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. 

The Error Cost Dynamic

The Error Cost Dynamic

We have started our new season for our UBC Certificate Course in Laboratory Quality Management and I have to say that this year is perhaps the most animated, most adventuresome group to date.  Day 3 and there is already a lot of mingling and interaction, which is incredibly special in an on-line virtual classroom course. It truly feels like if I should not be surprised if I were to have a tap on the door or a call on the phone.  This is a good thing.

One of the questions that has ready come up is on the impact of communication, or lack thereof, on laboratory error.  This is a very interesting topic  because communication is so multidimensional; there is communication in the form of person to person chitchat or communication in the form of information sharing or communication in the form of instruction - guidance - requirement.  Regardless of which form we are talking about communication can be either very positive or very not-positive depending on the clarity, understanding and intent.  Said in a way that is clear and precise in-laboratory communication is very helpful.  Said in a way that is muddled and ambiguous and a whole lot of bad consequences ensue.

That is a long way to get to the topic of error.  The point I am struggling to get to (talk about poor communication skills) is that in Quality, concepts that are expressed with clarity and brevity lead to new insights and new understanding.  Concepts presented as subtle nuanced and complicated are a struggle and are often dismissed. 

For me, I think I have developed a helpful way to express the dynamic impact of errors and causes of error on the costs of poor quality.

All organizations experience daily work pressures, many of which are addressable and potentially controllable: noise, crowdedness, clutter, work volume, time pressures, stress and anxiety, miscommunication, accidents and injury, and finances.  

As daily pressures rise, the risk of error rises in the same time or compounding at a faster rate.  

As the risk of error migrates to being the actually of error, the impact of error becomes an additional source of daily pressure, sometime impacting on finance, but more often on stress, anxiety, accident and injury, and time pressures. 

Increasing error is a leading indicator of deteriorating Quality, contributing to management dissatisfaction, customer dissatisfaction, staff dissatisfaction, more remediation and increased cost and usually reduced revenue streams, all of which are can be measured and compiled as the rising costs of poor quality. 

Recognizing this dynamic, leads to an important conclusion; addressing daily pressures before they lead to problems is the easiest way to prevent error and reduce poor quality costs.  

One can appreciate the dynamic graphically as a series of gears all moving in concert. 

It seems to me that thinking about quality from this dynamic there are some useful valuable insights and conclusions, the first of which is that the easiest way to reduce error and cost is to reduce pressures that lead to mistakes.  Many of them would be addressed through an active Lean campaign (think especially about Sorting, Streamlining, Shining, and Standardization) which would go a long way towards reducing noise, crowdedness, clutter, and time pressures. My guess is that the impact this would have on an organization’s work culture would be so powerful, that the drive to sustain the improvements would come from within rather than requiring management motivation.

My second conclusion is that trying to implement a new Quality system without first addressing these pressures would not solve the quality problems; indeed it would make them worse.

I wonder if that is why some many organizations that try to implement Quality systems through ISO9001, and probably 17025 and 15189 fail.  It’s not that these are bad systems, but if you don’t create the culture and  time-space in which the Quality system can grow, you can be surprised when it doesn’t.

More about Volunteer Quality

More about Volunteer Quality

Of all the topics relevant to Quality, in my opinion, the singlemost relevant issue is the role of Voluntary Quality.  

As a rule, we humans are best characterized as procrastinators with, of course the best of intentions, but woefully short attention span.  Given the opportunity to do something right (the first time) we generally would like to comply, but then we become distracted and more times than not don’t actually get around to following through.  It’s not that we are an evil or slothful species, we are however, well intentioned, but easily sidetracked with some occasional shining moments.  There are some who might resent my characterization, but with regret, history and the wealth of evidence are on my side.

Many of us over time have tried to keep the ship going in the right direction by building systems and circumstance (police, government and laws, rules, teachers, mothers, standards and Quality Management) to overcome our inherent nature.  It seems that with an aggressive oversight we will tend towards more success.  In the presence of the watchful eye, we are more likely to do the “right thing”.

In my own situation, I personally tend to complicate myself and those around me with push-back, especially if I think the oversight rules, laws, conventions and pressures are artificial and arbitrary.  I always have.  To this day I rarely wear a seatbelt, and generally I consider speed-limits more as guidelines.  (But I digress).  That being said, if I know, understand and respect oversight, odds are that I will be a lot more diligent.

And that brings me to the essence of this posting.  

Recently I have been looking at what it takes for me to participate and commit to a set of standards that can provide insight and guidance within the domain of Quality.  Clearly we are committed to Quality, but we are just like the rest of our species; the chances of our becoming engaged in a system in which we don’t know and understand and respect the rules, and further don’t know and understand and respect the oversight body, then we will likely not follow-through.  We would likely fail to take the document seriously and would in all probability lose interest quickly.  

We are not alone.  Consider that 75 percent of certifications to ISO 9001 fall apart or fail.  For many of the 75 percent who fail, investigation and study indicates there are internal barriers that account for the failure, but I also wonder to what degree the organizations’ respect for their assessment bodies played a role.

Fortunately for us we are part of the remaining 25 percent who continue to be successful after 10 years of participation.  We know and understand and respect what ISO9001:2008 can bring to our table.  

Recently I have been on the lookout of a new standard to supplement our Quality Management system requirements.  We became interested, indeed intrigued with one, which will remain nameless.  

Unfortunately after a lot of investigation and discussion we now understand that the document was written by a process that as best as I can tell without regard to community or consensus or validation, and is written by a group that distains oversight of its own process.  Interesting when I had a thorough conversation with them about consensus and external validation as components of standards development, their response was “We are not accredited and we don’t have to do any of those things”.  

 I know what they are doing, and I understand what they are doing, but it is very difficult for me to find that essential third requirement of respect.  The chances of our having any on-going success would be very limited.  Having a successful first assessment would be a “no-brainer” and I guess we could notch that into our belt as an accomplishment, but the likelihood of sustained follow-through (the true achievement) just wouldn’t happen. 

The search continues.

PS: Recently I learned the hard way what happens when you don’t wear a seat belt.  You get a heavy fine.

PPS: Looking forward to a positive and successful 2014

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.