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

Learning Objectives
Through training, students will learn to respond effectively to non-conformances, failures, deviations, and complaints by identifying root causes and implementing corrective and preventative actions. Students will also develop skills necessary to:

• Determine whether or not a complaint should go through a CAPA process.
• Perform trend analysis and 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 CAPA and Problem Solving
During this session students 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, students learn to:
   Identify the problem
   Clarify the problem
   Develop a problem statement
2. Cause Investigation
   During Cause Investigation, students learn to use several Root Cause Analysis (RCA) tools, including:
   Conducting a “5-Why” investigation to identify the root cause
   (For the specific problem, for the lack of detection, for system failures)
   Is/Is-Not Techniques
   Cause & Effect Diagrams
3. Problem Correction
   Problem Correction involves the use of specific actions to correct the problem. Students 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, students 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
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 students to use D 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. Students 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

Course Format
8 hours
8:30am-4:30pm (EST)
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization

Course Evaluations Set 1
Course Evaluations Set 2
Course Evaluations Set 3 – Montreal
Course Evaluations Set 4