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This study aims to investigate the adoption of Quality 4.0 (Q4.0) and assess the critical failure factors (CFFs) for its implementation and how its failure is measured.

A qualitative study based on in-depth interviews with quality managers and executives was conducted to establish the CFFs for Q4.0.

The significant CFFs highlighted were resistance to change and a lack of understanding of the concept of Q4.0. There was also a complete lack of access to or availability of training around Q4.0.

The study enhances the body of literature on Q4.0 and is one of the first research studies to provide insight into the CFFs of Q4.0.

Based on the discussions with experts in the area of quality in various large and small organizations, one can understand the types of Q4.0 initiatives and the CFFs of Q4.0. By identifying the CFFs, one can establish the steps for improvements for organizations worldwide if they want to implement Q4.0 in the future on the competitive global stage.

The concept of Q4.0 is at the very nascent stage, and thus, the CFFs have not been found in the extant literature. As a result, the article aids businesses in understanding possible problems that might derail their Q4.0 activities.

The 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.

A 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.

The 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.

All 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.

The 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.

There is growing recognition that effective project control systems (PCS) are critical to the success of projects. The relationship between the individual elements of PCS and successfully achieving project objectives has yet to be explored. This research investigates the enablers and barriers that influence the elements of PCS success and drive project objectives.

This study adopts a mixed approach of descriptive analysis and regression models to explore the impact of six PCS elements on project outcomes. Petroleum and chemical projects in Saudi Arabia were selected as a case study to validate the research model.

Data from a survey of 400 project managers in Saudi’s petroleum and chemical industry reveal that successful PCS are the key to achieving all project outcomes, but they are particularly critical for meeting project cost objectives. Project Governance was identified as the most important of the six PCS elements for meeting project objectives. A lack of standard processes emerged as the most significant barrier to achieving effective project governance, while having skilled and experienced project team members was the most significant enabler for implementing earned value.

The study offers a direction for implementing and developing PCS as a strategic tool and focuses on the PCS elements that can improve project outcomes.

This research contributes to project management knowledge and differs from previous attempts in two ways. Firstly, it investigates the elements of PCS that are critical to achieving project scope, schedule and cost objectives; secondly, enablers and barriers of PCS success are examined to see how they influence each element independently.