{"id":245056,"date":"2022-03-02T14:06:36","date_gmt":"2022-03-02T14:06:36","guid":{"rendered":"https:\/\/modelwise.ai\/?p=245056"},"modified":"2025-04-10T14:40:42","modified_gmt":"2025-04-10T13:40:42","slug":"modelwise-achieves-tuv-concept-report","status":"publish","type":"post","link":"https:\/\/modelwise.ai\/de\/modelwise-achieves-tuv-concept-report\/","title":{"rendered":"Modelwise achieves T\u00dcV concept report"},"content":{"rendered":"\n<div style=\"height:3em\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<pre class=\"wp-block-preformatted\"><strong>The TLDR: Too busy to read? Here's a quick summary of article<\/strong><br><br><strong>Big win for safety analysis!<\/strong> Modelwise's AI-powered safety analysis tool, Paitron, has earned a T\u00dcV S\u00dcD Concept Report. This article dives into the evaluation process.<br><br><strong>What is the T\u00dcV S\u00dcD Concept Report?<\/strong> It's an independent assessment by a reputable third-party (T\u00dcV S\u00dcD) verifying the safety concept of a product or service.<br><br><strong>Why it matters?<\/strong> Earning a T\u00dcV S\u00dcD Concept Report is a significant achievement for Paitron as this independent assessment boosts trust, credibility and also strengthens Paitron's potential for safety-critical applications.<br><\/pre>\n\n\n<div role=\"navigation\" aria-label=\"Inhaltsverzeichnis\" class=\"simpletoc wp-block-simpletoc-toc\"><h2 style=\"margin: 0;\"><button type=\"button\" aria-expanded=\"false\" aria-controls=\"simpletoc-content-container\" class=\"simpletoc-collapsible\">Contents<span class=\"simpletoc-icon\" aria-hidden=\"true\"><\/span><\/button><\/h2><div id=\"simpletoc-content-container\" class=\"simpletoc-content\"><ul class=\"simpletoc-list\">\n<li><a href=\"#concept-reportnbsp\">Concept Report&nbsp;<\/a>\n\n<\/li>\n<li><a href=\"#tool-qualification-in-safetycritical-industriesnbsp\">Tool Qualification in Safety-Critical Industries&nbsp;<\/a>\n\n<\/li>\n<li><a href=\"#evaluation-processnbsp\">Evaluation Process&nbsp;<\/a>\n\n<\/li>\n<li><a href=\"#conclusion-amp-outlooknbsp\">Conclusion &amp; Outlook&nbsp;<\/a>\n\n<\/li>\n<li><a href=\"#additional-resources\">Additional Resources<\/a>\n\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li><\/ul><\/div><\/div>\n\n\n<h2 id=\"concept-reportnbsp\" class=\"wp-block-heading\">Concept Report <\/h2>\n\n\n\n<p class=\"has-drop-cap\">In November 2021, the AI-powered Modelwise\u2019s Paitron was evaluated by T\u00dcV S\u00dcD for the development of safety-related products. According to our knowledge, this is the first tool of its kind whose concept was examined according to international standards and guidelines (ref. section &#8220;Evaluation Process&#8221;). The approval of the safety concept is based on the documents listed in the Evaluation Process&nbsp;section of this article.<\/p>\n\n\n\n<p>As the concept report marks the first step to a full tool qualification, Dr. Detlev Richter, VP of Industrial and Energy Products of the T\u00dcV S\u00dcD Product Service Division, commented on the milestone: <\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201cThis means that the integration and automation of Functional Safety validation have taken a step forward in the technical lifecycle of digital twin based systems with regards to product changes\u201d <a href=\"#1\">[1]<\/a>.<\/p>\n<\/blockquote>\n\n\n\n<p>The article covers the aspects that we, at Modelwise, have to cover and comply with in order to make our AI suitable for all Safety Integrity Levels (SIL). Currently, we are working on fully certifying Paitron according to IEC 61508:2010 and ISO 26262:2018. This is to be shown during the so-called <strong><em>detailed phase<\/em><\/strong> for the final certification of the tool.<\/p>\n\n\n\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;69f18753bc3d9&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"69f18753bc3d9\" class=\"wp-block-image aligncenter size-full is-style-default wp-lightbox-container\"><img loading=\"lazy\" decoding=\"async\" width=\"276\" height=\"534\" data-wp-class--hide=\"state.isContentHidden\" data-wp-class--show=\"state.isContentVisible\" data-wp-init=\"callbacks.setButtonStyles\" data-wp-on--click=\"actions.showLightbox\" data-wp-on--load=\"callbacks.setButtonStyles\" data-wp-on-window--resize=\"callbacks.setButtonStyles\" src=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/TUV-SUD-concept-report-certification.png\" alt=\"\" class=\"wp-image-245399\" srcset=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/TUV-SUD-concept-report-certification.png 276w, https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/TUV-SUD-concept-report-certification-155x300.png 155w, https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/TUV-SUD-concept-report-certification-6x12.png 