Dissertations / Theses on the topic 'Quality control methodology'

Engineering problems often involve many conflicting quality characteristics that must be optimized simultaneously. Engineers are required to select suitable design parameter values which provide better trade-off among all quality characteristics. Multiresponse optimization is one of the most essential tools for solving engineering problems involving multiple quality characteristics. Optimizing several quality characteristics when the quality characteristics are correlated makes the optimization process more complex. The aim of this research is to evaluate the performance of several existing multiresponse optimization methods and investigate their capabilities in dealing with correlated quality characteristics. This study also investigates the impact of uncertainty in terms of input parameter selection. A new multi-response optimization approach has been proposed for solving correlated quality characteristics. The proposed approach is compared with the existing methods and found more robust in terms dealing with uncertainty in target selection. The comparative study and application of the proposed approach is demonstrated by considering two examples from the literature having correlated quality characteristics.

Much attention has been directed at off-line quality control techniques in recent literature. This study is a refinement of and an enhancement to one technique, the Taguchi Method, for determining the optimum setting of design parameters in a product or process. In place of the signal-to-noise ratio, the mean square error (MSE) for each quality characteristic of interest is used. Polynomial models describing mean response and variance are fit to the observed data using statistical methods. The settings for the design parameters are determined by minimizing a statistical model. The model uses a multicriterion objective consisting of the MSE for each quality characteristic of interest. Minimum bias central composite designs are used during the data collection step to determine the settings of the parameters where observations are to be taken. Included is the development of minimum bias designs for various cases. A detailed example is given.

Globalisation has opened up international markets for South African companies, but has also introduced competition in the domestic market. As a result, South African organisations are forced to attain global efficiency levels if they are to compete on the world market as well as maintain their domestic market share. Organisations have to come with creative methods that can enhance their competitiveness, one of them being the Six Sigma. Six Sigma is a measurement-based strategy that focuses on process improvement and variation reduction as a means towards performance improvement. The methodology has a reputation of success, however a number of organisations believe that the methodology is not relevant to their specific competitive needs. Six Sigma is seen as another continuous improvement tool applicable to first world country organisations which will fade away with time. The study was undertaken to find out challenges and successes of implementing a Six Sigma methodology at Continental Tyre SA. The findings of the study revealed that the experience of implementing Six Sigma methodology at Continental Tyre SA is similar to those experienced by first world organisations. It is concluded that Six Sigma methodology can improve organisation processes and yield financial benefits irrespective of organisation location or background. However, organisations must follow a systematic guideline when implementing the methodology. The study provides recommendations on how Continental Tyre SA can align their strategy in order to achieve organisational objectives. The following recommendations were made: Roll out Six Sigma to support departments; Align the strategy to address critical success factors; Improve project turnover time and measure the success on financial savings and number of projects completed.

A new optimization technique for SPICE modeling parameters has been developed in this dissertation to increase the accuracy of the circuit simulation. The importance of having accurate circuit simulation models is to prevent the very costly redesign of an Integrated Circuit (IC). This radically new optimization technique utilizes the Taguchi method to improve the fit between measured and simulated I-V curves for GaAs MESFETs. The Taguchi method consists of developing a Signal-to-Noise Ratio (SNR) equation that will find the optimum combination of controllable signal levels in a design or process to make it robust or as insensitive to noise as possible. In this dissertation, the control factors are considered the circuit model curve fitting parameters and the noise is considered the variation in the simulated I-V curves from the measured I-V curves. This is the first known application of the Taguchi method to the optimization of IC curve fitting model parameters. In addition, this method is not technology or device dependent and can be applied to silicon devices as well. Improvements in the accuracy of the simulated I-V curve fit reaching 80% has been achieved between DC test extracted parameters and the Taguchi optimized parameters. Moreover, the computer CPU execution time of the optimization process is 96% less than a commercial optimizer utilizing the Levenberg-Marquardt algorithm (optimizing 31 FETs). This technique does a least square fit on the data comparing measured currents versus simulated currents for various combinations of SPICE parameters. The mean and standard deviation of this least squares fit is incorporated in determining the SNR, providing the best combination of parameters within the evaluated range. Furthermore, the optimum values of the parameters are found without additional simulation by fitting the response curves to a quadratic equation and finding the local maximum. This technique can easily be implemented with any simulator that utilizes simulation modeling parameters extracted from measured DC test data. In addition, two methods are evaluated to obtain the worst case modeling parameters. One method lobks at the correlation coefficients between modeling parameters and the second looks at the actual device parameters that define the +/- 30 limits of the process. Lastly, an example is given that describes the applicability of the Taguchi methodology in the design of a differential amplifier, that accounts for the effect of offset voltage.
Ph. D.

O montelucaste (MTC) sódico é um agente antagonista do receptor de cisteinilleucotrienos, utilizado para o tratamento da asma e comercializado no Brasil sob a forma de comprimidos revestidos, comprimidos mastigáveis e grânulos orais com o nome de Singulair®. Embora seja um medicamento amplamente comercializado, há poucas referências relativas aos métodos de análise da forma farmacêutica. Este trabalho teve como objetivos o desenvolvimento e a validação de métodos analíticos para o controle de qualidade do montelucaste sódico nos comprimidos revestidos, bem como a realização de estudos preliminares de estabilidade térmica e de fotoestabilidade. A análise qualitativa do MTC sódico foi realizada por cromatografia em camada delgada (CCD), espectrofotometria na região do ultravioleta (UV), cromatografia líquida de alta eficiência (CLAE) e eletroforese capilar (EC). Para análise quantitativa, foram validados os métodos por espectrofotometria na região do UV, CLAE e EC. A validação foi efetuada de acordo com as guias de validação disponíveis na literatura. No estudo preliminar de estabilidade térmica utilizaram-se amostras de comprimidos revestidos submetidos à temperatura de 60° C por 35 dias. A fotoestabilidade foi realizada em câmara de luz ultravioleta de 352 nm, por um período de 72 horas. Estas amostras foram analisadas por CLAE para determinação de MTC sódico e seus produtos de degradação. Os métodos qualitativos foram efetivos para identificação do MTC sódico. Os métodos quantitativos propostos foram validados de acordo com os parâmetros analíticos preconizados, podendo ser perfeitamente intercambiáveis. O estudo preliminar de estabilidade térmica não apresentou degradação da amostra nas condições de análise empregadas. O estudo de fotoestabilidade apresentou degradação intensa nas condições testadas.
The sodium montelukast is a selective leukotriene receptor antagonist used for the treatment of asthma, available in Brazil as a coated tablets, cheweble tablets and oral granules named Singulair®. Even though, it is widely commercialized, there are few references related to the quality control methods of it pharmaceutical dosage form. The aim of this work was the development and validation of analytical methodology for the quality control of sodium montelukast in coated tablets, as well the preliminary thermical and photostability studies. The qualitative analysis was performed by thin layer chromatography, ultraviolet spectrophotometry, high performance liquid chromatography (HPLC) and capillary electrophoresis (CE). For quantitative analysis, the methods of ultraviolet spectrophotometry, HPLC and CE were validated. The validation of the methods was performed according to the parameters of validation guidances available in the literature. The preliminary thermical studies were evaluated by exposing samples of coated tablets to temperatures of 60 °C for 35 days. The photostability was verified in an ultraviolet light chamber of 352 nm, during 72 hours. The sodium montelukast and their degradation products were determined in the samples by HPLC. The methods employed for the qualitative analysis demonstrated to be usefull for the sodium montelukast identification. The quantitative methods were validated in accordance to the analytic parameters related in the validation guides, allowing perfect interchanges. The thermical stability study had not presented sample degradation in the applied analysis conditions. The photostability study demonstrated an accentuated degradation in the described test conditions.

Relatório de Estágio de Mestrado em Enfermagem Perioperatória
O presente relatório incluí-se no plano de estudos do I Mestrado em Enfermagem Perioperatória, da Escola Superior de Saúde do Instituto Politécnico de Setúbal, realizado com o intuito da obtenção do grau de Mestre em Enfermagem e documento ilustrativo do desenvolvimento de competências no âmbito de enfermeiro perioperatório, competências essas que se procuraram desenvolver durante o estágio realizado no serviço do Bloco Operatório (BO) de um Hospital Privado (Hospital X) na margem sul do Rio Tejo. Neste contexto, foi desenvolvido um Projeto de intervenção, denominado de “Formação da Equipa de Enfermagem do Bloco Operatório no reprocessamento de Dispositivos Médicos (DM)” reutilizáveis, com o objetivo de melhorar a qualidade e a segurança dos cuidados de enfermagem prestados à pessoa submetida a cirurgia no Bloco Operatório do Hospital X. As áreas que se pretenderam abordar remetem-nos para o controlo de infeção e esterilização, nomeadamente os conhecimentos que a equipa de enfermagem do BO em estudo poderá deter, em termos de reprocessamento dos DM reutilizáveis que utilizam diariamente na sua prática profissional. As razões que levaram a esta escolha, prendem-se com o facto de serem áreas onde comummente surgem dúvidas durante a prática diária da equipa de enfermagem e por serem também, áreas pouco exploradas a nível académico e profissional. Através das metodologias descritiva e analítica, foram efetuadas análises reflexivas e críticas do percurso realizado, bem como uma exposição das competências de enfermagem abrangidas e de como as mesmas foram atingidas.
Abstract: This report is included in the study plan of the I Master in Perioperative Nursing, of Escola Superior de Saúde do Instituto Politécnico de Setúbal, conducted with the aim of obtaining a Master degree in Nursing and an illustrative document of the skills there where developed in the context of a master degree and in perioperative nursing, during the internship in the Operating Room of a Private Hospital (Hospital X) located on the south bank of Rio Tejo. In this context, we developed an intervention project called “Formation for the Operating Room Nurses in Reprocessing of Reusable Medical Devices” to try achieve the goal of improving the quality and safety of nursing care, provided to the person undergoing surgery in the Operating Room at Hospital X. The areas that are intended to achieve lead us to the infection control and sterilization process, including the knowledge that the operating room nursing team may hold, in terms of methods of reprocessing reusable medical devices, used in the professional daily practice. The reasons for this choice are related to the fact that these are commonly areas where doubts arise, during the daily nursing team practice and also these are areas whit low exploration in academic and professional terms. Through descriptive and analytical methodologies, reflective and critical analyses where made as well an exposure of the skills covered and how they where reached.

