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Aplicación de buenas prácticas de Enterprise Risk Management (ERM) a un proyecto inmobiliario / Application of Good practices of Enterprise Risk Management (ERM) to a real estate projectCasas Tuanama, Brenda Laura, Cirilo García, José, Guzmán Saavedra, Gabriela, Seminario Cruz, Isabel Elena 09 June 2019 (has links)
El rubro inmobiliario está expuesto a factores externos que varían constantemente, afectando el cumplimiento de los objetivos estratégicos de la organización.
La Inmobiliaria del caso en estudio, emplea gestión de riesgos sólo a nivel de proyectos y es necesario que incorpore otras fuentes de riesgos como financieros, operacionales y reputacionales que podrían impactar en el desempeño del proyecto y sus resultados.
En búsqueda de la creación de valor, se debe establecer que esto no sólo significa el éxito del proyecto sino también de la operación, gestión de activos, etc., es decir, una gestión integral y holística. Por lo que, se decidió investigar sobre el ERM, cuyo acrónimo significa Gestión de Riesgos Empresariales, y aplicar sus buenas prácticas en un proyecto en particular de la Inmobiliaria a través de la inclusión de riesgos organizacionales, del proyecto y externos.
Para ello, se conocerá la cultura de la empresa, se realizará el Caso de Negocio, el cual cubre la construcción y operación de un edificio de oficinas prime y retail de 10 pisos ubicado en el distrito de Miraflores en Lima Perú. Se estima que el proyecto va a tener un VAN de 68.6 MM USD con una TIR de 10.1% en un tiempo de operación de 40 años, así como un tiempo de ejecución de un (01) año para la fase de pre-construcción y dos (02) años para la fase de construcción. Además, se planteará una introducción teórica de ERM para culminar con el diseño del marco de referencia, en donde se exponen los riesgos a todo nivel.
Finalmente, se podrá evidenciar los beneficios que conlleva su implementación y se plasman las futuras recomendaciones para su puesta en práctica. / The real estate sector is exposed to external factors that constantly vary, affecting the fulfillment of the strategic objectives of the organization.
“The Inmobiliaria”, the Real Estate company of the case under study uses risk management only at the project level and it is necessary to incorporate other sources of risks such as financial, operational and reputational that could impact the performance of the project and its results.
In search of value creation, it must be established that this not only means the success of the project but also of the operation, asset management, etc., that is, a comprehensive and holistic management. Therefore, it was decided to investigate the ERM, whose acronym means Enterprise Risk Management, and apply its good practices in a particular the Inmobiliaria project through the inclusion of organizational, project and external risks.
For this, the culture of the company will be known, the Business Case will be carried out, which cover of the construction and operation of a 10-story prime and retail office building located in Miraflores district in Lima Peru. It is estimated that the project will have a NPV of 68.6 MM USD with an IRR of 10.1% in an operation time of 40 years, as well as an execution time of one (01) year for the pre-construction phase and two (02) years for the construction phase. In addition, a theoretical introduction to ERM will be considered to culminate with the design of the reference framework, where risks are exposed at all levels.
Finally, it will be possible to show the benefits that its implementation entails and future recommendations for its implementation will be reflected. / Trabajo de investigación
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Aplicación de acciones sostenibles para el eje social y ambiental en la gestión de operadores turísticos internacionales / Implementation of sustainable actions for the environmental and social thrust in the management of tour operatorsLiñer Elias, Diana Carolina 21 July 2020 (has links)
La finalidad de esta investigación es exponer las tendencias mundiales de gestión sostenible que mediante las acciones en los ejes social y ambiental han sido implementadas por los operadores turísticos. La metodología empleada fue la investigación bibliográfica iniciando con una revisión descriptiva de fuentes académicas que culmina con un análisis descriptivo y evaluativo para los fines de la investigación.
La investigación se basó en estudios académicos sobre la aplicación de la sostenibilidad social y ambiental en la gestión de los operadores turísticos internacionales. A partir de ello, se observa que en el eje ambiental existe un mayor número de acciones implementadas por los operadores turísticos. Estas están orientados a la gestión del consumo de agua y energía, manejo de residuos sólidos, reducción de materiales desechables, compras ecológicas, capacitaciones en conciencia ambiental, entre otras. Mientras que para el eje social se identificó que los operadores turísticos aplicaron un menor número de acciones, debido a que estas acciones resultan más complejas. Las acciones se enfocan en beneficios económicos para ambas partes (comunidad-operador turístico) y preservación de la cultura local. Pese a ello, se estableció que aún existen limitaciones para que los operadores turísticos apliquen acciones sostenibles tanto para el eje ambiental, como para el social. Una de las limitaciones es encontrar aliados entre sus proveedores que sigan las mismas prácticas, debido a que deben ofrecer un servicio que incluya estándares de sostenibilidad.