6w, https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/TUV-SUD-concept-report-certification-60x116.png 60w\" sizes=\"(max-width: 276px) 100vw, 276px\" \/><button\n\t\t\tclass=\"lightbox-trigger\"\n\t\t\ttype=\"button\"\n\t\t\taria-haspopup=\"dialog\"\n\t\t\taria-label=\"Vergr\u00f6\u00dfern\"\n\t\t\tdata-wp-init=\"callbacks.initTriggerButton\"\n\t\t\tdata-wp-on--click=\"actions.showLightbox\"\n\t\t\tdata-wp-style--right=\"state.imageButtonRight\"\n\t\t\tdata-wp-style--top=\"state.imageButtonTop\"\n\t\t>\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" fill=\"none\" viewBox=\"0 0 12 12\">\n\t\t\t\t<path fill=\"#fff\" d=\"M2 0a2 2 0 0 0-2 2v2h1.5V2a.5.5 0 0 1 .5-.5h2V0H2Zm2 10.5H2a.5.5 0 0 1-.5-.5V8H0v2a2 2 0 0 0 2 2h2v-1.5ZM8 12v-1.5h2a.5.5 0 0 0 .5-.5V8H12v2a2 2 0 0 1-2 2H8Zm2-12a2 2 0 0 1 2 2v2h-1.5V2a.5.5 0 0 0-.5-.5H8V0h2Z\" \/>\n\t\t\t<\/svg>\n\t\t<\/button><figcaption class=\"wp-element-caption\"><strong>Figure 1: Cover page of the concept report<\/strong><\/figcaption><\/figure>\n\n\n\n<div style=\"height:1em\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 id=\"tool-qualification-in-safetycritical-industriesnbsp\" class=\"wp-block-heading\">Tool Qualification in Safety-Critical Industries <\/h2>\n\n\n\n<p>To reach a defined safety goal, choosing the right software tool right from the beginning of development is important. Depending on the project&#8217;s needs, the required tools are planned based on the requirements from the safety standards and the related safety levels (ASIL, SIL, etc.) <a href=\"#2\">[2]<\/a>. As \u201ca tool error may lead to the injection or non-detection of a fault in the safety-product\u201d <a href=\"#3\">[3]<\/a>, standards demand that tools are evaluated and, if necessary, also qualified in the context of the development process &amp; toolchain.<\/p>\n\n\n\n<p>To provide a generic framework and simplify the process for customers and users of such tools, standards allow software providers to qualify tools independent of a specific safety-related project. This qualification depends on the desired safety level. The suggested methods for achieving ASILs (Automotive Safety Integrity Level) are shown in the following table:<\/p>\n\n\n\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;69f18753bc95a&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"69f18753bc95a\" class=\"wp-block-image aligncenter size-full is-style-default wp-lightbox-container\"><img loading=\"lazy\" decoding=\"async\" width=\"838\" height=\"192\" data-wp-class--hide=\"state.isContentHidden\" data-wp-class--show=\"state.isContentVisible\" data-wp-init=\"callbacks.setButtonStyles\" data-wp-on--click=\"actions.showLightbox\" data-wp-on--load=\"callbacks.setButtonStyles\" data-wp-on-window--resize=\"callbacks.setButtonStyles\" src=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-1-TCL-4-Software-Tool-Qualification-According-to-ISO-26262.png\" alt=\"\" class=\"wp-image-245477\" srcset=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-1-TCL-4-Software-Tool-Qualification-According-to-ISO-26262.png 838w, https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-1-TCL-4-Software-Tool-Qualification-According-to-ISO-26262-480x110.png 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 838px, 100vw\" \/><button\n\t\t\tclass=\"lightbox-trigger\"\n\t\t\ttype=\"button\"\n\t\t\taria-haspopup=\"dialog\"\n\t\t\taria-label=\"Vergr\u00f6\u00dfern\"\n\t\t\tdata-wp-init=\"callbacks.initTriggerButton\"\n\t\t\tdata-wp-on--click=\"actions.showLightbox\"\n\t\t\tdata-wp-style--right=\"state.imageButtonRight\"\n\t\t\tdata-wp-style--top=\"state.imageButtonTop\"\n\t\t>\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" fill=\"none\" viewBox=\"0 0 12 12\">\n\t\t\t\t<path fill=\"#fff\" d=\"M2 0a2 2 0 0 0-2 2v2h1.5V2a.5.5 0 0 1 .5-.5h2V0H2Zm2 10.5H2a.5.5 0 0 1-.5-.5V8H0v2a2 2 0 0 0 2 2h2v-1.5ZM8 12v-1.5h2a.5.5 0 0 0 .5-.5V8H12v2a2 2 0 0 1-2 2H8Zm2-12a2 2 0 0 1 2 2v2h-1.5V2a.5.5 0 0 0-.5-.5H8V0h2Z\" \/>\n\t\t\t<\/svg>\n\t\t<\/button><figcaption class=\"wp-element-caption\"><strong>Table 1: TCL 4 Software Tool Qualification According to ISO 26262 <a href=\"#4\">[4]<\/a><\/strong><\/figcaption><\/figure>\n\n\n\n<figure class=\"wp-block-table aligncenter is-style-stripes has-small-font-size\"><table><tbody><tr><td>Legend &#8211; Software Tool Qualification<\/td><\/tr><tr><td>++&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The method is highly recommended for this ASIL<br>+&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The method is recommended for this ASIL<br>o&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The method has no recommendation for or against its usage for this ASIL<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div style=\"height:1em\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>In our example, this requires a detailed analysis of the following documents to determine a<em> <strong>level of confidence<\/strong><\/em> in the use of the tool.