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:

  1. 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.
  2. 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.
  3. 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:

ISPE, Cultural Excellence Report

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.

Driving towards a Culture of Excellence

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.

Johnson & Scholes Cultural Web (this illustration: www.businessgrowthhub.com)

Why does culture matter, well for starts let’s look at some differences between high and low performing cultures.

High Performance CulturesLow Performance Cultures
Leaders are skilled, admired, and build organizations that excel at results and at taking excellent care of their people and their customersLeaders provide minimal leadership, are not trusted and admired, and do little to engage and involve their people
Clear and compelling vision, mission, goals, and strategyVision, mission, goals, and strategy are unclear, not compelling, not used, or do not exist
Core values drive the culture and are used in decision makingCore values are unclear, not compelling, not used, or do not exist
Committed to excellence, ethics, and doing things rightLack of commitment to excellence, questionable ethics, and a reputation for doing what is expedient rather than what is right
Clear roles, responsibilities, and success criteria, and strong commitment to engaging, empowering, and developing peopleUnclear roles and responsibilities and little interest in fully utilizing and developing the capabilities and potential of people
Positive, can-do work environmentNegative, tense, stressful, and/or resistant work environment
Open, candid, straightforward, and transparent communicationGuarded communication, reluctance to be open and straightforward, and consequences for saying things leaders do not want to hear
Teamwork, collaboration, and involvement are the normTop-down decision making with minimal teamwork, collaboration, and involvement
Emphasis on constant improvement and state-of-the-art knowledge and practicesSlow 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 thingsPoorly 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:

  1. Make strategy and culture important leadership priorities
  2. Develop a clear understanding of the present culture
  3. Identify, communicate, educate, and engage employees in the cultural ideals
  4. Role model desired behaviors
  5. Recruit and develop for culture
  6. Align for consistency between strategy and culture
  7. Recognize and reward desired behaviors and practices
  8. Use symbols, ceremonies, socialization, and stories to reinforce culture
  9. Appoint a culture team
  10. 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.

ISPE’s Six dimensions of cultural excellence framework

The six dimensions to build and maintain cultural excellence are:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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

Sources

  • 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)

Falsification and error

At the heart, data integrity is a lot about culture. There are technical requirements, but mostly we are returning to the same principles as quality culture and just keep coming back to Deming. A great example of this is the use of the fraud triangle and human error.

The fraud triangle was developed by Donald Cressey in the 1950s when investigating financial fraud and embezzlement. The principles Cressey identified are directly relevant to data integrity, and to quality culture as a whole.

Falsification Triangle
Element Exists When To Break
Incentive or Pressure Why commit falsification of data? Managerial pressure or financial gains are the two main drivers here to push people to commit fraud. Setting unrealistic objectives such as stretch goals, turnaround time or key performance indicators that are totally divorced from reality especially when these are linked to pay or advancement will only encourage staff to falsify data to receive rewards. These goals coupled with poor analytical instruments and methods will only ensure that corners will be cut to meet deadlines or targets. Management must lead by example – not through communication or establishing data governance structures but by ensuring the pressure to falsify data is removed. This means setting realistic expectations that are compatible with the organization’s capacity and process capability.
Rationalization or Incentive To commit fraud people must either have an incentive or can rationalize that this is an acceptable practice within an organization or department. Staff need to understand how their actions can impact the health of the patient. Ensure individuals know the importance of reliable and accurate data to the wellbeing of the patient as well as the business health of the company.
Opportunity The opportunity to falsify data can be due to encouragement by management as a means of keeping cost down or a combination of lax controls or poor oversight of activities that contribute to staff being able to commit fraud. Implement a process that is technically controlled so there is little, if any, opportunity to commit falsification of data.

Mistakes are human nature – we all have fat finger moments. This is why we build our processes and technologies to ensure we capture these errors and self-correct them. These errors should be tracked and trended, but only as a way to drive continuous improvement. It is important to have the capability in your quality systems to be able to evaluate mistakes up-to-and including fraud.