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Agro-industries stand out as large polluters in Brazil, particularly because of the large amounts of waste rich in organic substances, nutrients (especially nitrogen and phosphorus), solids, oils and greases. In this category, slaughterhouses and bird cold storage processing plants are known for their high pollution potential. The removal of nitrogen from wastewater is usually accomplished using biological conventional processes, by nitrification plus denitrification, involving aerobic and anaerobic phases that are generally carried out in separate reactors or by different aeration intervals. The sequencing batch reactor (SBR) uses multiple steps in the same reactor, which include filling, reaction, settling, withdrawal and idling. This study aimed to investigate how carbon:nitrogen ratios (COD/NO2 --N+NO3 --N) 3, 6 and 9, adjusted by manipueira (wastewater from cassava industry) and cycle time (CT) of 8,12 and 16 hours affects the nitrogen and organic matter removal from poultry wastewater, operating a sequencing batch reactor containing suspended biomass, in two different conditions: condition I, with the reaction step consisted by aerobic/anoxic phases and condition II, anoxic I/aerobic/anoxic II phases. It was also intended to optimize and validate the process of nitrogen removal in this type of effluent, to evaluate the reactor stability using Shewhart control charts for individual measures, and to study the kinetics behavior of organic matter (COD) and nitrogen (NH4 +-N, NO2 --N and NO3 --N) degradation. The conditions I and II were evaluated through factorial planning (32) and, in order to optimize the conditions obtained with the initial factorial design, it was used a central composite rotational design (CCRD) with four assays in levels -1 and +1, four assays on the axial points levels (-1.414 and +1.414) and five replicates at the central point (0). The nitrification process performance was evaluated by the efficiency of ammonia nitrogen removal (%), the pre-denitrification and denitrification processes by the efficiencies of nitrite and nitrate removal (%) and the whole process by total inorganic nitrogen removal (%). During the nitrification and denitrification processes, parameters like temperature, pH, alkalinity, redox potential, salinity and conductivity were monitored. The highest removal percentages of total inorganic nitrogen were obtained, for conditions I and II, at the cycle time range between 12 and 16 hours and the C/N ratio of 3 to 6, which showed average efficiencies of 80.76 and 85.57% in condition I, and 90.99 and 91.09% in condition II, respectively. Although the condition II obtained a higher removal percentage of total inorganic nitrogen, only condition I presented a regression statistically significant and predictive, with Fcal/Ftab values higher than 4 for all steps involved in nitrogen removal. Optimizing the condition I, the highest percentages of nitrogen removal were achieved with the cycle time of 16 hours and C/N ratio of 6, validated experimentally, achieving an overall removal of inorganic nitrogen of 85.83±0.87 %. Evaluating the reactor stability, the results of the 20 trials carried out with optimum conditions showed a total inorganic nitrogen average removal of 84.32±1.59% (CV=1.89%) and organic matter removal of 53.65±8.48% (CV=15.81%), considering the complete process (nitrification plus denitrification), being the process under statistical control. The evaluation of the kinetic behavior of nitrogen conversion indicated a possible reduction in the cycle time of the anoxic phase, since percentages of NO2 --N and NO3 -N removal higher than 90% were obtained in just one hour of denitrification.
As agroindústrias destacam-se como grandes poluidoras, devido, especialmente, às elevadas vazões com que geram seus efluentes ricos em carga orgânica, nutrientes (principalmente nitrogênio e fósforo), sólidos, óleos e graxas. Neste setor enquadram-se os abatedouros e frigoríficos de aves. A remoção de nitrogênio das águas residuárias é geralmente realizada por processos biológicos convencionais, que contemplam a nitrificação seguida da desnitrificação, envolvendo fases aeróbias e anaeróbias, separadas em diferentes reatores ou por diferentes intervalos de aeração. Os reatores em bateladas sequenciais (RBS) utilizam múltiplas etapas no mesmo reator, que incluem enchimento, reação, sedimentação, descarte e repouso. Esta pesquisa teve por objetivo investigar os efeitos da relação carbono:nitrogênio (DQO/N-NO2 -+N-NO3 -); 3, 6 e 9, ajustada pela adição de manipueira e do tempo de ciclo (TC); 8, 12 e 16 horas, na remoção de nitrogênio e matéria orgânica de efluente avícola, operando um RBS, em escala de bancada, com biomassa em suspensão em duas condições distintas, condição I com a etapa de reação composta pelas fases aeróbia/anóxica e condição II anóxica I/aeróbia/anóxica II. Objetivouse também, otimizar e validar o processo de remoção de nitrogênio, avaliar a estabilidade do reator através de gráficos de controle Shewhart para medidas individuais e, efetuar o estudo do comportamento cinético de degradação da matéria orgânica (DQO) e nitrogenada (N-NH4 +, N-NO2 - e N-NO3 -). Para avaliação das condições I e II elaborou-se um planejamento fatorial completo (32) e para otimização das condições obtidas com o planejamento fatorial inicial, utilizou-se um delineamento composto central rotacional (DCCR), com quatro ensaios nos níveis -1 e +1, quatro ensaios nos níveis dos pontos axiais (-1,414 e +1,414) e cinco repetições no ponto central (0). Avaliou-se o desempenho da nitrificação através da eficiência de remoção do nitrogênio amoniacal (%), o desempenho da pré-desnitrificação e desnitrificação através da eficiência de remoção de nitrito e nitrato (%) e a eficiência do processo completo pela remoção de nitrogênio inorgânico total (%), além do monitoramento de parâmetros, como a temperatura, pH, alcalinidade, potencial redox, salinidade e condutividade elétrica. Os maiores percentuais de remoção de nitrogênio inorgânico total foram obtidos, para ambas as condições I e II, usando as faixas de TC de 12 a 16 horas e relação C/N de 3 a 6, com valores médios de eficiências de 80,76 e 85,57% na condição I e, 90,99 e 91,09% na condição II, respectivamente. Apesar da condição II ter apresentado um percentual de remoção de nitrogênio inorgânico total superior, apenas a condição I apresentou uma regressão estatisticamente significativa e preditiva, com valores de Fcal/Ftab superiores a 4, para todas as etapas envolvidas na remoção de nitrogênio. Otimizando-se a condição I, os maiores percentuais de remoção de nitrogênio foram alcançados com o tempo de ciclo de 16h e a relação C/N de 6, validados experimentalmente, alcançando uma remoção global de nitrogênio inorgânico de 85,83±0,87%. Na avaliação da estabilidade do reator, os resultados dos 20 ensaios realizados com a condição ótima apontaram valores médios de remoção de nitrogênio inorgânico total de 84,32±1,59% (CV=1,89%) e, de matéria orgânica de 53,65±8,48% (CV= 15,81%), no processo completo (nitrificaçãodesnitrificação), estando o processo sob controle estatístico. A avaliação do comportamento cinético de conversão do nitrogênio indicou uma possível redução no tempo de ciclo da fase anóxica, uma vez que foram alcançadas remoções de N-NO2 -e N-NO3 - superiores a 90%, em apenas uma hora de desnitrificação.

