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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.

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 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.

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.

With the growing pressure to gain optimum level of quality and speed, Lean Six Sigma (LSS) practices have drawn considerable attention as a viable alternative for process improvement. However, previous studies revealed that there is very little systematic and rigorous research to validate the claims. In this regard, this paper aims to empirically examine the effect of LSS practices on quality performance in the medical device manufacturing industry.

For this study, partial least square–based structural equation modeling (PLS-SEM) was used to empirically examine the effect of LSS practices on quality performance in Malaysian medical device manufacturing industry.

The findings of this paper revealed that LSS practices have a significant and positive effect on quality performance in the medical device manufacturing industry.

This paper will serve as a valuable implication for industry practitioners in providing them with a clearer managerial direction to exploit the strength of LSS practices to achieve company’s quality goals. Moreover, this study will serve as a basis for future LSS scholars, providing them with valuable insights and directions for future research.

This paper develops a conceptual LSS framework that captures the integrated nature of two methodologies and provides empirical evidence that supports the positive influence of LSS practices on quality performance; hence, it contributes to the growing body of LSS literature in both theoretical and empirical sense.