{"id":11106,"date":"2024-12-11T15:23:55","date_gmt":"2024-12-11T14:23:55","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-4-massnahmen-der-verbesserung\/5-4-05-gefaehrdungsanalyse-und-risikomatrix\/"},"modified":"2025-02-04T13:38:32","modified_gmt":"2025-02-04T12:38:32","slug":"5-4-05-hazard-analysis-and-risk-matrix","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-4-massnahmen-der-verbesserung\/5-4-05-gefaehrdungsanalyse-und-risikomatrix\/","title":{"rendered":"5.4.05 Creating a risk matrix for clinical treatment patterns (FMEA)"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">Purpose and goal<\/h2>\n\n\n\n<p>A risk analysis is carried out for individual treatment patterns. The risks are identified according to the phases of a treatment, their probability, the severity of the consequences and the probability of timely detection are estimated and summarised in a risk indicator. Measures are introduced to reduce the risk and the expected risk reduction is then estimated. The results of the risk analysis are stored in the product documentation (configuration documents).<\/p>\n\n\n\n<p><em>DIN EN ISO 9001:2015 and DIN EN 15224:2017 6.1.2 Note; DIN EN ISO 14971:2012 4 Risk analysis; QM-RL:2015 \u00a7 4 (1) - Risk management sentence 1 - 3<\/em> <\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Area of application<\/h2>\n\n\n\n<p>Treatment patterns for which a risk matrix is to be created in order to analyse a particular hazard situation <\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Description of the<\/h2>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-da11a651-ae96-4208-a691-7356e5545997\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_00_qm_risikomatrix.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">To the text of the VA <\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_00_qm_risikomatrix.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-da11a651-ae96-4208-a691-7356e5545997\">Download<\/a><\/div>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"anlagen\">Attachments<\/h3>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-84c29629-7a2f-40f8-9dce-2623b367d845\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_01_qm_risikomatrix.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Appendix 1 Risk matrix<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_01_qm_risikomatrix.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-84c29629-7a2f-40f8-9dce-2623b367d845\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-cdca5447-0618-41fa-8d5d-87ae394b5bee\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_02_qm_merkmale_der_behandlung.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Appendix 2 Questions to identify characteristics of a treatment procedure<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_02_qm_merkmale_der_behandlung.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-cdca5447-0618-41fa-8d5d-87ae394b5bee\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-cee40058-edb5-45d5-b415-8a02cf8001bc\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_03_qm_beispiele_fuer_gefaehrdungen.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Appendix 3 Examples of hazards<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_03_qm_beispiele_fuer_gefaehrdungen.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-cee40058-edb5-45d5-b415-8a02cf8001bc\">Download<\/a><\/div>\n\n\n\n<p>Appendix 4 Assessment of the acceptability of hazards<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-356eaa9d-b1bd-4e0f-8757-a8c79473ffea\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_05_qm_beispiel_risikomatrix_herniotomie.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Appendix 5 Example of the risks of hernia operations<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_05_qm_beispiel_risikomatrix_herniotomie.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-356eaa9d-b1bd-4e0f-8757-a8c79473ffea\">Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-31353ed9-7eb2-4a73-a7e8-5437b071a612\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_06_qm_risikomatrix_endoprothese.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Appendix 6 Example of hazards in arthroplasty<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.4.05_06_qm_risikomatrix_endoprothese.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-31353ed9-7eb2-4a73-a7e8-5437b071a612\">Download<\/a><\/div>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Zweck und Ziel F\u00fcr einzelne Behandlungsmuster wird eine Risikoanalyse durchgef\u00fchrt. Geordnet nach den Phasen einer Behandlung werden die Risiken identifiziert, ihre Wahrscheinlichkeit, die Schwere der Folgen, die Wahrscheinlichkeit der rechtzeitigen Entdeckung abgesch\u00e4tzt und zu einer Risikokennzahl verdichtet. Zur Senkung des Risikos werden Ma\u00dfnahmen eingef\u00fchrt und anschlie\u00dfend die erwartete Gefahrenabsenkung abgesch\u00e4tzt. Die Ergebnisse der Risikoanalyse werden [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":11096,"menu_order":91,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11106","docs","type-docs","status-publish","hentry","no-post-thumbnail"],"acf":[],"author_avatar":"https:\/\/secure.gravatar.com\/avatar\/c6b2616140d9fcd6a1c5d6d2ebbf43422308c9322c032ef03f88ec3235855dcf?s=96&d=mm&r=g","author_name":"admin","_links":{"self":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11106","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/comments?post=11106"}],"version-history":[{"count":3,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11106\/revisions"}],"predecessor-version":[{"id":15161,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11106\/revisions\/15161"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11096"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=11106"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=11106"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=11106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}