Defining Values, with Speaking Out as an example

Which espoused values and desired behaviors will best enable an organization to live its quality purpose? There’s been a lot of writing and thought on this, and for this post, I am going to start with ISO 10018-2020 “Quality management — Guidance for people engagement” and develop an example of a value to build in your organization.

ISO 10018-2020 gives 6 areas:

Context of the organization and quality culture
Leadership
Planning and Strategy
Knowledge and Awareness
Competence
Improvement

This list is pretty well aligned to other models, including the Malcolm Baldrige Excellence Framework (NIST), EFQM Excellence Model, SIQ Model for Performance Excellence, and such tools as the PDA Culture of Quality Assessment.

A concept that we find in ISO 10018-2020 (and everywhere else) is the handling of errors, mistakes, everyday problems and ‘niggles’, near misses, critical incidents, and failures; to ensure they are reported and recorded honestly and transparently. That the time is taken for these to be discussed openly and candidly, viewed as opportunities for learning how to prevent their recurrence by improving systems but also as potentially protective of potentially larger and more consequential failures or errors. The team takes the time and effort to engage in ‘second order’ problem-solving. ‘First order’ problem solving is the quick fixing of issues as they appear so as to stop them disrupting normal workflow. ‘Second order’ problem solving involves identifying the root causes of problems and taking action to address these rather than their signs and symptoms. The team takes ownership of mistakes instead of blaming, accusing, or scapegoating individual team members. The team proactively seeks to identify errors and problems it may have missed in its processes or outputs by seeking feedback and asking for help from external stakeholders, e.g. colleagues in other teams, and customers, and also by engaging in frequent experimentation and testing.

We can tackle this in two ways. The first is to define all the points above as a value. The second would be to look at themes for this and the other aspects of robust quality culture and come up with a set of standard values, for example:

Accountable
Ownership
Action Orientated
Speak up

Don’t be afraid to take a couple of approaches to get values that really sing in your organization.

Values can be easily written in the following format:

Value: A one or two-word title for each value
Definition: A two or three sentence description that clearly states what this value means in your organization
Desired Behaviors: “I statement” behaviors that simply state activities. The behaviors we choose reinforce the values’ definitions by describing exactly how you want members of the organization to interact.
- Is this observable behavior? Can we assess someone’s demonstration of this behavior by watching and/or listening to their interactions? By seeing results?
- Is this behavior measurable? Can we reliably “score” this behavior? Can we rank how individual models or demonstrates this behavior?

For the rest of this post, I am going to focus on how you would write a value statement for Speak Up.

First, ask two questions:

Specific to your organization’s work environment, how would you define “Speak Up.”
What phrase or sentences describe what you mean by “Speak Up.”

Then broaden by considering how fellow leaders and team members would act to demonstrate “Speak Up”, as you defined it.

How would leaders and team members act so that, when you observe them, you would see a demonstration of Speaking Up? Note three or four behaviors that would clearly demonstrate your definition.

Next, answer these questions exclusively from your team member’s perspective:

How would employees define Speaking Out?
How would their definition differ from yours? Why?
What behaviors would employees feel they must model to demonstrate Speaking Out properly?
How would their modeled behaviors differ from yours? Why?

This process allows us to create common alignment based on a shared purpose.

By going through this process we may end up with a Value that looks like this:

Value: Speaking Out
Definition: Problems are reported and recorded honestly and transparently. Employees are not afraid to speak up, identify quality issues, or challenge the status quo for improved quality; they believe management will act on their suggestions.
Desired Behaviors:
- I hold myself accountable for raising problems and issues to my team promptly.
- I attack process and problems, not people.
- I work to anticipate and fend off the possibility of failures occurring.
- I approach admissions of errors and lack of knowledge/skill with support.

Managing Events Systematically

Being good at problem-solving is critical to success in an organization. I’ve written quite a bit on problem-solving, but here I want to tackle the amount of effort we should apply.

Not all problems should be treated the same. There are also levels of problems. And these two aspects can contribute to some poor problem-solving practices.

It helps to look at problems systematically across our organization. The iceberg analogy is a pretty popular way to break this done focusing on Events, Patterns, Underlying Structure, and Mental Model.

Events

Events start with the observation or discovery of a situation that is different in some way. What is being observed is a symptom and we want to quickly identify the problem and then determine the effort needed to address it.

This is where Art Smalley’s Four Types of Problems comes in handy to help us take a risk-based approach to determining our level of effort.