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Use Cases to visualize the intended process, highlighting all user inputs and information exchange and identifying all associated risks.<\/li>\n\n\n\n<li>Requirements for safe execution, including mitigation measures, were needed for each safety-critical element of the software architecture.<\/li>\n\n\n\n<li>Example project to show compliance with IEC 61508 and ensure our results&#8217; correctness, focusing on the automation capabilities and the distinction to user inputs.<\/li>\n\n\n\n<li>Tool providers\u2019 development processes are not in the scope of a concept report.<\/li>\n\n\n\n<li>Test Strategy and Test Cases are not in the scope of a concept report.<\/li>\n<\/ul>\n\n\n\n<p>This consists in balancing the potential impact of tool errors on the safety function with appropriate mitigation measures. The qualification allows stating an envisioned process, which customers and users only have to implement and follow.<\/p>\n\n\n\n<p>Currently, all AI approaches, including Neural Networks and Deep Learning, are not recommended by IEC 61508 <a href=\"#5\">[5]<\/a>, and ISO 26262 does not even mention AI. As of today, the discussion on how to qualify AI is still ongoing. <a href=\"#6\">[6]<\/a> offers a great summary of the current state of the discussion, as it aims to summarize the Technical Report ISO\/IEC TR\u202f 5469 Functional Safety and AI systems, which is still under development. The core idea currently floating around is that as long as the AI is comprehensible and valuable, it can be used in Functional Safety (ref. AI Class I in Table 2). One of the reasons for this restriction is that Functional Safety cannot accept unquantifiable risks, which makes \u201cnon-determinism [\u2026] hard to accept for safety\u201d <a href=\"#7\">[7]<\/a>.<\/p>\n\n\n\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;69f18753bd152&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"69f18753bd152\" class=\"wp-block-image aligncenter size-full is-style-default wp-lightbox-container\"><img loading=\"lazy\" decoding=\"async\" width=\"705\" height=\"542\" data-wp-class--hide=\"state.isContentHidden\" data-wp-class--show=\"state.isContentVisible\" data-wp-init=\"callbacks.setButtonStyles\" data-wp-on--click=\"actions.showLightbox\" data-wp-on--load=\"callbacks.setButtonStyles\" data-wp-on-window--resize=\"callbacks.setButtonStyles\" src=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-2-AI-Classification-according-to-TR-5469.png\" alt=\"\" class=\"wp-image-245478\" srcset=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-2-AI-Classification-according-to-TR-5469.png 705w, https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-2-AI-Classification-according-to-TR-5469-480x369.png 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 705px, 100vw\" \/><button\n\t\t\tclass=\"lightbox-trigger\"\n\t\t\ttype=\"button\"\n\t\t\taria-haspopup=\"dialog\"\n\t\t\taria-label=\"Vergr\u00f6\u00dfern\"\n\t\t\tdata-wp-init=\"callbacks.initTriggerButton\"\n\t\t\tdata-wp-on--click=\"actions.showLightbox\"\n\t\t\tdata-wp-style--right=\"state.imageButtonRight\"\n\t\t\tdata-wp-style--top=\"state.imageButtonTop\"\n\t\t>\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" fill=\"none\" viewBox=\"0 0 12 12\">\n\t\t\t\t<path fill=\"#fff\" d=\"M2 0a2 2 0 0 0-2 2v2h1.5V2a.5.5 0 0 1 .5-.5h2V0H2Zm2 10.5H2a.5.5 0 0 1-.5-.5V8H0v2a2 2 0 0 0 2 2h2v-1.5ZM8 12v-1.5h2a.5.5 0 0 0 .5-.5V8H12v2a2 2 0 0 1-2 2H8Zm2-12a2 2 0 0 1 2 2v2h-1.5V2a.5.5 0 0 0-.5-.5H8V0h2Z\" \/>\n\t\t\t<\/svg>\n\t\t<\/button><figcaption class=\"wp-element-caption\"><strong>Table 2: AI Classification According to TR 5469 <a href=\"#6\">[6]<\/a><\/strong><\/figcaption><\/figure>\n\n\n\n<div style=\"height:1em\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 id=\"evaluation-processnbsp\" class=\"wp-block-heading\">Evaluation Process <\/h2>\n\n\n\n<p>To meet the standards, multiple documents were reviewed by T\u00dcV S\u00dcD. A review is a verification activity during which the documents have been evaluated regarding deficiencies, faults, inconsistencies, and deviations from standards. Within this process, we were able to show and qualify Paitron\u2019s concept, which is fully based on formal verification and theorem proving and is therefore deterministic, comprehensible, and valuable.<\/p>\n\n\n\n<p>With more than 10 iterations between T\u00dcV S\u00dcD and us, the final concept approval was reached for all relevant documents consisting of:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>Use<\/em><em> cases analysis<\/em>, which describes for each use case,&nbsp; the preconditions, necessary steps, tools, and actors. Starting from the sea level use cases with a focus on the user goals, the document focuses on identifying all risks.