It helps to be able to classify issues and determine if there are changes to governance, management systems and behaviors necessary.

Events should be classified based on how intentional they are

Human error should be built into investigative systems. Yes, whenever possible we are looking for technical controls, but the human exists and needs to be fully taken into consideration.

The best way to ensure data integrity is the best way to build a quality culture.

System Model

Quality Management as a Program

Quality System Management should be viewed and governed as a program

Program management is commonly defined as “a group of projects that contribute to a common, higher order objective.” The projects in a program are related, and the intent of achieving benefits would not be realized if the projects were managed independently.

Program management includes the practices and processes of strategic alignment, benefits management, stakeholder management, governance, and lifecycle management. Program governance creates the control framework for delivering the programs’ change objectives and making benefit delivery visible to the organization’s control.

There are different styles of program management and what I am focusing on here is what is sometimes called “heartbeat”, which aims to achieve evolutionary improvement of existing systems and processes or organizational change. This program type creates value by reconciling contradicting views and demands for change from various organization actors in order to enhance existing systems and practices while sustaining operations.

Heartbeat program management is all about awareness of the contexts of the program and requires knowledge of strategy, competition, trends in the industry, and differences in management practices between the business units of the company. A good heartbeat program manager is highly concerned about their program’s long-term effects and implications for the company’s business.

Magic triangle of a program manager

Programs exist to create value by improving the management of projects and to create benefits through better organization of projects. The fundamental goals of program management are:

  • Efficiency and effectiveness: Aspects of management that a proficient project manager should address and benefit from coordination.
  • Business focus goal: The external alignment of projects with the requirements, goals, drivers and culture of the wider organization. These goals are associated with defining an appropriate direction for the constituent projects within a program as well as for the program as a whole.
GoalDescription
Efficiency and effectiveness goals
Improved co-ordinationAssist in identification and definition of project inter-dependencies and thereby reduce the incidence of work backlogs, rework and delays
Improved dependency managementReduce the amount of re-engineering required due to inadequate management of the interfaces between projects
More effective resource utilizationImprove the effectiveness and efficiency of the allocation of shared resources
Assist in providing justification for specialist resources that deliver an overall improvement to program delivery and/or business operations
More effective knowledge transferProvide a means to identify and improve upon transferable lessons.
Facilitate organizational learning
Greater senior management ‘visibility’Enable senior management to better monitor, direct and control the implementation process
Business focus goals
More coherent communicationImprove communication of overall goals and direction both internally and externally to the program
Target management attention clearly on the realization of benefits that are defined and understood at the outset and achieved through the lifetime of the program and beyond
Assist in keeping personal agendas in check
Improved project definitionEnsure that project definition is more systematic and objective, thereby reducing the prevalence of projects with a high risk of failure or obsolescence
Enable the unbundling of activities in a strategic project-set into specific projects
Enable the bundling of related projects together to create a greater leverage or achieve economies of scale
Better alignment with business drivers, goals and strategyImproves the linkage between the strategic direction of organizations and the management activities required to achieve these strategic objectives
Provide an enabling framework for the realization of strategic change and the ongoing alignment of strategy and projects in response to a changing business environment (via project addition/culling, etc.)

The Attributes of a Good Heartbeat Program Manager are the Attributes to a Good Quality Leader

As quality leaders we are often ambassadors to ensure that the quality program is progressing despite the conflicting requirements of the various stakeholders. We need to actively influence quality-related decisions of all stakeholders, including people holding superior positions. Having a well-developed personal network within the organization is particularly helpful.

It is critical to always be communicating about the quality program in a visionary way, to be seen as passionate ambassadors. Playing this role requires constant attention to differing expectations of the stakeholders and various ways to influence stakeholders for the benefit of the quality system. To always be striving to build quality, to advance quality.

As advocates for Quality, it is a core competency to be able to stand up and defend, or argue for, the quality program and team members. This ability to challenge others, including their superiors, in a productive way is a critical ability.

