On the 3nd Wednesday of each month, we invite you to join us for dinner to engage with a local quality practitioner at the Biltmore Hotel. View previous dinner presentations: navigate to the top tool bar, click on “RESOURCES” > “DOCUMENTS” (Documents for Members) > “Dinner Meeting Presentations”, select year, then month.
“Reducing Product Safety Risks“
Product safety risk management requires an enterprise wide approach which integrates knowledge creation, regulation controls, product development (requirements, design control, V&V) to reduce product safety risks in the course of life time for medical devices and the other complex product systems.
In this presentation, Jerry will show how to proactively reduce product safety risks during product design & development phases and continuously mitigate residual product risks in real time manner during the post market phase.
- August Meeting – To be announced
Quality and Risk Management.pdf
ISO 9001:2015 is promoting "Risk Based Thnking" similar to Other Standards, but does not call for particular tools to be used. The Organzation is required to take action to address Risks and Opportunities.
Dr. Flaig will provide a historical overview of risk assessment and management in business and engineering. He will discuss current risk management initiatives such as ISO 9001:2015. Additionally he will analyze some of the deficiencies in current risk assessment tools such as Risk Registers and FMEA and suggest better methods
|Date:||February 23, 2016|