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Abstract(s)
A Qualificação da Produção é uma etapa da validação de processos que, apesar de ser burocrática e de necessitar de uma estrutura organizacional robusta, é vista pelas principais entidades regulamentares de produtos cosméticos como sendo essencial à garantia da qualidade. Na Colep, a validação começa a dar os primeiros passos, de forma a poder estar na vanguarda dos seus pares europeus assegurando, assim, a entrega de produtos de qualidade, de confiança e de acordo com as especificações esperadas. O presente relatório relata as atividades desenvolvidas no âmbito de um estudo para a melhoria do processo de qualificação da produção do qual o Departamento Técnico tem a tutela. Para o desenvolvimento do trabalho, foi escolhido o ciclo PDCA (Plan-Do-Check-Act). Não só foi possível identificar que, uma grande parte das oportunidades de melhoria estavam relacionadas com a mão-de-obra, com o método e com o equipamento, mas também foi possível perceber que apesar de existirem procedimentos, e modelos de registo, o facto de estarem desajustados à realidade de produção, estavam a causar uma sobrecarga de trabalho nos departamentos envolvidos. Durante este trabalho de dissertação foram levantadas 23 hipóteses de causa que, depois de estudadas e a avaliadas, deram origem a 16 ações de melhoria. No presente trabalho, foram implementadas 8 dessas ações, resultando na melhoria do método de planeamento das primeiras produções, na redução em 7% do desperdício técnico do processo de qualificação, na diminuição dos tempos de linha parada, no desenvolvimento de um método para realização de estudos de capability, no aumento do conhecimento do processo e de equipamentos e, ainda, no maior compromisso entre departamentos envolvidos no processo de qualificação.
Production Qualification is a stage of process validation that, despite being bureaucratic and requiring a robust organizational structure, is seen by the major cosmetic product regulatory bodies as essential to quality assurance. At Colep, validation is starting to take its first steps so that it can be at the forefront of its European peers, thus ensuring the delivery of quality, reliable products to the expected specifications. This work reports the activities carried out as part of a study to improve the production qualification process of which the Technical Department is responsible. For the development of the work, the PDCA (Plan-Do-Check-Act) cycle was chosen. Not only was possible to identify that a large part of the improvement opportunities were related to the workforce, the method and the equipment, but it was also possible to realize that although there are procedures and models of registration, the fact because they were out of line with the reality of production, they were causing work overload in the departments involved. During this dissertation work, 23 hypotheses were raised that, after being studied and evaluated, led to 16 improvement actions. In the present work, 8 of these actions were implemented, resulting in the improvement of the first productions planning method, a 7% reduction in the technical waste of the qualification process, the reduction of downtime, the development of a method to perform capability studies, increased process and equipment knowledge, and greater commitment between departments involved in the qualification process.
Production Qualification is a stage of process validation that, despite being bureaucratic and requiring a robust organizational structure, is seen by the major cosmetic product regulatory bodies as essential to quality assurance. At Colep, validation is starting to take its first steps so that it can be at the forefront of its European peers, thus ensuring the delivery of quality, reliable products to the expected specifications. This work reports the activities carried out as part of a study to improve the production qualification process of which the Technical Department is responsible. For the development of the work, the PDCA (Plan-Do-Check-Act) cycle was chosen. Not only was possible to identify that a large part of the improvement opportunities were related to the workforce, the method and the equipment, but it was also possible to realize that although there are procedures and models of registration, the fact because they were out of line with the reality of production, they were causing work overload in the departments involved. During this dissertation work, 23 hypotheses were raised that, after being studied and evaluated, led to 16 improvement actions. In the present work, 8 of these actions were implemented, resulting in the improvement of the first productions planning method, a 7% reduction in the technical waste of the qualification process, the reduction of downtime, the development of a method to perform capability studies, increased process and equipment knowledge, and greater commitment between departments involved in the qualification process.
Description
Keywords
Aerossol Capability Qualidade Processo de qualificação Validação Quality Production qualification Validation