{"id":3799,"date":"2026-03-18T15:32:08","date_gmt":"2026-03-18T15:32:08","guid":{"rendered":"https:\/\/qmh-group.com\/guenter-nuss\/"},"modified":"2026-09-04T09:16:57","modified_gmt":"2026-09-04T09:16:57","slug":"guenter-nuss","status":"publish","type":"page","link":"https:\/\/qmh-group.com\/en\/guenter-nuss\/","title":{"rendered":"G\u00fcnter Nuss"},"content":{"rendered":"<div class=\"et_pb_section_0 et_pb_section et_section_regular et_block_section\"><div class=\"et_pb_row_0 et_pb_row et_flex_row\"><div class=\"et_pb_column_0 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_2_5 et_flex_column_2_5_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_image_0 et_pb_image et_pb_module et_flex_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/qmh-group.com\/wp-content\/uploads\/2025\/07\/qmh-Guenter-Nuss_Q-Format_2025.png\" alt=\"G\u00fcnter Nuss, Gesch\u00e4ftsf\u00fchrer\" width=\"500\" height=\"505\" class=\"wp-image-887\" \/><\/span><\/div><\/div><div class=\"et_pb_column_1 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_3_5 et_flex_column_3_5_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_1 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_2 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_0 et_pb_text et_pb_bg_layout_dark et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h1>G\u00fcnter Nuss<\/h1>\n<\/div><\/div><div class=\"et_pb_text_1 et_pb_text et_pb_bg_layout_dark et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Managing Director<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_text_2 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h2>Areas of Expertise<\/h2>\n<\/div><\/div><div class=\"et_pb_row_2 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_3 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_3 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><span class=\"\">Management systems<\/span><\/p>\n<\/div><\/div><div class=\"et_pb_text_4 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>IATF<\/p>\n<\/div><\/div><div class=\"et_pb_text_5 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>FMEA<\/p>\n<\/div><\/div><div class=\"et_pb_text_6 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>Audits<\/p>\n<\/div><\/div><div class=\"et_pb_text_7 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>Core Tools<\/p>\n<\/div><\/div><div class=\"et_pb_text_8 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>Problem-solving techniques<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_3 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_4 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_blurb_0 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_clickable et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>guenter.nuss@qmh-group.com<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_0_wrapper\"><a class=\"et_pb_button_0 et_pb_button et_pb_bg_layout_light et_pb_module et_block_module\" href=\"#arbeitsstil\" data-icon=\"\uf0a9\"><span class=\"et-pb-parallax-content\">This defines G\u00fcnter<\/span><\/a><\/div><\/div><\/div><\/div><div class=\"et_pb_section_1 et_pb_section et_section_regular et_flex_section\"><div class=\"et_pb_row_4 et_pb_row et_flex_row\"><div class=\"et_pb_column_5 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_3_5 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_9 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module et_pb_text_align_center\"><div class=\"et_pb_text_inner\"><h3>G\u00fcnter's Experiences and Competencies<\/h3>\n<\/div><\/div><div class=\"et_pb_text_10 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss brings with him<strong> experience spanning the entire automotive industry<\/strong> \u2013 from OEMs and Tier 1 suppliers to supplier development.<\/p>\n<p>As a<strong> graduate engineer in production engineering,<\/strong> he is now an expert in process quality, product safety and complex management systems.<\/p>\n<p>He thinks in terms of <strong>structures, analyses weaknesses and ensures that companies are positioned securely and are fit for the future<\/strong>. Whether it\u2019s VDA 6.3, FMEA, SPICE or risk analysis \u2013 <strong>G\u00fcnter not only knows the theory, but also ensures robust implementation.<\/strong><br \/>His ethos: technically strong, approachable \u2013 and always ready to share his knowledge. <\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_6 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_2_5 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_11 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module et_pb_text_align_center\"><div class=\"et_pb_text_inner\"><h3>Qualifications<\/h3>\n<\/div><\/div><div class=\"et_pb_blurb_1 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Trained Automobile-Mechatronic<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_2 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Dipl.-Ing. Production Techniques<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_3 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>REFA Industrial Engineer<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_4 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Automotive SPICE Provisional Assessor<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_5 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Process-Auditor VDA 6.3 (VDA-QMC)<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_6 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>1st and 2nd Party Auditor IATF 16949 (VDA-QMC)<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_row_5 et_pb_row et_flex_row et_animated\" id=\"arbeitsstil\"><div class=\"et_pb_column_7 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_3_5 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_12 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module et_pb_text_align_center\"><div class=\"et_pb_text_inner\"><h3>Personal way of working:<\/h3>\n<\/div><\/div><div class=\"et_pb_text_13 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter works<strong> strategically<\/strong> and in a <strong>structured<\/strong> manner, with a clear focus on sustainable business development. As managing director, he combines <strong>many years\u2019 experience i<\/strong>n the automotive industry with a <strong>practical and solution-oriented approach.<\/strong> <\/p>\n<p>He has a quick grasp on complex issues, creating clear structures and leading teams in a goal-oriented manner. In projects and when working with clients, he attaches great importance to <strong>efficiency, reliability <\/strong>and <strong>communication based on partnership and mutual respect.