{"id":290,"date":"2016-07-05T11:38:04","date_gmt":"2016-07-05T16:38:04","guid":{"rendered":"http:\/\/grupodesisa.mx\/blog\/?p=290"},"modified":"2016-07-05T12:12:46","modified_gmt":"2016-07-05T17:12:46","slug":"un-mini-capa-en-la-rap","status":"publish","type":"post","link":"https:\/\/grupodesisa.mx\/blog\/un-mini-capa-en-la-rap\/","title":{"rendered":"\u00bfUn mini CAPA en la RAP?"},"content":{"rendered":"<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-291\" src=\"http:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Acciones-Preventivas-en-la-RAP.jpg\" alt=\"Acciones-Preventivas-en-la-RAP\" width=\"100%\" height=\"auto\" srcset=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Acciones-Preventivas-en-la-RAP.jpg 1000w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Acciones-Preventivas-en-la-RAP-300x186.jpg 300w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Acciones-Preventivas-en-la-RAP-768x475.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/p>\n<p>La <strong>visi\u00f3n de la autoridad sanitaria<\/strong> (COFEPRIS) es establecer controles que garanticen que la realizaci\u00f3n de la RAP no se quede \u00fanicamente en el cumplimiento de un requisito regulatorio, sino que durante el proceso de conjuntar la informaci\u00f3n se vayan realizando los an\u00e1lisis de tendencia que permita ir estableciendo las acciones preventivas y correctivas(CAPA) derivadas de la revisi\u00f3n constante de indicadores de la calidad.<br \/>\n<!--more--><\/p>\n<h3>Acciones correctivas y preventivas en la RAP<\/h3>\n<p>Complementando esta visi\u00f3n, el mismo formato del <strong>Ap\u00e9ndice B Normativo<\/strong> (NOM-059-SSA1-2015), establece que se deben registrar las acciones derivadas de las conclusiones de la RAP del periodo en curso, as\u00ed como la revisi\u00f3n de las acciones de la revisi\u00f3n anual del periodo anterior. Con ello se est\u00e1 garantizando que se establezcan las CAPA&#8217;s, y que se les de el seguimiento necesarios para lograr la mejora real y continua de los procesos y productos. No tan s\u00f3lo presentar un reporte lleno de informaci\u00f3n que no tenga un enfoque objetivo para la tomar decisiones.<\/p>\n<h3>Nuevas secciones en el reporte RAP<\/h3>\n<p>As\u00ed como se\u00f1alamos la parte de las acciones derivadas de las conclusiones de las RAP y su seguimiento, tambi\u00e9n es importante mencionar que existen otras nuevas secciones que integran el reporte de revisi\u00f3n anual especificadas dentro del <strong>Ap\u00e9ndice B Normativo<\/strong> como lo son, revisi\u00f3n de muestras de retenci\u00f3n, actividades sub-contratadas, modificaci\u00f3n a las condiciones de registro, los compromisos post-mercadeo, notificaciones de sospechas de reacciones adversas, etc. y que adem\u00e1s de incrementar la carga de trabajo en la recopilaci\u00f3n, organizaci\u00f3n, procesamiento y presentaci\u00f3n de la informaci\u00f3n, nos da mayores elementos de an\u00e1lisis, por lo cual nos ser\u00e1 totalmente indispensable llevar un mejor control en el registro y en consecuencia obtener mejores herramientas de apoyo para cumplir con este tan importante requisito.<\/p>\n<p>Le invitamos a conocer una de las herramientas que le facilitar\u00e1n la administraci\u00f3n y el control de la informaci\u00f3n de la RAP, que adem\u00e1s de sistematizar el proceso de registro y seguimiento, le permitir\u00e1 el an\u00e1lisis constante durante el proceso de fabricaci\u00f3n con la generaci\u00f3n de informes y no solo revisar el reporte de revisi\u00f3n anual al final del periodo.<\/p>\n<p><a href=\"http:\/\/grupodesisa.mx\/software-revision-anual-producto\"><img decoding=\"async\" src=\"http:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Banner-RAPSys-V2-Horizontal.jpg\" alt=\"Banner-RAPSys-V2-Horizontal\" width=\"100%\" height=\"auto\" class=\"aligncenter size-full wp-image-294\" srcset=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Banner-RAPSys-V2-Horizontal.jpg 1200w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Banner-RAPSys-V2-Horizontal-300x63.jpg 300w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Banner-RAPSys-V2-Horizontal-768x160.jpg 768w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2016\/07\/Banner-RAPSys-V2-Horizontal-1024x213.jpg 1024w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La visi\u00f3n de la autoridad sanitaria (COFEPRIS) es establecer controles que garanticen que la realizaci\u00f3n de la RAP no se quede \u00fanicamente en el cumplimiento de un requisito regulatorio, sino que durante el proceso de conjuntar la informaci\u00f3n se vayan realizando los an\u00e1lisis de tendencia que permita ir estableciendo las acciones preventivas y correctivas(CAPA) derivadas [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[28,11],"class_list":["post-290","post","type-post","status-publish","format-standard","hentry","category-rap","tag-apendice-b-normativo","tag-revision-anual-de-producto"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6.1 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>\u00bfUn mini CAPA en la RAP? 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