Type 1 problems, Troubleshooting, allows us to set problems with a clear understanding of the issue and a clear pathway. Have a flat tire? Fix it. Have a document error, fix it using good documentation practices.

It is valuable to work the way through common troubleshooting and ensure the appropriate linkages between the different processes, to ensure a system-wide approach to problem solving.

Corrective maintenance is a great example of troubleshooting as it involved restoring the original state of an asset. It includes documentation, a return to service and analysis of data. From that analysis of data problems are identified which require going deeper into problem-solving. It should have appropriate tie-ins to evaluate when the impact of an asset breaking leads to other problems (for example, impact to product) which can also require additional problem-solving.

It can be helpful for the organization to build decision trees that can help folks decide if a given problem stays as troubleshooting or if it it also requires going to type 2, “gap from standard.”

Type 2 problems, gap from standard, means that the actual result does not meet the expected and there is a potential of not meeting the core requirements (objectives) of the process, product, or service. This is the place we start deeper problem-solving, including root cause analysis.

Please note that often troubleshooting is done in a type 2 problem. We often call that a correction. If the bioreactor cannot maintain temperature during a run, that is a type 2 problem but I am certainly going to immediately apply troubleshooting as well. This is called a correction.

Take documentation errors. There is a practice in place, part of good documentation practices, for addressing troubleshooting around documents (how to correct, how to record a comment, etc). By working through the various ways documentation can go wrong, applying which ones are solved through troubleshooting and don’t involve type 2 problems, we can create a lot of noise in our system.

Trends/Patterns

Core to the quality system is trending, looking for possible signals that require additional effort. Trending can help determine where problems lay and can also drive up the level of effort necessary.

Underlying Structure

Root Cause Analysis is about finding the underlying structure of the problem that defines the work applied to a type 2 problem.

Not all problems require the same amount of effort, and type 2 problems really have a scale based on consequences, that can help drive the level of effort. This should be based on the impact to the organization’s ability to meet the quality objectives, the requirements behind the product or service.

For example, in the pharma world there are three major criteria:

safety, rights, or well-being of patients (including subjects and participants human and non-human)
data integrity (includes confidence in the results, outcome, or decision dependent on the data)
ability to meet regulatory requirements (which stem from but can be a lot broader than the first two)

These three criteria can be sliced and diced a lot of ways, but serve our example well.

To these three criteria we add a scale of possible harm to derive our criticality, an example can look like this:

Classification	Description
Critical	The event has resulted in, or is clearly likely to result in, any one of the following outcomes: significant harm to the safety, rights, or well-being of subjects or participants (human or non-human), or patients; compromised data integrity to the extent that confidence in the results, outcome, or decision dependent on the data is significantly impacted; or regulatory action against the company.
Major	The event(s), were they to persist over time or become more serious, could potentially, though not imminently, result in any one of the following outcomes: harm to the safety, rights, or well-being of subjects or participants (human or non-human), or patients; compromised data integrity to the extent that confidence in the results, outcome, or decision dependent on the data is significantly impacted.
Minor	An isolated or recurring triggering event that does not otherwise meet the definitions of Critical or Major quality impacts.

Example of Classification of Events in a Pharmaceutical Quality System

This level of classification will drive the level of effort on the investigation, as well as drive if the CAPA addresses underlying structures alone or drives to addressing the mental models and thus driving culture change.

Mental Model

Here is where we address building a quality culture. In CAPA lingo this is usually more a preventive action than a corrective action. In the simplest of terms, corrective actions is address the underlying structures of the problem in the process/asset where the event happened. Preventive actions deal with underlying structures in other (usually related) process/assets or get to the Mindsets that allowed the underlying structures to exist in the first place.

By applying this system perspective to our problem solving, by realizing that not everything needs a complete rebuild of the foundation, by looking holistically across our systems, we can ensure that we are driving a level of effort to truly build the house of quality.

Dealing with Emotional Ambivalence

Ambivalence, the A in VUCA, is a concept that quality professionals struggle with. We often call it “navigating the gray” or something similar. It is a skill we need to grow into, and definitely an area that should be central to your development program.

There is a great article in Harvard Business Review on “Embracing the Power of Ambivalence” that I strongly recommend folks read. This article focuses on emotional ambivalence, the feeling of being “torn” and discusses the return to the office. I’m not focusing on that topic (though like everyone I have strong opinions), instead I think the practices described there are great to think about as we develop a culture of quality.

