{"id":874,"date":"2015-05-11T18:25:06","date_gmt":"2015-05-12T01:25:06","guid":{"rendered":"https:\/\/blogs.plm.automation.siemens.com\/t5\/Polarion-Blog\/Morris-Medical-Monthly-RiskPack-Basics-Part-1-of-2\/ba-p\/380959"},"modified":"2026-03-26T05:32:02","modified_gmt":"2026-03-26T09:32:02","slug":"morris-medical-monthly-riskpack-basics-part-1-of-2","status":"publish","type":"post","link":"https:\/\/blogs.sw.siemens.com\/polarion\/morris-medical-monthly-riskpack-basics-part-1-of-2\/","title":{"rendered":"Morris Medical Monthly: RiskPack Basics (Part 1 of 2)"},"content":{"rendered":"<p>Welcome back to Morris Medical Monthly: a monthly series for medical device development companies (and companies who are related to such companies), providing some useful information about&nbsp;<A href=\"http:\/\/www.polarion.com\/products\/index.php\" rel=\"nofollow noopener noreferrer\">Polarion solutions<\/A>&nbsp;and&nbsp;<A href=\"http:\/\/extensions.polarion.com\" rel=\"nofollow noopener noreferrer\">Polarion extensions<\/A>.<\/p>\n<p>Today we will start on the subject of Polarion&#8217;s&nbsp;<STRONG><A href=\"http:\/\/extensions.polarion.com\/extensions\/184-polarion-alm-riskpack-iso-14971\" rel=\"nofollow noopener noreferrer\">RiskPack extension<\/A><\/STRONG>, and have a look into RiskPack&#8217;s <EM>Basics<\/EM>.<\/p>\n<p><!--more--><br \/>\n<H2>The RiskPack approach to risk management<\/H2><br \/>\n<A href=\"http:\/\/community.plm.automation.siemens.com\/legacyfs\/online\/siemensplm_blogs\/2015\/05\/polarion-riskpack-extension.png\" rel=\"nofollow noopener noreferrer\"><IMG class=\"alignright  wp-image-7407\" src=\"http:\/\/community.plm.automation.siemens.com\/legacyfs\/online\/siemensplm_blogs\/2015\/05\/polarion-riskpack-extension.png\" alt=\"Screenshot image - Polarion RiskPack Extension\" width=\"303\" height=\"334\" \/><\/A>The RiskPack is build upon the requirements of the international standard for risk management for medical devices,<br \/>\nISO 14971. It supports all elements commonly used in risk management:<br \/>\n<UL><br \/>\n\t<LI>defining categories for the severities of harm and the probability of their occurrence<\/LI><br \/>\n\t<LI>defining acceptance levels for all risk\/probability-combinations<\/LI><br \/>\n\t<LI>defining harms, hazards, hazardous situations and sequences of events<\/LI><br \/>\n\t<LI>estimating and evaluating risks<\/LI><br \/>\n\t<LI>defining risk control measures and track their implementation and verification<\/LI><br \/>\n\t<LI>displaying all relevant information in a table view<\/LI><br \/>\n\t<LI>displaying risks before and after mitigation in a matrix view<\/LI><br \/>\n\t<LI>creating an overall risk-benefit analysis<\/LI><br \/>\n\t<LI>creating a risk management report<\/LI><br \/>\n<\/UL><br \/>\n<H2>How RiskPack deals with information<\/H2><br \/>\nIn traditional risk management approaches, all relevant information is stored in a table-like structure, applications like<br \/>\nMicrosoft&#8217;s Excel are often used for this. The problem with this approach is that when the table gets bigger, it&#8217;s<br \/>\ngetting more and more inconvenient to maintain. In addition to this, often information (like hazards or harm) have to<br \/>\nbe repeated and copy-and-pasted within the table. So, as the table grows, people are getting more and more<br \/>\nanxious to make any changes to the table and rather keep things like they are &#8211; which is exactly the opposite of what<br \/>\nrisk management should be.<br \/>\nThe RiskPack has a different approach &#8211; it stores its data as pieces of information. Those pieces can be entered in<br \/>\nany order and can be combined to rather complex statements by creating links between them. The RiskPack uses<br \/>\nPolarion&#8217;s work items to store these information and adds powerful visualization capabilities to create table views<br \/>\njust like in the &#8220;old Excel approach&#8221;. The resulting table view can be customized to only show the information that<br \/>\nare relevant for the device under consideration. Of course, only these information must then be provided by work<br \/>\nitems.<br \/>\nThis approach makes the RiskPack flexible to support an efficient risk management process that lets you<br \/>\nconcentrate on the facts independent on their representation.