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. The course is
designed for 16 hours of presentation.

Attendees:
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
appropriate CAPA procedures to assure the problem never occurs again.

 

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

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

Software: JMP, Microsoft Excel
Prerequisites:  None

Detailed Course Outline:

Define and Contain the Problem                                                    
Introduction to Root Cause Analysis and Six Sigma
Define the Problem
Contain the Problem
State the Problem, Objective, Goal, and Benefits
Perform Resource Analysis
Develop a High-Level Process Map
                                                
Measure the Problem
Define Data Collection Requirements
Process Reviews and Mapping
Develop a Data Collection Plan
Define the Process Baseline 
                         
Analyze the Data and Determine Root Cause
Analyze All Relevant Data
Explore All Probable Root Causes
Determine and Summarize the Root Cause  
                                                     
Improve Performance
Identify Owner and Opportunities for Standardization
Determine the Controls Needed to Sustain the Gains
Realize the Benefits of Improvement
Reflect on the Improvement Process      
                                                           
Control and Standardize Improvements
Identify Owner and Opportunities for Standardization
Determine the Controls Needed to Sustain the Gains
Realize the Benefits of Improvement
Reflect on the Improvement Process                 
                                              
Lean Basics
Identification of Waste
Value Stream Mapping
Lean Performance Measures
Lean Solutions