Risk Management

How to assess risk, how to control risk, how to evaluate risk, how to determine risk levels, how to mitigate risk, developing a risk plan, product risk determination, process risk review, the various risk models…etc…etc…

The Risk Process …
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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 throughout the Product and Process Life Cycle
U.S. & International ISO expectations relating to risk
Types of risk – product, quality, regulatory, technology,…
Risk principles
The two stage approach to risk management

Risk Assessment Tools
What are they and why use them?

Applying the risk tools, …

Model for Process Analysis and Improvement
Cause and Effect (Ishikawa or Fishbone analysis)
Fault Tree Analysis – FTA
Hazard and Operational Study – HAZOP
Failure Mode Effects Analysis – FMEA
Hazard Analysis
Etc., etc.

Determination of hazard, cause & harm
Top-down versus Bottom-up approaches
Scope and Problem determination

Assessing Risk
Severity, Probability and Detectability
Severity categories and descriptions
Considerations for determining severity
Methods of scoring severity
Probability estimate – quantitative, qualitative
Probability is associated with each potential cause of a Hazard – Data sources for estimating probability
Assessment of detectability
Detectability controls – prevention and/or reporting
Ranking of detectability – descriptive and numerical
Risk Levels, Risk Acceptability
Determining an acceptable level of risk
Numerical determination of risk level
Determining the Risk Prioritisation Number
Risk Matrices

The Risk Process
Risk Assessment, Rating and Minimization
Identifying the steps from inception and discovery of risks to controls and elimination
The Risk Model
Initiating a risk plan, defining the process, flowcharting, performing risk assessment, establishing risk levels, defining controls

Project Risk Management
Planning the project risk process. Identifying potential sources of risk in the project. Qualitative and quantitative risk analysis. Actions to address identified risks in projects. Project risk monitoring and control.

The Risk Management Plan
Integrating the various elements of risk into a risk plan
Plan approval
Implementation of the plan
On-going monitoring and revision

Risk in product and process Design
Integrating risk into product and process design
Design input and design output risk controls
Demonstrating risk management in the design history records

Integrating risk into the Validation process
Why use a risk based approach in product and process validation
Integrating risk into the validation process
Reducing risk via quality improvement

Risk Strategies
Developing a Risk Strategy. Determining the “appetite” for risk within an organization. Defining the Risk Strategy

Risk Management Summary
Management responsibilities for identification, minimization and control of risk
The Risk Management File