Successful organizations continually seek ways to improve productivity, reduce and control costs, and increase efficiency. Governmental entities also are driven by the need for increased efficiency and accountability in public service for their constituents.There is a continuing need for better tools and a number of government entities have turned to performance management systems due to their promise of improvement in various areas of productivity and accountability. This research focused on one such system, Six Sigma, which has recently experienced widespread adoption in industry in the United States, internationally, and in some government organizations. In this study Six Sigma was compared and contrasted with several performance management systems, and its effects and organizational cultural impacts on one organization were examined.The study investigated the financial implications and perceptions of organizational cultural change resulting from the Six Sigma system implementation in a large government enterprise. The first part of the study used the organization’s published financial information from 1997 through 2006 to determine whether there was a tangible financial benefit of implementing Six Sigma. The analysis indicated that the financial implications were statistically significant and quantified them as material and relevant to the organization’s two major business units.The second component of the research explored differences in organizational culture and attitudes among and between selected employee groups through the use of interviews and a survey instrument. Interviews were also conducted with a purposive sample of the executives who were involved in the decisions to implement Six Sigma. The Organizational Culture Inventory© and Organizational Effectiveness Inventory™ survey instruments were used to measure the organizational culture perceptions of the employee groups. Discriminant function analysis results suggested that the various groups shared a common organizational culture, which supports the null hypothesis that there were no differences in the organizational cultural perceptions among the organizational groups investigated.

O Sistema de Análise de Perigos e Pontos Críticos de Controle (APPCC) ou Hazard Analysis Critical Control Point (HACCP) é de grande importância para a Saúde Pública, quanto às doenças veiculadas por alimentos. O objetivo deste trabalho foi verificar a aplicabilidade do uso desse sistema na indústria de moagem de trigo, no processamento de farinha de trigo integral, produto com demanda crescente no mercado. Trinta produções de farinha foram coletadas numa indústria cuja capacidade de moagem é de 15ton./h na cidade de São Paulo. A população amostrada foi de 30 sub-amostras de trigo argentino (A) (12,8% de umidade média), 17 sub-amostras de trigo brasileiro (B) (13,1% de umidade média), 30 sub-amostras de trigo preparado para moagem (M) (15,6% de umidade média) e 30 sub-amostras de farinha de trigo integral (FTI), coletadas num período de 5 meses (de outubro de 97 à março de 98). A metodologia utilizada para pesquisa de sujidades leves foi a adotada pelos Métodos Oficiais da AOAC (1995). Houve modificações no método e um estudo foi realizado para conhecer sua performance. No isolamento de fungos foi utilizada a metodologia empregada pela AOAC/FDA Bacteriological Analytical manual (1992). Para identificação de fungos em relação ao gênero foi utilizado o método preconizado GELLI et al.(1990), SAMSON et al (1995), PITT and HOCKING (1997). Na análise de sujidades leves nos trigos foi evidenciada a contaminação por ácaros (A=90%, B=53%, M=77% e FTI=53%); no trigo argentino houve uma predominância para a família Tarsonemidae, enquanto que na respectiva farinha foi a família Acaridae. Alguns ácaros dessa última família estão implicados em reações alérgicas e estão sendo tratados como emergentes na segurança alimentar. Os insetos thisanópteros, os mais freqüentes nos trigos, foram eliminados na farinha de trigo integral. O percentual médio de contaminação fúngica dos grãos foi de A=99%, B=95% e M=94%. O principal gênero encontrado foi Aspergillus spp (A= 79,0%, B= 39,3% e M= 64,2%). O menos freqüente Fusarium spp (A= 2,9%, B= 2,7% e M=1,5%). Na farinha de trigo integral o principal gênero encontrado foi o Penicillium spp e o Fusarium não foi isolado. O desoxinivalenol foi encontrado em uma amostra de farinha de trigo integral a uma concentração de 231 ng/g. O sistema APPCC se aplica aos moinhos e os auxilia a controlar suas produções do ponto de vista da segurança alimentar.
Food safety is a major concern facing the food industry today. Hazard Analysis Critical Control Point (HACCP) provides a structured approach to the assurance of safety of products. The aim of this study was to verify the use of HACCP system in a milling industry, precisely in the whole wheat flour production. At first step two hazards were analyzed: deoxynivalenol and allergenic mites in whole wheat flour Thirty (30) lots of flour were collected in an industry which capacity was 15 ton./h in São Paulo city. Those lots had 30 sub-samples of argentine (A) wheat (12,8% average moisture content), 17 sub-samples of brazilian (B) wheat (13,1% m.c.), 30 sub-samples of wheat for milling (M) (15,6% m.c), and 30 sub-samples of whole wheat flour (FTI) that were analyzed in a five months period (from 97/october to 98/march). Light filth was isolated from grains and flour, according to Official Methods of AOAC International. Methodology of extraction of light filth from whole wheat flour was studied to know the repeatability according to AOAC methods. Fungi isolation was performed according to AOAC/FDA Bacteriological Analytical Manual (1992) methodology; genera were identified according GELLI et al.(1990), SAMSON et al (1995), and PITI and HOCKING (1997). Detection and quantification of deoxynivalenol (DON) were done by thin layer chromatography (TLC) according to SABINO et al. (1989).The most significant light filth contamination in wheat were mites (A= 90%, B= 53%, M= 77% e FTI= 57%), argentine wheat had as a predominant mite the family Tarsonemidae and flour had Acaridae. The average fungal contamination in grains was 99%, 95% e 94% in argentine, brazilian and wheat for milling respectively. The predominant genera was Aspergillus spp ( A= 79,0, B=39,3% e M= 64,2 %), and Fusarium was the least frequent in wheat (A>/b>=2,7%, B= 2,8% e M=1,5%). Only one lot of whole wheat flour was contaminated by DON at level 231 ng/g. This study showed that HACCP system is appropriated for control hazards in milling industry. However, DON should be controlled before wheat get into industry, and this control need to be registered. Mites are new emergentes to cause allergy by ingestion and have to be controlled by GMP procedures.

O presente trabalho visa a criação de novas propostas e soluções para o controle de qualidade de bases cartográficas, com ênfase na componente posicional. É feita uma revisão bibliográfica de normas cartográficas de mais de 60 países, resultando em sugestões para a norma brasileira. São discutidos elementos como: quantidade de pontos de controle, técnicas de coleta de pontos de controle para diversas escalas, com ênfase nas maiores (tipicamente 1:1.000 e 1:2.000), controle de qualidade posicional com GPS (associado a um mapa de ondulações geoidais para altimetria) e com documento cartográfico mais acurado. Na parte prática foram realizados os seguintes experimentos: a) O teste de um mapa na escala 1:10.000, sendo controlado por um mapeamento na escala 1:2.000, b) a partir de dados reais foram feitas simulações variando a qualidade do mapa e o número de pontos amostrais com resultados interessantes c) controle de qualidade de um mapeamento sistemático em meio digital (Cidade Universitária, na escala 1:1.000) para o qual é proposta uma metodologia mais abrangente e inovadora.
The purpose from this job is to create new alternatives and solutions for the mapping quality control with emphasis on the positional component. A bibliographic revision of cartography standards from over 60 countries have been done, what has resulted in suggestions for the Brazilian ones. The following themes have been tackled: number of control points for several scales with emphasis on the biggest control (usually 1:1.000 and 1:2.000), positional quality control with GPS (in association with a geoidal map for altimetry) and with better accuracy maps. In the practical part, one can observe the following experiments: a) 1:10.000 scale map experiment controlled by a 1:2.000 map scale, b) simulations from real data varying accord the map quality and the number of points samples with interesting results, c) systematic mapping control quality of the digital environment (Cidade Universitária, 1:10.000 scale) whose purpose in the adoption of comprehensive and advanced methodology.

Quality by Design (QbD) is a systematic approach that has been recommended as suitable for the development of quality pharmaceutical products. The QbD approach commences with the definition of a quality target drug profile and predetermined objectives that are then used to direct the formulation development process with an emphasis on understanding the pharmaceutical science and manufacturing principles that apply to a product. The design space is directly linked to the use of QbD for formulation development and is a multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide an assurance of quality. The objective of these studies was to apply the principles of QbD as a framework for the optimisation of a sustained release (SR) formulation of salbutamol sulphate (SBS), and for the establishment of a design space using Response Surface Methodology (RSM) and Artificial Neural Networks (ANN). SBS is a short-acting ♭₂ agonist that is used for the management of asthma and chronic obstructive pulmonary disease (COPD). The use of a SR formulation of SBS may provide clinical benefits in the management of these respiratory disorders. Ashtalin®8 ER (Cipla Ltd., Mumbai, Maharashtra, India) was selected as a reference formulation for use in these studies. An Ishikawa or Cause and Effect diagram was used to determine the impact of formulation and process factors that have the potential to affect product quality. Key areas of concern that must be monitored include the raw materials, the manufacturing equipment and processes, and the analytical and assessment methods employed. The conditions in the laboratory and manufacturing processes were carefully monitored and recorded for any deviation from protocol, and equipment for assessment of dosage form performance, including dissolution equipment, balances and hardness testers, underwent regular maintenance. Preliminary studies to assess the potential utility of Methocel® Kl OOM, alone and in combination with other matrix forming polymers, revealed that the combination of this polymer with xanthan gum and Carbopol® has the potential to modulate the release of SBS at a specific rate, for a period of 12 hr. A central composite design using Methocel® KlOOM, xanthan gum, Carbopol® 974P and Surelease® as the granulating fluid was constructed to fully evaluate the impact of these formulation variables on the rate and extent of SBS release from manufactured formulations. The results revealed that although Methocel® KlOOM and xanthan gum had the greatest retardant effect on drug release, interactions between the polymers used in the study were also important determinants of the measureable responses. An ANN model was trained for optimisation using the data generated from a central composite study. The efficiency of the network was optimised by assessing the impact of the number of nodes in the hidden layer using a three layer Multi Layer Perceptron (MLP). The results revealed that a network with nine nodes in the hidden layer had the best predictive ability, suitable for application to formulation optimisation studies. Pharmaceutical optimisation was conducted using both the RSM and the trained ANN models. The results from the two optimisation procedures yielded two different formulation compositions that were subjected to in vitro dissolution testing using USP Apparatus 3. The results revealed that, although the formulation compositions that were derived from the optimisation procedures were different, both solutions gave reproducible results for which the dissolution profiles were indeed similar to that of the reference formulation. RSM and ANN were further investigated as possible means of establishing a design space for formulation compositions that would result in dosage forms that have similar in vitro release test profiles comparable to the reference product. Constraint plots were used to determine the bounds of the formulation variables that would result in the manufacture of dosage forms with the desired release profile. ANN simulations with hypothetical formulations that were generated within a small region of the experimental domain were investigated as a means of understanding the impact of varying the composition of the formulation on resultant dissolution profiles. Although both methods were suitable for the establishment of a design space, the use of ANN may be better suited for this purpose because of the manner in which ANN handles data. As more information about the behaviour of a formulation and its processes is generated during the product Iifecycle, ANN may be used to evaluate the impact of formulation and process variables on measureable responses. It is recommended that ANN may be suitable for the optimisation of pharmaceutical formulations and establishment of a design space in line with ICH Pharmaceutical Development [1], Quality Risk Management [2] and Pharmaceutical Quality Systems [3]

