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.

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

Pós-graduação em Engenharia Mecânica - FEG

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

Pós-graduação em Engenharia Mecânica - FEG

Avaliação da prevenção de falhas em processos utilizando métodos de tomada de decisão

Este trabalho apresenta uma investigação sobre o emprego de FMEA (Failure Mode and Effect Analysis) de Processo com a exposição de irregularidades na sua utilização. O método AHP (Analytic Hierarchy Process) e os Conjuntos Fuzzy são aplicados no estudo das práticas atuais de utilização de FMEA. O AHP é aplicado para a priorização das irregularidades quanto à gravidade de sua ocorrência. Os Conjuntos Fuzzy são aplicados para avaliação do desempenho da utilização de FMEA em algumas empresas do ramo automotivo. Como resultado, tem-se a aceitação de oito e a não aceitação de três dos onze formulários de FMEA averiguados.

Avaliação de sistemas de prevenção de falhas em processos de manufatura na indústria automotiva com metodologia de auxílio à decisão

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Comportamento de pares fêmea-filhote de baleias-franca-austral, Eubalaena australis (Desmoulins, 1822) no litoral centro-sul de Santa Catarina

O litoral centro-sul do estado de Santa Catarina representa a mais importante área de concentração reprodutiva das baleias-franca-austral, Eubalaena australis, no Brasil. O objetivo deste estudo é caracterizar o padrão comportamental dos pares fêmea-filhote que migram para essas áreas ao longo de 10 temporadas reprodutivas (2003 a 2012). Observações realizadas em pontos fixos foram conduzidas de Julho a Novembro, entre 2003 e 2012, de seis a sete vezes por semana, entre as 6:00h e 17:00h. Os dados foram coletados com auxilio de binóculos Pentax 12x55 mm, bússola, relógio digital, e registrados em fichas de campo padronizadas. Os estados comportamentais (natação, descanso e ativo) foram registrados em intervalos de cinco minutos e a frequência de eventos registrada em cada intervalo de cinco minutos. Natação foi o estado comportamental que prevaleceu tanto para fêmeas e filhotes, seguido de descanso e ativo para as fêmeas e seguido de ativo e descanso para os filhotes. A natação e o descanso são importantes para as fêmeas pois exigem menos energia, já que precisam usá-la para atividades das quais a sobrevivência da espécie depende, como parir, amamentar e cuidar dos filhotes. Para os filhotes, o comportamento ativo é mais importante para o seu desenvolvimento motor e preparação para o processo migratório. Os eventos mais expressados por ambos fêmea e filhote foram exposições indefinidas, estas sendo duas vezes maior para os filhotes. Os filhotes apresentaram comportamentos aéreos em taxas maiores do que as fêmeas, o que denota a importância de tais comportamentos no auxílio ao desenvolvimento da coordenação e na aptidão motora e no fortalecimento da musculatura, melhorando a resistência para a migração. A taxa de ocorrência de eventos aéreos para as fêmeas foi geralmente mais baixa, provavelmente na tentativa de desencorajar os comportamentos ativos realizados pelos filhotes. Esses resultados reforçam a importância da área de estudo como área reprodutiva para a espécie. O número de baleias-franca está crescendo na área, bem como o potencial conflito com atividades humanas. Entender os padrões comportamentais dos pares fêmea-filhote de baleias-franca-austral no litoral de Santa Catarina podem servir como valiosas ferramentas para a elaboração de planos de manejo, contribuindo para a conservação da espécie no litoral brasileiro

Análise dos modos de falha e seus efeitos (FMEA) aplicada a um secador industrial

Trabalho Final de Mestrado para obtenção do grau de Mestre em Engenharia Mecânica

A guided rule reduction system for prioritization of failures in fuzzy FMEA

Traditional Failure Mode and Effect Analysis (FMEA) utilizes the Risk Priority Number (RPN) ranking system to evaluate the risk level of failures, to rank failures, and to prioritize actions. Although this method is simple, it suffers from several shortcomings. In this paper, use of fuzzy inference techniques for RPN determination in an attempt to overcome the weaknesses associated with the traditional RPN ranking system is investigated. However, the fuzzy RPN model, suffers from the combinatorial rule explosion problem. As a result, a generic rule reduction approach, i.e. the Guided Rule Reduction System (GRRS), is proposed to reduce the number of rules that need to be provided by users during the fuzzy RPN modeling process. The proposed approach is evaluated using real-world case studies pertaining to semiconductor manufacturing. The results are analyzed, and implications of the proposed approach are discussed.

Fuzzy FMEA with a guided rules reduction system for prioritization of failures

Purpose – To propose a generic method to simplify the fuzzy logic-based failure mode and effect analysis (FMEA) methodology by reducing the number of rules that needs to be provided by FMEA users for the fuzzy risk priority number (RPN) modeling process.