A key focus of the quality program should be on engagement with a conscious and sustained drive to secure buy-in from key stakeholders (including senior management) and win over the hearts and minds of those responsible for execution to make changes feel less painful and inflicted. As quality leaders our aim should always be to engender a climate of comprehension, inclusion and trust, and to draw upon expertise globally to create fit for purpose processes and systems

Effective quality leaders need to be “heavyweight” organizational players.

Core Competencies of the Heartbeat Manager

  • Contextual awareness
  • Scenario planning
  • Political skills
  • Courage
  • Networking

A note on program life

Many standard approaches perceive programs to have a finite life. This is constraining given that the strategies themselves, especially as applied to quality, have long lifetimes. I believe that program management has as much to learn from quality management,  and there is a lot of value in seeing an indefinite time horizon as beneficial.

Quality management is an evolutionary approach, and utilizing program management methodologies within it should be taken in the same light.

What is this quality profession all about?

A theme of this year for me has been focusing more and more on the difference between the product integrity focused approach to quality that folks in my profession normally focus in on and a more excellence focused approach. The two are not in opposition, but I can’t help feeling that the product integrity exclusiveness of many pharmaceutical quality professionals is holding us back.

This is especially on my mind coming back from ASQ WCQI and thinking about just how few of my pharma colleagues identify with that organization There are a whole host of reasons (including the fact that many people don’t associate with ANY professional association) but I can’t help but contemplate how do we make the excellence side of quality more relevant to not just pharmaceuticals but to wider questions of just what is quality anyway?

I’ve discussed the need to realize that we have different types of domain knowledges, but just what is this domain we call quality and is it truly its own discipline?

Disciplines can be modeled as a system comprising an “activity scope” that is enabled by a “knowledge base” but conditioned by a “guidance framework”.

From Rousseau, et al “A Typology for the Systems Field”
  • The guidance framework typically involves multiple worldviews. The same subject matter can be studied from different worldviews, and the theories around a given subject can be interpreted differently from different worldview perspectives. You can see this in the various flavors of continuous improvement or better yet, the presence of a sustainability push within the society.
  • The knowledge base is the data, theories and methodologies that drive the discipline
  • The activity scope describes the range of activities in a disciple, including the professional practice.

We’re probably truly multi-disciplinarian, in that the we draw from multiple other disciplines, a short list includes: Engineering, Computing, Control Theory, Mathematics, Information Theory, Operations research, system theory, Management sciences, a whole range of social sciences and more than I can think.

What does this mean?

I am more thinking aloud than anything at this point, but I think it’s important to work on developing the QBOK along a guidance framework, knowledge base and activity scope methodology. Then as we develop sub-body of knowledges we drill down from there, either in a very knowledge base way (such as the CMQ/OE) or in an activity scope (like the CPGP). I often feel that the way we develop these are more hit-and-miss and could do with some coherence – the biomedical auditor and hazop auditor are great examples of wanting to meet a very narrow need and thus being very very specific to a small set of the knowledge base.

I guess I’m striving towards applying theory to our practice a little more deliberately.

Some of the technical forums (Human Development and Leadership comes to mind) seem especially designed to pull information from one or two different originating disciplines and adapt it to the knowledge base. I think this process would be added by a coherent understanding of our guidance framework and just what the activity scope we are trying to address as discipline.

In short I am just thinking that a little more coherence, strategy and transparency would aid us as a profession. As I heard in many a conversation last week, we should probably as an organization be better at what we preach.

Sources

  • Bourke, J (2014). On Process Excellence vs. Operational Excellence vs. Business Excellence. BEX Institute.
  • Rousseau, D., Wilby, J., Billingham, J., & Blachfellner, S. (2016). A Typology for the Systems Field. Systema 4(1), 15-47
  • Wageeh, N. A. (2016). The Role of Organizational Agility in Enhancing Organizational Excellence: A Study on Telecommunications Sector in Egypt. International Journal of Business and Management, 11(4), 121