{"id":10336,"date":"2021-09-20T10:49:17","date_gmt":"2021-09-20T08:49:17","guid":{"rendered":"https:\/\/www.s4bt.it\/gestione-deviazioni-di-processo-change-control-capa\/"},"modified":"2026-02-02T09:10:45","modified_gmt":"2026-02-02T08:10:45","slug":"management-of-process-deviation-change-control-capa","status":"publish","type":"page","link":"https:\/\/www.s4bt.it\/en\/projects\/management-of-process-deviation-change-control-capa\/","title":{"rendered":"Management of Process Deviation, Change Control, CAPA"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"10336\" class=\"elementor elementor-10336 elementor-4881\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-44ba3faa elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"44ba3faa\" 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-faaf5f7\" data-id=\"faaf5f7\" 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-4e703ddf elementor-widget elementor-widget-heading\" data-id=\"4e703ddf\" 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\">PROJECTS<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-361ac9c0 elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"361ac9c0\" 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-77ca4610 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"77ca4610\" 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\">Management of Process Deviation, Change Control, CAPA<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d72f8f2 elementor-widget elementor-widget-text-editor\" data-id=\"6d72f8f2\" 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><strong>Client: <\/strong>well-known pharmaceutical multinational<\/p>\n<p><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\"><strong>Sector:<\/strong> Pharmaceuticals<\/span><\/p>\n<p><strong>Objective:<\/strong> To support the &#8220;Quality Assurance&#8221; department in the management of Process<br \/>Deviations, Change Control and CAPA (Corrective Actions Preventive Actions)<\/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-a5ab22e elementor-widget elementor-widget-heading\" data-id=\"a5ab22e\" 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\">Project<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6982f2ec elementor-widget elementor-widget-text-editor\" data-id=\"6982f2ec\" 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>Due to a peak in workload, the client company needed specific support in the area of Quality Assurance to manage the following processes:<\/p>\n<ul>\n<li>Process Deviation<\/li>\n<li>Change control<\/li>\n<li>CAPA (Corrective and Preventive Actions)<\/li>\n<\/ul>\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-1ccf7fc0 elementor-widget elementor-widget-heading\" data-id=\"1ccf7fc0\" 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\">Our contribution<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37554df7 elementor-widget elementor-widget-text-editor\" data-id=\"37554df7\" 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 project involved S4BT Consultants with proven experience in Quality Assurance acquired in a number of sectors, including chemical and microbiological. <\/p>\n<p>After an initial <b>analysis <\/b>phase of the client&#8217;s business processes, part of Team focused on <b>reducing <\/b>process <b>deviations <\/b>already <b>open<\/b>, actively collaborating with the entire company organisation to obtain the necessary information and to process the related reports in accordance with internal client procedures. <\/p>\n<p>The focus later shifted to<b> new deviations.<\/b><\/p>\n<p>By participating in the implementation of a targeted survey plan, through effective CAPAs, the team contributed to the achievement of two important objectives:<\/p>\n<ul>\n<li>closure of investigations within the established deadlines<\/li>\n<li>decrease in Root Causes of the most commonly encountered problems<\/li>\n<\/ul>\n<p>The resources involved in the management of <b>Change Control and<\/b> CAPA <span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">collaborated with the relevant departments for the following activities:<\/span><\/p>\n<ul>\n<li>preparation of reports and documentation necessary for the correct management and closure of activities<\/li>\n<li>drafting of operating procedures<\/li>\n<li>intensive monitoring of production<\/li>\n<\/ul>\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-9e4b97b elementor-widget elementor-widget-heading\" data-id=\"9e4b97b\" 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\">Result<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7d2b0c5e elementor-widget elementor-widget-text-editor\" data-id=\"7d2b0c5e\" 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>Already during the first phases of the project, the client company achieved two fundamental results:<\/p>\n<ul>\n<li>total <b>elimination<\/b> of the number of <b>deviations <\/b>not closed within the established times<\/li>\n<li>30% increase in the number of new closed Deviations without extension<\/li>\n<\/ul>\n<p>The contribution of the S4BT Specialists in the management of Change Control and CAPA activities proved to be fundamental, making it possible to:<\/p>\n<ul>\n<li>lighten the workload of the client&#8217;s internal Resources (who were able to focus more on routine production activities)<\/li>\n<li>reduce the time necessary for the correct management (and closing) of Change Controls<\/li>\n<li>implement truly effective CAPAs<\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6ba7e05e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6ba7e05e\" 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-66ac8e56\" data-id=\"66ac8e56\" 