Fault Tree Analysis: A Risk Management Tool

Fault Tree Analysis is an effective tool for evaluating how a medical device can cause harm to the user and how multiple factors affect a given issue. The output of an FTA includes a visual representation of not only hardware failure modes but also the software faults, user errors, device misuse, and environment factors. The tool can be used to predict the probability of harm and lead to robust design improvements. It is useful both for risk assessment and in developing monitoring programs.

Attend this webinar to learn how you can inherent safety in the product design and prevent product recalls. This seminar covers principles of risk analysis and risk mitigation.

Areas Covered in the Seminar:

• History of Fault Tree Analysis.
• Why all industries use it?
• Fault Tree Analysis procedure.
• Risk mitigation procedure.
• Fault Tree symbols.
• Fault Tree construction.
• Assessing the effectiveness of the product design.
• Calculating probability of harm.
• Using FTA for design improvements.
• Using FTA to assess the process vulnerability.
• Using FTA for developing product validation tests.

Agenda: (All time in EDT)

10:00 -11:30

• History of Fault Tree Analysis.
• Why all industries use it?
• Fault Tree Analysis procedure.
• Risk mitigation procedure
• Fault Tree symbols
• Fault Tree construction

11:30 -12:00 Break

12:00 -12:50

• Assessing the effectiveness of the product design.
• Calculating probability of harm.
• Using FTA for design improvements.
• Using FTA to assess the process vulnerability.
• Using FTA for developing product validation tests

12:50 -1:00  Q&A

Who Will Benefit:

This webinar will provide valuable assistance to all Medical Device companies/ manufacturing sites. Those that would benefit most would be:

• R&D, Scientists
• Senior management
• Engineers
• Product Management, Product development
• Manufacturing managers and engineers
• Safety, Reliability, Quality Assurance
• Regulatory
• Purchasing & Production
• Sales and Marketing
• Suppliers

Instructor Profile:

Dev Raheja , a respected and sought out expert on medical device and hospital care safety, draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety and reliability. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event. He applies analytical tools that can effectively measure efficiency, establish evidence between Lean strategies and patient satisfaction.

His focus is on using various types of innovations to encourage a culture conducive to high return on investment. He is the author of the books Assurance Technologies principles and Practices, and Safer Hospital Care. He has served as Associate Professor for the PhD degree in Reliability Engineering at University of Maryland during 1994-99.

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