{"id":10493,"date":"2021-10-04T09:09:00","date_gmt":"2021-10-04T07:09:00","guid":{"rendered":"https:\/\/www.s4bt.it\/tools-advice-quality-risk-management\/"},"modified":"2023-07-17T09:43:35","modified_gmt":"2023-07-17T07:43:35","slug":"tools-advice-quality-risk-management","status":"publish","type":"post","link":"https:\/\/www.s4bt.it\/en\/tools-advice-quality-risk-management\/","title":{"rendered":"Tools and advice to make the best use of Quality Risk Management"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10493\" class=\"elementor elementor-10493 elementor-1317\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-67c247f4 elementor-section-height-min-height elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"67c247f4\" data-element_type=\"section\" 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class=\"elementor-element elementor-element-4a65a4ca elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"4a65a4ca\" 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\">Tools and advice to make the best use of Quality Risk Management<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-54729158 elementor-hidden-phone elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"54729158\" 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\">Tools and advice to make the best use of Quality Risk Management<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6741ba11 elementor-widget elementor-widget-post-info\" data-id=\"6741ba11\" 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-1c562258 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1c562258\" 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-717150c9\" data-id=\"717150c9\" 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-611b523b elementor-widget elementor-widget-text-editor\" data-id=\"611b523b\" 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>Quality Risk Management is a forecasting model and a systematic process for <strong>assessing<\/strong>, <strong>controlling<\/strong>, communicating and reviewing risks to the quality (understood as safety and effectiveness) of a product or service throughout its life, from development to marketing.<\/p><p>QRM can be applied to different <strong>types of industries<\/strong>, such as Automotive and Food, but also to different areas of the company, from quality control to human resources.<\/p><p>Quality Risk Management is important for providing a <strong>structured and objective approach<\/strong> to the management of information and <strong>decision-making<\/strong>, through <strong>documented<\/strong>, consistent and communicative methods that support the development and production phases of the product or service.<\/p><p>In the Life Science sector, QRM is addressed in the <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-3.pdf\">ICH Q9<\/a>guidelines, in Part III of the <strong>GMP Guidelines<\/strong>, where the development of science and risk-based approaches to quality is encouraged.<\/p><h2>4 advantages of Quality Risk Management<\/h2><div class=\"wp-block-spacer\" style=\"height: 53px;\" aria-hidden=\"true\">\u00a0<\/div><p><strong>1. Quality<\/strong><\/p><p>Effective implementation of the entire Quality Risk Management process ensures <strong>high-quality<\/strong> medication for the patient. This is achieved through a <strong>proactive approach<\/strong> of identifying and controlling possible quality problems that may occur during its development and production (including raw ingredients and packaging materials).<\/p><p><strong>2. Decision making<\/strong><\/p><p>Systematic application of QRM also improves <strong>decision-making<\/strong> and increases <strong>confidence<\/strong> in the company&#8217;s ability to deal with potential risks.<\/p><p><strong>3. Productivity<\/strong><\/p><p>Furthermore, when well applied, Quality Risk Management significantly <strong>reduces<\/strong> the <strong>costs<\/strong> of pharmaceutical product <strong>development and production<\/strong> by reducing an organisation&#8217;s workload and focusing efforts on the most critical areas leading to higher product quality and patient safety chains.<\/p><p><strong>4. Knowledge anagement<\/strong><\/p><p>QRM can also be successfully used to enhance knowledge management by providing a comprehensive overview of processes or systems, their weaknesses and the critical controls that have been put in place to prevent problems from occurring.<\/p><h2>Some methods and tools to support QRM<\/h2><h3><strong>5 Whys<\/strong><\/h3><p>The method is to repeatedly ask the question &#8220;why&#8221; until you come to understand all the <strong>symptoms of a problem<\/strong> and get to the root. The method is usually used during <strong>problem-solving activities<\/strong> or in conjunction with other tools, such as the cause and effect diagram.