Numerous deaths, tragedies, and underreported drug side effects occur in outsourced clinical trials. Total quality system breakdowns occur even though quality agreement contracts and quality management systems are used by pharmaceutical organizations. The purpose of this single case study was to explore strategies clinical quality assurance managers use to avoid breakdowns in quality with outsourced clinical trials in Asia-Pacific countries. The study included a purposeful sample of 15 clinical quality assurance managers from 1 pharmaceutical organization located in the Northeast region of the United States. The conceptual framework was von Bertalanffy's general systems theory. Face-to-face semistructured interviews or e-mail questionnaires containing open-ended questions were used to gather data from clinical quality assurance managers who had a minimum of 5 years of experience with outsourced clinical trials. Coded data and themes were identified through the modified van Kaam method. The three emergent themes were the following: vendor quality management, building quality in outsourced clinical trials, and quality management systems. Results of the study may contribute to social change by helping pharmaceutical organizations' leaders develop strategies and tools to improve the quality of outsourced clinical trials.

Public Health Management Personnel‘s Attitude Towards the Implementation of the Quality System in a Hospital Reda Ambrazeviciene Scientific adviser Dr. Ilona Buciuniene Kaunas Medical University, Public Health Faculty, Department of Social Medicine.- Kaunas, 2005.-75 p. Aim of the work. To analyse personnel‘s attitude towards the implementation of the quality system in a hospital. Tasks. To estimate the level of the personnel participation in the implementation of the quality system and the attitude toward patients; as well as participation in the process of health care provision; to find out personnel’s attitude towards the main quality system’s documents that describe the work process; to give the recommendations of how to improve the implementation of the quality system in the surgery departments in hospitals. Methodics of the Research. Object of the research – personnel‘s of the surgery departments attitude towards quality improvement. Research methods – analysis of the newest Lithuanian and foreign scientific literature and juridical documents, questioning the personnel. Questionnaire was given to personnel members at the surgery department; the return rate was 69,93 per cent. Methods of the statistical analysis – statistical significance of the data was measured by the criteria χ², number of the freedom degree (df) and the statistical significance. Responses to the questions and statements were analysed by the method of averages. Difference between several different... [to full text]

Este trabalho descreve a implantação de um Sistema da Qualidade a partir da implementação das Boas Praticas de Fabricação e Controle em uma empresa farmacêutica em fase de importantes mudanças estratégicas, acompanhando a sua evolução no período compreendido entre setembro de 2001 a dezembro de 2003. A revisão bibliográfica contextualiza a empresa no cenário da indústria farmacêutica atual e reforça a idéia da complexidade de fatores envolvidos na implementação de um sistema de qualidade, como a cultura organizacional e o uso de ferramentas gerenciais. O embasamento teórico centra a pesquisa na literatura sobre o gerenciamento da qualidade, sistemas de medição e indicadores de desempenho. A pesquisa propôs um modelo que utiliza a medição de desempenho como suporte estratégico na implementação do Sistema da Qualidade e aplica este modelo no período da pesquisa. Os resultados indicam que o uso dos indicadores de desempenho como balizadores da execução da estratégia e como controladores das ações planejadas é uma ferramenta útil, mesmo dissociada de um sistema de medição corporativo. As medidas forneceram informações estratégicas, proporcionado oportunidades constantes de melhorias e correções no curso das implementações baseadas nas mudanças de cenário ou nas descobertas de novos fatores críticos. / This report has the purpose to introduce how the Quality System was implemented in a pharmaceutical company in a phase of significant strategic changes, following its evolution in the period from September 2001 to December 2003. A literature review was performed to situate the company in the current scenario of the pharmaceutical industry and to reinforce the intrinsic complexity involved in the establishment of a Quality System, as the organizational culture and the use of managerial tools. The theory construction concentrates the research in the literature regarding Quality Management, Performance Indicators and Measurement Systems. The methodology proposed includes performance measurement as a strategic support to the Quality System. The results has proven that the performance indicators are a useful to01 and can be use as delimitators of the establishment strategy and as controllers of planned actions, even when dissociated from the corporation rneasurement system. The measurernents are strategic feedback and create opportunities to improvements and to correct the course of the establishrnent in agreement with the scenery changes or new critical factors discoveries.

