We all try to do the best work that we can, however, there are times when things go wrong and problems arise. These things can be in or out of control and result in work that is less than it could be. That is why we take corrective action — to address any problems, deficiencies, or nonconformities that come up from time to time.

In this course, we discuss how collaborative problem-solving can lead us to the root causes of problems, deficiencies, or nonconformities so that we, with our team, can use a corrective action process to correct the problem and verify the success of our actions.

After you complete this course, you will be able to:

• Outline the corrective action process
• Compare and contrast nonconformances, correction, corrective action and preventive action
• Integrate preventive action into a corrective action process
• Identify problems through customer complaints and audits
• Use risk assessment to assess the significance of problems
• Apply various tools (brainstorming, brainwriting, fishbone diagrams) to identify possible underlying factors of a problem
• Understand the fundamentals of other tools (Pareto Analysis, FMEA, Control Charts) to identify possible underlying factors of a problem
• Use The Five Whys to identify the root cause of a problem
• Understand the importance of verifying the root cause
• Employ collaborative decision-making to apply the appropriate action to eliminate the root cause of a problem
• Use SMART Objectives to make corrective action verifiable
• Verify the effectiveness of corrective actions taken

Course Topics:

Session One: Course Overview

• Learning Objectives 

Session Two: Problem-Solving Model

• Corrective Action Model

Session Three: Preventative Action

• Definitions
• Preventive Action Plan
• Preventive Action Plan
• Identifying Potential Nonconformances
• Examples of Preventive Actions

Session Four: Corrective and Preventive Action Plan

• CAPA Plan
• CAPA Plan
• CAPA Form Example

Session Five: Identify a Problem Through Customer Complaints

• Customer Complaints/Feedback
• Customer Complaints
• Complaint Investigation
• Complaint Resolution: Customer Complaint Role Play

Session Six: Identify a Problem Through Internal Audits

• Nonconformances
• Sources for Discovering Nonconformances
• Basics of an Internal Audit
• Identifying, Collecting, and Preserving Evidence
• Questioning Exercise
• Developing an Audit Checklist
• Observational Classroom Audit Checklist
• Audit Checklist Exercise One
• Audit Checklist Exercise Two

Session Seven: Assess the Significance of the Problem

• Risk Assessment
• Significance Rating

Session Eight: Identify the Root Cause

• Root Cause Analysis
• Root Cause Analysis
• Tools to Identify Possible Underlying Factors
• Brainstorming
• Limitations of Brainstorming
• Brainwriting
• Fishbone Diagrams
• Finding Potential Causes of Nonconformances
• Other Tools to Identify Possible Underlying Factors
• Identify the Root Cause(s)
• Finding Root Cause of Nonconformances using ‘The Five Whys’
• Reasons for Incorrect Root Cause Determination
• Verify the Root Cause

Session Nine: Determine and Apply the Appropriate Action

• Collaborative Decision-Making
• Collaborative Decision-Making Exercise
• Making your Corrective Action Verifiable
• SMART Objectives
• SMART Objectives for Corrective Action
• Implement Corrective Actions

Session Ten: Verify the Effectiveness of the Actions Taken

• Verification
• Verification
• SMART Objectives for Corrective Action
• SMART Objectives for Corrective Action with Verification Activities
• Why Do Some Recent ISO Standards not Include Preventive Action?