “polite” assertiveness (some might say aggressiveness), but I come with an agenda and have a goal to have my issues addressed, preferably successfully.  Personally I see little value in traveling long distances to attend a meeting only to spend my time being quiet and passive and not addressing the issues that are important to me.  

A good friend, a successful senior bureaucrat, taught me his secret; set your agenda, and push hard for what you think is important.  Celebrate your successes and walk away from your failures knowing that you tried.  You won’t win them all, but you can’t win any if you don’t step up to the plate.

As a side note I have a lot of empathy for the folks who attend the meeting with English not being a fluent language.  For them, making their issues understood is unfairly very difficult, considering that these are international meetings.  I would like to think that there could be an easy and effective and equitable solution.  

The final international vote on the next iteration of ISO 15189 is underway.  It is an OK document, not a perfect document,  with the same mistakes and errors carried forward for another 5 years.  Changing words with changing content, in my opinion, is not what standards development should be about.

But with respect to the issues that I consider important, I pushed hard to promote the newest iteration ISO 15189 to respect the ISO CASCO neutrality principle when it comes to recognition of third-party organizations including both certification bodies and accreditation bodies.  This would have significant positive ripple effect for Canadian standards development.  We hopefully will get a senior level ISO opinion on our position soon.  Maybe this can get squeezed in as a last moment editorial change.

For a long time I have advocated that Measurement Uncertainty should be recognized as a useful laboratory tool, but only as one of a variety of techniques to measure variation rather than as the sole and mandated requirement.  Requiring laboratories to perform complex statistical analysis like MU for the sole purpose of satisfying an accreditation body requirement is probably one of the best examples of Poor Quality Practices and generally a total waste of time and effort.  

At this meeting I think we had a major step forward with respect to MU.  While I was not able to get everything I wanted written into the next version of the standard, the other options are going to be included within a new international MU implementation guide being developed within the technical committee.   It should carry a lot the weight, so that is a good thing.

Another important development is that for the first time, TC212 is going to be writing a document that extends beyond the traditional scope of the laboratory and diagnostics manufacturers.  The plan is to re-develop our document on the use of Point-of-Care instruments for organizations that are not directly affiliated with the medical laboratory.  Consider the use of breathalysers and drugs-of-abuse testing and full blood chemistry by police, pharmacies, and schools.  A guidance document that explains appropriate quality control and assessment will be very useful.   

More importantly this writing committee will have consumer representatives from ISO COPOLCO [see http://www.medicallaboratoryquality.com/2012/01/protecting-our-consumers.html ].  We talk about patient's interests; now we are involving their voice.  That is a big step forward.

It is important for laboratorians to remember that all organizations, even including the august and respected International Organization for Standardization are the sum total of volunteers efforts, usually well-intended and well-meaning but all  with their own competitive biases and influences and memory lapse foibles.  Consensus is not always easy to come by, and sometimes document development does not follow in a straight line.  We had a good example with a document being approved as a work project in last years’ meeting only to be rejected this year.  It makes some people wonder about why they put effort into developing documents; that is never a way to encourage participation.  I expect that the decision will be addressed yet again.

The problem is a combination of long intervals between meetings, vague minutes, not so diligent project tracking, and a general short term approach.  It may be just “human factor” at work or play, but somehow I think we should be able to do better, including myself. 

By bottom line: ISO is big and clumsy and vulnerable to human foible.  It is also the only organization that can create truly international guidance.  It is a real opportunity to work with them.  

ISO and its Neutrality Principle: just words?

The International Organization for Standardization knows and understands its role: through the development of standards through a steadfast commitment to consensus, the organization creates a voice of equality for all its member countries, and establishes a basis to promote non-barrier trade.  The organization is so committed to the concept that it framed its logo identification not as a mnemonic by as the Greek root ISO for “equal”.  Old stuff but worth repeating, in part because sometimes this commitment to equality is not always so apparent, unless excluding developing countries and regions is fully compatible with ISO equality.

But back to being more positive, recently an important committee known as  ISO CASCO circulated a new document entitled “Conformity Assessment for standards writers: Do’s and Don’t’s”.  Before I continue, a moment of explanation is in order.  When ISO committees write documents they fall into two main categories; the ones that provide information on best practices, methods, procedures, and the other ones that provide statements that can be understood as rules or expectations.  The first group are called informative documents, and the second are called normative documents. 

