Cultivating a Culture of Quality


Insights from Clinical Quality Oversight Forum.

At the heart of every successful organization lies a robust and adaptive culture, a direction The International Council for Harmonization (ICH) and FDA have moved toward in the past few years through their guidance documents. Momentum Events' Clinical Quality Oversight Forum sought to emphasize this, shedding light on the importance of fostering a "Culture of Quality" within biopharmaceutical enterprises through its panel discussion, led by Jonathan Rowe, principal, head of R&D quality, operations and risk management at ZS, Jacalyn Vander Ploeg, senior director, culture of quality at Bristol Myers Squibb, and David Fryrear, EVP, head of quality assurance at Astellas. This concept is about compliance with rules and regulations and emphasizes trust, dialogue, and critical thinking among all stakeholders.

The concept of a "culture of quality"

A "culture of quality" is more than just a buzzword. Its philosophy permeates every aspect of a business, from its people to its processes. Quality should not be viewed as a cost but as an investment. A strong culture of quality encourages companies to deliver exceptional clinical trial results, including patient safety, operational excellence, and data quality, earning the trust of patients and regulators alike.

"Quality is not just a department or a person. It's not just the VP of quality; it's not just the director of quality; it's not just the quality engineer. It's everyone's responsibility," said Fryrear during the panel.

The role of leadership in cultivating a culture of quality

Leaders play a crucial role in cultivating a culture of quality. They must create an environment that fosters open dialogue and encourages employees to voice their ideas and concerns without fear of reprisal. Ploeg highlighted this concept, "A leader's role is to create psychological safety so that people can have those types of challenging conversations without repercussion."

Ploeg noted that creating a quality culture requires a "top-down" approach, with leadership setting the tone. Ploeg explained, "Quality culture starts at the top. The board sets it, it's set by the CEO, and it's lived by the leadership."

Encouraging dialogue and critical thinking

The panel emphasized the importance of dialogue and critical thinking in fostering a culture of quality. As Ploeg noted, "Measuring a healthy culture isn't just about quantifying the number of conversations. It's about capturing the essence of that culture through effective dialogue and critical thinking, these are the key elements to return to when assessing the health of a company's culture."

To truly cultivate a culture of quality, organizations need to encourage dialogue and critical thinking at all levels. Doing so can foster a sense of trust and mutual respect among their employees.

The culture of quality in small companies

The discussion also touched on smaller companies' challenges in cultivating a quality culture. Formal roles may not be necessary for a small company to drive a quality culture. Instead, someone passionate about quality can take on an informal role as a quality ambassador, raising awareness and discussions around quality. "In certain situations, someone may naturally adopt an informal role within a group. This usually happens when an individual is passionate about something and takes the initiative, even without an official title or designation," Ploeg suggested.


Cultivating a culture of quality is not a universal solution. It necessitates a bespoke approach that mirrors a company's unique context, requirements, and values. This culture is essential for both large corporations and small companies. It's about constructing an environment where quality is everyone's responsibility, promoting open dialogue, encouraging critical thinking, and fostering trust among all stakeholders.

The Clinical Quality Oversight Forum offered invaluable insights into the importance of a culture of quality, accentuating the role of leadership and the value of dialogue and critical thinking. It emphasized that a culture of quality is not solely about adhering to standards but also about nurturing a work environment that encourages all employees to contribute towards the company's quality objectives.

Check out Momentum Events’ upcoming GCP Inspection Readiness Conference, a hybrid event taking place December 4-6, 2023 in Philadelphia, PA.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and regular contributor to Applied Clinical Trials.

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