{"id":341,"date":"2019-02-01T08:08:55","date_gmt":"2019-02-01T08:08:55","guid":{"rendered":"https:\/\/glutenfreepleasure.com\/__proxy_domain\/racer.com.sg\/?page_id=341"},"modified":"2024-01-17T08:31:36","modified_gmt":"2024-01-17T08:31:36","slug":"quality-system","status":"publish","type":"page","link":"https:\/\/glutenfreepleasure.com\/__proxy_domain\/racer.com.sg\/quality-system\/","title":{"rendered":"Quality System"},"content":{"rendered":"<div class=\"wpb-content-wrapper\" id=\"wpb-content-root\"><p>[vc_row css=&#8221;.vc_custom_1543394941992{margin-bottom: 50px !important;}&#8221;][vc_column][rev_slider_vc alias=&#8221;quality-system&#8221;][vc_separator][vc_column_text]&nbsp;<\/p>\n<p>&nbsp;[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1543469557138{margin-bottom: 20px !important;}&#8221; el_id=&#8221;quality-system&#8221;][vc_column css=&#8221;.vc_custom_1543394957854{margin-bottom: 25px !important;}&#8221;][vc_tta_tour style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; controls_size=&#8221;md&#8221; active_section=&#8221;1&#8243;][vc_tta_section title=&#8221;Supply Chain Management&#8221; tab_id=&#8221;1543469504366-933c0baf-ea3b&#8221;][vc_single_image image=&#8221;67&#8243; img_size=&#8221;full&#8221; onclick=&#8221;link_image&#8221;][vc_column_text]&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\">We are <strong>constantly improving our processes<\/strong> to keep up with stringent manufacturing demands and technological advancements. Harnessing the power of <strong>LEAN and KANBAN methodologies<\/strong>, we empower businesses to streamline operations, reduce waste, and achieve operational excellence.<\/span><\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<p>&nbsp;<\/p>\n<ol>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>LEAN Principles:<\/strong>\u00a0We are committed to the fundamental principles of LEAN, focusing on the elimination of waste, continuous improvement, and respect for people. Our experts work closely with your team to identify inefficiencies and implement sustainable solutions that optimise your processes.<\/span><\/li>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>KANBAN Methodology:<\/strong> Leveraging the visual and adaptive KANBAN approach, we help organisations visualise workflow, manage work in progress, and achieve a smooth, just-in-time production flow. This results in improved communication, reduced lead times, and increased overall productivity.\u00a0<\/span><\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<hr \/>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>The adaptive nature of our processes\u00a0<\/strong>allows our organisation to quickly respond to changes in demand, market conditions, and internal dynamics, fostering agility and resilience.<strong>\u00a0As a result,<\/strong> we managed to &#8212; Double our labour productivity | Cut production throughput time | Reduce inventories by 90 percent | Cutting errors , hence building better partnership with our partners.<\/span><\/p>\n<p>&nbsp;[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quality Control Systems&#8221; tab_id=&#8221;1543469504528-f628f176-50b9&#8243;][vc_column_text]<img decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/sle.ie\/app\/uploads\/2021\/07\/ISOpng.png\" alt=\"ISO 13485 &amp; ISO 14001 - Smithstown Light Engineering\" \/><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\">Adherence to quality control principles is essential to ensure the <strong>safety, efficacy, and reliability of medical devices<\/strong> <strong>throughout their lifecycle.<\/strong> Additionally, compliance with relevant regulatory standards, such as ISO 13485 and FDA<strong> regulations<\/strong>, is critical for market approval and maintaining the trust of stakeholders.<\/span><\/p>\n<p>&nbsp;<\/p>\n<ol>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>Quality Management System (QMS):<\/strong><\/span>\n<ul>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\">Implement and maintain a robust Quality Management System that complies with relevant standards and regulations (e.g., ISO 13485). A QMS provides a framework for documenting, monitoring, and improving processes.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>Document Control:<\/strong><\/span>\n<ul>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\">Establish procedures for document control to ensure that all documents related to manufacturing processes, specifications, and quality standards are controlled, updated, and easily accessible.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>Design Controls:<\/strong><\/span>\n<ul>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\">Integrate design controls to manage the development and design changes of medical devices. This includes validation and verification processes to ensure the safety and efficacy of the device.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>Non-Conforming Product Management:<\/strong><\/span>\n<ul>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\">Establish procedures for identifying, segregating, and addressing non-conforming products. Implement corrective and preventive actions to mitigate the risk of recurrence.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>Traceability and Lot Control:<\/strong><\/span>\n<ul>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\">Ensure traceability of materials and components throughout the manufacturing process. Implement lot control to facilitate the identification and tracking of batches or lots.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>Calibration and Maintenance:<\/strong><\/span>\n<ul>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\">Regularly calibrate and maintain equipment used in the manufacturing process to ensure accuracy and reliability. Establish a calibration schedule and maintain records.