Quality Digest
Published: Monday, June 13, 2022 - 12:51 (Omnex: Ann Arbor, MI) -- Omnex has announced three new webinars for June 2022. Webinar name: Proposed Changes to 21 CFR 820 Date and Time: Jun 14 2022 11:00 a.m. Eastern Time The FDA regulatory requirement 21 CFR 820 for medical device Current Good Manufacturing Practice (CGMP) for Quality System Regulations (QSR) is undergoing a significant revision. The purpose of this webinar is to familiarize medical device manufacturers who are marketing or intend to market in the USA with the proposed upcoming changes. Though the standard has been around since 21 Jul 1978, the FDA is proposing to amend regulations to align more closely with the international consensus standard for devices by converging with the Quality Management System (QMS) requirements used by other regulatory authorities from other countries. They are therefore incorporating the international standard ISO 13485:2016 into CFR 820. This action, when finalized, is expected to align the regulatory framework for the USA with that used by other global regulatory authorities to promote consistency and provide a timelier introduction of safe, effective, high-quality devices for patients. Interested parties may attend this webinar series for a more thorough understanding, and participate in a discussion on the forthcoming changes and the possible impact on business practices. Speaker: Mike Checketts Webinar name: SOTIF Mission Accomplished: The New International Standard ISO 21448 Date and Time: Jun 21 2022 11:00 a.m. Eastern Time According to the US Department of Transportation's National Highway Traffic Safety Administration (NHTSA), fewer than 1% of vehicle crashes are attributed to vehicle failure (the domain of ISO 26262), and the remaining are attributed to other reasons, all of which involve hazardous scenarios containing one or more vehicles. Automated vehicles have the potential of reducing the number of accidents involving driving scenarios where one or more vehicles are present. The newly released international standard ISO 21448 is poised to help the automotive industry in the design and deployment of automated vehicles to realize the potential of reducing the number of accidents, in addition to other advantages. Unlike ISO 26262 which focuses on component failures or malfunctions, ISO 21448 addresses the safety of the intended function (SOTIF). In this webinar, the scope, goals, and organization of the SOTIF standard will be presented. In addition, the processes behind the SOTIF standard will be summarized with explanations as to how they will help achieve a reduction in the number of vehicle accidents in a multi-agent driving environment. Speaker: Juan Pimentel Webinar name: Reverse FMEA: A Trending OEM Requirement Date and Time: Jun 23 2022 11:00 a.m. Eastern Time The purpose of this Webinar is to introduce Reverse FMEA and show the steps required to perform, mitigate risk and report results. The concept of Reverse FMEA has been around for years, but recently has been showing up in OEM customer specifics for verification of process preventions and controls from the supplier’s PFMEA. If done properly it will reduce risk, improve quality and production performance. These changes are much easier when using a FMEA software tool, such as AQuA Pro, that links foundation FMEAs to part FMEAs. Join Mike Down, who has represented GM at both SAE and AIAG, in the development of Global Automotive Standards reference documents on Quality and Core tools, including APQP/CP, PPAP, SPC, MSA, and DRBFM. He is currently actively working on the SAE J1739 committee updating the FMEA standard. Speaker: Mike Down For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.
Risk Management Omnex Upcoming Webinars for June 2022
Three webinars to increase participation and understanding within the world of quality assurance
Michael Checketts is a certified Lead Auditor for ISO 13485:2016, ISO 14001:2015, ISO 17025:2017, and ISO 9001:2015. Michael is a Senior Manager with extensive Engineering, Quality and Regulatory management experience.
Juan Pimentel is the Omnex principal Cyber Security consultant. He is a member of the US technical Advisory Group for ISO 21448 and writer of the standard. He has extensive Engineering, Safety and Cybersecurity experience.
Michael Down is a Senior Consultant with extensive Engineering, Quality and Reliability experience and is one of the writers of SAE J1739. He was on the AIAG Core Tools Committees for FMEA, SPC, MSA, PPAP and APQP as the Committee Leader. Michael has extensive experience working in the automotive industry from manufacturing and assembly to vehicle design development and software/hardware Reliability, DMFEA and PFMEAs.
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