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This study explores how Lean was deployed in several hospitals in the Apulia region in Italy over 3.5 years.

An exploratory qualitative design was drawn up based on semi-structured interviews.

The drivers of Lean in hospitals were to increase patient satisfaction and improve workplace well-being by eliminating non-value-add waste. The participants highlighted three key elements of the pivotal implementation stages of Lean: introduction, spontaneous and informal dissemination and strategic level implementation and highlighted critical success and failure factors that emerged for each of these stages. During the introduction, training and coaching from an external consultant were among the most impactful factors in the success of pilot projects, while time constraints and the adoption of process analysis tools were the main barriers to implementation. The experiences of the Lean teams strongly influence the process of spontaneous dissemination aided by the celebration of project results and the commitment of the departmental hospital heads.

Lean culture can spread to allow many projects be conducted spontaneously, but the Lean paradigm can struggle to be adopted strategically. Lean in healthcare can fail because of the lack of alignment of Lean with leadership in healthcare and with their strategic vision, a lack of employees' project management skills and crucially the absence of a Lean steering committee.

The absence of managerial expertise and a will to support Lean implementation do not allow for systemic adoption of Lean. This is one of the first and largest long-term case studies on a Lean cross-regional multi-hospital application in healthcare.

The European Union (EU) Medical Device Regulations (MDR) 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study aims to investigate the impact of these strengthened requirements on medical device manufacturers by investigating the challenges they encounter while generating an MDR-compliant clinical evaluation report.

A systematic literature review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses method of peer-reviewed literature and various government jurisdictional reports and legislation.

The findings from the study understanding what constitutes sufficient clinical evidence poses the biggest challenge to the generation of an MDR-compliant clinical evaluation report. Resulting from the challenges they are facing, manufacturers of certain CE-marked medical devices are planning to remove (and have removed) devices from the EU market upon expiration of their certificate, and in the case of new and innovative devices, some manufacturers are planning to launch in other markets ahead of the EU. These challenges will lead to a potential shortage of certain medical devices in the EU and a delay in access to new devices, thereby negatively impacting patients’ quality of life.

This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the EU. A limitation is the lack of literature analysing the regulations and their effects.

This study has both theoretical contributions in that, to the best of the authors’ knowledge, it is the first detailed and systematic review of the new MDR Regulations and has implications for practice as manufacturers and policymakers can leverage it alike to understand the challenges of the new MDR.

This study describes how two organisations transitioned to teaching Lean online during and post Covid-19. This study aims to establish how Lean teaching and training can be designed and delivered effectively online without adverse effects on the student’s learning experience of Lean concepts.

A case study approach was used to review the design, application and results of the transition to online Lean teaching and training. Qualitative and quantitative methods were deployed to assess the results.

Online Lean learning and application were assured via the design of practical problem-based teaching environments, aided by using the virtual classroom as an obeya room and as a kaizen environment where students worked in teams. Students were enabled to learn and apply Lean tools practically and reflect on their learnings.

This study demonstrates that effective online design can ensure. Lean methods are understood without affecting the student's learning, classroom experience and grasp of concepts.

To the best of the author’s knowledge, this is one of the first studies on implementing Lean training and education online during COVID-19 under the lens of both a training provider and university education viewpoint. The changes validated best practices for virtual Lean education and training in the organisations under study, maintained post-COVID.

This research aims to establish the applicability of the International Organisation for Standardisation (ISO) 18404 standard to the service sector, identify any required amendments and identify the critical success factors and barriers to deploying the standard within the service sector.

The study used a qualitative approach by interviewing operational excellence (OPEX) professionals who work in the service sector.

The findings indicate a significant lack of knowledge about the existence of the standard and a general scepticism regarding the applicability of the current ISO 18404 standard to the service sector.

Limited examples of the application of ISO 18404 in organisations exist, as only a few organisations have adopted the standard. Therefore, the research focussed on the challenges and obstacles that experienced OPEX professionals perceived could be an issue.

The study will aid service sector organisations in understanding the standard and, subsequently, determine whether to pursue it as part of an OPEX programme. This research is the first study on the application of ISO 18404 to the service sector.

This paper outlines how Design for Lean Six Sigma methods aided a medical device manufacturing company in developing a new strategic space management and approval process for its manufacturing site.

The project demonstrates the application of the Design for Lean Six Sigma and structured Define, Measure, Analyse, Design, and Verify methodology in designing and implementing a process that enables the case study manufacturing site to improve its space utilisation and free up space.

The project was validated in one manufacturing department, and the Design for Lean Six Sigma methodology resulted in creating 15% new space for that area, with opportunities identified to free up 44.7% of the total manufacturing floor space and realise over €2.2 million cost savings as well as start to manufacture new products launched.

