By Judy Carmody, Ph.D., Carmody Quality Solutions, LLC
The U.S. Food and Drug Administration (FDA) cites corporate culture as a root cause of many compliance issues. It also says a strong quality culture “can lead to sustainable compliance.”1 How can pharmaceutical companies encourage a quality culture that empowers employees to own quality, so they operate in ways that allow maximum performance and safe, effective products?
Begin by believing that people are your most valuable asset and that quality is a corporate pillar. Quality must be a shared value throughout the organization: CEO, bench chemist, CMC (chemistry, manufacturing, and controls) director, lab manager, marketing, sales, etc. Maintaining quality is everyone’s job, a team effort. Much is written about how high-performing teams and mutual respect remove the “us vs. them” dynamic. The goal is collaboration and mutual trust – vital for a voluntary QA (VQA) culture.
How To Evaluate Your Current Quality Culture
Achieving a VQA culture first requires you to assess and measure what people think about quality. It begins with these questions:
1. Do people feel safe talking about quality issues? Amy C. Edmondson, Novartis Professor of Leadership and Management at Harvard Business School, defined psychological safety as a “shared belief held by members of a team that the team is safe for interpersonal risk-taking.”2 Does the team have “a sense of confidence that the team will not embarrass, reject or punish someone for speaking up”? Do people take risks, ask questions, or communicate mistakes without feeling as if they will be chastised? Does quality help promote a climate characterized by trust and respect?
2. Does the quality organization act like a coach or a cop? Have people clearly engrained in their daily activities the “whys” of quality, or do they see it as a mandatory part of their job, perhaps even one they resent? Do people know what procedures to follow? Do training programs allow people to learn and understand the roadmap so they can navigate it properly? Is training and education ongoing and comprehensive? Is the quality organization more interested in helping people resolve issues or affixing blame?
3. Do you spend more time on fire prevention or on firefighting? Is more time invested in dealing with noncompliance issues than in training and educating employees? Do employees feel equipped to address quality issues? Does the quality organization clearly inform employees about how to remain compliant and what actions to take when concerns arise? Are there clear channels of communication? Do people know when and how to elevate issues?
4. Does quality matter for people in their daily activities? Do employees know how quality fits into their daily roles? Do they understand, and can they articulate, the quality mission? Is there commitment from company leadership, or is quality merely a mysterious and vague notion, always hovering above people and descending upon them without just cause? Is quality seen as an ongoing process — continuous quality improvement (CQI) — or just a rigid control of enforcement for enforcement’s sake?
At its core, a VQA culture involves trust, collaboration, and ownership among many people and departments so that they:
- Know, understand, and accept their role in maintaining quality,
- Always perceive quality in a proactive, positive manner,
- Feel safe and empowered to speak up when they believe issues exist, and
- Know how to escalate issues to proper personnel and help provide potential solutions.
Quality is not what you must do, but rather what we can do as a team, as a company. Collaboration, communication, and cooperation build trust and provide a better understanding and acceptance of quality. The shared mission is to remain compliant and remain sane, rejecting knee-jerk, short-term fixes that (more often than not) create more serious long-term compliance issues than they solve.
The Pillars Of A Voluntary QA (VQA) Culture
Four pillars form the basis of a VQA culture. They consistently build collabortive and productive environments in which people feel ownership and feel valued. In addition, employees develop satisfaction and achievement by developing institutional knowledge and continuous improvement so they perform at a higher level.
Pillar #1: Proper Education and Training
Training is an investment in your company’s long-term success. It makes employees more efficient and more likely to identify and raise issues. Nearly 80% of all compliance issues can be addressed with proper training.
A robust training program that is part of new-employee orientation, as well as ongoing quarterly sessions (i.e., lunch and learns, interactive training sessions, special guest seminars, or post-mortem training) communicate how seriously an organization takes quality. It can also include examining “near-misses” or holding mock audits (similar to surprise inspections) as ways to offer real-life examples from which people can learn.
During a mock audit, a chemist, when asked for his CV (curriculum vitae), suspiciously replied, “Why do you need my CV?” What he really said was, “You don’t trust me, so why should I trust you?” He was clearly unaware that having CVs of existing chemists (not just his but everyone’s in the lab) provides necessary documented evidence to an auditor that the company has qualified individuals who are properly educated/trained to conduct the required work. Explaining this in a group setting provided a perfect training moment.
Pillar #2: Structured Quality Expectations
Setting specific and measurable expectations allows people to know what to anticipate, leaving no room for interpretation. Being clear on expectations makes goals, objectives, and critical success obvious and well-defined to everyone.
Invest time up front to train and educate staff so they understand processes and procedures. Education — i.e., helping people understand the “why” rather than enforcing the “how” — helps people to engage with and understand quality. Start with the strong list of requirements that everyone must meet so there is a buy-in on how to meet them specifically, and you help shape a process that has consensus. Focus on the what, as well, but get a group to work on the how together.
Pillar #3: Accountability
Developing well-written standard operating procedures (SOPs) with clearly defined roles and responsibilities can lay the groundwork for building an accountable working environment. Such an approach helps people understand expectations for their specific roles and where they fit into the overall company mission of maintaining compliance. Once established, quality can then help people feel empowered and responsible.
Nothing is more empowering than employees feeling responsible for their own work and actions. Accountability can ensure performance. It provides employees the freedom to speak up and identify issues before they become crises. People take ownership, want to succeed, and have a desire to develop and work within reliable processes and procedures. And when issues arise, the quality team is in a better position to work with the group and focus on finding solutions rather than affixing blame.
Pillar #4: Collaboration not Confrontation
Collaboration is a key factor to ensure value, because there is more inherent trust and confidence when people work together. Quality departments must foster openness and information sharing in order to raise their profile, confidence, and trust among employees. When the quality staff operates as a team coach, rather than an officer “enforcing the law,” people better understand and accept the role and responsibility they play in quality. And, they perceive quality as a trusted resource that can help them be more effective. Collaboration can help improve compliance and performance — while reducing delays, waste, and redundancy.
Achieve Lasting Change
The mission is to get people to own quality. In a VQA culture, all employees have ownership and responsibility for exercising quality in their tasks and activities. Everyone has a stake in quality, success, and working together to continuously improve it.
Building a VQA culture through building better teams is the best way to create lasting change and to build a high-performance organization with strong levels of collaboration, trust, and accountability.
“Alone we can do so little; together we can do so much.”
- Helen Keller
- Friedman, Richard L., Current Expectations for Pharmaceutical Quality Systems (presentation), PDA/FDA Executive Management Workshop, Sept. 2012.
- Edmondson, Amy, “Psychological Safety and Learning Behavior in Work Teams”, Administrative Science Quarterly, June 1999.
About the Author:
Judy Carmody, Ph.D., is the founder and principal consultant of Carmody Quality Solutions, LLC, based in the Boston area. With 20+ years of expertise driving vision in operations, quality assurance, control, systems, validation, and analytical development, she has a reputation as a quality turnaround specialist in the pharmaceutical and biotechnology industries. Find her on LinkedIn.