<br \/>\n<H2>Which information can be stored<\/H2><br \/>\nIn general, RiskPack can store any kind of information. For a proper risk management, harms must be identified and<br \/>\nboth their severity and the probability of their occurrence must be recorded. With this information, risk analysis<br \/>\ncompliant to ISO 14971 is possible. RiskPack provides a data type &#8220;harm&#8221; with an attribute &#8220;severity&#8221; and a data<br \/>\ntype &#8220;risk&#8221; with the attribute &#8220;probability&#8221;. So identification of possible harms and their severity can be done<br \/>\nindependently of considering the probability of their occurrence. A &#8220;risk&#8221; then estimates the probability that a harm<br \/>\ncan occur. The harm that is considered by that risk is simply linked to the risk.<br \/>\nUnfortunately, things are rarely that easy and the sequence of events that finally leads to a harm can be quite<br \/>\ncomplex. RiskPack provides a data type &#8220;sequence of events&#8221; for exactly that purpose. A sequence of events<br \/>\ndescribes something that is going on, it has a start and an end and &#8220;something in between&#8221;. For example, a<br \/>\nsequence of events might start with a system component, taking hazards and hazardous situations into account and<br \/>\nfinally ending with a harm to a patient. All this can be documented using distinct work item types for system&nbsp;components, hazards, hazardous situations and &#8211; as described above &#8211; harms. The sequence of events that glues&nbsp;all this together is also a work item type and provides link possibilities for all the other types mentioned above. A<br \/>\n&#8220;risk&#8221; would now consider the probability of occurrence of a whole sequence of events instead of a single harm. But<br \/>\nas a harm is part of the sequence of events, the severity of it can be identified and the risk can be estimated for both<br \/>\nseverity (which is an attribute of the harm) and probability of occurrence (which is an attribute of the risk).<br \/>\nTo sum it up, information storage within the RiskPack can be quite detailed or quite simple &#8211; it only depends on the<br \/>\nlevel of detail needed for the device risk management is done for. The major point is to decide where the risk<br \/>\nanalysis starts and which information is considered along the way to the harm. In any case, compliance to ISO<br \/>\n14971 can be achieved.<\/p>\n<p>For more information about Polarion&#8217;s RiskPack visit our Extension Portal using following link:<\/p>\n<p><A href=\"http:\/\/extensions.polarion.com\/extensions\/184-polarion-alm-riskpack-iso-14971\" rel=\"nofollow noopener noreferrer\">http:\/\/extensions.polarion.com\/extensions\/184-polarion-alm-riskpack-iso-14971<\/A>.&nbsp;I hope you liked this article and you will visit our Blog again when there is another&nbsp;<B>Morris Medical Monthly&nbsp;<\/B>article.<\/p>\n<p><HR \/><br \/>\n<P style=\"text-align: center;\"><A href=\" http:\/\/www.polarion.com\/resources\/download.php?dl=Polarion-Risk-Analysis-As-A-First-Class-Citizen.pdf&amp;utm_source=morrismedicalmonthly2&amp;utm_medium=web&amp;utm_campaign=blog\" rel=\"nofollow noopener noreferrer\"><IMG class=\"alignnone\" src=\"http:\/\/www.polarion.com\/resources\/img\/dlcovers\/Polarion-Risk-Analysis-As-A-First-Class-Citizen.pdf.jpg\" alt=\"Free eGuide: How to Make Risk a First-class Citizen in Your Development\" width=\"349\" height=\"477\" \/><\/A><\/P><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Welcome back to Morris Medical Monthly: a monthly series for medical device development companies (and companies who are related to such companies), providing some useful information about&nbsp;Polar&#8230;<\/p>\n","protected":false},"author":63333,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"spanish_translation":"","french_translation":"","german_translation":"","italian_translation":"","polish_translation":"","japanese_translation":"","chinese_translation":"","footnotes":""},"categories":[1],"tags":[],"industry":[],"product":[],"coauthors":[],"class_list":["post-874","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/posts\/874","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/users\/63333"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/comments?post=874"}],"version-history":[{"count":1,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/posts\/874\/revisions"}],"predecessor-version":[{"id":875,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/posts\/874\/revisions\/875"}],"wp:attachment":[{"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/media?parent=874"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/categories?post=874"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/tags?post=874"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/industry?post=874"},{"taxonomy":"product","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/product?post=874"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/coauthors?post=874"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}