Дисертаційне дослідження спрямоване на вирішення проблеми формування теоретико-методологічних і організаційних засад, методичного забезпечення та практичних рекомендацій щодо становлення і розвитку державного аудиту в Україні. Проведено ретроспективу контролю державних фінансів для з’ясування місця і ролі в ньому державного аудиту; конкретизовано сутність поняття “державний аудит”, уточнено його функції, предмет, об’єкти та суб’єкти. Обґрунтовано класифікацію видів і форм державного аудиту; сформульовано постулати державного аудиту, розкрито його основоположні принципи. Внесено пропозиції щодо удосконалення законодавчого і нормативного забезпечення державного аудиту; проаналізовано ефективність чинної системи контролю державних фінансів, визначено основні фактори, що впливають на якість контролю; розкрито передумови становлення і розвитку державного аудиту в Україні; обґрунтовано критерії ефективності системи державного аудиту. Запропоновано організаційну структуру системи державного аудиту з визначенням функціональних взаємозв’язків і закріпленням статусу вищого органу державного аудиту за Рахунковою палатою України. Сформульовано і охарактеризовано методологічні засади організації і проведення основних форм державного аудиту. Обґрунтовано напрями розвитку методичних основ організації і проведення державного аудиту ефективності.
Диссертационное исследование направлено на решение проблемы разработки теоретических, методологических и организационных основ формирования целостной системы государственного аудита в Украине с учетом требований Международных стандартов высших органов государственного аудита (ISSAI). Объектом исследования является система государственного аудита как взаимосвязанная совокупность субъектов, контрольных действий, подконтрольных объектов и результатов государственного аудита. Предмет исследования – теоретические, методологические, организационные основы и методы реализации государственного аудита в Украине. Предложенная в диссертации концепция построения целостной системы государственного аудита в Украине имеет практическое значение в контексте разработки стратегии развития национальной экономики, основанной на принципах общественной ответственности. Основные научные положения диссертации доведены до уровня методических разработок и практических рекомендаций, которые могут применяться государственными учреждениями и организациями в зависимости от их полномочий, общественными организациями, другими субъектами хозяйствования различных форм собственности, а также высшими учебными заведениями. Наиболее значимые результаты исследования состоят в следующем. Проведена периодизация становления и развития государственного аудита. Обосновано выделение последнего этапа, который характеризуется изменением подходов к организации государственного аудита, сопровождающимся обновлением полномочий высших контрольных органов зарубежных стран, разработкой стандартов государственного аудита с учетом глобальных потребностей развития цивилизации, расширением круга подконтрольных субъектов. Получили развитие теоретические основы государственного аудита, включающие его определение, уточнение функций, предмета, задач, объектов и субъектов. Сформулированы общественно-экономические, институциональные, организационные, информационно-технические и научные предпосылки, достаточные для становления и необходимые для развития государственного аудита, что позволило определить направление системного усовершенствования института государственного аудита в Украине в соответствии с требованиями мировых стандартов и внутренних национальных потребностей повышения эффективности государственного управления. Научно обоснованы классические постулаты аудита, сохраняющие свою истинность для сферы государственного аудита, предложены три авторских постулата, учитывающих особенности целей и задач государственного аудита. Усовершенствован порядок определения эффективности системы государственного аудита. Разработаны организационно-правовые мероприятия повышения качества функционирования Счетной палаты Украины, как высшего органа государственного аудита, на современном этапе её институционального развития с учетом результатов проведенного анализа соблюдения требований стандартов ISSAI. Усовершенствован инструментарий реализации принципа независимости государственного аудита в Украине, что позволит гарантировать сбалансированность, надежность и объективность заключений государственных аудиторов, будет способствовать достижению гласности и поддерживать эффективность системы государственного аудита. Аргументирована целесообразность принятия национальных стандартов государственного аудита, основанных на третьем уровне стандартов ISSAI. Такой подход учитывает степень готовности системы государственного аудита в Украине к внедрению международных стандартов и обеспечивает методологическую основу проведения государственных аудитов. Предложена комплексная система контроля качества государственного аудита, внедрение которой обеспечит достижение цели государственного аудита и повышение степени доверия общественности к результатам деятельности высшего органа государственного аудита. Разработано методическое обеспечение организации и проведения различных форм государственного аудита с учетом обновленных требований стандартов ISSAI. Обоснована необходимость привлечения к проведению государственного аудита независимых аудиторов. Получили развитие методические основы организации и проведения государственного аудита эффективности. Обоснован алгоритм контроля выполнения рекомендаций Счетной палаты Украины.
Thesis research solves a problem of theoretic and methodological bases forming, methodological support and practical recommendations as to establishing and developing of public audit in Ukraine. The retrospect of public finance control is conducted to explore the position and the role of public audit; the essence of the concept of public audit is specified, its functions, subjects and objects are also concretized. Classification of public audit kinds and forms is justified; postulates of public audit as well as its basic principles are formulated. The offers are made as to improving public audit legislative and standard supporting; the effectiveness of modern control of public finances is analyzed, the main factors impacting the control quality are determined; the background of establishing and developing public audit in Ukraine are disclosed; criteria of public audit effectiveness are proved. The organizational structure of public audit system along with the defining the operating interrelations and assigning the status of the supreme body of the state audit to Accounting Chamber of Ukraine is proposed. Methodological bases of organization and realization of main forms of public audit are formulated and characterized. The directions of developing methodical bases of performance public audit organization and realization are justified.

Orientador: Antonio Batocchio
Dissertação (mestrado profissional) - Universidade Estadual de Campinas, Faculdade de Engenharia Mecanica
Made available in DSpace on 2018-08-05T20:01:02Z (GMT). No. of bitstreams: 1 Scatolin_AndreCelso_M.pdf: 1108284 bytes, checksum: 1834481388729e17c9e3a8744641a821 (MD5) Previous issue date: 2005
Resumo: Este trabalho tem o objetivo de mostrar a eficiência da aplicação da metodologia Seis Sigma para a redução das perdas num processo de manufatura. O processo de fabricação de respiradores descartáveis foi escolhido para o estudo de caso porque gerava uma enorme quantidade de perda das fibras utilizadas como matéria-prima. As metodologias de melhorias até então aplicadas tinham reduzido significativamente o nível das perdas, porém se fazia necessária uma abordagem diferente para se reduzir ainda mais. Seguindo a metodologia Seis Sigma, uma equipe foi formada para focar a atenção na redução destas perdas e quebrar o paradigma que não se pode eliminar as perdas inerentes de um processo. Através da adição de uma fase de desfibramento da perda ¿ fibra prensada que era descartada ao final do processo ¿ recuperou-se toda esta fibra, deixando-a com características semelhantes à fibra virgem. Portanto, as perdas foram 100% eliminadas. O nível sigma, que era historicamente menor que 3, passou para maior que 6 ao final do trabalho. A aplicação de ferramentas estatísticas demonstrou qual o ponto otimizado da mistura de fibras virgens e fibras recuperadas, para que as propriedades finais do produto não sofressem alterações significativas sob o ponto de vista do usuário final. Este trabalho gerou um desenvolvimento técnico da equipe envolvida e preciosa economia de recurso não renovável
Abstract: This work aims to show the efficiency of Six Sigma Methodology application in reducing waste of a manufacturing process. The making process of disposable respirator was chosen to this case study because it generated an enormous amount of fiber scrap used as raw material. Improving methodologies applied every since had reduced significantly the waste level but a different approach was needed to reduce it even more. Following the Six Sigma Methodology, a team was formed to focus the whole attention on reducing this waste and breaking the paradigm which inherent waste of a process cannot be eliminated. Through an addition of a new process step in order to reprocess the waste ¿ pressed fiber discharged by the end of this process - all of it was recovered, keeping the same characteristics of raw fiber. Therefore, the waste was 100% eliminated. Sigma level, which was historically lower than 3, became higher than 6 by the end of the work. The statistics tools applied demonstrated the optimized set point of the raw and recovered fiber mixture in order to maintain the final product properties under the point of view of end-users. This work resulted in team technical development and precious non-renewed raw material savings
Mestrado
Planejamento e Gestão Estrategica da Manufatura
Mestre em Engenharia Mecânica