<\/p><p><strong>Ishikawa Diagram (fishbone diagram)<\/strong><\/p><p>So-called because it looks like a fishbone with a rectangle at the end containing the effect or problem. In the manufacturing field, the <strong>causes<\/strong> or factors that influence a production process are often organised into four <strong>macro groups<\/strong>, which are: <strong>labour<\/strong>, <strong>machines<\/strong> (including the energy used and working and measuring instruments), <strong>materials<\/strong> (raw and auxiliary materials) and <strong>methods<\/strong> (procedures or operating practices). It can be used in brainstorming sessions with the team.<\/p><h3><strong>Fault Tree Analysis (FTA)<\/strong><\/h3><p>This helps determine the cause of failure or tests the <strong>reliability<\/strong> of a system by logically checking for a series of events. The FTA <strong>starts from failure<\/strong> to logically arrive at the causes. It can be used for:<\/p><ul><li>establishing the route to the right cause of failure;<\/li><li>evaluating the system or subsystem of failures one at a time, although it can also combine several causes of failure by identifying causal chains;<\/li><li>investigating complaints and deviations so as to fully understand their cause and ensure that the planned improvements will solve the problem and not lead to others;<\/li><li>evaluating how different factors influence a certain problem. It is useful for both risk assessment and monitoring development programmes.<\/li><li>It relies on a total understanding of the process so as to identify causative factors.<\/li><\/ul><h3><strong>Failure Mode and Effect Analysis (FMEA)<\/strong><\/h3><p>Methodology used to <strong>analyse failure or defect modes<\/strong> of a process, product or system, analyse their causes and assess their effects on the whole system\/plant. Generally (but not necessarily) the analysis is carried out beforehand and is therefore based on theoretical and not experimental considerations. It allows organisations to anticipate possible defects and errors in process design during the design phase.<\/p><p><strong>It can be used for: <\/strong><\/p><ul><li>designing a new product, process or service;<\/li><li>planning to carry out an existing process in a different way;<\/li><li>when you have the objective of improving the quality of a specific process;<\/li><li>when you need to understand and &#8220;improve&#8221; the errors in a process.<\/li><\/ul><h3><strong>HAZOP<\/strong><\/h3><p>Tool based on the theory that <strong>risk events are caused by deviations from the design<\/strong> or operational goals. It uses a systematic technique to identify potential deviations. It is often used by a team that already knows the design of a process or product and its application.<\/p><p><strong>It can be used for:<\/strong><\/p><ul><li>production processes;<\/li><li>equipment and services;<\/li><li>finished products and raw materials;<\/li><li>assessing the dangers within safety processes;<\/li><li>as a starting point for the HACCP methodology;<\/li><\/ul><h3><strong>HACCP<\/strong><\/h3><p>Identifies and implements <strong>process controls<\/strong> that consistently and effectively prevent the occurrence or spread of dangerous conditions. It emphasises problem <strong>prevention<\/strong> rather than its detection, which is why it is recommended for proactive and non-reactive applications.<\/p><p><strong>It can be used for:<\/strong><\/p><ul><li>identifying and managing the risks associated with physical, chemical and biological hazards (including microbiological contamination);<\/li><li>supporting the identification of critical control points (critical variables\/parameters) when product and process knowledge is comprehensive;<\/li><li>facilitating the monitoring of critical points in production processes.<\/li><\/ul><h3><strong>Preliminary Hazard Analysis (PHA)<\/strong><\/h3><p>Analysis tool that <strong>applies experience or prior knowledge<\/strong> of the hazard or failure to identify future hazards, hazardous situations and events that could cause harm and to assess their likelihood of occurrence in relation to a certain activity, product functionality or system.<\/p><p><strong>It can be used for:<\/strong><\/p><ul><li>analysing existing systems or prioritising hazards where conditions preclude the use of a more extensive technique;<\/li><li>products, processes and functionalities and to assess the types of hazard by product type or class and for the specific product;<\/li><li>the development of a project when there is little information on the detail of the design or operational procedures (i.e. it is often a predecessor of later studies);<\/li><li>in general, the hazards identified are assessed with other risk management methods<\/li><\/ul><p><strong>MORE INFO:<\/strong> <a href=\"https:\/\/www.s4bt.it\/change-control-digitalizzazione\/\" target=\"_blank\" rel=\"noreferrer noopener\">The challenges of Change Control including sharing, documentation, training and digitisation<\/a><\/p><h3><strong>Risk Ranking and Filtering<\/strong><\/h3><p>Method used to <strong>compare and classify risks<\/strong>. It usually includes the evaluation of several quantitative and qualitative factors for each risk and risk weighting and scoring.