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Application of DMAIC Methodology for Productivity Increase and Optimization of a Pharmaceutical Spray Drying Process
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Quando um processo produtivo é interrompido devido à paragem súbita e inesperada de um equipamento reflete num atraso do planeamento produtivo tendo custos associados, assim o principal objetivo é minimizar a ocorrência destes acontecimentos.
O presente trabalho pretende fornecer à Hovione uma análise feita através da metodologia de Lean Six Sigma DMAIC (Definir, Medir, Analisar, Melhorar e Controlar) acerca do impacto de paragens descontroladas no processo produtivo tendo como base as ocorrências dos anos fiscais de 2021 e 2022 e focando nos parâmetros: impacto da qualidade do produto, impacto financeiro e nas causas raízes que levaram o equipamento a falhar.
Ao longo destes dois anos, cerca de 297 desvios referentes ao tipo de desvio "Instruções relacionadas com processo de produção não seguidas" com os subtipos "Variável do processo (pH, temperatura, pressão, tempo, etc.) fora dos limites definidos" e "Instrução não seguida" foram abertos, concluindo que 5% dos 738 lotes produzidos na área PharmOps sofreram paragens descontroladas devido ao controlo de automação. Ao identificar que 60% destes acontecimentos, ocorreram devido à atuação de interlocks foi essencial averiguar se a sua ação foi correta sendo feita uma análise de risco, concluindo que 19 paragens descontroladas do spray dryer poderiam ter sido evitadas.
A análise financeira associada às paragens descontroladas é composta por 3 fatores, downtime, quantidade de produto segregado e custos operacionais. O downtime manifesta-se como o fator com maior relevância, representando cerca de 80% do custo total de $4M, valor este correspondente aos dois anos fiscais.
A partir dos parâmetros estudados, foi possível concluir a dimensão do problema e sugerir ações de melhoria para diminuir a ocorrência de paragens descontroladas, sendo fundamental a padronização de interlocks de equipamento para equipamento e a investigação interna da causa e recorrência destes acontecimentos.
When a production process stops due to a sudden and unexpected halt in equipment, it results in a delay in production planning with associated costs. Therefore, the main objective is to minimize the occurrence of these events. This work aims to provide Hovione with an analysis conducted using the Lean Six Sigma DMAIC (Define, Measure, Analyze, Improve and Control) methodology, regarding the impact of uncontrolled shutdowns in the production process based on occurrences in the fiscal years of 2021 and 2022. It focuses on the parameters of product quality impact, financial impact, and root causes that led to equipment failure. Over these two years, about 297 deviations related to the type of deviations "Product related process instruction not followed" with subtypes "Process variables (pH, temperature, pressure, time, etc.) out of defined range" and "Instructions not followed" were opened, concluding that 5% of the 738 batches produced in the PharmOps area suffered uncontrolled shutdowns due to automation control. Identifying that 60% of these events occurred due to the action of interlocks, it was essential to determine if their action was correct, through a risk analysis, concluding that 19 uncontrolled shutdowns of the spray dryer could have been avoided. The financial analysis associated with uncontrolled shutdowns consists of three factors: downtime, quantity of segregated product, and operating costs. Downtime emerges as the most relevant factor, accounting for approximately 80% of the total cost of $4M, a value corresponding to the two fiscal years. From the parameters studied it was possible to conclude the dimension of the problema and suggest improvement actions to reduce the occurrence of uncontrolled shutdowns, being fundamental the standardization of interlocks from equipment to equipment and the internal investigation of the cause and recurrence of these events.
When a production process stops due to a sudden and unexpected halt in equipment, it results in a delay in production planning with associated costs. Therefore, the main objective is to minimize the occurrence of these events. This work aims to provide Hovione with an analysis conducted using the Lean Six Sigma DMAIC (Define, Measure, Analyze, Improve and Control) methodology, regarding the impact of uncontrolled shutdowns in the production process based on occurrences in the fiscal years of 2021 and 2022. It focuses on the parameters of product quality impact, financial impact, and root causes that led to equipment failure. Over these two years, about 297 deviations related to the type of deviations "Product related process instruction not followed" with subtypes "Process variables (pH, temperature, pressure, time, etc.) out of defined range" and "Instructions not followed" were opened, concluding that 5% of the 738 batches produced in the PharmOps area suffered uncontrolled shutdowns due to automation control. Identifying that 60% of these events occurred due to the action of interlocks, it was essential to determine if their action was correct, through a risk analysis, concluding that 19 uncontrolled shutdowns of the spray dryer could have been avoided. The financial analysis associated with uncontrolled shutdowns consists of three factors: downtime, quantity of segregated product, and operating costs. Downtime emerges as the most relevant factor, accounting for approximately 80% of the total cost of $4M, a value corresponding to the two fiscal years. From the parameters studied it was possible to conclude the dimension of the problema and suggest improvement actions to reduce the occurrence of uncontrolled shutdowns, being fundamental the standardization of interlocks from equipment to equipment and the internal investigation of the cause and recurrence of these events.
Descrição
Palavras-chave
Uncontrolled Shutdown Interlocks Causes Financial Impact DMAIC (Define, Measure, Analyze, Improve and Control).