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.

Being a Quality Leader

Domain Knowledge

Having recently said farewell to a leader in our quality organization, I have been reflecting on quality leaders and what makes one great. As I often do, I look to standards, in this case the American Society of Quality (ASQ).

The Certified Manager of Quality/Organizational Excellence (CMQ/OE)leads and champions process improvement initiatives—that can have regional or global focus—in various service and industrial settings. A CMQ/OE facilitates and leads team efforts to establish and monitor customer/supplier relations,supports strategic planning and deployment initiatives, and helps develop measurement systems to determine organizational improvement.

American Society of Quality

The ASQ’s Certified Manager of Quality/Operation Excellence (CMQ/OE) body of knowledge‘s first section is on leadership. 

To be honest, the current body of knowledge (bok) is a hodge-podge collection of stuff that is sort of related but often misses a real thematic underpinning. The bok (and the exam) could use a healthy dose of structure when laying out the principles of roles and responsibilities, change management, leadership techniques and empowerment.

There are fundamental skills to being a leader:

  • Shape a vision that is exciting and challenging for your team (or division/unit/organization).
  • Translate that vision into a clear strategy about what actions to take, and what not to do.
  • Recruit, develop, and reward a team of great people to carry out the strategy.
  • Focus on measurable results.
  • Foster innovation and learning to sustain your team (or organization) and grow new leaders.
  • Lead yourself — know yourself, improve yourself, and manage the appropriate balance in your own life.

In order to do these things a leader needs to demonstrate skills in communication, critical thinking, problem solving, and skills motivating and leading teams (and self).

The best leaders know a lot about the domain in which they are leading, and part of what makes them successful in a management role is technical competence. A Quality leader needs to know quality as a domain AND the domain of the industry they are within.

Three domains necessary for a quality leader

In my industry it is just not enough to know quality (for now we’ll define that as the ASQ BoK) nor is it enough to know pharmaceuticals (with regulatory being a subdomain). It is not enough just to have leadership skills. It is critical to be able to operate in all three areas. 

To excel as a leader in practice, you also need a lot of expertise in a particular domain. 

As an example, take the skill of thinking critically in order to find the essence of a situation. To do that well, you must have specific, technical expertise. The critical information an engineer needs to design a purification system is different from the knowledge used to understand drug safety, and both of those differ in important ways from what is needed to negotiate a good business deal.

When you begin to look at any of the core skills that leaders have, it quickly becomes clear that domain-specific expertise is bound up in all of them. And the domains of expertise required may also be fairly specific. Even business is not really a single domain. Leadership in pharmaceuticals, transportation, and internet (for example) all require a lot of specific knowledge.

Similarly, with only leadership and technical, you are going to fumble. Quality brings a set of practices necessary for success. A domain filled with analytical and decision making capabilities that cross-over with leadership (critical thinking and problem-solving) but are deepened with that perspective. 

There are also other smaller domains, or flavors of domains. If I was building this model out more seriously I would have an interesting cluster of Health and Safety with Quality (the wider bucket of compliance even). I’m simplifying for this post.

Development of knowledge

To go a step further. These three domains are critical for any quality professional. What changes is the development of wisdom and the widening of scope. This is why tenure is important. People need to be able to settle down and develop the skills they need to be successful in all three domains. 

Good quality leaders recognize all this and look to build their organizations to reflect the growth of technical, quality and leadership domain. 

Creative teams

The secret to unlocking creativity is not to look for more creative people, but to unlock more creativity from the people who already work for you. The same body of creativity research that finds no distinct “creative personality” is incredibly consistent about what leads to creative work, and they are all things you can implement within your team. Here’s what you need to do:

Greg Satell “Set the Conditions for Anyone on Your Team to Be Creative”  05Dec2018 Harvard Business Review

In this great article Greg Satell lays out what an organization that drives creativity looks like. Facilitating creativity is crucial for continuous improvement and thus a fundamental part of a culture of quality. So let’s break it down.

Cultivate Expertise

In order to build expertise our organizations need to be apply to provide deliberate practice: identify the components of a skill, offer coaching, and encourage employees to work on weak areas.

Bring knowledge management to bear to ensure the knowledge behind a skill has been appropriately captured and published. To do this you need to identify who the expert performers currently are.

