PTI - international

I. Introduce Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA)

• Outline course goals and objectives
• Understand customer and FDA requirements
• Identify drug, biologic, and medical device RCA and CAPA requirements
• Define different types of actions: corrective, preventive, and remedial
• Prepare for the FDA's new systems-based approach to drug manufacturing inspections

Exercise: Examine recent warning letters and 483s

II. Develop and Implement an Effective CAPA Program

• Understand the difference between corrective and preventive actions
• Analyze and prepare for FDA approach to CAPA
• Avoid common pitfalls of a CAPA program
• Review the closed loop approach to problem solving
• Establish key elements and terms of a well run CAPA program

Exercise: Determine Significance of Product Issues: Corrective or Preventive 

III. Properly Collect and Analyze Data

• Examine a high level approach to CAPA
• Recognize and prioritize problem issues
• Differentiate between primary causes, secondary causes, and symptoms
• Utilize various data evaluating tools:
  • histogram
  • trend plot
  • Pareto chart
  • X-bar and R chart
  • Measurement System Analysis (MSA)
  • Design of Experiments (DOE)
• Evaluate key criteria of effective training

IV. Conduct Root Cause Analysis (RCA)

• Understand the basics of root cause analysis
• Recognize root causes to respond to non-compliances, failures, deviations, and complaints
• Define frequent types of non-compliance
• Avoid common pitfalls when conducting RCA
• Evaluate common categories of root causes and contributing causes
• Apply effective RCA techniques

Exercise: Statapult!  A Combination of Statistics and a Catapult 

V. Analyze RCA Data and Select the Solution

• Develop and refine a problem statement
• Select the best solution from a deviation
• Employ trend and other analysis and measuring tools
• Measure and analyze using problem solving forms
• Improve problem solving skills for RCA process
• Utilize problem solving tools:
  • prioritization matrix
  • scatter diagram
  • control chart
  • Ishikawa diagrams (fishbone)

Exercise: Examine "Red Sweat" Case Study and Apply RCA Techniques