Sobre a implantação de boas práticas de distribuição de produtos médicos de acordo com a RDC nº 59 de 27 de junho de 2000 - ANVISA e NBR ISO 9001:2000

Pós-graduação em Ciências Farmacêuticas - FCFAR

Um estudo sobre a relação entre o sistema de gestão da qualidade ISO 9001 e a inovação em empresas industriais do Estado de São Paulo

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Um estudo sobre as boas práticas e principais dificuldades na implantação de um sistema de gestão de qualidade com base na ISO 9001 e seus reflexos na área ambiental

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Um estudo sobre a certificação ISO 9001 no Brasil: mapeamento de motivações, benefícios e dificuldades

This work aims to identify the main motivations and difficulties faced by Brazilian companies to obtain ISO 9001 certification. The key quality management practices that provide support to this certification and the relationship with other types of systems, such as ISO 14001 (Environmental Management) and OHSAS 18001 (Occupational Health and Safety Management System), were also investigated. A survey research was conducted with 191 companies. The main motivations for implementing ISO 9001 are the following: internal organization improvement, production efficiency increase, and brand reliability improvement. Employee resistance was the greatest challenge found during the implementation process. On the other hand, the main benefits identified were: quality processes improvement and increased employee awareness of quality. The results reveal that the most common quality programs and tools used are: 5S, brainstorming, and Ishikawa diagram, while the least common are SERVQUAL and QFD.

Adoção de práticas ambientais operacionais e do desempenho ambiental: survey com empresas Brasileiras certificadas com ISO 9001

Pós-graduação em Engenharia de Produção - FEB

Sistemas de gestão da qualidade ISO 9001: survey sobre os desafios da implantação

Pós-graduação em Engenharia de Produção - FEB

Aplicação de sistema de gestão da qualidade na execução de obras de pavimentação asfáltica, baseado nas diretrizes da ABNT NBR ISO 9001:2008

This work brings to its content proposed deployment of a system of quality management in paving asphalt based on the elaboration of a basic training to meet those entering this area of civil engineering at a technical manual for the implementation of major services running on paving of roads. The training was designed to serve both those entering the field of asphalt paving, synthesizing the complex processes involved in paving services and providing an overview of the steps in implementation thereof, as well as entrants must meet the enterprise user of this system, providing them an idea of the method used by the company designing the paving of roads. The technical manual presented in turn, has 8 (eight) of the main services components of a work of paving, which are: Mobilization and Maintenance of construction site, Regularization and subfloor preparation, execution or sub-base BGS base (graded gravel plain), Execution of sub-base or base BGTC (graded gravel treated with cement), Implementation of subbase or base Macadam hydraulic Priming bituminous waterproofing, asphalt binder Priming and finally the execution flexible pavement - HMA (hot milled asphalt concrete). These services are presented in the form of IT-Education work, this seven items are presented that guide the performance of services, thus providing overall guidelines to perform the services described in it. The development of IT's was based on experiences in day-to-day paving near the theoretical precepts presented in the literature, so the conditions specified in these documents aim to always guide the implementation of services in general, giving the process a versatility major operation, as this work takes into account the dynamics of such services, as well as the variety of their execution according to local conditions and specified in the project. So in general we can say that this ... (Complete abstract click electronic access below)

Implantação da ISO 9001:2008: estudo de caso em empresado setor de construção civil

In Brazil , the construction industry is on an upward trend, mainly by the housing shortage , and yet there are few builders that take a Quality Management System ( QMS ) to improve the quality of its services and processes . The ISO 9001 standards are guidelines for an effective QMS and this certificate is recognized worldwide as a seal of quality standard. This paper will describe and analyze the implementation of a QMS in a small construction company of Guaratinguetá - SP, identifying best practices and major difficulties , besides proposing preparatory recommendations for other companies that seek the ISO 9000 certification. Access to company’s data made the nonconformities and the customer satisfaction research analysis possible, and a questionnaire and unstructured interviews allowed a deeper understanding of the situation. Despite this ISO 9000 QMS not being fully implemented, the company has already conquered some improvements in document control, project planning, process traceability and established focus on customer

