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)

John Oliver on Medical Devices

I firmly believe that quality and ethics go hand-in-hand, and frankly it shakes some of my confidence on my profession when I read of organizations that supposedly subscribe to quality principles and standards (such as the ISOs) still not meeting the grade.

There are four widely accepted principles in biomedicine, which applies equally to medical devices and pharmaceuticals:

  • Principle of respect for autonomy
  • Principle of nonmaleficence
  • Principle of beneficence
  • Principle of justice

It seems a failure of ISO 13458 that adherence to this quality standard does not lead to results aligned to these four principles. It should surprise no one who knows me that this is one of the reasons I support strong regulations in this space.

Sources

  • Beauchamp T, Childress J. Principles of Biomedical Ethics, 7th  Edition. New York: Oxford University Press, 2013

Quality and Ethics are Inseparable

There is a strong correlation between quality and ethics. Leadership’s demonstration of their philosophy and practice of ethical behavior impacts the whole organization in education, government or commercial enterprises

Dennis Sergent, The Ethics of Quality. The W. Edwards Deming Institute Blog

Quality is a management methodology, a set of ethics and a grab-bag of technical skills and tools (many of which are not unique to quality).  Dennis Sergent does a good job riffing off of Deming’s Code of Professional Conduct, and in light of my recent post “Being a Quality Leader” I wanted to briefly talk about how leadership is perhaps the most effective lever in producing an ethical organization.

There are three major parts of ethical leadership:

  1. Conscientiousness
  2. Moral identity
  3. Cognitive moral development, meaning how sophisticated one’s thinking is about ethical issues

Ethics and Quality are hand-in-hand. You cannot create a quality product if you do not have an ethical framework. I often think this is a part of Deming’s message that has been lost.

When things go seriously bad

An owner and four former employees of a now-shuttered Framingham compounding pharmacy were convicted Thursday of federal charges related to a 2012 meningitis outbreak that’s killed more than 100 people who took tainted drugs made at the facility, authorities said.

Travis Anderson “5 people convicted of federal charges in Framingham compounding pharmacy case” Boston Globe (2018)

To say that the crimes of the  New England Compounding Center have changed the very regulations for compounding pharmacy in this country is no overstatement. For those of us in other  regulated industries, and for those in quality in other fields, this is an important case to reflect on.

According to prosecutors, pharmacists “knowingly made and sold numerous drugs” in an unsafe manner. “The unsafe manner included, among other things, the pharmacists’ failure to properly sterilize NECC’s drugs, failure to properly test NECC’s drugs for sterility, and failure to wait for test results before sending the drugs to customers. They also approved the use of expired drug ingredients, and the mislabeling of those drugs in order to deceive customers.”

Travis Anderson “5 people convicted of federal charges in Framingham compounding pharmacy case” Boston Globe (2018)

It is important to reflect that we in Quality, that everyone in our industries, has a commitment to the health and well-being of our customers that is nothing less than a moral imperative. That the imperative question for us and our organizations is always “Have I done enough to ensure the best quality and safety.”

There have now been 11 employees or executives of the drug compounding company convicted of ignoring safety precautions and forging documents to allow contaminated drugs to be manufactured and shipped.

Shira Schoenberg “Former compounding center employees convicted in deadly meningitis outbreak ” Boston Business Journal (2018)

Prominent Doctors Aren’t Disclosing Their Industry Ties in Medical Journal Studies. And Journals Are Doing Little to Enforce Their Rules

Prominent Doctors Aren’t Disclosing Their Industry Ties in Medical Journal Studies. And Journals Are Doing Little to Enforce Their Rules
— Read on www.propublica.org/article/prominent-doctors-industry-ties-disclosures-medical-journal-studies/amp

People need to realize the only way to truly build trust is through transparency. If there is nothing to hide, don’t hide it.