Do you really have a learning culture ?
Matthew Wictome
Quality System Improvement Specialist / Author / Vice President of Quality Assurance and Regulatory Affairs at Trinity Biotech
One of Peter Drucker’s famous quotes was that “Culture eats strategy for breakfast.” - meaning that you could have all the best laid plans, roadmaps and objectives for your organisation, but these would all lead nowhere unless the underlying culture was working in alignment with where you want to go.?
Culture can be defined as behaviors demonstrated on a daily basis, often our own.
There is much discussion around the importance of a Culture Of Quality within organisations, but this newsletter covers an aspect that underpins the ability of any organisation to foster a Culture of Quality ie: Is it a learning organisation ?
Would you consider your Quality organisation to be learning organisation ???
“ Absolutely !” – I hear you cry.
So let's unpack this a bit.
The concept of a continuous improvement culture underpins much of the expectations of effective quality management. Think of Deming’s Plan, Do, Check, Act - which could be argued preceded much of the methodology around Process Excellence and all continuous improvement approaches are essentially just variants thereof.?
When we talk about continuous improvement, we almost feel it is synonymous with the Quality organisation itself. But in this edition, I pose the uncomfortable question:
Is that really true ??
Are most Quality organisations hot beds of continuous improvement and learning, dissatisfied with the status-quo ? Or are some actually functions that defend current ways of doing things, and dare I say it even at times stifle change ?
Many organisations say that quality is in their DNA – whatever that means - and continuous improvement is hardwired into their organisation.?????????????????
So let us scratch the surface and see whether underneath this is true.
Certainly, one area where learning is expected is the CAPA system. There are regulatory expectations of measuring CAPA effectivity ie: did your solution prevent the reoccurrence or occurrence of the problem ?
But let’s be honest CAPA effectivity is often the weakest step in the CAPA process, tagged on at the end, with little thought as to how to best measure the effectiveness of the CAPA and the means to do so.
I would argue that whilst regulations and standards mandate learning for changes in the CAPA system, such a learning approach is seldom taken with other subsystems of the QMS.
How many organisations measure how effective change control was and assess retrospectively whether the change implemented delivered against expectations and the resources expected ? Seldom is there a change effectivity step, and usually we just move on.
How many organisations ask why internal audit isn’t detecting quality issues that external inspections are ?
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How many quality projects are subjected to a fierce learning exercise at closure, to learn how they could be done better next time ??
How many Quality organisations question why despite scores of hours of effort completing Quality System Management Review this is never evidenced in moving the business forward ?
Or why despite application of countless CAPA events the number of non-conformances are still not going down ?
I could go on and on.
I would argue that whilst many Quality organisations talk about a learning environment this is not always evidenced in behaviors that underpin the culture that is hope for and proclaimed.?
This is in part related to the conflict that Quality has to straddle - one of maintaining consistency, but also encouraging improvement. In general, maintaining consistency wins and whilst many Quality leaders talk about developing a learning and growing organisation maintaining control usually dominates.
There are many reasons for this, but one is the poor application of effective risk management throughout the Quality organisation on a daily basis.?Control usually out-trumps ideas.
All Quality leaders play a key role in influencing this balance, a balance between control and innovation, compliance and improvement. Through their actions this balance is set.
Frankly often new approaches are not considered, or individuals invited in to critique - with fresh eyes - systems and approaches in the same way Operational leaders have long since embraced, knowing that the gains of lifting up the car bonnet outweigh any embarrassment in finding out their system is far from perfect.
And to be honest this really has to change. Quality leaders may be comfortable enforcing rules, deciding for others and judging good from bad, but often the doctor is the worst patient with respect to taking their own medicine, and this often goes for how Quality organisations look at themselves and their systems in a truly learning way.
For those interested in more practical ways to better balance control with innovation, they can be found in Ian Wells ’ and my new book: Transforming Quality Organizations: A Practical Guide, which is out now. We both hope it helps Quality organizations do better for patients, customers and their shareholders in achieving an often delicate balance between controlling and protecting, and learning and improving.
All the best
matt
Out now:-
Quality and Regulatory Executive in the Healthcare Industry | Helping companies leverage quality to maximise customer experience, minimise waste, and drive down operating costs
1 年Another very insightful article, Matt. The Quality department should be the tip-of-the-spear for continuous improvement activities, but more often acts as the anchor holding an organisation back from change, due to fear of a perceived loss of control. Often industry best practices are only implemented when a regulation forces that change, and that isn't healthy for organisational growth.