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ASQ RU: 0.8       Prerequisite: None required Proposed Benefits: Risk Management is the implementation of an organizational process to address Risk. Risk Analysis is the process of identifying potential hazards/risks that can have negative consequences on operations and customers; and taking action to mitigate, prevent said hazards/risks. This workshop is applicable to all organizations (manufacturing, service, health care, non-profit) that are required or committed to the determination, assessment, and understanding of Risk in their organizations. Participants will be able to: 1.   apply/deploy the FMEA methodology to product/process 2.   apply basic tools of root cause analysis 3.   apply the Bow Tie risk assessment model 4. SWOT Analysis Class Details: This course provides overview and application of Risk Analysis models – FMEA, DFMEA, Bow Tie, SWOT Analysis, to evaluate and identify Risks in your organization.

Root Cause Analysis and Project Management as tools needed to take risk remedial action will be reviewed. In addition the relationship between various standards – ISO, ISO Guide 83, ISO 31000-2009, TS 16949, FDA QSR, ICH Q9 – and Risk Analysis will be reviewed. Topics to be covered: Risk Management as an organizational strategy/process Risk Analysis – identification of risks and risk mitigation ·                         The relationship between Risk Management/Risk Analysis and various standards ·                                           Satisfaction of risk requirements by various standards Course Applicability: Employees that have responsibility for risk management applicable to various standards – ISO, TS, FDA QSR, ICH Q9, etc.  All levels of quality staff: VP, Director, Manager, Supervisor, QE, Auditors About the Instructor – Roy Kinkaid: Roy Kinkaid is an independent quality consultant (25+ years of experience) with an extensive background in the implementation of various quality management systems – Six Sigma/Lean, Baldrige, Continuous Improvement, ISO and the Carnegie Mellon Capability Maturity Model.
Roy has a degree in management/ statistics from Jefferson University, certification in Six Sigma/Lean, and is a member of ASQ. He has practical process improvement experience in manufacturing, non-profit, education, healthcare, service, software, and electronic commerce industries, helping companies to achieve six sigma quality performance levels.  In addition Roy has hands on experience with change management, coaching and the facilitation skills necessary to implement a quality program. He has extensive experience working in Europe, the UK and Asia. Training materials are included in the course fee. Please bring your laptop. Materials will be distributed via USB Flash Drive at the session. We are going paperless. Morning and afternoon refreshments and lunch are included in the registration fee..

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