<\/strong> <\/p>\n<\/div><\/div><div class=\"et_pb_row_6 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_8 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_blurb_7 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap et_pb_only_image_mode_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/qmh-group.com\/wp-content\/uploads\/2026\/01\/QMH-Consulting-Ansprechpartner-Sprachen-Deutsch.webp\" width=\"150\" height=\"150\" class=\"wp-image-2176\" \/><\/span><\/div><div class=\"et_pb_blurb_container\"><h4 class=\"et_pb_module_header\">German<\/h4><div class=\"et_pb_blurb_description\"><p>Native Speaker<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_8 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap et_pb_only_image_mode_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/qmh-group.com\/wp-content\/uploads\/2026\/01\/QMH-Consulting-Ansprechpartner-Sprachen-Englisch.webp\" width=\"150\" height=\"150\" class=\"wp-image-2177\" \/><\/span><\/div><div class=\"et_pb_blurb_container\"><h4 class=\"et_pb_module_header\">English<\/h4><div class=\"et_pb_blurb_description\"><p>Fluent<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_column_9 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_2_5 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_14 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module et_pb_text_align_center\"><div class=\"et_pb_text_inner\"><h3>This defines G\u00fcnter:<\/h3>\n<\/div><\/div><div class=\"et_pb_blurb_9 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Many years\u2019 experience across the entire value chain of the automotive industry<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_10 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Strategic thinking combined with practical implementation<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_11 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Extensive expertise in process quality, product safety and management systems<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_12 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Structured analysis of complex challenges<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_13 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>A strong team player with clear leadership and organisational skills<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_row_7 et_pb_row et_flex_row\"><div class=\"et_pb_column_10 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_1_wrapper\"><a class=\"et_pb_button_1 et_pb_button et_pb_bg_layout_light et_pb_module et_block_module\" href=\"https:\/\/qmh-group.com\/termin-vereinbaren\/\" target=\"_blank\" data-icon=\"\uf0a9\"><span class=\"et-pb-parallax-content\">Arrange consultation<\/span><\/a><\/div><\/div><\/div><\/div><div class=\"et_pb_section_2 et_pb_section et_section_regular et_block_section\" id=\"vorteile\"><div class=\"et_pb_row_8 et_pb_row et_flex_row\"><div class=\"et_pb_column_11 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_15 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module et_flex_column_24_24 et_flex_column_24_24_tablet\"><div class=\"et_pb_text_inner\"><h3>Technology and Industry Experience<\/h3>\n<\/div><\/div><div class=\"et_pb_blurb_14 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Project management in development projects<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_15 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Establishing effective risk management structures<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_16 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Optimisation of structural and operational organisations<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_17 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Cross-sector industrial experience<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_18 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Introduction of integrated management systems<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_19 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Quality assurance in process engineering<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_20 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Process optimisation and strategy projects<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_21 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Optimising business processes across the value chain<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_column_12 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_16 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_inner\"><h3>Challenges I Can Help You Overcome<\/h3>\n<\/div><\/div><div class=\"et_pb_blurb_22 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Process- und Systemaudits (z. B. VDA 6.3)<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_23 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Risik analysis and FMEA<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_24 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Automotive SPICE and Quality Management<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_25 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Establishment and further development of management systems<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_26 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_block_module\"><div class=\"et_pb_blurb_content\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Process optimisation and sustainable quality improvement<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_row_9 et_pb_row et_flex_row\"><div class=\"et_pb_column_13 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_2_wrapper\"><a class=\"et_pb_button_2 et_pb_button et_pb_bg_layout_light et_pb_module et_block_module\" href=\"https:\/\/qmh-group.com\/termin-vereinbaren\/\" target=\"_blank\" data-icon=\"\uf0a9\"><span class=\"et-pb-parallax-content\">Arrange consultation<\/span><\/a><\/div><\/div><\/div><\/div><div class=\"et_pb_section_3 et_pb_section et_section_regular et_flex_section\"><div class=\"et_pb_row_10 et_pb_row et_block_row\"><div class=\"et_pb_column_14 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\"><div class=\"et_pb_text_17 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>References<\/p>\n<\/div><\/div><div class=\"et_pb_text_18 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h2>G\u00fcnter's projects<\/h2>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_11 et_pb_row et_flex_row\"><div class=\"et_pb_column_15 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_group_carousel_0 et_pb_group_carousel et_pb_group