Operating Context Determines Enabler Performance Relation: Three Distinct Patterns in Pharmaceutical Quality Control Labs

Purpose To address the increasing number of quality issues, the pharmaceutical industry has expanded its continuous improvement focus to the quality control lab as one of the bottlenecks in pharmaceutical value creation. We replicate the relation between enablers (also known as practices) and perfor...

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Bibliographic Details
Published in:Journal of pharmaceutical innovation 2021-06, Vol.16 (2), p.198-212
Main Authors: Köhler, Stephan, Friedli, Thomas
Format: Article
Language:English
Subjects:
Biochemical Engineering
Biomedical and Life Sciences
Biomedicine
Biotechnology
Industrial and Production Engineering
Original Article
Pharmacology/Toxicology
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Summary:Purpose To address the increasing number of quality issues, the pharmaceutical industry has expanded its continuous improvement focus to the quality control lab as one of the bottlenecks in pharmaceutical value creation. We replicate the relation between enablers (also known as practices) and performance in pharmaceutical quality control labs, in order to identify decisive factors potentially increasing quality performance. Methods We employ a sequential mixed-methods approach to analyze the enabler performance relation. Standardized data from 53 quality control labs was collected for the quantitative analysis. The results formed the a priori construct for three qualitative case studies. The explanatory case studies were used to better understand the phenomenon. Results Empirical evidence exists for three distinct clusters of labs showing a differing enabler-performance relation. One of these clusters contradicts existing theory. It shows a mismatch between the business environment and the approach to continuous improvement. Conclusion This paper represents a first analysis of the enabler-performance relation in quality control labs and meets the much-issued call to investigate the operating context. The findings, partially contradicting theory, enhance current understanding of the enabler-performance relation.
ISSN:1872-5120
1939-8042
DOI:10.1007/s12247-020-09436-2