It is crucial when thinking about deliberate practice to recognize that this is not shallow work, those tasks we can do in our sleep. Unlike chess or weight-lifting you really do not get anything from the 100th validation protocol or batch record reviewed. For work to be of value for deliberate practice it needs to stretch us, to go a little further than before, and give the opportunity for reflection.

Geoff Colvin in Talent is Overrated gave six traits for deliberate practice:

  • It’s designed to improve performance. “The essence of deliberate practice is continually stretching an individual just beyond his or her current abilities. That may sound obvious, but most of us don’t do it in the activities we think of as practice.”
  • It’s repeated a lot. “High repetition is the most important difference between deliberate practice of a task and performing the task for real, when it counts.”
  • Feedback on results is continuously available. “You may think that your rehearsal of a job interview was flawless, but your opinion isn’t what counts.”
  • It’s highly demanding mentally. “Deliberate practice is above all an effort of focus and concentration. That is what makes it ‘deliberate,’ as distinct from the mindless playing of scales or hitting of tennis balls that most people engage in.”
  • It’s hard. “Doing things we know how to do well is enjoyable, and that’s exactly the opposite of what deliberate practice demands.”
  • It requires (good) goals. “The best performers set goals that are not about the outcome but rather about the process of reaching the outcome.”

Encourage Exploration

The Innovators DNA by Dyer, Gregersen, and Christensen state that creativity is a function of five key behaviours

  • Associating: drawing connections between questions, problems, or ideas from unrelated fields
  • Questioning: posing queries that challenge common wisdom
  • Observing: scrutinizing the behavior of customers, suppliers, and competitors to identify new ways of doing things
  • Networking: meeting people with different ideas and perspectives
  • Experimenting: constructing interactive experiences and provoking unorthodox responses to see what insights emerge

Exploration can be seen as observing outside your sphere of knowledge, networking and experimenting.

Empower with Technology

Sure, I guess. Call me a luddite but I still think a big wall, lots of post-its, markers and some string work fine for me.

Reward Persistance

Remember this, we are always in this for the long haul. I think remembering the twelve levers can help give perspective.

Understanding Data – A Core Quality Skill

A critical skill of a quality professional (of any professional), and a fundamental part of Quality 4.0, is managing data — knowing how to acquire good data, analyze it properly, follow the clues those analyses offer, explore the implications, and present results in a fair, compelling way.

As we build systems, validate computer systems, create processes we need to ensure the quality of data. Think about the data you generate, and continually work to make it better.

I am a big fan of tools like the Friday Afternoon Measurement to determine where data has problems.

Have the tools to decide what data stands out, use control charts and regression analysis. These tools will help you understand the data. “Looks Good To Me: Visualizations As Sanity Checks” by Michael Correll is a great overview of how data visualization can help us decide if the data we are gathering makes sense.

Then root cause analysis (another core capability) allows us to determine what is truly going wrong with our data.

Throughout all your engagements with data understand statistical significance, how to quantify whether a result is likely due to chance or from the factors you were measuring.

In the past it was enough to understand a pareto chart, and histogram, and maybe a basic control chart. Those days are long gone. What quality professionals need to bring to the table today is a deeper understanding of data and how to gather, analyze and determine relevance. Data integrity is a key concept, and to have integrity, you need to understand data.

Lessons in Lean – Structured Problem-Solving: Rarely Given the Attention it Deserves

There is little argument regarding the critical role that structured problem-solving plays in a lean transformation. Besides the business results associated with solving problems, developing problem-solving skills increases learning, drives the desired change in thinking, and helps people more clearly understand how lean works as a system. With this said, however, it is amazing how little effort many organizations put into developing effective problem-solving skills. It seems like more time is spent on things like 5S, value stream mapping, and other tools that are generally considered easier to apply and less likely to be met with resistance.  As a result, transformation does not occur, improvements are not sustainable, and the big gains possible through lean thinking are never achieved.

Lessons in Lean: Structured Problem-Solving: Rarely Given the Attention it Deserves
by Greg Stocker

Good discussion on the importance of rigorous, sustained problem-solving as part of Lean initiatives. I think many of us have experienced this in our own organizations.

Utilizing problem solving tools in a structured way helps us better understand what is happening, how it is happening and most importantly, why it is happening. Armed with this understanding we can then engage in those improvements. Problem solving is key to getting those improvements because it allows us to discover why a problem is actually happening and not to just treat symptoms.

Problem Solving needs to reach a level of detail that accurately identifies an actionable cause that can then be addressed.