Join us for our 9 April 2024 Chapter meeting featuring:
Main Presentation: "Risk Management and Systems Engineering: The Shaping of New and Future Activities of the INCOSE Risk Management WG", by Jack Stein and Bob Parro
Abstract:
Systems engineers as individuals, and the field of systems engineering as a whole, are faced with an enormous challenge. Increasing system complexity, and ever more rapid and unpredictable developments and changes in technology, and in the socio-technical environments in which we will engineer and use the systems of the future, are creating levels of uncertainty, risk, and opportunity never before encountered.
In response, the practice of risk (and opportunity) management, in general and specifically as related to systems engineering, are undergoing significant change.
This presentation will inform attendees of recent changes in the practice of risk (and opportunity) management, and will provide an overview of INCOSE Risk Management Working Group (RMWG) current and future planned activities. The session will include an open Q&A segment, and is intended to be engaging two-way exchange of information, thoughts and ideas, aimed at directing, prioritizing, and improving the activities and work products of the INCOSE RMWG.
Bio:
The INCOSE Risk Management Working Group (WG) was established in 1998, making it one of INCOSE’s longest running working groups. Currently, the WG has just over 120 members world-wide. The size and scope of activities of the WG are expected to increase as fundamental changes in the concepts, principals and practices of risk management defined in the 1st (2009) edition of overarching international risk standard ISO 31000, Risk Management — Principles and guidelines, are implemented in an increasing number of organizations and systems engineering projects and programs. These changes are reflected in ISO/IEC/IEEE 16085:2021, Systems and software engineering — Life cycle processes — Risk management, and in the 5th Edition of the INCOSE Systems Engineering Handbook.
Bob Parro and Jack Stein share in the chair-person duties of the Risk Management WG, making sure the WG is represented at monthly TechOps meetings and Annual International Workshops (IWs). As WG co-chairs, Jack and Bob have co-authored the Risk Management sections of both the 4th and 5th editions of the INCOSE SE Handbook. Together with WG member and standards specialist Paul Heininger, they represented INCOSE and the WG in the ISO/IEC/IEEE 16085:2021 work.
Jack Stein resides in Michigan and is a Past President of the INCOSE Michigan Chapter. Bob Parro resides in the Chicago area and is a Past President of the Chicagoland Chapter. They are both strong advocates of WG-Chapter interaction.
C-NO Chapter Meeting - December 2019
Cleveland
Presentation: Medical Device Risk Management
Topic: Medical Device Risk Management
Speaker: Jim Richards
Abstract
Medical devices are globally regulated and safety and effectiveness are mandated to have controlled design processes that consider safety risks throughout the product lifecycle. The talk will present an overview of applicable standards and how product risk management interacts with the design process. Some detailed examples of design guidance from the standards will be presented.
Bio
Senior Systems Engineer at Philips Healthcare since 2005 with experience as lead for teams of system engineers, physicists, and system designers to deliver top tier CT products with a focus on problem solving and integration of new technologies. Extensive experience in design controls and quality systems and as a risk management process owner. Support for the business as a lead for compliance audits with TUV, FDA and other international and independent auditors. Experience with product and process CAPA’s and development of training for post market risk management and complaints handling. Past experience includes systems design, physics and electrical engineering in the development of advanced technologies and feasibility studies for product development of multiple CT scanner family platforms and imaging systems development for invasive cardiac, cardiovascular and x-ray products. Working in the Medical device industry since 1979.
Member of IEEE and the following societies:
- IEEE Electromagnetic Compatibility Society Membership
- IEEE Product Safety Engineering Society Membership
- IEEE Reliability Society Membership
- IEEE Systems Council
Outside Interests include:
- Father of 2 teen boys
- Outdoor sports - hiking, canoeing and kayaking
- Nature Photography
- Music – Guitar, Fiddle and Mandolin.
Venue: Webinar (your computer) or two locations:
- NASA Glenn, Building 162, room 209 (NASA-badged members/guests)
- Philips Healthcare/Orange Village (Philips Healthcare-badged members/guests)
Registration Requested: Register Here (https://www.eventbrite.com/e/medical-device-risk-management-tickets-85257422245) via EventBrite
Flyer
NASA Glenn location:
Building 162, room 209.
Philips Healthcare/ location:
Philips Healthcare,
100 Park Avenue, Suite 300
Orange Village, OH, 44122
Philips Healthcare Map
Note: This is in the Pinecrest development in Beachwood/Orange Village and is located East of I-271 in between Harvard Road and Chagrin Blvd exits.
- From Parking Deck, one can walk out onto Park Avenue to the front entrance on street level (100 Park Avenue).
- Please assemble in the lobby (first floor) and Sastry Kasibhatla [(440)-241-3731] will escort you to the 3rd Floor.
- Visitors will then be able to sign in visitors log on 3rd Floor.