et_pb_module et_pb_group_carousel_arrows_outside et_pb_group_carousel_dots_center et_pb_group_carousel_dots_below\"><div class=\"et_pb_group_carousel_container\"><div class=\"et_pb_group_carousel_track\"><div class=\"et_pb_group_carousel_slide\"><div class=\"et_pb_group_0 et_pb_group et_pb_module et_flex_group et_pb_css_mix_blend_mode_passthrough\" data-loop-item=\"0\" data-loop-key=\"loop-myvyepgi0i\" data-loop-source=\"loop-myvyepgi0i\"><div class=\"et_pb_row_12 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_16 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_13 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_17 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_19 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h3>European aircraft manufacturer \u2013 FMEA<\/h3>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_14 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_18 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_15 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_19 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_phone\"><div class=\"et_pb_group_1 et_pb_group et_pb_module et_flex_group et_pb_css_mix_blend_mode_passthrough\"><div class=\"et_pb_row_16 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_20 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_20 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Category<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_21 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_21 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>FMEA<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_17 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_22 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_22 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Industry<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_23 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_23 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Aerospace<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_18 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_24 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_24 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Company<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_25 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_25 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>International aerospace group with approximately 150,000 employees<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_19 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_26 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_26 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Contact person<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_27 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_27 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_text_28 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Initial situation<\/h4>\n<\/div><div class=\"et_pb_text_29 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Highly complex development and manufacturing processes; global engineering teams; stringent documentation and traceability requirements<\/p>\n<\/div><\/div><\/div><div class=\"et_pb_text_30 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Challenge<\/h4>\n<\/div><div class=\"et_pb_text_31 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Aviation projects require robust and systematic risk analyses. FMEA processes had been applied inconsistently, in some cases having developed over time. The client was seeking methodological expertise, experience with safety-critical and complex systems, and professional facilitation in a demanding and critical team environment.  <\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_column_28 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_phone\"><div class=\"et_pb_text_32 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h4>Approach to a solution<\/h4>\n<\/div><div class=\"et_pb_blurb_27 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Analysis of existing FMEA structures and identification of opportunities for optimisation<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_28 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Harmonisation of procedures to ensure consistent and effective application of FMEA<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_29 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Facilitating interdisciplinary FMEA workshops with the relevant departments<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_30 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Development of a consistent approach to risk and measures<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_31 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Coaching the engineering teams and ensuring that documentation is audit-ready<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_text_33 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Result<\/h4>\n<\/div><div class=\"et_pb_text_34 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Significantly improved traceability and quality of risk analyses; standardised FMEA methodology; reduction in safety-critical risks<\/p>\n<\/div><\/div><\/div><div class=\"et_pb_row_20 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_29 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_image_1 et_pb_image et_pb_module et_flex_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/qmh-group.com\/wp-content\/uploads\/2025\/07\/qmh-Guenter-Nuss_Q-Format_2025.png\" width=\"500\" height=\"505\" class=\"wp-image-887\" alt=\"Dr. Tobias Montag, Senior Consultant\" \/><\/span><\/div><\/div><div class=\"et_pb_column_30 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_35 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss<\/p>\n<\/div><\/div><div class=\"et_pb_text_36 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>Managing Director<\/p>\n<\/div><\/div><div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_3_wrapper\"><a class=\"et_pb_button_3 et_pb_button et_pb_bg_layout_light et_pb_module et_flex_module\" href=\"https:\/\/qmh-group.com\/termin-vereinbaren\/\"><span class=\"et-pb-parallax-content\">Arrange consultation<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_group_carousel_slide\"><div class=\"et_pb_group_2 et_pb_group et_pb_module et_flex_group et_pb_css_mix_blend_mode_passthrough\" data-loop-item=\"1\" data-loop-key=\"loop-myvyepgi0i\" data-loop-source=\"loop-myvyepgi0i\"><div class=\"et_pb_row_21 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_31 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_22 