* Starting from Need* Evolution of the Toyota Production System* Further Development* Genealogy of the Toyota Production System* The True Intention of the Ford System* Surviving the Low-Growth Period

Toyota production system : beyond large-scale production

Quality 4.0 corresponds to the growing digitisation of industry, which uses advanced technologies to enhance the quality of manufacturing and services. This fourth quality revolution is envisaged to digitise the entire quality systems and subsequently improve the existing quality approaches. Innovative industries adopt cloud-based quality 4.0 innovations in the controlled production process. It is used to resolve quality problems satisfactorily when they emerge and carry out real-time quality analyses to improve competitiveness and use them. Various ongoing challenges are take-over by Quality 4.0 technologies, such as automated root cause analysis, machine-to-machine connectivity to parameter auto adjustment, simulation of real-time processes and more. Quality 4.0 is a modern form of quality management. Digital technologies paired with more sophisticated methods and smarter processes will allow high-performance teams to provide consumers with high-performance and quality goods reliably. Sensors play an essential role in improving the quality of manufacturing and services. These can improve protection, increased internal productivity and sustainable operations. This paper provides how quality 4.0 will have a significant impact in the field of manufacturing. Various Key Aspects and enablers of Quality 4.0 for Manufacturing are discussed, finally, Identified and discussed eighteen significant applications of Quality 4.0 in the field of manufacturing. Quality 4.0 not only concerns the things happening inside a factory; it also includes the complete supply chain from Research and Development (R&D), manufacturing, development, distribution, sales, and service after-sales.

Significance of Quality 4.0 towards comprehensive enhancement in manufacturing sector

PurposeQuality 4.0 has a unique potential to create a competitive advantage for organisations by improving customer experience and enhancing profitability. The purpose of this study is to examine Quality 4.0, the9; benefits, motivating factors, critical success factors and the skills required by quality professionals in the successful implementation of Quality 4.0. The study also investigates the organisational readiness factors9 and challenges that need to be addressed before Quality 4.0 adoption and assess their importance.Design/methodology/approachA qualitative interview approach was utilised by interviewing a panel of senior management, engineering and continuous improvement (CI); professionals working in leading companies in Asia, Europe and America who are currently deploying Quality 4.0.FindingsThis study provides a theoretical base for the Quality 4.0 body of knowledge in terms of an organisation’s adoption and overcoming implementation challenges and providing examples of Quality 4.0 application. Organisations can use this study to understand what Quality 4.0 means to industry, the benefits and motivating factors for implementing, the Critical Success Factors, challenges, the organisational readiness factors and the role of leadership in a Quality 4.0 deployment. In addition, the study looks at the skills required by future Quality 4.0 professionals in terms of hard skills, soft skills and a curriculum for educating future quality management professionals. The respondents cited that predictive analytics, sensors and tracking, and electronic feedback loops are the most critical technologies for driving Quality 4.0.Research limitations/implicationsOne of the limitations of this research was that as this area is a nascent area the researchers were limited in their literature review. The second limitation was that the study was based on 12 interviews. A more comprehensive longitudinal study would yield more data so that better and robust conclusions can be derived from the study.Originality/valueThis is the first empirical study on Quality 4.0, which captures the viewpoints of senior management professionals on a full range of topics related to Quality 4.0 motivation for deployment, implementation and readiness for its adoption.

Quality 4.0 conceptualisation and theoretical understanding: a global exploratory qualitative study

PurposeThe 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.Design/methodology/approachA 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.FindingsThe 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.Research limitations/implicationsAll 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.Originality/valueThe 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.

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Critical failure factors for continuous improvement methodologies in the Irish MedTech industry

Worldwide, industries are emphasizing the development of an agile system to sustain higher productivity, which can be applied to ensure improvements in all production conditions in industry 4.0. In the present scenario, several methods are used for improvements in production, such as value stream mapping, kaizen, just in time, Kanban, and total productive maintenance, etc., The objective of the present research article is to produce an agile system to sustain improvements in productivity through a methodology coupled with value stream mapping in industry 4.0. Value stream mapping is a lean-based method and is used for the maximization of productivity by the elimination of non-value-added activities. The proposed methodology has been validated by productivity enhancements achieved in a case study of the earthmoving machinery manufacturing sector. The study establishes that the proposed methodology would encourage industry personnel during decision-making processes, which would lead to improvements in production in industry 4.0.

