Achieving a Culture of Quality in Pharmaceutical Biostatistics: One Approach to Achieving Quality Deliverables.

Abstract

Biostatistics units within the pharmaceutical industry are faced with the challenge of increasing productivity, reducing costs, and accelerating timelines while at the same time maintaining high quality. This paper describes how the global biostatistics unit in one company is addressing this challenge by nurturing a "culture of quality" to engage frontline staff responsible for daily deliverables. The approach ties together the measurement, improvement, and maintenance of quality, thus inviting staff to understand their role in achieving quality deliverables. Appointment within the operations unit of a quality lead, who is responsible for quality oversight, further increases visibility and contributes to the culture. Measurement is addressed through the use of a quarterly quality report card in which quality-related metrics are consolidated and tracked over time. Trends and outliers are explored. Through established process improvement practices, a Lean Sigma team tackles select high-value processes. Quality is maintained through continuous feedback loops driven by formal quality assurance audits and logs of lessons learned. This paper first considers how to define quality in this context; then addresses the sometimes disjointed areas of measurement, improvement, and maintenance; and ultimately ties them together to drive a culture of quality.