Green Manufacturing: Relationship between Adoption of Green Operational Practices and Green Performance of Brazilian ISO 9001-Certified Firms

The present work aims at analyzing how the adoption of a proactive environmental management via green operational practices (GOPs) correlates to the Green Performance (GrP) of a given set of ISO 9001-certified firms in Brazil. To this end, we elaborated a conceptual framework about environmental management, GOPs, and GrP Such theoretical foundation supported the development of empirical research through quantitative analysis. For the analysis, 75 questionnaires were collected from ISO 9001 certified companies. Data was analyzed by with statistical tools such as descriptive analysis, correlation analysis, and Structural Equation Modeling (SEM). The results demonstrate that the adoption of GOPs, in fact, exerts a positive impact on the GrP of the firms. This work contributes to a better understanding of green manufacturing in Brazil's industrial sector

Planejamento para a implantação da ISO 9001 em uma empresa do setor industrial

The fierce competitiveness of the current market and the sophistication of customer requirements made the commitment to quality a need within organizations. The search for quality has been carried out by the adoption of quality management systems, a formal organization that should be present throughout the organization, from the initial identification of market needs to the satisfaction of customer requirements. The methodology most commonly used for this purpose is based on the requirements of ISO 9001, latest version of 2008. Considering this scenario, was developed a case study in a small company of the industrial sector with the development of a plan for the implementation of ISO 9001. The proposed methodology involved the construction of a theoretical framework on the subject and the development of a case study with a qualitative approach. Initially, was applied a questionnaire to the representative of the organization about the company's operating procedures, activity logs held, current documentation, planning and resource management for the construction of an assessment about the adequacy of the company needs to ISO 9001. Were obtained as results the characterization of production processes and organizational structure of the company and examples of policy and objectives of quality, performance indicators, document control, system for visualization of non-compliances, among others. Finally, the benefits of adopting a quality management system based on ISO 9001 requirements for the company and its environmental issues such as increased process efficiency, less waste and greater profitability, were pointed out, and the conditions for effective certification in the future

Green and competitive: empirical evidence from ISO 9001 certified Brazilian companies

There are many arguments in the literature on environmental management stating that companies that have a significant environmental performance tend to be more competitive, because environmental management tends to generate positive effects on their operational performance. Despite the fact that such arguments are widely accepted, there is little empirical evidence yet of such a relationship in manufacturing contexts that are rarely studied thus far, such as those of developing countries. The paper aims to discuss these issues. Design/methodology/approach – With the objective of testing the positive relationship between environmental performance and operational performance, this research presents the data of a survey conducted with 75 ISO 9001-certified Brazilian companies. Such data were analyzed by means of structural equation modeling. Findings – The paper discovered that, indeed, environmental management relates in a positive, significant manner and large effect to the operational performance of companies.

Characterization of a new platelet aggregating factor from crotoxin Crotalus durissus cascavella venom

In this article we investigated the platelet aggregating activity of whole crotoxin and its subunits isolated from Crotalus durissus cascavella venom. During the purification protocols of the venom, using HPLC molecular exclusion, we detected the presence of two different serine protease activities in the gyroxin fraction, and another in the crotoxin fraction, which induced strong and irreversible platelet aggregation, in addition to blood coagulation. From crotoxin, we isolated PLA(2), crotapotin (both fractions corresponding approximately 85% of whole crotoxin) and another minor fraction (F20) that exhibited serine protease activity. After a new fractionation on reverse phase HPLC chromatography, we obtained three other fractions named as F201, F202 and F203. F202 was obtained with high degree of molecular homogeneity with molecular mass of approximately 28 kDa and a high content of acidic amino residues, such as aspartic acid and glutamic acid. Other important amino acids were histidine, cysteine and lysine. This protein exhibited a high specificity for BApNA, a Michaelis-Menten behavior with Vmax estimated in 5.64 mu M/min and a Km value of 0.58 mM for this substrate. In this work, we investigated the ability of F202 to degrade fibrinogen and observed alpha and beta chain cleavage. Enzymatic as well as the platelet aggregation activities were strongly inhibited when incubated with TLCK and PMSF, specific inhibitors of serine protease. Also, F202 induced platelet aggregation in washed and platelet-rich plasma, and in both cases, TLCK inhibited its activity. The N-terminal amino acid sequence of F202 presented a high amino acid sequence homology with other thrombin-like proteins, but it was significantly different from gyroxin. These results showed that crotoxin is a highly heterogeneous protein composed of PLA(2), thrombin-like and other fractions that might explain the diversity of physiological and pharmacological activities of this protein.

