Within the clinical research enterprise, as can be seen elsewhere in business and regulatory landscapes, the terms “quality” and “compliance” often intersect, creating what some feel is a symbiotic relationship crucial for organizational success. However, despite their frequent association, these terms embody distinct philosophies and practices.
Quality is a holistic concept referring to the degree of excellence of a product or service in all aspects that contribute to customer satisfaction, including performance, reliability, durability, and aesthetics. It focuses proactively on meeting or exceeding customer needs, wants, and expectations through diligent process management and continuous improvement and innovation.
By prioritizing quality in clinical research, organizations aspire to enhance their competitive edge, reduce costs through efficient processes, and foster a culture of excellence. Everyone benefits, especially the participants in clinical trials and the ultimate recipients of the data they produce—patients undergoing treatment.
Compliance, on the other hand, is the act of adhering to laws, regulations, and standards by following specifically established internal policies. For clinical researchers, as well as professionals in other industries, it ensures that an organization operates within the legal and ethical boundaries set by regulatory bodies, which are often related to issues of workplace and customer safety.
Compliance is fundamentally reactive; its primary aim is to avoid penalties, legal issues, and reputational damage by strictly following rules and guidelines established by external agencies.
Elements of a Quality Culture
The requirements for both compliance and safety are embedded constructs of a quality culture, and thus are supported by the maturity of an organization’s commitment to quality. In other words, compliance and safety are produced from the implementation of a quality culture because they are derivatives or by-products of a work culture’s stability, due diligence, ethical conduct, and customer awareness.
A quality culture is built upon the foundation of specific attributes or “values,” beginning with the twin anchors of a shared passion for doing things right and the synergy produced by the vocational certainty of its individuals. Vocational certainty refers to the skills, education, diverse experience, and the devotion to improving that a person brings to a team, and more specifically, to their job description. These values are empowered by motivations from the inside out, or “from the heart,” as opposed to what is often described as the drudgery of compliance activities and reporting.
Clinical research is far from the only realm in which people are often misled into thinking that an organization is trying to achieve quality outcomes by its emphasis on compliance activities and safety, when it’s actually all too often more about the mitigation of liability and the avoidance of government regulatory interference. Sadly, resource-intensive compliance efforts that foster the appearance of accountability and ethical behavior can drain the energy of a workplace and distract people from the work processes that produce quality products or services. In this way, “the good”—compliance, becomes the thief of “the best”—quality, and its inherent human and financial benefits.
A Silver Lining
Fortunately, an organization that emphasizes building a quality culture achieves both the benefits of effective process quality and relief from the stress and the mind-numbing compliance mentality of regulatory-driven safety and goodness. As quality guru Philip Crosby once said, “Goodness isn’t good enough.” The goodness of compliance certainly does not produce quality products or services, nor a sustainable organizational path.
Quality management employs two primary concepts or methodologies to achieve its objectives. One of the most common methods is “quality control” (QC), which is accomplished by taking bad things out of a process to prevent errors and defects in products or services from reaching customers. This is done by checking, inspecting, auditing, and similar attempts to “control” the quality of our efforts. The second is “quality assurance” (QA), which is accomplished by putting good things into processes, like reliable materials, equipment, and human resources, to prevent errors and defects from occurring.
QC informs QA on what to do next to improve things with its reports of what went wrong and where, often resulting in relevant cost savings through lower defect rates, reduced rework, and efficient resource utilization—in part, through improvements in employee engagement.
People, Processes, and Tools—All in Their Proper Places
When we speak of solving the problems associated with failures of either quality or compliance, we are essentially talking about the performance of people, their motivations, and the incentives we use to encourage behavior consistent with our corporate goals—a rich topic for discussion in another post.
The necessity of improving the synergies of people, processes, and tools has become an almost constant theme in training programs for clinical researchers and other professionals. However, when we look closely, it appears that the primary effort put forth by industry leaders has been to discover “magical, silver-bullet technologies” that can do two things at once: 1) force people into productive conformance to corporate goals and 2) overcome the problems of employee disengagement and turnover.
Is it possible that our corporate leaders lack the operational knowledge and experience to “fix” the people-based problems that technologies only slightly improve? Or are those pesky, short-term financial incentives interfering with the proper, long-term investments in people and technologies so that the required technologies are supporting a devoted and motivated workforce?
An effective organization is one in which the elements of people, processes, and tools are properly balanced; and where the most essential element is vocationally certain people who have formed a quality culture to effectively implement the processes and tools. When this happens, we can easily achieve both regulatory compliance and quality products or services.
You Can Have it Both Ways
In conclusion, quality is not the same as compliance. Quality and compliance are distinct concepts that play crucial roles in organizational success. Quality focuses on meeting or exceeding customer expectations through continuous improvement and innovation, while compliance ensures adherence to laws, regulations, and ethical standards. Both are essential for building trust, achieving excellence, and mitigating risks.
Submitted by Larry Kennedy, PhD, Executive Director of the Site Accreditation and Standards Institute (SASI) and Founder and CEO of the Quality Management Institute, which offers a Clinical Research Quality Manager credential developed in cooperation with ACRP.
