* 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

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

In today's global economy, developing supply chain agility (SCA) and lean practices (LP) as resource-based view and dynamic capabilities are essential for firms to sustain their competitive advantage (CA) and enhance their operational performance (OP). The purpose of this paper is to develop and empirically test a framework to investigate how CA is achieved through SCA and LP and how these, in turn, can enhance a firm's OP.,For data collection, the authors adopted the survey method using self-administered questionnaires. Two-source survey data were collected in two rounds (separated by a two-month lag time) from supply chain managers, operational managers and general managers. The purpose of collecting data in two rounds was to reduce common-method bias. Likert scale (1–5) was used in the questionnaire. Smart PLS 3 and SPSS 23 were used for the data analysis purpose.,SCA was found to directly and positively affect OP. LP also positively affected OP. In addition, CA fully mediated the relationship between SCA, LP and OP.,This study encourages the managers of manufacturing firms to adapt LP and their supply chains (SCs) to become agile and leverage the advantages of their implementation to improve their OP and succeed in the market.,This study is one of the first to investigate the effect of SCA and LP on OP. Furthermore, the first study examines CA's mediating impact on the relationship between SCA, LP and OP.

The effect of supply chain agility and lean practices on operational performance: a resource-based view and dynamic capabilities perspective

There have been many literature reviews carried out on Lean implementation in larger organisations with specific focus on the automobile industry. Lean implementation in the medical device industry has not been extensively investigated. Thus, this research endeavored to analyse the benefits of Lean, tools utilised and challenges and results of Lean implementation in Medtech companies. This article aims to bridge a gap in the literature by reviewing the literature that discusses Lean implementation in MedTech companies in Ireland with a perspective of identifying the benefits and challenges faced. The quantitative methodology allows us to review the comprehensive numbers and data which were collected from 20 Enterprise Ireland MedTech case studies. There are very few published case studies in the literature on Lean due to the highly regulated nature of MedTech sector and the vast array of medical devices, which are often under privacy and confidentiality constraints. The results showed that integration of Lean has brought benefits to companies by increasing productivity and product quality, optimised cost, and time. An inclusive discussion of Lean tools for Lean implementation within MedTech was established and suggestions for future research orientations are thus provided.

https://www.mdpi.com/2227-9717/10/2/391/pdf?version=1645168439

A Review of Lean Adoption in the Irish MedTech Industry

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

John Noonan

Papers

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