Meeting requirements in normative documents is known as being in conformance, and formally demonstrating that conformance is being met both to the word and spirit is called conformity assessment.  So ISO CASCO is the committee that oversees the rules of creating normative documents and oversees the rules for organizations that do conformity assessment.

In general there are two types of business organizations that do conformity assessment; one group calls itself Certification Bodies, and the other group calls itself Accreditation Bodies.  There are definitions that distinguish between these two groups (one group says that it measures not only compliance, but also competency and states that the group only measures compliance), but in my experience, when boots are on the ground, it is pretty difficult to see real differences between how the two actually do their assessments differently.  One group says that it perceives what it does is assures a higher level of quality, but from my perspective and experience that is pretty iffy.  

Most importantly for the present discussion, both AB’s and CB’s are represented on ISO CASCO which means they are both third party participants in standards application.  In order to be seen as not representing one group over the other, ISO CASCO has created its Neutrality Principle. It is very important to know and understand what the neutrality principle states and means.

The Do’s and Don’t’s document states: “The “neutrality principle” means that the content of the standard shall not state a preference for a form of one type of assessment over another.  In other words, the standard must be written so it can be applied by any of the following: - (a) a manufacturer or supplier (b) a user of purchaser or user and (c) an independent [third] party. “  This is very clear.  It says that a standard has to be written in a way that its application is seen to be neutral for all and exclusionary to none, on the assumption that the assessment is done competently.      

What this says to the laboratory community is that a document like ISO 15189 can be adopted by any laboratory, and that laboratory user can assess whether or not it is adopting the rules in the documents.  This is separate from the process of accreditation.  If you believe in Quality you can apply the document.  If you believe that external assessment improves the degree of compliance, then you can invite an independent third party to made an assessment over and above adoption.  

This is very important to understand, especially for small laboratories in countries that do not legislate accreditation because it reinforces the point that a laboratory can (and I think should) adopt 15189 at its own pace, and when it is ready make the second decision based on finances and commitment and business advantage as to whether it sees advantage in having a competent third party do an independent assessment about the degree of compliance.  

But here is my concern; the third iteration of ISO 15189 is about to have its final vote before formal adoption, but it contains the sentence “This international standard is not intended to be used as the basis for certification of laboratories”.  

So exactly how does that mesh with the words and the spirit of  ISO CASCO neutrality principle?  

Words or rhetoric?

Proficiency Testing in the News

It is always exciting to see stories in the media on topics that are of interest, even if the stories are not exactly positive.  It means that the shining light of public scrutiny approach to Quality is at work.

This story was first reported by a news affiliate in Columbus Ohio and was then widely communicated by Robert Michel in the Dark Daily [http://www.darkdaily.com/ebriefings#axzz23SJDJout].  It brings light to a prominent academic centre in the United States that has run into difficulties because they apparently “inadvertently” referred proficiency testing samples to another laboratory.  

Before going on, let me say that Dark Daily is one of the most valuable medical laboratory Quality oriented sites on the web.  It is highly informative and a must read.

The story does not give a lot of details, so I will describe the following discussion based on my own experiences rather than on the specifics of what did or did not happen in Ohio.

First of all let me start with the following bold statement.  Laboratorians as a collective have always shown an ambivalent attitude towards Quality Control, and Quality Assessment.  We know that QC and QA are critical components of ensuring confidence in laboratory performance, but that is pretty much tempered by an overwhelming libertarian nature that resents intrusions into our professionalism.  We may do QC and QA but we don’t like it. 

Many laboratorians have a flexible approach to demonstrating laboratory Quality Given a choice, many laboratories take the approach that the best Proficiency Testing program is the cheapest with the least number of samples and the most simplistic of challenges.  Others (I suspect and trust as not many) unfortunately go one step further taking it as far as they can through gaming and cutting corners.   You might call it being deceptive or maybe even dishonest.

In the “olden days” we used to regularly have laboratories that would send samples to reference laboratories for testing and then report the results as their own.  Even today, we have laboratories that don’t fill in forms, don’t adhere to deadlines, and quibble over ambiguities that they uniquely envision, and then gripe and complain.  It’s pretty much a “get out of our hair:” approach.  So with this as background, I can understand why officials at CMS would take a dim view towards finding laboratories that apparently are referring samples to other laboratories.  

