{"id":10495,"date":"2021-10-04T09:09:00","date_gmt":"2021-10-04T07:09:00","guid":{"rendered":"https:\/\/www.s4bt.it\/quality-risk-management-lifecycle\/"},"modified":"2021-10-18T11:01:54","modified_gmt":"2021-10-18T09:01:54","slug":"quality-risk-management-lifecycle","status":"publish","type":"post","link":"https:\/\/www.s4bt.it\/en\/quality-risk-management-lifecycle\/","title":{"rendered":"Quality Risk Management Lifecycle &#8211; Part 2"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10495\" class=\"elementor elementor-10495 elementor-1292\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2800be8b elementor-section-height-min-height elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"2800be8b\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4d7814b8\" data-id=\"4d7814b8\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-796ba48e elementor-widget elementor-widget-heading\" data-id=\"796ba48e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">BLOG<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a341213 elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"4a341213\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\" style=\"--divider-pattern-url: url(&quot;data:image\/svg+xml,%3Csvg xmlns=&#039;http:\/\/www.w3.org\/2000\/svg&#039; preserveAspectRatio=&#039;none&#039; overflow=&#039;visible&#039; height=&#039;100%&#039; viewBox=&#039;0 0 20 16&#039; fill=&#039;none&#039; stroke=&#039;black&#039; stroke-width=&#039;1&#039; stroke-linecap=&#039;square&#039; stroke-miterlimit=&#039;10&#039;%3E%3Cg transform=&#039;translate(-12.000000, 0)&#039;%3E%3Cpath d=&#039;M28,0L10,18&#039;\/%3E%3Cpath d=&#039;M18,0L0,18&#039;\/%3E%3Cpath d=&#039;M48,0L30,18&#039;\/%3E%3Cpath d=&#039;M38,0L20,18&#039;\/%3E%3C\/g%3E%3C\/svg%3E&quot;);\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-13781744 elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"13781744\" data-element_type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Quality Risk Management Lifecycle &#8211; Part 2<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5cbd1f80 elementor-hidden-phone elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"5cbd1f80\" data-element_type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Quality Risk Management Lifecycle &#8211; Part 2<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eb646ce elementor-widget elementor-widget-post-info\" data-id=\"eb646ce\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-b0a0713 elementor-inline-item\" itemprop=\"author\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.s4bt.it\/en\/author\/silvia\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-user-circle\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-author\">\n\t\t\t\t\t\t\t\t\t\tSilvia Di Gennaro\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-92e643a elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.s4bt.it\/en\/2021\/10\/04\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-calendar\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\t<time>04\/10\/2021<\/time>\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-66f461fe elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"66f461fe\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-2e421867\" data-id=\"2e421867\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c5da47f elementor-widget elementor-widget-text-editor\" data-id=\"c5da47f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div id=\"x-content-band-9\" class=\"x-content-band vc\">\n<div class=\"x-container wpb_row\">\n<div class=\"x-column x-sm vc x-1-1\">\n<div class=\"wpb_text_column wpb_content_element \">\n<div class=\"wpb_wrapper\">\n<p>According to ICH Q9, the <strong>benefits of risk management<\/strong> are to be achieved through the application of a QRM lifecycle. This is an iterative process consisting of <strong>four<\/strong> <strong>primary phases<\/strong> (risk assessment, risk control, risk review, risk communication), each facilitated by the application of risk management tools.<\/p>\n<p>While ICH Q9 recognises that other lifecycle models can be used, most companies have adopted the <strong>model contained in the guidelines<\/strong>.<\/p>\n<\/div>\n<\/div>\n<p>In the <strong>start-up and planning<\/strong>phase, ICH Q9 describes the activities that could be performed as follows:<\/p>\n<ul>\n<li aria-level=\"1\">define the <strong>problem<\/strong> and\/or <strong>risk situation<\/strong>, including the relevant assumptions to identify the risk potential;<\/li>\n<li aria-level=\"1\">identify <strong>personnel<\/strong> and <strong>leadership<\/strong>;<\/li>\n<li aria-level=\"1\">outline the <strong>expected results<\/strong>; <\/li>\n<li aria-level=\"1\">specify a <strong>timeline<\/strong>, <strong>documents<\/strong> and an adequate level of <strong>decision-making<\/strong> for the risk management process;<\/li>\n<li aria-level=\"1\">collect basic information and\/or data on the potential danger, damage or impact on human health that is relevant for the Risk Assessment.<\/li>\n<\/ul>\n<p>The ICHQ9 guideline does not indicate when or under <strong>what circumstances<\/strong> the Quality risk management process should be initiated, or which triggers could activate this first critical step.