Se concluye que las prácticas sociales y ambientales están siendo usadas por operadores turísticos a nivel internacional, y se encuentran principalmente motivadas por los beneficios que traen, tales como, menores costos en operaciones, mayores ingresos por la atención de clientes que demandan experiencias social y ambientalmente sostenibles y lograr una mayor captación de mercado. / The purpose of this research is to expose the global trends of sustainable management that through actions on the environmental and social trust have been implemented by tour operators. The methodology used was bibliographic research initiating with a descriptive review of academic sources that culminates with a descriptive and evaluative analysis for research purposes.
The research was based on academic studies on the application of environmental and social sustainability in the management of international tour operators. From this, it is observed that there is a greater number of actions implemented by tour operators in the environmental axis. These actions are oriented to the management of water and energy consumption, solid waste management, reduction of disposable materials, ecological purchases, training in environmental awareness, among others. While for the social axis, it was identified that tour operators applied fewer but more complex actions. Those actions focus on economic benefits for both parties (community-tourist operator) and preservation of local culture. Despite this, it was established that there still are limitations for tour operators to implement sustainable actions for the environmental and social axes. One of the limitations is the difficulty to find allies among their suppliers who follow these same practices, because they must offer a service that includes sustainability standards.
It is concluded that social and environmental practices are being used by tour operators internationally and are mainly motivated by the benefits it brings such as, lower costs in operations, higher revenue from the attention of customers who demand social and environmentally sustainable experiences and achieving greater market acquisition. / Trabajo de investigación
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Deterring violent extremism in America by utilizing good counter-radicalization practices from abroad: a policy perspectiveBonanno, Amy Fires 03 1900 (has links)
Approved for public release; distribution is unlimited / The problem of violent extremism is approaching a critical point in America. American government and community leaders must find an effective approach to deterring violent extremism immediately. A national and comprehensive approach to deter violent extremism in America is currently lacking. This comparative policy perspective seeks to determine whether the United Kingdom and Australia have good practices to deter violent extremism that can be useful in America. Secondly, this thesis also seeks to determine whether the United States can implement potential good practices to deter violent extremism. After a thorough review of the issue of violent extremism in America, this thesis studies similar background, research, and violent extremism issues in the United Kingdom and Australia. This thesis concludes that a variety of good practices in the United Kingdom and Australia can counter radicalize and deter violent extremists in America. The findings and recommendations from this research include challenges and a way forward to implement certain potential best practices for the United States. The arguments offer viable options and alternatives that the United States should consider when creating a national deterring-violent-extremism strategy. The details and information regarding understanding and implementing good practices to deter violent extremism in America are contained in this thesis. / Major, New York Army National Guard, Latham, New York
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Boas práticas voltadas à gestão ambiental, da qualidade e da segurança para obras de empresas construtoras de micro porteBianco, Monica 03 August 2012 (has links)
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Previous issue date: 2012-08-03 / Nenhuma / A indústria da construção civil é responsável por uma parcela significativa dos impactos ambientais que vêm ocorrendo, especialmente em relação ao consumo de recursos não renováveis e à geração de resíduos. É também responsável por contabilizar um alto número de acidentes de trabalho em seus canteiros de obras, e o elevado índice de perdas, nos quais são incluídos desperdícios e resíduos, é considerado um dos principais desafios do setor da construção, e se constitui em um agravante no consumo de materiais. Além desses, a alteração do ecossistema durante a execução das obras e os incômodos causados à vizinhança – poluição sonora, visual e do ar (poeira) também são considerados impactos ambientais atribuídos à construção. Diversas são as mudanças que o setor da construção civil vem sofrendo nos últimos anos, tanto em relação à qualidade de seus produtos quanto às preocupações ambientais e de segurança de seus operários. Tem-se percebido que existe um número expressivo de leis, regulamentações, certificações e programas que tangem essas questões através de um conjunto de critérios e procedimentos a serem seguidos, e que as grandes empresas do setor possuem maior agilidade na implementação destas normas, pois apresentam sistemas de gestão mais robustos e canteiros de obras melhor organizados. No entanto, uma das peculiaridades do setor da construção civil é a concentração de micro e pequenas empresas que contam com um reduzido número de profissionais, especialmente no corpo técnico, o que dificulta o atendimento a esses programas, geralmente extensos, e que demandam consideráveis investimentos e esforços gerenciais. Neste contexto, o trabalho tem como objetivo propor um conjunto de práticas voltadas à gestão ambiental, de qualidade e segurança para obras de construtoras de pequeno porte, através de um estudo de caso conduzido durante a fase de produção de uma obra residencial por uma empresa construtora familiar de pequeno porte. Na primeira etapa foram identificados os principais problemas gerados por cada fase de construção em termos de qualidade, segurança e meio ambiente. A segunda etapa da pesquisa consistiu em relacionar os princípios de normas de sistemas de gestão para redução dos problemas identificados (NBR ISO 9001:2008, NBR ISO 18801:2010 e NR-18, ISO 14001:2004). Na terceira etapa, foi elaborado um conjunto de boas práticas a serem implementadas por empresas construtoras de micro porte, sem objetivos de certificação. As boas práticas propostas incluem organização de canteiro e documentos, redação de procedimentos e parâmetros de controle e itens de segurança individual e coletivos. / The construction industry is responsible for a significant share of environmental impacts taking place nowadays, and account for a high number of accidents in the worksites. One of the main challenges of the