{"id":7654,"date":"2024-01-10T04:26:07","date_gmt":"2024-01-10T04:26:07","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7654"},"modified":"2024-01-12T20:11:17","modified_gmt":"2024-01-12T20:11:17","slug":"mdsap-impacts-ra-and-qa","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/mdsap-impacts-ra-and-qa\/","title":{"rendered":"MDSAP Mock Audits &#8211; Getting QA and RA on the Same Page"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7654\" class=\"elementor elementor-7654\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\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-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&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-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\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-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/10\/\">\n\t\t\t\t\t\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\tJanuary 10, 2024\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<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">MDSAP Mock Audits - Getting QA and RA on the Same Page<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"363\" height=\"263\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2017\/06\/4_MDSAP_osam1.png\" class=\"attachment-full size-full wp-image-44\" alt=\"Oriel STAT A MATRIX can help answer your questions about the Medical Device Single Audit Program.\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2017\/06\/4_MDSAP_osam1.png 363w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2017\/06\/4_MDSAP_osam1-300x217.png 300w\" sizes=\"(max-width: 363px) 100vw, 363px\" \/>\t\t\t\t\t\t\t\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-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>As companies grow larger, they often split the responsibilities of QMS management and regulatory compliance. Typically, QA will handle ISO 13485, FDA QSR, product quality, CAPA compliance, and so on. Regulatory tends to manage product registrations, clinical evaluation reports, risk management, and the like. As companies grow, the scope of responsibilities narrows and people in QA and RA don&#8217;t interact as much as they should.<\/p><p><strong>That&#8217;s about to change and it&#8217;s being driven by one thing: MDSAP.<\/strong><\/p><p>As you may know, the\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/mdsap-audit-approach\/\">Medical Device Single Audit Program<\/a> is a cooperative program between the US, Canada, Brazil, Japan, and Australia (but not Europe). The program was established so manufacturers could have their QMS audited once against the QMS requirements of all five markets. Overall, that&#8217;s beneficial for all parties involved, but it does bring new challenges.<\/p><p>\u00a0<\/p><h3>The QMS audit will no longer focus solely on quality<\/h3><p>To get the Medical Device Single Audit Program to satisfy the needs of all five Auditing Organizations, compromises had to be made. The end result is that MDSAP audits have a wider scope that pulls Regulatory into the fray. You will be asked questions related to regulatory compliance, not just QMS compliance. The MDSAP Audit Model requires review of your entire QMS as well as your device registration processes and regulatory notification (Adverse Event) notification systems. For example, a question that might come up is how your regulatory strategy impacts your product design. Other regulatory-related questions are sure to arise. During the audit you can expect a LOT more emphasis on risk, outsourced activities, validation, and change management.<\/p><p>Don\u2019t be surprised if two or three auditors darken your door. In one recent audit attended by Oriel STAT A MATRIX consultants, two FDA auditors and one Heath Canada auditor were present. The number of auditors that show up for your audit &#8220;and the length of the audit&#8221; will now depend on the complexity of your organization and the number of applicable MDSAP tasks involved in the audit. Also, don\u2019t be surprised if you get a notice of your audit date only 4-6 weeks prior to the auditors arriving at your company.<\/p><p>\u00a0<\/p><h3>MDSAP preassessment and audit tips<\/h3><h5>1. Assess compliance now, then schedule<\/h5><p>Recently, some Oriel STAT A MATRIX clients have found that certain Auditing Organizations are refusing to even schedule an audit until the client can show evidence that they have completed their own internal MDSAP pre-assessment and MDSAP\/ISO 13485:2016 mock audit. Before you do that, thoroughly study this\u00a0<a href=\"https:\/\/www.fda.gov\/media\/147457\/download\" target=\"_blank\" rel=\"noopener noreferrer\">231-page MDSAP audit approach guide<\/a>\u00a0most recently updated in April 2021. We can help you with the\u00a0<a href=\"https:\/\/www.orielstat.com\/practice\/MDSAP-medical-device-single-audit-program\" target=\"_blank\" rel=\"noopener noreferrer\">preassessment \/ baseline audit<\/a>.<\/p><h5>2. Have someone from QA and RA be part of the audit<\/h5><p>Questions related to regulatory issues will come up during the audit. Don&#8217;t get caught slack-jawed; be prepared to have someone from Regulatory in the room at all times. Make sure you have &#8220;runners&#8221; assigned (QA and RA roles) to quickly retrieve documents and records. Ensure coverage during lunchtime as well.<\/p><h5>3. Be prepared to shift gears quickly<\/h5><p>MDSAP uses a true process-based approach. Auditors may begin reviewing one process and, while following the linkages between other processes, may continue the path of the new process to assure effective implementation across the organization. Don&#8217;t get flustered if the audit strays off topic. It&#8217;s the new reality of an MDSAP audit, so get used to it.<\/p><h5>4. Double-check your approved suppliers list<\/h5><p>Your European Authorized Representative and distributors should be treated as suppliers and included on your approved vendors list. Likewise, testing labs and calibration labs should be added as critical suppliers.<\/p><h5>5. Double up on the morning coffee<\/h5><p>These audits can be intense, so you need to be prepared for long days. It is not unusual for these audits to run from 8:00 a.m. to 6:00 p.m. or later.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a24cfc2 elementor-widget elementor-widget-heading\" data-id=\"a24cfc2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Your Next Step<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91e0879 elementor-widget elementor-widget-text-editor\" data-id=\"91e0879\" 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<p>The MDSAP audit will require some changes in how QA and RA think about audit preparation. Conducting <a href=\"https:\/\/www.orielstat.com\/practice\/MDSAP-medical-device-single-audit-program\" target=\"_blank\" rel=\"noopener noreferrer\">MDSAP mock audits and baseline audits<\/a> will become more important than ever before. If you are leading the team, you should consider our\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/mdsap-internal-auditor-training-class\" target=\"_blank\" rel=\"noopener noreferrer\">MDSAP internal auditor class<\/a> or engaging our experienced MDSAP auditor consultants to provide <a href=\"https:\/\/www.orielstat.com\/practice\/quality-system-audit-services-training\" target=\"_blank\" rel=\"noopener noreferrer\">outsourced audit support<\/a>.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3400fd elementor-widget elementor-widget-shortcode\" data-id=\"a3400fd\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. 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href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>MDSAP Mock Audits &#8211; Getting QA and RA on the Same Page As companies grow larger, they often split the responsibilities of QMS management and regulatory compliance. Typically, QA will handle ISO 13485, FDA QSR, product quality, CAPA compliance, and so on. Regulatory tends to manage product registrations, clinical evaluation reports, risk management, and the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":44,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[18],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/mdsap-impacts-ra-and-qa\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"MDSAP Mock Audits &#8211; Getting QA and RA on the Same Page As companies grow larger, they often split the responsibilities of QMS management and regulatory compliance. Typically, QA will handle ISO 13485, FDA QSR, product quality, CAPA compliance, and so on. 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