{"id":10539,"date":"2021-10-04T09:09:15","date_gmt":"2021-10-04T07:09:15","guid":{"rendered":"https:\/\/www.s4bt.it\/complaints-management\/"},"modified":"2021-12-03T11:44:57","modified_gmt":"2021-12-03T10:44:57","slug":"complaints-management","status":"publish","type":"post","link":"https:\/\/www.s4bt.it\/en\/complaints-management\/","title":{"rendered":"Complaints as an opportunity for continuous improvement for Life Science companies"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10539\" class=\"elementor elementor-10539 elementor-1350\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3104215c elementor-section-height-min-height elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"3104215c\" 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-160a0437\" data-id=\"160a0437\" 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-439e204d elementor-widget elementor-widget-heading\" data-id=\"439e204d\" 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-16e9b8ca elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"16e9b8ca\" 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-2a6e73b elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"2a6e73b\" 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\">Complaints as an opportunity for continuous improvement for Life Science companies<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-72e86082 elementor-hidden-phone elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"72e86082\" 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\">Complaints as an opportunity for continuous improvement for Life Science companies<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-791239bd elementor-widget elementor-widget-post-info\" data-id=\"791239bd\" 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-64550cb7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"64550cb7\" 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-398ace9c\" data-id=\"398ace9c\" 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-469f8a65 elementor-widget elementor-widget-text-editor\" data-id=\"469f8a65\" 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 <strong>complaint<\/strong> from an end or intermediate <strong>customer<\/strong> may occur when something goes wrong and a <strong>defect<\/strong> is found in the product or service.<\/p><p>Complaints can concern <strong>any aspect<\/strong> of the drug or device, from a packaging defect to an unexpected reaction during use.<\/p><p>Complaint Management is part of the <strong>Good Manufacturing Practice<\/strong> (GMP) and is subject to inspection by regulatory bodies. It therefore requires a great deal of attention and adequate <strong>documentation<\/strong>.<\/p><p>Beyond this regulatory aspect, however, complaints management can also represent a <strong>competitive opportunity<\/strong> for Life Science companies. Through the Quality Risk Management approach, companies can put in place a robust and dynamic quality control system.<\/p><p>Moreover, the <strong>transversal management<\/strong> of complaints throughout the company can lead, with the support of digital systems, to greater awareness and involvement of internal stakeholders in a process of continuous improvement towards the quality and <strong>productivity<\/strong> of the company.<\/p><h2>Handling complaints<\/h2><p>Complaint management, as we have said, requires a lot of attention, a robust quality control system and supporting documentation. This enables comprehensive <strong>investigations<\/strong> to be carried out in order to achieve, if the defect is confirmed, prompt corrective action, such as withdrawing the entire batch from the market, and preventing problems from recurring in the future.<\/p><p>Complaints management is also subject to <strong>inspections<\/strong> by regulatory bodies. In spite of the existing guidelines outlining the way forward, there are still many Warning Letters issued by the FDA for poor complaint management.<\/p><p>Receiving and managing a complaint is the responsibility of the <strong>Quality Assurance<\/strong> department, which acts as a bridge for external stakeholders, to whom it must provide a response regarding the complaint, and for internal stakeholders, who it must interview and involve, especially during the investigation phase, in order to determine the <strong>root cause<\/strong> of the problem and organise response activities.<\/p><h2>Continuous improvement through digital technology<\/h2><p>Having centralised and organised documentation greatly <strong>facilitates<\/strong> the investigation phase of the complaint. This phase is divided into two parts: Document Analysis and Laboratory Investigation.<\/p><p>In analysing the documents, the QA team checks whether there have been <strong>previous complaints<\/strong> about the same batch and, if so, what the response was. If there have been no complaints, QA checks <strong>batch records<\/strong> for a <strong>deviation<\/strong> or <strong>non-compliance<\/strong> and then proceeds in greater depth to trace the root cause for a confirmed complaint or declare it unconfirmed. The investigation may also involve external suppliers, in the case of different packaging colour, for example, the root cause may be found in the supplier&#8217;s production process.