An analysis of quality culture and quality management practices in selected South African pharmaceutical organisations

Abstract

South African pharmaceutical organisations struggle to compete with their counterparts in other countries. To overcome this challenge, a suitable Operational Excellence (OpEx) strategy in their manufacturing environment can improve the quality of pharmaceutical products and encourage economic growth in South Africa. This study examined the contribution of a Quality Culture on OpEx in selected pharmaceutical organisations. The objective of this study was to develop a conceptual Model of Quality Management Practices supported by Quality Culture, for Category A pharmaceutical manufacturers in the South African Pharmaceutical Industry, to promote OpEx. This study followed a two-phase sequential embedded mixed method approach. Statistical results were derived from the analysis of quantitative data from a questionnaire which used a census sample. Thereafter, a qualitative phase included an in-depth exploration of a smaller purposefully selected sample of individuals. The sample size of the pilot study was one manufacturer while the main study target population consisted of 30 pharmaceutical manufacturers. Internal validity (reliability) was assured by Cronbach’s alpha in the quantitative phase for both the pilot and main study. External validity was assured through the use of a standard instrument in the pilot study and main study. Data saturation and peer review assured validity in the qualitative phase of the pilot and main study. Ethical clearance for this study was granted through DUT’s institutional channels. Results of the quantitative phase of the main study (n=17, response rate 57%) found a significant regression relationship (68%) between successful Quality Management Practices and the Quality Culture in pharmaceutical organisations. Quantitative analysis statistically confirmed the suitability of OpEx dimensions for the Model and established a correlation between these OpEx dimensions and four important organisational culture types namely: clan culture, hierarchical culture, adhocracy culture and market-driven culture. Results of qualitative data analysis (n=3) indicated that an appropriate blend of culture types supports OpEx in the South African pharmaceutical industry. Based on these findings, an OpEx Model was developed for South African pharmaceutical manufacturers. This study recommends that the OpEx model be adopted by South African pharmaceutical manufacturers to cultivate an appropriate blend of organisational culture types, within their overall Quality Culture. This will support and enable effective Quality Management Practices and OpEx. A limitation of the SA Pharma OpEx Model developed was that it lacked a financial component. Future research should include the financial component to expand on the SA Pharma OpEx Model.