Course Description
When failure occurs, we demand a rigorous process of investigation be initiated to identify why it occurred. Corrective Action Preventive Action (CAPA) is a process that investigates and solves problems, identifies causes, takes corrective action, and prevents recurrence of the root causes. The ultimate purpose of CAPA is to ensure the problem can never be experienced again. CAPA can be applied in many disciplines, including:

• Manufacturing
• Product Design
• Testing Verification and Validation
• Distribution, Shipping, Transport and Packaging
• Use-Applications

Corrective Action Preventive Action (CAPA) is also a US FDA requirement, FDA 21 CFR 820.100. The CAPA requirement applies to manufacturers of medical devices and compels them to include CAPA in their Quality Management System (QMS).

This course provides a clear and concise introduction to Corrective Action/Preventive Action (CAPA), as well as a detailed review of step-by-step problem-solving processes, including 8D (8 Disciplines) and RCA (Root Cause Analysis). Participants will learn how to make their CAPA program a valuable and meaningful tool for realizing cost savings and process improvement.

8D is used by a wide variety of industries, from service to design, manufacturing, and fulfillment. 8D has been used by sales, development, purchasing, production as well as other processes, and is a technique that is easily understood and mastered.

Who Should Attend
This course is appropriate for anyone who participates in addressing product quality issues, regulatory concerns, supplier corrective actions, internal corrective actions/deviations, or who is tasked with eliminating or minimizing defects as part of a Continual Improvement (CI) program. This includes those that have Regulatory, Quality, Environmental, or Occupational Health/Safety Management Systems responsibilities for making general improvements in their organization’s performance, as well as the specialists in various areas who are the subject matter experts.

Learning Objectives
Through training, participants will learn to respond effectively to non-conformances, failures, deviations, and complaints by identifying root causes and implementing corrective and preventative actions. They will learn how to respond to problems/deviations with a process that is focused, rapid, and fully documented.

Participants will also develop skills necessary to:

• Determine the optimum problem-solving methodology
• Determine whether a problem or complaint should go through a CAPA process
• Use effective 8D and Root Cause Analysis (RCA) tools
• Verify and validate a CAPA/RCA process corrective action
• Integrate RCA with other systems, such as Internal Auditing, CAPA, and complaint handling

Course Outline

Introduction to the CAPA and Problem Solving Process
During this session, participants will learn how to integrate problem solving processes in their own initiatives and make their CAPA program a valuable and meaningful tool for realizing cost savings and process improvement.

The problem-solving process has four major parts:

1. Grasp the Situation
During the first part of the problem-solving process, Grasp the Situation, participants learn to:

• • Identify the problem
  • Clarify the problem
  • Develop a problem statement
    • Use the 5W2H tool

2. Cause Investigation
During Cause Investigation, participants learn to use several Root Cause Analysis (RCA) tools, including:

• Conducting a “5-Why” investigation to identify the root cause
• Is/Is-Not Techniques
• Cause & Effect Diagrams

3. Problem Correction
Problem Correction involves the use of specific actions to correct the problem. Participants learn to implement short-term temporary measures (required to protect their customers) and follow with longer-term corrective actions.

4. Prevention
In the fourth and final part of the problem-solving process, participants learn to take specific actions to make sure a problem cannot recur, typically through error proofing and capturing the lessons learned.

8D Problem Solving Process Steps
This session begins with an overview of the Eight Disciplines (8D) Problem Solving Process, a method for product and process improvement that emphasizes the Team. Training includes case studies and hands-on exercises to prepare participants to use 8D effectively within their organizations. The Eight Disciplines are:

1. Establish the Team
2. Describe the problem
3. Develop an Interim Containment Action
4. Define / Verify Root Cause
5. Choose / Verify Permanent Corrective Action
6. Implement / Validate Permanent Corrective Action
7. Prevent Recurrence
8. Recognize the Team

RCA – A Systems View
Root Cause Analysis (RCA) is a method of problem solving that attempts to identify the origin of problem or nonconformance. This session begins with a discussion about the definitions of “Problem” and “Root Cause” and an overview of the RCA problem solving procedure. Participants learn to identify root cause and prevent reoccurrence using the following steps:

1. Organize for RCA
Roles of the Facilitator
Holding an effective meeting

2. Select a Problem
Who selects the problem?
Criteria for selection

3. Define the Problem
What to look for
Developing a Problem Statement
Refining the Problem Specification

4. Analyze Information
Forms & Checklists
Trend Charts
Process Charts & Fishbone Diagrams

5. Identify the Problem Source
Fishbone Diagrams
Is/Is-Not Analysis
Search for Solutions
Five Why’s
Pareto Charts
Brainstorming

6. Identify the Best Solution
Cost-Benefit Analysis

7. Take Action
Planning Implementation
Presenting a Proposal

8. RCA Verification
Monitoring
Preventing Re-occurrence
Trend Chart
Control Chart
Check Sheet

Prerequisites
None

Course Format
16 hours (8:30am – 4:30pm EST each day or 4 x 4-hour virtual sessions)
Combination lecture and classroom exercises
Available virtually, at QSG’s training facilities or on-site at your organization

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