<\/li>\n\n\n\n<li><em>Software Architecture Description<\/em> contains distinct architectural views to depict various aspects of the system.&nbsp; It is intended to outline and inform about the significant architectural decisions relevant to the system. These are the elements and behaviors that are most fundamental for guiding the development of the software and for understanding Paitron as a whole.<\/li>\n\n\n\n<li><em>Software Requirements Specification, <\/em>where the requirements are specified, prioritized, and linked to respective work items. This document shows a structured separation of the different functionalities into dedicated software components.<\/li>\n\n\n\n<li><em>Review of an output FMEDA<\/em> of an exemplary system model. The general structure of the output FMEDA was evaluated with a focus on the automated tool features and their incorporation into the user\u2019s workflow.<\/li>\n<\/ul>\n\n\n\n<p>The regulations and guidelines which form the basis of the concept evaluation are listed below.<\/p>\n\n\n\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;69f18753bd731&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"69f18753bd731\" class=\"wp-block-image aligncenter size-full is-style-default wp-lightbox-container\"><img loading=\"lazy\" decoding=\"async\" width=\"702\" height=\"123\" data-wp-class--hide=\"state.isContentHidden\" data-wp-class--show=\"state.isContentVisible\" data-wp-init=\"callbacks.setButtonStyles\" data-wp-on--click=\"actions.showLightbox\" data-wp-on--load=\"callbacks.setButtonStyles\" data-wp-on-window--resize=\"callbacks.setButtonStyles\" src=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-3-Evaluation-basis.png\" alt=\"\" class=\"wp-image-245479\" srcset=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-3-Evaluation-basis.png 702w, https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-3-Evaluation-basis-480x84.png 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 702px, 100vw\" \/><button\n\t\t\tclass=\"lightbox-trigger\"\n\t\t\ttype=\"button\"\n\t\t\taria-haspopup=\"dialog\"\n\t\t\taria-label=\"Vergr\u00f6\u00dfern\"\n\t\t\tdata-wp-init=\"callbacks.initTriggerButton\"\n\t\t\tdata-wp-on--click=\"actions.showLightbox\"\n\t\t\tdata-wp-style--right=\"state.imageButtonRight\"\n\t\t\tdata-wp-style--top=\"state.imageButtonTop\"\n\t\t>\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" fill=\"none\" viewBox=\"0 0 12 12\">\n\t\t\t\t<path fill=\"#fff\" d=\"M2 0a2 2 0 0 0-2 2v2h1.5V2a.5.5 0 0 1 .5-.5h2V0H2Zm2 10.5H2a.5.5 0 0 1-.5-.5V8H0v2a2 2 0 0 0 2 2h2v-1.5ZM8 12v-1.5h2a.5.5 0 0 0 .5-.5V8H12v2a2 2 0 0 1-2 2H8Zm2-12a2 2 0 0 1 2 2v2h-1.5V2a.5.5 0 0 0-.5-.5H8V0h2Z\" \/>\n\t\t\t<\/svg>\n\t\t<\/button><figcaption class=\"wp-element-caption\"><strong>Table 3: Evaluation Basis<\/strong><\/figcaption><\/figure>\n\n\n\n<div style=\"height:1em\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 id=\"conclusion-amp-outlooknbsp\" class=\"wp-block-heading\">Conclusion &amp; Outlook <\/h2>\n\n\n\n<p>The concept report from T\u00dcV S\u00dcD is the <strong>first step to proving<\/strong> Paitron\u2019s reliability and safety. We are currently following up on the verification of the underlying algorithms and an evaluation of the processes and test strategy. Furthermore, our mission continues by achieving the same trust in further industries, from automotive (ISO 26262) to machinery (ISO 13849) and Aerospace (DO 254).<\/p>\n\n\n\n<p>The key benefits of receiving the concept report are the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Reduce customers\u2019 liability by following industry standards.<\/li>\n\n\n\n<li>Independent third-party review.<\/li>\n\n\n\n<li>Transparency on the use cases, restrictions, and the technology.<\/li>\n<\/ul>\n\n\n\n<p>We believe that Paitron is a game-changer for the development of safety-related products, as it enables faster, easier, and more accurate verification and validation of system models.&nbsp;We are excited to share our progress and achievements, and we invite you to join us in our journey to make AI a trusted and valuable partner for Functional Safety.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-default\"\/>\n\n\n\n<div style=\"height:1em\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Comments, suggestions? Brickbats, bouquets? Please send your feedback to <a href=\"mailto:editor@modelwise.ai?subject=Feedback%20for%20%22modelwise%20achieves%20T%C3%9CV%20concept%20report%22%20article\" data-type=\"mailto\" data-id=\"mailto:editor@modelwise.ai?subject=Feedback%20for%20%22modelwise%20achieves%20T%C3%9CV%20concept%20report%22%20article\">our editor<\/a>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 id=\"additional-resources\" class=\"wp-block-heading\">Additional Resources<\/h2>\n\n\n\n<h5 id=\"referencesnbsp\" class=\"wp-block-heading\">References <\/h5>\n\n\n\n<p