Information and Training Presentation.
Understand Risk Management …
- Risk Identification. Risk Analysis. Risk Evaluation. Risk Rating. Etc..
- Over 490 pages of information.
- Use to develop your personal understanding.
- Use as a support if providing your own training.
- Step through at your own pace, in your own time, from the convenience of your desktop, laptop, tablet, mobile.
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Contents:Introduction to Risk Management
Why perform risk management?
How to integrate risk into the Quality Management System and into the Risk Life Cycle.
Approaches to Risk Management
Risk management throughout the Product Life Cycle.
U.S. & International ISO expectations relating to risk.
Risk management principles.
Risk Assessment Tools
What are they and why use them.
Preliminary hazard analysis – Brainstorming.
Cause and Effect (Ishikawa or Fishbone analysis).
Fault Tree Analysis – FTA.
Hazard and Operational Study – HAZOP.
Failure Mode Effects Analysis – FMEA.
Hazard Analysis. … etc.
Determination of hazard, cause & harm
Scope and Problem determination.
Severity, Probability and Detectability.
Methods of scoring severity.
Probability estimate – quantitative, qualitative.
Assessment of detectability.
Risk Levels, Risk Acceptability.
Determining an acceptable level of risk.
Determining the Risk Prioritisation Number.
Matrices of risk – Acceptable, ALARP, Intolerable.
The Risk Management Process
Risk Management, Risk Assessment and Risk Minimization.
The Risk Management Model.
The Risk Management Plan
Integrating the various elements of risk into a Risk Plan.
On-going monitoring and revision.
Risk in Product and Process Design
Integrating risk into product and process design considerations.
Integrating risk into the validation process
Integrating risk management into the validation process.
Quality Improvement processes – Statistics and Risk Assessment.
Risk Management Summary
Management responsibilities for identification, minimization and control of risk.
The Risk Management File.
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