The manuscript highlights for the first time how the Design for Lean Six Sigma methodology can be utilised for space utilisation and can be leveraged by other manufacturers. The current study's limitations are that it is a single-site case study application. Future longitudinal case studies on Design for Lean Six Sigma application in more manufacturing space utilisation projects would be useful. This study has implications for identifying best practices for Design for Lean Six Sigma methodology application in the device industry, thus improving the state of the art for introducing new manufacturing lines.

This is the first published work to utilise Design for Lean Six Sigma methodology for space utilisation in a medical device company. This review will provide medical devices and other manufacturing organisations with recommendations on utilising Design for Lean Six Sigma and design for improved space utilisation to reduce costs.

This study aims to improve a construction company's overall project delivery by utilising lean six sigma (LSS) methods combined with building information modelling (BIM) to design, modularise and manufacture various building elements in a controlled factory environment off-site.

A case study in a construction company utilised lean six sigma (LSS) methodology and BIM to identify non-value add waste in the construction process and improve sustainability.

An Irish-based construction company manufacturing modular pipe racks for the pharmaceutical industry utilised LSS to optimise and standardise their off-site manufacturing (OSM) partners process and leverage BIM to design skids which could be manufactured offsite and transported easily with minimal on-site installation and rework required. Productivity was improved, waste was reduced, less energy was consumed, defects were reduced and the project schedule for completion was reduced.

The case study was carried out on one construction company and one construction product type. Further case studies would ensure more generalisability. However, the implementation was tested on a modular construction company, and the methods used indicate that the generic framework could be applied and customized to any offsite company.

This is one of the few studies on implementing offsite manufacturing (OSM) utilising LSS and BIM in an Irish construction company. The detailed quantitative benefits and cost savings calculations presented as well as the use of the LSM methods and BIM in designing an OSM process can be leveraged by other construction organisations to understand the benefits of OSM. This study can help demonstrate how LSS and BIM can aid the construction industry to be more environmentally friendly.

This study aims to utilise Six Sigma in an Irish-based red meat processor to reduce process variability and improve yields.

This is a case study within an Irish meat processor where the structured Define, Measure, Analyse, Improve and Control (DMAIC) methodology was utilised along with statistical analysis to highlight areas of the meat boning process to improve.

The project led to using Six Sigma to identify and measure areas of process variation. This resulted in eliminating over-trimming of meat cuts, improving process capabilities, increasing revenue and reducing meat wastage. In addition, key performance indicators and control charts, meat-cutting templates and smart cutting lasers were implemented.

The study is one of Irish meat processors' first Six Sigma applications. The wider food and meat processing industries can leverage the learnings to understand, measure and minimise variation to enhance revenue.

Organisations can use this study to understand the benefits of adopting Six Sigma, particularly in the food industry and how measuring process variation can affect quality.

This is the first practical case study on Six sigma deployment in an Irish meat processor, and the study can be used to benchmark how Six Sigma tools can aid in understanding variation, thus benefiting key performance metrics.

This project aims to optimise a secondary agricultural company’s reporting and data lifecycle by providing self-help business intelligence at an optimal price point for all business users.

A design for Lean Six Sigma approach utilising the define, measure analyse, design and verify methodology was utilised to design a new reporting and data product lifecycle.

The study found that this approach allowed a very structured delivery of a complex program. The various tools used assisted greatly in delivering results while balancing the needs of the team.

This study demonstrates how improving data analysis and enhanced intelligence reporting in agribusinesses enable better decision making and thus improves efficiencies so that the agribusiness can leverage the learnings.

Improving data analysis increases efficiency and reduces agrifood food wastage thus improving sustainability and environmental impacts.

This paper proposes creating a standardised approach to deploying Six Sigma methodology to correct both the data provisioning lifecycle and the subsequent business intelligence reporting lifecycle. It is the first study to look at process optimisation across the agricultural industry’s entire data and business intelligence lifecycle.

This study aimed to bridge the gap between the financial measurement of process improvement ideas and Lean Six Sigma measurements. It was required to increase employee engagement in process improvement initiatives.

Through both a practical and theoretical application of the Design for Lean Six Sigma methodology, the researcher was able to design a process and a benefit measuring methodology that was acceptable by finance and aligns with the benefits expected from the elimination of the Lean wastes.

The project found that benefit measurement methodology is not understood by most employees, which leads to a lack of engagement in working on improvements. The result of the study was a model for employees to identify and quantify these benefits. This has resulted in a model for cost-benefit analysis aligning financial costs with non-value add waste costs and cost of poor-quality costs resulting in increased process improvement ideas and activity.

While this study was limited to one company, applying this methodology could benefit any company experiencing the same difficulties.

This is one of the first studies to try and cost the benefits of LSS projects both from an organisational and generic viewpoint.

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.