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:
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)
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.
What do we mean when we discuss culture, which is sort of an all-encompassing word that seems difficult to pin down, or can be a rather nebulous way to refer to something bigger than any one individual or team.
Many definitions are available to describe culture. Formally, culture can be defined as “the [predominant] beliefs, values, attitudes, behaviors, and practices that are characteristic of a group of people” (Warrick, 2015). Culture can usually be described as the symbols, power structures, organisational structures, control systems, rituals & routines, and stories of a group.
Why does culture matter, well for starts let’s look at some differences between high and low performing cultures.
High Performance Cultures
Low Performance Cultures
Leaders are skilled, admired, and build organizations that excel at results and at taking excellent care of their people and their customers
Leaders provide minimal leadership, are not trusted and admired, and do little to engage and involve their people
Clear and compelling vision, mission, goals, and strategy
Vision, mission, goals, and strategy are unclear, not compelling, not used, or do not exist
Core values drive the culture and are used in decision making
Core values are unclear, not compelling, not used, or do not exist
Guarded communication, reluctance to be open and straightforward, and consequences for saying things leaders do not want to hear
Teamwork, collaboration, and involvement are the norm
Top-down decision making with minimal teamwork, collaboration, and involvement
Emphasis on constant improvement and state-of-the-art knowledge and practices
Slow to make needed improvements and behind times in knowledge and practices
Willingness to change, adapt, learn from successes and mistakes, take reasonable risk, and try new things
Poorly planned change, resistance to change, minimal learning from successes and mistakes, and either risk averse or risk foolish
Culture can either be built in a purposeful way or left to chance. As we strive for excellence we need to be methodical about building and sustaining cultures we want to drive excellence. A few guidelines then:
Make strategy and culture important leadership priorities
Develop a clear understanding of the present culture
Identify, communicate, educate, and engage employees in the cultural ideals
Role model desired behaviors
Recruit and develop for culture
Align for consistency between strategy and culture
Recognize and reward desired behaviors and practices
Use symbols, ceremonies, socialization, and stories to reinforce culture
Appoint a culture team
Monitor and manage the culture
What most of struggle with is how to actually do that. Of the many papers and articles I’ve read on the subject, my favorite might be from the International Society of Pharmaceutical engineers (ISPE).
The ISPE in 2015 introduced a cultural excellence framework which was expanded on in their 2017 Cultural Excellence Report. I’ve returned to this report again and again and continue to mine it for ideas for continual improvement and change in my organization.
The six dimensions to build and maintain cultural excellence are:
Leadership and vision: Leaders establish and engender the vision for the organization. Their thoughts, words, and actions about quality are critical in establishing and maintaining a culture of operational excellence. Leadership and vision, therefore, play a key role in establishing the culture, either within a local manufacturing site or across the company.
Mindset and attitudes: These play a key role in driving cultural performance, although they can be difficult to define, observe, and measure. Leaders can assess, monitor, and develop the desired cultural excellence mindset and attitudes within their organizations, using the practical and powerful approaches outlined in this report.
Gemba walks: Management engagement on the floor is a powerful way to demonstrate quality commitment to all members of the organization. Gemba walks allow site leaders to communicate clear messages using open and honest dialogue, and provide a real indication of progress toward desired behaviors at all levels. Gemba walks also empower front-line employees by recognizing their contributions to site results and involving them in problem-solving and continuous improvement.
Leading quality indicators and triggers: There are inherent links between culture, behavior, and leading quality indicators (LQIs) that drive desired patient-focused behaviors. Monitoring and surveillance of key triggers and the design of LQIs are highly recommended practices to help shape cultural excellence.
Oversight and review: Management oversight and review practices that engage both management and employees support a healthy quality culture because they demonstrate transparency, facilitate dialogue, bring attention to issues so they can be addressed, and highlight best practices so they can be replicated.
Structural enablers: These support the desired behaviors, help speed the pace of change, and improve performance over time. They include: –– Develop a learning organization –– Establish learning teams –– Influence and recognize organizational change –– Solve problems proactively –– Identify true root cause
R.D. Day. Leading and Managing People in the Dynamic Organization. Psychology Press, London, UK (2014)
ISPE. Cultural Excellence Report. ISPE, Bethesda (2017)
R.N. Lussier, C.F. Achua. Leadership: Theory, application, and skill development (6th ed.), Cengage Learning, Boston (2016)
D.D. Warrick, J. Mueller (Eds.), Lessons in changing cultures: Learning from real world cases, RossiSmith Academic Publishing, Oxford, UK (2015)
While focused on medical devices, this proposal is interesting read for folks interested in applying machine learning and artificial intelligence to other regulated areas, such as manufacturing.
We are seeing is the early stages of consensus building around the concept of Good Machine Learning Practices (GMLP), the idea of applying quality system practices to the unique challenges of machine learning.
Every change (and lets be frank, most everything involves change) requires understanding the individuals and groups that will participate or are affected – directly or indirectly.
Stakeholder analysis involves identifying the stakeholders and analyzing their various characteristics. These characteristics can include:
Level of authority within the organization and the domain of change
Attitudes toward or interest in the change
Attitudes towards the process
Level of decision-making authority
The goal of stakeholder analysis is to choose the best collaboration and communication approaches and to appropriately plan for stakeholder risks.
There are a variety of mechanisms for doing this and then mapping it out.
Start by brainstorming a list of the stakeholders by answering these questions:
Who will be impacted?
Who will be responsible or accountable
Who will have decision authority
Who can support
Who can obstruct
Who has been involved in something similar in the past?
Map these on a stakeholder matrix based on relative power and interest. This should be an iterative process.
High influence/High Impact: these are key players and effort should be focused here to engage this group regularly
High influence/Low impact: these stakeholders have needs that should be met so engage and consult with them while also attempting to increase their level of interest.
Low influence/High impact: these stakeholders are supporters and potential goodwill ambassadors. Engage the group for their input and show interests in their needs.
Low influence/Low impact: the stakeholders can be kept informed using general communications. Additional targeted engagement may move them into the goodwill ambassador quadrant.
Another way to look at stakeholders is though an onion diagram.
A RACI is another popular way to look at stakeholders.
Once stakeholders are identified is is important to define how communication and engagement will achieved. There is usually no one sized fits all approach and it is important to meet the needs of each stakeholder group to ensure their interest and involvement is maintained. Some considerations include:
timing and frequency
delivery methods (in-person or virtual)
preferences of the stakeholders
geographic considerations or impact
Document this in a communication plan, including:
what needs to be communicated
what is the appropriate delivery method
who the appropriate audience is
when communication should occur
frequency of communication
level of detail appropriate for the communication and stakeholder
Luigi Sille on sharequality answered the June 2019 ASQ Roundtable Topic asks: “How can an individual become a successful Change Leader?” I’m a big fan of both blog carnivals and change management so here goes my answer, which is pretty similar to Luigi’s, and I would guess many other’s – just with my own spin.
A few things immediately come to mind.
Change management (and this is another great example of really meaning people change management) should be a competency on the ladder for any quality professional. It certainly needs to be a core area for anyone in a quality leadership position.
There are a lot of competency models out there for change management. Instead of pointing to just one, let’s try to find what they actually have in common. To do so it is important to set out the critical activities of change management: