{"id":10506,"date":"2021-10-04T09:09:05","date_gmt":"2021-10-04T07:09:05","guid":{"rendered":"https:\/\/www.s4bt.it\/the-management-of-deviations\/"},"modified":"2023-07-17T09:41:41","modified_gmt":"2023-07-17T07:41:41","slug":"the-management-of-deviations","status":"publish","type":"post","link":"https:\/\/www.s4bt.it\/en\/the-management-of-deviations\/","title":{"rendered":"Reducing the impact of Deviations and simplifying their management using digital technology"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10506\" class=\"elementor elementor-10506 elementor-1319\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-718f17d elementor-section-height-min-height elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"718f17d\" 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-745f6a04\" data-id=\"745f6a04\" 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-3e5a605f elementor-widget elementor-widget-heading\" data-id=\"3e5a605f\" 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-7ff8c360 elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"7ff8c360\" 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-4746cf72 elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"4746cf72\" 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\">Reducing the impact of Deviations and simplifying their management using digital technology<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98a0d0b elementor-hidden-phone elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"98a0d0b\" 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\">Reducing the impact of Deviations and simplifying their management using digital technology<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34260ef2 elementor-widget elementor-widget-post-info\" data-id=\"34260ef2\" 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-60a85018 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"60a85018\" 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-754c2c11\" data-id=\"754c2c11\" 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-2e81857 elementor-widget elementor-widget-text-editor\" data-id=\"2e81857\" 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>Deviations are very frequent within Life Science companies, arising when\u00a0<strong>unforeseen events or problems deviate from an approved GMP process<\/strong>\u00a0and\/or from what is required\/accepted in terms of GMP.<\/p><p>Deviations have a significant impact on the entire corporate system. They can\u00a0<strong>result in the blocking or rejection of entire batches<\/strong>, lead to several departments being involved in investigations and generate CAPAs with actions that cascade throughout the company.<\/p><p>They also require \u00a0<strong>very careful management<\/strong>\u00a0because they can affect the identity, strength, quality, purity, safety, efficacy, performance, reliability or durability of a drug or device. This is another reason why deviations receive\u00a0a lot of attention during <strong>inspections<\/strong>\u00a0.<\/p><p>Each unforeseen event or problem must therefore be\u00a0<strong>documented, evaluated and, where necessary,<\/strong>\u00a0investigated in order to determine its causes and avoid any recurrence.<\/p><p>In the following paragraphs, we will outline\u00a0<strong>useful tools and approaches for reducing the impact of deviations<\/strong>\u00a0and simplifying their management using a digital system.<a>Interesting question: Are Non-Compliances and Deviations the same thing?<\/a><\/p><h2>Tools and approaches to lessen the impact of deviations<\/h2><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><p>As we have said, deviations can impact the production of drugs and devices, can be detected by anyone in the company and the resulting actions can affect every department.<\/p><p>Keeping track of the\u00a0<strong>number of deviations<\/strong>\u00a0and seeking to reduce them is paramount for the\u00a0<strong>productivity<\/strong>\u00a0and\u00a0<strong>efficiency<\/strong>\u00a0of the company. Shifting from a reactive to a proactive approach improves the quality control system, reduces costs and increases company productivity.<\/p><p>The\u00a0<strong>Quality risk management<\/strong>\u00a0tool is required to support quality processes by an increasing number of inspection bodies. This is complemented by an <strong>in-depth analysis of Trends<\/strong>, as well as an increased\u00a0<strong>focus on staff training<\/strong>.<\/p><p>As far as deviation management is concerned, the complex task of keeping track of all activities, deadlines and documents produced can be reduced by using a \u00a0<strong>digital system\u00a0<\/strong>, which provides essential support to QA Compliance for the execution and supervision of the process.<\/p><h2>Quality Risk Management and Deviations<\/h2><div class=\"wp-block-spacer\" style=\"height: 52px;\" aria-hidden=\"true\">\u00a0<\/div><p>Quality Risk Management (QRM) as a strategic, systemic and documented approach to risk management has become a key requirement for modern GMP and is recommended by\u00a0<strong>international standards such as WHO or ICH Q9<\/strong>.<\/p><p>An efficient deviation management system should implement a mechanism to\u00a0<strong>differentiate events based on their relevance<\/strong>\u00a0and objective categorisation, thus focusing resources and efforts on only investigating the root causes of relevant deviations.<\/p><p>Even a robust CAPA system depends on efficient deviation management upstream, which assesses the event according to the associated risk, classifies it and acts accordingly and in a timely manner, checking the effectiveness of the actions taken.<\/p><p>QRM, as a formal or informal tool applied to deviations, offers the ability to\u00a0<strong>determine the impact of a deviation on a process or product in an objective manner<\/strong>, so as to categorise and facilitate its management. ICH Q9 recommends using this approach for different purposes, such as identifying root causes and corrective actions during OOS investigations, complaints, quality defects, deviations, trends, etc.<\/p><p>In the\u00a0document\u00a0&#8220;Deviation Handling and Quality Risk Management&#8221;, the\u00a0<strong>World Health Organisation<\/strong>, proposes a possible strategy for using QRM to differentiate non-significant events that have no impact on product quality from events that violate standards and procedures and deviations with a probable impact on product quality.<\/p><p><strong>MORE INFO<\/strong>\u00a0<a href=\"https:\/\/www.s4bt.it\/en\/tools-advice-quality-risk-management\/\" target=\"_blank\" rel=\"noreferrer noopener\">Tools and advice to make the best use of Quality Risk Management<\/a><a>Interesting question: Who initiates deviations? Centralised vs decentralised initiation<\/a><\/p><h2>Human error and Staff Training<\/h2><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><p>Human error is one of the most frequent causes of deviations. The employee was given the procedure, maybe even trained and qualified, but nothing came of it.