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>&nbsp;[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Process Validation (IOPQ)&#8221; tab_id=&#8221;1543469504681-99bf629f-edf5&#8243;][vc_single_image image=&#8221;69&#8243; img_size=&#8221;full&#8221; onclick=&#8221;link_image&#8221;][vc_column_text]&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\">Implement process validation protocols to ensure that manufacturing processes consistently produce products that meet pre-defined specifications. This includes <strong>IQ (Installation Qualification)<\/strong>, <strong>OQ (Operational Qualification)<\/strong>, and P<strong>Q (Performance Qualification)<\/strong> processes. Here are a few key reasons why process validation is important:\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>1. Ensures Consistency and Reproducibility:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\">Process validation confirms that a manufacturing process consistently produces products meeting predetermined specifications. This consistency is crucial for the reliability and effectiveness of the final product.\u00a0<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>2. Reduces Risk of Defects and Non-Conformities:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\">Through thorough validation, manufacturers can identify and mitigate potential sources of defects or non-conformities in the manufacturing process. This risk mitigation is essential for preventing product recalls and ensuring customer safety.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>3. Facilitates Continuous Improvement:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-family: Arial, Helvetica, sans-serif;\">The data collected during the validation process provides valuable insights into the manufacturing process. This information can be used to identify areas for improvement and drive continuous process improvement initiatives.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\">It is a <strong>fundamental aspect of quality management systems<\/strong> and regulatory compliance, contributing to the overall safety, efficacy, and reliability of products in the medical device industry.\u00a0<\/span><\/p>\n<p>&nbsp;[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Global Regulatory Framework&#8221; tab_id=&#8221;1704422228605-020bb364-27cd&#8221;][vc_column_text]<img decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/glutenfreepleasure.com\/__proxy_domain\/www.racermedical.com.sg\/wp-content\/uploads\/2023\/12\/ASEAN.jpeg\" \/><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\">As part of our ongoing commitment with our customers, we are able to provide regulatory advice to aid our customers in selling their products to their desired market. This is a tedious process as <strong>each country has different regulations<\/strong> (E.g., FDA, CE Marking, HSA, AFTA).<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\"><strong>Key Challenges:<\/strong>\u00a0Regulatory Divergence, Language and Cultural Barriers, Resource and Capacity Gap in some regulatory bodies, Market Protectionism<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: Arial, Helvetica, sans-serif;\">Take for example the Asia market, every product needs to be duly approved by each individual regulatory authority in every Asia country. Therefore, ASEAN countries came up with the <strong>\u201cASEAN Guidelines for Harmonisation of Standards\u201d<\/strong>. This is adopted by all ASEAN member states, to complement ASEAN Free Trade Area (AFTA). In particular, to eliminate technical barriers, but without compromising product quality, efficacy, and safety.\u00a0<\/span>[\/vc_column_text][\/vc_tta_section][\/vc_tta_tour][\/vc_column][\/vc_row][vc_row][vc_column][vc_hoverbox image=&#8221;766&#8243; primary_title=&#8221;&#8221; hover_title=&#8221;&#8221; el_width=&#8221;80&#8243;]<a href=\"https:\/\/glutenfreepleasure.com\/__proxy_domain\/sgmedtech.com.sg\/\"><strong>The Singapore Medtech Consortium<\/strong><\/a> also plays a pivotal role in working to build the strong research base that helps the Singapore&#8217;s Medtech industry to leverage its own supply management. To adopt systems approach, we need to constantly discover with updated technology and entities that are both up and down the value chain. By understanding products better, we can help all the aspects in Validation Protocol.[\/vc_hoverbox][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row css=&#8221;.vc_custom_1543394941992{margin-bottom: 50px !important;}&#8221;][vc_column][rev_slider_vc alias=&#8221;quality-system&#8221;][vc_separator][vc_column_text]&nbsp; &nbsp;[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1543469557138{margin-bottom: 20px !important;}&#8221; el_id=&#8221;quality-system&#8221;][vc_column css=&#8221;.vc_custom_1543394957854{margin-bottom: 25px !important;}&#8221;][vc_tta_tour style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; controls_size=&#8221;md&#8221; active_section=&#8221;1&#8243;][vc_tta_section title=&#8221;Supply Chain Management&#8221; tab_id=&#8221;1543469504366-933c0baf-ea3b&#8221;][vc_single_image image=&#8221;67&#8243; img_size=&#8221;full&#8221; onclick=&#8221;link_image&#8221;][vc_column_text]&nbsp; We are constantly improving our processes to keep up with stringent manufacturing demands and technological advancements. Harnessing the power of LEAN and KANBAN methodologies, we empower businesses to streamline operations, [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"fullwidth.php","meta":{"footnotes":""},"class_list":["post-341","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Quality System - Racer Technology<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/glutenfreepleasure.com\/__proxy_domain\/racer.com.sg\/quality-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality System - Racer Technology\" \/>\n<meta property=\"og:description\" content=\"[vc_row css=&#8221;.vc_custom_1543394941992{margin-bottom: 50px !important;}&#8221;][vc_column][rev_slider_vc alias=&#8221;quality-system&#8221;][vc_separator][vc_column_text]&nbsp; &nbsp;[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1543469557138{margin-bottom: 20px !important;}&#8221; el_id=&#8221;quality-system&#8221;][vc_column css=&#8221;.vc_custom_1543394957854{margin-bottom: 25px !important;}&#8221;][vc_tta_tour style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; controls_size=&#8221;md&#8221; active_section=&#8221;1&#8243;][vc_tta_section title=&#8221;Supply Chain Management&#8221; tab_id=&#8221;1543469504366-933c0baf-ea3b&#8221;][vc_single_image image=&#8221;67&#8243; img_size=&#8221;full&#8221; onclick=&#8221;link_image&#8221;][vc_column_text]&nbsp; We are constantly improving our processes to keep up with stringent manufacturing demands and technological advancements. 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