construction sector lies on the high rate of losses, which includes waste and residues. In addition to that, the tampering of the ecosystem, the discomfort caused to the neighboring areas – visual, noise and air (dust) pollution – and the substantial depletion of natural resources are also considered environmental impacts attributed to construction. Nevertheless, the construction industry has gone through several changes in recent years regarding the environmentally-suited quality of products and safety of labor workers. An expressive number of laws, regulations and certification programs guideline these issues through a set of criteria and procedures that have come into effect lately. Due to the fact that large companies feature more well-structured management systems and better organized construction sites, they seem to have greater flexibility on implementing these standards. However, one of the peculiarities of the civil construction sector is the concentration of micro and small enterprises that rely on a small number of professionals, especially in the technical team, thus making it difficult to meet the requirements of such extensive and high-investment programs. In this context, this paper aims to propose a set of practices concerning environmental management, quality and safety directed to small construction works, through a case study conducted during the production phase in a residential construction work carried out by a small family-owned company. In the first stage, the main impacts generated by each construction phase in terms of quality, safety and the environment were identified. The second stage of the research consisted of relating the management systems regulation principles in order to reduce identified impacts (NBR ISO 9001: 2008, NBR ISO 18801: 2010 and NR-18, ISO 14001: 2004). And in the third stage, we designed a set of good practices to be implemented by micro firms without certification goals. Good practices proposals comprehend organization of job site construction and documents, drafting of procedures and parameters of security control, as well as individual and collective safety items.
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A Aplica??o de Boas Pr?ticas: Uma Contribui??o para a Atualiza??o das Compet?ncias nos Curr?culos dos Cursos T?cnico em Agropecu?ria e Agroind?stria do IFTM ? Campus Uberl?ndia. / In this work was studied the contribution of Good Agricultural and Manufacturing Practices in the acquisition of abilities proposed by the curriculum of the Agriculture and Livestock Technical Course and Agroindustry Technical Course of Federal Institute of Tri?ngulo Mineiro- Uberl?ndia Campus (IFTM-Uberl?ndia Campus). An interdisciplinary proposal was applied to the production of vegetables destined to the consumption in the sector of feeding and nutrition of the Institution. 20 students from the Agriculture Technical course and 17 from the Agroindustry Technical course from IFTM-Uberl?ndia Campus. It was used as the object of work for the pedagogical evaluation planting of lettuce, one in the conventional way and another with the application of Good Agricultural Practices. In the evaluation of the pedagogical process, the method of evaluation of individual attitude was used, constructing relative affirmative questions to the main phases of development of the steps that made this work (process and its controls and microbiological analyses). The evaluation tools contained affirmations referring to the concepts and necessary knowledge to understand the good stages that involve the process of the good practical. These were punctuated with a scale ranging from ?I disagree very much? to ?I agree very much?, with a total of seven points. These were applied in two different stages, being first the representative one of zero condition, which is, without any involvement with the activities of the project and second, after concluding the practical activities. For each plantation, 50 randomly harvested heads of lettuce were selected. The samples of each plantation (conventional and GAP) and each processing (conventional and GMP), after the collection, were transported to the laboratory of Food Microbiological Analyses of the IFTM- Uberl?ndia Campus, where Total and Fecal Coliforms were analyzed. The diagnostic tests on the knowledge in GAP and GMP presented average above 6 for the four evaluated groups, but there was an increase in the values of notes of the evaluations, after the applied training. However, the results did not present significant statistical differences between the groups, both in the first and in the second moment in relation to the knowledge level on GAP and GMP. This result can e justified, because the study had the limitation to a small sample. In the analysis of images of subjects at different stages of labor was observed cooperation and organization of the group leaders with the creation of better performance of the activities. The present work allowed the academic knowledge to the applied research. It was possible to follow the construction of the knowledge of the students and researcher, which was accomplished by means of the principles that support interdisciplinary practices, who contribute to the formation of citizens critical and participative.Rosa, M?rcia de Freitas 08 October 2010 (has links)
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Previous issue date: 2010-10-08 / In this work was studied the contribution of Good Agricultural and Manufacturing Practices
in the acquisition of abilities proposed by the curriculum of the Agriculture and Livestock
Technical Course and Agroindustry Technical Course of Federal Institute of Tri?ngulo
Mineiro- Uberl?ndia Campus (IFTM-Uberl?ndia Campus). An interdisciplinary proposal was
applied to the production of vegetables destined to the consumption in the sector of feeding
and nutrition of the Institution. 20 students from the Agriculture Technical course and 17
from the Agroindustry Technical course from IFTM-Uberl?ndia Campus. It was used as the
object of work for the pedagogical evaluation planting of lettuce, one in the conventional way
and another with the application of Good Agricultural Practices. In the evaluation of the
pedagogical process, the method of evaluation of individual attitude was used, constructing
relative affirmative questions to the main phases of development of the steps that made this
work (process and its controls and microbiological analyses). The evaluation tools contained
affirmations referring to the concepts and necessary knowledge to understand the good stages
that involve the process of the good practical. These were punctuated with a scale ranging
from ?I disagree very much? to ?I agree very much?, with a total of seven points. These were
applied in two different stages, being first the representative one of zero condition, which is,
without any involvement with the activities of the project and second, after concluding the
practical activities. For each plantation, 50 randomly harvested heads of lettuce were selected.