The thesis will discuss the Systems Engineering phase of an original Conceptual Design Engineering Methodology for Aerospace Engineering-Vehicle Synthesis. This iterative phase is shown to benefit from digitization of Integrated Product&Process Design (IPPD) activities, through the application of Product Lifecycle Management (PLM) technologies. Requirements analysis through the use of Quality Function Deployment (QFD) and 7 MaP tools is explored as an illustration. A "Requirements Data Manager" (RDM) is used to show the ability to reduce the time and cost to design for both new and legacy/derivative designs. Here the COTS tool Teamcenter Systems Engineering (TCSE) is used as the RDM. The utility of the new methodology is explored through consideration of a legacy RFP based vehicle design proposal and associated aerospace engineering. The 2001 American Helicopter Society (AHS) 18th Student Design Competition RFP is considered as a starting point for the Systems Engineering phase. A Conceptual Design Engineering activity was conducted in 2000/2001 by Graduate students (including the author) in Rotorcraft Engineering at the Daniel Guggenheim School of Aerospace Engineering at the Georgia Institute of Technology, Atlanta GA. This resulted in the "Kingfisher" vehicle design, an advanced search and rescue rotorcraft capable of performing the "Perfect Storm" mission, from the movie of the same name. The associated requirements, architectures, and work breakdown structure data sets for the Kingfisher are used to relate the capabilities of the proposed Integrated Digital Environment (IDE). The IDE is discussed as a repository for legacy knowledge capture, management, and design template creation. A primary thesis theme is to promote the automation of the up-front conceptual definition of complex systems, specifically aerospace vehicles, while anticipating downstream preliminary and full spectrum lifecycle design activities. The thesis forms a basis for additional discussions of PLM tool integration across the engineering, manufacturing, MRO and EOL lifecycle phases to support business management processes.

Natural products or traditional medicine has been used for centuries to treat various ailments by mankind. The World Health Organization estimates that in recent times 80% of people in emerging economies rely on traditional medicine as their primary health care [1]. However, unlike pharmaceutical products which have methods in place for quantification of the active compounds traditional medicine still requires a lot of focus in this area. Moringa oleifera is one of those species that have been used traditionally to cure various ailments for centuries. Even though extensive phytochemical and pharmacological studies have been conducted on the different parts of the plant, there is still no analytical method that enables the quantification of the compounds in the Moringa products in the market. The aim of this research was to develop an HPLC separation method that can be used to quantify the compounds found in the Moringa oleifera products. Compounds were extracted from the seeds of Moringa oleifera using the maceration method with a mixture of water and ethanol (1:1 v/v). The compounds were isolated using preparative HPLC. The structures of the compounds were elucidated using FTIR, NMR and MS. An HPLC separation method for quantification of the isolated compounds was developed and validated. The method was applied to the crude extract to quantify the isolated compounds in the extract. The following compounds 3-caffeoylquinic acid, 4-(α-L-Rhamnosyloxy) benzyl isothiocyanate, O-ethyl-[4-(α-L-Rhamnosyloxy) benzyl] thiocarbamate and O-butyl-[4-(α-L-Rhamnosyloxy) benzyl] thiocarbamate were isolated at percentage purities ranging from 90 to 99%. The HPLC separation method for quantification showed a linear relationship between peak area and concentration of the compounds with regression coefficients ranging from 0.9977 to 0.9994. The method is also precise with % RSD values between 0.01 and 1.16%. The method was shown to be specific to the compounds of interest. The percentage distribution of compounds in 50 mg of the seeds extract was between 0.25 and 1.10 % w/w. This study successfully developed and validated an HPLC separation method for four compounds found in the seeds of Moringa oleifera and quantified them in the crude extract of the seeds found in Zambia. This method can be used for identification and quantification of these four compounds in any of the Moringa products. As far as it could be ascertained this is the first time that such a method has been developed for these compounds
Chemistry
M. Sc. (Chemistry)

The principal objective of this study was to compare the results of a proposed method based upon the response surface model to the Taguchi method. To modify the Taguchi method, the proposed model was developed to encompass the following objectives. The first, with the exception of the Taguchi inner array, was obtain optimal design variable settings with minimum variations, at the same time achieving the target value of the nominal-the best performance quality characteristics. The second was to eliminate the need for the use of a noise matrix (that is, the Taguchi outer array), resulting in the significant reduction of the number of experimental runs required to implement the model. The final objective was to provide a method whereby signal-tonoise ratios could be eliminated as performance statistics. To implement the proposed method, a central composite design (CCD) experiment was selected as a second-order response surface design for the estimation of mean response functions. A Taylor's series expansion was applied to obtain estimated variance expressions for a fitted second-order model. Performance measures, including mean squared error, bias and variance, were obtained by simulations at optimal settings. Nine test problems were developed to test the accuracy of the proposed CCD method. Statistical comparisons of the proposed method to the Taguchi method were performed. Experimental results indicated that the proposed response surface model can be used to provide significant improvement in product quality. Moreover, by the reduction of the number of experimental runs required for use of the Taguchi method, lower cost process design can be achieved by use of the CCD method.
Graduation date: 1993

One of the major challenges for organisations operating in today's global business environment is to improve productivity, reduce costs and enhance customer service. Six Sigma methodology has become a popular approach in a number of organisations as a business improvement tool. This research presented Six Sigma as a business transformation methodology within Lonmin operations. The purpose of this research was to identify the primary factors in the Six Sigma framework, and to evaluate the relationship between these factors in the framework and their contribution towards transformation in terms of business improvement. This research critically evaluated the application of Six Sigma within Lonmin in the South African context. Quantitative data was obtained from questionnaires distributed to the different Six Sigma role players within Lonmin. A probability sample was used; sixty five (65) Six Sigma candidates were drawn from Lonmin with a Six Sigma population size of one hundred and twenty (120) employees listed in the Six Sigma database. Data was collected using an e-mail based questionnaire developed by the researcher. The main contributions of this study showed that communication and organisational culture were the most important factors to transform business performance when Six Sigma was integrated with business principles. The study revealed that project selection was a vital element in the process that determined the value towards business improvement. Six Sigma must be supplemented by other programmes (Theory of Constraints, Design For Six Sigma) in order to be more effective in attaining business performance. This research will benefit management to evaluate and structure an aligned methodology for transformation. Employees will be motivated to attain greater knowledge and skill. Research will prove beneficial to organisations that need to transform their organisation.
Thesis (MBA)-University of KwaZulu-Natal, Westville, 2010.

博士
國立陽明大學
藥理學研究所
104
The material basis of the pharmacological effects of Chinese Materia medica is poorly understood and an efficient quality control method available for Chinese Materia medica (CMM) is insufficient. These issues have led to various problems including inconsistent quality of product. Therefore, this study focuses on two aspects: firstly an investigation of the protective effects of a common component of pharmaceutical plants on metabolic diseases, and, secondly, the development of a new methodology for the quality control of CMM. Gallic acid (GA), a naturally abundant plant phenolic compound present in vegetables and fruits, has been shown to have potent anti-oxidative and anti-obesity activity. However, the effects of GA on metabolic disease are poorly understood. In the first part of this study, the beneficial effects of GA administration on a nutritional hepatosteatosis model and on a high‐fat diet‐fed, streptozotocin (HFD/STZ) treated diabetes model were investigated using a more “holistic view” approach, namely 1H NMR-based metabolomics. The aim was to confirm the efficacy of gallic acid in this context and to obtain information that might lead to a better understanding of the mode of action of gallic acid. Liver histopathology and serum biochemical examinations indicated that the daily administration of GA protects against hepatic steatosis, obesity, hypercholesterolemia, and insulin resistance among the HFD-induced NAFLD mice and against nonalcoholic steatohepatitis and hyperglycemia among HFD/STZ-induced diabetes mice. The findings show that GA has beneficial effects with respect to both models and that this in part occurs through a reversal of HFD or HFD/STZ caused disturbances to a range of metabolic pathways, including lipid metabolism, glucose metabolism, and gut-microbiota-associated metabolism. The selected metabolites identified during this part of the study are also potentially useful as preventive action biomarkers and, furthermore, could also be used to help our understanding of the effect of GA on mice with metabolic disease. As more people worldwide are beginning to use traditional Chinese medicine (TCM), the quality assurance issue regarding CMM has begun to raise international concerns. In the second part of this study, an exploratory study was conducted to try and develop a new approach to quality control assurance of CMM products. A number of appropriate methods have been developed over the years for the authentication of CMMs. Nevertheless, how to differentiate “good” from “bad” CMM remains a relatively undeveloped field. Unlike Western medicine, TCM has a totally different philosophical system. The traditional usage of CMM products makes it difficult to use Western medicine quality control methods in order to achieve CMM quality control. We used Astragalus radix as a model CMM and propose a new methodology for quality control of CMM products. Initially, a literature review approach was used to determine what criteria are needed to differentiate “good” from “bad” CMM. Additionally, different batches of samples were examined by a panel of experts and these individuals then scored the CMM samples independent of each other in terms of quality. On the basis of the expert scores, the various samples were classified into three classes. When the experts’ scores were examined they were found to be highly reproducible. Secondly, we used a metabolomics approach and biological response assays in order to evaluate the various different batches of Astragalus radix. Correlation analysis was then carried out and this showed it was possible to detect a number of chemical components changes that were reflected in the expert scores; however this was not true for the biological response results. These findings demonstrated that traditional usage is not equal to modern pharmacological effects and imply that when developing a useful platform for CMM evaluation there is a need to consider the traditional usage of CMM products. Another important topic that affects the quality control of CMM products is post-harvest processing, which involves drying; this is believed to have a significant effect on the effectiveness of Uraria crinita (UC) as a CMM. UC is traditionally and widely used for digestion regulation and deworming in Taiwan. However little is known about how post-harvest operations affect chemical composition/bioactivity of UC. We assessed three drying methods (oven-drying/air-drying/sun-drying), as well as oven drying temperature, by exploring the herb’s metabolic profile and biological activity profile. NMR spectra showed that extracts from UC contained various secondary metabolites namely triterpenoids, apigenin, glycosides and salicylic acid, as well as a range of primary metabolites. Multivariate analysis showed a clear separation of the samples into three groups that were consistent with their biological activity assays. These findings can ascribed to the presence of higher amounts of secondary metabolites in the oven-dried samples. The recommended oven-drying method gave good reproducibility when two batches were compared using the same PCA score plot as samples from other groups. Thus metabolomics is a useful tool when evaluating processing methods. An appropriate post-harvest drying method is a good approach to increase the bioactivity and quality of UC, both being required to fulfill Good Agricultural and Collection Practices. Taken as a whole, this study suggests that a metabolomics approach is a useful platform for the functional evaluation of natural products. The targets of GA treatment are lipid metabolism and ketogenesis, glucose metabolism and gut-microbiota metabolism. The current investigation provides further evidence supporting GA as a natural dietary compound that is able to ameliorate NAFLD and other metabolic disorders. The findings also suggest that QC is still a very important key issue that will affect CMM development in the future. An appropriate post-harvesting process and a good QC method are necessary if there are to be improvements in the quality of CMM.

Dissertação de Mestrado em Estatística, Matemática e Computação apresentada à Universidade Aberta
O presente trabalho apresenta uma breve revisão e aplicação da metodologia de Planeamento de experiências e Controlo da Qualidade no processo na Indústria. Esta pesquisa incidiu no processo de fabrico de sumo e foram definidas duas variáveis resposta: a presença de bolhas de ar no interior das embalagens e defeitos da colagem das embalagens, que são as ocorrências frequentes provocadas por diferentes causas, conhecidas e desconhecidas. O principal objectivo desta pesquisa é a identificação das causas dos defeitos durante o processo de fabrico do produto em estudo e, consequentemente procurar a sua diminuição. Para se atingir o objectivo preconizado, aplicou-se a técnica de planeamento factorial completo 2k para a identificação dos principais factores que influenciam o processo de produção. De entre os diferentes factores que envolvem o processo, destacam-se a velocidade, a pressão, a temperatura, o tempo e a quantidade. Identificados os factores, fez-se a optimização do processo para definição dos melhores níveis. Para a primeira variável usou-se a técnica de Planeamento factorial Composto; ao passo que para segunda variável, para além dessa técnica, usou-se ainda a técnica de Planeamento Composto Central. Para verificação dos resultados, usou-se a metodologia de superfície de resposta.
In this work a brief revision and an application of Experimental Design and Quality Control methodologies in industry is presented. This research is essentially based in the process of manufacturing juice, and has been defined into two ways. In the process of manufacturing, the presence of air balls within the packages and general defects of the package, due to unknown causes were detected. The main objective of this research is to identify the causes of such defects during the manufacturing process of the product and consequently to try to minimize them. In order to achieve this objective, a study has begun with the identification of the main factors that influence the production process. In between the different factors of the production process, speed, pressure and temperature, time and quantity are some of the most prominent factors. The causes were identified, and complete factorial design 2k. To verify the results, the methodology of response surface has been used.

Dissertação de mestrado integrado em Engenharia e Gestão Industrial
O setor industrial, cada vez mais complexo, exige um conhecimento daquilo que são chamadas as boas práticas, tanto para garantir o cumprimento dos requisitos dos clientes como os prazos de entrega. É relevante considerar que o avanço no conhecimento científico resultou em produtos mais complexos e impôs desafios muito maiores às empresas. A utilização de metodologias de melhoria da Qualidade possibilita uma aproximação aos padrões mais exigentes, podendo aplicar-se em qualquer tipo de Indústria produtiva. Esta dissertação apresenta um caso prático de aplicação de ferramentas da qualidade para apoio à resolução de problemas de qualidade numa indústria têxtil. Foi seguida a metodologia PDCA para resolução de problemas de qualidade e recorrendo a ferramentas de Qualidade foram identificados os problemas mais críticos da empresa e atuou-se de acordo com o plano de ações definido por uma equipa multidisciplinar formada por pessoas experientes no processo. Tentou-se, numa primeira fase, identificar as variáveis do processo que provocam a variabilidade do processo num dos artigos mais críticos da empresa e assim tentar solucionar o problema. Em seguida calculou-se o Cpk para inferir a capacidade do processo para produzir o artigo e reduzir a variabilidade do processo. A causa raíz não foi claramente identificada e corrigida e consequentemente o desvio padrão não foi alterado, em alternativa, sugeriu-se um novo plano de ação, aumentar a média do processo para um valor mais próximo do limite superior de especificação, definindo-se um novo valor nominal, de forma a reduzir o número de peças para sucata. A mesma metodologia deve ser empregue para futuras produções até ser encontrada as causas raíz e assim atuar na redução do desvio padrão, aumentando o índice de capacidade do processo. Devem ser empregues na empresa sistemas de controlo de Qualidade com o objectivo de criar bases sólidas para ajudar nas tomadas de decisão que têm em vista a redução de problemas de Qualidade, e assim aumentar os índices de Qualidade da Empresa.
The industrial sector, increasingly complex, requires a knowledge of what are called good practices, both to ensure compliance with customer requirements and delivery times. It is important to consider that the advance in scientific knowledge has resulted in more complex products and imposed far greater challenges to companies. The use of Quality Improvement Methodologies allows an approach to the highest standards and may be applied in any type of production industry. This dissertation presents the application of Quality Tools to support the resolution of Quality problems in textile industry. Followed the PDCA methodology for Quality problem solving and using Quality Tools the most critical problems of the company were identified and acted in accordance with the action plan defined by a multidisciplinary team formed by experienced people in the process. It was tried to initially identify the process variables that cause process variability in the most critical articles of the company and thus try to solve the problem. Then it was calculated the Cpk to infer the process capability to produce the article and decrease the standard deviation. The root cause has not been clearly identified and corrected and therefore the standard deviation has not changed, alternatively, was a new action plan to divert the process to the upper specification limit, setting a new nominal value in order to reduce the number of parts for scrap. The same methodology should be used for future productions until found the root causes and thus act to reduce the standard deviation by increasing the Process Capability index. Quality Control Systems should be employed in the company with the aim of creating a solid foundation to help making decisions that are aimed at the reduction of Quality Problems, and thus increase the Company's Quality indices.

Indiana University-Purdue University Indianapolis (IUPUI)
Evidence based practice (EBP) is essential to the practice of nursing for purposes of promoting optimal patient outcomes. Research suggests that the implementation of EBP by staff nurses is problematic and influenced by beliefs, nursing leadership and the work environment. The purpose of this descriptive study was to examine variables that describe the relationship among beliefs about EBP, the work environment and nursing leadership on the EBP implementation activities of the staff nurse. The variables of interest were 1) individual staff nurse characteristics, 2) beliefs about EBP, 3) the EBP work environment and 4) nursing leadership for EBP. A descriptive, quantitative method was used. A sample of 422 Registered Nurses from two urban hospitals (one Magnet and one non-Magnet) completed an online 58 item survey that included questions related to individual belief’s about EBP, the EBP work environment and nursing leadership for EBP as well as EBP implementation activities. Education, tenure and Magnet status were not significantly related to EBP implementation activities in either the univariate or multivariate analysis. EBP beliefs had a significantly positive relationship with EBP implementation activities in both the univariate and multivariate analyses. Work environment and nursing leadership support for EBP had significant positive relationships with self-reported implementation activities in only the univariate analysis. The most surprising finding was that there were no differences between Magnet and non-Magnet work environments for EBP implementation scores, yet the Magnet hospitals reported higher means on the EBP Beliefs Scale than the non-Magnet hospital. The results of this have implications for identifying and testing strategies to influence EBP implementation activities through development of nursing leadership skills for EBP and creating a more EBP friendly work environment.

Relatório de Trabalho de Projeto apresentado para cumprimento dos requisitos necessários à obtenção do grau de Mestre em Enfermagem Médico-Cirúrgica
O presente relatório reflete o processo de aquisição de competências de Mestre durante o curso (e respetivos estágios), com o intuito da obtenção do grau de Mestre em Enfermagem Médico-Cirúrgica. Através da metodologia de projeto, desenvolvemos as competências comuns e específicas do Enfermeiro Especialista em Enfermagem Médico-Cirúrgica, designadamente em Enfermagem em Pessoa em Situação Crítica. De salientar que nos estágios foram desenvolvidos dois projetos: Projeto de Intervenção no Serviço e Projeto de Aprendizagem Clínica. A prestação de cuidados em ambiente complexo obriga o enfermeiro a ter uma preparação ajustada às diversas situações. É essencial a criação de ambientes que potenciem o bem estar e que sejam ambientes verdadeiramente seguros. O enfermeiro é um dos pilares fundamentais à prevenção e controlo de infeções nos serviços de saúde. O Projeto de Intervenção em Serviço desenvolveu-se numa Comissão de Controlo de Infeção de um Hospital. Constatada a elevada taxa de incidência de infeções urinárias em doentes internados no serviço de cirurgia e especialidades cirúrgicas, trabalhou-se a área da Prevenção e Controle de Infeção do Trato Urinário em Contexto Hospitalar. O objetivo foi Melhorar a Qualidade da Prestação de Cuidados à pessoa com cateter urinário, no Serviço de Cirurgia e Especialidades Cirúrgicas. O Projeto de Aprendizagem Clínica desenvolveu-se no Serviço de Urgência de um Hospital. Constatada a falta de informação sobre o Plano de Catástrofe Externa na equipa de enfermagem, divulgámos o plano implementado no hospital. O objetivo foi Desenvolver as Competências da Equipa de Enfermagem do Serviço de Urgência na resposta a situações de Catástrofe Externa. Com todo o trabalho realizado, desenvolvemos competências na equipa de enfermagem e assistentes operacionais no serviço de Cirurgia no âmbito da prestação de cuidados à pessoa com cateter urinário, e aumentámos os conhecimentos sobre o plano de catástrofe externa na equipa de enfermagem do Serviço de Urgência.
Abstract: This report reflects the process of acquiring skills of Master during the course (and respective internship), with the aim of obtaining the degree of Master of Medical-Surgical Nursing. We develop the common and specific skills of the Nurse Specialist in Medical- Surgical Nursing, specifically in Person in Critical Care, by applying the project methodology. Noteworthy that in the internships, two projects were developed: Intervention Project in Service and Project Learning Clinic. The provision of care in complex environment obliges the nurses to have a preparation adjusted to various situations. It is essential to create environments that enhance the well being and that are truly, in itself, safe environments. The nurse is a fundamental key in the prevention and control of infections in health care services. The Intervention Project in Service was developed in a Hospital's Infection Control Committee. Considering a high incidence of urinary tract infections in the inpatients in Surgery and Surgical specialties Service, we worked the area of Prevention and Control of Infection Urinary Tract Infection in Hospital Context . The objective was to improve the quality of care for patients with urinary catheter, in the Department of Surgery and Surgical Specialties. The Clinical Learning Project was developed in the Emergency Service of a hospital. Considering the lack of information about the External Emergency Plan in the nursing team, we advertised the plan implemented in the hospital. The objective was to develop the skills of ER Nursing Team in case of a foreign disaster . Due to all the work done, we develop skills in nursing assistants and operational staff in the surgery department in the provision of care to people with urinary catheter , and increased knowledge about the external disaster plan in the nursing team of the Emergency Service.

Indiana University-Purdue University Indianapolis (IUPUI)
A study design has been developed that employs a dual modeling approach to identify factors associated with facility-level cancer screening improvement and how this is mediated by the use of clinical decision support. This dual modeling approach combines principles of (1) Health Informatics, (2) Cancer Prevention and Control, (3) Health Services Research, and (4) Organizational Change/Theory. The study design builds upon the constructs of a conceptual framework developed by Jane Zapka, namely, (1) organizational and/or practice settings, (2) provider characteristics, and (3) patient population characteristics. These constructs have been operationalized as measures in a 2005 HRSA/NCI Health Disparities Cancer Collaborative inventory of 44 community health centers. The first, statistical models will use: sequential, multivariable regression models to test for the organizational determinants that may account for the presence and intensity-of-use of clinical decision support (CDS) and information systems (IS) within community health centers for use in colorectal, breast, and cervical cancer screening. A subsequent test will assess the impact of CDS/IS on provider reported cancer screening improvement rates. The second, computational models will use a multi-agent model of network evolution called CONSTRUCT® to identify the agents, tasks, knowledge, groups, and beliefs associated with cancer screening practices and CDS/IS use to inform both CDS/IS implementation and cancer screening intervention strategies. This virtual experiment will facilitate hypothesis-generation through computer simulation exercises. The outcome of this research will be to identify barriers and facilitators to improving community health center facility-level cancer screening performance using CDS/IS as an agent of change. Stakeholders for this work include both national and local community health center IT leadership, as well as clinical managers deploying IT strategies to improve cancer screening among vulnerable patient populations.

Indiana University-Purdue University Indianapolis (IUPUI)
Lafora disease is a neurodegenerative disorder caused by mutations in either the EPM2A or the EPM2B gene that encode a glycogen phosphatase, laforin and an E3 ubiquitin ligase, malin, respectively. A hallmark of the disease is accumulation of insoluble, poorly branched, hyperphosphorylated glycogen in brain, muscle and heart. The laforin-malin complex has been proposed to play a role in the regulation of glycogen metabolism and protein degradation/quality control. We evaluated three arms of protein quality control (the autophagolysosomal pathway, the ubiquitin-proteasomal pathway, and ER stress response) in embryonic fibroblasts from Epm2a-/-, Epm2b-/- and Epm2a-/- Epm2b-/- mice. There was an mTOR-dependent impairment in autophagy, decreased proteasomal activity but an uncompromised ER stress response in the knockout cells. These defects may be secondary to the glycogen overaccumulation. The absence of malin, but not laforin, decreased the level of LAMP1, a marker of lysosomes, suggesting a malin function independent of laforin, possibly in lysosomal biogenesis and/or lysosomal glycogen disposal. To understand the physiological role of malin, an unbiased diGly proteomics approach was developed to search for malin substrates. Ubiquitin forms an isopeptide bond with lysine of the protein upon ubiquitination. Proteolysis by trypsin cleaves the C-terminal Arg-Gly-Gly residues in ubiquitin and yields a diGly remnant on the peptides. These diGly peptides were immunoaffinity purified using anti-diGly antibody and then analyzed by mass spectrometry. The mouse skeletal muscle ubiquitylome was studied using diGly proteomics and we identified 244 nonredundant ubiquitination sites in 142 proteins. An approach for differential dimethyl labeling of proteins with diGly immunoaffinity purification was also developed. diGly peptides from skeletal muscle of wild type and Epm2b-/- mice were immunoaffinity purified followed by differential dimethyl labeling and analyzed by mass spectrometry. About 70 proteins were identified that were present in the wild type and absent in the Epm2b-/- muscle tissue. The initial results identified 14 proteins as potential malin substrates, which would need validation in future studies.

Indiana University-Purdue University Indianapolis (IUPUI)
Derived from the field of art curation, digital provenance is an unforgeable record of a digital object's chain of successive custody and sequence of operations performed on the object. It plays an important role in accessing the trustworthiness of the object, verifying its reliability and conducting audit trails of its lineage. Digital provenance forms an immutable directed acyclic graph (DAG) structure. Since history of an object cannot be changed, once a provenance chain has been created it must be protected in order to guarantee its reliability. Provenance can face attacks against the integrity of records and the confidentiality of user information, making security an important trait required for digital provenance. The digital object and its associated provenance can have different security requirements, and this makes the security of provenance different from that of traditional data. Research on digital provenance has primarily focused on provenance generation, storage and management frameworks in different fields. Security of digital provenance has also gained attention in recent years, particularly as more and more data is migrated in cloud environments which are distributed and are not under the complete control of data owners. However, there still lacks a viable secure digital provenance scheme which can provide comprehensive security for digital provenance, particularly for generic and dynamic ones. In this work, we address two important aspects of secure digital provenance that have not been investigated thoroughly in existing works: 1) capturing the DAG structure of provenance and 2) supporting dynamic information sharing. We propose a scheme that uses signature-based mutual agreements between successive users to clearly delineate the transition of responsibility of the digital object as it is passed along the chain of users. In addition to preserving the properties of confidentiality, immutability and availability for a digital provenance chain, it supports the representation of DAG structures of provenance. Our scheme supports dynamic information sharing scenarios where the sequence of users who have custody of the document is not predetermined. Security analysis and empirical results indicate that our scheme improves the security of the typical secure provenance schemes with comparable performance.

