Stephan Köhler

In pharmaceutical companies, it is universally understood that a robust Pharmaceutical Quality System (PQS) provides key elements of assurance and oversight for pharmaceutical manufacturing and quality control laboratory processes. However, despite recent advances in the manufacturing sector, quality issues remain a frequent occurrence. The research shows that a high degree of PQS Effectiveness is accompanied with a high level of Cultural Excellence.

This report presents the findings from three years of Quality Metrics Research and builds on seminal outcomes from earlier operations and quality management research, e.g. Voss et al. (Voss, Blackmon, Hanson, & Oak, 1995), Ferdows and De Meyer (Ferdows & De Meyer, 1990), Deming (Deming, 1986). The work undertaken in year 3 has deepened the insights and enhanced the models developed in the first two years of Quality Metrics Research by the University of St.Gallen (Friedli, Köhler, Buess, Basu, & Calnan, 2017, 2018). The following main results are highlighted below and are further described in more detail in this report in the relevant chapters noted.