Building Maturity and Resilience Through Quality Culture

The U.S. Food Drug Administration’s (FDA) Quality defines Management Maturity (QMM) as the “state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement” (1,2).

FDA’s Center for Drug Evaluation and Research actively promotes a QMM program, whose goals are fourfold (3):

1. Foster a strong quality culture mindset.
2. Recognize establishments that have advanced quality management practices and acknowledge establishments that strive to continually improve quality management practices.
3. Identify areas where quality management practices can be enhanced and provide suggestions for growth opportunities.
4. Minimize risks to product availability to ensure reliable market supply.

Note that a “strong quality culture mindset” is listed as the first goal, but the term itself can be somewhat abstract in nature. This begs several questions:

• What does a strong quality culture mindset mean?
• How can it be influenced and maintained?
• Why invest time in fostering a strong quality culture?

How is a Quality Culture Defined?

In a recent Forbes article, a company culture was defined as being “about the shared norms, values, attitudes and practices that form the collective identity of your company” (4). FDA further defines a quality culture as “an environment in which those who have responsibility for oversight and control over manufacturing take ownership of quality.” Furthermore, a quality culture is foundational for QMM.

In essence, a quality culture is the secret sauce for the team. It helps to establish the moral compass guiding everyone to do the right thing, even when no one is looking. It demonstrates that there is a symbiotic relationship between business and quality objectives. Simply put, when asked, “Who owns quality?” the prevailing and instinctive response from everyone in the organization is, quite candidly, “I own quality.”

In reality, however, every operating company has its own subtle interpretation of a quality culture and the quality culture in each organization is unique—no two are alike. Even within the same parent company, individual operating pharmaceutical companies might have subtle differences in their quality management systems, sometimes influenced by fundamental factors such as geographical location, local regulatory requirements, types of activities, professional practices and social norms. Thus, understanding quality culture—including what makes people comfortable and uncomfortable to share or learn—and how to continuously shape it is essential to building a reliable organization that can maintain performance during expected and unexpected supply chain disruptions.

Maintaining a Positive Company Culture

Here are some tips on influencing a positive and sustainable company culture:

• Define the company’s quality culture and ensure everyone is aligned on its purpose, mission and vision. Paraphrase key ideas of culture and do not underestimate the power of social influence. Culture takes hold when people express the key ideas in their own words and implement the appropriate behavior in their own ways. Quality culture also gains strength from mutual reinforcement, thus seamlessly allowing the culture to become ingrained in operations.
• Lead by example and live the culture: Everyone has heard the term “walk the talk,” but as part of living the culture, it is essential to stay informed and stay connected. If leaders and colleagues are seen to take actions that promote a positive company culture—thoughtful, public and permanent—they tend to encourage others to do the same.
• Communicate: A critical aspect of a reliable quality culture is the communication of errors and the availability of a structured forum for reporting, discussing and identifying preventive solutions for such errors. If colleagues do not know how to learn from mistakes, they are unlikely to notice or correct many of their own. If, however, the organization invests in improving its ability to conduct thorough after-action reviews of what went wrong and how to implement the lessons learned, errors are more likely to be noticed, reported and, ultimately, addressed. Candid reporting of errors requires creating a safe environment and an open forum that is built on trust and trustworthiness. Some useful tools to empower employees to speak up include
• Establishing cultural committees to proactively seek feedback
• Conducting anonymous surveys to take the pulse of the entire organization and encourage feedback through newsletters and town halls
• Examine how feedback is managed: As detailed in Section 2.6(a) of the International Council for Harmonization’s Quality Guideline Q10: Quality Pharmaceutical Systems: “Senior management should be responsible for pharmaceutical quality system governance through management review to ensure its continuing suitability and effectiveness” (5). Feedback and perceptions of its importance are affected by whether they have any effect. It is important to ensure an open and transparent feedback loop, where colleagues can be assured that feedback is not only reviewed but also responded to. Such an environment nurtures the active pursuit of quality-focused actions by tapping into the operators' knowledge. This, in turn, makes quality and a quality culture intrinsic to their daily activities and complementary to driving an effective and efficient management review process. It encourages informed decision-making by proactively identifying areas for enhancement based on trend data and on “what went well/areas for improvement” during the review period to adapt to changing market dynamics and regulatory standards.
• Treat quality culture competency as an investment in the organization’s resilience. Ensure that it starts at the hiring phase by defining critical skills in the job description and by ensuring new hires fit the organization's culture. Competency progression starts at hiring and onboarding but needs to continue through continuous training initiatives, including patient stories and testimonials. It is rare for a candidate at the hiring phase to have every skill and competency desired, but a good approach might best be summarized as “Hire for Attitude, Train for Skills.” Skills can always be taught, but attitudes and values are often deeply rooted, making them much harder to change. Furthermore, ensure cultural leadership capabilities are factored into succession planning and senior management recruitment—do not assume those capabilities are inherent to longevity of service.
• Strong training program is foundational to an active quality culture, and a key indicator of its effectiveness is when it focuses on ensuring people are educated in proactive quality risk management, understand patient safety risks, and recognize how their performance directly impacts patient safety. This helps employees recognize missed steps and the risks associated with quality issues and empowers them to stop production as needed, confident that those decisions are always patient-centric. Conversely, a red flag for an organization is its tolerance or acceptance of late/overdue training, as this indicates a lack of attention to competency levels—thus potentially hindering employees from making patient-safety-based decisions. In the regulated pharmaceutical industry, it is mandatory to follow quality guidelines, such as good manufacturing practices (6).
• Encourage teamwork and collaboration, while often understated, they are essential to building a strong company culture of quality. Employees who work collaboratively experience not only increased productivity but also strengthened relationships with their coworkers, leading to a more connected and cohesive culture (4). A strong quality culture is one in which everyone in the organization is responsible for quality; however, “to achieve the desired culture, everyone must have a clear, consistent, and common understanding of it — and everyone must work together in a deliberate, coordinated effort to cultivate it. While each person or group is accountable in their own way, everyone shares accountability for achieving the desired culture” (7).
• Recognize and reward employees for their hard work, commitment and dedication. These can be maximized for effectiveness by aligning the company’s core values and culture with the behaviors and actions that need to be promoted, communicated and celebrated. Companies with an effective reward and recognition program are mindful of demonstrating and communicating what goals were accomplished and emphasizing how they were accomplished.
• Ensure a consistent interpretation of the term “near miss.” Does everyone in your organization have the same understanding of a near miss? And are near misses discussed in an open forum when they occur? Does your organization interpret a near miss as a sign that your system’s safeguards are working or as a sign that the system is vulnerable? Embracing and learning from mistakes and near misses is crucial to understanding what worked and what did not so risk-reducing, quality-focused actions can be identified and implemented.
• Pursue the anomalies without hesitation or be fearful of the outcomes. Ask colleagues, “Have you noticed anything different?” “Is there any atypical variation?” Create an inclusive and open environment or forum to evaluate and discuss the observations and actions taken. Be clear on “objective evidence.” What is the difference between opinion-based and objective evidence? Ensure reporting is standardized, with tools built in to prompt for evidence, such as the standards used, statistical techniques and the design of experiments.

