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

Abstract

PurposeThe 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/approachPartial 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.FindingsFindings 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/valueLSS 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.

The Effect of Medical Device Regulations on Deploying a Lean Six Sigma Project

“…Lean Six Sigma methodology contains some benefits in saving money, improving competencies and performances, and achieving a better customer relationship, thus achieving an almost perfect performance at business levels, including in the medical device industry [51]. In addition, this method can be effectively used in an unregulated environment without regulatory procedures, which would hinder its application.…”

Pragmatism as a paradigm for quality management research in bridging academic-practitioner gaps

“…Academic researchers tend to theorize organizational phenomena by either develop or validate theories/frameworks using scientifically rigorous data analysis tools to explore the inter-relationship among the indicators in explaining a phenomenon but pay little attention in making academic research relevant to business organization and industrial practitioners (Panda and Gupta, 2014;Kelly and Cordeiro, 2020). Similarly, recent studies claimed that heavy reliance on a quantitative approach may have failed to address the existing issues faced by organizations, hence, the use of a mixed-method approach to investigate evolving organizational phenomena is suggested (Sim et al, 2022a(Sim et al, , 2022b. Literally, scholars tend to identify research problems via extensive literature review and not often collaborate with practitioners in developing research agenda.…”

“…Management and business environments have evolved considerably; hence, it is necessary to determine whether the existing practices are capable of providing effective means to respond to the new competitive settings (Escrig-Tena et al , 2011). QM research should be revamped to include qualitative or mixed-method approaches by working collaboratively with practitioners to enhance the quality and relevance of management research as well as gain better insights on the research findings (Sim et al , 2022a). Following the calls made by Shokri (2017) who pointed out that future scholars should opt for more collaboration between academics and industry players such as by following-up with second phase of qualitative approach to allow a wider perspective on a specific phenomenon as well as further in-depth interpretation on research findings to address current research gaps.…”

The Role of Lean Six Sigma in Boosting Competitive Advantage in the Governance of Healthcare Organizations: A Conceptual Framework

“…Furthermore, LSS helps to minimize variation, reduce waste, eliminate unnecessary processes, and reduce waiting times between value-added activities to enhance quality which helps, accordingly, hospitals to gain a sustainable CA (Ahmed, 2019). Furthermore, focusing on satisfying patients' needs has been an essential motivator for the implementation of various quality initiatives, such as LSS, throughout the HC industry (Zakuan, 2009;Sim et al, 2022). This has led organizations to focus more on the opinions of their patients, fulfill patients' needs and expectations (Citybabu & Yamini, 2022;Sodikoglu & Zehir, 2010), and predict patients' demands (Shah & Ward, 2007).…”