Conference Program

Tuesday, September 23, 2008

200 Root Cause Investigation for CAPA - A Proven Technique to Investigate & Solve Technical CAPA Problems

Instructor: Tom Weaver, President, Weaver Consulting, LLC

Introduction:

  • Define a technical problem
  • Discuss common problem solving mistakes
  • Introduce the problem solving template

    • Describe the Problem

  • Describe the problem in 8 dimensions
  • Conduct Workshop 1
  • Collect background information with emphasis on the process flow or product usage diagram and the input –output diagram

    • Collect Existing Data

  • Examine data collection tools and techniques
  • Develop measurement plan

    • Identify Possible Causes

  • Develop a timeline of changes
  • Search for differences
  • Use brainstorming techniques

    • Test Possible Causes

  • Test the possible causes
  • Understand the historical perspective – the greatest detective who never lived

    • Identify Root Causes

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

    • Determine Best Solution

  • Consider mistake proofing techniques
  • Consider variation reduction and optimization techniques

    • Verify Solution

  • Measure effectiveness and evaluate results of corrective and preventive actions

    • Third Case Study

  • Compare and contrast this new investigational methodology with the traditional methodology

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    A complete conference brochure PDF is available by clicking here

    ABOUT THE INSTRUCTOR

    Tom Weaver, President, Weaver Consulting, LLC

    Mr. Weaver is a quality and operations improvement consultant whose expertise includes strategic planning, quality and operations improvement, root cause investigation, design control, and project management. Prior to starting his own consulting business, Mr. Weaver had a 28 year career with Baxter Healthcare with management positions in the Manufacturing, R&D, and Quality functions. He retired in 2003 as the Vice President, Quality Management, leading its Total Quality Management and Six Sigma processes. He founded Weaver Consulting in 2003 which today provides services to clients globally. Mr. Weaver holds a Bachelor of Science Degree from the United States Military Academy at West Point, NY.

     

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