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_32 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_37 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h3>Company-wide training on the implementation of an FMEA process<\/h3>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_23 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_33 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_24 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_34 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_phone\"><div class=\"et_pb_group_3 et_pb_group et_pb_module et_flex_group et_pb_css_mix_blend_mode_passthrough\"><div class=\"et_pb_row_25 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_35 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_38 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Category<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_36 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_39 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Training<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_26 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_37 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_40 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Industry<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_38 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_41 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Mechanical Engineering<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_27 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_39 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_42 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Company<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_40 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_43 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>A medium-sized German manufacturer <\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_28 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_41 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_44 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Contact person<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_42 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_45 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_text_46 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Initial situation<\/h4>\n<\/div><div class=\"et_pb_text_47 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Different RD departments without a standardised methodology; specific characteristics were not consistently identified; no professional FMEA software was in use <\/p>\n<\/div><\/div><\/div><div class=\"et_pb_text_48 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Challenge<\/h4>\n<\/div><div class=\"et_pb_text_49 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>A lack of standardisation led to significant variation in the way FMEA was carried out. The client was seeking methodological expertise, process design know-how and experience in selecting and implementing professional FMEA software. Furthermore, coaching for the facilitators was crucial to ensuring the sustainable application of FMEA.  <\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_column_43 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_phone\"><div class=\"et_pb_text_50 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h4>Approach to a solution<\/h4>\n<\/div><div class=\"et_pb_blurb_32 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Analysis of existing processes as a basis for the reorientation of the FMEA<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_33 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Design and implementation of a harmonised FMEA workflow<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_34 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Definition of a clear logical framework for identifying specific characteristics<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_35 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Evaluation, selection and piloting of suitable FMEA tools<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_36 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Training, coaching for facilitators and support during the roll-out<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_text_51 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Result<\/h4>\n<\/div><div class=\"et_pb_text_52 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>A standardised FMEA process, improved risk transparency, a clear framework for special characteristics, carefully selected and implemented software, and trained facilitators with long-term practical expertise<\/p>\n<\/div><\/div><\/div><div class=\"et_pb_row_29 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_44 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_image_2 et_pb_image et_pb_module et_flex_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/qmh-group.com\/wp-content\/uploads\/2025\/07\/qmh-Guenter-Nuss_Q-Format_2025.png\" width=\"500\" height=\"505\" class=\"wp-image-887\" alt=\"Dr. Tobias Montag, Senior Consultant\" \/><\/span><\/div><\/div><div class=\"et_pb_column_45 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_53 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss<\/p>\n<\/div><\/div><div class=\"et_pb_text_54 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>Managing Director<\/p>\n<\/div><\/div><div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_4_wrapper\"><a class=\"et_pb_button_4 et_pb_button et_pb_bg_layout_light et_pb_module et_flex_module\" href=\"https:\/\/qmh-group.com\/termin-vereinbaren\/\"><span class=\"et-pb-parallax-content\">Arrange consultation<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_group_carousel_slide\"><div class=\"et_pb_group_4 et_pb_group et_pb_module et_flex_group et_pb_css_mix_blend_mode_passthrough\" data-loop-item=\"2\" data-loop-key=\"loop-myvyepgi0i\" data-loop-source=\"loop-myvyepgi0i\"><div class=\"et_pb_row_30 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_46 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_31 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_47 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_55 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h3>International medical technology manufacturer \u2013 FMEA facilitation<\/h3>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_32 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_48 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_33 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_49 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_phone\"><div