Digital innovation and quality improvement in Industry 4.0: the mediating role of TQM critical success factors

Purpose Despite the growing adoption of Industry 4.0 (I4.0) technologies, their effects on quality performance vary widely across different organizational contexts. This raises a central question in the literature on digital transformation: similar technological investments often yield significantly different quality outcomes across organizations. This variability is significant because it indicates that digital innovation does not automatically translate into quality improvements but depends on specific organizational conditions. Understanding this phenomenon is therefore essential to explain the nonlinear and contingent nature of quality performance in digitized systems. This study addresses this issue by analyzing how and under which organizational conditions digital innovation translates into quality improvement. It examines the mediating role of the critical success factors (CSFs) of total quality management (TQM) in determining the outcomes of Quality 4.0. Design/methodology/approach The study employs a systematic literature review (SLR) based on 88 peer-reviewed articles. A combined deductive–inductive content analysis was conducted to identify recurring organizational mechanisms and their relationships with I4.0 enabling technologies. Frequency analysis and co-occurrence techniques were used to identify structural patterns in the literature. Findings The results show that I4.0 technologies – such as IoT, big data analytics, simulation, cloud computing, and augmented reality – do not directly generate quality improvements. Their impact is mediated by a set of TQM CSFs, specifically Information and Analysis, Continuous Improvement, Strategic Planning, Process Management, and Customer Focus. These factors operate as socio-technical mechanisms that enable organizations to transform digital inputs into organizational learning, process optimization, and value creation. Originality/value The study contributes to the literature by moving beyond a technology-driven perspective and proposing a theoretical reinterpretation of TQM CSFs as socio-technical mechanisms through which digital innovation translates into quality outcomes. In particular, the work explains why similar digital investments can generate different quality outcomes, highlighting the role of organizational conditions in mediating this relationship. In this sense, the theoretical contribution consists of linking research strands on digital transformation and quality management through a socio-technical and capability-based perspective. From a managerial perspective, the results offer an operational interpretation of the CSFs, which can be used to guide the implementation of Quality 4.0.