Regulatory governance in lean digital transformation: institutional adaptation in digitally enabled operations

Purpose This study aims to examine the role of regulatory governance in lean digital transformation. While prior Lean 4.0 research has primarily focused on technological enablers, the institutional positioning of regulatory governance within digitally enabled operational systems remains underexplored. Design/methodology/approach A three-phase research framework comprising a systematic literature review, an empirical survey of 220 professionals and Fuzzy Decision-Making Trial and Evaluation Laboratory analysis was used. Exploratory factor analysis (EFA) was conducted to validate the dimensional structure of the identified factors before examining their causal relationships. Findings The findings indicate that technological capabilities, particularly artificial intelligence (AI), robotic process automation (RPA) and digital simulation systems, act as the primary drivers of lean digital transformation. Organizational resource allocation further strengthens transformation initiatives. In contrast, regulatory governance mechanisms, including data governance frameworks, regulatory compliance and digital standards, emerge predominantly as effect variables shaped by technological and organizational transformation processes. Practical implications Organizations should prioritize developing technological capabilities and organizational readiness while progressively integrating governance and compliance mechanisms to support operational transparency, accountability and sustainability. Originality/value This study extends Lean 4.0 literature by reconceptualizing regulatory governance as an institutional outcome rather than a primary driver of lean digital transformation.