id=\"1\">[1]&nbsp;&nbsp;&nbsp; Dr. Detlev Richter, VP Industrial and Energy Products of the T\u00dcV S\u00dcD Product Service Division, 26.01.2022<\/p>\n\n\n\n<p id=\"2\">[2]&nbsp;&nbsp;&nbsp; T\u00dcV S\u00dcD Ltd. <em>Functional Safety \u2013 Software tool certification for Functional Safety projects <\/em>[online] Available at: <a href=\"https:\/\/www.tuvsud.com\/en-gb\/services\/functional-safety\/software-tool-certification-for-functional-safety-projects\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.tuvsud.com\/en-gb\/services\/functional-safety\/software-tool-certification-for-functional-safety-projects<\/a> [Accessed 16.12.2021]<\/p>\n\n\n\n<p id=\"3\">[3]&nbsp;&nbsp;&nbsp; Oscar Slotosch et al. (2012) &#8211; <em>ISO 26262 &#8211; Tool Chain Analysis Reduces Tool Qualification Costs<\/em> [online] Available at: <a href=\"https:\/\/dl.gi.de\/bitstream\/handle\/20.500.12116\/17563\/27.pdf?sequence=1&amp;isAllowed=y\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/dl.gi.de\/bitstream\/handle\/20.500.12116\/17563\/27.pdf?sequence=1&amp;isAllowed=y<\/a> [Accessed 16.12.2021]<\/p>\n\n\n\n<p id=\"4\">[4]&nbsp;&nbsp;&nbsp; ISO 26262-8:2010, <em>Road vehicles <\/em><em>\u2013<\/em><em> <\/em><em>Functional Safety \u2013 Part 8: Supporting Processes.<\/em><\/p>\n\n\n\n<p id=\"5\">[5]&nbsp;&nbsp;&nbsp; IEC 61508-3:2010, <em>Functional safety of electrical\/electronic\/programmable electronic safety-related systems <\/em><em>\u2013<\/em><em> Part 3: Software requirements.<\/em><\/p>\n\n\n\n<p id=\"6\">[6]&nbsp;&nbsp;&nbsp; Holger Laible. Computer &amp; Automation. <em>KI Klassifikation f\u00fcr Safety<\/em> [online] Available at:&nbsp;<a href=\"https:\/\/www.computer-automation.de\/steuerungsebene\/safety-security\/ki-klassifikation-fuer-safety.187488\/seite-2.html\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.computer-automation.de\/steuerungsebene\/safety-security\/ki-klassifikation-fuer-safety.187488\/seite-2.html<\/a> [Accessed 25.06.2021]<\/p>\n\n\n\n<p id=\"7\">[7]&nbsp;&nbsp;&nbsp; Tom Meany. ez.analog.com. <em>Functional Safety and Artificial Intelligence <\/em>[online] Available at: <a href=\"https:\/\/ez.analog.com\/ez-blogs\/b\/engineerzone-spotlight\/posts\/functional-safety-and-artificial-intelligence-268912509\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/ez.analog.com\/ez-blogs\/b\/engineerzone-spotlight\/posts\/functional-safety-and-artificial-intelligence-268912509 <\/a>[Accessed 16.12.2021]<\/p>\n\n\n\n<div style=\"height:1em\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>This article aims to show how the tool concept of paitron was evaluated from T\u00dcV S\u00dcD and regarding its certification ability as a qualified software for the use in safety-critical applications. <\/p>","protected":false},"author":4,"featured_media":245409,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"off","_et_pb_old_content":"<!-- wp:spacer {\"height\":\"50px\"} -->\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<!-- \/wp:spacer -->\n\n<!-- wp:preformatted -->\n<pre class=\"wp-block-preformatted\"><strong>The TLDR: Too busy to read? Here's a quick summary of article<\/strong>\n\nThis article aims to show how the tool concept of paitron was evaluated from T\u00dcV S\u00dcD and regarding its certification ability as a qualified software for the use in safety-critical applications.<\/pre>\n<!-- \/wp:preformatted -->\n\n<!-- wp:simpletoc\/toc {\"title_level\":1,\"accordion\":true,\"wrapper\":true} \/-->\n\n<!-- wp:heading {\"level\":1} -->\n<h1 class=\"wp-block-heading\">Concept Report&nbsp;<\/h1>\n<!-- \/wp:heading -->\n\n<!-- wp:paragraph {\"dropCap\":true} -->\n<p class=\"has-drop-cap\">In November 2021, the AI-powered modelwise\u2019s paitron was evaluated by T\u00dcV S\u00dcD for the development of safety-related products. According to our knowledge, this is the first tool of its kind, which concept was examined according to international standards and guidelines (ref. chapter 3). The approval of the safety concept is based on the documents listed in chapter 3 of this report.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>As the concept report marks the first step to a full tool qualification, Dr. Detlev Richter, VP of Industrial and Energy Products of the T\u00dcV S\u00dcD Product Service Division commented on the milestone: <\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:quote -->\n<blockquote class=\"wp-block-quote\"><!-- wp:paragraph -->\n<p>\u201cThis means that the integration and automation of Functional Safety validation have taken a step forward in the technical lifecycle of digital twin based systems with regards to product changes\u201d <a href=\"#1\">[1]<\/a>.<\/p>\n<!-- \/wp:paragraph --><\/blockquote>\n<!-- \/wp:quote -->\n\n<!