Effective Root Cause Analysis: The key to an effective corrective actions system

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Effective Root Cause Analysis The key to an
effective corrective actions system
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• Instructor Profile
• 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.
• Bettys training experience includes over 25
  years of training on all areas ISO 13485 and FDA
  cGMP, in companies, 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.

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• Description
• In this presentation you will
  learn the importance of root cause analysis and
  how it fits into an effective corrective and
  preventive action system. We will cover where
  else in your quality management system it can be
  used, and describe some of the techniques for
  effective root cause analysis. Examples will be
  cited to illustrate how each technique works.
• Corrective Actions are one of the top areas of
  FDA 483 citations from audits they perform at
  medical device manufacturers. The FDA once shut
  down almost all the diagnostic manufacturing of a
  company that consistently failed to implement an
  effective corrective action system. 

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• 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. Learn how Root cause
  analysis can be used in process control.

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• Objectives of the Presentation In this
  presentation you will learn the importance of
  root cause analysis and how it fits into an
  effective corrective and preventive action
  system. We will cover where else in your quality
  management system it can be used, and describe
  some of the techniques for effective root cause
  analysis. We will cover
• 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
• Techniques for Root Cause Analysis

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• Who can Benefit
• This presentation will benefit all
  those involved with internal or supplier
  corrective actions. If you issue corrective
  actions, you need to know what an effective
  root-cause analysis looks like. If you are
  assigned to complete a corrective action, you
  need to know what is expected for a root-cause
  analysis. If you manage the corrective action
  system or those doing corrective actions, it is
  also important that you understand root-cause
  analysis. So that means almost anyone working
  within a medical device quality system could
  benefit from understanding the how and why of
  root-cause analysis.This webinar will provide
  valuable assistance to all personnel in
• Quality Management
• Quality Engineers
• Manufacturing Engineers
• Internal auditors
• Quality specialists
• Quality Associates
• Operations and Manufacturing Managers
• Process Engineers

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• Live Session - How it works
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf formate will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Please let us know your thoughts and views at the
  end of webinar, your valuable feedback will help
  us improve
• Get certification of attendance.
• Recorded Session - How it works
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf formate will be
  mailed to you
• Get certification of attendance.

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Get Connected

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www.onlinecompliancepanel.com 510-857-5896
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