An Agile System to Enhance Productivity through a Modified Value Stream Mapping Approach in Industry 4.0: A Novel Approach

This research examines a case study on the implementation of an effective approach to advanced Lean Six Sigma problem-solving within a pharmaceutical manufacturing site which manufactures acetaminophen (paracetamol containing pain relief) tablets. Though this study was completed in a single manufacturing company, the implementation of this study delivers important application and results that can be deployed in other such manufacturing companies. The manufacturing site faced backlogs in customer orders due to increased demand. Increased demand is due to brand popularity and recognition, product efficacy and a COVID 19 pandemic that intensified the demand for pain relief tablets in an already very busy site. With increased demand, to ensure timely deliveries, customer satisfaction and minimize delays, sources of site productivity losses and wastes needed to be analyzed and reduced or eliminated. Manufacturing Packaging line downtime was identified as one area of concern. The goal of the research was to introduce a problem-solving technique to reduce downtime within a manufacturing site without affecting the production required to fulfil customer demand while increasing product quality. The research utilized an integrated LSS methodology which identifies, stratifies and effectively eliminates non-value adding (waste) activities, by following a 7-step customized problem-solving methodology which resulted in complete elimination of the issue under investigation and savings of just under half a million dollars. The learnings are being deployed and leveraged worldwide across the pharmaceutical organizations parent site and sister sites. The presented results demonstrated that Lean Six Sigma methodology and tools are effective for accurate root causing of problems and enablers of implementation of continuous improvement.

https://www.mdpi.com/2227-9717/9/3/550/pdf

Applying Lean Six Sigma methodology to a pharmaceutical manufacturing facility: A case study

Quality 4.0 is the new buzzword among quality professionals. There has been no empirical study of Quality 4.0 yet. Hence, the purpose of this paper is to investigate what are the motivations, barriers and readiness factors for Quality 4.0 implementation.,This study uses an online survey on senior quality professionals working in leading companies in Europe and America. In total, 50 participants participated in this study.,This study finds the top five motivating, barriers and readiness factors for Quality 4.0 implementation. These factors are ranked in terms of the order of importance as perceived by senior quality professionals.,This is the first empirical study on Quality 4.0 that investigates the motivation, barriers and readiness factors of Quality 4.0. This study provides a theoretical base of Quality 4.0 body of knowledge in terms of its practical relevance and adoption in modern-day organizations.,Organizations can use this study to understand what the motivation and barriers for implementing Quality 4.0. In addition, before implementation of Quality 4.0, the readiness factor for Quality 4.0 can be used by organizations to evaluate their preparedness before the actual implementation of the initiative.,This is the first empirical study on Quality 4.0 that captures the viewpoints of senior quality professionals on the motivation, barriers and readiness factors of Quality 4.0.

Motivations, barriers and readiness factors for Quality 4.0 implementation: an exploratory study

Organizations use Industry 4.0 readiness models to evaluate their preparedness prior to the implementation of Industry 4.0. Though there are many studies on Industry 4.0 readiness models, the dimensions of readiness differ. Besides, there is no study empirically validating the readiness model in different sectors or types of organization. The purpose of this study is to conceptualize the dimensions of the Industry 4.0 readiness model and subsequently evaluate the criticality of these dimensions in manufacturing, service, small and medium-sized enterprises (SMEs) and large enterprises (LEs).,The study uses an exploratory sequential mixed method design. In phase one, 37 senior managers participated through a purposive sampling frame. In phase two, 70 senior managers participated in an online survey.,The results of the study indicated that the Industry 4.0 readiness model has 10 dimensions. Further, the criticality of the dimensions as applied to different sectors and type of organizations is put forward. This study will help manufacturing, services, SMEs and LEs to evaluate Industry 4.0 readiness before commencing the deployment of Industry 4.0.,The findings can be very beneficial for Industry 4.0 practitioners and senior managers in different organisations to understand what readiness dimensions need to be considered prior to implementation of Industry 4.0 technology.,This paper makes an attempt to conceptualize the Industry 4.0 readiness model and utilizes an exploratory mixed method for critically evaluating the dimensions related to the model.

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Conceptualizing Industry 4.0 readiness model dimensions: an exploratory sequential mixed-method study

PurposeThis paper aims to present the results of a study carried out by the authors in the form of research interviews on the topic: “Exploring the use of operational excellence methodologies in the era of COVID-19.”Design/methodology/approachA qualitative interview approach was utilized by interviewing a panel of leading academics and practitioners who are familiar with operation excellence methodologies.FindingsOperational excellence methodologies are proven and can be utilized in pandemic situations to improve efficiency in the healthcare system and preparedness for pandemics.Research limitations/implicationsOne limitation of this research was that most of the interviewees who participated in this study came from Europe, North America, South America and Asia, representing four continents. It would have been better to have different views from other continents such as Australia and Africa. Also, the interviews were short and at a high level. There is an opportunity for further study and analysis.Practical implicationsOperational excellence methodologies are proven and can be utilized in pandemic situations to improve efficiency in the healthcare system and preparedness for pandemics.Originality/valueThe paper provides an excellent resource for those people to get an insight into the value of the application of operations excellence methodologies in pandemic situations to aid healthcare process improvement and aid public and patient safety.

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Olivia McDermott

Papers

Applying Lean Six Sigma methodology to a pharmaceutical manufacturing facility: A case study

Motivations, barriers and readiness factors for Quality 4.0 implementation: an exploratory study

Conceptualizing Industry 4.0 readiness model dimensions: an exploratory sequential mixed-method study

Quality 4.0 conceptualisation and theoretical understanding: a global exploratory qualitative study

Exploring the use of operational excellence methodologies in the era of COVID-19: perspectives from leading academics and practitioners