{"id":10519,"date":"2021-10-04T09:09:09","date_gmt":"2021-10-04T07:09:09","guid":{"rendered":"https:\/\/www.s4bt.it\/writing-effective-procedures\/"},"modified":"2021-12-03T12:07:34","modified_gmt":"2021-12-03T11:07:34","slug":"writing-effective-procedures","status":"publish","type":"post","link":"https:\/\/www.s4bt.it\/en\/writing-effective-procedures\/","title":{"rendered":"6 Tips for writing effective procedures (and reducing the number of deviations)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10519\" class=\"elementor elementor-10519 elementor-1308\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-20ad2410 elementor-section-height-min-height elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"20ad2410\" 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-4b4594b9\" data-id=\"4b4594b9\" 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-55e7760c elementor-widget elementor-widget-heading\" data-id=\"55e7760c\" 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-466f7383 elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"466f7383\" 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-40978c2e elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"40978c2e\" 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\">6 Tips for writing effective procedures (and reducing the number of deviations)<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b1857c3 elementor-hidden-phone elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"b1857c3\" 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\">6 Tips for writing effective procedures (and reducing the number of deviations)<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-66cb2c5f elementor-widget elementor-widget-post-info\" data-id=\"66cb2c5f\" 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-571bfb53 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"571bfb53\" 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-7df84222\" data-id=\"7df84222\" 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-654d5528 elementor-widget elementor-widget-text-editor\" data-id=\"654d5528\" 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>Can procedures <strong>impact<\/strong> the number of deviations?<\/p><p>Deviations arise when unforeseen events or problems deviate from an approved\u00a0<strong>GMP process<\/strong>\u00a0and\/or from what is required\/accepted in the GMP area.\u00a0<\/p><p>One of the reasons why people deviate from a GMP process is that it is not effectively and clearly explained in the\u00a0<strong>SOP<\/strong>\u00a0. This can cause\u00a0<strong>lack of understanding<\/strong>\u00a0on the part of staff and\u00a0<strong>misinterpretation<\/strong>\u00a0of the process, which can then result in deviations.<\/p><p><strong>How do we write efficient procedures? <\/strong><\/p><p>We have identified 6 useful tips.<\/p><h2>1. Keep four simple concepts in mind:<\/h2><div class=\"wp-block-spacer\" style=\"height: 51px;\" aria-hidden=\"true\">\u00a0<\/div><p><em>Say what you do<\/em>. When writing the SOP, describe what you do and outline the steps taken to achieve compliance with a regulatory requirement.<\/p><p><em>Do what you say<\/em>\u00a0This is equivalent to following the standard procedure.<\/p><p><em>Prove it<\/em>. This means collecting and being able to present data demonstrating that you have followed the instructions in the procedure and have investigated any incidents in which you have deviated from those instructions.<\/p><p><em>Improve it<\/em>. Once you have mastered the first three concepts, you can start working on the concept of &#8220;improvement&#8221; by reviewing and updating your procedures to reflect current practices and process refinements.<\/p><h2>2. Balanced information<\/h2><div class=\"wp-block-spacer\" style=\"height: 51px;\" aria-hidden=\"true\">\u00a0<\/div><p>Writing an SOP with the correct amount of information, neither too restrictive nor too ambiguous, is not an easy task. It takes\u00a0<strong>time and effort<\/strong>\u00a0to create an SOP with the right balance of information.<\/p><p>Procedures should have the correct amount of information for\u00a0<strong>keeping the process under control<\/strong>\u00a0and reducing deviations. An example of an SOP with too much information would be one that lists the serial number of a piece of equipment. If the equipment has to be changed for any reason, this will result in a deviation. An example of ambiguous information is not indicating the specific order in which reagents must be added to generate a reaction. If it is important to add the reagents in a certain order, this information must be specified in the SOP.<\/p><h2>3. Target audience<\/h2><div class=\"wp-block-spacer\" style=\"height: 51px;\" aria-hidden=\"true\">\u00a0<\/div><p>When writing an SOP, it is a good idea to keep in mind the target audience and adapt the\u00a0<strong>language<\/strong>\u00a0to the intended audience. In any event, we should avoid overly technical language in favour of clarity and precision. We should also aim for concise and\u00a0<strong>action-oriented<\/strong> sentences.<\/p><h2>4. Check and measure understanding of an SOP using qualitative and quantitative data.<\/h2><div class=\"wp-block-spacer\" style=\"height: 49px;\" aria-hidden=\"true\">\u00a0<\/div><p>This links back to point 3, namely keeping the audience in mind and checking whether they actually understand the SOP. How do we do this? For instance, by involving the end user in the\u00a0<strong>review<\/strong>\u00a0phase and then analysing\u00a0<strong>quantitative and qualitative data<\/strong>, such as the number and type of wrong answers during training, the implementation of the process described in the SOP on a target group and the number and type of deviations related to the SOP.<\/p><h2>5. Follow clear formatting<\/h2><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><p>Paragraphs that contain too much information are difficult to read. One suggestion is to add an extra paragraph to make the information more user-friendly and to use\u00a0<strong>bullet points<\/strong>, images and graphics to make it even clearer.<\/p><h2>6. Revision History and Current Version<\/h2><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><p>Keep track of the revision history and ensure that the current version of the SOP is available to everyone involved. Obsolete procedures represent\u00a0a very serious error, which can be particularly common in companies that use a\u00a0<strong>paper SOP system<\/strong>. A digital system, on the other hand, automatically blocks the obsolete version, making only the current version available centrally to all staff involved.<\/p><p>References: S. Schniepp, \u201cWriting Effective SOPs,\u201d\u00a0<em>Pharmaceutical Technology<\/em>\u00a044 (10) 2020,\u00a0<a href=\"https:\/\/www.pharmtech.com\/view\/writing-effective-sops\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.pharmtech.com\/view\/writing-effective-sops<\/a><\/p><hr id=\"scopri-pragma\" class=\"wp-block-separator has-text-color has-background is-style-wide\" style=\"background-color: #24d900; color: #24d900;\" \/><h2>Digitise your processes with PRAGMA4U<\/h2><div class=\"wp-block-spacer\" style=\"height: 52px;\" aria-hidden=\"true\">\u00a0<\/div><p><a href=\"https:\/\/pragma4u.it\/?lang=en\" target=\"_blank\" rel=\"noreferrer noopener\">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-236c8e0a\" data-id=\"236c8e0a\" 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-131bbfb5 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"131bbfb5\" 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-6d92a2a3\" data-id=\"6d92a2a3\" 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-1f94354d elementor-align-center elementor-widget elementor-widget-button\" data-id=\"1f94354d\" 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-3ccdd8e8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3ccdd8e8\" 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-75c9296b\" data-id=\"75c9296b\" 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-58d74238 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"58d74238\" 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-e681489 elementor-widget elementor-widget-text-editor\" data-id=\"e681489\" 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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aria-hidden=\"true\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\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\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>BLOG Can procedures impact the number of deviations? Deviations arise when unforeseen events or problems deviate from an approved\u00a0GMP process\u00a0and\/or from what is required\/accepted in the GMP area.\u00a0 One of the reasons why people deviate from a GMP process is that it is not effectively and clearly explained in the\u00a0SOP\u00a0. This can cause\u00a0lack of understanding\u00a0on [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10526,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_canvas","format":"standard","meta":{"footnotes":""},"categories":[44],"tags":[],"class_list":["post-10519","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>6 Tips for writing effective procedures (and reducing the number of deviations)<\/title>\n<meta name=\"description\" content=\"Procedures can affect the number of deviations when a process is not described in a clear and understandable way. 6 tips\" \/>\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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