The Certified Quality Process Handbook Chapter 22: Preventive Action Presented by Dr. Joan Burtner Certified Quality Engineer Associate Professor and Chair Dept. of Industrial Engineering and Industrial Management Mercer University

Introduction to Preventive Action Actions taken to avoid making a mistake or creating a defective product Formal definitions – Preventive action is … action taken to remove or improve a process to prevent potential future occurrences of a nonconformance (ASQ Glossary) action taken to eliminate the potential causes of a nonconformity, defect, or other undesirable situation in order to prevent occurrence (CQPA 2nd edition) Process steps Identify potential problems Identify potential causes Develop preventive action plan Implement preventive action plan Verify and confirm effectiveness IDM ISE ETM 2017 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

Identify Potential Problems Standard (straightforward) sources of information Customer feedback Quality records Audit results Analytical methods Review corrective action reports (CAR) and look for applicability to similar processes or products Review product and process monitoring reports and look for trends Use Failure Mode and Effects Analysis (FMEA) results IDM ISE ETM 2017 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

Identify Potential Causes Use flowcharts or value stream maps Document “as-is” condition of a process Serve as a communication tool for preventive action team members Use a team to conduct a failure mode and effects analysis (ASQ Glossary) A systemized group of activities to recognize and evaluate the potential failure of a product or process and its effects, identify actions that could eliminate or reduce the occurrence of the potential failure and document the process Ideally, FMEA is conducted early in the product life cycle Quality Function Deployment may be helpful for some new products IDM ISE ETM 2017 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

FMEA Methodology Potential failures are brainstormed and placed in a table as shown in Table 22.1 of the CPQA 2nd edition Risk priority number (RPN) is calculated to help prioritize the order in which each potential failure should be addressed. RPN = S x O x D S = severity, O = likelihood of occurrence D = probability of detection IDM ISE ETM 2017 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

Preventive Action Plans Address potential failures that have high RPN ratings Identify recommended actions May completely eliminate the cause May reduce the occurrence May improve detection Action plan implementation should be tracked Preventive action effectiveness should be verified and confirmed IDM ISE ETM 2017 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering