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The purpose of this systematic review is to critically analyze pharmaceutical industry case studies on the implementation of Lean 4.0 methodologies to synthesize key lessons, benefits and best practices. The goal is to inform decisions and guide investments in related technologies for enhancing quality, compliance, efficiency and responsiveness across production and supply chain processes.

The article utilized a systematic literature review (SLR) methodology following five phases: formulating research questions, locating relevant articles, selecting and evaluating articles, analyzing and synthesizing findings and reporting results. The SLR aimed to critically analyze pharmaceutical industry case studies on Lean 4.0 implementation to synthesize key lessons, benefits and best practices.

Key findings reveal recurrent efficiency gains, obstacles around legacy system integration and data governance as well as necessary operator training investments alongside technological upgrades. On average, quality assurance reliability improved by over 50%, while inventory waste declined by 57% based on quantified metrics across documented initiatives synthesizing robotics, sensors and analytics.

As a comprehensive literature review, findings depend on available documented implementations within the search period rather than direct case evaluations. Reporting bias may also skew toward more successful accounts.

Synthesized implementation patterns, performance outcomes and concealed pitfalls provide pharmaceutical leaders with an evidence-based reference guide aiding adoption strategy development, resource planning and workforce transitioning crucial for Lean 4.0 assimilation.

This systematic assessment of pharmaceutical Lean 4.0 adoption offers an unprecedented perspective into the real-world issues, dependencies and modifications necessary for successful integration, absent from conceptual projections or isolated case studies alone until now.

Organizations are continually improving their practices to improve operational performance. They already employ Lean Manufacturing techniques (LM) to reduce unnecessary waste. Industry 4.0 techniques enhance operational performance in association with LM. Despite the proven benefits of LM principles and the advancements offered by Industry 4.0 technologies, many organizations struggle to integrate these approaches effectively. This research paper explores how LM principles can be combined with Industry 4.0 technologies to provide valuable guidance for businesses looking to adopt lean automation strategies.

A systematic literature review on LM and Industry 4.0 was done to investigate the possible technical integration of both methods. Ninety-two articles are extracted systematically from the Scopus and Web of Science databases. This study states a systematic literature review, including quantitative analysis of bibliographic networks and cluster analysis, to identify emergent ideas and their further implementation.

The research findings highlight the positive impact of integrating lean production with Industry 4.0 techniques, benefiting organizations in achieving their goals. A lean automation integration framework is proposed based on the literature review and the findings.

This study provides industry administrators and practitioners valuable guidance for enhancing organizational productivity. These implications can provide businesses with competitive advantages, enhance customer satisfaction, and enable them to adapt to the dynamic demands of the contemporary business environment.

This literature review study has substantially contributed to the technological integration of lean and Industry 4.0. The work has also identified potential emerging areas that warrant further research.

The purpose of this study is to explore the relationship between Lean manufacturing and Industry 4.0 for small and medium size of enterprise in Japan and Brazil.

The authors conducted a quantitative survey (20 companies in Japan and 30 companies in Brazil) combined with a qualitative interview (2 companies in Japan and 15 companies in Brazil).

According to the quantitative study, 90% of them practice Lean manufacturing and 40% of them practice Industry 4.0. In the qualitative study in Brazil, four managers responded that the Lean manufacturing is a prerequisite for Industry 4.0 since any production process with waste cannot be productive, even with sophisticated digitalization technology.

The authors explored further the relationship between “defensive Digital Transformation (DX),” which is based mainly on Lean manufacturing, and “offensive DX,” which relates to customer value creation through Industry 4.0. This study clarifies the relationship and plays as a roadmap to develop better the manufacturing from current status to the vision of Industry 4.0.

This study aims to provide an overall framework that connects and explains a macro-perspective of the findings from the five studies of this special issue. Through this, we aim to answer two main questions: How can Lean and Industry 4.0 be integrated, and what are the outcomes for workers from such integration?

The special issue received 64 papers that were evaluated in multiple stages until this final sample of five papers that describe different facets of the integration between Lean and Industry 4.0 and their relationship with worker activities. In this introduction, we review the main findings of these five studies and propose an integrative view and associated propositions. A discussion provides directions to advance the field further.

The framework shows that when Lean and Industry 4.0 are integrated, companies will face two types of tensions, dialectical and paradoxical, which require different managerial approaches. By managing such tensions, the Lean-Industry 4.0 integration can help improve social performance, as well as develop systematic problem-solving and cumulative learning capabilities. Five important themes for this field of research are outlined: the importance of work routines, legitimation, competence, sense and mental flexibility.