-- wp:paragraph -->\n<p>The following publication covers the aspects, that we at modelwise have to cover and comply with in order to make our AI suitable for all safety integrity levels (SIL). Currently, we are working on fully certifying paitron according to IEC 61508:2010 and ISO 26262:2018. This is to be shown during the so-called detailed phase for the final certification of the tool.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:spacer {\"height\":\"50px\"} -->\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<!-- \/wp:spacer -->\n\n<!-- wp:image {\"align\":\"center\",\"id\":245399,\"sizeSlug\":\"full\",\"linkDestination\":\"none\",\"className\":\"is-style-default\"} -->\n<figure class=\"wp-block-image aligncenter size-full is-style-default\"><img src=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/TUV-SUD-concept-report-certification.png\" alt=\"\" class=\"wp-image-245399\"\/><figcaption class=\"wp-element-caption\"><strong>Figure 1: Cover page of the concept report<\/strong><\/figcaption><\/figure>\n<!-- \/wp:image -->\n\n<!-- wp:heading {\"level\":1} -->\n<h1 class=\"wp-block-heading\">Tool Qualification in Safety-Critical Industries&nbsp;<\/h1>\n<!-- \/wp:heading -->\n\n<!-- wp:paragraph -->\n<p>To reach a defined safety goal, it is important to choose the right software tool right from the beginning of development. Depending on the project needs, the required tools are planned based on the requirement from the safety standards and the related safety levels (ASIL, SIL, etc.) <a href=\"#2\">[2]<\/a>. As \u201ca tool error may lead to the injection or non-detection of a fault in the safety-product\u201d <a href=\"#3\">[3]<\/a>, standards demand that tools are evaluated, and if necessary also qualified, in the context of the development process &amp; toolchain.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>To provide a generic framework and simplify the process for customers and users of such tools, standards allow software providers to qualify tools independent of a specific safety-related project. This qualification depends on the desired safety level. The suggested methods for achieving ASILs are shown in the following table.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:image {\"align\":\"center\",\"id\":245477,\"sizeSlug\":\"full\",\"linkDestination\":\"none\",\"className\":\"is-style-default\"} -->\n<figure class=\"wp-block-image aligncenter size-full is-style-default\"><img src=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-1-TCL-4-Software-Tool-Qualification-According-to-ISO-26262.png\" alt=\"\" class=\"wp-image-245477\"\/><figcaption class=\"wp-element-caption\"><strong>Table 1: TCL 4 Software Tool Qualification According to ISO 26262 <a href=\"#4\">[4]<\/a><\/strong><\/figcaption><\/figure>\n<!-- \/wp:image -->\n\n<!-- wp:table {\"align\":\"center\",\"className\":\"is-style-stripes\",\"fontSize\":\"small\"} -->\n<figure class=\"wp-block-table aligncenter is-style-stripes has-small-font-size\"><table><tbody><tr><td>Legend - Software Tool Qualification<\/td><\/tr><tr><td>++&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The method is highly recommended for this ASIL<br>+&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The method is recommended for this ASIL<br>o&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The method has no recommendation for or against its usage for this ASIL<\/td><\/tr><\/tbody><\/table><\/figure>\n<!-- \/wp:table -->\n\n<!-- wp:spacer {\"height\":\"50px\"} -->\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<!-- \/wp:spacer -->\n\n<!-- wp:paragraph -->\n<p>In our example, this requires a detailed analysis of the following documents to determine a<em> <strong>level of confidence<\/strong><\/em> in the use of the tool.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:list -->\n<ul><!-- wp:list-item -->\n<li>Use Cases to visualize the intended process, highlighting all user inputs and information exchange and identifying all associated risks.<\/li>\n<!-- \/wp:list-item -->\n\n<!-- wp:list-item -->\n<li>Requirements for safe execution incl. mitigation measures were needed for each safety-critical element of the software architecture.<\/li>\n<!-- \/wp:list-item -->\n\n<!-- wp:list-item -->\n<li>Example project, to show compliance with IEC 61508 and to ensure the correctness of our results focusing on the automation capabilities and the distinction to user inputs.<\/li>\n<!-- \/wp:list-item -->\n\n<!-- wp:list-item -->\n<li>Tool providers\u2019 development processes are not in the scope of a concept report.<\/li>\n<!-- \/wp:list-item -->\n\n<!-- wp:list-item -->\n<li>Test Strategy and Test Cases, not the scope of a concept report.<\/li>\n<!-- \/wp:list-item --><\/ul>\n<!-- \/wp:list -->\n\n<!-- wp:paragraph -->\n<p>This consists in balancing the potential impact of tool errors on the safety function with appropriate mitigation measures. The qualification allows stating an envisioned process, which customers and users only have to implement and follow.