دورية أكاديمية
The Impact of Quality Culture on Operational Performance-An Empirical Study from the Pharmaceutical Industry.
| العنوان: | The Impact of Quality Culture on Operational Performance-An Empirical Study from the Pharmaceutical Industry. |
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| المؤلفون: | Friedli T; University of St. Gallen, Dufourstrasse 40a CH-9000, St. Gallen, Switzerland., Buess P; University of St. Gallen, Dufourstrasse 40a CH-9000, St. Gallen, Switzerland; paul.buess@unisg.ch., Köhler S; University of St. Gallen, Dufourstrasse 40a CH-9000, St. Gallen, Switzerland., Chen C; Amgen, 1 Amgen Center Dr., Thousand Oaks, CA 91320, USA; and., Mendivil S; Amgen, 1 Amgen Center Dr., Thousand Oaks, CA 91320, USA; and., Baker D; Parenteral Drug Association, Bethesda Towers, Suite 600, 4350 E. West Highway, Bethesda, MD 20814, USA. |
| المصدر: | PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2018 Sep-Oct; Vol. 72 (5), pp. 531-542. Date of Electronic Publication: 2018 Jul 20. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Pda (Parenteral Drug Association) Country of Publication: United States NLM ID: 9439538 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1948-2124 (Electronic) Linking ISSN: 10797440 NLM ISO Abbreviation: PDA J Pharm Sci Technol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Bethesda Md : Pda (Parenteral Drug Association) |
| مواضيع طبية MeSH: | Quality Improvement* , Total Quality Management*, Drug Industry/*standards, Humans ; Organizational Culture ; Surveys and Questionnaires |
| مستخلص: | 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, Inc. 2018.) |
| معلومات مُعتمدة: | U01 FD005675 United States FD FDA HHS |
| تواريخ الأحداث: | Date Created: 20180722 Date Completed: 20190529 Latest Revision: 20191023 |
| رمز التحديث: | 20240628 |
| DOI: | 10.5731/pdajpst.2018.008771 |
| PMID: | 30030348 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1948-2124 |
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| DOI: | 10.5731/pdajpst.2018.008771 |