Root Cause Analysis - The Heart of Corrective Action

Why Should You Attend:

Is your corrective action system effective or do the same or similar problems keep occurring? If so you may not be doing root cause analysis in sufficient depth. Corrective and Preventive actions (CAPA) are key to an effective quality management system. And the key to an effective CAPA system is to know how to do an in-depth root cause analysis.

This presentation will explain the importance of root cause analysis and how it fits into an effective corrective and preventive action system. It will cover where else in your quality management system root cause analysis can be used and will give examples of some of the techniques for doing an effective root cause analysis. Attendees will learn how root cause analysis can be used in process control.

Learning Objectives:

• Reviewing CAPA
  • The difference between Correction, Corrective Action and Preventive Action
• Understand what root cause is
• Learn why root cause analysis is important
• Understand where root cause analysis is valuable
• Relationship between root cause and risk management
• Explore several techniques for doing root cause analysis

Areas Covered in the Webinar:

• What is root cause
• The difference between Correction, Corrective Action and Preventive Action
• Why root cause analysis is important
• Where root cause analysis is valuable
• Corrective and Preventive Action
• Risk Management
• Process Control
• Several techniques for doing root cause analysis

Who Will Benefit:

• Quality Management
• Quality Engineers
• Manufacturing Engineers
• Internal Auditors
• Quality Specialists
• Quality Associates
• Operations and Manufacturing Managers
• Process Engineers

Betty Lane
Founder and President, Be Quality Associates LLC

Betty Lane, has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate compliance with design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.

Topic Background:

CAPA is one area where the FDA continually finds problems in quality systems. And if you do not do an effective root cause you will not have a good corrective action system and will find that problems will reoccur, and are likely to lead to increasingly more serious problems.

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