class=\"et_pb_group_5 et_pb_group et_pb_module et_flex_group et_pb_css_mix_blend_mode_passthrough\"><div class=\"et_pb_row_34 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_50 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_56 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Category<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_51 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_57 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>FMEA<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_35 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_52 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_58 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Industry<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_53 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_59 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Medical technology<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_36 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_54 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_60 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Company<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_55 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_61 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>A medical technology manufacturer based in northern Germany with around 16,000 employees<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_37 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_56 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_62 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Contact person<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_57 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_63 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_text_64 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Initial situation<\/h4>\n<\/div><div class=\"et_pb_text_65 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Development projects running in parallel; different teams specialising in mechanics, electronics, software and production; FMEA methods not applied consistently, particularly at the interface with FTA and FMEDA<\/p>\n<\/div><\/div><\/div><div class=\"et_pb_text_66 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Challenge<\/h4>\n<\/div><div class=\"et_pb_text_67 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>There was a significant need for coordination between interdisciplinary teams; the lack of a structured facilitation approach led to long lead times and a lack of transparency in risk assessment. The client was seeking a facilitator with a sound grasp of methodology and a comprehensive understanding of systems, design, processes and medical technology. <\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_column_58 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_phone\"><div class=\"et_pb_text_68 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h4>Approach to a solution<\/h4>\n<\/div><div class=\"et_pb_blurb_37 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Establishment of the FMEA structure at system level, including requirements management and coordination of mechanical, hardware and software aspects<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_38 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Facilitating DFMEA and PFMEA workshops with the relevant departments<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_39 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Harmonisation of the assessment framework and the structured development of effective measures<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_40 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Methodology coaching for participants to ensure the reliable and consistent application of FMEA<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_41 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Documentation, review and support with the approval process, including change management<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_text_69 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Result<\/h4>\n<\/div><div class=\"et_pb_text_70 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>More efficient and effective FMEA creation; improved team collaboration (CFT); clear risk transparency, including residual risks; reduced development risks; audit-ready, structured FMEA documentation <\/p>\n<\/div><\/div><\/div><div class=\"et_pb_row_38 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_59 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_image_3 et_pb_image et_pb_module et_flex_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/qmh-group.com\/wp-content\/uploads\/2025\/07\/qmh-Guenter-Nuss_Q-Format_2025.png\" width=\"500\" height=\"505\" class=\"wp-image-887\" alt=\"Dr. Tobias Montag, Senior Consultant\" \/><\/span><\/div><\/div><div class=\"et_pb_column_60 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_71 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss<\/p>\n<\/div><\/div><div class=\"et_pb_text_72 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>Managing Director<\/p>\n<\/div><\/div><div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_5_wrapper\"><a class=\"et_pb_button_5 et_pb_button et_pb_bg_layout_light et_pb_module et_flex_module\" href=\"https:\/\/qmh-group.com\/termin-vereinbaren\/\"><span class=\"et-pb-parallax-content\">Arrange consultation<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_group_carousel_slide\"><div class=\"et_pb_group_6 et_pb_group et_pb_module et_flex_group et_pb_css_mix_blend_mode_passthrough\" data-loop-item=\"3\" data-loop-key=\"loop-myvyepgi0i\" data-loop-source=\"loop-myvyepgi0i\"><div class=\"et_pb_row_39 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_61 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_40 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_62 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_73 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h3>Global medical technology manufacturer \u2013 FDA-compliant risk management<\/h3>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_41 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_63 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_42 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_64 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_phone\"><div class=\"et_pb_group_7 et_pb_group et_pb_module et_flex_group et_pb_css_mix_blend_mode_passthrough\"><div class=\"et_pb_row_43 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_65 