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This study aims to fully assess the readiness for Lean Six Sigma (LSS) and Quality Performance Improvement (QPI) in an Italian Public Healthcare ecosystem.

Drawing from previously established survey development and adaptation protocols, a replication study was carried out; Lean, Six Sigma and QPI were extracted and validated through confirmatory factor analysis in an Italian Public Healthcare setting, with a sample of health professionals from the Campania region.

This study reports the adaptation of an existing scale for measuring LSS and QPI in an Italian public healthcare organisation. This analysis extracts six conceptual domains and constitutes an original adaptation of an existing scale to assess the readiness to adopt Lean, Six Sigma and Quality Performance in Italian Public Health Organizations. The constructs show strong levels of internal consistency, as demonstrated by each item factor loading and each subscale reliability.

Managers, policymakers and academics can employ the proposed tool to assess the public healthcare ecosystem’s capability to implement LSS initiatives and strategies to improve quality performance.

This is one of the first studies to assess cross-regional organisational readiness for LSS and QPI in an Italian Public Healthcare environment at this scope and level.

This study aims to investigate the adoption of Quality 4.0 (Q4.0) and assess the critical failure factors (CFFs) for its implementation and how its failure is measured.

A qualitative study based on in-depth interviews with quality managers and executives was conducted to establish the CFFs for Q4.0.

The significant CFFs highlighted were resistance to change and a lack of understanding of the concept of Q4.0. There was also a complete lack of access to or availability of training around Q4.0.

The study enhances the body of literature on Q4.0 and is one of the first research studies to provide insight into the CFFs of Q4.0.

Based on the discussions with experts in the area of quality in various large and small organizations, one can understand the types of Q4.0 initiatives and the CFFs of Q4.0. By identifying the CFFs, one can establish the steps for improvements for organizations worldwide if they want to implement Q4.0 in the future on the competitive global stage.

The concept of Q4.0 is at the very nascent stage, and thus, the CFFs have not been found in the extant literature. As a result, the article aids businesses in understanding possible problems that might derail their Q4.0 activities.