Modelo conceitual para a aplicação de FMEA de processo na indústria automotiva

Pós-graduação em Engenharia Mecânica - FEG

APR e FMEA em trocador de calor de bomba

The modernization of the world made the speed, accuracy and reliability of all existing processes become increasingly necessary. For this evolution to occur every day, the evolution of the equipment was strategic, but not as much as needed. It is necessary for such equipment to ensure its function and, in case of failure, an early diagnosis to prevent loss. Therefore the evolution of maintainability and reliability in equipment is also paramount. Thus, the growth of forms of maintenance was driven by this scenario, forming maintenance philosophies. Among many, there is the RCM, which have its focus on the identification, parameters development and performance preview. One of those methodologies from this idea is the FMEA, process that has been studied and implemented this work, aiming the anticipation of failure modes and guidance for the use of a heat exchanger and a pump. This implementation has the aid of another process of RCM, the PHA, which was also shown and implemented, these results being used to start the FMEA process. The results show the activities with the highest chance of failure, presenting also the measures to be taken to avoid or minimize them. It is shown, in this paper, concern with the valves because they maintain control and system security, and its flaws related to accidents with possible danger to people and the whole system, emphasizing the priority of action

Estratégias de sinalização da qualidade da carne suína ao consumidor final

A suinocultura destaca-se na economia brasileira. Contudo, avaliando-se o consumo interno da carne suína in natura, observa-se uma estagnação em patamares baixos. O artigo tem como objetivo analisar as principais iniciativas adotadas pelo Sistema Agroindustrial (SAG) da carne suína no Brasil visando sinalizar qualidade aos consumidores. Devido à marcante assimetria de informações, ressalta-se a importância da organização da cadeia produtiva, melhor direcionando esforços para a expansão do mercado interno. Este trabalho sugere ações visando aprimorar a coordenação deste SAG com vistas à melhoria na qualidade da carne ao consumidor e à redução da informalidade.

Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool

With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and effect analysis (FMEA) is a powerful risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to biopharmaceutical processes brings about some difficulties. The proposal presented here is intended to serve as a brief but nevertheless comprehensive and detailed guideline on how to conduct a biopharmaceutical process FMEA. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. The application for such a biopharmaceutical process FMEA is widespread. It can be useful whenever a biopharmaceutical manufacturing process is developed or scaled-up, or when it is transferred to a different manufacturing site. It may also be conducted during substantial optimization of an existing process or the development of a second-generation process. According to their resulting risk ratings, process parameters can be ranked for importance and important variables for process development, characterization, or validation can be identified. LAY ABSTRACT: Health authorities around the world ask pharmaceutical companies to manage risk during development and manufacturing of pharmaceuticals. The so-called failure mode and effect analysis (FMEA) is an established risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to pharmaceutical processes that use modern biotechnology (biopharmaceutical processes) brings about some difficulties, because those biopharmaceutical processes differ from processes in mechanical and electrical industries. The proposal presented here explains how a biopharmaceutical process FMEA can be conducted. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. With the help of this guideline, different details of the manufacturing process can be ranked according to their potential risks, and this can help pharmaceutical companies to identify aspects with high potential risks and to react accordingly to improve the safety of medicines.