<\/p>\n<h2>Risk Assessment<\/h2>\n<\/p>\n<p>The <b>Risk Assessment<\/b> consists of <b>identifying hazards<\/b> and<b>analysing and assessing the risks<\/b> associated with exposure to these hazards. It is typically based on the use of <b>risk management tools<\/b>, which allow a methodical and structured means of identifying and analysing risks.<\/p>\n<p>The Quality Risk Assessment begins with a well-defined <b>description of the problem<\/b> or risk issue. At this point, a risk management tool and the type of information needed to address the risk will be more easily identified. <\/p>\n<p>To define the risks, it is useful to <strong>answer 3 questions<\/strong>:<\/p>\n<ol>\n<li aria-level=\"1\"><b>What could go wrong?<\/b> (Risk identification). Systematic use of information (historical data, theoretical analysis, knowledge-based opinions, stakeholder concerns) to identify dangers related to a problem. <\/li>\n<li aria-level=\"1\"><b>What is the probability that it will go wrong?<\/b> (Risk Analysis). Each hazard is analysed to determine its relative criticality, using the risk equation (probability x severity = risk). It is a qualitative or quantitative process that links the probability of occurrence and the severity of damage. <\/li>\n<li aria-level=\"1\"><b>What are the consequences (severity)?<\/b> (Risk Evaluation) Finally, the identified and analysed risks are compared with predefined criteria to determine their acceptability (risk assessment).<\/li>\n<\/ol>\n<h3>Our Risk Assessment Advice<\/h3>\n<p>In carrying out an effective Risk Assessment, the <b>robustness of the data set<\/b> is important because it determines the quality of the output. Showing assumptions and reasonable sources of uncertainty <b>increases confidence in this output and\/or helps to identify its limitations<\/b>. <\/p>\n<p>The uncertainty is due to the combination of:<\/p>\n<ul>\n<li aria-level=\"1\">incomplete<strong>knowledge<\/strong> of a process and its expected or unexpected variability;<\/li>\n<li aria-level=\"1\"> knowledge gaps in pharmaceutical science and in the understanding of the process, in the sources of harm (e.g. failure modes of a process, sources of variability) and in the probability of identifying problems. <\/li>\n<\/ul>\n<p><strong>The output<\/strong> of a Risk Assessment is a <strong>quantitative estimate of the risk or a qualitative description<\/strong> of a series of risks.<\/p>\n<h2>Risk Control<\/h2>\n<p>In this phase,<strong>the risks are reduced to an acceptable level<\/strong>. This is perhaps the most important stage, as it is the point in the process where control strategies are identified, implemented and continuously improved; risk control is the phase that guarantees adequate patient protection. <\/p>\n<p>The <strong>main activities<\/strong> are:<\/p>\n<ul>\n<li aria-level=\"1\"><strong>Risk reduction<\/strong> &#8211; actions taken to reduce the probability of damage occurrence and severity. Focuses on quality risk mitigation and prevention processes;<\/li>\n<li aria-level=\"1\"><strong>Risk acceptance<\/strong> &#8211; Confirmation that risk mitigation actions have not adversely affected the overall risk profile by introducing new risks or increasing risk levels, the risks are adequately controlled (i.e., that risk mitigation actions and other risk controls are effective) and the resulting risks are acceptable. Risk acceptance consists of a formal decision to accept the residual risk or a passive decision in which the residual risk is not specified.<\/li>\n<\/ul>\n<p>In the event that the risk remains unacceptable following risk reduction, the cycle returns to the risk assessment stage and the process can be repeated.<\/p>\n<h3>Our advice for the Risk Control phase<\/h3>\n<p>The amount of work and resources invested in risk control should be proportional to the magnitude of the risk. Decision-makers can use several processes, including cost-benefit analysis, to understand the optimal level of risk control.<\/p>\n<p>Risk Control could focus on the <strong>following questions<\/strong>: <\/p>\n<ol>\n<li>Is the risk above an acceptable level? <\/li>\n<li>What can be done to reduce or eliminate the risks? <\/li>\n<li>What is the right balance between the benefits, risks and resources? <\/li>\n<li>Did the new risks start as a result of the identified risks being controlled?<\/li>\n<\/ol>\n<hr class=\"x-gap\">\n<div class=\"x-prompt s4btconsulting_maggioriInfo message-left\">\n<div class=\"x-prompt-section x-prompt-section-message\"> <\/div>\n<div class=\"x-prompt-section x-prompt-section-button\">Quality Risk Management Output\/Result<\/div>\n<\/div>\n<p>After risk control, there is an output. Although included in the QRM life cycle, ICH Q9 does not provide any narrative description of what such an output or result might entail. <\/p>\n<p>Generally, at this stage a <strong>report is compiled on the results of the risk assessment and risk control<\/strong>, the risk reduction efforts undertaken and the acceptability of the residual risk.<\/p>\n<h2>Risk Review<\/h2>\n<p>Once the risk control has been completed and the results documented, the risk review phase begins. The goal is to ensure that previous activities and associated <strong>deliverables<\/strong> remain <strong>accurate<\/strong>, <strong>relevant<\/strong> and <strong>complete<\/strong> in light of changing conditions. Knowledge gained during the product lifecycle, ongoing activities, such as product, process or system changes, unplanned events, such as customer deviations and complaints, and changes in internal and external business and regulatory climate can impact the decisions taken in the risk assessment and acceptance phases. <\/p>\n<p>Risk review, therefore, involves a<strong>periodic or event-driven review<\/strong> to determine whether the original risk assessment needs to be updated and whether risk acceptability will therefore be affected. In this sense, ICH Q9 presents the risk review as an opportunity to confirm the continued validity of decisions made within the QRM process.