Este trabalho descreve a implantação de um Sistema da Qualidade a partir da implementação das Boas Praticas de Fabricação e Controle em uma empresa farmacêutica em fase de importantes mudanças estratégicas, acompanhando a sua evolução no período compreendido entre setembro de 2001 a dezembro de 2003. A revisão bibliográfica contextualiza a empresa no cenário da indústria farmacêutica atual e reforça a idéia da complexidade de fatores envolvidos na implementação de um sistema de qualidade, como a cultura organizacional e o uso de ferramentas gerenciais. O embasamento teórico centra a pesquisa na literatura sobre o gerenciamento da qualidade, sistemas de medição e indicadores de desempenho. A pesquisa propôs um modelo que utiliza a medição de desempenho como suporte estratégico na implementação do Sistema da Qualidade e aplica este modelo no período da pesquisa. Os resultados indicam que o uso dos indicadores de desempenho como balizadores da execução da estratégia e como controladores das ações planejadas é uma ferramenta útil, mesmo dissociada de um sistema de medição corporativo. As medidas forneceram informações estratégicas, proporcionado oportunidades constantes de melhorias e correções no curso das implementações baseadas nas mudanças de cenário ou nas descobertas de novos fatores críticos. / This report has the purpose to introduce how the Quality System was implemented in a pharmaceutical company in a phase of significant strategic changes, following its evolution in the period from September 2001 to December 2003. A literature review was performed to situate the company in the current scenario of the pharmaceutical industry and to reinforce the intrinsic complexity involved in the establishment of a Quality System, as the organizational culture and the use of managerial tools. The theory construction concentrates the research in the literature regarding Quality Management, Performance Indicators and Measurement Systems. The methodology proposed includes performance measurement as a strategic support to the Quality System. The results has proven that the performance indicators are a useful to01 and can be use as delimitators of the establishment strategy and as controllers of planned actions, even when dissociated from the corporation rneasurement system. The measurernents are strategic feedback and create opportunities to improvements and to correct the course of the establishrnent in agreement with the scenery changes or new critical factors discoveries.

Este trabalho descreve a implantação de um Sistema da Qualidade a partir da implementação das Boas Praticas de Fabricação e Controle em uma empresa farmacêutica em fase de importantes mudanças estratégicas, acompanhando a sua evolução no período compreendido entre setembro de 2001 a dezembro de 2003. A revisão bibliográfica contextualiza a empresa no cenário da indústria farmacêutica atual e reforça a idéia da complexidade de fatores envolvidos na implementação de um sistema de qualidade, como a cultura organizacional e o uso de ferramentas gerenciais. O embasamento teórico centra a pesquisa na literatura sobre o gerenciamento da qualidade, sistemas de medição e indicadores de desempenho. A pesquisa propôs um modelo que utiliza a medição de desempenho como suporte estratégico na implementação do Sistema da Qualidade e aplica este modelo no período da pesquisa. Os resultados indicam que o uso dos indicadores de desempenho como balizadores da execução da estratégia e como controladores das ações planejadas é uma ferramenta útil, mesmo dissociada de um sistema de medição corporativo. As medidas forneceram informações estratégicas, proporcionado oportunidades constantes de melhorias e correções no curso das implementações baseadas nas mudanças de cenário ou nas descobertas de novos fatores críticos. / This report has the purpose to introduce how the Quality System was implemented in a pharmaceutical company in a phase of significant strategic changes, following its evolution in the period from September 2001 to December 2003. A literature review was performed to situate the company in the current scenario of the pharmaceutical industry and to reinforce the intrinsic complexity involved in the establishment of a Quality System, as the organizational culture and the use of managerial tools. The theory construction concentrates the research in the literature regarding Quality Management, Performance Indicators and Measurement Systems. The methodology proposed includes performance measurement as a strategic support to the Quality System. The results has proven that the performance indicators are a useful to01 and can be use as delimitators of the establishment strategy and as controllers of planned actions, even when dissociated from the corporation rneasurement system. The measurernents are strategic feedback and create opportunities to improvements and to correct the course of the establishrnent in agreement with the scenery changes or new critical factors discoveries.

As an efficient filter of airborne Hg compounds, forests retain a significant portion of the Hg deposited to the land. Forested watersheds have been identified as major sources of low-concentration Hg compounds to surrounding streams and lakes. Mercury export from forests is highly variable in both space and time. It is difficult to use field surveys alone to capture the spatiotemporal variation inherent in this variable. Mathematical models are required for improved representation. The objective of this Thesis is to develop and test a monthly dynamic model that can be used to estimate seasonal Hg export from forested watersheds to low-ordered forest streams. The fully developed model consists of four model components: (i) a forest hydrology component, to simulate variation in soil temperature, soil moisture, and stream discharge for input to the other model components; (ii) a forest nutrient cycling and biomass growth component, to simulate forest growth and litter production; (iii) a forest litter decomposition component, to simulate seasonal production of dissolved organic carbon (DOC); and (iv) a monthly DOC and Hg export component to simulate the translocation of DOC and Hg from forested watersheds to low-ordered streams. The Hg-export component incorporates an Hg-to-DOC binding coefficient estimated from a one-time stream survey of Hg and DOC concentrations. Simulations of in-stream Hg concentrations show two main trends: (i) an annual trend, associated with the seasonal (monthly) dynamics of forest litter production, decomposition, and DOC production and export, and (ii) a multiple-year trend, associated with forest harvesting and re-growth patterns of regenerating forests. This study demonstrates that (i) wetland- and conifer-dominated watersheds release a greater amount of Hg to aquatic ecosystems than upland- and deciduous species-dominated watersheds, and (ii) forests nearing maturity, export more Hg than young forests.