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-395cdfa4 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"395cdfa4\" 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\">read about other projects<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-737ccf80 elementor-widget elementor-widget-text-editor\" data-id=\"737ccf80\" 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<ul><li><a href=\"https:\/\/www.s4bt.it\/en\/projects\/new-product-introduction-manufacturing-process\/\"><em>Introduction of a new product on an industrial scale<\/em><\/a><\/li><li><a class=\"row-title\" href=\"https:\/\/www.s4bt.it\/en\/projects\/technology-transfer-of-the-manufacturing-process\/\" aria-label=\"\u201cTransfer Tecnologico del processo di Manifattura di un prodotto solido orale\u201d (Modifica)\">Technology transfer of the manufacturing process for a solid oral product<\/a><\/li><\/ul>\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-461976f1 elementor-absolute elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"461976f1\" 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\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-524fb5f5\" data-id=\"524fb5f5\" 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-2c7ca536 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"2c7ca536\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:4876,&quot;url&quot;:&quot;https:\\\/\\\/www.s4bt.it\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/almighty-pill.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\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-7d6791ce\" data-id=\"7d6791ce\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:4876,&quot;url&quot;:&quot;https:\\\/\\\/www.s4bt.it\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/almighty-pill.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-12f46125 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"12f46125\" 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\/attivita-di-consulenza-e-validazione\/quality-regulatory-s4bt-consulting\/\">\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\">QUALITY &amp; REGULATORY<\/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-6c97fd0c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6c97fd0c\" 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-2614c702\" data-id=\"2614c702\" 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-3de6059 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"3de6059\" 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\">consulting services acquired by the client company<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c06b6b0 elementor-widget elementor-widget-text-editor\" data-id=\"3c06b6b0\" 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<ul><li><a href=\"https:\/\/www.s4bt.it\/en\/consulting\/quality-regulatory\/\">Deviation management<\/a><\/li><li><a href=\"https:\/\/www.s4bt.it\/en\/consulting\/quality-regulatory\/\">Change Control Management<\/a><\/li><li><a href=\"https:\/\/www.s4bt.it\/en\/consulting\/quality-regulatory\/\">CAPA management<\/a><\/li><\/ul>\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-5a403f85 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"5a403f85\" 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\">REQUEST MORE INFORMATION<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-644b9c4 elementor-widget elementor-widget-html\" data-id=\"644b9c4\" data-element_type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>@import url(https:\/\/fonts.bunny.net\/css?family=poppins:400,700);<\/style>\n<style>\n#_form_46_{font-size:14px;line-height:1.6;font-family:arial, helvetica, 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>\n      <label for=\"field[25]\" class=\"_form-label\">\n        How can we help?*\n      <\/label>\n      <div class=\"_field-wrapper\">\n        <select name=\"field[25]\" id=\"field[25]\" required>\n          <option selected>\n          <\/option>\n          <option value=\"Validation and Qualification Consulting\" >\n            Validation and Qualification Consulting\n          <\/option>\n          <option value=\"Project Management\" >\n            Project Management\n          <\/option>\n          <option value=\"Quality and Regulatory\" >\n            Quality and Regulatory\n          <\/option>\n          <option value=\"Other information\" >\n            Other information\n          <\/option>\n        <\/select>\n      <\/div>\n    <\/div>\n    <div class=\"_form_element _x10568941 _full_width \" >\n      <label for=\"field[6]\" class=\"_form-label\">\n        Message*\n      <\/label>\n      <div class=\"_field-wrapper\">\n        <textarea id=\"field[6]\" name=\"field[6]\" placeholder=\"Please leave us a message\"  required><\/textarea>\n      <\/div>\n    <\/div>\n    <div class=\"_form_element _x49521979 _full_width \" >\n      <fieldset class=\"_form-fieldset\">\n        <div class=\"_row\">\n          <legend for=\"field[22][]\" class=\"_form-label\">\n          <\/legend>\n        <\/div>\n        <input data-autofill=\"false\" type=\"hidden\" id=\"field[22][]\" name=\"field[22][]\" value=\"~|\">\n        <div class=\"_row _checkbox-radio\">\n          <input id=\"field_22I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)\" type=\"checkbox\" name=\"field[22][]\" value=\"I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)\"   required>\n          <span>\n            <label for=\"field_22I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)\">\n              I have read the Privacy 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