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Tuesday, January 2, 2018

Fit for Process versus Fit for Purpose

Recently I have had the chance to work with a number of laboratories around the world that are relatively early on in their march to Quality Progress (by this I don’t mean subscribing to the ASQ magazine, but actually trying to making progress implementing Quality Management in their laboratories).  What I have seen is a lot of implementing new procedures which will be hopefully in time active and appropriate. But so far maybe not so much. 

What I see a lot of is laboratories deciding they want to get accredited tomorrow or they are told by their overseers that they have to implement a quality system NOW.  So they buy a book, or hire a consultant and they start by looking at the documents that they have to create: Organizational Chart, Quality Manual, Mission and Vision statements, Standard Operating Procedure forms, Document Control List, Corrective Action Form, Quality Indicator Forms, plus, plus.  

So the documents get created “by the book”, and get set up for use “by the book”.  I call this Fit-for-Process; documents that can be shown to an assessor so that they can get a checkmark in the appropriate box.  

What I also see with these documents is a ton of documentation that that looks pretty, but seems to exist solely for the purpose of being seen.  They are not designed so they can be used to actually make the quality process work better.  They become documents of busy work.  What they are NOT are documents Fit-for-Purpose.

They remind me of Billy Crystal’s character Fernando who would follow up his catch phrase in some generically hip pseudo-Spanish accent, “you look MARVELLOUS” followed by “It is better to look good than to feel good (and you know what I mean)”.  

The problem of course is that the documents get created in response to the question, “what do we need?” rather than “why do we need?”

What happens is inevitable; documents get created to record everything on every topic on every occasion.  And then fatigue sets in and they get filled in not with everything or on every occasion, but with less stuff and less often. And not far down the road, they just stop, and the complaints start; “this Quality stuff is a waste of time, and we are so busy and we don’t have the time to waste!”  

The problem was not that Quality takes too much time, it is that implementation was done in a hurry, to Fit-the-Process, to get that checkmark, to get that accreditation done and out of the way.  The purpose, if there was any, was solely about getting the certificate NOW.  
The reality is the Quality takes time, and grows with insight and with organizational culture.  And if it takes a year or so, then let that happen.  

Quality Management systems create a framework for planning and assessing risk and reducing the number of repeated errors.  When implemented Fit-for-Purpose, the process saves time rather than consumes time.  When implemented Fit-for-Purpose, the process reduces stress rather than driving the Qualitists crazy filling in the pretty documents with the excessive information.  When implemented Fit-for-Purpose, your next steps are refinements, not overhauls or do-overs.

So as you charge forward towards getting your stars or your certificate, let me ask you the obvious…”what’s your hurry?”

Upon reflection, when it comes to building your Quality system, Crosby was spot-on.  Do it Right the First Time (DIRFT).