{"id":10518,"date":"2021-10-04T09:09:09","date_gmt":"2021-10-04T07:09:09","guid":{"rendered":"https:\/\/www.s4bt.it\/10-tips-an-effective-internal-audit\/"},"modified":"2021-12-03T11:47:00","modified_gmt":"2021-12-03T10:47:00","slug":"10-tips-an-effective-internal-audit","status":"publish","type":"post","link":"https:\/\/www.s4bt.it\/en\/10-tips-an-effective-internal-audit\/","title":{"rendered":"10 tips (+1) for an effective Internal AUDIT"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10518\" class=\"elementor elementor-10518 elementor-1346\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-39941ac5 elementor-section-height-min-height elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"39941ac5\" 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-22cd5bc6\" data-id=\"22cd5bc6\" 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-12338ea2 elementor-widget elementor-widget-heading\" data-id=\"12338ea2\" 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-312fa18 elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"312fa18\" 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-77099955 elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"77099955\" 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\">10 tips (+1) for an effective Internal AUDIT<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c21b074 elementor-hidden-phone elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"c21b074\" 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\">10 tips (+1) for an effective Internal AUDIT<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-49b67ac8 elementor-widget elementor-widget-post-info\" data-id=\"49b67ac8\" 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-6cf78333 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6cf78333\" 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-940a54d\" data-id=\"940a54d\" 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-4efe0483 elementor-widget elementor-widget-text-editor\" data-id=\"4efe0483\" 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>The Audit is a fundamental process within a company concerned with quality because it allows the risks associated with compliance to be identified and the most appropriate corrective and preventive action to be taken.<\/p><p>Internal audits are carried out periodically and systematically within the Life Science company and allow an objective assessment of whether an activity complies with a specific standard.<\/p><p>Internal Audit Regulations and Guidelines:<\/p><p><strong>Pharmaceutical<\/strong><\/p><ul><li><a href=\"https:\/\/ec.europa.eu\/health\/documents\/eudralex\/vol-4_en\">Eudralex Volume IV<\/a>\u00a0&#8211; Chapter 1, 9 &#8211; Annex 16<\/li><li><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-q-7-good-manufacturing-practice-active-pharmaceutical-ingredients-step-5_en.pdf\">ICH Q7 Good manufacturing practice for active pharmaceutical ingredients<\/a><\/li><li><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/good-manufacturing-practices\/guidance-documents\/gmp-guidelines-0001.html\">Canadian Good Manufacturing Practice Guideline<\/a><\/li><li>Japanese GMP Regulations<\/li><\/ul><p><strong>Medical Devices<\/strong><\/p><ul><li>FDA CFR 820<\/li><\/ul><h2>10 Tips for carrying out an effective internal Audit<\/h2><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><p>1-\u00a0<strong>Frequency and Priority<\/strong>. Adopt a risk-based approach to the frequency and priority of audits. Have a minimum frequency for each area to ensure none are overlooked. In assessing frequency and priority, consider also the complexity of the operational activities and the severity of the risk to the patient and product in the area being inspected.<\/p><p>2-\u00a0<strong>Training and Skills Updates<\/strong>. Train your audit team and keep them constantly updated on regulatory changes, observations received from external inspections, quality indicators (number of deviations, NC, etc.) for inspected sections, significant changes in processes, organisational changes in the section, assessments and risk areas. In the latter case, the use of a digital tool for centralised Quality Risk Management throughout the company helps to provide a comprehensive and up-to-date overview of the company.<\/p><p>3-\u00a0<strong>Planning<\/strong>. Prepare a periodic audit programme, including who the auditor will be, the topics, processes and section of the company to be audited. Internal audits are carried out under the following circumstances: in accordance with the annual internal audit plan; for a specific reason; in preparation for a regulatory inspection; whenever required by management.<\/p><p>NB. Management of Internal Audits requires independence between the qualified inspector and the activity being audited.<\/p><p>4-\u00a0<strong>Preparation<\/strong>. Once the audit programme has been planned, it should be communicated to the sections concerned well in advance. This will allow possible changes to be planned, as well as giving the section concerned the opportunity to prepare for the internal audit. The Lead Auditor should prepare and share an agenda that includes a list of records, processes and systems to be reviewed and a review of any open CAPAs arising from previous internal audits or external inspections with any changes made within the section.<\/p><p>5-\u00a0<strong>Launch<\/strong>. If possible, organise a launch meeting with all operational sections at the start of the audit. An internal audit should not take the same form as an audit carried out by a regulatory authority. An internal audit should be a collaboration between the audited function and the auditor. It should be an open, honest, collaborative learning forum where operational sections have the opportunity to openly discuss concerns and problem areas.