Mindsets and Attitudes

Mindsets are lenses or frames of mind that orient individuals to particular sets of associations and expectations. Mindsets help individuals make sense of complex information by offering them simple schematics about themselves and objects in their world. For employees, mindsets provide scaffolding for understanding the broad nature of their work. Mindsets can be intentionally and adaptively changed through targeted interventions, so the goal is to build the processes to assess, monitor and shape as part of our quality systems.

Attitudes are the beliefs and feelings that drive individuals’ intentions and actions. Attitudes are the lens through which individuals make sense of their surroundings and impart consistency to guide their behavior .

Mindset influences attitudes, which influence behaviors, which influence actions, which influence results, which influence performance. And performance leas to changes in mindsets, and is a continuous improvement loop.

Since behaviors drive the actions we want to see, they are often a great pivot point. By thinking and working on mindsets and attitudes we are targeting the fourth and second leverage points.

Another way to think about this is we are developing habits. The same three factors apply:

Start small: If you have ever tried to tackle multiple resolutions all at once, you know it is next to impossible. Often, the habits will lack cohesion with one another, leading to more stress and less progress. The cognitive load increases, and the brain processes things in a more scattered, less congruent manner. It’s better to focus on one new habit at a time.
Enact the new habit daily: We can’t predict how long a specific habit will take to form, but all the research I’ve seen indicates that the more often people account on the new behavior, the more likely it is to become routine.
Weave into existing processes: When we blend the new behavior with current activities, it’s easier to latch on to, which make sit become an unconscious action more quickly.

Habits are contagious within social contexts, but scaling positive pressure on an organization level is a big challenge.

Another way to view this is in the framework of experiences, build beliefs, which lead to actions and give us results. By building this into our systems we can make sure the appropriate processes are in place to make sure these new habits stick. Building a quality culture is a multi-year journey requiring incremental, layered and additive formation.

This formation comes through building the mindsets that lead to the behaviors we want to see. Following the ISPE’s recommendations there are four good behaviors we can target (these are not the only ones nor are they exhaustive).

Accountability: Employees consistently see quality and compliance as their personal responsibilities. Establishing clear individual accountability for quality and compliance is a foundational step in helping shape quality mindset and cultural excellence. Accountability should be communicated consistently through job descriptions, onboarding, current good manufacturing practice (cGMP) training, and performance goals, and be supported by coaching, capability development programs, rewards, and recognition. Leaders should hold themselves and others accountable for performing to quality and compliance standards
Ownership: Employees have sufficient authority to make decisions and feel trusted to do their jobs well. Individual ownership of quality and compliance is a primary driver for shaping quality mindset. When individuals are fully engaged, empowered, and taking action to improve product quality, organizations typically benefit from continuous improvement and faster decision-making.
Action orientation: Employees regularly identify issues and intervene to minimize potential negative effects on quality and compliance. Establishing the expectation that individuals demonstrate action orientation helps shape quality mindset and foster cultural excellence. Leaders should promote and leverage proactive efforts (e.g., risk assessments, Gemba walks, employee suggestions) to reinforce support for the desired behavior. Additionally, it is important that rewards and recognition be aligned to support proactive efforts, rather than reactive fire-fighting efforts.
Speak up: Employees are not afraid to speak up, identify quality issues, or challenge the status quo for improved quality; they believe management will act on their suggestions. Empowering individuals to speak up and raise quality issues help foster quality mindset. Leaders should support this by modeling the desired behavior, building trust, and creating an environment in which individuals feel comfortable raising quality issues, engaging front-line personnel in problem solving, and involving employees in continuous-improvement activities.

Creating a high level action plan of experience -> Target Belief -> Target Action ->Target Result might look like this:

Sources

Aguire, D., von Post, R & Alpern, M. (2013). Culture’s role in enabling organization change. PWC
Ajzen, I. (2005). Attitudes, personality and behavior. (2nd ed.). Berkshire, GBR: McGraw-Hill Professional Publishing
Ball, K., Jeffrey, R.W., Abbott, G., McNaughton, S.A. & Crawford, D (2010). Is Healthy behavior contagious: associations with social norms with physical activity and healthy eating. International Journal of Behavioural Nutrition and Physical Activity, 7 (86)
Fujita, K., Gollwitzer, P. M., & Oettingen, G. (2007) . Mindsets and pre-conscious open-mindedness to incidental information. Journal of Experimental Social Psychology, 43(1), 48-61.
Gollwitzer, P. M. (1990). Action phases and mind-sets. In E. T. Higgins & R. M. Sorrentino (Eds.), Handbook of motivation and cognition: Foundations of social behavior, Vol. 2, pp. 53-92). New York, NY, US: The Guilford Press.