The samples of each plantation (conventional and GAP) and each processing (conventional
and GMP), after the collection, were transported to the laboratory of Food Microbiological
Analyses of the IFTM- Uberl?ndia Campus, where Total and Fecal Coliforms were analyzed.
The diagnostic tests on the knowledge in GAP and GMP presented average above 6 for the
four evaluated groups, but there was an increase in the values of notes of the evaluations, after
the applied training. However, the results did not present significant statistical differences
between the groups, both in the first and in the second moment in relation to the knowledge
level on GAP and GMP. This result can e justified, because the study had the limitation to a
small sample. In the analysis of images of subjects at different stages of labor was observed
cooperation and organization of the group leaders with the creation of better performance of
the activities. The present work allowed the academic knowledge to the applied research. It
was possible to follow the construction of the knowledge of the students and researcher,
which was accomplished by means of the principles that support interdisciplinary practices,
who contribute to the formation of citizens critical and participative. / Neste trabalho foi estudada a contribui??o das Boas Pr?ticas Agr?colas e de Fabrica??o na
aquisi??o de compet?ncias propostas pelas matrizes curriculares dos Cursos T?cnicos em
Agropecu?ria e Agroind?stria do Instituto Federal do Tri?ngulo Mineiro-Campus Uberl?ndia
(IFTM-Campus Uberl?ndia). Foi utilizada uma proposta interdisciplinar aplicada ? produ??o
de hortali?as folhosas destinada ao consumo no Setor de Alimenta??o e Nutri??o da
Institui??o. Participaram da pesquisa 20 estudantes do Curso T?cnico em Agropecu?ria e 17
do Curso em Agroind?stria do IFTM-Campus Uberl?ndia. Utilizou-se como objeto de
trabalho para a avalia??o pedag?gica o plantio de alface, sendo um na forma convencional e
outro com a aplica??o das Boas Pr?ticas Agr?colas. Na avalia??o do processo pedag?gico,
utilizou-se o m?todo de avalia??o de atitude do indiv?duo, construindo-se quest?es afirmativas
relativos ?s principais fases de desenvolvimento das etapas que compuseram este trabalho
(processo e seus controles e an?lises microbiol?gicas). Os instrumentos de avalia??o
continham afirmativas referentes aos conceitos e conhecimentos necess?rios para
compreender as etapas que envolvem o processo das boas pr?ticas. Estas foram pontuadas
com uma escala variando entre o ?discordo muito? ao ?concordo muito?, com um total de sete
pontos. Esses foram aplicados em duas etapas diferentes, sendo a primeira representativa da
condi??o zero, ou seja, sem qualquer envolvimento com as atividades do projeto e a segunda,
ap?s concluir as atividades pr?ticas. Utilizou-se ainda, an?lise das imagens dos sujeitos nas
diferentes etapas do trabalho. Para cada plantio foram selecionados 50 p?s de alface, colhidos
aleatoriamente. As amostras de cada plantio (convencional e BPA) e cada processamento
(convencional e BPF), ap?s a coleta, foram transportadas para o Laborat?rio de An?lises
Microbiol?gicas de Alimentos do IFTM-Campus Uberl?ndia, onde foram realizadas as
an?lises de Coliformes a 35?C e Coliformes a 45?C. Os testes diagn?sticos sobre os
conhecimentos em BPA e BPF apresentaram notas m?dias superiores a 6 para os quatro
grupos avaliados, houve um aumento nos valores das notas das avalia??es, ap?s o treinamento
aplicado. Entretanto, os resultados n?o demonstraram diferen?as estat?sticas significativas
entre os grupos, tanto no primeiro quanto no segundo momento em rela??o ao n?vel de
conhecimento sobre BPA e BPF. Esse resultado pode ser justificado, uma vez que o estudo
teve a limita??o quanto ao pequeno tamanho da amostra. Na an?lise das imagens dos sujeitos
nas diferentes etapas do trabalho foi observada a coopera??o e a organiza??o do grupo com a
cria??o de lideres melhorando o desempenho das suas atividades. O presente trabalho
permitiu vincular o conhecimento acad?mico ? pesquisa aplicada. Foi poss?vel acompanhar a
constru??o do conhecimento por parte dos estudantes e pesquisador, que se efetivou por meio
dos princ?pios que embasam a pr?tica interdisciplinar, os quais contribuem para a forma??o de
cidad?os cr?ticos e participativos.
