Root Cause Analysis and CAPA

Course Description

This course is specifically designed to meet the analytical needs of people working within FDA regulated industries. This course is designed for those individuals working directly on product and process development and corrective / preventative action. It is assumed they come from a variety of backgrounds and disciplines and will be working on a variety of process improvement areas across the company.


This course is required for all scientists, engineers and quality professionals who actively work on all aspects of discovery, product and process development where the goal is to understand the root cause of performance problems and implement CAPA procedures to assure the problem never occurs again.



16 Hours

Contact Information


1 (650) 967-2700

P.O. Box 2103
Sunnyvale, CA 94087-0103

Course Objectives

Upon completion of the course the participants will be able to:

  • Identify a problem that requires action
  • Define a problem in measurable terms
  • Contain the problem while developing a durable solution
  • Measure core performance and establish metrics
  • Collect and analyze data relevant to the problem of interest
  • Analyze the system of causes and determine root cause
  • Plan and implement corrective and preventative relevant to the root cause of theproblem
  • Evaluate the effectiveness of the solutions
  • Establish controls to sustain solutions
  • Use Excel or JMP for basic statistics and data analysis


Course Outline:

Introduction to Root Cause Analysis
Need for improvement
Savings associated with root cause analysis Eight+ basic quality tools

Define and Contain the Problem
Define the problem
Contain the problem
Determine scope, objectives and goals Project leadership and planning

Measure the Problem
Map the process
Determine data collection plan
Establish metrics and capability

Analyze Data and Determine Root Cause
Analyze and summarize the data
Analyze and summarize the process map
Determine root causes and summarize all findings

Improve Performance
Brainstorming solutions and CAPA
Benefit, cost, risk and complexity determination
Measuring solution effectiveness

Control and Standardize Improvements
Process owner Select controls