<\/p><p>Having a <strong>centralised digital system<\/strong> for the whole company means that it is possible to trace back the <strong>related processes<\/strong> and all the documentation produced together with the owners and activities carried out, simply by searching for the batch number. This drastically <strong>reduces<\/strong> the <strong>search time<\/strong>, and at the same time, also increases compliance. With a centralised digital system, the documentation produced for the complaint remains archived and protected, accessible to authorised persons for potential requests during inspections and future investigations, as well as <strong>facilitating<\/strong> the final response to the customer and the <strong>extraction of KPIs<\/strong>.<\/p><p>Another <strong>difficulty<\/strong> that a digital system solves is the direct involvement of departments with assigned tasks. Indeed, there is often a tendency to rely solely on the Quality Assurance department to carry out the complaints process, when it actually concerns the whole company in terms of both cooperation during the investigation phase and any subsequent <strong>corrective and preventive action<\/strong>.<\/p><p>An opportunity for improvement here lies in the <em>accountability<\/em> of the whole company to the quality control system.<\/p><h2>Risk Management as a Product Lifecycle Document<\/h2><p>Using risk-based management to handle complaints can provide an opportunity for continuous improvement. When we <strong>launch a product<\/strong> we also create a risk management document containing the <strong>probability<\/strong> and <strong>severity<\/strong> of potential incidents that could occur when the product is on the market.<\/p><p>When we receive a complaint or even feedback, in addition to managing it, it is important to go back to that document and discuss with the people involved whether elements have been underestimated, overestimated or not considered. This discussion may, for example, reveal the need for further action beyond complaint management, such as opening a Change, conducting a new <strong>assessment<\/strong> re-evaluating the likelihood and severity of a risk or, perhaps, raising awareness of a particular process within the company.<\/p><p>The risk management document can become a true <strong>product lifecycle document<\/strong> that continuously strengthens and improves the system and the product.<\/p><p>In short, a <strong>living and dynamic document<\/strong> available to all departments concerned, not only those involved in the operational phase, but also for <strong>Top Management<\/strong> analysis.<\/p><h2>\u00a0<\/h2><h2>Digitise complaints using a Workflow Management System<\/h2><p>A <strong>Workflow Management System<\/strong> digitises business processes, bringing what happens in the offline world into a protected digital environment, where tasks can be assigned directly to owners and executed\/recorded on the system to advance the process.<\/p><p>The advantage is that there is <strong>general monitoring<\/strong> of the process and its progress, with centralised and activity-related documentation.<\/p><p>Additionally, people are <strong>empowered<\/strong> and and directly involved in the activities, with deadlines and follow-up notifications that reduce the possibility of delays.<\/p><p>Two other major advantages are its integration with other complaint-related processes, such as <strong>CAPA<\/strong>, and with other systems, such as <strong>ERP<\/strong>, which provide up-to-date data on products.<\/p><p>Finally, a digital system allows you to extract <strong>dossiers<\/strong>, <strong>reports<\/strong> and <strong>KPIs<\/strong> for:<\/p><ul><li>giving a response to the customer, including the actions put in place by the company to address the complaint;<\/li><li>providing complete documentation during an inspection;<\/li><li>and constantly monitoring trends and performance in order to implement supporting actions.<\/li><\/ul><div class=\"wp-block-spacer\" style=\"height: 44px;\" aria-hidden=\"true\">\u00a0<\/div><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\" 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-3bfa9631\" data-id=\"3bfa9631\" 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-6206115a elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"6206115a\" 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-417f73b8\" data-id=\"417f73b8\" 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-62668a17 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"62668a17\" 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-6e202de8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6e202de8\" 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-2ae9a84d\" data-id=\"2ae9a84d\" 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-6d590560 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"6d590560\" 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-c337059 elementor-widget elementor-widget-text-editor\" data-id=\"c337059\" 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\/en\/management-of-capa\/\"><em>Discovering CAPA. 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Complaints can concern any aspect of the drug or device, from a packaging defect to an unexpected reaction during use. Complaint Management is part of the Good Manufacturing Practice (GMP) [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10560,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[44],"tags":[],"class_list":["post-10539","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-science-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Complaints as a competitive opportunity for Life Science companies<\/title>\n<meta name=\"description\" content=\"Using risk-based management to handle complaints can provide an opportunity for company-wide improvement.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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