{"id":329,"date":"2018-04-09T00:59:06","date_gmt":"2018-04-09T00:59:06","guid":{"rendered":"http:\/\/tgfrconsulting.com\/blog\/?p=329"},"modified":"2024-01-20T22:27:34","modified_gmt":"2024-01-20T22:27:34","slug":"system-realization","status":"publish","type":"post","link":"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/","title":{"rendered":"System Realization"},"content":{"rendered":"<div class=\"entry\">\n<p>System Realization begins following the deployment of the design inputs to the subsystems.\u00a0 The following table describes the inputs and outputs of the realization process<\/p>\n\n<table id=\"tablepress-21\" class=\"tablepress tablepress-id-21\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">Inputs<\/th><th class=\"column-2\">Key Activities<\/th><th class=\"column-3\">Outputs<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\"><strong>System Transfer Functions<\/strong><br \/>\nThe details of the interrelationships between requirements, the transfer functions.<br \/>\n<br \/>\n<strong>Workflow Diagrams<\/strong><br \/>\nThe details of the workflow and subsystem interactions.<br \/>\n<br \/>\n<strong>Design Worksheet<\/strong><br \/>\nThe details of how the system design inputs and subsystem requirements interrelate<br \/>\n<br \/>\n<strong>N2 Chart<\/strong><br \/>\nThe details of the subsystem interactions<br \/>\n<br \/>\n<strong>Subsystem Requirements<\/strong><br \/>\nThe subsystem requirements <br \/>\n<br \/>\n<strong>System Use Cases<\/strong><br \/>\nWorkflows, both primary and secondary<br \/>\nSystem Requirements<br \/>\nThe Design Inputs<br \/>\n<\/td><td class=\"column-2\"><strong>Subsystem Development<\/strong><br \/>\nThe development of the design, manufacturing and service procedures<br \/>\n<br \/>\n<strong>Subsystem Integration<\/strong><br \/>\nThe planning and execution of the integration between subsystems<br \/>\n<br \/>\n<strong>Subsystem Integration<\/strong><br \/>\nThe planning and execution of the integration between subsystems<br \/>\n<br \/>\n<strong>Manufacturing and Service Design<\/strong><br \/>\nThe processes used to manufacture and service the product<br \/>\n<br \/>\n<strong>Process Characterization<\/strong><br \/>\nThe characterization of the manufacturing and service procedures<br \/>\n<br \/>\n<strong>System Verification<\/strong><br \/>\nThe verification that the design inputs meet the design outputs.<br \/>\nRegression Development<br \/>\nResponse to the issues uncovered in verification<br \/>\n<\/td><td class=\"column-3\"><strong>System Design <\/strong><br \/>\nThe design (including software) for the system<br \/>\n<br \/>\n<strong>Manufacturing Design<\/strong><br \/>\nManufacturing Procedures and test methods.<br \/>\n<br \/>\n<strong>Service Design<\/strong><br \/>\nService Procedures and test methods.<br \/>\n<br \/>\n<strong>Verification Results<\/strong><br \/>\nThe objective evidence that the system design meets the Design Inputs<br \/>\n<br \/>\n<strong>Process Characterization Results<\/strong><br \/>\nThe objective evidence that the process can produce the finished device <br \/>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-21 from cache -->\n<p>The following summarizes the activities involved in system realization<\/p>\n<ul>\n<li><strong>Subsystem Development<\/strong> \u2013 this involves the development of the subsystem and the associated test methods.<\/li>\n<li><strong>Subsystem Integratio<\/strong>n \u2013 the focus here is on the piecewise integration of the system, relying on the worksheet and transfer functions to dictate the staging and integration steps<\/li>\n<li><strong>Manufacturing and Service Design<\/strong> \u2013 the interaction with the Development through test methods and the system design<\/li>\n<li><strong>Process Characterization<\/strong> \u2013 this identifies which processes require verification and which require validation (this will help considerably during the process qualification)<\/li>\n<li><strong>Verification<\/strong> &#8211; the final confirmation of requirements and use cases. This is closely linked to the subsystem deployment (section 4.1)<\/li>\n<li><strong>Regression Development<\/strong> &#8211; the incremental adjustments conducted as a result of verification. Again, the subsystem deployment (section 4.1) is critical to the effective execution of regression and associated development<\/li>\n<\/ul>\n<p>The following figure shows the relationship of these activities<\/p>\n<figure id=\"attachment_553\" aria-describedby=\"caption-attachment-553\" style=\"width: 5905px\" class=\"wp-caption alignnone\"><a href=\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2018\/04\/System-Realization-Workflow.png\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-553\" src=\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2018\/04\/System-Realization-Workflow.png\" alt=\"System Realization Workflow\" width=\"5905\" height=\"3994\" srcset=\"https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2018\/04\/System-Realization-Workflow.png 5905w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2018\/04\/System-Realization-Workflow-300x203.png 300w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2018\/04\/System-Realization-Workflow-768x519.png 768w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2018\/04\/System-Realization-Workflow-1024x693.png 1024w\" sizes=\"auto, (max-width: 5905px) 100vw, 5905px\" \/><\/a><figcaption id=\"caption-attachment-553\" class=\"wp-caption-text\">System Realization Workflow<\/figcaption><\/figure>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>System Realization begins following the deployment of the design inputs to the subsystems.\u00a0 The following table describes the inputs and outputs of the realization process The following summarizes the activities involved in system realization Subsystem Development \u2013 this involves the development of the subsystem and the associated test methods. Subsystem Integration \u2013 the focus here &#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[61,6],"tags":[43,44,45],"class_list":{"0":"post-329","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-archived","7":"category-product-design-and-development","8":"tag-system-development","9":"tag-test-methods","10":"tag-user-interface-development","11":"anons"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>System Realization - TGFR Consulting LLC<\/title>\n<meta name=\"description\" content=\"System realization transforms requirements into the final medical device finished device. This transforms the requirements into the system design, manufacturing ans service processes.\" \/>\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.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"System Realization - TGFR Consulting LLC\" \/>\n<meta property=\"og:description\" content=\"System realization transforms requirements into the final medical device finished device. This transforms the requirements into the system design, manufacturing ans service processes.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/\" \/>\n<meta property=\"og:site_name\" content=\"TGFR Consulting LLC\" \/>\n<meta property=\"article:published_time\" content=\"2018-04-09T00:59:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-01-20T22:27:34+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2018\/04\/System-Realization-Workflow.png\" \/>\n<meta name=\"author\" content=\"Timothy Robinson\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Timothy Robinson\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/\"},\"author\":{\"name\":\"Timothy Robinson\",\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/#\/schema\/person\/5e055d3bb1c73babd5af6a3d1f31ca05\"},\"headline\":\"System Realization\",\"datePublished\":\"2018-04-09T00:59:06+00:00\",\"dateModified\":\"2024-01-20T22:27:34+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/\"},\"wordCount\":181,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2018\/04\/System-Realization-Workflow.png\",\"keywords\":[\"System Development\",\"Test Methods\",\"User Interface Development\"],\"articleSection\":[\"Archive\",\"Product Design and Development\"],\"inLanguage\":\"en\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/\",\"url\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/\",\"name\":\"System Realization - TGFR Consulting LLC\",\"isPartOf\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-design-and-development\/system-realization\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2018\/04\/System-Realization-Workflow.png\",\"datePublished\":\"2018-04-09T00:59:06+00:00\",\"dateModified\":\"2024-01-20T22:27:34+00:00\",\"description\":\"System realization transforms requirements into the final medical device finished device. 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