This study brings a new theoretical perspective to the integration of Lean with Industry 4.0-related digital technologies. The results go beyond the usual view of improving operational performance and dig into the effects on workers. It also shows that the integration process relies on and can enhance human capabilities such as learning and problem-solving.

This study aims to examine the impact of Lean 4.0 practices on value co-creation in the dairy ecosystem.

Data collection were carried out through a questionary application with 126 professionals linked to the dairy ecosystem, including milk producers, milk cooperatives and milk transporters. The data were analyzed using Cluster Analysis, Mann-Whitney test and Chi-Square test.

A strong relation was found between the use of Lean 4.0 tools and the increase in operational performance, in addition to milk quality. Moreover, it can be noted that the use of digital technologies from Industry 4.0 has a strong relation with dairy production optimization, in other words, it is possible to be more efficient in the dairy process via Lean 4.0 adoption.

The study is limited to analyzing the Brazilian dairy ecosystem. The results presented may not reflect the characteristics of the other countries.

Once the potential empirical impacts of the relation between Lean 4.0 and value co-creation are elucidated, it is possible to direct strategies for decision-making and guide efforts by researchers and professionals to deal with the waste mitigation present in the dairy sector.

Lean 4.0 proves to be a potential solution to improve the operational performance of the dairy production system. Lean 4.0, linked to value co-creation, allows the integration of the production sector with consumers, through smart technologies, so new services and experiences can be provided to the consumer market. Additionally, the consumer experience can be stimulated based on Lean 4.0, once the quality specification is highlighted based on data science and smart management control.

To the best of the authors’ knowledge, this is the first study that analyzes the interrelationship between the Lean 4.0 philosophy and the value co-creation in the dairy ecosystem. In this sense, the study reveals the main contributions of this interrelation to the dairy sector via value co-creation, which demonstrates a new perspective on the complementarity of resources, elimination of process losses and new experiences for the user through digital technologies integrated with the Lean Thinking approach.

Maintenance represents an indispensable role in the productive sector of the steel industry. The increasing use of operating with a high level of precision makes hydraulic systems one of the issues that require a high level of attention. This study aims to explore an empirical investigation for decreasing the occurrences of corrective maintenance of hydraulic systems in the context of Lean 4.0.

The maintenance model is developed based on action-research methodology through an empirical investigation, with nine stages. This approach aims to build a scenario to analyze and interpret the occurrences, seeking to implement and evaluate the actions to be performed. The undertaken initiatives demonstrate that this approach can be applied to optimize the maintenance of an organization.

The main contribution of this paper is to demonstrate that the applied method allows the overviewing results, with a qualitative approach concerning the maintenance actions and management processes to be considered, allowing a holistic understanding and contributing to the current literature. The results also indicated that Lean 4.0 has direct and mediating effects on maintenance performance.

This research intends to propose an evaluation framework with an interdimensional linkage between action research methodology and Lean 4.0, to explore an empirical investigation and contributing to understanding the actions to reduce the occurrences of hydraulic systems corrective maintenance in a production line in the steel industry.

This study aims to carry out a systematic literature review (SLR) on the integration of Lean, Industry 4.0 and the supply chain or the Lean Supply Chain (LSC) 4.0. The research analyses the current research on the LSC 4.0 concept in an increasingly digitalised world. The authors present the benefits, motivations, critical success factors and challenges of integrating the LSC with Industry 4.0 technologies within this emerging area of research.

An SLR is carried out on how Lean can be integrated with Supply Chain 4.0. Using the search strings of “Lean Supply Chain 4.0,” “Lean Supply Chain Management 4.0” and “Lean Supply Chain Digitalisation,” a review of published literature was carried out via searches on academic databases.

Industry 4.0 has a synergistic effect on the LSC and, depending on the technology and sector applied in, can complement and enhance the LSC. Similarly, the LSC is a precursor for digitalisation. There are considerable implications in the LSC 4.0 for green and sustainable processes.

Organisations can use this study to understand what the LSC 4.0 means to industry, the benefits and motivating factors for implementation, the critical success factors (CSFs) to implementation and the challenges for implementation.

This study adds to state of the art around the LSC 4.0 and future directions in this nascent research area. This study will aid organisations in understanding how Lean, supply chain management and Industry 4.0 can be integrated.

This study aims to explore the integration of Industry 4.0 technologies with lean six sigma practices in the manufacturing sector for enhanced process improvement.

This study used a fuzzy decision-making trial and evaluation laboratory approach to identify critical Industry 4.0 technologies that can be harmonized with Lean Six Sigma methodologies for achieving improved processes in manufacturing.

