837 resultados para Good manufacturing practices


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Multiprofessional collaboration in all-day schools refers to teamwork and coordination that takes place between professionals with different vocational backgrounds. In Switzerland, all-day schoolscomprise regular school instruction and school-based extracurricular activities. Nevertheless, multiprofessional collaboration can also refer to collaboration between education professionals in all-day schools and professionals outside the school in a community-based setting of extracurricular activities. A synthesis of the literature shows that collaboration inside and outside the school setting is promoted by conditions in three areas: structural characteristics of the institution, characteristics of the team, and interpersonal processes (Schüpbach, Jutzi & Thomann 2012). In view of these findings, it was the aim of this study to analyze conditions of good collaboration practices in all-day schools in Switzerland. This qualitative study examined 10 all-day schools in five different cantons in the German-speaking part of Switzerland that showed good collaboration practice. In the course of this study, we conducted 18 problem-centered interviews and 10 focus group discussions. In the process of data evaluation, we applied the method of qualitative content analy sis. The findings show that all of the three areas of conditions promoting good collaboration proved to be relevant in the whole sample of all-day schools. Nevertheless, for the three different types of collaboration found? The school- oriented, the mixed/in termediate, and the social environment-oriented type? We identified different conditions of good collaboration practice.

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Presently, the manufacturing sector faces unprecedented levels of competition in both the domestic and international markets. This competition is mainly as a result of rapidly expanding international trade, gradual removal of protection, substantial reforms in labour markets and industrial relations, rapid technological changes and discerning customers. Intense global competition requires manufacturers to deliver products with higher quality in a shorter time. Simultaneously, owing to new technological innovations, the complexity of the products is increasing. In Australia, the impact of this intense competition and structural changes appear to be having negative effects on the manufacturing sector. This paper discusses the quality and reliability (Q & R) practices and associated drawbacks of Australian manufacturers and presents the findings of an investigation of the challenges Australian manufacturers are currently facing. The results reported in the paper are based on the data collected from a survey using the standard questionnaire. The study was driven by a conceptual model, which relates advanced quality practices to manufacturing performance and manufacturing difficulties.Evidence indicates that Q & R is the main competitive factor for Australian manufacturers. Design capability and on time delivery (OTD) came second. Results show that Australian manufacturers in general are facing some manufacturing difficulties. The relationship between advanced quality practices and company performance and manufacturing difficulties are explored. It is found that the companies who have more emphasis on advanced quality practices have fewer problems in manufacturing practices. Moreover, companies who have actively implemented the advanced quality practices have managed to improve the quality of the product continuously. The results validate the proposed hypothesis and lend credence to current thinking that improvement in Q & R is a vital tool for competitive advantage.

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Purpose: Important performance objectives manufacturers sought can be achieved through adopting the appropriate manufacturing practices. This paper presents a conceptual model proposing relationship between advanced quality practices, perceived manufacturing difficulties and manufacturing performances. Design/methodology/approach: A survey-based approach was adopted to test the hypotheses proposed in this study. The selection of research instruments for inclusion in this survey was based on literature review, the pilot case studies and relevant industrial experience of the author. A sample of 1000 manufacturers across Australia was randomly selected. Quality managers were requested to complete the questionnaire, as the task of dealing with the quality and reliability issues is a quality manager’s major responsibility. Findings: Evidence indicates that product quality and reliability is the main competitive factor for manufacturers. Design and manufacturing capability and on time delivery came second. Price is considered as the least important factor for the Australian manufacturers. Results show that collectively the advanced quality practices proposed in this study neutralize the difficulties manufacturers face and contribute to the most performance objectives of the manufacturers. The companies who have put more emphasize on the advanced quality practices have less problem in manufacturing and better performance in most manufacturing performance indices. The results validate the proposed conceptual model and lend credence to hypothesis that proposed relationship between quality practices, manufacturing difficulties and manufacturing performances. Practical implications: The model shown in this paper provides a simple yet highly effective approach to achieving significant improvements in product quality and manufacturing performance. This study introduces a relationship based ‘proactive’ quality management approach and provides great potential for managers and engineers to adopt the model in a wide range of manufacturing organisations. Originality/value: Traditional ways of checking product quality are different types of testing, inspection and screening out bad products after manufacturing them. In today’s manufacturing where product life cycle is very short, it is necessary to focus on not to manufacturing them first rather than screening out the bad ones. This study introduces, for the first time, the idea of relationship based advanced quality practices (AQP) and suggests AQPs will enable manufacturers to develop reliable products and minimize the manufacturing anomalies. This paper explores some of the attributes of AQP capable of reducing manufacturing difficulties and improving manufacturing performances. The proposed conceptual model contributes to the existing knowledge base of quality practices and subsequently provides impetus and guidance towards increasing manufacturing performance.

