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.

PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections.

The Parenteral Drug Association (PDA) has identified 11 current questions related to data management and control that have been frequently cited in U.S. Food and Drug Administration (FDA) inspections or have led to FDA regulatory actions. The purpose of this document is to help to clarify some of these issues for industry and to help facilitate better compliance by sharing PDA members' expertise in and understanding of current best practices.Data integrity inspectional observations by health authorities can have a severe impact on a firm from a regulatory and public perception perspective and should not result from a lack of clarity by industry about what is required. In addition, firms are concerned that the inability to produce a requested record or document during an inspection, even if not a standard report or existing quality system document, could be construed as delaying, denying, limiting, or refusing inspection, which also has significant consequences.The PDA acknowledges it may not be possible for a single firm or site to have a meaningful discussion of these issues in the context of an inspection or inspection response and is offering these best practices so that industry can proactively comply and properly prioritize its efforts to improve document management and control and good manufacturing practices in the most efficient and effective means possible. The PDA acknowledges there are many more questions to be addressed and hopes that there can be an ongoing dialogue between industry and regulators to facilitate answers.

Quality Culture Survey Report.

The Parenteral Drug Association conducted an anonymous global survey of quality culture in the pharmaceutical industry to determine whether there is a relationship between certain quality behaviors and certain quality attributes, and whether these quality attributes could be used as surrogates (or proxy variables) to assess quality culture. Other studies have shown that an unhealthy quality culture is a root cause of many quality or compliance issues seen by sites and organizations. Statistical analysis of survey data suggests that certain attributes are driving good behaviors, and the demographic data suggests that this relationship holds irrespective of the geographic location of the site. Executive survey respondents had a more optimistic view of the current state of quality culture than survey respondents at large, with cross-functional vision showing the biggest gap (P-value = 0.07, F-Test). The top five quality attributes that can serve as surrogates for quality culture were (1) Management communication that quality is everyone's responsibility, (2) Site has formal quality improvement objectives and targets, (3) Clear performance criteria for feedback and coaching, (4) Quality topics included in at least half of all-hands meetings, and (5) Collecting error prevention metrics. These identified mature quality attributes are related to management responsibility, and continual improvement of the pharmaceutical quality system sections of ICH Q10, and therefore may be amenable to be incorporated in audit programs or in regulatory inspections. Additional research and discussion is required to build a coherent approach, which the pharmaceutical industry and regulators can adopt.