9004 - once more with passion

In 2009, Boiral and Amara published in Quality Management Journal (QMJ VOL. 16, 2009, ASQ: 36-60) that only about 25 percent of adoptions of ISO 9001 were effective, with the ineffective ones marred by internal or external barriers, or by little evidence of ongoing activity.  Those situations where there was little activity but few barriers to explain the failure were referred to as Managerial adoptions (the manager may care but no one else does).  Those with lots of activity but huge road blocks and pitfalls were referred to as Ceremonial (we adopted it, but we have no intention of allowing this to actually work).   Those where there was poor activity and huge barriers were called Ineffective (why did you even bother?), and the remainder showed ongoing success (Effective…Hooray!). 

I raise this because I suspect a similar pattern with ISO 9004:2009  Managing for the sustained success of an organization – A quality management approach.  There will be those (some) who become aware of ISO 9004:2009, and progress towards sustained success, but the majority will be unsuccessful.

ISO 9004 provides a useful approach to take the requirements of ISO 9001, but help enhance the view of shifting from just implementing because you have to in order to maintain your certification, to seeing value and purpose.  It promotes the use of factual evidence, awareness of changing environment, valuing employees, and monitoring customer satisfaction as tools to keep the organization moving forward towards success.  Success is enhanced not by creating a strategic plan and policies, but by communicating the strategic plan and policies, and setting forth to action and implement.  And succeed through success, meaning learning from your experiences and adopting  innovation for progress through positive change. 

One can see the influences behind 9004.  Focus on measurement (Six Sigma); focus on involvement and motivation of staff (Toyota) and focus on analysis and review (PDSA).  It completes the loop back to the beginnings of quality management.

9004 should be a roadmap to success. 

So why do I think that adoption and success will be small, especially in medical laboratories?  First and foremost, at least in Canada – and indeed probably most or all public sector funded organizations - there are no longer any traditional measures of success, because there is no incentive for success.  Medical laboratories will always “succeed” in the sense that patients will always come for care, and physicians will always send samples.  And the budget will always be there.  Closures don’t result from doing bad things, or bankruptcy; they come from higher level “efficiencies”.  And in a union shop environment, the concepts of personal pay-for-performance or bonus-for-excellence have been wiped off the table.  Laboratorians in institutional laboratories no longer know what success looks like.

The only real measure for effective success is, in my opinion, professional pride, and the sense that MY laboratory is the best, a concept much more of the ‘60s and ‘70s than of today.  Today the notion of organizational pride and the spark of competitive edge are all but completely wiped out.  That is not to say there are not still organizations committed to National Quality Awards and the Baldrige Award, but they are truly few and far between.

So does that mean that Qualitologists should write this document off as “interesting but not realistic”?  I don’t think so.   Read it, and think about it.  There are some pearls here.  Some of them may even be enough to help overcome some of the afore-mentioned barriers which could contribute to some of the ceremonial adoptions may shift over to being more effective.  Some of the practices may improve to the point where more than just the manager cares. 

Long term hopes and aspirations? Absolutely.  That is what we call strategic planning for long term success.

PS:       I am aware that few medical laboratories focus on 9001 as their source document for quality.  9004 is fully compatible with ISO 15189, and as far as I can tell, with CLIA.

Next time.  The two major holes in ISO 9004:2009.