The objective of this diploma thesis is to recommend an optimal way of creating a reliable quality assessment system for products of crop and livestock origin. The selected companies have been searched for key aspects of these systems and evaluated. Further, the certification of quality systems in the Czech Republic was also examined.

The diploma thesis deals with the area of quality of further education. It focuses in detail on the concepts of quality of further education, standardized quality management systems at international level (ISO 9000, EFQM Model Excellence) and specific systems used abroad (Swiss model eduQua and German model LQW). The work focuses on specific concepts and proposals of quality education systems developed and implemented in the Czech Republic. The output of the thesis is an analysis of selected concepts (National Qualification System, Project Concept, Quality in Further Professional Education), critical assessment of their form (methods, methodology) and reflection of their implementation into practice and impacts on quality in further education. The thesis links the theoretical knowledge with the practice of solution of system quality assurance in further education. Key words: quality, further education, quality in further education, quality systems, ISO 9000, EFQM Excelence Model

The diploma thesis deals with the area of quality of further education. It focuses in detail on the concepts of quality of further education, standardized quality management systems at international level (ISO 9000, EFQM Model Excellence) and specific systems used abroad (Swiss model eduQua and German model LQW). The work focuses on specific concepts and proposals of quality education systems developed and implemented in the Czech Republic. The output of the thesis is an analysis of selected concepts (National Qualification System, Project Concept, Quality in Further Professional Education), critical assessment of their form (methods, methodology) and reflection of their implementation into practice and impacts on quality in further education. The thesis links the theoretical knowledge with the practice and on their basis it presents its own proposal of possibilities of solution of system quality assurance in further education. Key words: quality, further education, quality in further education, quality systems, ISO 9000, EFQM Excelence Model

This paper tries to identify and understand the human social obstacles for developing quality software. These include lip-service, cutting corners, deception and effects of internal politics. These obstacles can undermine the good intentions behind the software methodologies. The paper draws from the literature in different disciplines and uses an ethnographic research methodology to create a rich picture of the concerning aspects in the framework of one software development company in India. What stands out among the findings are that internal audits has mainly focused on finding errors in documentation procedures but study of the actual practices has often been shallow. In addition the understanding of business risks by the internal auditors have often been weak. Context. The human based obstacles affecting Software Development Methodology analysed in the context of an ISO 9000 quality system in an Indian Software Development company working mainly with Swedish companies. Objectives. Identifying and increasing the understanding of intrinsic negative social aspects such as lip service, cheating and politics which are affecting the results of Software Development Methodologies and if possible suggest some means to mitigate them. In particular to create a deeper understanding of why people cheat and pay lip service to methodologies and to try to understand the political aspects of methodology and quality systems. There are other positive social aspects, but they are not considered since the objective is about understanding the negative aspects and possibly mitigate them. Methods. Ethnographic research using analysis of ISO 9000 and design artefacts, semi-structured interviews, participation in internal audits, Results. Most focus in audits was on documentation and very less focus on underlying methodologies, some indications of lip-service to process and processes were also mainly managed on a higher level in the organization while the understanding and practices were less well established on lower level. It was hard to get a grip on the internal political aspects since the perception of the subject in the informants view was that it is mainly malicious and therefore embarrassing to speak about. Some conflicts between internal quality goals and customers’ needs were also identified. Conclusions. An ethnographic research methodology gives a rich picture. The analysis gives deeper understanding of the problem areas, but not necessary solutions. The author suggests that at the heart of the problem is a difference in world view. Software professionals generally tend to resolve [technical] problems using a reductionist approach, while these intricate challenges cannot easily be resolved by this approach. A more holistic systemic approach is required and while the software methodology is useful to structure the development it does not resolve these dysfunctions. They have to be resolved on another level. It was also found that further studies is required in particular to better understand Internal politics, the effect of Positive and Negative Incentives, the effect of software metrics on quality performance and subjectivity in customers’ perception and expectation. / Uppsatsen försöker förstå mänskliga sociala hinder för att utveckla programvara med hög kvalitet. Dessa hinder inkluderar "läpparnas bekännelser", ta genvägar, vilseleda och internpolitik. Sådana hinder kan underminera utvecklingsmetoder. Denna uppsats bygger på literatur från olika discipliner och använder etnografisk forskningsmetodik för att skapa en rik bild av dessa oroande aspekter inom ramen för ett IT-företag i Indien. Vad står ut är att intern kvalitetsrevision fokuserar för mycket på att finna fel i dokumentationsprocesser medan revision av hur utvecklingsarbetet faktiskt sker har varit för ytligt. Dessutom har de interna revisorernas förståelse av affärsrisker varit svag.