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_74 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Category<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_66 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_75 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>ISO 13485<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_44 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_67 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_76 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Industry<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_68 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_77 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Medical technology<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_45 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_69 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_78 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Company<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_70 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_79 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>International holding company with approximately 31,000 employees<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_46 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_71 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_80 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Contact person<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_72 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_81 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_text_82 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Initial situation<\/h4>\n<\/div><div class=\"et_pb_text_83 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Several global production sites; a process landscape that has evolved over time with inconsistent RM; validation documentation (IQ, Installation, OQ, Operational, PQ, Performance) not consistently harmonised; FDA audits are becoming increasingly critical, highlighting non-conformities<\/p>\n<\/div><\/div><\/div><div class=\"et_pb_text_84 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Challenge<\/h4>\n<\/div><div class=\"et_pb_text_85 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Complex regulatory requirements (FDA, ISO 14971, MDR). A lack of consistent PFMEA structures across critical \u2013 and, in particular, innovative \u2013 manufacturing processes such as vacuum brazing, assembly and testing. The client required a partner with an in-depth understanding of medical technology processes, regulatory compliance and the practical implementation of PFMEA.  <\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_column_73 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_phone\"><div class=\"et_pb_text_86 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h4>Approach to a solution<\/h4>\n<\/div><div class=\"et_pb_blurb_42 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Documentation and analysis of current processes<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_43 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Establishment of an FDA-compliant PFMEA framework<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_44 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Derivation of process test strategies<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_45 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Preparation and harmonisation of validation documents (IQ\/OQ\/PQ)<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_46 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Workshops with RD and Q; support until the organisation is ready for an FDA audit<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_text_87 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Result<\/h4>\n<\/div><div class=\"et_pb_text_88 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Robust, audit-proof PFMEA for critical and innovative processes; a targeted, clearly defined validation workflow; a reduction in regulatory FDA findings; improved and systematic root cause analysis, reproducibility and process stability<\/p>\n<\/div><\/div><\/div><div class=\"et_pb_row_47 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_74 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_image_4 et_pb_image et_pb_module et_flex_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/qmh-group.com\/wp-content\/uploads\/2025\/07\/qmh-Guenter-Nuss_Q-Format_2025.png\" width=\"500\" height=\"505\" class=\"wp-image-887\" alt=\"Dr. Tobias Montag, Senior Consultant\" \/><\/span><\/div><\/div><div class=\"et_pb_column_75 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_89 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss<\/p>\n<\/div><\/div><div class=\"et_pb_text_90 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>Managing Director<\/p>\n<\/div><\/div><div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_6_wrapper\"><a class=\"et_pb_button_6 et_pb_button et_pb_bg_layout_light et_pb_module et_flex_module\" href=\"https:\/\/qmh-group.com\/termin-vereinbaren\/\"><span class=\"et-pb-parallax-content\">Arrange consultation<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_group_carousel_slide\"><div class=\"et_pb_group_8 et_pb_group et-last-child et_pb_module et_flex_group et_pb_css_mix_blend_mode_passthrough\" data-loop-item=\"4\" data-loop-key=\"loop-myvyepgi0i\" data-loop-source=\"loop-myvyepgi0i\"><div class=\"et_pb_row_48 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_76 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_49 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_77 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_91 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h3>Premium German car manufacturer \u2013 DFMEA process harmonisation<\/h3>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_50 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_78 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_row_51 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_79 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_phone\"><div class=\"et_pb_group_9 et_pb_group et_pb_module et_flex_group et_pb_css_mix_blend_mode_passthrough\"><div class=\"et_pb_row_52 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_80 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_92 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Category<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_81 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_93 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>FMEA<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_53 