Fator de correção para indivíduos com capacidade acomodativa baseado no uso do refrator automático

OBJETIVO: Pesquisar um fator de correção para avaliação do erro refrativo sem a utilização da cicloplegia. MÉTODOS: Foram estudados 623 pacientes (1.246 olhos), de ambos os sexos, com idade entre 3 e 40 anos. As refratometrias estática e dinâmica foram obtidas usando-se o refrator automático Shin-Nippon Accuref-K 9001. A cicloplegia foi obtida com a instilação de uma gota de colírio ciclopentolato a 1%, com refratometria estática 30 minutos após. Os dados foram submetidos à análise estatística usando a técnica do modelo de regressão linear e modelo de regressão múltipla do valor dióptrico com e sem cicloplegia, em função da idade. RESULTADOS: A correlação entre valores dióptricos sem e com cicloplegia quanto ao erro astigmático variou de 81,52% a 92,27%. Quanto ao valor dióptrico esférico, a correlação foi menor (53,57% a 87,78%). O mesmo se observou em relação ao eixo do astigmatismo (28,86% a 58,80%). O modelo de regressão múltipla em função da idade mostrou coeficiente de determinação múltiplo maior para a miopia (86,38%) e astigmatismo (79,79%). O menor coeficiente foi observado para o eixo do astigmatismo (17,70%). CONCLUSÃO: Avaliando-se os erros refrativos com e sem cicloplegia, observou-se alta correlação nas ametropias cilíndricas. Foram desenvolvidas equações matemáticas como fator de correção para refratometrias dos pacientes sem cicloplegia, portadores de ametropias cilíndricas e esféricas.

Um estudo sobre a utilização de sistemas, programas e ferramentas da qualidade em empresas do interior de São Paulo

O desenvolvimento e implantação de sistemas de gestão da qualidade e o uso de programas e ferramentas da qualidade são algumas das opções mais utilizadas pelos gestores para aumentar a competitividade de suas empresas. Nesse contexto, o objetivo deste artigo é apresentar o resultado de uma pesquisa tipo survey em que se verificaram e analisaram as principais características do processo de certificação ISO 9001, seus benefícios, suas dificuldades e quais programas e ferramentas da qualidade são utilizados em 236 empresas do interior do Estado de São Paulo. A pesquisa revelou que a certificação ISO 9001 gera benefícios significativos às organizações, tais como: melhoria dos processos internos e nos seus produtos; aumento da satisfação dos clientes; diminuição do número de não conformidades e de devoluções; aumento da produtividade e do lucro; melhoria no gerenciamento dos recursos e valorização da imagem da empresa no mercado. Ela também ratificou a importância da utilização dos programas e ferramentas da qualidade como forma de as empresas se adequarem melhor aos requisitos da norma ISO 9001. As dificuldades de desenvolvimento e implantação desses sistemas não se confirmaram para a amostra pesquisada. Apenas a resistência à mudança, dentre todas apresentadas, mereceu destaque para os pesquisados.

Uso do AHP na avaliação do desempenho do sistema de gestão da qualidade, meio ambiente e segurança e saúde ocupacional integrados

The paper analyses the application of the AHP method together with the attach A of ISO 9004:2000 in order to evaluate the performance of two industrial organizations, both possessing quality management systems with ISO 9001:2000 certifications, based on the specific requirements of quality, environment, occupational health and management systems. The evaluated organizations were a government-owned company from the science and technology sector that works in the nuclear area, and a private company that works in the automotive and railroad area. The open software Web-Hipre version 1.22 from Helsinki University of Technology, Finland, was used. The results demonstrated that the AHP method together with the attach A of ISO 9004:2000 is adequate to evaluate organizational performances. Both organizations presented similar performance levels.