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Thursday December 7, 2017
Best Practices – Applications of “Risk Based Thinking” Model for ISO 9001:2015
The inclusion of risk and related topics (e.g. opportunities, consequences, controls) is likely the most-discussed change to be seen in 9001:2015. As examples, “Actions to address risks and opportunities” can be found in section 6, and evidence of risk can also be seen in requirements for the QMS and its processes (4.4), Customer focus (5.1.2), and Management review (9.3). Related references to impacts, consequences, controls, etc. can be found in virtually every section of ISO 9001:2015 requirements. The term “Risk-Based Thinking” has been coined to help the concept of risk pervade throughout the QMS, and risk has also been incorporated into the process approach model.
Before anyone makes changes to their system, we need to understand why the addition of risk was incorporated in this revision. It will also be necessary to replace the term “risk management” with “risk based thinking”.
This presentation will show how risk based thinking is part of the process approach and drives a preventative continual improvement process. A model will be presented to show how an organization can analyze and prioritize the risks, plan actions to address the risks, implement the plan and check effectiveness.
Speaker: Angelo Scangas
Angelo is President of Quality Support Group, Inc., an International Consulting and Training organization. Angelo has a B.S. in Chemical Engineering, M.S. in Manufacturing Engineering and a MBA. Angelo is a senior member of the American Society of Quality and member of the ASQ Audit Division (Webinar Chair).
Angelo has more than 30 years of experience in the Medical Device, Consumer, Electronic, Healthcare and Chemical Industries working in product development, manufacturing, quality assurance and process improvement. His background includes product development, supplier quality, (ISO 9001, ISO 14001, ISO 13485, AS9100 TS 16949) quality system design and implementation, regulatory compliance, internal and external audits and FDA submittals. His specialty areas include strategic quality planning, risk management, supply chain management, corrective and preventive action (CAPA) programs, validation programs, third-party assessments and HACCP analysis.
Location (see map)
Holiday Inn Tewksbury –Andover
4 Highwood Dr
Tewksbury, MA 01876
6:00-7:00 Dinner and Networking
All American Buffet w/ Marinated Beef Tips, Lemon Herb Grilled Chicken and Chef’s Selection of Potato