Root Cause Analysis and CAPA

Course Description

This course is specifically designed to meet the analytical needs of those individuals 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.

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Prerequisites

There are no prerequisites for this course.

Course Objectives

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

Detailed Course Outline

Section I: Introduction to root cause analysis

Need for improvement
Savings associated with root cause analysis
Eight+ basic quality tools

Section II: Define and contain the problem

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

Section III: Measure the problem

Map the process
Determine data collection plan
Establish metrics and capability

Section III: Measure the problem

M

Section IV: Analyze data and determine root cause

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

Section V: Improve performance

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

Section VI: Control and standardize improvements

Process owner
Select controls