{"id":9457,"date":"2021-10-25T19:22:43","date_gmt":"2021-10-25T23:22:43","guid":{"rendered":"https:\/\/www.spartasystems.com\/resources\/closed-152\/"},"modified":"2022-10-17T09:46:15","modified_gmt":"2022-10-17T13:46:15","slug":"how-to-establish-supplier-qualifications-session","status":"publish","type":"resources","link":"https:\/\/www.spartasystems.com\/resources\/how-to-establish-supplier-qualifications-session\/","title":{"rendered":"Q&#038;A from Sparta\u2019s \u201cHow to Establish Supplier Qualifications\u201d Session"},"content":{"rendered":"\n<p>At the Q1 11<sup>th<\/sup> Annual Medical Device <a href=\"https:\/\/medicaldeviceevents.com\/calendar\/11th-annual-medical-device-supplier-quality-assurance-conference-2\/\" target=\"_blank\" rel=\"noreferrer noopener\">Supplier Quality Assurance Conference<\/a>, Sparta\u2019s Zillery Fortner presented her topic \u201cHow to Establish Supplier Qualifications.\u201d<\/p>\n\n\n\n<p>This conference was a forum to deliver a first-in-class educational and networking platform for supplier professionals. The 2-day event focused on strategies to align compliance, utilizing a risk-based approach, system management, maintaining supply chain control and fostering collaborative supplier relationships.&nbsp;<\/p>\n\n\n\n<p>Fortner\u2019s session provided attendees with the overall knowledge and resources needed to build supplier qualifications.&nbsp;<\/p>\n\n\n\n<p>We\u2019ve rounded up some of the insights and practical takeaways from Fortner\u2019s Q&amp;A session below:<\/p>\n\n\n\n<p class=\"has-drop-cap\"><strong>Q:<\/strong> <strong>How are quality agreements best incorporated into supply chain management and how often should they be reviewed? What measures should be in place when deficiencies are found?<\/strong><\/p>\n\n\n\n<p class=\"has-drop-cap\"><strong>A:<\/strong> Quality agreements are a tricky subject.&nbsp; Using a <a href=\"https:\/\/www.spartasystems.com\/integrated-risk-management\/\">risk assessment approach,<\/a> determine if the agreements are applicable and what frequency they should be reviewed.&nbsp; Quality agreements should not be cut and paste; they need to be tailored to each customer containing at a minimum:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Appropriate written responsibilities for cGMP activities&nbsp;<\/li><li>Purpose\/scope&nbsp;<\/li><li>Product\/service(s)&nbsp;<\/li><li>Contact information&nbsp;<\/li><li>Terms and expirations&nbsp;<\/li><li>Quality control, change control, change management&nbsp;<\/li><li>Dispute resolution&nbsp;<\/li><li>Regulatory compliance&nbsp;<\/li><li>Reporting support&nbsp;<\/li><\/ul>\n\n\n\n<p>During the supplier review, take time to go through the quality agreement providing both parties expectations.&nbsp; Ensure both parties have a point of contact, providing a streamlined system for communication. &nbsp;Maintain supplier agreements per your retention policy.&nbsp;<\/p>\n\n\n\n<p class=\"has-drop-cap\"><strong>Q: Where would you draw the line between software suppliers that need to be on your approved supplier list and ones that don\u2019t?<\/strong> <strong>We are going through this exercise now. There are many debates between who should be in scope and monitored versus well-known sources that wouldn\u2019t pose any risk or take time to complete any customer qualification paperwork.<\/strong><\/p>\n\n\n\n<p class=\"has-drop-cap\"><strong>A: <\/strong>The first step would be to review what services and support apply to the software.&nbsp; Then ask them, \u201cwhat if\u201d?&nbsp; What if this happened, or what if the label was printed wrong?&nbsp; Document this process.&nbsp; Then if the software does not affect parts of the quality management system (QMS), they would not be included on the approved supplier list (ASL).&nbsp; The documentation would be your risk overview.&nbsp; But let\u2019s say component numbers were transferred from the software to XYZ system to build a product, then you would evaluate just that section and add just that section to the ASL.<\/p>\n\n\n\n<p class=\"has-drop-cap\"><strong>Q: I haven\u2019t seen a supplier tier system described the way it was in this presentation. Do others use a similar approach and incorporate volume\/spend into these designations for suppliers?<\/strong><\/p>\n\n\n\n<p class=\"has-drop-cap\"><strong>A:<\/strong> When COVID-19 hit, I quickly learned that we had a significant disconnect with our supply chain. Like most companies, we did not understand supplier risk and inventory.&nbsp; Using a \u201cholistic\u201d approach to supplier management and implementing a tier classification system will allow companies to be proactive with their suppliers, showing customers that their products\/services are safe and reliable.&nbsp; When supplier systems are siloed, there is no flexibility or resilience.