Angelo Rosa, Giuliano Marolla and Olivia McDermott
This study explores how Lean was deployed in several hospitals in the Apulia region in Italy over 3.5 years.
Abstract
Purpose
This study explores how Lean was deployed in several hospitals in the Apulia region in Italy over 3.5 years.
Design/methodology/approach
An exploratory qualitative design was drawn up based on semi-structured interviews.
Findings
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.
Practical implications
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.
Originality/value
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.
Details
Keywords
Olivia McDermott and Breda Kearney
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…
Abstract
Purpose
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.
Design/methodology/approach
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.
Findings
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.
Practical implications
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.
Originality/value
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.
Details
Keywords
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…
Abstract
Purpose
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.
Design/methodology/approach
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.
Findings
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.
Practical implications
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.
Originality/value
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.
Details
Keywords
Olivia McDermott, Aneta Magdalena Wojcik, Anna Trubetskaya, Michael Sony, Jiju Antony and Manjeet Kharub
This study investigates the readiness for and understanding of Industry 4.0 in a pharmaceutical manufacturer.
Abstract
Purpose
This study investigates the readiness for and understanding of Industry 4.0 in a pharmaceutical manufacturer.
Design/methodology/approach
Utilising qualitative interviews within a single-site case study in a pharmaceutical organisation, the understanding of Industry 4.0 and the challenges, benefits and critical success factors for Industry 4.0 readiness therein and applications of Industry 4.0 are assessed.
Findings
The research findings found that Industry 4.0 implementation has implications for regulatory compliance and enhancing operational excellence on the site. The Pharma site is embracing Industry 4.0 technologies, particularly for paperless systems and data collation and analytics, but the site is somewhat of a late adaptor of Industry 4.0 implementation and is on a path towards increased digitalisation.
Research limitations/implications
A limitation of the study is that it is a single-site case study, but the results can be generalisable in demonstrating how Industry 4.0 is being deployed and its challenges and benefits.
Originality/value
This study is unique and novel because to the authors knowledge, it is one of the first studies on Industry 4.0 readiness and status in an Irish Pharma site within a single pharmaceutical organisation. This study can be leveraged and benchmarked by all pharmaceutical organisations as it demonstrates the complexity of Industry 4.0 deployment from a highly regulated and complex pharmaceutical manufacturing and processing viewpoint.
Details
Keywords
Anna Trubetskaya, Olivia McDermott and Anthony Ryan
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…
Abstract
Purpose
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.
Design/methodology/approach
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.
Findings
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.
Research limitations/implications
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.
Originality/value
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.
Details
Keywords
José Carlos Vieira De Sá, Francisco J. G. Silva, José Dinis-Carvalho and Olivia McDermott
Olivia McDermott, Kevin ODwyer, John Noonan, Anna Trubetskaya and Angelo Rosa
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…
Abstract
Purpose
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.
Design/methodology/approach
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.
Findings
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.
Research limitations/implications
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.
Originality/value
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.
Rebecca Gilligan, Rachel Moran and Olivia McDermott
This study aims to utilise Six Sigma in an Irish-based red meat processor to reduce process variability and improve yields.
Abstract
Purpose
This study aims to utilise Six Sigma in an Irish-based red meat processor to reduce process variability and improve yields.
Design/methodology/approach
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.
Findings
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.
Research limitations/implications
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.
Practical implications
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.
Originality/value
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.
Details
Keywords
Michael Sony, Mariam Ali Ramadan, Jiju Antony, Maha Khalifa Al Dhaheri, Olivia McDermott and Elizabeth A. Cudney
This research aims to establish the applicability of the International Organisation for Standardisation (ISO) 18404 standard to the service sector, identify any required…
Abstract
Purpose
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.
Design/methodology/approach
The study used a qualitative approach by interviewing operational excellence (OPEX) professionals who work in the service sector.
Findings
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.
Research limitations/implications
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.
Originality/value
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.
Details
Keywords
Anna Trubetskaya, Olivia McDermott, Pierre Durand and Daryl John Powell
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…
Abstract
Purpose
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.
Design/methodology/approach
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.
Findings
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.
Practical implications
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.
Social implications
Improving data analysis increases efficiency and reduces agrifood food wastage thus improving sustainability and environmental impacts.
Originality/value
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.