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Omnex Winter Navigator 2021
Omnex is delighted to announce the release of our newsletter “2021 Winter Navigator” edition. Since its first publication in 1985, we have been proud to provide value for our clients every year through our newsletter focusing on Business Excellence and Continual Improvement. We hope the information will help your organization better familiarize itself with the changes happening in our industry. Check for our articles, case studies, whitepapers, training programs, news around the world, and more in the latest issue of our Newsletter “2021 Winter Navigator” edition.
Solvay Composites: Digitalization of APQP/PPAP Documentation for Aerospace
Implementing EwQIMS Helped Reduce PPAP Preparation Time By 50% Solvay is a global leader in advanced materials and specialty chemicals. Solvay’s tailor-made range of products and constantly evolving market solutions offer everyday sustainable solutions for next-generation transportation, resource efficiency, consumer goods, healthcare, and industrial production to easily accommodate every single one of the ever-changing demands. Read More...
Yazaki: Transformation to a Digital Platform Led to an Exponential Growth of Business Productivity
The Customer - This Automotive Tier-1 Wiring Harness Company was established in 1941 and is one of the world’s leading independent automotive component manufacturers. In addition to the company’s score product, wire harnesses, they also develop and manufacture meters, electronic components, and a host of other innovative products for automotive use. Read More...
The AIAG-VDA FMEA Process and Approach
In the past six months, the use of the AIAG-VDA FMEA Handbook, released in June 2019 has begun to gain popularity in the Global Automotive Industry. Both USA and European OEMs have started to require the use of the AIAG VDA FMEAs in their programs. Like the AIAG Guidebook, 4th edition, the Handbook provides guidance, instruction, and illustrative examples of the requisite analytical techniques. Read More...
AS9145: Standard of Choice for the Aerospace Industry
The new AS9145 standard of Aerospace Requirements for Advanced Product Quality Planning and Production Part Approval Process is coming soon to an Aerospace OEM near you. For those who are already familiar with the new APQP and PPAP standard written by IAQG, congratulations, as you may be ahead of the curve. This paper will illustrate just what the standard is, its requirements, along with a few ways for your organization to get ahead.
Automotive Cybersecurity and Controls: The Single Most Important Standard in the Connected Car
The Nature of Automotive Cybersecurity - In the last few years and months especially, we have seen a significant rise in the number and types of cyber-attacks occurring around the world. These attacks targeted various sectors including, but not limited to, governments, commercial institutions, private companies, smart grid installations, and automotive companies. Read More...
Sanctioned Interpretations: Why IATF 16949:2016 is Incomplete?
Catchy title, yes? Let me not trick you, I am talking about Sanctioned Interpretations. The IATF Sanctioned Interpretations (SIs) is now in its eleventh revision in 4 years and with 20 changes to the standard (some of those revisions have even been revised!). The latest issue was released in December 2020 and was effective January 2021. 20 changes mean 20 risks of getting third-party non-conformances if an organization has not kept up with the SIs.
The Medical Device Risk Management Standard - What’s New with ISO 14971:2019?
The turn of the decade isn’t going unnoticed when it comes to medical device standards. The long-awaited Risk Management standard (ISO 14971, 3rd Ed.) was released for publication in late 2019. In addition, there is a new companion guidance document released, known as ISO/TR 24971:2019. Technical Reports (TR) are one of the types of documents that ISO publishes. Read More...
Omnex Training Calendar
Omnex offers training and competency development programs for various companies in Automotive, Aerospace, Electric & Autonomous Vehicles, Medical Devices, High-Tech / Semiconductors, General Manufacturing, and other Manufacturing Sectors. Omnex has more than 240 training workshops that are being conducted worldwide and the available in more than a dozen languages and dialects. Many of our workshop training programs are accredited worldwide by renowned bodies such as Exemplar Global, AIAG, and IRCA. Omnex provides training, consulting, and software solutions to the international market with offices in the USA, Canada, Mexico, China (PRC), Germany, India, United Arab Emirates, and Thailand. Omnex offers over 400 standards and customized training courses in Business Management Systems, Quality Management Systems, Environmental Management Systems, Energy Management Systems, Food Safety Management Systems, Laboratory Management Systems, and Health and Safety Management Systems worldwide.
Author
Mary Rowzee
Mary Rowzee is an Omnex consultant with extensive experience and achievements in Quality Systems development, implementation and auditing to ISO 9000 series and IATF 16949 standards; Six Sigma Black Belt Problem Solving and Advance Quality Tools including: Design and Process FMEA, Design and Process Verification and Test Planning, Complex Statistical Analyses and Reliability Prediction, Modelling and Risk Reduction. Mary is a writing member of AIAG-VDA FMEA 1st edition and the Core Tools Guidelines: SPC 2nd edition, MSA 4th edition, EFMEA 1st edition, PPAP 4th edition and APQP 2nd edition. Mary has been actively leading industry practices and application of ISO 26262 Functional Safety Standard for Electrical/ Electronic Products; Software FMEAs, ASPICE, CMMI and Quality; Supplemental Monitoring and Systems Response (MSR) FMEAs; Safety of the Intended Functionality (SOTIF) ISO 21448 and use of Safety Engineering tools (Reliability Block Diagrams, Hazard and Risk Analyses, Addressing ASIL rated risks) in Advanced Driver Assistance Systems (ADAS). She also served as GM Global representative on AIAG-VDA and SAE Quality Standards development teams.
Chad Kymal
Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.