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BETWEEN THE NARROW LIMITS OF STRUCTURAL VIOLENCE AND ARMED CONFLICT VIOLENCE : Case Study of Indigenous Peoples in Arauca, ColombiaArenas Cano, Ana Catalina January 2012 (has links)
Indigenous communities living in Arauca department, a region located on the Eastern Plains of Colombia, are at an imminent risk of physical and cultural extermination -according to the orders 004 and 382 from the Constitutional Court of Colombia- due to a double vulnerability which stems from a historic structural violence dating from the creation of the nation-state and direct violence as a consequence of armed conflict. The physical extermination refers to the high mortality rates that this population suffers either by violence or natural death, while the cultural extermination is a result of both an accelerated process of acculturation and a progressive loss of culture, territory and respect from traditional authorities. This study, by analyzing the local context and the actions that have done harm, addresses the best practices for humanitarian interventions over the role of territory, culture, governance and autonomy as key factors for empowering community members to overcome, face or diminish the consequences of these vulnerabilities.
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Avaliação das condições higiênico-sanitárias dos serviços de alimentação de um shopping center do município de Porto Alegre/RS / Evaluation of the hygienic status of food services located in a shopping mall from Porto Alegre, BrazilWingert, Carine January 2012 (has links)
Diversas condições durante as etapas de produção dos alimentos podem levar à introdução de micro-organismos patogênicos nas refeições. Esse fato pode ser relevante nos serviços de alimentação localizados em shopping centers pela limitada área física, número de equipamentos insuficientes e volume de refeições servidas. O objetivo do presente estudo foi avaliar esse tipo de estabelecimento quanto ao cumprimento de boas práticas e verificar a presença de matéria orgânica e contaminação bacteriana residual em refrigeradores que haviam sido submetidos à limpeza de rotina. Vinte estabelecimentos localizados em um shopping center de Porto Alegre foram incluídos no estudo. Em cada estabelecimento foi aplicada a Lista de Verificação em Boas Práticas para Serviços de Alimentação prevista na Portaria nº 78 de 28 de Janeiro de 2009 (CEVS) e foram colhidas três amostras com intervalo mensal da parede interna do refrigerador no dia subsequente à limpeza de rotina. As amostras foram avaliadas pelo sistema Clean Trace (3M), quanto à presença de Listeria sp., Coliformes Totais e Escherichia coli. Os dados resultantes da aplicação da Lista de Verificação apontaram que 55% dos estabelecimentos não atingiram a pontuação mínima (>75%) para serem considerados satisfatórios. Em 95% (57/60) das amostras colhidas nos refrigeradores, demonstrou-se a presença de matéria orgânica residual. Já as análises microbiológicas apontaram ausência de Listeria sp., presença de de Coliformes Totais e E. coli em 8,3% e 1,6% das amostras, respectivamente. Não houve associação entre a classificação do estabelecimento (satisfatório/insatisfatório) e a presença de matéria orgânica residual ou Coliformes Totais nos refrigeradores. Estes resultados demonstram a necessidade de constante revisão e monitoramento dos processos de higienização de equipamentos em serviços de alimentação. / Several conditions during all stages of food production can lead to the introduction of pathogenic micro-organisms in food. This fact may be relevant in the food service located in shopping malls by limited physical area, insufficient number of equipment and volume of meals served. The aim of this study was to evaluate this type of establishment for compliance with good practices and verify the presence of organic matter and residual bacterial contamination in refrigerators that had been submitted to routine cleaning. Twenty establishments located in a shopping center from Porto Alegre were included in the study. In each establishment a Checklist for Good Practice for Food Services, provided by Resoltuion No. 78 published on January 28th 2009 (CEVS), was aplied, and three samples were collected at monthly intervals from the inner wall of the refrigerator on the day following the routine cleaning. The samples were evaluated by the Clean Trace system (3M) for the presence of Listeria sp., Total Coliforms and Escherichia coli. The data resulting from application of the Checklist showed that 55% of establishments didn’t attained the minimum score (> 75%) to be classified satisfactory. From de samples taken on the refrigerator’s inner wall, 95% (57/60) demonstrated the presence of residual organic. Nevertheless, microbiological analyzes showed absence of Listeria sp., and isolation of Total Coliforms and E. coli in 8.3% and 1.6% of the samples, respectively. There was no association between the classification of the establishment (satisfactory / unsatisfactory) and the presence of residual organic matter or total coliform in the refrigerator. The results demonstrate the need for constant review and monitoring and improvement of sanitizing procedures of equipment in food service.
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Avaliação da capacidade instalada para a produção e certificação de células animaisBretas, Rodrigo Martins January 2011 (has links)
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Previous issue date: 2011 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil. / A cultura de células animais tem sido usada como ferramenta em diversas áreas das
ciências biológicas, desde a pesquisa básica até asaplicações em medicina. Como plataforma
tecnológica, substratos celulares são úteis, em especial quando armazenados na forma de
bancos, para a produção de inúmeros produtos biológicos, dentre os quais figuram as
proteínas recombinantes de interesse terapêutico e vacinas virais para uso humano. A
caracterização ou certificação de tais bancos está baseada na determinação de seus aspectos de
identidade, pureza e estabilidade.
