Sunday, January 26, 2014

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. 

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