Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica
Autor(a) principal: | |
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Data de Publicação: | 2017 |
Tipo de documento: | Dissertação |
Idioma: | por |
Título da fonte: | Biblioteca Digital de Teses e Dissertações da Uninove |
Texto Completo: | http://bibliotecatede.uninove.br/handle/tede/1703 |
Resumo: | This research deals with a quantitative and qualitative case study aimed at the critical analysis of the contribution of risk management in projects of pharmaceutical intracompany technology transfer. It was considered a project to change the location of manufacturing, packaging and quality control of a solid oral medicine performed at a regional level, between sites located in different municipalities of the state of São Paulo to meet the commercial strategy of a multinational pharmaceutical company. This project began in 2013, including planning, organization and execution with completion expected in 2015. A qualitative assessment of the risks related to the scope and quality requirements of the project was performed, as well as a quantitative assessment of the risks related to compliance with the project deadline. In order to confirm or refute the six research propositions presented, it was conducted semi-structured interviews and direct observation in the unit of analysis, bibliographic review and data analysis. The results show that after qualitative analysis of the project risks related to the scope and quality requirements using the Failure Mode and Effect Analysis - FMEA tool, 39 failure modes were identified, with Priority Risk Number - PRN values varying from 70 to 288, the failure modes of greater severity and therefore, priority, it was the quality requirement for health regulations. They also indicate that from the Monte Carlo Simulation the maximum expected time for the project is 1841 days and the minimum of 1473 days. The conclusion of the research shows that the propositions are not fully confirmed. An action plan was proposed to mitigate the risks analyzed. |
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Berssaneti, Fernando TobalBerssaneti, Fernando TobalSantana, José Carlos CurveloFleury, André Lemehttp://lattes.cnpq.br/8868794635240284Barakat, Májida Farid2017-08-04T21:37:42Z2017-03-07Barakat, Májida Farid. Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica. 2017. 96 f. Dissertação( Programa de Mestrado em Engenharia de Produção) - Universidade Nove de Julho, São Paulo.http://bibliotecatede.uninove.br/handle/tede/1703This research deals with a quantitative and qualitative case study aimed at the critical analysis of the contribution of risk management in projects of pharmaceutical intracompany technology transfer. It was considered a project to change the location of manufacturing, packaging and quality control of a solid oral medicine performed at a regional level, between sites located in different municipalities of the state of São Paulo to meet the commercial strategy of a multinational pharmaceutical company. This project began in 2013, including planning, organization and execution with completion expected in 2015. A qualitative assessment of the risks related to the scope and quality requirements of the project was performed, as well as a quantitative assessment of the risks related to compliance with the project deadline. In order to confirm or refute the six research propositions presented, it was conducted semi-structured interviews and direct observation in the unit of analysis, bibliographic review and data analysis. The results show that after qualitative analysis of the project risks related to the scope and quality requirements using the Failure Mode and Effect Analysis - FMEA tool, 39 failure modes were identified, with Priority Risk Number - PRN values varying from 70 to 288, the failure modes of greater severity and therefore, priority, it was the quality requirement for health regulations. They also indicate that from the Monte Carlo Simulation the maximum expected time for the project is 1841 days and the minimum of 1473 days. The conclusion of the research shows that the propositions are not fully confirmed. An action plan was proposed to mitigate the risks analyzed.Este trabalho trata de um estudo de caso quantitativo e qualitativo dirigido para a análise crítica da contribuição do gerenciamento de riscos em projetos de transferência de tecnologia intracompanhia farmacêutica. Foi considerado um projeto de alteração do local de fabricação, embalagem e controle de qualidade de um medicamento sólido oral realizado em nível regional, entre plantas localizadas em diferentes municípios do estado de São Paulo para atender a estratégia comercial de uma companhia multinacional farmacêutica. Este projeto teve início em 2013, incluindo planejamento, organização e execução com previsão de conclusão em 2015. Foi realizada análise qualitativa dos riscos relacionados aos atendimentos de escopo e requisitos da qualidade do projeto e também análise quantitativa dos riscos relacionados ao cumprimento do prazo do projeto. Para confirmar ou refutar as seis proposições de pesquisa apresentadas, foram realizadas entrevistas semiestruturadas e observação direta na unidade de análise, revisão bibliográfica e análise de dados. Os resultados mostram que após análise qualitativa dos riscos do projeto relacionados aos atendimentos de escopo e requisitos da qualidade utilizando a ferramenta Análise de Modo de Falha e seus Efeitos - FMEA, foram identificados 39 modos de falha, com valores de Número de Prioridade de Risco - NPR variando de 70 a 288, sendo os de maior severidade e, portanto, prioridade os referentes aos requisitos da qualidade quanto a regulamentação sanitária. Indicam, também, que a partir da Simulação de Monte Carlo o prazo máximo esperado para o projeto é de 1841 dias e o mínimo de 1473 dias. A conclusão da pesquisa mostra que as proposições não se confirmam de forma plena. Foi proposto um plano de ação objetivando a mitigação dos riscos analisados.Submitted by Nadir Basilio (nadirsb@uninove.br) on 2017-08-04T21:37:42Z No. of bitstreams: 1 Majida Farid Barakat.pdf: 1578082 bytes, checksum: 0ce4d1fce799ec5caafefd77e0d78c25 (MD5)Made available in DSpace on 2017-08-04T21:37:42Z (GMT). No. of bitstreams: 1 Majida Farid Barakat.pdf: 1578082 bytes, checksum: 0ce4d1fce799ec5caafefd77e0d78c25 (MD5) Previous issue date: 2017-03-07application/pdfporUniversidade Nove de JulhoPrograma de Pós-Graduação de Mestrado e Doutorado em Engenharia de ProduçãoUNINOVEBrasilEngenhariagerenciamento de projetosgerenciamento de riscoprojeto de transferência de tecnologiaproject managementrisk managementtechnology transfer projectENGENHARIAS::ENGENHARIA DE PRODUCAOGerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêuticaRisk management in an intracompany pharmaceutical technology transfer projectinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesis2551182063231974631600info:eu-repo/semantics/openAccessreponame:Biblioteca Digital de Teses e Dissertações da Uninoveinstname:Universidade Nove de Julho (UNINOVE)instacron:UNINOVEORIGINALMajida Farid Barakat.pdfMajida Farid Barakat.pdfapplication/pdf1578082http://localhost:8080/tede/bitstream/tede/1703/2/Majida+Farid+Barakat.pdf0ce4d1fce799ec5caafefd77e0d78c25MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-82165http://localhost:8080/tede/bitstream/tede/1703/1/license.txtbd3efa91386c1718a7f26a329fdcb468MD51tede/17032021-10-08 17:07:52.802oai:localhost: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Biblioteca Digital de Teses e Dissertaçõeshttp://bibliotecatede.uninove.br/PRIhttp://bibliotecatede.uninove.br/oai/requestbibliotecatede@uninove.br||bibliotecatede@uninove.bropendoar:2021-10-08T20:07:52Biblioteca Digital de Teses e Dissertações da Uninove - Universidade Nove de Julho (UNINOVE)false |
dc.title.por.fl_str_mv |
Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica |
dc.title.alternative.eng.fl_str_mv |
Risk management in an intracompany pharmaceutical technology transfer project |
title |
Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica |
spellingShingle |
Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica Barakat, Májida Farid gerenciamento de projetos gerenciamento de risco projeto de transferência de tecnologia project management risk management technology transfer project ENGENHARIAS::ENGENHARIA DE PRODUCAO |
title_short |
Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica |
title_full |
Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica |
title_fullStr |
Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica |
title_full_unstemmed |
Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica |
title_sort |
Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica |
author |
Barakat, Májida Farid |
author_facet |
Barakat, Májida Farid |
author_role |
author |
dc.contributor.advisor1.fl_str_mv |
Berssaneti, Fernando Tobal |
dc.contributor.referee1.fl_str_mv |
Berssaneti, Fernando Tobal |
dc.contributor.referee2.fl_str_mv |
Santana, José Carlos Curvelo |
dc.contributor.referee3.fl_str_mv |
Fleury, André Leme |
dc.contributor.authorLattes.fl_str_mv |
http://lattes.cnpq.br/8868794635240284 |
dc.contributor.author.fl_str_mv |
Barakat, Májida Farid |
contributor_str_mv |
Berssaneti, Fernando Tobal Berssaneti, Fernando Tobal Santana, José Carlos Curvelo Fleury, André Leme |
dc.subject.por.fl_str_mv |
gerenciamento de projetos gerenciamento de risco projeto de transferência de tecnologia |
topic |
gerenciamento de projetos gerenciamento de risco projeto de transferência de tecnologia project management risk management technology transfer project ENGENHARIAS::ENGENHARIA DE PRODUCAO |
dc.subject.eng.fl_str_mv |
project management risk management technology transfer project |
dc.subject.cnpq.fl_str_mv |
ENGENHARIAS::ENGENHARIA DE PRODUCAO |
description |
This research deals with a quantitative and qualitative case study aimed at the critical analysis of the contribution of risk management in projects of pharmaceutical intracompany technology transfer. It was considered a project to change the location of manufacturing, packaging and quality control of a solid oral medicine performed at a regional level, between sites located in different municipalities of the state of São Paulo to meet the commercial strategy of a multinational pharmaceutical company. This project began in 2013, including planning, organization and execution with completion expected in 2015. A qualitative assessment of the risks related to the scope and quality requirements of the project was performed, as well as a quantitative assessment of the risks related to compliance with the project deadline. In order to confirm or refute the six research propositions presented, it was conducted semi-structured interviews and direct observation in the unit of analysis, bibliographic review and data analysis. The results show that after qualitative analysis of the project risks related to the scope and quality requirements using the Failure Mode and Effect Analysis - FMEA tool, 39 failure modes were identified, with Priority Risk Number - PRN values varying from 70 to 288, the failure modes of greater severity and therefore, priority, it was the quality requirement for health regulations. They also indicate that from the Monte Carlo Simulation the maximum expected time for the project is 1841 days and the minimum of 1473 days. The conclusion of the research shows that the propositions are not fully confirmed. An action plan was proposed to mitigate the risks analyzed. |
publishDate |
2017 |
dc.date.accessioned.fl_str_mv |
2017-08-04T21:37:42Z |
dc.date.issued.fl_str_mv |
2017-03-07 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
format |
masterThesis |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
Barakat, Májida Farid. Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica. 2017. 96 f. Dissertação( Programa de Mestrado em Engenharia de Produção) - Universidade Nove de Julho, São Paulo. |
dc.identifier.uri.fl_str_mv |
http://bibliotecatede.uninove.br/handle/tede/1703 |
identifier_str_mv |
Barakat, Májida Farid. Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica. 2017. 96 f. Dissertação( Programa de Mestrado em Engenharia de Produção) - Universidade Nove de Julho, São Paulo. |
url |
http://bibliotecatede.uninove.br/handle/tede/1703 |
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por |
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info:eu-repo/semantics/openAccess |
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openAccess |
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Universidade Nove de Julho |
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Programa de Pós-Graduação de Mestrado e Doutorado em Engenharia de Produção |
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UNINOVE |
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Brasil |
dc.publisher.department.fl_str_mv |
Engenharia |
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Universidade Nove de Julho |
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