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.

Análise da eficácia da aplicação da Metodologia FMEA do Processo: Caso de estudo numa empresa certificada

Num mercado globalizado, a procura contínua de vantagens competitivas é um fator crucial para o sucesso das organizações. A melhoria contínua dos processos é uma abordagem usual, uma vez que os resultados destas melhorias vão se traduzir diretamente na qualidade dos produtos. Neste contexto, a metodologia Failure Mode Effect Analysis (FMEA) é muito utilizada, especialmente pelas suas características proactivas, que permitem a identificação e a prevenção de erros do processo. Assim, quanto mais eficaz for a aplicação desta ferramenta, mais benefícios terá a organização. Assim, quando é utilizado com eficácia, o FMEA de Processo, além de ser um método poderoso na análise do processo, permite a melhoria contínua e a redução dos custos [1] . Este trabalho de dissertação teve como objetivo avaliar a eficácia da utilização da ferramenta do FMEA de processo numa organização certificada segundo a norma ISO/TS16949. A metodologia proposta passa pela análise de dados reais, ou seja, comparar as falhas verificadas no mercado com as falhas que tinham sido identificadas no FMEA. Assim, ao analisar o nível de falhas identificadas e não identificadas durante o FMEA e a projeção dessas falhas no mercado, consegue-se determinar se o FMEA foi mais ou menos eficaz, e ainda, identificar fatores que condicionam a melhor utilização da mesma. Este estudo, está organizado em três fases, a primeira apresenta a metodologia proposta , com a definição de um fluxograma do processo de avaliação e as métricas usadas, a segunda fase a aplicação do modelo proposto a dois casos de estudo, e uma última fase, que consiste na análise comparativa, individual e global, que visa, além de comparar esultados, identificar pontos fracos durante a execução do FMEA. Os resultados do caso de estudo indicam que a ferramenta do FMEA tem sido usada com eficácia, pois consegue-se identificar uma quantidade significativa de falhas potenciais e evitá-las. No entanto, existem ainda falhas que não foram identificadas no FMEA e que apareceram no cliente, e ainda, algumas falhas que foram identificadas e apareceram no cliente. As falhas traduzem-se em má qualidade e custos para o negócio, pelo que são propostas ações de melhoria. Pode-se concluir que uma boa utilização do FMEA pode ser um fator importante para a qualidade do serviço ao cliente, e ainda, com impacto dos custos.

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)

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

Failure Mode and Effect Analysis (FMEA) for confectionery manufacturing in developing countries: Turkish delight production as a case study

The Failure Mode and Effect Analysis (FMEA) was applied for risk assessment of confectionary manufacturing, in whichthe traditional methods and equipment were intensively used in the production. Potential failure modes and effects as well as their possible causes were identified in the process flow. Processing stages that involve intensive handling of food by workers had the highest risk priority numbers (RPN = 216 and 189), followed by chemical contamination risks in different stages of the process. The application of corrective actions substantially reduced the RPN (risk priority number) values. Therefore, the implementation of FMEA (The Failure Mode and Effect Analysis) model in confectionary manufacturing improved the safety and quality of the final products.

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

CRITICAL POINTS OF THE PRODUCTION PROCESS OF SOLID WOOD FLOORING

The quality concepts represent one of the important factors for the success of organizations and among these concepts the stabilization of the production process contributes to the improvement, waste reduction and increased competitiveness. Thus, this study aimed to evaluate the production process of solid wood flooring on its predictability and capacity, based on its critical points. Therefore, the research was divided into three stages. The first one was the process mapping of the company and the elaboration of flowcharts for the activities. The second one was the identification and the evaluation of the critical points using FMEA (Failure Mode and Effect Analysis) adapted methodology. The third one was the evaluation of the critical points applying the statistical process control and the determination of the process capability for the C-pk index. The results showed the existence of six processes, two of them are critical. In those two ones, fifteen points were considered critical and two of them, related with the dimension of the pieces and defects caused by sandpaper, were selected for evaluation. The productive process of the company is unstable and not capable to produce wood flooring according to the specifications and, therefore these specifications should be reevaluated.

Evaluation and FMEA of Fabrication Techniques for Metallic Grating Couplers on Polymer Substrates with Low Glass Transition Temperatures

The main task is to analyze the state of the art of grating couplers production and low-cost polymer substrates. Then to provide a recommendation of a new or adapted process for the production of metallic gratings on polymer sheets, based on a Failure Mode and Effect Analysis (FMEA). In order to achieve that, this thesis is divided into four chapters. After the first introductory chapter, the second section provides details about the state-of-the-art in optical technology platforms with focus on polymers and their main features for the aimed application, such as flexibility, low cost and roll to roll compatibility. It defines then the diffraction gratings and their specifications and closes with the explanation of adhesion mechanisms of inorganic materials on polymer substrates. The third chapter discusses processing of grating couplers. It introduces the basic fabrication methods and details a selection of current fabrication schemes found in literature with an assessment of their potential use for the desired application. The last chapter is a FMEA analysis of the retained fabrication process, called Flip and Fuse, in order to check its capability to realize the grating structure.