<\/p>\n<p>The <strong>review frequency<\/strong> should be based on the level of risk. <\/p>\n<h2>Risk Communication<\/h2>\n<p>A critical and often overlooked element of the QRM lifecycle is <strong>risk communication<\/strong>. The objective is to ensure that all interested parties are aware of the information on risks, including aspects such as &#8220;existence, nature, form, probability, severity, acceptability, control, treatment, detectability or other aspects of quality risks&#8221;. <\/p>\n<p>Such communication occurs most commonly in the <strong>output phase of the QRM lifecycle<\/strong>, through documentation associated with risk assessment and control activities as the primary communication mechanism; however, risk communication can and should occur at other stages of the QRM lifecycle, depending on the nature and criticality of the identified risks. <\/p>\n<p>A significant <strong>challenge<\/strong> in quality risk communication lies in the relatively limited options for communication between QRM professionals, decision-makers and the patient. Unlike intrinsic risks (such as known adverse reactions), which are typically communicated through product labelling, extrinsic risks, including quality risks, have no defined communication mechanism.<\/p>\n<h3>Our advice for the Risk Communication phase<\/h3>\n<p>In Risk Communication, it is important to take into account the following <strong>elements<\/strong>:<\/p>\n<ul>\n<li aria-level=\"1\">stakeholders must <strong>communicate in all stages<\/strong> of the Risk Management process; <\/li>\n<li aria-level=\"1\">the result of the Risk Management process must be adequately communicated and documented;<\/li>\n<li aria-level=\"1\">the <strong>information contained in the report<\/strong> may relate to the existence, nature, form, probability, severity, acceptability, control, treatment, recognition or other aspects of risks; <\/li>\n<li aria-level=\"1\">communication is not required for each acceptance of risk; <\/li>\n<li aria-level=\"1\">between industry and regulatory authorities, communication relating to Quality Risk Management decisions can be made through existing channels, as specified by the regulations and guidelines<\/li>\n<\/ul>\n<p><strong>References:<\/strong><\/p>\n<p><em>ICH. ICH Q9: Quality Risk Management. June 2005<br \/>Quality Risk Management 101: ICH Q9 In Context &#8211; Pharmaceutical Online &#8211; March 28, 2018<\/em><\/p>\n<\/div>\n<\/div>\n<\/div>\n<div id=\"x-content-band-10\" class=\"x-content-band vc\">\n<div class=\"x-container wpb_row\">\n<div class=\"x-column x-sm vc x-1-1\">\n<h2>How can we help you?<\/h2>\n<p><a href=\"https:\/\/www.s4bt.it\/consulenza-life-science-csv-data-integrity\/\" target=\"_blank\" rel=\"noopener noreferrer\">Specialist Consultancy for Computer System Validation &amp; Data Integrity<\/a><\/p>\n<p><a href=\"https:\/\/www.s4bt.it\/consulenza-life-science-qualifiche\/\" target=\"_blank\" rel=\"noopener noreferrer\">Specialist consultancy for Equipment Qualifications, environments and utilities<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n\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<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-5dbf9866\" data-id=\"5dbf9866\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-5ba9c19c elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"5ba9c19c\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-4a7c8a22\" data-id=\"4a7c8a22\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:6084,&quot;url&quot;:&quot;https:\\\/\\\/www.s4bt.it\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/computer-system-validation-data-integrity.jpg&quot;}],&quot;background_slideshow_loop&quot;:&quot;yes&quot;,&quot;background_slideshow_slide_duration&quot;:5000,&quot;background_slideshow_slide_transition&quot;:&quot;fade&quot;,&quot;background_slideshow_transition_duration&quot;:500}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5a928dd3 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"5a928dd3\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.s4bt.it\/en\/consulting\/computer-system-validation-data-integrity\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CSV &amp; DATA INTEGRITY CONSULTING<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-56c58fac elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"56c58fac\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-542822dc\" data-id=\"542822dc\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4f45bb6 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"4f45bb6\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">MORE INFO<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18306204 elementor-widget elementor-widget-text-editor\" data-id=\"18306204\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"https:\/\/www.s4bt.it\/gestione-del-capa\/\"><em>Discovering CAPA. 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