Gestión de Auditorías Internas en un Laboratorio Nacional de Dispositivos Médicos para el cumplimiento de las Buenas Prácticas de Manufactura
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre profesionales tuvo como objetivo desarrollar una gestión de las auditorías internas en un Laboratorio Nacional de Dispositivos Médicos para el cumplimiento de las Buenas Prácticas de Manufactura, adaptando a la guía de inspección interna de acuerdo a las necesidades de los protocolos internos del laboratorio fabricante de dispositivos médicos. Para ello, se realizaron dos auditorias durante el año 2021, en los meses de mayo y noviembre. Ambas se enfocaron en verificar la documentación y el sistema de control interno implementado por el laboratorio con el fin de determinar si cumplen con las Buenas Prácticas de Manufactura. Para ello se planificó una serie de actividades que favorecieron el desarrollo de las dos auditorías internas, alcanzando los siguientes resultados: el número de hallazgos de no conformidades disminuyó de la auditoria 2021-II respecto a la auditoria 2021-I en casi todas las áreas en estudio, excepto en el área de Almacén; pero la evaluación en su totalidad, resultó un descenso del 50% del número de hallazgos de no conformidades en la auditoria 2021-I respecto a la auditoría 2021-I. Asimismo, se logró determinar las observaciones, de las cuales se efectuó el análisis de la causa raíz para así proponer las óptimas acciones correctivas y deshacerse de la no conformidades detectadas. Se concluyó que, la gestión de calidad del laboratorio nacional de dispositivos médicos demuestra una mejora continua y el buen cumplimiento de las Buenas Prácticas de Manufactura, tomando como indicador a las auditorías internas.
ABSTRACT The objective of this pre-professional practice report was to develop a management of internal audits in a National Laboratory of Medical Devices for compliance with Good Manufacturing Practices, adapting the internal inspection guide according to the needs of internal protocols. of the medical device manufacturing laboratory. For this, two auditoriums were held during the year 2021, in the months of May and November. Both focused on verifying the documentation and the internal control system implemented by the laboratory in order to determine if they comply with Good Manufacturing Practices. For this, a series of activities were planned that favored the development of the two internal audits, achieving the following results: study, except in the Warehouse area; but the evaluation as a whole resulted in a 50% decrease in the number of non-conformity results in the 2021-I audit compared to the 2021-I audit. Likewise, the observations will be determined, of which the root cause analysis was carried out in order to propose the optimal corrective actions and discover the non-conformities detected. It was concluded that the quality management of the national medical device laboratory demonstrates continuous improvement and good compliance with Good Manufacturing Practices, taking internal audits as an indicator.
ABSTRACT The objective of this pre-professional practice report was to develop a management of internal audits in a National Laboratory of Medical Devices for compliance with Good Manufacturing Practices, adapting the internal inspection guide according to the needs of internal protocols. of the medical device manufacturing laboratory. For this, two auditoriums were held during the year 2021, in the months of May and November. Both focused on verifying the documentation and the internal control system implemented by the laboratory in order to determine if they comply with Good Manufacturing Practices. For this, a series of activities were planned that favored the development of the two internal audits, achieving the following results: study, except in the Warehouse area; but the evaluation as a whole resulted in a 50% decrease in the number of non-conformity results in the 2021-I audit compared to the 2021-I audit. Likewise, the observations will be determined, of which the root cause analysis was carried out in order to propose the optimal corrective actions and discover the non-conformities detected. It was concluded that the quality management of the national medical device laboratory demonstrates continuous improvement and good compliance with Good Manufacturing Practices, taking internal audits as an indicator.
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Keywords
Auditorías internas, No conformidades, BPM.