11 resultados para Good manufacturing practices
em Cambridge University Engineering Department Publications Database
Resumo:
BACKGROUND: The utilisation of good design practices in the development of complex health services is essential to improving quality. Healthcare organisations, however, are often seriously out of step with modern design thinking and practice. As a starting point to encourage the uptake of good design practices, it is important to understand the context of their intended use. This study aims to do that by articulating current health service development practices. METHODS: Eleven service development projects carried out in a large mental health service were investigated through in-depth interviews with six operation managers. The critical decision method in conjunction with diagrammatic elicitation was used to capture descriptions of these projects. Stage-gate design models were then formed to visually articulate, classify and characterise different service development practices. RESULTS: Projects were grouped into three categories according to design process patterns: new service introduction and service integration; service improvement; service closure. Three common design stages: problem exploration, idea generation and solution evaluation - were then compared across the design process patterns. Consistent across projects were a top-down, policy-driven approach to exploration, underexploited idea generation and implementation-based evaluation. CONCLUSIONS: This study provides insight into where and how good design practices can contribute to the improvement of current service development practices. Specifically, the following suggestions for future service development practices are made: genuine user needs analysis for exploration; divergent thinking and innovative culture for idea generation; and fail-safe evaluation prior to implementation. Better training for managers through partnership working with design experts and researchers could be beneficial.
Resumo:
Validation is important in the design, development and production of medical devices since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations.
Resumo:
Sir John Egan’s 1998 report on the construction industry (Construction Task Force 1998) noted its confrontational and adversarial nature. Both the original report and its subsequent endorsement in Accelerating Change (Strategic Forum 2002) called for improved working relationships—so-called ‘integration’—within and between both design and construction aspects. In this paper, we report on our observations of on-site team meetings for a major UK project during its construction phase. We attended a series of team meetings and recorded the patterns of verbal interaction that took place within them. In reporting our findings, we have deliberately used a graphical method for presenting the results, in the expectation that this will make them more readily accessible to designers. Our diagrams of these interaction patterns have already proved to be intuitively and quickly understood, and have generated interest and discussion among both those we observed and others who have seen them. We noted that different patterns of communication occurred in different types of meetings. Specifically, in the problem-solving meeting, there was a richness of interaction that was largely missing from progress meetings and technical meetings. Team members expressed greater satisfaction with this problem-solving meeting where these enriched exchanges took place. By making comparisons between the different patterns, we are also able to explore functional roles and their interactions. From this and other published evidence, we conclude that good teamworking practices depend on a complex interplay of relations and dependencies embedded within the team.
Resumo:
This article explores risk management in global industrial investment by identifying linkages and gaps between theories and practices. It identifies opportunities for further development of the field. Three related bodies of literature have been reviewed: risk management, global manufacturing and investment. The review suggests that risk management in global manufacturing is overlooked in the literature; that existing theoretical risk management processes are not well developed in the global manufacturing context and that the investment literature applies mainly to financial risk assessment rather than investment risk management structures. Further, there appears to be a serious lack of systematic industrial risk management in investment decision making. This article highlights the opportunities to deploy current good practices more effectively as well as the need to develop more robust theories of industrial investment risk management. The approach adopted to investigate this multidisciplinary topic included a historical review of literature to understand the diverse background of theoretical development. A case study research approach was adopted to collect data, involving four global manufacturing companies and one risk management advisory company to observe the patterns and rationale of current practices. Supporting arguments from secondary data sources reinforced the findings. The research focuses risk management in global industrial investment. It links theories with practice to understand the existing knowledge gap and proposes key research themes for further research. © 2013 Macmillan Publishers Ltd. 1460-3799 Risk Management.