Why invest the time in fostering a quality culture as the bedrock to QMM

“QMM assessments focus on evaluating if a culture of quality exists at the establishment and how this mindset is reflected in the quality practices employed. QMM is NOT an additional burden or requirement. It is, in fact, integral to an establishment’s quality system” (3). Thus, an organization that perceives QMM as a wise investment to enable a reliable supply chain and promote an engaged and committed culture is immediately on a path to success for the following reasons:

• Business savvy: Manufacturing issues and quality defects in finished products are typically the main culprits of drug shortages or supply disruptions. An active quality culture results in fewer mistakes and fewer repeat issues attributed to human error. Cost avoidance in the business can be quantitatively measured through metrics such as reductions in defect rates, deviations, increased yields and, of course, the human capital element through staff retention. Lastly, the immeasurable cost that can be incurred when a company’s reputation or brand reliability is impacted cannot be forgotten.
• Enabler to high levels of QMM: While QMM includes an array of inputs—metrics, leadership commitment to quality, business continuity, communication and collaboration, customer experience, sustainable compliance, enhanced pharmaceutical quality system, advanced analytics, employee ownership and engagement, continual improvement, risk management, process optimization, manufacturing strategy, operations and productivity optimization)—fostering a quality culture is essential to achieving sustained QMM, employee engagement and motivation and can be more aligned with resilience (1).

Patients and consumers deserve confidence in the availability and continuity of medicinal products and as noted in a Harvard Business Review article, “In an environment where customers’ tolerance for quality problems is declining, a workforce that embraces quality as a core value has a significant competitive advantage” (8).

The Path to a Strong Quality Culture

Pharmaceutical organizations that are continuously improving embrace maintaining a strong quality culture as an ongoing, evolving activity with long-term benefits, such as enabling the optimization of manufacturing process performance and product quality, enhancing supply chain reliability and fostering an engaged and motivated workforce.

References

1. Kopcha, Michael. 2022. The Future of Quality Management Maturity. U.S. Food and Drug Administration, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research. Quality Management Maturity Workshop, May 24-25, 2022. https://www.fda.gov/media/166244/download.
2. U.S. Food and Drug Administration, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research. 2022. Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals (OPQ White Paper). March 2022. https://www.fda.gov/media/157432/download.
3. U.S. Food and Drug Administration. 2023. CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development. Silver Spring, MD: Food and Drug Administration. https://www.fda.gov/media/171705/download.
4. O’Reilly, Dennis. 2025. “What Is Company Culture? Definition and Development Strategies.” Forbes Advisor. Sept. 12. https://www.forbes.com/advisor/business/company-culture/.
5. International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 2008. Quality Guideline Q10: Pharmaceutical Quality System. Geneva, Switzerland. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf.
6. Richey, Londa. 2025. “How the Quality Culture Impacts GMP Activity.” Pharmalex Talks, Episode 16. Pharmaceutical Online. https://www.pharmaceuticalonline.com/doc/how-the-quality-culture-impacts-gmp-activity-0001.
7. Yohn, Denise Lee. 2021. “Company Culture Is Everyone’s Responsibility.” Harvard Business Review. Feb. 8. https://hbr.org/2021/02/company-culture-is-everyones-responsibility.
8. Srinivasan, Ashwin, and Bryan Kurey. 2014. “Creating a Culture of Quality.” Harvard Business Review. April, Vol. 92(4), pp. 23-25. https://hbr.org/2014/04/creating-a-culture-of-quality.