{"id":231,"date":"2024-02-27T20:10:50","date_gmt":"2024-02-27T23:10:50","guid":{"rendered":"https:\/\/sitemakers.com.br\/bm\/?page_id=231"},"modified":"2024-03-05T06:44:55","modified_gmt":"2024-03-05T09:44:55","slug":"complaint-handling-capa","status":"publish","type":"page","link":"https:\/\/sitemakers.com.br\/bm\/index.php\/qm-systems\/complaint-handling-capa\/","title":{"rendered":"\u00a0Complaint Handling \/ CAPA"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"231\" class=\"elementor elementor-231\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ed4858d e-con-full e-flex e-con e-parent\" data-id=\"ed4858d\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;full&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2500e8a elementor-invisible elementor-widget elementor-widget-image\" data-id=\"2500e8a\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1720\" height=\"300\" src=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages.jpg\" class=\"attachment-full size-full wp-image-186\" alt=\"\" srcset=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages.jpg 1720w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-300x52.jpg 300w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-1024x179.jpg 1024w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-768x134.jpg 768w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-1536x268.jpg 1536w\" sizes=\"(max-width: 1720px) 100vw, 1720px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-68894a7 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"68894a7\" data-element_type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInDown&quot;,&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c73e16b elementor-widget elementor-widget-heading\" data-id=\"c73e16b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\"> Complaint Handling \/ CAPA<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a9fbb9c e-flex e-con-boxed e-con e-parent\" data-id=\"a9fbb9c\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-10a837d e-con-full e-flex e-con e-child\" data-id=\"10a837d\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;full&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7902328 animated-slow elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"7902328\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>Die Prozesse zur Erfassung, Bearbeitung und Auswertung von Nichtkonformit\u00e4ten spielen eine zentrale Rolle in allen QM Systemen.\u00a0<\/p><p>Erf\u00fcllt z.B. ein Produkt einzelne der vorgegebenen Freigabekriterien nicht, so kann es nicht freigegeben, erst nach eingehender Bewertung ausgeliefert oder anders disponiert werden. Diese Anforderung ist in der ISO 13485:2016, Kapitel 8.3 sowie in der QSR in Kapitel 820.90 beschrieben.\u00a0<\/p><p>Jegliche Fehler bez\u00fcglich Produkten oder Prozessen m\u00fcssen evaluiert und auf Ihre Kritikalit\u00e4t hin gepr\u00fcft werden.\u00a0<\/p><p>Nachfolgend einige Definitionen zum Complaint \/ CAPA Management:\u00a0<\/p><p><b>Correction \/ Korrektur<\/b><\/p><p><b>FDA (USA)\u00a0<\/b><\/p><p>Correction: Action to eliminate a detected nonconformity<\/p><p><b>ISO 13485<\/b><\/p><p>Korrektur: Massnahme zur Beseitigung eines erkannten Fehlers<\/p><p>Correction oder Korrektur heisst das Wiederherstellen der Spezifikation!<\/p><p>(\u201cReparatur des oder der betroffenen Produkte\u201d)\u00a0<\/p><p><b>Corrective Action \/ Korrekturmassnahme\u00a0<\/b><\/p><p><b>FDA (USA) (Basis: ISO 9000)\u00a0<\/b><\/p><p>Corrective Action: Action to eliminate the cause of a detected nonconformity or other undesirable situation<\/p><p><b>ISO 13485 (Basis: ISO 9000)\u00a0<\/b><\/p><p>Korrekturmassnahme: Massnahme zur Beseitigung der Ursache eines Fehlers oder einer anderen erkannten unerw\u00fcnschten Situation<\/p><p><b>Preventive Action \/ Vorbeugungsmassnahme\u00a0<\/b><\/p><p><b>FDA (USA) (Basis: ISO 9000)\u00a0<\/b><\/p><p>Preventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable situation<\/p><p><b>ISO 13485 (Basis: ISO 9000)\u00a0<\/b><\/p><p>Vorbeugemassnahme: Massnahme zur Beseitigung der Ursache eines m\u00f6glichen Fehlers oder einer anderen m\u00f6glichen unerw\u00fcnschten Situation<\/p><p>\u00a0<\/p><p>Sprechen Sie mit uns! Wir sind Spezialisten auf dem Gebiet Fehleranalyse und Fehlerbehebung!\u00a0<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8657ec9 animated-slow elementor-invisible elementor-widget elementor-widget-image\" data-id=\"8657ec9\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"700\" height=\"465\" src=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/capa.jpg\" class=\"attachment-large size-large wp-image-334\" alt=\"\" srcset=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/capa.jpg 700w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/capa-300x199.jpg 300w\" sizes=\"(max-width: 700px) 100vw, 700px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ea8728a e-flex e-con-boxed e-con e-parent\" data-id=\"ea8728a\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9b3b1db elementor-widget elementor-widget-spacer\" data-id=\"9b3b1db\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-column .elementor-spacer-inner{height:var(--spacer-size)}.e-con{--container-widget-width:100%}.e-con-inner>.elementor-widget-spacer,.e-con>.elementor-widget-spacer{width:var(--container-widget-width,var(--spacer-size));--align-self:var(--container-widget-align-self,initial);--flex-shrink:0}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container,.e-con>.elementor-widget-spacer>.elementor-widget-container{height:100%;width:100%}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer,.e-con>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer{height:100%}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer>.elementor-spacer-inner,.e-con>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer>.elementor-spacer-inner{height:var(--container-widget-height,var(--spacer-size))}.e-con-inner>.elementor-widget-spacer.elementor-widget-empty,.e-con>.elementor-widget-spacer.elementor-widget-empty{position:relative;min-height:22px;min-width:22px}.e-con-inner>.elementor-widget-spacer.elementor-widget-empty .elementor-widget-empty-icon,.e-con>.elementor-widget-spacer.elementor-widget-empty .elementor-widget-empty-icon{position:absolute;top:0;bottom:0;left:0;right:0;margin:auto;padding:0;width:22px;height:22px}<\/style>\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Complaint Handling \/ CAPA Die Prozesse zur Erfassung, Bearbeitung und Auswertung von Nichtkonformit\u00e4ten spielen eine zentrale Rolle in allen QM Systemen.\u00a0 Erf\u00fcllt z.B. ein Produkt einzelne der vorgegebenen Freigabekriterien nicht, so kann es nicht freigegeben, erst nach eingehender Bewertung ausgeliefert oder anders disponiert werden. Diese Anforderung ist in der ISO 13485:2016, Kapitel 8.3 sowie in [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":23,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-231","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/231","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/comments?post=231"}],"version-history":[{"count":7,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/231\/revisions"}],"predecessor-version":[{"id":337,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/231\/revisions\/337"}],"up":[{"embeddable":true,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/23"}],"wp:attachment":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/media?parent=231"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}