Driving for Mature Quality Organizations – FDA recent perspective

Theresa Mullin, FDA’s Associate Director for Strategic Initiatives for the Center for Drug Evaluation and Research recently gave a presentation “Update from FDA CDER” at GMP by the Sea (I need to go to that that some-year).

As in other FDA presentations this presentation summarized the Quality Metrics Research Final Report by the University of St. Gallen as the appropriate steps to ensure quality maturity:

Optimized set-up and cleaning procedures are documented as best practice process and rolled out throughout the whole plant.
A large percentage of equipment on the shop floor is currently under statistical process control.
For root cause analysis, the firm has standardized tools to get a deeper understanding of the influencing factors for problems.
Goals and objectives of the manufacturing unit are closely linked and consistent with corporate objectives and the site has a clear focus.
Manufacturers have joint improvement programs with suppliers to increase performance.
All potential bottleneck machines are identified and supplied with additional spare parts.
For product and process transfers between different units or sites,standardized procedures exist that ensure a fast, stable and compliant knowledge transfer.
Charts showing the current performance status such as current scrap rates and current up times are posted on the shop floor and visible for everyone.
The firm regularly surveys customers’ requirements.
The firm ranks its suppliers and conducts supplier qualifications and audits.

This are some pretty low hanging fruit. They are also the pretty necessary in any organization, not just pharmaceuticals.

There was also a little discussion on the use of Q10 that really makes me wish I had been there to hear exactly what was said. I hope it was “Just freaking implement it already.”

In general, useful slides, I recommend going and checking them out.

Overcoming Subjectivity in Risk Management and Decision Making Requires a Culture of Quality and Excellence

Risk assessments, problem solving and making good decisions need teams, but any team has challenges in group think it must overcome. Ensuring your facilitators, team leaders and sponsors are aware and trained on these biases will help lead to deal with subjectivity, understand uncertainty and drive to better outcomes. But no matter how much work you do there, it won’t make enough of a difference until you’ve built a culture of quality and excellence.

The mindsets we are trying to build into our culture will strive to overcome a few biases in our teams that lead to subjectivity.

Bias Toward Fitting In

We have a natural desire to want to fit in. This tendency leads to two challenges:

Challenge #1: Believing we need to conform. Early in life, we realize that there are tangible benefits to be gained from following social and organizational norms and rules. As a result, we make a significant effort to learn and adhere to written and unwritten codes of behavior at work. But here’s the catch: Doing so limits what we bring to the organization.

Challenge #2: Failure to use one’s strengths. When employees conform to what they think the organization wants, they are less likely to be themselves and to draw on their strengths. When people feel free to stand apart from the crowd, they can exercise their signature strengths (such as curiosity, love for learning, and perseverance), identify opportunities for improvement, and suggest ways to exploit them. But all too often, individuals are afraid of rocking the boat.

We need to use several methods to combat the bias toward fitting in. These need to start at the cultural level. Risk management, problem solving and decision making only overcome biases when embedded in a wider, effective culture.

Encourage people to cultivate their strengths. To motivate and support employees, some companies allow them to spend a certain portion of their time doing work of their own choosing. Although this is a great idea, we need to build our organization to help individuals apply their strengths every day as a normal part of their jobs.

Managers need to help individuals identify and develop their fortes—and not just by discussing them in annual performance reviews. Annual performance reviews are horribly ineffective. Just by using “appreciation jolt”, positive feedback., can start to improve the culture. It’s particularly potent when friends, family, mentors, and coworkers share stories about how the person excels. These stories trigger positive emotions, cause us to realize the impact that we have on others, and make us more likely to continue capitalizing on our signature strengths rather than just trying to fit in.

Managers should ask themselves the following questions: Do I know what my employees’ talents and passions are? Am I talking to them about what they do well and where they can improve? Do our goals and objectives include making maximum use of employees’ strengths?

Increase awareness and engage workers. If people don’t see an issue, you can’t expect them to speak up about it.

Model good behavior. Employees take their cues from the managers who lead them.

Bias Toward Experts

This is going to sound counter-intuitive, especially since expertise is so critical. Yet our biases about experts can cause a few challenges.