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Background/Aim. Mesenchymal stromal cells (MSCs) have been utilised in many clinical trials as an experimental treatment in numerous clinical settings. Bone marrow remains the traditional source tissue for MSCs but is relatively hard to access in large volumes. Alternatively, MSCs may be derived from other tissues including the placenta and adipose tissue. In an initial study no obvious differences in parameters such as cell surface phenotype, chemokine receptor display, mesodermal differentiation capacity or immunosuppressive ability, were detected when we compared human marrow derived- MSCs to human placenta-derived MSCs. The aim of this study was to establish and evaluate a protocol and related processes for preparation placenta-derived MSCs for early phase clinical trials. Methods. A full-term placenta was taken after delivery of the baby as a source of MSCs. Isolation, seeding, incubation, cryopreservation of human placentaderived MSCs and used production release criteria were in accordance with the complex regulatory requirements applicable to Code of Good Manufacturing Practice manufacturing of ex vivo expanded cells. Results. We established and evaluated instructions for MSCs preparation protocol and gave an overview of the three clinical areas application. In the first trial, MSCs were co-transplanted iv to patient receiving an allogeneic cord blood transplant as therapy for treatmentrefractory acute myeloid leukemia. In the second trial, MSCs were administered iv in the treatment of idiopathic pulmonary fibrosis and without serious adverse effects. In the third trial, MSCs were injected directly into the site of tendon damage using ultrasound guidance in the treatment of chronic refractory tendinopathy. Conclusion. Clinical trials using both allogeneic and autologous cells demonstrated MSCs to be safe. A described protocol for human placenta-derived MSCs is appropriate for use in a clinical setting, relatively inexpensive and can be relatively easily adjusted to a different set of regulatory requirements, as applicable to early phase clinical trials.

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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.

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The present paper reports the results of a study aiming to describe the attitudes of teachers in adult continuous education in the Autonomous Community of Andalusia (Spain) towards the use and integration of information and communication technologies (ITC) in the educational centres they work in, while identifying those factors that favour the development of good practice. It is a mixed methods descriptive research, and information collection techniques include a questionnaire and in-depth interviews. A total number of 172 teachers were surveyed, as well as 18 head teachers and coordinators, in adult education. For questionnaire validation the expert judgment technique was used, as they were selected by the «expert competence coefficient» or «K coefficient» procedure. To improve its psychometric properties, construct validity was determined by means of Varimax factor analysis and maximum likelihood extraction (two factors were extracted). Confidence was set by Cronbach's alpha (0.88). The interview guide was also validated by this group of experts. Results point out, on one hand, that teachers hold positive attitudes towards ICT regarding both ICT's role in professional development and their ease of use and access. On the other hand, among the most important factors for ICT-supported good educational practices lies in ICT's capacity to favour personalized work.

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The speed of manufacturing processes today depends on a trade-off between the physical processes of production, the wider system that allows these processes to operate and the co-ordination of a supply chain in the pursuit of meeting customer needs. Could the speed of this activity be doubled? This paper explores this hypothetical question, starting with examination of a diverse set of case studies spanning the activities of manufacturing. This reveals that the constraints on increasing manufacturing speed have some common themes, and several of these are examined in more detail, to identify absolute limits to performance. The physical processes of production are constrained by factors such as machine stiffness, actuator acceleration, heat transfer and the delivery of fluids, and for each of these, a simplified model is used to analyse the gap between current and limiting performance. The wider systems of production require the co-ordination of resources and push at the limits of human biophysical and cognitive limits. Evidence about these is explored and related to current practice. Out of this discussion, five promising innovations are explored to show examples of how manufacturing speed is increasing—with line arrays of point actuators, parallel tools, tailored application of precision, hybridisation and task taxonomies. The paper addresses a broad question which could be pursued by a wider community and in greater depth, but even this first examination suggests the possibility of unanticipated innovations in current manufacturing practices.