\u00a0<em>Errare Humanum Est (To err is Human)<\/em>. Most of the time they are assigned a\u00a0<strong>CAPA action retraining course<\/strong>.<\/p><p>However, many procedures, training courses or processes are not well understood by staff and often even retraining is not sufficient to prevent recurrence. There might also be\u00a0<strong>other causes behind human error<\/strong>, such as a process that is not designed to prevent error or an environment that hinders optimal staff performance.\u00a0<\/p><p>One suggestion is\u00a0<strong>to delve into the root cause<\/strong>\u00a0of human error by going beyond simple retraining.<\/p><p>With regard to the latter in particular, it is also important to assess the effectiveness of training. Here are some\u00a0<strong>questions<\/strong>\u00a0that might be useful:<\/p><ul><li>Does the training reflect the content of the procedure? Do the operators and staff all perform the tasks in the same way?<\/li><li>Did the staff member perform the task alone the first time?<\/li><li>Did the staff member practice the task enough, or was the training quick?<\/li><li>Was the training time used for appropriate training activities?<\/li><li>Did the trainer check the staff member&#8217;s ability to perform each required part of the task? According to what standard?<\/li><li>Can the staff member freely access the information needed to perform the task?<\/li><li>Did the trainer show the staff member how to correctly perform the task? Does the trainer have the knowledge and skills required to teach?\u00a0<\/li><\/ul><p>Another suggestion is to also review the\u00a0<strong>reference procedure<\/strong>:<\/p><ul><li>Does the procedure have a clear, simple description of the actions?\u00a0<\/li><li>Could there be errors or ambiguities,\u00a0 or could the procedure be inadequate and impossible to perform?<\/li><\/ul><h2>Management of deviations with a digital system<\/h2><div class=\"wp-block-spacer\" style=\"height: 49px;\" aria-hidden=\"true\">\u00a0<\/div><p>Managing deviations along with other processes in a\u00a0<strong>single digital system<\/strong>\u00a0is now a necessary measure for quality control in the company, in order to keep processes under control and to avoid unpleasant situations in the event of an inspection.<\/p><p>Companies that choose the path of a digital system for the management of deviations and other processes can also count on the availability of a large amount of data, to carry out\u00a0<strong>in-depth analysis<\/strong>, cross-referencing, measuring performance indices and improving risk calculation from historical data, as well as for structuring targeted strategies and preventive actions.<\/p><hr class=\"wp-block-separator has-text-color has-background is-style-wide\" style=\"background-color: #24d900; color: #24d900;\" \/><h2>PRAGMA4U<\/h2><p><a href=\"https:\/\/pragma4u.it\/platform\/?lang=en\">PRAGMA4U<\/a>\u00a0is a\u00a0<strong>modular<\/strong>\u00a0and\u00a0<strong>scalable<\/strong>\u00a0Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.<\/p><p>It enables companies to: have\u00a0<strong>documentation<\/strong>\u00a0that is protected, always up-to-date, organised and linked to the source processes; assign and implement\u00a0work<strong>activities<\/strong>\u00a0directly on the platform; easily share information between departments; keep\u00a0processes under <strong>control<\/strong>\u00a0using KPIs; and compile\u00a0<strong>reports<\/strong>\u00a0 and\u00a0<strong>dossiers<\/strong>\u00a0 that will be useful\u00a0for <strong>inspections<\/strong>.<\/p><p>The platform can contain multiple processes, creating a true\u00a0<strong>digital map of the company<\/strong>. It also integrates with other systems, such as\u00a0<strong>ERP,<\/strong>\u00a0simplifying 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-604c109c\" data-id=\"604c109c\" 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-17b31087 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"17b31087\" 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-704e4b80\" data-id=\"704e4b80\" 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-60238a10 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"60238a10\" 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-26869298 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"26869298\" 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-1a8881b6\" data-id=\"1a8881b6\" 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-17bc58d5 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"17bc58d5\" 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-82fa3ab elementor-widget elementor-widget-text-editor\" data-id=\"82fa3ab\" 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. Tools and techniques for optimising the process<\/em><\/a><\/p>\n<p><em><a href=\"https:\/\/www.s4bt.it\/change-control-digitalizzazione\/\">The challenges of Change Control: sharing, documentation, training and digitisation<\/a><\/em><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18fc967b elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-heading\" data-id=\"18fc967b\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Subscribe to our newsletter<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-adf3c6d elementor-absolute elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"adf3c6d\" data-element_type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" 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\">\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-7f69fe46 elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"7f69fe46\" 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>Increase your knowledge, join a community of professionals and stay up to date each week on the latest industry news.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-11a11475 elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile 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Deviations have a significant impact on the entire corporate system. They can\u00a0result in the blocking or rejection of entire batches, lead to several departments being involved in [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10021,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[27,26],"tags":[],"class_list":["post-10506","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>Simplifying deviation management in Life Science companies<\/title>\n<meta name=\"description\" content=\"Deviation management is very common in Life Science companies. 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