Process Risk Management
(8 hour course)

Thursday (1:30 p.m. - 5:30 p.m.)

 Friday (8:30 a.m. - 12:30 p.m.)

Course Content:

• Risk Management Planning

  • How to use risk management to better understand and improve your processes

  • Vocabulary of process risk management and the proper use of terms

• Process Risk Assessment

  • Life cycle risk management: why risk management must take place throughout the lifetime of a manufacturing process

  • ISO 14971 risk management model

  • How Six Sigma and the risk management process interact

• Risk Management Report and Process Control Plan

  • Proven ways to assess, evaluate and prioritize risks

  • Risk management tools: processing mapping, HAZOP, Ishikawa diagrams, Fault Tree, HACCP, FMEA and more

  • Preparing and implementing a plan to mitigate identified risks

• Process Risk Performance and Feedback

  • How to factor risk mitigations into residual risk estimates

  • When and how quality system feedback should be used to manage post-launch process risks

• Practical Exercises

  • Learn the right way to do process risk management

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