VALIDAÇÃO DE PROCESSO APLICADO A LABORATÓRIOS DE HEMATOLOGIA
Resumo
Resumo: A validação de processo / produto aplicados a serviços de hemoterapia é o estudo detalhado dos dados e valores resultantes do processo com ênfase nos resultados obtidos a partir de parâmetros e/ou serviços considerados críticos a fim de avaliar a robustez e garantir a qualidade desses processos. A validação irá prover evidências documentadas que os serviços considerados críticos envolvidos no ciclo de sangue são reprodutíveis e consistentes, cumprem com as especificações estabelecidas e estão de acordo com os princípios de boas práticas do ciclo produtivo do sangue. O estudo de validação requer uma integração entre equipamentos, sistemas e processos, envolvendo os sistemas de qualidade aplicáveis, como por exemplo, programação de calibração, manutenção e controle de mudanças. Através da ferramenta, controle de mudanças, que os serviços serão revalidados caso haja alterações significativas em suas etapas críticas, ou seja, toda e qualquer alteração que possa interferir nos produtos / processos afetando o status validado.
Palavras-chave: validação de processo, qualificação, serviços de hemoterapia, garantia da qualidade, ciclo do sangue.
Abstract: The process / product validation applied to hemotherapy services is the detailed study of the results and data and values from process with emphasis on the results obtained from parameters and / or services considered as critical in order to evaluate the robustness and assure the quality of these processes. The validation will provide documented evidences that services classified as critical related to blood cycle are reproducible and consistent, meet the established specifications and are in accordance with the principles of good practices of productive cycle of blood. The study of validation requires an integration between equipment, systems and process involving applicable quality systems, such as, calibration program, maintenance and change management. Through the tool, change management, the services will be re-validated in the event of significant changes in critical stages, it is, any changes that may interfere in products / process affecting the validated status.
Key-Words: process validation, qualification, hemotherapy services, quality assurance, blood cycle.
Palavras-chave: validação de processo, qualificação, serviços de hemoterapia, garantia da qualidade, ciclo do sangue.
Abstract: The process / product validation applied to hemotherapy services is the detailed study of the results and data and values from process with emphasis on the results obtained from parameters and / or services considered as critical in order to evaluate the robustness and assure the quality of these processes. The validation will provide documented evidences that services classified as critical related to blood cycle are reproducible and consistent, meet the established specifications and are in accordance with the principles of good practices of productive cycle of blood. The study of validation requires an integration between equipment, systems and process involving applicable quality systems, such as, calibration program, maintenance and change management. Through the tool, change management, the services will be re-validated in the event of significant changes in critical stages, it is, any changes that may interfere in products / process affecting the validated status.
Key-Words: process validation, qualification, hemotherapy services, quality assurance, blood cycle.