Design/methodology/approach – The fuzzy RPN approach typically requires a large number of rules, and it is a tedious task to obtain a full set of rules. The larger the number of rules provided by the users, the better the prediction accuracy of the fuzzy RPN model. As the number of rules required increases, ease of use of the model decreases since the users have to provide a lot of information/rules for the modeling process. A guided rules reduction system (GRRS) is thus proposed to regulate the number of rules required during the fuzzy RPN modeling process. The effectiveness of the proposed GRRS is investigated using three real-world case studies in a semiconductor manufacturing process.

Findings – In this paper, we argued that not all the rules are actually required in the fuzzy RPN model. Eliminating some of the rules does not necessarily lead to a significant change in the model output. However, some of the rules are vitally important and cannot be ignored. The proposed GRRS is able to provide guidelines to the users which rules are required and which can be eliminated. By employing the GRRS, the users do not need to provide all the rules, but only the important ones when constructing the fuzzy RPN model. The results obtained from the case studies demonstrate that the proposed GRRS is able to reduce the number of rules required and, at the same time, to maintain the ability of the Fuzzy RPN model to produce predictions that are in agreement with experts' knowledge in risk evaluation, ranking, and prioritization tasks.

Research limitations/implications – The proposed GRRS is limited to FMEA systems that utilize the fuzzy RPN model.

Practical implications – The proposed GRRS is able to simplify the fuzzy logic-based FMEA methodology and make it possible to be implemented in real environments.

Originality/value – The value of the current paper is on the proposal of a GRRS for rule reduction to enhance the practical use of the fuzzy RPN model in real environments.

Application of fuzzy inference techniques to FMEA

In traditional Failure Mode and Effect Analysis (FMEA), the Risk Priority Number (RPN) ranking system is used to evaluate the risk level of failures, to rank failures, and to prioritize actions. This approach is simple but it suffers from several weaknesses. In an attempt to overcome the weaknesses associated with the traditional RPN ranking system, several fuzzy inference techniques for RPN determination are investigated in this paper. A generic Fuzzy RPN approach is described, and its performance is evaluated using a case study relating to a semiconductor manufacturing process. In addition, enhancements for the fuzzy RPN approach are proposed by refining the weights of the fuzzy production rules.

Metodologia integrada para mapeamento de falhas: uma proposta de utilização conjunta do mapeamento de processos com as técnicas FTA, FMEA e a análise crítica de especialistas

As falhas representam não conformidades nas atividades produtivas, de tal modo que pesquisas para seu controle e prevenção são, no mínimo, desejáveis. Na literatura sobre o assunto, observa-se uma gama variada de técnicas, porém, quase sempre, usadas isoladamente e, em poucos casos, no setor de serviços. Observando essa lacuna, propõe-se uma metodologia de Mapeamento de Falhas que integra diferentes abordagens que se complementam, aproveitando-se o potencial e o benefício de cada técnica para análise e controle de falhas. Para a consecução dessa proposta, efetuou-se uma pesquisa bibliográfica para conceituação e entendimento das técnicas utilizadas, um estudo e análise de integração dessas técnicas e, por fim, um exemplo real de aplicação em processo notarial de serviço, tema este ainda não explorado na literatura pertinente e, portanto, bastante auspicioso. Como resultado, observa-se uma ferramenta que permite uma visualização completa e objetiva das atividades desencadeadas pelos processos, seus pontos críticos e suas potenciais falhas, podendo ser aplicada com propriedade em empresas de prestação de serviços.

Aplicação dos conceitos de RCM e a ferramenta FMEA no aumento de confiabilidade em equipamentos de uma indústria química

The growing demand for quality at competitive prices and fast production process put to the test function in the industrial Maintenance. The need for equipment with high availability to fit this fierce competitiveness makes maintenance becomes essentially reliable. Despite this current context, many companies still have an old view of maintenance, focused only on corrective services, and proposals for change are often neglected due to the sense of urgency day to day. Thus, this study aims to demonstrate through theoretical applicability of simple tool, but of great value in increasing reliability within the maintenance sector of an industry, applying the concepts of Reliability Centered Maintenance – RCM and Analysis tool Failure Modes and Effects – FMEA in equipment of a chemical company directly involved in the manufacturing process of the brake fluid, which this product is used in vehicles around the country. That way, you can identify the types, occurrence and criticality of each failure and evaluate assertively decision making for each device, avoiding unnecessary downtime and potential failures of the same

Implementação de FMEA em uma linha de produção de caminhonetes

Currently the quality of a final product is as important as the price they pay for it, to the satisfaction of having something durable and exercising its function as well as has been informed. This work aims to define the stages of the process of implementing a new project in a production line in order to ensure product quality and process, defining each step with those responsible for each area of the factory, implementing new tools and methods, improving process with lessons learned from previous projects, gathering information on the production line to analyze the need for rigorous controls to prevent errors. With the definition of schedule after studies of the plant where the new project was implemented, establish the goals of each phase to ensure the quality of process and product

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

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