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Dr. Wayne Taylor - Taylor Enterprises, Inc.
Applied Statistics
for Engineers and Quality in the FDA Regulated Industries

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Libertyville, IL 60048
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Six Sigma Problem Solving Process (1 day)


Dr. Wayne A. Taylor

Course Description

Teaches how to apply the six sigma tools to solve sudden onset problems.  A sudden onset problem is one where previously everything was OK but something changed to so that things are no longer OK.  The course teaches the step-by-step six sigma problem solving procedure for identifying the root cause of the problem.  This process combines the six sigma tools with more classical problem solving methods.  This supplements the Six Sigma Breakthrough Improvement process for solving chronic problems and the DFSS process for solving design problems.

Six Sigma Probplem Solving Process

As most Corrective Action - Preventive Action (CAPA) investigations are involve sudden onset problems, this is the ideal process for CAPA investigations.  This course teaches how to effectively resolve and document CAPA investigations.

What You Will Learn

  • Step-by-step process for conducting a CAPA or problem investigation of a sudden onset problem.
  • How to effectively document the CAPA for FDA review.
  • How to create a problem statement.
  • How to determine when the problem started.
  • How to compare facts to causes to determine root cause and to document the logic used.

Primary Audience

All scientist, engineers and other technical staff serving on a CAPA or crisis team. 

Course Outline


  • Introduction
  • Describe the Problem
  • Measure Magnitude of Problem
  • Determine When Problem Started
  • Identify Potential Causes
  • Analyze Existing Data
  • Construct List of Verified Facts


  • Compare Causes to Facts
  • Collect Additional Data Until Root Cause Identified
  • Determine Best Solution
  • Pilot Solution
  • Verify Solution Works
  • Implement Solution



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Last modified: September 08, 2017