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Currently the market requires companies to adapt for they can have the lowest possible cost in their manufacturing, be it a good or service, thus obtaining a greater profit. For this profit the Toyota Production System applies lean manufacturing practices actions with reduced spending, smaller lots and stocks, generated by market demand. The technique allows SMED with few actions, changes and investments that time does not exceed one digit on your total time. This case study shows that only with standardization and use of inexpensive improvements, could reduce setup time on a machine for 70 minutes to time of approximately 48 minutes with little investment, demonstrating the viability of the tool presented

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Purpose – The purpose of this paper is to present the results of a success story involving the extending of lean manufacturing practices between a focal firm and its supplier, both located in Brazil, thereby configuring a case of excellence. Design/methodology/approach – An in-depth case study was conducted involving two companies: Company A, focal, leader in its segment, located in Brazil; and Company B, Company A's supplier, also located in Brazil. Findings – Results indicate there are several mechanisms for extending lean manufacturing practices in the supply chain, such as workshops, training, and integrated teams. These mechanisms are shown and guidelines are also introduced for companies seeking to successfully extend lean manufacturing practices. Originality/value – An original use of define, measure, analyze, improve, control for structuring the extending of lean manufacturing practices to suppliers and, consequently, the importance of the lean six-sigma relationship in this context. Furthermore, the guidelines introduced serve as a benchmark for other companies interested in the topic.

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Most consumers consider complementary and alternative medicine (CAM) products inherently safe. The growing simultaneous use of CAM products and pharmaceutical drugs by Australian consumers increases the risk of CAM-drug interactions. The Therapeutic Goods Administration (TGA) has a two-tier, risk-based regulatory system for therapeutic goods - CAM products are regulated as low risk products and are assessed for quality and safety; and sponsors of products must hold the evidence for any claim of efficacy made about them. Adverse reactions to CAM products can be classified as intrinsic (innate to the product), or extrinsic (where the risk is not related to the product itself, but results from the failure of good manufacturing practice). Adverse reactions to CAM practices can be classified as risks of commission (which includes removal of medical therapy) and risks of omission (which includes failure to refer when appropriate). While few systematic studies of adverse events with CAM exist, and under-reporting is likely, most CAM products and practices do not appear to present a high risk; their safety needs to be put into the perspective of wider safety issues. A priority for research is to rigorously define the risks associated with both CAM products and practices so that their potential impact on public health can be assessed.

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Redistributed manufacturing is an emerging concept which captures the anticipated reshoring and localisation of production from large scale manufacturing plants to smaller-scale localised, customisable production units, largely driven by new additive digital production technologies. Critically, community based digital fabrication workshops, or makespaces, are anticipated to be the hothouse for this new era of localised production and as such are key to future sustainable design and manufacturing practices. In parallel, the concept of the circular economy (CE) conceptualises the move from a linear economy of take-make-waste to a closed loop system, through repair, remanufacturing, refurbishment and recycling which maintains the value of materials and resources. Despite the clear interplay between RdM and CE, there is limited research exploring this relationship. In light of these interconnected developments, the aim of this paper is to explore the role of makespaces in contributing to a circular economy through RdM activities. This is achieved through six semi-structured interviews with thought leaders on these topics. The research findings identify barriers and opportunities to both CE and RdM, uncover key overlaps between CE and RdM, and identify a range of future research directions that can support the coming together of these areas. The research contributes to a wider conversation on embedding circular practices within makespaces and their role in RdM.

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Redistributed manufacturing is an emerging concept which captures the anticipated reshoring and localisation of production from large scale mass manufacturing plants to smaller-scale localised, customisable production units, largely driven by new digital production technologies. Critically, community-based digital fabrication workshops, or makespaces, are anticipated to be one hothouse for this new era of localised production and as such are key to future sustainable design and manufacturing practices. In parallel, the concept of the circular economy conceptualises the move from a linear economy of take-make-waste to a closed loop system, through repair, remanufacturing, and recycling to ultimately extend the value of products and materials. Despite the clear interplay between redistributed manufacturing and circular economy, there is limited research exploring this relationship. In light of these interconnected developments, the aim of this paper is to explore the role of makespaces in contributing to a circular economy through redistributed manufacturing activities. This is achieved through six semi-structured interviews with thought leaders on these topics. The research findings identify barriers and opportunities to both circular economy and redistributed manufacturing, uncover overlaps between circular economy and redistributed manufacturing, and identify a range of future research directions that can support the coming together of these areas. The research contributes to a wider conversation on embedding circular practices within makespaces and their role in redistributed manufacturing.

