Risk Management. 

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

Risk Management Full Details
The requirements for effective Risk Management …
  • Risk management, explained in an easy to understand, logical, format.
  • Inform yourself about the elements of risk management.
  • Step through at your own pace from the convenience of your desktop, laptop, tablet, mobile.
  • Use the information provided to educate or train your work peers.
  • 490 pages.
 

Available for $15 (Standard price $39) until Friday 21st December.

 

Risk Management 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
Types of risk – product, quality, regulatory, technology,…
Potential failure modes – chemical, data, physical, biological,…
Causes of failure modes – method, man, environment, machine,…
Risk management principles
The two stage approach to risk management

Risk Assessment Tools
What are they and why use them?

Typical approaches to the risk tools, inputs, outputs, advantages, disadvantages, how to apply…

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
Matrices of risk – Acceptable, ALARP, Intolerable
Summary of risk level and risk acceptability

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

The Risk Management Plan
Integrating the various elements of risk into a risk plan
Plan approval
Implementation of the plan
Communication
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 management into the validation process
Reducing risk via quality improvement

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

 

View pages from Risk Management   >>>

 

 
MedicalDeviceValidation-small
 Any Questions? Please ask.