<\/p><p>6-\u00a0<strong>Collaboration<\/strong>. During the internal audit, auditors should be direct and avoid questions that mislead people. Internal audits are an opportunity to instruct staff, explaining why certain questions are being asked and providing a regulatory explanation of the review being conducted. It is also important to listen carefully to staff responses and to adopt a friendly, non-confrontational tone with them.\u00a0<\/p><p>7-\u00a0<strong>Participation<\/strong>. The people directly responsible for carrying out the operations usually have a deeper insight into what is going on and what needs to be improved. This is why it is essential to involve them in the internal audit process, so that critical issues come to light during the inspection and are not overlooked.<\/p><p>8-\u00a0<strong>Conclusion<\/strong>. Organise a wrap-up meeting at the end of the audit to take stock of the situation and the next steps. There should be no surprises at this meeting, as all observations should already have been discussed during the day.\u00a0<\/p><p>9 &#8211;\u00a0<strong>Documentation<\/strong>. All documentation produced in connection with conducting the audit (audit plan, audit report, follow-up, etc.) must be organised, filed and always available, whether on paper or in digital form. It may also be required during the regulatory inspection.<\/p><p>10-\u00a0<strong>Monitoring <\/strong>. Internal audit observations may result in corrective and preventive actions that are not always easy to monitor and track, not least because it may take months before tasks are completed. We recommend using a digital system that monitors and sends notifications and alerts to the persons in charge of the tasks and that allows the Audit to be concluded only when all tasks have been completed.<\/p><p>11\u00a0<strong>Report<\/strong>. At the end of the audit, the Lead Auditor shall draw up a report, with the assistance of the Audit Team. The report should be shared with the team, managers of the departments involved (always including the QA manager), the plant manager and the person in charge.<\/p><h2>Audit management with a digital system<\/h2><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><p>Managing the audit process with a digital system allows you to:<\/p><ul><li>log internal and external audits received and carried out;<\/li><li>continuously keep track of the progress of Observations generated throughout their life cycle;<\/li><li>monitor the processes and tasks resulting from the observations, such as CAPA, non-compliance, Change Control, etc;<\/li><li>send follow-up notifications to the people in charge in order to finish the tasks;<\/li><li>conclude the Audit only when all actions to resolve observations have been completed;<\/li><li>track and monitor the impacts of audits on processes and the organisation;<\/li><li>archive and organise the documentation produced (audit plan, audit report, follow up, wrap-up documents) and make it available if requested during the audit;<\/li><li>draw up and keep track of the Action Plan needed to resolve deficiencies;<\/li><li>create a strong link between Processes: for example, a dedicated system allows a CAPA, Change or Non-Compliance process to be initiated directly from an Audit.<\/li><\/ul><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><h2>PRAGMA4U<\/h2><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><p><a href=\"https:\/\/pragma4u.it\/platform\/?lang=en\" target=\"_blank\" rel=\"noreferrer noopener\">PRAGMA-WFM<\/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-4472f6ea\" data-id=\"4472f6ea\" 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-167bac39 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"167bac39\" 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-7358852b\" data-id=\"7358852b\" 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-61af274e elementor-align-center elementor-widget elementor-widget-button\" data-id=\"61af274e\" 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-18878b20 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"18878b20\" 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-478d1f5e\" data-id=\"478d1f5e\" 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-a7f8109 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"a7f8109\" 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-bfedd08 elementor-widget elementor-widget-text-editor\" data-id=\"bfedd08\" 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-277f890 elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-heading\" data-id=\"277f890\" 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-139bffcc elementor-absolute elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"139bffcc\" 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-3387fb68 elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"3387fb68\" 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-62aab16f elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile 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Internal audits are carried out periodically and systematically within the Life Science company and allow an objective assessment of whether [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10533,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[44],"tags":[],"class_list":["post-10518","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>10 tips (+1) for an effective Internal AUDIT<\/title>\n<meta name=\"description\" content=\"Internal audits are a vital process for a company committed to quality. 10 tips for doing it effectively.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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