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_82 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_94 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Industry<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_83 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_95 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Automotive<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_54 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_84 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_96 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Company<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_85 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_97 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Global OEM with approximately 175,000 employees<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_row_55 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_86 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_98 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><strong>Contact person<\/strong><\/p>\n<\/div><\/div><\/div><div class=\"et_pb_column_87 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_99 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_text_100 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Initial situation<\/h4>\n<\/div><div class=\"et_pb_text_101 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Various engineering sites worldwide, diverse FMEA methods; a documentation landscape that has evolved over time; a lack of harmonisation between product families<\/p>\n<\/div><\/div><\/div><div class=\"et_pb_text_102 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Challenge<\/h4>\n<\/div><div class=\"et_pb_text_103 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>High complexity due to multiple product lines and global development sites. A lack of consistency led to quality risks. The client was seeking a partner with a deep methodological understanding of DFMEA, basic and family FMEA, and automotive best practices.  <\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_column_88 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_24_24_phone\"><div class=\"et_pb_text_104 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h4>Approach to a solution<\/h4>\n<\/div><div class=\"et_pb_blurb_47 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Analysis of existing FMEA processes<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_48 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p> Definition of the target methodology<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_49 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Establishing a scalable family FMEA structure<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_50 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Workshops with RD<\/p>\n<\/div><\/div><\/div><\/div><div class=\"et_pb_blurb_51 et_pb_blurb et_pb_bg_layout_light et_pb_blurb_position_left et_pb_module et_flex_module acf-blurb-hide-empty\"><div class=\"et_pb_blurb_content et_flex_module\"><div class=\"et_pb_main_blurb_image\"><span class=\"et_pb_image_wrap\"><span class=\"et-pb-icon\"><\/span><\/span><\/div><div class=\"et_pb_blurb_container\"><div class=\"et_pb_blurb_description\"><p>Pilot phase and global roll-out<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"et_pb_text_105 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Result<\/h4>\n<\/div><div class=\"et_pb_text_106 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>A standardised, robust DFMEA structure across all relevant product families; increased reusability; reduced development effort; improved predictive quality assurance<\/p>\n<\/div><\/div><\/div><div class=\"et_pb_row_56 et_pb_row et_pb_row_nested et_flex_row\"><div class=\"et_pb_column_89 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_image_5 et_pb_image et_pb_module et_flex_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/qmh-group.com\/wp-content\/uploads\/2025\/07\/qmh-Guenter-Nuss_Q-Format_2025.png\" width=\"500\" height=\"505\" class=\"wp-image-887\" alt=\"Dr. Tobias Montag, Senior Consultant\" \/><\/span><\/div><\/div><div class=\"et_pb_column_90 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_16_24 et_flex_column_16_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_text_107 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>G\u00fcnter Nuss<\/p>\n<\/div><\/div><div class=\"et_pb_text_108 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>Managing Director<\/p>\n<\/div><\/div><div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_7_wrapper\"><a class=\"et_pb_button_7 et_pb_button et_pb_bg_layout_light et_pb_module et_flex_module\" href=\"https:\/\/qmh-group.com\/termin-vereinbaren\/\"><span class=\"et-pb-parallax-content\">Arrange consultation<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><span class=\"et_pb_group_carousel_arrow et_pb_group_carousel_arrow_prev\" role=\"button\" tabindex=\"0\" aria-label=\"Previous slide\"><span class=\"et-pb-icon\">4<\/span><\/span><span class=\"et_pb_group_carousel_arrow et_pb_group_carousel_arrow_next\" role=\"button\" tabindex=\"0\" aria-label=\"Next slide\"><span class=\"et-pb-icon\">5<\/span><\/span><div class=\"et_pb_group_carousel_dots\"><\/div><\/div><\/div><\/div><div class=\"et_pb_row_57 et_pb_row et_flex_row\"><div class=\"et_pb_column_91 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\"><div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_8_wrapper\"><a class=\"et_pb_button_8 et_pb_button et_pb_bg_layout_light et_pb_module et_block_module\" href=\"\" target=\"_blank\" data-icon=\"\uf0a9\"><span class=\"et-pb-parallax-content\">See all use cases<\/span><\/a><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":10,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-3799","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/qmh-group.com\/en\/wp-json\/wp\/v2\/pages\/3799","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/qmh-group.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/qmh-group.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/qmh-group.com\/en\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/qmh-group.com\/en\/wp-json\/wp\/v2\/comments?post=3799"}],"version-history":[{"count":10,"href":"https:\/\/qmh-group.com\/en\/wp-json\/wp\/v2\/pages\/3799\/revisions"}],"predecessor-version":[{"id":3866,"href":"https:\/\/qmh-group.com\/en\/wp-json\/wp\/v2\/pages\/3799\/revisions\/3866"}],"wp:attachment":[{"href":"https:\/\/qmh-group.com\/en\/wp-json\/wp\/v2\/media?parent=3799"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}