Relatório de estágio de mestrado em Enfermagem da Pessoa em Situação Crítica
A Infeção Associada aos Cuidados de Saúde (IACS) é uma infeção causada pelos cuidados prestados pelos profissionais de saúde aos doentes. Nos últimos anos, em Portugal, a infeção ao nível hospitalar tem aumentado consideravelmente, sendo mais prevalente nas Unidades de Cuidados Intensivos (UCI). As IACS comprometem a qualidade dos cuidados de enfermagem e a segurança dos doentes, razão pela qual, a evidência recomenda que os profissionais de saúde devem utilizar medidas de proteção para a prevenção e controlo das IACS. Nesse sentido, realizou- se um relatório de estágio adotando a metodologia de projeto, a qual tem como objetivo a resolução ou a minimização de um problema real identificado, mediante a implementação de atividades e de estratégias. Recorreu-se à aplicação de um questionário de avaliação diagnóstica aos enfermeiros de uma Unidade de Cuidados Intensivos Polivalente (UCIP) (n=30), sobre medidas de prevenção e controlo de IACS. Os resultados do questionário sugerem que 30% dos enfermeiros “não“ usam sempre luvas na prestação de cuidados ao doente ou contato com os seus pertences e 13,3% só ”às vezes” as usam, de salientar também, que, 40% dos enfermeiros referem que “às vezes” tocam com as luvas, após o contacto com um doente no computador da unidade do doente. 13,3% dos enfermeiros referem que “não” lavam sempre as mãos após o contato com o ambiente envolvente ao doente e 13,3% “às vezes”, 23,3% dos enfermeiros consideram que só é necessário o uso de luvas no contato com a unidade do doente se este estiver infetado, 20% dos enfermeiros referem que só lavam as mãos antes de prestar cuidados aos doentes “às vezes” e 6,7% reportam que “não”. De realçar ainda que, 33,3% dos enfermeiros conhecem as medidas de proteção que devem usar na prestação de cuidados a um doente com gripe A. A partir dos resultados da avaliação diagnóstica foi realizada uma atividade formativa aos enfermeiros da UCIP, com o objetivo de colmatar lacunas de conhecimentos e de os sensibilizar para a necessidade de adopção de medidas de controlo e prevenção das IACS. Os resultados deste trabalho podem contribuir para a melhoria da qualidade dos cuidados e segurança dos doentes em geral, e, em particular, dos doentes internados numa UCI, nomeadamente no que diz respeito à prevenção e controlo de IACS.
Health Care Associated Infection is an infection caused by the care provided to the patients by the health professionals. Over the last years, in Portugal, the infection acquired in hospitals has increased considerably, especially in the Intensive Care Units. The Health Care associated infections compromise the quality of nursing care and the safety of patients, reason which the evidence recommends that health professionals should use protective measures to prevent and control the Health Care associated infections. On that note, it was developed an intern report adopting the project methodology, which the objective is solving or minimizing the real identified problem due to the implementation of activities and strategies. In order to do so, the nurses of an ICU (n=30) were submitted to a questionnaire of diagnostics about preventing measures and Health Care associated infections control. The results of the questionnaire suggest that 30% of the nurses “don’t” always use gloves when providing care to the patients or dealing with their belongings and 13,3% state that only use gloves “sometimes”. 40% of the nurses refer that “sometimes” they touch the computer with the gloves after proving care to patients. The data suggests that 13,3% of the surveyed “do not always” wash their hands after being in contact with the patient and the same percentage only do it “sometimes”. 23,3% of the nurses only consider necessary the use of gloves when contacting with the patient’s unit if he is infected. 20% of the respondents refer that only “sometimes” wash their hands before providing health care to the patient and 6,7% state they “don’t”. The data suggests that 33,3% of the professionals are aware of the protection measures that should be used when dealing with an Influenzavirus A patient. With the results, it was made a formative activity to the ICU nurses with the objective of filling the missing knowledges and to getting them in touch of the necessity of adopting the control and prevention measures of the Health Care associated infections. The results of this work may contribute significantly to the improvement of the quality of the provided care and the safety of patients in general, and particularly of those admitted in an Intensive Care Unit, as regards to the prevention and control of Health Care associated infections.

Indiana University-Purdue University Indianapolis (IUPUI)
In 2009, Indianapolis Emergency Medical Service (I-EMS, formerly Wishard Ambulance Service) launched an electronic medical record system within their ambulances and started to exchange patient data with the Indiana Network for Patient Care (INPC). This unique system allows EMS personnel in an ambulance to get important medical information prior to the patient’s arrival to the accepting hospital from incident scene. In this retrospective cohort study, we found EMS personnel made 3,021 patient data requests (14%) of 21,215 EMS transports during a one-year period, with a “success” match rate of 46%, and a match “failure” rate of 17%. The three major factors for causing match “failure” were (1) ZIP code 55%, (2) Patient Name 22%, and (3) Birth Date 12%. This study shows that the ZIP code is not a robust identifier in the patient identification process and Non-ZIP code identifiers may be a better choice due to inaccuracies and changes of the ZIP code in a patient’s record.

LOW power operation for wireless radio receivers has been gaining importance lately on account of the recent spurt of growth in the usage of ubiquitous embedded mobile devices. These devices are becoming relevant in all domains of human influence. In most cases battery life for these devices continue to be an us-age bottleneck as energy storage techniques have not kept pace with the growing demand of such mobile computing devices. Many applications of these radios have limitations on recharge cycle, i.e. the radio needs to last out of a battery for long duration. This will specially be true for sensor network applications and for im-plantable medical devices. The search for low power wireless receivers has become quite advanced with a plethora of techniques, ranging from circuit to architecture to system level approaches being formulated as part of standard design procedures. However the next level of optimization towards “Smart” receiver systems has been gaining credence and may prove to be the next challenge in receiver design and de-velopment. We aim to proceed further on this journey by proposing Power Scalable Wireless Receivers (PSRX) which have the capability to respond to instantaneous performance requirements to lower power even further. Traditionally low power receivers were designed for worst-case input conditions, namely low signal and high interference, leading to large dynamic range of operation which directly im-pacts the power consumption. We propose to take into account the variation in performance required out of the receiver, under varying Signal and Interference conditions, to trade-off power. We have analyzed, designed and implemented a Power Scalable Receiver tar-geted towards low data-rate receivers which can work for Zigbee or Bluetooth Low Energy (BLE) type standards. Each block of such a receiver system was evaluated for performance-power trade-offs leading to identification of tuning/control knobs at the circuit architecture level of the receiver blocks. Then we developed an usage algorithm for finding power optimal operational settings for the tuning knobs, while guaranteeing receiver reception performance in terms of Bit-Error-Rate (BER). We have proposed and demonstrated a novel signal measurement system to gen-erate digitized estimates of signal and interference strength in the received signal, called Received Signal Quality Indicator (RSQI). We achieve a RSQI average energy consumption of 8.1nJ with a peak energy consumption of 9.4nJ which is quite low compared to the packet reception energy consumption for low power receivers, and will be substantially lower than the energy savings which will be achieved from a power scalable receiver employing a RSQI. The full PSRX system was fabricated in UMC 130nm RF-CMOS process to test out our concepts and to formally quantify the power savings achieved by following the design methodology. The test chip occupied an area of 2.7mm2 with a peak power consumption of 5.5mW for the receiver chain and 18mW for the complete PSRX. We were able to meet the receiver performance requirements for Zigbee standard and achieved about 5X power savings for the range of input condition variations.

Indiana University-Purdue University Indianapolis (IUPUI)
A move toward care of residents in nursing homes where they are respected and heard is finally emerging. Common strategies used in nursing homes to improve quality of care for residents are integration of person-centered care and assessing care using satisfaction surveys. Although approaches of integrating person-centered care and satisfaction surveys have been valuable in improving nursing home quality, strategies of care that include things that matter from residents’ perspectives while living in nursing homes need investigation. The purpose of this qualitative descriptive study was to describe things that residents age 65 and older state matter to them while living in the long-term care sections of nursing homes. A qualitative mode of inquiry using purposeful sampling led to a natural unfolding of data that revealed things that mattered to residents. Content analysis was used to reduce the data in a manner that kept the data close to the context yet moved the data toward new ideas about including things that mattered to residents in nursing care. The findings revealed residents’ positive and negative experiences and addressed the question: How can nurses manage residents’ positive and negative aspects of care in nursing homes? This study substantiated the importance of developing nursing care strategies derived from residents’ descriptions of care. Finding ways to promote nurses’ investment in attitudes about a person-centered care philosophy is essential for successful person-centered care implementation. Enhancing nurses’ knowledge, skills, and attitudes with an investment in person centeredness will be more likely to put nurses in a position to role-model care that is person-centered from residents’ perspectives.