Fishing for answers - Part 2.
Matthew Wictome
Quality System Improvement Specialist / Author / Vice President of Quality Assurance and Regulatory Affairs at Trinity Biotech
In the last edition of Quality Rebooted we looked at the importance of addressing the right problems with the correct solutions.
Whilst a view that may be rather unfashionable, the role of the Quality professional is more than just?maintaining quality and ensuring adherence to regulations.?
It is striving to better understand customer / patient needs and making sure that changes happen that position your business to deliver on these needs. A job in Quality is more than just maintaining the status quo.?
This offers up some distinct challenges, including whether Quality professionals always have the appropriate skills, competencies and get the training to achieve this end, now and in the future. A subject certainly worthy of another edition of this newsletter.
It, however, poses a more fundamental question.
Are we using the best approaches to deliver the changes we want to make ?
Thinking differently?
Over last 30 years significant improvements have been made in the capability of manufacturing systems with approaches such as lean and Process Excellence amongst others.
But we have to face the fact that these approaches have not always been successful. This is especially the case when they are applied within the healthcare industry [1].
Any of those who think that rigorous application of such methodology to the UK's NHS will solve all of its problems - well, good luck with that one.
There is an argument that the delivery of quality patient-focused care requires organisational transformation, with approaches such as lean being only one component?[1].
One of the foundations of all of these methodologies is the presumption of cause-and-effect. Inputs can be controlled; outputs verified and factories behave like machines, and by extension organisations behave like machines.
This is clearly not the case.?
As processes become systems, and systems become organisations, interactions increase and the whole system becomes more difficult to understand and influence. On the macro-scale we would call this ‘society’.
Ask yourself this question.
Has your life-plan gone exactly how you predicted it would ??
It is extremely unlikely it has. But it’s also extremely unlikely that it has been a complete mess as well.??It has probably gone somewhere in between.?
The world between these extremes is the world of complexity, and the world where we all live in.?
Complex systems grow, adapt and change. There are hard to understand and control but are the reality of the world around us, which is rarely as predictable and controllable as we would like it to be [2].
A complexity view of the world has been successfully applied within the social sciences for many years, but less so within organisations embedded in engineering and only sporadically applied to the world of Quality.
However, there is a growing body of thought that Quality Systems and Quality organisations are complex adaptive systems and should be treated as such, rather than the machines we would like them to be [3-5].?
One of the practical applications that complexity has spawned is the Cynefin framework developed by David Snowden [6]. It is a powerful tool to aid better decision making and nobody would argue that everybody in Quality need to be able to make better decisions.
In his framework, the ordered world - described on the right-hand side, is split into either the Clear or Complicated. In the former domain, the link between cause-and-effect is very easy to get. Whilst in a Complicated world the relationship still holds, but needs expertise, or experimentation to fully understand.?
The left-hand side includes domains where the world is less ordered. It is split into either a domain described as Complex, where the relationship between cause-and-effect doesn’t always hold or changes, and finally a region that describes a Chaotic world.?
This four domains generally make up the world around us. Often at the same time.
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So was does this mean I practice ?
One good example of multiple worlds existing simultaneously is the shambolic evacuation of?Kabul airport in August 2021.
We need to get out of Kabul?
The evacuation was the result of the fall of the Afghanistan government and the Taliban offensive that was rapidly overrunning the country. During the final days of the regime NATO forces attempted to evacuate around 120,000 refugees in a matter of days.
It presented the NATO commanders with the need to make split-second decisions that would impact the lives of many, with decisions being made under intense media scrutiny and the hostile gaze of Taliban forces surrounding the airport.
Issues that presented themselves in the Clear domain included the need for security of the airport to maintained, army personnel to be fed and watered, and life protected. The needs and solutions were obvious. Whilst issues that presented themselves in the Complicated domain included the need to determine who was eligible for evacuation, the clearance and paperwork needed etc. Here the process may have been complicated and intricate, but with trained expertise and knowledge on the ground the task was achievable.??
Items in the Complex domain were the “unknown unknowns”. How would the Taliban react to the evacuation ? Would these views change throughout the evacuation exercise?? How would the country function ? Here the best approach was to observe and try and understand an evolving situation.?
Finally, items in the Chaotic domain included catastrophic events that caused loss of life. ie: bombings and riots. These events required commanders gain control and order immediately.
In any organisation the world is presented to you in multiple ways.
It applies to your business.
It applies to your job as a Quality professional.
Sometimes the solutions are Clear with best practice easily available ie: lean / PEx. Sometimes?issues are more?Complicated with expert opinion needed to translate requirements into activities ie: MDR / IVDR.?
Issues that sit in the Complex domain are the meat of the Quality professional: changing, evolving events where decisions can have unintended consequences. Who said being a Quality professional would be easy ?
Finally, issues in the Chaotic domain need addressing swiftly ie: flagrant breaches of good manufacturing practice, loss of process control.??Hard calls need to be made based on incomplete information.??
This also drive differing levels of intervention. Sometimes Quality needs to be in-with-the-weeds and hands-on eg: audit preparation. At other times we need to take a step back and constrain less eg: blue-sky thinking during new product development.
In our forthcoming book Ian Wells and myself explore in more detail how such world-view approaches can be applied practically. Approaches to not just maintain quality and implement standards, but go beyond these basic needs. To pro-actively improve quality, to better serve patients and to grow a business [7].
As any good captain of a fishing trawler knows, at times it is better to watch and observe the shoal to have any chance of making a successful catch.
And that is at times all we are trying to do in Quality. We are all just fishing for answers.
Best regards
matt
[1]?Kaplan?GS,?Patterson?SH,?Ching?JM, et al Why Lean doesn't work for everyone BMJ Quality & Safety?2014;23:970-973.
[2]???????Boulton, Jean, G., Peter M. Allen, and Cliff Bowman?Embracing Complexity: Strategic Perspectives for an Age of Turbulence. Oxford University Press. 2015
[3] Alba N. Zaretzky. “Quality management systems from the perspective of??organization of complex systems”,?Mathematical and Computer Modelling, Volume 48, Issues 7–8, 2008, Pages 1170-1177, ISSN 0895-7177, https://doi.org/10.1016/j.mcm.2007.12.023.
[4]???????Dooley, Kevin, Timothy Johnson, and David Bush. “TQM, chaos, and complexity.”?Human Systems Management. 14. 1995: 1-16. 10.3233/HSM-1995-14403.?
[5]????????gland, Petter. “Designing quality management systems as complex adaptive??systems.”?Systemist, 30(3), 2008, 468-491
[6] Snowden, Dave, and Alessandro Rancati. (2021) “Managing complexity (and chaos) in times of crisis. A field guide for decision makers inspired by the Cynefin framework.”??Publications Office of the European Union, Luxembourg, 2021. https://publications.jrc.ec.europa.eu/repository/handle/JRC123629
[7] Wictome, Matthew P. and Ian Wells. Transforming Quality Organizations: A Practical Guide. Business Expert Press, New York. 2023, In press.