PTI - international

Agenda: Day Two

VI. Conduct Risk Analysis

• Recognize and evaluate different failure modes and causes 
• Differentiate between types of Failure Mode Effect Analysis (FMEA):
  • system, design, process or service FMEA
• Describe important risk analysis brain storming techniques
• Explore Fault Tree Analysis (FTA)

Exercise: Create an FTA from Real-Life Scenario

VII. Close Out an Investigation

• Review the problem solving process
• Determine if corrective and preventive actions were effective
• Develop an After Action Review (AAR)
• Confirm that the corrective actions did not adversely affect the product or system
• Identify items that should potentially be tracked and monitored

VIII. Communicate with Key Stakeholders

• Foster effective team interaction
• Obtain commitment and buy-in from affected departments
• Convey CAPA issues to management

Exercise: Brainstorm Effective "Buy-in" points 

IX. Streamline CAPA Process

• Examine and plot entire sequence of CAPA events
• Determine flow of the entire CAPA process
• Remove redundancies and unnecessary loops within CAPA process
• Identify process improvement opportunities

Exercise: Create a High Level CAPA "Should Map"

X. Meeting Review and Close

• Examine key points from past two days of training