The influences of structural capability and lean six sigma practices on quality management practices and quality performance in medical device manufacturing industry

Recent years have witnessed the growing popularity of quality management practices (QMPs) in developing countries especially with quality becoming a top priority to all manufacturing industries. The motivation for this study was driven by the attempt to gain a better understanding on the effect of QMPs on quality performance which has been the subject of inconclusive findings in the existing QM literatures. In this regard, this study aims to develop a conceptual model that integrates the perspective of resource-based view theory and dynamic capability theory to uncover the role of structural capability as a mediator in bridging the relationship between QMPs and quality performance. In addition, grounding on contingency theory this study examines the role of LSS practices as a moderator to better explain the relationship between QMPs and quality performance. Next, a total of 164 questionnaires were distributed to medical device manufacturing (MDM) companies in Malaysia with 103 returned and usable questionnaires. The assessment of measurement and structural model in this study is performed using SmartPLS v. 3.2.7 software. The findings of this study revealed that structural capability is statistically significant and partially mediates the relationship between QMPs and quality performance. Furthermore, LSS practices were found to have a significant and negative interaction effect on QMPs and quality performance. In addition, the results indicated that QMPs, structural capability and LSS practices are positive and significant predictors of quality performance. Lastly, both the implications and limitations of this study will be highlighted as well as suggestion of possible directions for future research.