“A high-performing culture of quality should be firmly in the sights of sponsors of clinical research,” says Leslie Sam, BA, LSS BB, CIQ, president of Leslie Sam and Associates, LLC. “Rewarding critical thinking and open dialogue is critical to the success of high-quality studies and development programs.”
Quality by design (QbD) continues to be vital to compliance with the ICH E8(R1) guideline from the International Council for Harmonization, General Considerations for Clinical Studies. Finalized in October 2021 and adopted by the U.S. Food and Drug Administration (FDA) in April 2022, this guideline introduced a culture of quality and the strategic enablers, critical thinking and open dialogue.
“If asked, most if not all organizations would agree they already have a culture of quality,” Sam says. “In fact, many organizations refer to a ‘culture of quality’ in their publicly available quality policy on their website. However, when questioned, they would be unable to describe how the culture has evolved over time or how they are measuring the effectiveness or impact of the culture of quality. By defining the organization’s vision for the culture of quality and continuously assessing its status, monitoring can then take place to judge the progress and determine the necessary actions to influence the culture of quality.”
A Culture of Quality: Are We Achieving the Desired Impact?
Join Sam at ACRP 2023 [April 28 – May 1; Dallas, TX], where case studies will illustrate how existing quality metrics can be used to monitor an organization’s culture of quality and its impact. View complete schedule.
“A high-performing quality culture—based on established values, traditions, procedures, and expectations that promote continuous quality improvement—should be a goal for all stakeholders,” Sam adds.
“In this culture, employees follow quality expectations,” Sam explains. “They see others taking quality-focused actions, hear others talking about quality, and feel quality all around them. The result is a constant focus on leveraging critical thinking and open dialogue to achieve the quality objectives (patient safety and data reliability) that benefit everyone.”
Author: Jill Dawson