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Data-driven quality management systems, brought about by the implementation of digitisation and digital technologies, is an integral part of improving supply chain management performance. The purpose of this study is to determine a methodology to aid the implementation of digital technologies and digitisation of the supply chain to enable data-driven quality management and the reduction of waste from manufacturing processes.

Methodologies from both the quality management and data science disciplines were implemented together to test their effectiveness in digitalising a manufacturing process to improve supply chain management performance. The hybrid digitisation approach to process improvement (HyDAPI) methodology was developed using findings from the industrial use case.

Upon assessment of the existing methodologies, Six Sigma and CRISP-DM were found to be the most suitable process improvement and data mining methodologies, respectively. The case study revealed gaps in the implementation of both the Six Sigma and CRISP-DM methodologies in relation to digitisation of the manufacturing process.

Valuable practical learnings borne out of the implementation of these methodologies were used to develop the HyDAPI methodology. This methodology offers a pragmatic step by step approach for industrial practitioners to digitally transform their traditional manufacturing processes to enable data-driven quality management and improved supply chain management performance.

This study proposes the HyDAPI methodology that utilises key elements of the Six Sigma DMAIC and the CRISP-DM methodologies along with additions proposed by the author, to aid with the digitisation of manufacturing processes leading to data-driven quality management of operations within the supply chain.

The purpose of this paper is to extend the understanding of Six Sigma (SS) and the underlying dimensions of its critical success factors (CSF) via an analysis of the effects of top management support (TMS), implementation strategy (IS), and collaborative team (CT) on project performance (PP) in Mexican manufacturing companies.

Based on a SS literature review, a survey was conducted to capture practitioners’ viewpoints about CSFs for SS implementation and their impact on performance in manufacturing companies. A factor analysis and structural equation modeling were conducted in order to identify and analyze causal relationships.

The results suggest that CSFs grouped in the constructs TMS, IS, and CT have a positive impact on PP as measured by cost reduction, variation reduction, and quality improvement.

Although the empirical data collected supported the proposed model, results might differ among organizations in different countries. In addition, the study did not analyze a unique performance metric; instead, general PP dimensions were used.

Boosting the TMS, IS, and CT enhances positive PP of SS in manufacturing companies.

IS as a construct has not been studied exhaustively; this work contributes to a better understanding of it and its impact on PP. Additionally, studies of SS in Latin America are limited, so this study gives a complementary vision to practitioners and researchers about it.

The main objective of this study is to investigate what are the critical success factors that exist for continuous improvement (CI) methodology deployment in the Irish medical technology (MedTech) industry. The research will, in particular, seek to establish if the highly regulated nature of the global MedTech industry is an additional critical failure factor (CFF) for the deployment of CI methodology. The study involves the analysis of the benefits, challenges, CFFs and tools most utilised for the application to the deployment of CI methodologies in the Irish medical device (MD) industry.

A quantitative survey was utilised in this study. The main participants were made up of senior quality professionals working in operational excellence, quality consultants, quality directors, quality engineers, quality managers and quality supervisors working in both manufacturing and service sectors from Irish MD companies. A total of 94 participants from the Irish MedTech industry responded to the survey.

The main finding of this study is that 42% of participants perceived that a highly regulated environment was a CFF to CI, whilst 79% of respondents utilised Lean Six Sigma in their organisations, and productivity and financial factors were found to be the highest reasons for CI deployment amongst the Irish MedTech industry. The top CFFs highlighted for CI in regulated industries were fear of extra validation activity, compliance versus quality culture and a regulatory culture of being “safe”. Another relevant finding presented in this paper is that just over 48% of participants felt that CI tools are very strongly integrated into the industries quality management systems (QMSs) such as the corrective and preventative action system, non-conformance and audit systems.

All data collected in the survey came from professionals working for Irish indigenous and multinational MedTech companies. It is important to highlight that n = 94 is a low sample size, which is enough for a preliminary survey but reinforcing the limitation in terms of generalisation of the results. A further study on a wider European and global scale as well as a comparison with the highly regulated pharma industry would be informative.

The authors understand that this is the very first research focussed on the CFFs for CI in the MedTech/MD manufacturing industry with a specific focus on the highly regulated nature of the industry as a potential CFF. The results of this study represent an important first step towards a full understanding of the applicability and use of CI in the medical-device-manufacturing industries on a global scale.

Improving productivity and efficiency has always been crucial for industrial companies to remain competitive. In recent years, the topic of environmental impact has become increasingly important. Published research indicates that environmental and economic goals can enforce or rival each other. However, few papers have been published that address the interaction and integration of these two goals.

