{"id":7691,"date":"2024-01-10T19:43:55","date_gmt":"2024-01-10T19:43:55","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7691"},"modified":"2024-01-12T20:12:45","modified_gmt":"2024-01-12T20:12:45","slug":"medical-device-supplier-quality-risks","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/medical-device-supplier-quality-risks\/","title":{"rendered":"Understanding the Risks Posed by Your Medical Device Suppliers and How Supplier Quality Fits"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7691\" class=\"elementor elementor-7691\" 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\">Understanding the Risks Posed by Your Medical Device Suppliers and How Supplier Quality Fits<\/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\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/04\/Medical-manufacturing-AdobeStock_1758607-Resized-1104W736H.jpg\" class=\"attachment-full size-full wp-image-1738\" alt=\"Medical manufacturing\" loading=\"lazy\" \/>\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>\u00a0<\/p><p><strong>With each passing decade, the world economy becomes more interconnected.<\/strong><\/p><p>It is not unusual for today&#8217;s medical device manufacturer to source circuit boards from South Korea, display screens from China, injection-molded components from Mexico, and precision bearings from Germany, all of which are assembled into a finished device in Costa Rica before being sent to the US for distribution all over the world.<\/p><p>The geographic dispersion of suppliers, combined with the fact that more device companies are choosing to become virtual manufacturers, means medical device companies have to be ever-more vigilant about maintaining control over their suppliers.<\/p><p>\u00a0<\/p><h3>The impact medical device suppliers and subcontractors have on your overall business risk<\/h3><p>Suppliers can introduce significant risk to your company that extends well beyond the safety and efficacy of finished devices they impact your ongoing compliance with regulations and present operational risks that might not be obvious. Here\u2019s a quick story to illustrate that point.<\/p><p>This is the first installment of a 4-part blog series on supplier management. In subsequent posts we talk about\u00a0<strong><a href=\"https:\/\/www.orielstat.com\/blog\/evaluating-new-medical-device-suppliers\/\">evaluating new suppliers<\/a><\/strong><strong>,\u00a0<\/strong><strong><a href=\"https:\/\/www.orielstat.com\/blog\/medical-device-supplier-auditing\/\">auditing them<\/a><\/strong>, and\u00a0<strong><a href=\"https:\/\/www.orielstat.com\/blog\/medical-device-contractor-evaluation\/\">evaluating their output<\/a><\/strong><strong>.\u00a0<\/strong>We&#8217;ve combined all four posts into one easy-to-read PDF. <strong><a href=\"https:\/\/www.orielstat.com\/Supplier-Quality-Management-101\" target=\"_blank\" rel=\"noopener noreferrer\">Download it here<\/a>.<\/strong><\/p><p>In late 2017, Kentucky Fried Chicken (KFC) changed their delivery logistics provider in the UK. Their previous delivery logistics provider had distribution centers throughout the UK. The new provider was large and reputable, promised lower costs, but had only one UK distribution center. While the new supplier did indeed deliver lower costs, they forgot to deliver the chicken. For weeks, hundreds of UK outlets were KF minus the C. The fiasco resulted in tens of millions of dollars in lost sales, angry customers, an avalanche of negative press, and social media mockery heard across the world.<\/p><p>The point is that traditional Supplier Quality Management (SQM) often focuses on product quality (the chicken) and not risks associated with suppliers that are independent of the actual product (delivering the chicken). Communication breakdowns. Supply interruptions. Trade disputes. Currency fluctuations. All of these factors have little to do with product quality, but they certainly can have a massive impact on the risk associated with your suppliers. You need to evaluate and mitigate them.<\/p><h3>\u00a0<\/h3><h3>Regulatory requirements related to medical device purchasing and supplier controls<\/h3><p>Manufacturers that outsource some or all of their manufacturing and assembly sometimes assume that their regulatory obligations are shared with their manufacturing partners, but this is often not the case. If you put your name on a device, you are legally responsible for all aspects of quality and safety, regardless of whether you actually make the device! Also, when we talk about purchased products, those products don\u2019t actually have to be purchased, they could be sourced from another facility in your organization that has its own quality management system. Purchased products can also be services (e.g., sterilization).<\/p><p>In a nutshell, regulators want to make sure you have:<\/p><ul><li style=\"list-style-type: none;\"><ul><li>Defined, documented, and implemented procedures to ensure that purchased or otherwise supplied products conform to specified purchase requirements.<\/li><li>Established criteria for the selection, evaluation, and reevaluation of suppliers based on the type and significance of the product and its impact on subsequent product realization or the finished device quality.<\/li><li>Performed the evaluation and selection of suppliers based on the capability of the supplier to meet specified requirements.<\/li><li>Developed, implemented, and continue to monitor supplier metrics to assure ongoing compliance with established quality requirements and performance.<\/li><\/ul><\/li><\/ul><p>Every year, the US FDA cites hundreds of manufacturers for failing to properly implement purchasing controls. It&#8217;s a major source of Form 483 and warning letter citations by FDA. Here is an actual published example written by an FDA inspector:<\/p><p><em>Your firm\u2019s purchasing control procedure was inadequate in that there were no specified requirements for critical suppliers or non-critical suppliers and annual assessments were to be conducted based on quality\/QMS among other criteria; the procedure did not describe how quality would be assessed. Furthermore, your firm did not follow the purchasing control procedure. Specifically, Section 2 of your purchasing control procedure mentions the selection of potential suppliers is based on technological and operational capabilities, logistics, quality, and technical risks. Additionally, Section 4 of the same procedure mentions the requirement that annual assessments be conducted for suppliers. Your QA Manager stated that your firm assesses quality based on discussions held with customers and distributors; however, this was not documented<\/em>.