Organizational Quality and Competence (Part 3)

 

I have been arguing that when documents use the phrase “Quality and Competence” they are causing confusion the poor word choice and definition.  Using the word Competence to mean  “ability to apply knowledge and skills to achieve intended results”, diminishes the meaning of competence because it excludes the essential abilities of judgement and nuance.  As mentioned (see  Organizational Quality and Competence (Part 2)) Gonczi, a scholar expert on competency based standards (along with his colleague Hanger) made the point in 1996 that competence is not just about a checklist of knowledge and skills; it also encompasses  attributes such as problem solving, analysis, pattern recognition, interpersonal skills, affective attributes and working ethically.  

Using “competence” to mean meeting an achievable bar for only knowledge and skills assessment is incorrect and inappropriate and sets the bar too low.  Competence includes knowledge and skills and judgement and problem solving; it is the term that expresses the High bar.  

I understand that the ISO official definition for competence does not include judgement and the other soft skills, but their definition is out of date and needs revision.

So what is the better word that can be used to describe the person who has the knowledge and skills, but may not be sufficiently talented to also address problem solving or interpersonal skills or ethical dimension into performance?

As it turns out English has a word that describes that situation.   We can use the word “able”, or more effectively “capable”.

Capable is an old (circa 1590) word derived from an even older word “ capabilis " (Latin) meaning “able to grasp or hold” .  It is linked to another term capax, which is the adjectival form of the verb capere which means to grasp, to undertake; take in, to take hold.  [see: https://www.etymonline.com/word/capable.  ]

If Competence is the High bar and being capable is the lower achievable bar, Standards bodies  have to a few choices. (a)  If the point of the exercise is to express the sense of quality and excellence, then they can continue to use the term “Quality and Competence” but change their terms and definitions so that they use the term as best described by Gonczi and acknowledge that competence requires evidence of judgement and problem solving.  (b) If it is more important to set standards that are more at the level of being achievable by most (“Good Enough” is good enough) then the standards need to be retitled, perhaps on the line of  “Quality and Capability” or perhaps take an asperational approach “Achieving Quality”, as in "if you follow this standard to are moving along the path to Quality through being more capable with knowledge and skills"

So perhaps some standards need to be retitled:

ISO 15189:2012 – medical laboratories – requirements for achieving quality.

ISO/IEC 17025: 2015 - General requirements for the capability of testing and calibration laboratories   

ISO/IEC 17043:2010 - Conformity assessment — General requirements for proficiency testing (soon to be revised to General requirements for achieving quality of proficiency testing providers).

I can hear the muttering now.  This guy has a word fetish; he needs help; he is wasting my time, Competence versus Capability… Who cares. 

But I would argue the other side.  Words have meaning and words matter.  Standards are hard enough to interpret at the best of times.  Adding confusion by making up its own meanings for the words that are used, as opposed to using the best definitions available does not make their documents better… it makes them worse. 

Standards bodies want to define themselves as a core of precision and excellence.  Maybe rightly so.  But that requires a demonstration that their documents shall meet the high bar for understanding and precision. When that is achieved they will move from being capable to competent.

 

Understanding Requirements

Understanding Requirements

I was reading ISO9001:2008 recently, in part in response to an interesting article in Quality Progress, but more importantly because we are going through the standard in our on-line Certificate Course in Laboratory Quality Management.  

In the article “Standard Wise” Oscar Coombs pointed out a line in the standard that I had either missed or unappreciated over all these many years.   In the Introduction section, which contains information about quality management systems and a process approach to their adoption it includes the statement:  “When used within a quality management system such an approach emphasises the importance of (a) understanding and meeting requirements …”

Understanding and Meeting.  I am not sure how I had missed this or underappreciated its presence because I have dedicated a substantial portion of my career to this very issue.  Understanding and Meeting is an absolute and critical imperative before ever considering any movement towards writing, reading, and applying and adopting standards.  How did I miss this!

Let me say from the get-go that “understanding” in particular is one of those “easy-to-say-difficult-to-do” type statements.   I suspect that I didn’t so much miss the statement in ISO9001, as much as I ignored it as a throw-away.

Let me start from the beginning which is all about the crafting of a standard.  The standard process brings together many people from around the world to work on creating a document.  While the original proposal may come from the mind of 1 or 2, in order to progress, the writing process quickly starts to escalate to 20 or 30 or more people.  Many of these folks take the document back to their constituencies at home and soon the number of people involved in the crafting of the document gets into the hundreds.  

All this input gets distilled down to its essence many times over before the document reaches even its first stage.    Through this input there are huge infusions of knowledge, experience, expertise, opinion and bias and prejudices and politics; regional differences, national differences, economy differences and language differences all get infused.  