Challenge #1: An overly narrow view of expertise. Organizations tend to define “expert” too narrowly, relying on indicators such as titles, degrees, and years of experience. However, experience is a multidimensional construct. Different types of experience—including time spent on the front line, with a customer or working with particular people—contribute to understanding a problem in detail and creating a solution.

A bias toward experts can also lead people to misunderstand the potential drawbacks that come with increased time and practice in the job. Though experience improves efficiency and effectiveness, it can also make people more resistant to change and more likely to dismiss information that conflicts with their views.

Challenge #2: Inadequate frontline involvement. Frontline employees—the people directly involved in creating, selling, delivering, and servicing offerings and interacting with customers—are frequently in the best position to spot and solve problems. Too often, though, they aren’t empowered to do so.

The following tactics can help organizations overcome weaknesses of the expert bias.

Encourage workers to own problems that affect them. Make sure that your organization is adhering to the principle that the person who experiences a problem should fix it when and where it occurs. This prevents workers from relying too heavily on experts and helps them avoid making the same mistakes again. Tackling the problem immediately, when the relevant information is still fresh, increases the chances that it will be successfully resolved. Build a culture rich with problem-solving and risk management skills and behaviors.

Give workers different kinds of experience. Recognize that both doing the same task repeatedly (“specialized experience”) and switching between different tasks (“varied experience”) have benefits. Yes, Over the course of a single day, a specialized approach is usually fastest. But over time, switching activities across days promotes learning and kept workers more engaged. Both specialization and variety are important to continuous learning.

Empower employees to use their experience. Organizations should aggressively seek to identify and remove barriers that prevent individuals from using their expertise. Solving the customer’s problems in innovative, value-creating ways—not navigating organizational impediments— should be the challenging part of one’s job.

In short we need to build the capability to leverage all level of experts, and not just a few in their ivory tower.

These two biases can be overcome and through that we can start building the mindsets to deal effectively with subjectivity and uncertainty. Going further, build the following as part of our team activities as sort of a quality control checklist:

Check for self-interest bias
Check for the affect heuristic. Has the team fallen in love with its own output?
Check for group think. Were dissenting views explored adequately?
Check for saliency bias. Is this routed in past successes?
Check for confirmation bias.
Check for availability bias
Check for anchoring bias
Check for halo effect
Check for sunk cost fallacy and endowment effect
Check for overconfidence, planning fallacy, optimistic biases, competitor neglect
Check for disaster neglect. Have the team conduct a post-mortem: Imagine that the worst has happened and develop a story about its causes.
Check for loss aversion

Burnout Needs a Systematic fix

It is more like being involved in a complicated love affair. One minute it’s thrilling, passionate, engaging. The next, it’s exhausting and overwhelming, and I feel like I need a break.
— Read on hbr.org/2019/07/when-passion-leads-to-burnout
Jennifer Moss, When Passion Leads to Burnout. HBR

It is the responsibility of leaders “to keep an eye on the well-being of their staff.” Organizations whose staff feel unmotivated due to stress and burnout cannot aspire to achieve a culture of excellence. Our systems need to be designed to eliminate the root cause for stress and burnout.

Five mechanisms can be leveraged to improve organizational system design: 1) Eliminate organizational issues related to roles, responsibilities and authorities of employees, 2) establish a policy of transparency and effective “bottom-up” internal communication channel to permit employee contribution and recognition, 3) establish criteria for resource distribution, 4) establish a commitment to identify needed training and provide resources for the purpose and 5) establish a systemic feedback loop for analysis and improvement of employee motivation based on periodic measurement of employee motivational levels.

If employees know exactly what their tasks are, without sustained overload, with necessary resources and competence, and recognition for the task well performed, there will be no major system-induced reason for demotivation.

This gets to the heart of Deming’s use of psychology in his System of Profound Knowledge. Lean calls it Respect-for-People. This is all about ensuring our organizations are healthy places to work and thrive.

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.

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 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
Committed to excellence, ethics, and doing things right	Lack 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 people	Unclear roles and responsibilities and little interest in fully utilizing and developing the capabilities and potential of people
Positive, can-do work environment	Negative, tense, stressful, and/or resistant work environment
Open, candid, straightforward, and transparent communication	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.

ISPE’s Six dimensions of cultural excellence framework

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

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)