In defense of the laboratory, I will point out that many academic centres have huge numbers of samples received every day, often reaching into the millions per year.  And life has become more complicated these days with organizations relying on transporting samples into specific regional centres rather than doing testing locally. So if a laboratory sends a sample or two  to a place it was not supposed to, the error rate would be pretty low (six sigma metric >5.5).  

But if they sent the sample to another laboratory, and then also reported the other laboratory’s results as their own, that is a big problem.

It is possible that there is another issue here; one where there is an absence of appropriate reporting choices.  The laboratory may be stuck with a form that they cannot fill in without creating another problem.

In our program we do have laboratories that receive our package of samples, which may contain challenges for certain tests that they would normally perform.   With CMPT our challenge menu is set annually and the package may include certain tests that are not normally performed by the laboratory.  For example they may do clinical bacteriology, but ship enteric samples (feces) to another laboratory.  They may do bacterial identification, but not susceptibility testing.  In those situations we cannot customize the packages, but we do not expect them to perform tests that they would normally not perform. 

 

We have a number of solutions.  The laboratory can complete and submit their report with the designation “SNNP” meaning “sample not normally processed”, which once confirmed results in an automatic “ungraded” sample.  

If they would normally do only a preliminary investigation and then send to another laboratory for completion, we make it clear that they provide us with the preliminary information that they generate and report that they would send it on. Clear instruction is given that they should not send the sample onward.

If they want to perform the challenge on an educational, self-interest, but not reported basis, they can also do that, with the result remaining as “ungraded”.  

Maybe these were options that the laboratory in Ohio did not have.

So at this point we don’t know if Dark Daily is reporting a problematic-shipping issue, or a caught-in-deception issue.  I hope for one and fear the other.

I will follow Dark Daily to see how the story unfolds.

The bright ugly shining light of discovery

One of Canada’s two national newspapers carried an interesting article today about a federal study that identified problems with transfusion medicine in Canada.  See National Post: “Errors, mislabelled samples pose ‘staggering’ cost to Canada’s blood banks” [http://news.nationalpost.com/2012/08/06/errors-mislabelled-samples-pose-staggering-cost-to-canadas-blood-banks/] .  

The studied identified collection errors, transport delay errors, and identification errors and others that collectively resulted in loss and destruction of units of blood, inconvenience to patients, and loss of money.  It was a small study, involving about 10 percent of facilities and still found over 6000 errors.

This is not really a surprise.  In our own studies, about 80 percent of reported laboratory errors occur in the pre-examination phase of sample testing, with the issues identified being the most common problems.  

But it is disappointing, and should be a national embarrassment.  

Our Canadian blood system was torn apart in 1996-7 as a result of pretty serious errors in judgement that resulted in a Royal Commission of Inquiry lead by Mr. Justice Horace Krever.  While Krever did not address issues of collection errors, the government was sufficiently motivated to seek the creation of a quality standard on blood services practices by the Canadian Standards Association which was published as “Z902:2004(?) Blood and blood components”.  Z902 was identified as a national standard.  It has recently been republished under its current iteration Z902:2010.  

Z902 had a Quality Management section within it, albeit not as complete or as rigorous as ISO 15189, but had sufficient clarity around issues of collection and labelling and transport and corrective action and internal audit that by now these practices should be routine practices and well established.  

Today’s report suggests that that is not necessarily be the case.  

My own speculation is that the problem is that in too many laboratories, the notion of Quality is still stuck in the 1980’s at the level of Quality Control within the 4 walls of the laboratory.  Laboratory personnel are very strong on control charts and SOPs, but still weak on internal audits, preventive action, and active continuous improvement strategies.  As much as we talk about a laboratory cycle and all the steps that occur before the sample gets to the laboratory window and all the steps that occur after, we still focus the majority of our time on technical procedures inside those secure walls that separate us from the outside world.   
And that is not a good thing. 

A bold statement? Perhaps.  But I have a lot of evidence to support my speculation.

