The Impact of Quality Culture on Operational Performance-An Empirical Study from the Pharmaceutical Industry.

Quality culture as an enabler of high-quality performance and subsequently as a source of competitive advantage is increasingly discussed among operational excellence (OPEX) and quality executives. Research studies indicate an impact of quality culture on performance, especially on the success of quality improvement programs, such as Total Quality Management initiatives. A continual challenge in quality culture research, however, remains the lack of practical and accepted metrics to assess culture. In 2014, the Parental Drug Association (PDA) conducted a quality culture survey within the pharmaceutical industry. The results indicate a positive and significant correlation between quality (culture) behavior of a production site's employees and quality (system) maturity, which represents the maturity of the quality system in place. As the maturity of the quality system is more comfortable to assess by objective criteria, the positive correlation between quality (culture) behavior and quality (system) maturity may be exploited by using the latter as an indicator for quality culture. This paper confirms this positive relationship by exploring the comprehensive St. Gallen OPEX database for pharmaceutical production plants. Furthermore, data analysis shows that high-performing production sites, regarding timely provision of high-quality drugs, reveal a higher level of both quality (system) maturity and quality (culture) behavior than low-performing sites.