Cleanroom Operations

Risk Assessments for Cleanrooms and Controlled Environments

This course will address the use of risk assessments for cleanrooms and associated controlled environments to assist in investigations, deviations, analysis, and corrective actions. The course will explain techniques such as Hazard Analysis and Critical Control Points (HACCP), fishbone diagrams, and Failure Modes and Effects Analysis (FMEA).

Course outline     Who should attend?     Course materials     Instructor

Course outline
  1. Background on risk
    • Definitions of risk
    • Types of risk
    • Case study information
  2. HACCP
    • Understanding HACCP
    • 7 steps to HACCP
    • Case study analysis
    • Determining the CCP
  3. FMEA
    • Understanding FMEA
    • 10 steps of FMEA
    • Assigning the ratings
    • Calculating the RPN
    • Case study analysis
  4. Fishbone and Fault Tree Analysis
    • Understanding Bones and Trees
    • 4 steps to creating a fishbone
    • 8 steps for FTA
    • Case study analysis
    • 5 WHY's

Who should attend?

I need to learn about risk assessments for cleanrooms and controlled environments because I want to:
  • Become familiar with the risk methods
  • Recognize that there are many existing tools that can be used to support the process
  • Practice using existing tools and examples
Course materials
  • Copy of PowerPoint presentation in course binder
  • Certificate of attendance for completion of CEUs

Continuing Education Units: .6 CEUs


Instructor, Anne Marie Dixon, IEST
 Anne Marie Dixon