Purpose

Scholars often associate Operational Excellence (OPEX) enablers with high operational performance. Several studies have concluded that advancing OPEX enablers helps improve organizational performance. This paper aims to better understand the relation between OPEX enablers and a robust quality control lab. Integral to pharmaceutical quality systems, robust quality control labs ensure effective drug provision to patients. We examine how implementing OPEX enablers in quality control labs contributes to strengthening quality effectiveness a pharmaceutical manufacturing organization.

Methods

The analysis was based on a database of the University of St.Gallen comprising 53 pharmaceutical quality control labs. An independent t-test and multiple linear regressions were used to study the relation between OPEX enablers and quality control lab effectiveness.

Results

The results show that highly effective quality control labs exhibit significantly higher OPEX enabler implementation. Thirty-five percent of the variance in lab performance can be explained by enabler implementation.

Conclusion

High OPEX enabler implementation contributes to robust quality control labs achieving high-level quality and service. Organizations thus attain effective and efficient drug release.

中文翻译：

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药品质量控制实验室的卓越运营：有效质量体系的驱动力

目的

学者们经常将卓越运营（OPEX）促成因素与高运营绩效联系在一起。多项研究得出结论，推进OPEX推动因素有助于提高组织绩效。本文旨在更好地了解OPEX支持者与强大的质量控制实验室之间的关系。强大的质量控制实验室与药品质量体系集成在一起，可确保为患者提供有效的药品。我们研究了在质量控制实验室中实施OPEX支持因素如何有助于增强制药生产组织的质量有效性。

方法

该分析基于圣加仑大学的数据库，该数据库包含53个制药质量控制实验室。使用独立的t检验和多元线性回归来研究OPEX支持因素与质量控制实验室有效性之间的关系。

结果

结果表明，高效的质量控制实验室展示了更高的OPEX支持者实施方案。实验室性能差异的百分之三十五可以通过启动器实现来解释。

结论

较高的OPEX支持器实施有助于强大的质量控制实验室实现高水平的质量和服务。因此，组织可以获得有效的药物释放。