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:
- 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 - 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 - 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. - 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:
- Establish the Team
- Describe the problem
- Develop an Interim Containment Action
- Define / Verify Root Cause
- Choose / Verify Permanent Corrective Action
- Implement / Validate Permanent Corrective Action
- Prevent Recurrence
- 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:
- Organize for RCA
Roles of the Facilitator
Holding an effective meeting - Select a Problem
Who selects the problem?
Criteria for selection - Define the Problem
What to look for
Developing a Problem Statement
Refining the Problem Specification - Analyze Information
Forms & Checklists
Trend Charts
Process Charts & Fishbone Diagrams - Identify the Problem Source
Fishbone Diagrams
Is/Is-Not Analysis
Search for Solutions
Five Why’s
Pareto Charts
Brainstorming - Identify the Best Solution
Cost-Benefit Analysis - Take Action
Planning Implementation
Presenting a Proposal - 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
8:30am-4:30pm (EST)
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