The moderating role of Lean Six Sigma practices on quality management practices and quality performance in medical device manufacturing industry.

Purpose: The purpose of this paper is to explore the moderating role of Lean Six Sigma (LSS) practices in explaining the relationship between quality management practices (QMPs) and quality performance. Design/methodology/approach: Partial least square-based structural equation modeling (PLS-SEM) was used to empirically examine the moderating effect of LSS practices on QMPs and quality performance in Malaysian medical device manufacturing companies. Findings: Findings revealed that both QMPs and LSS practices have a significant and positive effect on quality performance. Furthermore, LSS practices served as a substitute for moderating the positive relationship between QMPs and quality performance in such a way that the relationship becomes weaker as LSS practices increase. Originality/value: LSS is acknowledged as the most well-known hybrid methodology; however, due to its relative newness, it has not been studied in great detail. Unlike previous studies, this paper argued that Lean and Six Sigma practices are distinct from its predecessor TQM practices; moreover, both Lean and Six Sigma practices do not need to substitute QM/TQM practices instead of complimenting the QMPs. In addition, this study adds to the growing body of QM literature by empirically examine the effect of LSS practices in moderating the relationship between QMPs and quality performance. [ABSTRACT FROM AUTHOR]

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