O presente trabalho teve por objetivo avaliar a capacidade instalada no país para o
estabelecimento e certificação de células animais, em especial as de mamíferos, visando à
produção de medicamentos biológicos. Para tal, foram investigados os centros nacionais que
atuam com pesquisa, desenvolvimento, controle e produção usando bancos de células.
Cientistas de tais centros foram procurados para preencher um questionário a fim de
estabelecer o perfil e capacidades presentes no país. Paralelamente, foi realizado levantamento
e análise de toda regulamentação, nacional e internacional, relacionada à geração e
certificação de substratos celulares usados com fins industriais.
A comparação entre o cenário nacional e o internacional revelou que a maioria dos
centros no país atua na pesquisa e desenvolvimento de biológicos; alguns desenvolvem
atividades de testes de controle; e apenas dois produzem biofármacos ou vacinas. Os centros
buscam adequação a regulações para que suas atividades sejam reconhecidamente aderentes a
um sistema de qualidade; vários destes são potenciais parceiros para Bio-Manguinhos. Em
contraste, a maioria das empresas identificadas no exterior já desenvolve bancos de células
animais em conformidade às Boas Práticas de Fabricação.
Foi identificada uma lacuna regulatória nacional com relação aos temas específicos
levantados na pesquisa. Neste sentido, o trabalho culmina com uma proposta inicial de guia
para orientar o setor produtivo quanto ao estabelecimento e certificação de bancos de células.
A geração dos substratos celulares deve ser realizada em conformidade às Boas Práticas de
Fabricação, em especial no que tange a aspectos como classificação de salas limpas,
validações e qualificações; tal adesão deve ser verificada por inspeção por parte de
Autoridade Sanitária. De forma similar, os testes para determinação do perfil de segurança
devem seguir métodos validados, quando aplicável, realizados por laboratórios aderentes a um
sistema de qualidade; tal fato deve ser verificado pelo cumprimento das Boas Práticas de
Laboratório ou acreditação por uma Autoridade Nacional.
A geração de bancos de células em condições certificadas, bem como sua caracterização
por métodos válidos e aceitos, confere os atributosde autenticidade, pureza e estabilidade a
esses substratos, o que irá implicar na produção demedicamentos biológicos de qualidade,
eficazes e seguros. / Animal cell culture has been used as a tool in several fields within biology, from basic
research to medical applications. As a technological platform, cell substrates are useful,
especially when stored as banks, for the productionof many biologicals such as recombinant
proteins of therapeutic interest and viral vaccinesfor human use. The characterization or
certification of such banks is based on the determination of their identity, purity and stability
features.
The present work aimed to assess the installed capacity in the country for establishing
and certifying animal cells, especially the ones from mammals, for the production of
biologicals. Thus, national centers dealing with research, development, control and production
were investigated. Their scientists were requested to fill in a questionnaire in order to draw
the profile and capacities present in the country. In parallel, all regulation, national and
international, was searched and analyzed, regardinggeneration and certification of cell
substrates used for industrial purposes.
The comparison between national and international scenarios showed that most national
centers are involved with biologicals research and development; some act in testing and
control; and only two produce biomedicines or vaccines. Centers seek adequacy to regulations
so that their activities be acknowledged as compliant to a quality system; several of such
centers are potential partners to Bio-Manguinhos. In contrast, most international companies
identified already develop animal cell banks according to Good Manufacturing Practices.
A national regulatory gap was identified regarding specific topics raised in the research.
This way, the work culminates with an initial draftversion of a guideline to orient the
productive sector in establishing and certifying cell banks. Such banks must be generated in
conformity to Good Manufacturing Practices, especially in aspects as classification of clean
rooms, validations and qualifications; such compliance must be verified by the Health
Authority. Similarly, tests to determine the safetyprofile must follow validated methods,
when applicable, performed by laboratories which comply to a quality system; this must be
verified by fulfillment of Good Laboratory Practices or accreditation by a National Authority.
Generation of cell banks under certified conditions, as well as their characterization by
valid and accepted methods, grants the attributes of authenticity, purity and stability to these
substrates, which will implicate in the production of biologicals with quality, efficacy and
safety.
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DIAGNÓSTICO DO PERFIL DOS ESTABELECIMENTOS DO SETOR SUPERMERCADISTA DE ACORDO COM A LEGISLAÇÃO DE ALIMENTOS / PROFILE DIAGNOSYS OF ESTABLISHMENTS FROM THE SUPERMARKET SECTOR IN ACCORDANCE TO THE FOOD LEGISLATIONBrasil, Carla Cristina Bauermann 24 October 2011 (has links)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / The competition and the concentration of business, observed in the Brazilian market,
increase more and more the necessity of searching for quality and differentiation by
the supermarket sector, seeing that the consumer is more and more demanding.