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>Currently, all AI approaches, incl. Neural Networks and Deep Learning, are not recommended by IEC 61508 <a href=\"#5\">[5]<\/a>, and ISO 26262 does not even mention AI. As of today, the discussion on how to qualify AI is still ongoing. <a href=\"#6\">[6]<\/a> offers a great summary of the current state of the discussion, as it aims to summarize the Technical Report ISO\/IEC TR\u202f5469 Functional Safety and AI systems, which is still under development. The core idea currently floating around is, that as long as the AI is comprehensible and valuable, it can be used in Functional Safety (ref. AI Class I in table 2). One of the reasons for this restriction is, that Functional Safety cannot accept unquantifiable risks, which makes \u201cnon-determinism [\u2026] hard to accept for safety\u201d <a href=\"#7\">[7]<\/a>.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:image {\"align\":\"center\",\"id\":245478,\"sizeSlug\":\"full\",\"linkDestination\":\"none\",\"className\":\"is-style-default\"} -->\n<figure class=\"wp-block-image aligncenter size-full is-style-default\"><img src=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-2-AI-Classification-according-to-TR-5469.png\" alt=\"\" class=\"wp-image-245478\"\/><figcaption class=\"wp-element-caption\"><strong>Table 2: AI Classification According to TR 5469 <a href=\"#6\">[6]<\/a><\/strong><\/figcaption><\/figure>\n<!-- \/wp:image -->\n\n<!-- wp:heading {\"level\":1} -->\n<h1 class=\"wp-block-heading\">Evaluation Process&nbsp;<\/h1>\n<!-- \/wp:heading -->\n\n<!-- wp:paragraph -->\n<p>To meet the standards, multiple documents were reviewed by T\u00dcV S\u00dcD. A review is a verification activity, during which the documents have been evaluated regarding deficiencies, faults, inconsistency, and deviations from standards. Within this process, we were able to show and qualify paitron\u2019s concept, which is fully based on formal verification and theorem proving and is therefore deterministic, comprehensible, and valuable.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>With more than 10 iterations between T\u00dcV S\u00dcD and us, the final concept approval was reached for all relevant documents consisting of:<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:list -->\n<ul><!-- wp:list-item -->\n<li><em>Use<\/em><em> cases analysis<\/em>, which describes for each use case,&nbsp; the preconditions, necessary steps, tools, and actors. Starting from the sea level use cases with a focus on the user goals, the document focuses on identifying all risks.<\/li>\n<!-- \/wp:list-item -->\n\n<!-- wp:list-item -->\n<li><em>Software Architecture Description<\/em> contains distinct architectural views to depict various aspects of the system.&nbsp; It is intended to outline and inform about the significant architectural decisions relevant to the system. These are the elements and behaviors that are most fundamental for guiding the development of the software and for understanding paitron as a whole.<\/li>\n<!-- \/wp:list-item -->\n\n<!-- wp:list-item -->\n<li><em>Software<\/em><em> Requirements Specification, <\/em>where the requirements are specified, prioritized and linked to respective work items. This document shows a structured separation of the different functionalities into dedicated software components.<\/li>\n<!-- \/wp:list-item -->\n\n<!-- wp:list-item -->\n<li><em>Review of an output FMEDA<\/em> of an exemplary system model. The general structure of the output FMEDA was evaluated with a focus on the automated tool features and their incorporation into the user\u2019s workflow.<\/li>\n<!-- \/wp:list-item --><\/ul>\n<!-- \/wp:list -->\n\n<!-- wp:paragraph -->\n<p>The regulations and guidelines which form the basis of the concept evaluation are listed below.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:image {\"align\":\"center\",\"id\":245479,\"sizeSlug\":\"full\",\"linkDestination\":\"none\",\"className\":\"is-style-default\"} -->\n<figure class=\"wp-block-image aligncenter size-full is-style-default\"><img src=\"https:\/\/modelwise.ai\/wp-content\/uploads\/2022\/03\/Table-3-Evaluation-basis.png\" alt=\"\" class=\"wp-image-245479\"\/><figcaption class=\"wp-element-caption\"><strong>Table 3: Evaluation Basis<\/strong><\/figcaption><\/figure>\n<!-- \/wp:image -->\n\n<!-- wp:heading {\"level\":1} -->\n<h1 class=\"wp-block-heading\">Conclusion and Outlook&nbsp;<\/h1>\n<!-- \/wp:heading -->\n\n<!-- wp:paragraph -->\n<p>The concept report from T\u00dcV S\u00dcD is the <strong>first step to proving<\/strong> paitron\u2019s reliability and safety. We are currently following up on the verification of the underlying algorithms and an evaluation of the processes and test strategy.