&nbsp; Moving towards a robust Supply Chain 4.0 system will allow for continuous monitoring, efficiency and reduced cost. It will also provide real-time information, and enable you to identify external factors that influence your business.&nbsp; &nbsp;&nbsp;<\/p>\n\n\n\n<p>Get more insight into <a href=\"https:\/\/info.spartasystems.com\/TWD-SQM-Datasheet_ThankYou.html\" target=\"_blank\" rel=\"noreferrer noopener\">supplier management<\/a>, specifically remote supplier audits, by downloading our latest eBook.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-background\" href=\"https:\/\/info.spartasystems.com\/HCLS-HCE-21-EB-RemoteAudits-WEB_LP-ThankYou.html\" style=\"background-color:#e63462\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>FREE EBOOK<\/strong><\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>At the Q1 11th Annual Medical Device Supplier Quality Assurance Conference, Sparta\u2019s Zillery Fortner presented her topic \u201cHow to Establish Supplier Qualifications.\u201d This conference was a forum to deliver a first-in-class educational and networking platform for supplier professionals. The 2-day event focused on strategies to align compliance, utilizing a risk-based approach, system management, maintaining supply&#8230;<\/p>\n","protected":false},"author":3,"featured_media":9477,"menu_order":125,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"modular_category":[180,76,77,75,71,63],"resources_category":[176],"class_list":["post-9457","resources","type-resources","status-publish","has-post-thumbnail","hentry","modular_category-audit-management","modular_category-biotechnology","modular_category-medical-devices-and-diagnostics","modular_category-pharmaceutical","modular_category-supplier-quality","modular_category-trackwise-digital","resources_category-blog"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Q&amp;A from Sparta\u2019s \u201cHow to Establish Supplier Qualifications\u201d Session - Honeywell<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.spartasystems.com\/resources\/how-to-establish-supplier-qualifications-session\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Q&amp;A from Sparta\u2019s \u201cHow to Establish Supplier Qualifications\u201d Session - Honeywell\" \/>\n<meta property=\"og:description\" content=\"At the Q1 11th Annual Medical Device Supplier Quality Assurance Conference, Sparta\u2019s Zillery Fortner presented her topic \u201cHow to Establish Supplier Qualifications.\u201d This conference was a forum to deliver a first-in-class educational and networking platform for supplier professionals. The 2-day event focused on strategies to align compliance, utilizing a risk-based approach, system management, maintaining supply...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.spartasystems.com\/resources\/how-to-establish-supplier-qualifications-session\/\" \/>\n<meta property=\"og:site_name\" content=\"Honeywell\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/SpartaSystems\/\" \/>\n<meta property=\"article:modified_time\" content=\"2022-10-17T13:46:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.spartasystems.com\/wp-content\/uploads\/2021\/10\/meddev-supplier-quality-assur-conf-QA.png\" \/>\n\t<meta property=\"og:image:width\" content=\"400\" \/>\n\t<meta property=\"og:image:height\" content=\"191\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@SpartaSystems\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.spartasystems.com\\\/resources\\\/how-to-establish-supplier-qualifications-session\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.spartasystems.com\\\/resources\\\/how-to-establish-supplier-qualifications-session\\\/\"},\"author\":{\"name\":\"Sparta Systems\",\"@id\":\"https:\\\/\\\/www.spartasystems.com\\\/#\\\/schema\\\/person\\\/6a0ce7eac89172041d40bd1d00839b17\"},\"headline\":\"Q&#038;A from Sparta\u2019s \u201cHow to Establish Supplier Qualifications\u201d Session\",\"datePublished\":\"2021-10-25T23:22:43+00:00\",\"dateModified\":\"2022-10-17T13:46:15+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.spartasystems.com\\\/resources\\\/how-to-establish-supplier-qualifications-session\\\/\"},\"wordCount\":591,\"publisher\":{\"@id\":\"https:\\\/\\\/www.spartasystems.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.spartasystems.com\\\/resources\\\/how-to-establish-supplier-qualifications-session\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.spartasystems.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/meddev-supplier-quality-assur-conf-QA.png\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.spartasystems.com\\\/resources\\\/how-to-establish-supplier-qualifications-session\\\/\",\"url\":\"https:\\\/\\\/www.spartasystems.com\\\/resources\\\/how-to-establish-supplier-qualifications-session\\\/\",\"name\":\"Q&A from Sparta\u2019s \u201cHow to Establish Supplier Qualifications\u201d Session - 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