Despite this, this segment remains little studied as for the hygienic-sanitary, food
manipulators and managing conditions. Thus, this study aimed to develop and apply
a specific list of Good Practices inspection for the supermarket sector; to characterize
and verify the level of adequacy of this segment to the Good Practices; to identify the
social- economical and demographic profile of managers and food manipulators in
the establishments; and, to verify their level of knowledge in relation to the food
security. The evaluation of hygienic-sanitary conditions was done in 69
establishments from the supermarket sectors which were registered at the National
Health Surveillance Agency - VISA, during the period between April and July 2011
through the development and application of the list of Good Practices, having the
current legislation as basis. He data were collected by in loco observation, using the
List of Good Practices inspection, which were filled in by a technical and capable
professional in the area of food quality. The data referring to the 345 food
manipulators and 69 managers were obtained through interviews with questionnaires
previously tested and approved by the Committee of Ethics in Research (CEP) from
the Federal University of Santa Maria (UFSM). The data analysis revealed that the
average percentage of general adequacy of the 69 establishments is of 29,07%,
being that the blocks that show bigger conformity were related to the external area
(64,73%) and storing at ambient temperature (64,13%), respectively. the
establishments showed a less satisfying performance in the other blocks and sectors,
mainly in the bakery and patisserie (14,93%), water supply (18,30%), food
manipulators (21,01%), sausage and cold meats factory (36,38%), butcher and
fishery (40,06%), beyond the items referring to the Good Practices documentation
(4,97%), seeing that any establishment from the supermarket sector had the Good
Practice Manual, the Operational Standard Procedures and the other necessary
documents for the implementation of the quality systems. Beyond that, all
establishments from the supermarket sector showed inefficiency to the application of
the Good Practices. The information from the interviews done with the food
manipulators and the establishment managers revealed that these professionals
have right perceptions about the food hygiene and manipulation; however, the
knowledge related to the food security may not result in its effective application. It is
suggested greater applicability of the Good Practices in the establishments analyzed,
as well as the adoption of programs for continuing capability for the food
manipulators and establishment managers in order to guarantee the quality in the
food production and manipulation. the results of this work evidence lacks in the
procedures adopted in the segment in study, what allows to assume potentials and
expressive risks of impulsive occurrence of diseases passed through food in these
environments and the like, yet, the establishments where the research happened
mirror the conditions of common occurrence in our country. Investments in manpower
capacitance and the urgent and effective implementation of right procedures of
manipulation, in a way to guarantee food according to the sanitary standards
adequate to the health protection of the consumer public, are recommended. / A competição e a concentração de negócios, observados no mercado brasileiro,
aumentam ainda mais a necessidade de busca de qualidade e diferenciação por
parte do setor supermercadista, visto que o consumidor está a cada dia mais
exigente. No entanto, este segmento permanece pouco estudado quanto aos
aspectos relacionados às condições higiênico-sanitárias, manipuladores de
alimentos e gestores. Sendo assim, este estudo teve por objetivos desenvolver e
aplicar uma lista de verificação de Boas Práticas específica para o setor
supermercadista; caracterizar e verificar o nível de adequação do segmento quanto
às Boas Práticas; identificar o perfil socioeconômico e demográfico do gestor e dos
manipuladores de alimentos dos estabelecimentos; e, verificar o nível de
conhecimento desses em relação à segurança dos alimentos. A avaliação das
condições higiênico-sanitárias foi realizada em 69 estabelecimentos do setor
supermercadista cadastrado na Vigilância Sanitária, no período de abril a julho de
2011 por meio do desenvolvimento e aplicação da lista de verificação de Boas
Práticas, tendo como base as legislações vigentes. Os dados foram coletados por
observação in loco utilizando a lista de verificação de Boas Práticas e foram
preenchidos por um profissional técnico e capacitado na área de qualidade dos
alimentos. Os dados referentes aos 345 manipuladores de alimentos e 69 gestores
foram obtidos por meio de entrevistas com questionários previamente testados e
aprovados pelo Comitê de Ética em Pesquisa (CEP) da Universidade Federal de
Santa Maria (UFSM). A análise de dados revelou que o percentual médio de
adequação geral dos 69 estabelecimentos é de 29,07%, sendo que os blocos que
apresentaram maior conformidade foram relativos à área externa (64,73%) e
armazenamento a temperatura ambiente (64,13%), respectivamente. Os
estabelecimentos apresentaram um desempenho menos satisfatório nos demais
blocos e setores, principalmente na padaria e confeitaria (14,93%), abastecimento
de água (18,30%), manipuladores de alimentos (21,01%), salsicharia e fiambreria
(36,38%), açougue e peixaria (40,06%), além de itens referentes à documentação de
Boas Práticas (4,97%), visto que nenhum estabelecimento do setor supermercadista
possuía o Manual de Boas Práticas, os Procedimentos Operacionais Padrão e as
demais documentações necessárias para a implementação dos sistemas de
qualidade. Além disso, todos os estabelecimentos do setor supermercadista
demonstraram ineficiência quanto à aplicação das Boas Práticas. As informações
das entrevistas realizadas junto aos manipuladores de alimentos e gestores dos
estabelecimentos revelaram que esses profissionais possuem percepções corretas
quanto à higiene e manipulação dos alimentos; no entanto, o conhecimento relatado
sobre a segurança dos alimentos pode não resultar na sua efetiva aplicação.