In this paper, we identify both, synergies and trade-offs based on a systematic review incorporating 66 publications issued between 1992 and 2021. We analyze, quantify and cluster examples of conjunctions of ecological and economic measures and thereby develop a framework for the combined improvement of performance and environmental compatibility.

Our findings indicate an increased significance of a combined consideration of these two dimensions of sustainability. We found that cases where enforcing synergies between economic and ecological effects were identified are by far more frequent than reports on trade-offs. For the individual categories, cost savings are uniformly considered as the most important economic aspect while, energy savings appear to be marginally more relevant than waste reduction in terms of environmental aspects.

No previous literature review provides a comparable graphical treatment of synergies and trade-offs between cost savings and ecological effects. For the first time, identified measures were classified in a 3 × 3 table considering type and principle.

This study proposes a machine learning framework to predict customer complaints from production line tests in an automotive company's lot-release process, enhancing Quality 4.0. It aims to design and implement the framework, compare different machine learning (ML) models and evaluate a non-sampling threshold-moving approach for adjusting prediction capabilities based on product requirements.

This study applies the Cross-Industry Standard Process for Data Mining (CRISP-DM) and four ML models to predict customer complaints from automotive production tests. It employs cost-sensitive and threshold-moving techniques to address data imbalance, with the F1-Score and Matthews correlation coefficient assessing model performance.

The framework effectively predicts customer complaint-related tests. XGBoost outperformed the other models with an F1-Score of 72.4% and a Matthews correlation coefficient of 75%. It improves the lot-release process and cost efficiency over heuristic methods.

The framework has been tested on real-world data and shows promising results in improving lot-release decisions and reducing complaints and costs. It enables companies to adjust predictive models by changing only the threshold, eliminating the need for retraining.

To the best of our knowledge, there is limited literature on using ML to predict customer complaints for the lot-release process in an automotive company. Our proposed framework integrates ML with a non-sampling approach, demonstrating its effectiveness in predicting complaints and reducing costs, fostering Quality 4.0.

Many manufacturers are exploring adopting smart technologies in their operations, also referred to as the shift towards “Industry 4.0”. Employees' contribution to high-tech initiatives is key to successful Industry 4.0 technology adoption, but few studies have examined the determinants of employee acceptance. This study, therefore, aims to explore how managers affect employees' acceptance of Industry 4.0 technology, and, in turn, Industry 4.0 technology adoption.

Rooted in the unified theory of acceptance and use of technology model and social exchange theory, this inductive research follows an in-depth comparative case study approach. The two studied Dutch manufacturing firms engaged in the adoption of Industry 4.0 technologies in their primary processes, including cyber-physical systems and augmented reality. A mix of qualitative methods was used, consisting of field visits and 14 semi-structured interviews with managers and frontline employees engaged in Industry 4.0 technology adoption.

The cross-case comparison introduces the manager's need to adopt a transformational leadership style for employees to accept Industry 4.0 technology adoption as an organisational-level factor that extends existing Industry 4.0 technology user acceptance theorising. Secondly, manager's and employee's recognition and serving of their own and others' emotions through emotional intelligence are proposed as an additional individual-level factor impacting employees' acceptance and use of Industry 4.0 technologies.

Synthesising these insights with those from the domain of Organisational Behaviour, propositions were derived from theorising the social aspects of effective Industry 4.0 technology adoption.

The purpose of this study is to investigate the perceived effects between soft management practices, employee behaviours and the implementation of digital technologies in manufacturing plants, as well as how these relate to the emergence of digital waste.

This paper uses case-based research. Data was collected in two large manufacturing companies based in Norway and Sweden through semi-structured interviews with two management representatives and four shop-floor employees. The data was used to evaluate 29 variables describing lean- and total quality management (TQM)-associated employee behaviours and soft management practices, in light of digital transformation.

The results suggest that several variables were positively influenced by the digital transformation process. These were top management leadership, middle management involvement, employee education, corporate social responsibility focus, innovation, knowledge sharing, work-family balance, psychological capital, job satisfaction and career commitment. Training employees, creativity, discretionary effort, turnover intention and proactivity appear to be negatively influenced by digital transformation The findings also indicate that several soft management practices and employee behaviours were not only influenced by manufacturing digitalization but also themselves influenced the process. The potential for digital waste creation was also detected in several variables, including reward and recognition and training employees.

Managers, practitioners and academics may learn about the importance of certain managerial practices and employees’ behavioural needs during the digital transformation process. The findings may help in prioritizing TQM and soft lean management practices and certain employee behaviours during the digital transformation and in creating awareness of digital waste.

This study builds on several existing studies discussing the impact of digital transformation on soft management practices and employee behaviours. It provides insights from a lean and TQM angle and offers a means of prioritizing certain practices and behaviours during a digital transformation. This study also highlights the significance of digital waste.