Thomas Friedli, University of St.Gallen, Paul Buess, University of St.Gallen, Stephan Köhler, University of St.Gallen, Cylia Chen-Ooi, Amgen, Steven Mendivil, Amgen, and Denyse Baker, PDA | Oct 01, 2018
The following is a summary of a study published in the September/October issue of the PDA Journal of Pharmaceutical Science and Technology.
After many discussions within various facets of the pharmaceutical industry over the last three years, it became apparent that quality
culture is increasingly considered a competitive advantage by operational excellence (OPEX) and quality executives. Recent research indicates the positive impact of quality culture on a broad range of performance indicators, especially on the success of quality improvement
programs. Currently, however, a shared understanding of quality culture, as well as practical and accepted metrics for assessing quality
culture, is lacking.
In 2014, PDA conducted a survey on quality culture in the pharmaceutical industry. Based on this data, quality culture was assessed in a
later survey by distinguishing quality system maturity from quality culture behavior (1).
The former focuses on objective characteristics of a
quality system that can be verified upon inspection. In contrast, the latter aims to assess employee behavior at the site/organization associated with a strong quality culture, such as open communication and engagement. The later survey looked at whether there is a positive
relationship between quality system maturity and quality culture behavior. If so, assessing the maturity of a quality system might serve as
a surrogate indicator for quality culture behavior, which is comparably difficult to assess with reasonable effort. Statistical regression line
analysis between composed quality system maturity and quality culture behavior scores revealed a positive correlation, thus supporting
quality system maturity as a proxy of quality culture behavior.
Since 2016, the Institute of
Technology Management at the University of St. Gallen, Switzerland, has been conducting a long-term
research project on quality metrics,
financed by the U.S. FDA. In the course of the project, the team integrated quality culture into the
research scope. For operationalizing quality culture as a precondition for statistical analysis, the St. Gallen team adopted a two-sided perspective on quality culture (1).
The quantitative research is based on the comprehensive St. Gallen OPEX database, consisting of more
than 350 pharmaceutical production sites. The database consists of a broad range of performance metrics, along with so-called enablers,
from several pharmaceutical companies worldwide.
The paper “The Impact of Quality Culture on Operational Performance – An Empirical Study from the Pharmaceutical Industry,” available in the September/October
PDA Journal of Pharmaceutical Science and Technology,
summarizes the essential findings of this quality
culture research. First, the research team retested the relationship between quality system maturity and quality culture behavior documented in 2015. This required the research team to operationalize both categories by matching the enabler from the OPEX database to
the PDA definition. A regression analysis documents a strong positive correlation between both categories, substantiating prior findings.
Second, the paper links the discussion of quality culture to performance outcomes. The team formulated the hypothesis that sites with
a high capability of delivering high-quality drugs in the right amount and at the right time also demonstrate a significantly higher level
of quality culture. A t-test analysis supports this assumption. Sites with high performance regarding quality and delivery reveal a significantly (p-value =.05) higher level of quality culture compared to sites with low performance.
The paper contributes to the ongoing discussion on quality culture. It confirms a positive correlation between improvements of the quality system maturity and the actual quality behavior of the employees. Further research might focus on identifying those elements of the
quality system that have a comparably strong impact on quality behavior.
, the paper links quality culture, which is considered
an enabler, to performance outcomes. The analysis indicates that investments in quality culture, including both the quality system and
is positively associated
with long-term benefits
in terms of
the ability to deliver high-quality products without the risk
The PDA Education course, “Quality Culture Assessment
Training,” will be offered throughout
November in Singapore,
Taiwan and Santa Monica, Calif. For more information, visit the PDA website.]
- Patel, Pritesh, et al. “Quality Culture Survey Report.”
PDA Journal of Pharmaceutical Science and Technology
69 (2015): 631–642.