Training & Events

Root Cause Investigation For CAPA

Course Description

September 21-23, 2021

Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges. Problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others are leveraged to identify technical as well as systemic root causes, corrective and/or preventive actions, and control plans for monitoring/preventing recurrence.

This training is designed to engage the participants the entire time. In addition to the instructor case study, lecture, polls, quizzes, and conversations, participants will apply the methodology during the training collaborating with other participants on two separate real-life case studies.

Participants are provided a training manual, an Investigation Roadmap, and a set of electronic templates that guide them through the methodology, recommend tools, and establish the basis for documentation.



  • Overview of the methodology and when to use
  • Discuss common investigation mistakes
  • Define critical terms
  • Introduce participant real life case study

Step 1: Define the Performance Problem

  • Introduce instructor case study
  • Problem statement (investigation focus)
  • Problem description (investigation scope)
  • Workshop
  • Flow chart with key inputs of process(es) within scope of investigation

Step 2: Collect Data

  • Determine data needed (verify and narrow investigation scope)
  • Identify methods for collecting data
  • Consider tools and techniques for analyzing data
  • Workshop

Step 3: Identify Possible Causes

  • Timeline of changes
  • Differences and changes
  • Workshop
  • Risk analysis review
  • Brainstorming techniques (gemba, fishbone, group, individual, etc.)

Step 4: Test Possible Causes

  • Challenge possible causes against data
  • Define "reasonable" assumptions
  • Document testing process results
  • Summarize testing leveraging contradiction matrix
  • Workshop

Step 5: Identify Technical and Systemic Root Cause(s)

  • Verify assumptions
  • Studies/experiments
  • Identify technical root cause(s)
  • Identify systemic root cause(s)

Step 6: Determine Corrective/Preventive Actions

  • Mistake proofing (poke-yoke) vs. variation reduction and optimization techniques
  • Corrective/preventive action(s)
  • Risk mitigation
  • Control plan
  • Acceptance criteria
  • Workshop

Step 7: Verify Corrective/Preventive Actions

  • Implement corrective/preventive actions
  • Evaluate effectiveness (control plan)
  • Determine additional preventive actions
  • Disseminate knowledge gained

Second Participant Real Life Case Study

  • Introduction
  • Workshop developing problem statement, problem description
  • Workshop developing data collection plan
  • Workshop to select and test a possible cause
  • Workshop to develop corrective/preventive action plans for technical and systemic root causes


  • Compare/contrast this investigation methodology with other approaches
  • Shortcuts
  • Simple investigations
  • Investigation report
  • Return on investment

 If you are interested, please contact Greg Scheelar at BAM members may qualify for a discounted rate.