The research reveals that key technologies such as modeling and simulation, artificial intelligence (AI) and machine learning, big data analytics, automation and industrial robots and smart sensors are paramount for achieving operational excellence when integrated with Lean Six Sigma.

The study is limited to the identification of pivotal Industry 4.0 technologies for Lean Six Sigma integration in manufacturing. Further studies can explore the implementation challenges and the quantifiable benefits of such integrations.

Integrating Industry 4.0 technologies with Lean Six Sigma enhances manufacturing efficiency. This approach leverages AI for predictive analysis, uses smart sensors for energy efficiency and adaptable robots for flexible production. It is vital for competitive advantage, significantly improving decision-making, reducing costs and streamlining operations in the manufacturing sector.

The integration of Industry 4.0 technologies with Lean Six Sigma in manufacturing has significant social implications. It promotes job creation in high-tech sectors, necessitating advanced skill development and continuous learning among the workforce. This shift fosters an innovative, knowledge-based economy, potentially reducing the skills gap. Additionally, it enhances workplace safety through automation, reduces hazardous tasks for workers and contributes to environmental sustainability by optimizing resource use and reducing waste in manufacturing processes.

This study offers a novel perspective on synergizing advanced Industry 4.0 technologies with established Lean Six Sigma practices for enhanced process improvement in manufacturing. The findings can guide industries in prioritizing their technological adoptions for continuous improvement.

The purpose of this paper is to investigate the research landscape of LSS 4.0 papers published in two well-known repositories, Scopus and Web of Science (WoS), in terms of publication trends, article distribution by author, journal, affiliations and country, and article clustering based on keywords, authors and countries. In addition, a literature review was carried out to build a conceptual framework of integrated Lean Six Sigma and Industry 4.0 (LSS 4.0) that encompasses operational, sustainability and human factors or ergonomics aspects.

The literature review of integrated Lean Six Sigma and I4.0 publications published in Scopus and WoS databases in the current decade was conducted for the present study. This study categorizes LSS, I4.0 and related research articles based on publication patterns, journals, authors and affiliations, country and continental-wise distribution and clustering the articles based on keywords and authors from the Scopus and WoS databases from 2011 to 2022 using the search strings “Lean”, “Six Sigma”, “Lean Six Sigma” and “Industry 4.0” in the Title, Abstract and Keywords using Biblioshiny, VOS viewer and Microsoft Excel.

In the recent three years, from 2020 to 2022, LSS 4.0 has been substantially increasing and is seen as an emerging and trending area. This research identifies the most influential authors, most relevant affiliations, most prolific countries and most productive journals and clusters based on keywords, authors and countries. Further, a conceptual framework was developed that includes the impact of operational, sustainability and ergonomic or human factors in LSS 4.0.

This article assists in comprehending the trends and patterns of LSS 4.0. Further, the conceptual framework helps professionals and researchers understand the significance and impact of integrating LSS and Industry 4.0 in the aspects of human factors/ergonomic, sustainability and operations. Also, the research induce professionals to incorporate all these factors while designing and implementing LSS 4.0 in their organization.

This conceptual framework and bibliometric analysis would aid in identifying potential areas of research and providing future directions in the domain of LSS 4.0. It will be beneficial for academicians, professionals and researchers who are planning to apply and integrate techniques of LSS and technologies of I4.0 in their organizations and research.

Quality management practitioners have yet to cease the potential of digitalisation. Furthermore, there is a lack of tools such as frameworks guiding practitioners in the digital transformation of their organisations. The purpose of this study is to provide a framework to guide quality practitioners with the implementation of digitalisation in their existing practices.

A review of literature assessed how quality management and digitalisation have been integrated. Findings from the literature review highlighted the success of the integration of Lean manufacturing with digitalisation. A comprehensive list of Lean Six Sigma tools were then reviewed in terms of their effectiveness and relevance for the hybrid digitisation approach to process improvement (HyDAPI) framework.

The implementation of the proposed HyDAPI framework in an industrial case study led to increased efficiency, reduction of waste, standardised work, mistake proofing and the ability to root cause non-conformance products.

The activities and tools in the HyDAPI framework are not inclusive of all techniques from Lean Six Sigma.

The HyDAPI framework is a flexible guide for quality practitioners to digitalise key information from manufacturing processes. The framework allows organisations to select the appropriate tools as needed. This is required because of the varying and complex nature of organisation processes and the challenge of adapting to the continually evolving Industry 4.0.

This research proposes the HyDAPI framework as a flexible and adaptable approach for quality management practitioners to implement digitalisation. This was developed because of the gap in research regarding the lack of procedures guiding organisations in their digital transition to Industry 4.0.