How we tell our story

“If it Isn’t Written Down, then it Didn’t Happen” is a guiding principle of the quality profession.

There are four major types of writing in quality: instructional, informational, persuasive and transactional. When evaluated against the three major document types instructional is a functional document, informational is a report and transactional is a record. This is not to say that all transactional business writing should be considered a record, the traditional argument against emails in quality systems for example.

It is important to understand these differences as they require differences in writing style, format and grammar. An SOP (instructional/functional) is very different that an informational/report). When building your writing competencies it is important to remember these are different (with a common foundation).

We utilize reports in our quality systems (and everywhere else) to act, to communicate information, to capture work completed, to record incidents, to finalize projects and recommendations, and to act as an archive. A well written report allows the reader to easily grasp the content and, if applicable, make informed decision. Report writing is a cornerstone of a CAPA system (from incident identification to root cause through CAPA completion and effectiveness review), validation, risk management and so much more.

In short, reports are our stories, they form the narrative. And how we tell that narrative determines how we think of an issue, and how we will continue to thing of it in the future.

We tend to mix and match two modes in our report writing — Story thought and system:

  • Story thought emphasizes subjective human experience, the primacy of individual actors, narrative and social ordering, messiness, edge cases, content, and above all meaning.
  • System thought emphasizes 3rd-person descriptions of phenomena from a neutral perspective, the interchangeability of actors and details, categorical or logical ordering, measurements, flow, form, and above all coherence.

We tend to lean more heavily on system thought in quality,the roots of the discipline and the configuration of our organizations make us predisposed to the system thought mode. This means that over time, best practices accumulate that favor system thought, and many of our our partners (regulatory agencies, standard setting bodies, etc) favor the measurable and the reducible. However, by favoring the system thought mode we are at jeopardy of missing how human beings function in our organizations and how our organizations need to deal with society. And we make mistakes. Me make bad decisions. We fail to deal with the truly complicated problems.

It is time to learn how to utilize story though more in quality.

Coherence and Quality

Sonja Blignaut on More Beyond wrote a good post “All that jazz … making coherence coherent” on coherence where she states at the end “In order to remain competitive and thrive in the new world of work, we need to focus our organisation design, leadership and strategic efforts on the complex contexts and create the conditions for coherence. “

Ms. Blignaut defines coherence mainly through analogy and metaphor, so I strongly recommend reading the original post.

In my post “Forget the technology, Quality 4.0 is all about thinking” I spelled out some principles of system design.

PrincipleDescription
BalanceThe system creates value for the multiple stakeholders. While the ideal is to develop a design that maximizes the value for all the key stakeholders, the designer often has to compromise and balance the needs of the various stakeholders.
CongruenceThe degree to which the system components are aligned and consistent with each other and the other organizational systems, culture, plans, processes, information, resource decisions, and actions.
ConvenienceThe system is designed to be as convenient as possible for the participants to implement (a.k.a. user friendly). System includes specific processes, procedures, and controls only when necessary.
CoordinationSystem components are interconnected and harmonized with the other (internal and external) components, systems, plans, processes, information, and resource decisions toward common action or effort. This is beyond congruence and is achieved when the individual components of a system operate as a fully interconnected unit.
EleganceComplexity vs. benefit — the system includes only enough complexity as is necessary to meet the stakeholder’s needs. In other words, keep the design as simple as possible and no more while delivering the desired benefits. It often requires looking at the system in new ways.
HumanParticipants in the system are able to find joy, purpose and meaning in their work.
LearningKnowledge management, with opportunities for reflection and learning (learning loops), is designed into the system. Reflection and learning are built into the system at key points to encourage single- and double-loop learning from experience to improve future implementation and to systematically evaluate the design of the system itself.
SustainabilityThe system effectively meets the near- and long-term needs of the current stakeholders without compromising the ability of future generations of stakeholders to meet their own needs.

I used the term congruence to summarize the point Ms. Blignaut is reaching with alignment and coherence. I love her putting these against the Cynefin framework, it makes a great of sense to see alignment for the obvious domain and the need for coherence driving from complexity.

So what might driving for coherence look like? Well if we start with coherence being the long range order (the jazz analogy) we are building systems that build order through their function – they learn and are sustainable.

To apply this in the framework of ICHQ10 or the US FDA’s “Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations” one way to drive for coherence is to use similar building blocks across our systems: risk management, data integrity and knowledge management are all examples of that.

Building relationships is critical for tackling complexity

If we want to address the complex problem situations that the world is facing, being a smart systems thinker and innovator is not enough. We need to engage in new ways of collaborating that promote continuous, productive and collective learning and innovation. These collaborations require us to learn social skills, build social structures, and adopt attitudes of openness to learning, trust and responsibility, however hard it is to let go of the behaviours and structures that hold us back.

Mieke van der Bijl “Why being smart is not enough — the social skills and structures of tackling complexity

Good article on problem-solving and complexity that is very sympathetic with Donella Meadows Leverage Points. This article and my recent post on creativity are both coming from similar points by stressing many of the same solutions to solving problems.

I liked the discussion on creating the right organization structures to allow problem-solving to happen. As someone who is very worried that can contribute to laying the bricks in Kafka’s castle and the bars in Weber’s Iron Cage, I am always striving to push for better ways of working, of creating structures that both amplify freedom and responsibility, that drive for innovation. Applying basic principles is pretty important to ensure we build for now and the future.

Effective Organizations — Think Different

Effectiveness I recently had a bit of a wake-up call via Twitter. I asked the following question: “What’s the one thing /above all/ that makes for an effective organisation?” My thanks to all those who took the time to reply with their viewpoint. The wake-up call for me was the variety of these responses. All […]

via Effectiveness — Think Different

Great thought-piece over on “Think Different” on effectiveness, with a nice tie-in to Donnella Meadow’s “Twelve Leverage Points to Intervene in a System.”

In quality management systems, it is critical to look at effectiveness. If you do not measure, you do not know if the system is working the ways you expect and desire.

We often discuss lagging (output measurement) and leading (predictive) indicators, and this is a good way to start, but if we apply System Thinking and use Meadow’s twelve leverage points we can see that most metrics tend to be around 7-12, with the more effective levers being the least utilized.

I think there are a lot of value in finding metrics within these levers.

So for example, a few indicators on the effectiveness of lever 4 “The Power to Add, Change, Evolve, or Self-Organize System Structure”:

Lagging Leading
Effective CAPAs to the System Number of changes initiated by level of organization and scale of change
Deviation Reduction

 

Improving But Not Learning by Doing

Alex Tarbok on Marginal revolution wrote “Improving But Not Learning by Doing” looking at a paper “Causal understanding is not necessary for the improvement of culturally evolving technology” — which has interesting things to say to those interested in knowledge management. In short it demonstrates that the complex problems we have today need to be approached multi-dimension approach, in short system thinking is required to do true knowledge management.

Knowledge management Circular_Process_6_Stages (for expansion)

Throughout the six stages we need to be evaluating for complexities and interfaces. It is very easy to think in a silo and then create bigger problems done the line.

The DIKW pyramid is a great resource to keep in mind here.dikw pyramid

  • —Data comprises facts, observations, or perceptions
  • —Information is a subset of data, only including those data that possess context, relevance, and purpose
  • Knowledge is —Information with direction, i.e., leads to appropriate actions
  • Wisdom is the understanding of the why

I know that in many knowledge management models wisdom is often discounted, but that is to our detriment. Quality is often all about the why, whether a regulatory commitment, or a deep understanding of history, or as is relevant here , the relationship between parts of a complex system (or the interrelationship between systems).