In our proficiency testing program we have always taken the position that all errors are errors, including transcription errors.  This started when we worked in pencils and paper, and has continued on as we moved to internet based reporting forms.  Every send-out we have laboratories that fill in reports using the wrong identifiers and then complain when we grade them down.  But if laboratories will do tests and mix them up in proficiency testing where they know that the results are being scrutinized, then how do we know that they don’t do the same with clinical samples?  

I personally keep a watch of how many misdirected, mislabelled reports I receive from clinical laboratories.  I have talked about this before.  Over the years it is in the 10s of thousands, with no evidence that it will ever slow down or stop.  

We have made big strides on our internal Quality, but our communication with the outside world is probably as bad today as it ever was.

 If this was isolated to a few laboratories, we could focus on the problematic few and move on.  But this is not an isolated issue.  It is widespread and systemic.  It is nation-wide and international.  

So am I surprised? Not at all.  But I am encouraged.  

Here we are in Canada, 15 years “post-Krever”.  A study is performed by the Public Health Agency of Canada.  It is reported by the National Post newspaper.  Our public Quality Partners are doing their work, shining a very bright light on a very ugly problem.  

Let’s see what happens next.

Obama - Entrepreneurs and Quality

I have been reflecting on a political story that developed last week in the United States.  It has become fodder for all sides of the election debate.  In a recent speech President Obama made comments that some have interpreted as saying that entrepreneurs do not build their own businesses because someone else created the roads, and infrastructure that made the business possible.  Now I am not entering into the discussion or the debate.  I am sure that all the parties can get along without my help or interference.


But the essence of the comment rang with a certain resonance because in our view we take the position that laboratory directors and administrators can take comfort from the array of Quality Partners that provide active Quality supports and infrastructure that make implementing laboratory Quality Management systems possible.  Quality Partners make laboratories better.


In our course (www.POLQM.ca) we recognize the following as laboratory Quality Partners:

• Standards Development Organizations that develop the standards and guidelines that form the foundation of Quality process.
• Inspection Bodies (Accreditation and Certification Bodies) that ensure that laboratories competently interpret and implement standards and guidelines.
• Proficiency Testing Providers that provide Quality based challenges to ensure testing and interpretation competence and provide and early warning system for systemic error.
• Professional Organizations that motivate towards continuing education and continual improvement.
• Educators that provide the knowledge foundations and continuing education  infrastructure for all laboratory personnel
• Equipment and Reagent manufacturers and suppliers who provide traceable materials and equipment capable of reproducible accuracy, and 
• An active Public, as represented by the media, the legislators and the litigators that shine a bright light on actions that need attention and repair.  

Now I know and understand that the system does not always work as well and it could or should.  There are standards and guidelines created that contain anachronisms and errors, and there are accreditation bodies that make up their own rules and interpretations, and there are proficiency testing bodies who put their own costs and interests over the provision of challenges that look and act like true samples, and there are media folks more interested in the drama and tension of a spectacular story than they are on accuracy and relevancy, but by-and-large and for the most part the system works pretty well when we let it.  


Recently I was chatting with a colleague about the role of accreditation and certification and proficiency in laboratory quality and in particular if there are some approaches better than others.  As we reflected on the experiences in North America we came to consensus that all  systems have stories of problematic laboratories that met the letter of accreditation and proficiency testing but not the spirit, until they were caught out in a disaster situation, but clearly the worst outcomes come to light in the laboratories  that don’t have and never had any form of regular external Quality  assessment of any kind.


In too many laboratories we still have directors and that don’t have the slightest interest in implementing Quality systems and participating in laboratory error reduction plans.  For this group the bottom line is to keep the results flowing and do it on the cheap with minimal staff and with as little supervision as possible.  Accreditation and proficiency are nuisance activities that are best dealt with by gaming and obfuscation.
   
But over the last years that group has continued to shrink, and we see more and more laboratory directors that understand that patient safety and staff engagement and bottom line costs are all made better through design and management of a laboratory Quality system in all its parts. 
This has not come spontaneously, out of the ether, so to speak.  It has come from increasing literature and attention and education and awareness, all thanks in large part to the increasing visibility and activist nature of all the Quality Partner groups. 


So do entrepreneurs build their own businesses? I don’t know.  


But I know and understand deeply that better laboratories are the result of a team effort.