&nbsp; Furthermore, our mission continues by achieving the same trust in further industries, from automotive (ISO 26262) to machinery (ISO 13849) and Aerospace (DO 254).<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>The key benefits of receiving the concept report are the following:<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:list -->\n<ul><!-- wp:list-item -->\n<li>Reduce customers\u2019 liability by following industry standards<\/li>\n<!-- \/wp:list-item -->\n\n<!-- wp:list-item -->\n<li>Independent third-party review<\/li>\n<!-- \/wp:list-item -->\n\n<!-- wp:list-item -->\n<li>Transparency on the use cases, restrictions and the technology<\/li>\n<!-- \/wp:list-item --><\/ul>\n<!-- \/wp:list -->\n\n<!-- wp:separator {\"className\":\"is-style-default\"} -->\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-default\"\/>\n<!-- \/wp:separator -->\n\n<!-- wp:spacer {\"height\":\"10px\"} -->\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<!-- \/wp:spacer -->\n\n<!-- wp:paragraph -->\n<p>Comments, suggestions? Brickbats, bouquets? Please send your feedback to <a href=\"mailto:editor@modelwise.ai?subject=Feedback%20for%20%22modelwise%20achieves%20T%C3%9CV%20concept%20report%22%20article\" data-type=\"mailto\" data-id=\"mailto:editor@modelwise.ai?subject=Feedback%20for%20%22modelwise%20achieves%20T%C3%9CV%20concept%20report%22%20article\">our editor<\/a>.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:separator -->\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n<!-- \/wp:separator -->\n\n<!-- wp:heading -->\n<h2 class=\"wp-block-heading\">References&nbsp;<\/h2>\n<!-- \/wp:heading -->\n\n<!-- wp:paragraph -->\n<p id=\"1\">[1]&nbsp;&nbsp;&nbsp; Dr. Detlev Richter, VP Industrial and Energy Products of the T\u00dcV S\u00dcD Product Service Division, 26.01.2022<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p id=\"2\">[2]&nbsp;&nbsp;&nbsp; T\u00dcV S\u00dcD Ltd. <em>Functional Safety \u2013 Software tool certification for Functional Safety projects <\/em>[online] Available at: <a href=\"https:\/\/www.tuvsud.com\/en-gb\/services\/functional-safety\/software-tool-certification-for-functional-safety-projects\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.tuvsud.com\/en-gb\/services\/functional-safety\/software-tool-certification-for-functional-safety-projects<\/a> [Accessed 16 December 2021]<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p id=\"3\">[3]&nbsp;&nbsp;&nbsp; Oscar Slotosch et al. (2012) - <em>ISO 26262 - Tool Chain Analysis Reduces Tool Qualification Costs<\/em> [online] Available at: <a href=\"https:\/\/dl.gi.de\/bitstream\/handle\/20.500.12116\/17563\/27.pdf?sequence=1&amp;isAllowed=y\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/dl.gi.de\/bitstream\/handle\/20.500.12116\/17563\/27.pdf?sequence=1&amp;isAllowed=y<\/a> [Accessed 16.12.2021]<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p id=\"4\">[4]&nbsp;&nbsp;&nbsp; ISO 26262-8:2010, <em>Road vehicles <\/em><em>\u2013<\/em><em> <\/em><em>Functional Safety \u2013 Part 8: Supporting Processes.<\/em><\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p id=\"5\">[5]&nbsp;&nbsp;&nbsp; IEC 61508-3:2010, <em>Functional safety of electrical\/electronic\/programmable electronic safety-related systems <\/em><em>\u2013<\/em><em> Part 3: Software requirements.<\/em><\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p id=\"6\">[6]&nbsp;&nbsp;&nbsp; Holger Laible. Computer &amp; Automation. <em>KI Klassifikation f\u00fcr Safety<\/em> [online] Available at:&nbsp;<a href=\"https:\/\/www.computer-automation.de\/steuerungsebene\/safety-security\/ki-klassifikation-fuer-safety.187488\/seite-2.html\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.computer-automation.de\/steuerungsebene\/safety-security\/ki-klassifikation-fuer-safety.187488\/seite-2.html<\/a> [Accessed 25.06.2021]<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p id=\"7\">[7]&nbsp;&nbsp;&nbsp; Tom Meany. ez.analog.com. <em>Functional Safety and Artificial Intelligence <\/em>[online] Available at: <a href=\"https:\/\/ez.analog.com\/ez-blogs\/b\/engineerzone-spotlight\/posts\/functional-safety-and-artificial-intelligence-268912509\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/ez.analog.com\/ez-blogs\/b\/engineerzone-spotlight\/posts\/functional-safety-and-artificial-intelligence-268912509 <\/a>[Accessed 16.12.2021]<\/p>\n<!-- \/wp:paragraph -->","_et_gb_content_width":"","content-type":"","footnotes":""},"categories":[133],"tags":[50,34,38,52],"class_list":["post-245056","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tech-takes","tag-concept-report","tag-modelwise","tag-paitron","tag-tool-qualification"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Modelwise Achieves T\u00dcV S\u00dcD Concept Report<\/title>\n<meta name=\"description\" content=\"Ensure trustworthy AI for safety-critical systems! 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