<\/p><h3>\u00a0<\/h3><h3>Important regulations and standards relevant to supplier and purchasing controls<\/h3><p>We won&#8217;t take a deep dive into specific supplier quality regulations in this article, but if you are new to medical device purchasing and supplier controls management you should definitely be aware of (and study) the following key regulations, standards, and guidance documents. This is not a comprehensive list.<\/p><p><strong>ISO 13485:2016 <\/strong>&#8211; Section 7.4 pertains to purchasing and section 4.1.5 deals with general requirements, including outsourced processes. Also see sections 8.2.6 and 8.3.<\/p><p><strong>US:\u00a0<\/strong><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm'fr=820.50\">21 CFR Part 820.50<\/a> &#8211; Purchasing Controls<\/p><p><strong>US:<\/strong>\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm'fr=820.80\">21 CFR Part 820.80<\/a> &#8211; Receiving, In-Process and Finished Device Acceptance<\/p><p><strong>US:<\/strong>\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm'fr=820.30\">21 CFR Part 820.30<\/a> &#8211; Design Controls<\/p><p><strong>US<\/strong>:\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm'fr=820.20\">21 CFR Part 820.20<\/a> &#8211; Management Responsibility<\/p><p><strong>Europe:\u00a0<\/strong><a href=\"http:\/\/ww2.orielstat.com\/rs\/231-KOL-532\/images\/EU-MDR-2017-745-Regulation-and-TOC.pdf\">Medical Device Regulation<\/a>\u00a0(2017\/745)<\/p><p><strong>GHTF\/SG3\/N17:2008<\/strong> &#8211; Read <a href=\"http:\/\/www.imdrf.org\/docs\/ghtf\/final\/sg3\/technical-docs\/ghtf-sg3-n17-guidance-on-quality-management-system-081211.pdf\">this document<\/a>, entitled &#8220;Guidance on the control of products and services obtained from suppliers&#8221;.<\/p><h3>\u00a0<\/h3><h3>The mechanics of supplier quality management and how it fits in the broader QMS<\/h3><p>Supplier quality management is an important subset of your broader quality management system (QMS) and functions as a cyclical process linked to other sections of your QMS. There are three basic components.<\/p><p><strong>1 \u2013 INPUTS:<\/strong>\u00a0This is where you define the requirements for purchased products, including overall quality planning plus specifying requirements for monitoring outsourced processes, drafting quality agreements, risk management for supplier quality, verification criteria, material specifications, design\/development acceptance criteria, traceability, and more.<\/p><p><strong>2 \u2013 PURCHASING: <\/strong>The purchasing process has three parts:<\/p><ul><li><strong>Supplier evaluation, selection, and approval:<\/strong>\u00a0Implementing a supplier selection process proportionate to the risk associated with the finished device.<\/li><li><strong>Purchased product information:<\/strong>\u00a0Appropriate information describing the purchased product, including specifications, acceptance requirements, supplier personnel qualification, supplier change notification requirements, traceability, and more. Also includes quality agreements.<\/li><li><strong>Verification of purchased product:<\/strong>\u00a0Defined inspection or other activities to confirm that purchased product meets requirements. This may include inspection instructions, sampling plans, pre-shipment inspections at the supplier, and change risk assessments.<\/li><\/ul><p><strong>3 \u2013 OUTPUTS:<\/strong>\u00a0Data from the purchasing process feeds multiple interrelated QMS processes. There are three primary outputs:<\/p><ul><li><strong>Purchased product and related data:<\/strong>\u00a0You must monitor and measure product quality throughout the product realization process. This applies to parts and materials too, not just finished devices! Nonconforming products must be identified, documented, controlled, segregated, evaluated, and dispositioned.<\/li><li><strong>Supplier performance measures:<\/strong>\u00a0Appropriate monitoring and measurement must be established for the supplier QMS processes.<\/li><li><strong>Overall supplier QMS performance:<\/strong>\u00a0Monitoring and measurement of the processes will provide both immediate (i.e., catch a problem immediately) and longer-term feedback (i.e., via management review) for system improvements.<\/li><\/ul><h3>\u00a0<\/h3><h3>Want to learn more about supplier management\u2019 We&#8217;re just getting started.<\/h3><p>If you are enjoying this article, continue reading about how to evaluate medical device suppliers and implement effective controls, the\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/evaluating-new-medical-device-suppliers\/\" target=\"_blank\" rel=\"noopener noreferrer\">second post<\/a>\u00a0in this four-part series. Alternatively, you can download all four posts in a single PDF\u00a0<a href=\"https:\/\/www.orielstat.com\/Supplier-Quality-Management-101\" target=\"_blank\" rel=\"noopener noreferrer\">Know More<\/a>. Also, if you want to take the next step and truly enhance your knowledge on this topic, consider our comprehensive <a href=\"https:\/\/www.orielstat.com\/courses\/supplier-quality-management-designing-and-implementing-a-successful-program-medical-devices\" target=\"_blank\" rel=\"noopener noreferrer\">Medical Device Supplier Quality Management Training<\/a> class. 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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>Understanding the Risks Posed by Your Medical Device Suppliers and How Supplier Quality Fits \u00a0 With each passing decade, the world economy becomes more interconnected. It is not unusual for today&#8217;s medical device manufacturer to source circuit boards from South Korea, display screens from China, injection-molded components from Mexico, and precision bearings from Germany, all [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1738,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[32],"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\/medical-device-supplier-quality-risks\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Understanding the Risks Posed by Your Medical Device Suppliers and How Supplier Quality Fits \u00a0 With each passing decade, the world economy becomes more interconnected. 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