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      Validación de procesos con análisis inicial de criticidad aplicado a la obtención del principio activo policosanol (PPG) Translated title: Processes validation with initial analysis of criticality applied to obtaining the active ingredient policosanol (PPG)

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          Abstract

          Resumen Identificar cuáles son los activos que se someterán al proceso de validación es una tarea prioritaria para cualquier empresa que implemente un Sistema de Gestión de la Calidad, lo cual repercute de manera directa en el éxito de cualquier empresa. Como consecuencia de esto en septiembre de 2014 se diseñó un procedimiento en el departamento de Aseguramiento de la Calidad, dirección de Producción, CNIC; con el objetivo de determinar aquellos equipos o sistemas de apoyo auxiliar que serán sometidos al proceso de validación en la fabricación del principio activo del Policosanol (PPG). Para darle cumplimiento a nuestro objetivo el método utilizado se basa en la combinación de técnicas de riesgos tradicionales como son los métodos comparativos, diagramas lógicos de fallas, estudios de riesgo y operatividad, análisis de modos de falla y efectos, y otros. Como resultado se obtuvo un procedimiento general para la aplicación de la técnica de criticidad, la cual denominamos HAZID (HAZard-IDentification), basado en el análisis de riesgos. Como conclusión fundamental se obtiene un criterio de partida para justificar la inclusión de un equipo o sistema al proceso de validación.

          Translated abstract

          Abstract Identifying the assets that will be submitted to the validation process is a priority task for any company that implements a Quality Management System, wicth has a direct impact on the success of any company. Taking into account the previous approach, it was designed in September 2014 a procedure in the department of Quality Assurance, Production Management, CNIC; with the aim of identifying those equipment or auxiliary systems that will be included in the validation process in the manufacture of the active ingredient Policosanol (PPG). To meet the principal goal, it was used a method based on the combination of techniques traditional risks such as comparative methods, fault logic diagrams, risk studies and operability, analysis of failure modes and effects, and others. As a result, it was obtained a general procedure for the implementation of the technique of criticality, it was named HAZID (HAZard-IDentification), based on risk analysis. As a fundamental conclusion, it was obtained a starting point to justify the inclusion of an equipment or auxiliary system to the validation process.

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          Most cited references 23

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          Hazard and operability (HAZOP) analysis. A literature review.

          Hazard and operability (HAZOP) methodology is a Process Hazard Analysis (PHA) technique used worldwide for studying not only the hazards of a system, but also its operability problems, by exploring the effects of any deviations from design conditions. Our paper is the first HAZOP review intended to gather HAZOP-related literature from books, guidelines, standards, major journals, and conference proceedings, with the purpose of classifying the research conducted over the years and define the HAZOP state-of-the-art.
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            Análisis de modos de falla, efectos y criticidad (AMFEC) para la planeación del mantenimiento empleando criterios de riesgo y confiabilidad,

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              Practical large scale what-if queries: case studies with software risk assessment

               T Menzies,  E. Sinsel (2000)
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Journal
                biote
                Revista Colombiana de Biotecnología
                Rev. colomb. biotecnol
                Instituto de Biotecnología, Universidad Nacional de Colombia (Bogotá, Distrito Capital, Colombia )
                0123-3475
                June 2017
                : 19
                : 1
                : 124-132
                Affiliations
                La Habana La Habana orgnameCentro Nacional de Investigaciones Científicas Cuba yoenia.duani@ 123456cnic.edu.cu
                La Habana orgnameUniversidad Tecnológica de la Habana José A. Echeverría orgdiv1Facultad de Ingeniería Automática y Biomédica: Entidad secundaria Cuba michaelhg@ 123456automatica.cujae.edu.cu
                Article
                S0123-34752017000100124
                10.15446/rev.colomb.biote.v19n1.50002

                This work is licensed under a Creative Commons Attribution 4.0 International License.

                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 23, Pages: 9
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