Conducting Advanced Root Cause Analysis and CAPA Investigations

precon

8:00 a.m. – 8:30 a.m.

Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m.

Welcome, introductions, and agenda

Why investigate?

  • Interactive activity: Reasons for and benefits of investigations
  • Patient safety
  • Quality reasons
  • Business reasons
  • Investigations, Q10, and process understanding
  • Regulatory expectations
  • Regulatory agency findings, FDA observations, and Warning Letters

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Definitions and models

  • Interactive activity: Important definitions
  • Six accident models: The value of models and how they can be used in investigations
  • What about “human error”?
  • Applying risk-based thinking to investigations, part 1

13 steps to better investigations

  • The big picture
  • Worksheets and data collection
  • Interactive activity: Making the case for an investigation team
  • The investigation plan
  • The importance of the “golden hours”

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

After-lunch energizer

Conducting the investigation: tools to help identify the causes and contributors

  • Flow charting, process mapping
  • Fishbone / cause-effect diagrams
  • Fault trees
  • Effect diagrams
  • Timelines/chronologies
  • Five whys
  • Visualizations
  • Change analysis
  • Interactive activity: Small group work—Your experiences with the tools

Interviewing skills

  • What makes for a good interview?
  • Triangulation
  • Interactive activity: Interviewing

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:45 p.m.

Working with subject matter experts

  • How experts “do it” – intuition and analysis
  • Caveats when working with experts
  • Interactive activity: Factors that can affect intuition

What if you can’t find the root cause?

  • Demonstrating diligence
  • The known/unknown matrix worksheet

Putting it together: creating an investigation plan

  • Interactive activity: Writing an investigation plan for incidents.

4:45 p.m.

Summary/Wrap up for the day

 

register