Conducting Advanced Root Cause Analysis and CAPA Investigations


8:00 a.m. – 8:30 a.m.

Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m.

Welcome and agenda for the day

Interactive activity: Review of Day 1

Where we were, where we are, where we’re going

Interactive activity: Four groups who read reports – and what they want to know

Assessing and managing risks related to investigations

  • Key definitions
  • The risk management process
  • Formulating the risk question
  • Tools for assessing risk
  • Using RA/RM in the investigation process

10:00 a.m. – 10:15 a.m.


10:15 a.m. – 12:00 p.m.

Corrections and corrective actions (and preventive actions)

  • How they differ, what they include
  • Think Swiss cheese!
  • Actions that add/don’t add value
  • Actions to consider when “human error” is involved

Interactive activity: What would you do? Finding new solutions

12:00 p.m. – 1:00 p.m.


1:00 p.m. – 2:30 p.m.

After-lunch energizer

Writing it up: key elements in a report

  • How much? How long?
  • What to include
  • One purpose of the report: reducing fear

“Writing comes easier when you have something to say”

  • Suggestions and hints for better reports
  • Critical thinking and writing

Interactive activity: Finding the good (and the bad) in a sample report

2:30 p.m. – 2:45 p.m.


2:45 p.m. – 4:00 p.m.

Interactive activity: Re-write! How would you write it?

Your investigation system: what will you take back and do differently?

  • Interactive activity: small group discussions and idea sharing

4:00 p.m.