Documentar un manual de calidad según normas BPM, para que grocalidad conceda certificación a Molerpa
Fecha
2016
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Universidad de Guayaquil Facultad de Ciencias Administrativas
Resumen
El Sector veterinario ecuatoriano está regulado por Agrocalidad, quien inscribe, regula y audita a los establecimientos agropecuarios y empresas dedicadas a la fabricación, manufactura, comercialización, importación y exportación de productos veterinarios. MOLERPA S.A. fue auditada en el año 2015 por el organismo estatal, obteniendo un resultado poco favorable debido a las no conformidades encontradas en sus procesos productivos tanto en documentación como en infraestructura. Por este motivo se propone el desarrollo del Manual de Calidad, que comprende la información estructurada de la organización en la cual se describirán sus políticas de calidad, procedimientos documentados, procesos y protagonistas a intervenir. Todos estos elementos estarán armonizados en un sistema de gestión de calidad, que permitirá dirigir y orientarlos a los protagonistas-establecimiento hacia una calidad total. El desarrollo del Manual de Calidad va a estar alineados según las Normativas de Buenas Prácticas de Manufactura (GMP) y Normativa ISO 9001-2015; complementándose para dirigir, planear, organizar, controlar e integrar los procesos productivos y administrativos. Un punto muy importante es definir los costos operativos que van a generar el desarrollo del Manual de Calidad y si la organización cuenta con el presupuesto necesario para iniciar las mejoras y el compromiso de la dirección para la implementación del mismo. Al término de las mejoras se obtendrá el Manual de Calidad, para proceder a solicitar a Agrocalidad una auditoria para confirmar el levantamiento de las no conformidades, al obtener un resultado favorable se emitirá el certificado de cumplimiento BPM que permite a la organización seguir con el desarrollo de sus actividades por el periodo de diez años, con aspiración de iniciar la exportación de los productos a los países centroamericanos y brindar un servicio de maquila a terceros.
The Ecuadorian veterinary sector is regulated by Agrocalidad, who enrolls, regulates and audits to agricultural establishments and companies engaged in the production, manufacturing, marketing, import and export of veterinary products. MOLERPA S.A. It was audited in 2015 by the state agency, obtaining an unfavorable outcome due to non-conformities in their production processes in both documentation and infrastructure. For this reason the development of the Quality Manual, which includes information structured organization in which its quality policies, documented procedures, processes and actors to intervene described is proposed. All these elements will be harmonized on a quality management system, which will lead and guide them to the protagonists-establishment towards total quality. The development of the Quality Manual will be aligned according to the Standards of Good Manufacturing Practices (GMP) and ISO 9001-2015; complementing to direct, plan, organize, control and integrate the productive and administrative processes. A very important point is to define the operating costs that will generate the development of the Quality Manual and if the organization has the necessary to initiate improvements and management commitment to implement the same budget. At the end of the improvements the Quality Manual will be obtained to proceed to request Agrocalidad an audit to confirm the lifting of nonconformity, to obtain a favorable result in the BPM certificate compliance enables the organization to continue the development issue of its activities for the period of ten years, with aspiration to start exporting products to Central American countries and provide maquila services to third parties.
The Ecuadorian veterinary sector is regulated by Agrocalidad, who enrolls, regulates and audits to agricultural establishments and companies engaged in the production, manufacturing, marketing, import and export of veterinary products. MOLERPA S.A. It was audited in 2015 by the state agency, obtaining an unfavorable outcome due to non-conformities in their production processes in both documentation and infrastructure. For this reason the development of the Quality Manual, which includes information structured organization in which its quality policies, documented procedures, processes and actors to intervene described is proposed. All these elements will be harmonized on a quality management system, which will lead and guide them to the protagonists-establishment towards total quality. The development of the Quality Manual will be aligned according to the Standards of Good Manufacturing Practices (GMP) and ISO 9001-2015; complementing to direct, plan, organize, control and integrate the productive and administrative processes. A very important point is to define the operating costs that will generate the development of the Quality Manual and if the organization has the necessary to initiate improvements and management commitment to implement the same budget. At the end of the improvements the Quality Manual will be obtained to proceed to request Agrocalidad an audit to confirm the lifting of nonconformity, to obtain a favorable result in the BPM certificate compliance enables the organization to continue the development issue of its activities for the period of ten years, with aspiration to start exporting products to Central American countries and provide maquila services to third parties.
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DOCUMENTAR, MANUAL DE CALIDAD, BUENAS PRÁCTICAS DE MANUFACTURA, CERTIFICACIÓN