<\/p><p><strong>Can be used:<\/strong><\/p><ul><li>to prioritise production sites for inspections and audits by regulatory bodies or the industry;<\/li><li>in situations where the portfolio of risks and the underlying consequences to be managed are different and difficult to compare using a single instrument;<\/li><li>when management needs to address both qualitative and quantitative risks in the same organisational structure.<\/li><\/ul><p>To learn more about other tools, we recommend the World Health Organisation&#8217;s Quality Risk Management Guidelines.<\/p><h2>\u00a0<\/h2><h2><span style=\"color: var( --e-global-color-secondary ); font-family: var( --e-global-typography-7eb7931-font-family ); font-size: var( --e-global-typography-7eb7931-font-size ); font-weight: var( --e-global-typography-7eb7931-font-weight ); letter-spacing: var( --e-global-typography-7eb7931-letter-spacing );\">QRM management with a digital system<\/span><\/h2><div class=\"wp-block-spacer\" style=\"height: 54px;\" aria-hidden=\"true\"><span style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\">Using a digital system to manage the entire Quality Risk Management process simplifies documenting all stages, adhering to regulations, sharing information within the QRM team and reporting for further analysis. It also allows Top Management to have an overview and supervise the processes, vulnerabilities and actions put in place by the company to mitigate risks. <\/span><\/div><hr class=\"wp-block-separator has-text-color has-background is-style-wide\" style=\"background-color: #24d900; color: #24d900;\" \/><h2>\u00a0<\/h2><h2>\u00a0<\/h2><h2>PRAGMA4U<\/h2><p><a href=\"https:\/\/pragma4u.it\/platform\/?lang=en\" target=\"_blank\" rel=\"noreferrer noopener\">PRAGMA4U<\/a> is a <strong>modular<\/strong> and <strong>scalable<\/strong> Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.<\/p><p>It enables companies to: have <strong>documentation<\/strong> that is protected, always up-to-date, organised and linked to the source processes; assign and implement work<strong>activities<\/strong> directly on the platform; easily share information between departments; keep processes under <strong>control<\/strong> using KPIs; and compile <strong>reports<\/strong> and <strong>dossiers<\/strong> that will be useful for <strong>inspections<\/strong>.<\/p><p>The platform can contain multiple processes, creating a true <strong>digital map of the company<\/strong>. It also integrates with other systems, such as <strong>ERP<\/strong>, simplifying the compilation and updating of data.<\/p>\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-64dc8af6\" data-id=\"64dc8af6\" 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-1e56c2c0 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"1e56c2c0\" 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-48af4d76\" data-id=\"48af4d76\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:6961,&quot;url&quot;:&quot;https:\\\/\\\/www.s4bt.it\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/digital-business-and-technology-SNQVNDV.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-56a22df4 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"56a22df4\" 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:\/\/pragma4u.it\/?lang=en\" target=\"_blank\">\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\">PRAGMA4U<\/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-6adf5245 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6adf5245\" 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-29095a03\" data-id=\"29095a03\" 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-2097dd01 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"2097dd01\" 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-5f4ebac6 elementor-widget elementor-widget-text-editor\" data-id=\"5f4ebac6\" 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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QRM can be applied to different types of industries, such as Automotive and Food, but also [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10501,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[27,26],"tags":[],"class_list":["post-10493","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-digital-transformation","category-life-science"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Tools and advice to make the best use of Quality Risk Management<\/title>\n<meta name=\"description\" content=\"Quality Risk Management is a forecasting model and a systematic process of assessment, control and communication. 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