Sugere-se maior aplicabilidade das Boas Práticas nos estabelecimentos analisados,
bem como a adoção de programas de capacitação contínuos para os manipuladores
de alimentos e gestores dos estabelecimentos a fim de garantir a qualidade na
produção e manipulação dos alimentos. Os resultados deste trabalho evidenciam
falhas nos procedimentos adotados no segmento em estudo, o que permite supor
potenciais e expressivos riscos de ocorrência de surtos de doenças transmitidas por
alimentos nestes ambientes e em seus similares, já que os estabelecimentos onde a
pesquisa se ambientou espelham condições de ocorrência comum em nosso país.
Recomendam-se investimentos em capacitação de mão-de-obra e a urgente e
efetiva implementação de procedimentos corretos de manipulação, de forma a
garantir alimentos segundo padrões sanitários adequados à proteção da saúde do
público consumidor.
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Avaliação das condições higiênico-sanitárias dos serviços de alimentação de um shopping center do município de Porto Alegre/RS / Evaluation of the hygienic status of food services located in a shopping mall from Porto Alegre, BrazilWingert, Carine January 2012 (has links)
Diversas condições durante as etapas de produção dos alimentos podem levar à introdução de micro-organismos patogênicos nas refeições. Esse fato pode ser relevante nos serviços de alimentação localizados em shopping centers pela limitada área física, número de equipamentos insuficientes e volume de refeições servidas. O objetivo do presente estudo foi avaliar esse tipo de estabelecimento quanto ao cumprimento de boas práticas e verificar a presença de matéria orgânica e contaminação bacteriana residual em refrigeradores que haviam sido submetidos à limpeza de rotina. Vinte estabelecimentos localizados em um shopping center de Porto Alegre foram incluídos no estudo. Em cada estabelecimento foi aplicada a Lista de Verificação em Boas Práticas para Serviços de Alimentação prevista na Portaria nº 78 de 28 de Janeiro de 2009 (CEVS) e foram colhidas três amostras com intervalo mensal da parede interna do refrigerador no dia subsequente à limpeza de rotina. As amostras foram avaliadas pelo sistema Clean Trace (3M), quanto à presença de Listeria sp., Coliformes Totais e Escherichia coli. Os dados resultantes da aplicação da Lista de Verificação apontaram que 55% dos estabelecimentos não atingiram a pontuação mínima (>75%) para serem considerados satisfatórios. Em 95% (57/60) das amostras colhidas nos refrigeradores, demonstrou-se a presença de matéria orgânica residual. Já as análises microbiológicas apontaram ausência de Listeria sp., presença de de Coliformes Totais e E. coli em 8,3% e 1,6% das amostras, respectivamente. Não houve associação entre a classificação do estabelecimento (satisfatório/insatisfatório) e a presença de matéria orgânica residual ou Coliformes Totais nos refrigeradores. Estes resultados demonstram a necessidade de constante revisão e monitoramento dos processos de higienização de equipamentos em serviços de alimentação. / Several conditions during all stages of food production can lead to the introduction of pathogenic micro-organisms in food. This fact may be relevant in the food service located in shopping malls by limited physical area, insufficient number of equipment and volume of meals served. The aim of this study was to evaluate this type of establishment for compliance with good practices and verify the presence of organic matter and residual bacterial contamination in refrigerators that had been submitted to routine cleaning. Twenty establishments located in a shopping center from Porto Alegre were included in the study. In each establishment a Checklist for Good Practice for Food Services, provided by Resoltuion No. 78 published on January 28th 2009 (CEVS), was aplied, and three samples were collected at monthly intervals from the inner wall of the refrigerator on the day following the routine cleaning. The samples were evaluated by the Clean Trace system (3M) for the presence of Listeria sp., Total Coliforms and Escherichia coli. The data resulting from application of the Checklist showed that 55% of establishments didn’t attained the minimum score (> 75%) to be classified satisfactory. From de samples taken on the refrigerator’s inner wall, 95% (57/60) demonstrated the presence of residual organic. Nevertheless, microbiological analyzes showed absence of Listeria sp., and isolation of Total Coliforms and E. coli in 8.3% and 1.6% of the samples, respectively. There was no association between the classification of the establishment (satisfactory / unsatisfactory) and the presence of residual organic matter or total coliform in the refrigerator. The results demonstrate the need for constant review and monitoring and improvement of sanitizing procedures of equipment in food service.
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