Reevaluación del proveedor de la materia prima Olopatadina Clorhidrato, 2022
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Date
2022
Journal Title
Journal ISSN
Volume Title
Publisher
Universidad Nacional de Trujillo
Abstract
El presente trabajo tuvo como objetivo reevaluar al proveedor de la materia prima Olopatadina Clorhidrato en el año 2022. Para ello se empleó el formato “Lista de Verificación de Proveedores” establecido por la empresa auditora aplicado a través de una auditoría de tipo remota, donde se contemplan indicadores para cada uno de los factores, los factores evaluados fueron en total 17. El factor 1 evaluó la responsabilidad de la gestión, el factor 2 el sistema de calidad, el factor 3 el control de la documentación, el factor 4 el control de registros, el factor 5 el control de cambios, el factor 6 las compras y control de material, el factor 7 la identificación de producto y trazabilidad, el factor 8 la producción y control en proceso, el factor 9 la inspección y análisis, el factor 10 el control de inspección, medición y equipamiento; el facto 11 el control de productos no conforme, el factor 12 las acciones correctivas y preventivas, el factor 13 la manipulación, almacenamiento, conservación y entrega, el factor 14 el entrenamiento y personal, el factor 15 el etiquetado y embalaje, el factor 16 la validación de equipos, instalaciones y proceso y el factor 17 el manejo de quejas y retiro de producto. Se obtuvo un resultado del 100% en todos los factores lo que garantiza un proveedor altamente confiable al cual se le asigna el estatus de “APROBADO” como dictamen de la reevaluación.
ABSTRACT The objective of this work was to reevaluate the supplier of the raw material Olopatadine Hydrochloride in the year 2022. For this purpose, the "Supplier Verification List" format was used, established by the auditing company applied through a remote type audit, where indicators are contemplated for each of the factors, the factors evaluated were a total of 17. Factor 1 evaluated the responsibility of the management, factor 2 the quality system, factor 3 the control of the documentation, factor 4 the control of records, factor 5 the control of changes, factor 6 the purchases and material control, factor 7 product identification and traceability, factor 8 production and process control, factor 9 inspection and analysis, factor 10 inspection control, measurement and equipment; factor 11 the control of non-conforming products, factor 12 corrective and preventive actions, factor 13 handling, storage, conservation and delivery, factor 14 training and personnel, factor 15 labeling and packaging, factor 16 the validation of equipment, facilities and process and factor 17 the management of complaints and product withdrawal. A result of 100% was obtained in all factors, which guarantees a highly reliable supplier to which the status of "APPROVED" is assigned as a result of the reevaluation.
ABSTRACT The objective of this work was to reevaluate the supplier of the raw material Olopatadine Hydrochloride in the year 2022. For this purpose, the "Supplier Verification List" format was used, established by the auditing company applied through a remote type audit, where indicators are contemplated for each of the factors, the factors evaluated were a total of 17. Factor 1 evaluated the responsibility of the management, factor 2 the quality system, factor 3 the control of the documentation, factor 4 the control of records, factor 5 the control of changes, factor 6 the purchases and material control, factor 7 product identification and traceability, factor 8 production and process control, factor 9 inspection and analysis, factor 10 inspection control, measurement and equipment; factor 11 the control of non-conforming products, factor 12 corrective and preventive actions, factor 13 handling, storage, conservation and delivery, factor 14 training and personnel, factor 15 labeling and packaging, factor 16 the validation of equipment, facilities and process and factor 17 the management of complaints and product withdrawal. A result of 100% was obtained in all factors, which guarantees a highly reliable supplier to which the status of "APPROVED" is assigned as a result of the reevaluation.
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Keywords
Proveedor, Cumplimiento, Auditoría, Olopatadina Clorhidrato, Calidad.