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Currently, well-established clinical therapeutic approaches for bone reconstruction are restricted to the transplantation of autografts and allografts, and the implantation of metal devices or ceramic-based implants to assist bone regeneration. Bone grafts possess osteoconductive and osteoinductive properties, however they are limited in access and availability and associated with donor site morbidity, haemorrhage, risk of infection, insufficient transplant integration, graft devitalisation, and subsequent resorption resulting in decreased mechanical stability. As a result, recent research focuses on the development of alternative therapeutic concepts. The field of tissue engineering has emerged as an important approach to bone regeneration. However, bench to bedside translations are still infrequent as the process towards approval by regulatory bodies is protracted and costly, requiring both comprehensive in vitro and in vivo studies. The subsequent gap between research and clinical translation, hence commercialization, is referred to as the ‘Valley of Death’ and describes a large number of projects and/or ventures that are ceased due to a lack of funding during the transition from product/technology development to regulatory approval and subsequently commercialization. One of the greatest difficulties in bridging the Valley of Death is to develop good manufacturing processes (GMP) and scalable designs and to apply these in pre-clinical studies. In this article, we describe part of the rationale and road map of how our multidisciplinary research team has approached the first steps to translate orthopaedic bone engineering from bench to bedside byestablishing a pre-clinical ovine critical-sized tibial segmental bone defect model and discuss our preliminary data relating to this decisive step.

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Polyfluoroalkyl chemicals (PFCs) have been used worldwide for more than 50 years in a wide variety of industrial and consumer products. Limited data exist on human exposure to PFCs in the Southern Hemisphere. Human blood serum collected in southeast Queensland, Australia, in 2006−2007 from 2420 donors was pooled according to age (cord blood, 0−0.5, 0.6−1, 1.1−1.5, 1.6−2, 2.1−2.5, 2.6−3, 3.1−3.5, 3.6−4, 4.1−6, 6.1−9, 9.1−12, 12.1−15, 16−30, 31−45, 46−60, and >60 years) and gender and was analyzed for eight PFCs. Across all pools, perfluorooctane sulfonate (PFOS) was detected at the highest mean concentration (15.2 ng/mL) followed by perfluorooctanoate (PFOA, 6.4 ng/mL), perfluorohexane sulfonate (PFHxS, 3.1 ng/mL), perfluorononanoate (PFNA, 0.8 ng/mL), 2-(N-methyl-perfluorooctance sulfonamide) acetate (Me-PFOSA-AcOH, 0.66 ng/mL), and perfluorodecanoate (PFDeA, 0.29 ng/mL). Perfluorooctane sulfonamide was detected in only 24% of the pools, and 2-(N-ethylperfluorooctane sulfonamide) acetate was detected in only one. PFOS concentrations were significantly higher in pools from adult males than from adult females (p = 0.002); no gender differences were apparent in the pools from children (<12 years old). The highest mean concentrations of PFOA, PFHxS, PFNA, PFDeA, and Me-PFOSA-AcOH were found in children <15 years, while PFOS was highest in adults >60 years. Investigation into the sources and exposure pathways in Australia, in particular for children, is necessary as well as continued biomonitoring to determine the potential effects on human concentrations as a result of changes in the PFC manufacturing practices, including the cessation of production of several PFCs.

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Seventy-six librarians participated in a series of focus groups in support of research exploring the skills, knowledge and attributes required by the contemporary library and information professional in a world of every changing technology. The project was funded by the Australian Learning and Teaching Council. Text data mining analysis revealed three main thematic clusters (libraries, people, jobs) and one minor thematic cluster (community). Library 2.0 was broadly viewed by participants as being about change whilst librarian 2.0 was perceived by participants as not a new creation but just about good librarian practices. Participants expressed the general belief that personality traits, not just qualifications, were critical to be a successful librarian or information worker in the future.