Root Cause Investigation for CAPA

Most organizations have procedures for implementing corrective and preventive actions, but many do not have an effective methodology to actually investigate to find the root cause. As a result the investigation is often careless, unsuccessful, and costly. Root Cause Investigation for CAPA is a proven methodology to investigate and identify the root cause when there has been a shift in the performance of a product, machine, equipment, work process, or system. The methodology identifies the change (or changes) that have been occurred so that the change can be eliminated and the performance can return to its previous level. It is ideal for investigating an increase in:

  • Product or service defect levels
  • Customer complains
  • Negative patient reactions with the product
  • Manufacturing scrap or rework
  • Equipment or process aberrations
  • Any performance change where a CAPA investigation is required

In this exciting and team-based seminar you will be challenged to apply the methodology and tools on real case studies. This will prepare you to confidently conduct successful investigations immediately upon returning to work.

Learning Objectives

Upon completion of this course, you will be able to:

  • Apply a seven step investigational methodology to determine the root cause of a technical problem
  • Identify the technical root cause(s) and any systemic root causes(s)
  • Implement effective/preventive actions to restore the original product or process performance
  • Develop and implement a control plan to assure you do not have this issue again

Who Should Attend

This is a highly practical and workshop-oriented course for those in the pharmaceutical or medical device industry who conduct Corrective and Preventive Action (CAPA) investigations, especially those in the following areas:

  • Regulatory Affairs
  • R&D
  • Quality Assurance
  • Maintenance
  • Manufacturing
  • Distribution
  • Product/Process

Course Director

Mr. Tom 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 Baxter’s Total Quality Management and Six Sigma processes. In 2003, he founded Weaver Consulting which provides services to clients globally.

Course Outline

Day 1


  • Define a technical CAPA problem
  • Discuss common investigation mistakes
  • Introduce the CAPA investigation template
  • Introduce the first case study

Step 1: Describe the Performance Problem

  • Develop a problem statement
  • Describe the problem in 8 dimensions
  • Conduct Workshop 1
  • Describe the processes under investigation and identify their inputs
  • Conduct Workshop 2
  • Develop a time-line of events
  • Develop the charter including the performance and cost savings goals

Step 2: Collect Data

  • Determine what data is needed
  • Examine data collection tools and techniques
  • Develop a measurement plan
  • Conduct Workshop 3

Day 2

Step 3: Identify Possible Causes

  • Develop a time-line of changes
  • Search for differences
  • Conduct Workshop 4
  • Identify changes associated with any difference
  • Review the risk analysis
  •  Apply brainstorming techniques
  •  Conduct Workshop 5

Step 4: Test Possible Causes

  • Test the possible causes against the facts
  • Summarize the testing on a contradiction matrix
  • The greatest detective that never lived – an historical perspective
  • Conduct Workshop 6

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

  • Verify Assumptions
  • Conduct studies / experiments
  • Identify technical root cause(s)
  • Identify systemic root cause(s) (system and detection failures)
  • Conduct Workshop 7

Step 6: Determine Corrective / Preventive Actions

  • Examine mistake-proofing techniques
  • Apply variation reduction and optimization techniques
  • Determine corrective / preventive action(s)
  • Identify acceptance criteria
  • Workshop to determine corrective action and acceptance criteria
  • Evaluate the risk and determine any risk mitigation
  • Risk mitigation workshop
  • Develop/revise the control plan
  • Control plan workshop

Step 7: Verify Corrective / Preventive Actions

  • Implement and measure effectiveness of corrective / preventive actions
  • Evaluate the control plan
  • Determine additional preventive actions

Day 3

Second Case Study

  • Introduction
  • Workshop to define the performance problem and identify possible causes
  • Workshop to collect data
  • Workshop to test possible causes
  • Workshop to determine corrective actions including risk mitigation, control plan, and acceptance criteria

The Finale

  • Compare and contrast the investigation methodology with the traditional approach
  • Shortcuts
  • Handling the simple investigation
  • Handling the difficult investigation
  • The investigation report
  • Institutionalizing the methodology (ROI)
  • References for the journey


Note: English will be used in all lectures and course notes. 


Course information

Course Code 304.02
Course Title Root Cause Investigation for CAPA
Partnership CfPA
Language English
Course Duration 24

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