In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective.
We will also cover where else in your quality management system root-cause analysis can be used. Learn how Root cause analysis can be used in process control. We will describe and give examples of some of the techniques for doing and effective root cause analysis. You will learn about various techniques that are available so you can choose the one or ones that fit your situation.
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. Corrective and Preventive Action 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.
Areas Covered in the Session:
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
Several techniques for doing Root Cause Analysis
Relationship between Root Cause and Risk Management
Looking other places in the QMS where Root Cause Analysis is valuable
Who Will Benefit:
Quality Managers and Directors
Operations and Manufacturing Managers
Betty LaneBetty 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 for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for 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 aspects of ISO 13485, the ISO standard for Medical Device - Quality Management Systems - System Requirements for regulatory purposes, and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct 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 (RPI), and an MBA from Northeastern University.