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3.
Einstein (Säo Paulo) ; 10(4): 491-497, Oct.-Dec. 2012. ilus, tab
Artículo en Inglés | LILACS | ID: lil-662476

RESUMEN

OBJECTIVE: To evaluate the process of implementing a quality management system in a basic research laboratory of a public institution, particularly considering the feasibility and impacts of this improvement. METHODS: This was a prospective and qualitative study. We employed the norm "NIT DICLA 035 - Princípios das Boas Práticas de Laboratório (BPL)" and auxiliary documents of Organisation for Economic Co-operation and Development to complement the planning and implementation of a Quality System, in a basic research laboratory. In parallel, we used the PDCA tool to define the goals of each phase of the implementation process. RESULTS: This study enabled the laboratory to comply with the NIT DICLA 035 norm and to implement this norm during execution of a research study. Accordingly, documents were prepared and routines were established such as the registration of non-conformities, traceability of research data and equipment calibration. CONCLUSION: The implementation of a quality system, the setting of a laboratory focused on basic research is feasible once certain structural changes are made. Importantly, impacts were noticed during the process, which could be related to several improvements in the laboratory routine.


OBJETIVO: Avaliar o processo de implantação de um sistema de qualidade em um laboratório de pesquisa básica, avaliando a viabilidade e os impactos dessa melhoria. MÉTODOS: Tratou-se de um estudo qualitativo prospectivo. Utilizou-se a norma NIT DICLA 035 - Princípios das Boas Práticas de Laboratório (BPL) e documentos da Organisation for Economic Co-operation and Development para complementar o planejamento e a implantação de um Sistema de Gestão da Qualidade, em um laboratório de pesquisa básica. Em paralelo, utilizou-se a ferramenta PDCA para definir os objetivos de cada etapa de implantação do sistema de qualidade. RESULTADOS: Este trabalho possibilitou ao laboratório atender requisitos solicitados pela norma NT DICLA 035 e implementá-los durante a execução de um projeto, dentre eles a elaboração de documentos, bem como estabelecer rotinas importantes para o andamento do mesmo, como a identificação de não conformidades, rastreabilidade de dados e calibração de equipamentos. CONCLUSÃO: A implantação do Sistema da Qualidade BPL, nesse cenário, é viável, gerando impactos positivos na rotina do laboratório.


Asunto(s)
Humanos , Investigación Biomédica/organización & administración , Laboratorios/normas , Desarrollo de Programa/normas , Evaluación de Programas y Proyectos de Salud/normas , Mejoramiento de la Calidad/organización & administración , Investigación Biomédica/tendencias , Estudios de Casos Organizacionales , Estudios Prospectivos , Control de Calidad , Mejoramiento de la Calidad/tendencias , Proyectos de Investigación , Encuestas y Cuestionarios
4.
Einstein (Sao Paulo) ; 10(4): 491-7, 2012.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-23386091

RESUMEN

OBJECTIVE: To evaluate the process of implementing a quality management system in a basic research laboratory of a public institution, particularly considering the feasibility and impacts of this improvement. METHODS: This was a prospective and qualitative study. We employed the norm "NIT DICLA 035--Princípios das Boas Práticas de Laboratório (BPL)" and auxiliary documents of Organisation for Economic Co-operation and Development to complement the planning and implementation of a Quality System, in a basic research laboratory. In parallel, we used the PDCA tool to define the goals of each phase of the implementation process. RESULTS: This study enabled the laboratory to comply with the NIT DICLA 035 norm and to implement this norm during execution of a research study. Accordingly, documents were prepared and routines were established such as the registration of non-conformities, traceability of research data and equipment calibration. CONCLUSION: The implementation of a quality system, the setting of a laboratory focused on basic research is feasible once certain structural changes are made. Importantly, impacts were noticed during the process, which could be related to several improvements in the laboratory routine.


Asunto(s)
Investigación Biomédica/organización & administración , Laboratorios/normas , Desarrollo de Programa/normas , Evaluación de Programas y Proyectos de Salud/normas , Mejoramiento de la Calidad/organización & administración , Investigación Biomédica/tendencias , Humanos , Estudios de Casos Organizacionales , Estudios Prospectivos , Control de Calidad , Mejoramiento de la Calidad/tendencias , Proyectos de Investigación , Encuestas y Cuestionarios
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