In order to cope with all this diverse input there is by necessity, a large amount of wordsmithing and nuance building.  Standards are not textbooks and they have limited numbers of words.  

Words get selected based largely on meaning but also on subtlety and tone and compromise.  Often words are selected as an inverse way make a point of what was not said and to imply what was not to be included.

If you were not at or near the table, the likelihood that you can truly appreciate what is being said and why it was said becomes a monumental task.  To truly understand the requirements can almost be impossible!  (And while not to extend this further, once the document is signed off and is ready to publish in English, someone armed only with language skills and not of the insights from the writers is given the awful task of translating the document into another language. ) 

And so it is, when the organization thinking about adopting the standard and the respective agency that plans to get involved in assessing against the standard, is it any surprise that there are so many different interpretations and so many different implementation approaches.  

There are some approaches to how to work through this mire.  Individual countries can write their own implementation guides, hopefully with the hands on expertise of someone who was engaged in the “writing wars” who understands what was meant and what was intended.  Or one can take courses that pick the document apart and study it for inner meeting.  Or one can hire a consultant with sufficient knowledge and expertise in decoding understanding standards that they can help shepherd implementation.

When it comes to applying a standard to your own organization, let me offer the following:

1.    Understand that the phrase “understanding and meeting requirements” has to mean understanding and meeting as it makes sense to you in the context of your organization. 

2.    Put together your argument based upon how you interpret the document.  If it makes sense to you, then go about the business of deciding how you plan to implement.

3.    If an assessor disagrees with your interpretation, recognize that your opinion has strength and value.  Don’t assume that the assessor is right and you are wrong.  It is after all, your organization.  With constructive discussion there is always a happy and healthy midpoint compromise. 

What is a standard?

Over the years of my career I have had the opportunity to be engaged in the domains of standards development and application.  I have had a hands-on relationship that has involved documents from the very local to the very international.  

There are differences between those documents written very local versus those written far and abroad.  Those written “closer-to-home” tend to get right to the point and can be very specific.  They don’t need to worry too much about being too broad in nature because they are written and designed for local use only.  There are no concerns about having conflicts with regulation because local regulations requirements can be written in from the get-go.  You never see the sentence that says “national regulations need apply” because that is a given.  On the other hand, the international documents take a broader and more generalized perspective.  The notion of variation has to be build in through lack of specificity.  The documents need to address the needs for laboratories of all capabilities from the resource-wealthy and resource-limited alike.

There are two essential characteristics that bring these documents together.  Regardless of where they are designed they have to be consensus documents and they have to be regularly reviewed to ensure they are fresh and relevant. 

They are written by groups of people and validated by even larger groups of people at support the documents or do not.  There must be an agreement everyone agrees to agree.  Not everyone has to love it, or even like it, but there is universal that everyone can live with it.  Everyone.  Period.  That is what makes standards so powerful.  Everyone has a say and everyone has a buy-in and everyone agrees.  

Further, the group has an obligation to study the document again, perhaps every five or seven years.  The group may not necessarily be the same people, but the group will have a consistent interest in the topic at hand.  That way the document can continue to be relevant or it will come to an appropriate end.

As a user, these are very important concept.  If a document exists as a standard, it means that it has been seen by many people, all of whom have agreed to support it.  Before you disregard the document as a waste of time, or a personal mission, you need to accept and recognize and appreciate that many people had the chance to reject it, and chose to not.  Before rejecting it out of hand, perhaps you have to give it a second look.

As a comment, one of the problems that we have in laboratories is that many of our colleagues are not aware what the term “consensus document” means.  Many don’t recognize or appreciate the power of consensus and renewal.  That is not totally the audience’s fault.  Most documents are published without mentioning these critical factors.  

If I was a standards editor and publisher, I would gather information about the voting response rate and include it as an informative note on page 2.  “This international document was reviewed and approved by 7500 informed persons from 700 institutions from 73 countries.”  That information is all available and the reader would likely have to think about it.  

One organization that I work with includes a comment sheet which presents every comment submitted as evidence that consensus was actually achieved.  That could get difficult and onerous with open international documents that get many, many letters of concern.

But recently I have run into a document that seems to take a different path.  This is an organization (for the purposes of this entry the organization shall go unnamed) that writes what it purports to be a standard (they call it a standard), but as best as I can sort out, it is written only by internal writers.  I understand that there may be some external reviewers, but nowhere does one find evidence of consensus agreement.  To my sense and sensibilities this is a severe credibility gap.   

I will approach them with all due caution.