Surprising Mitigations from Fault Tree Analysis

ASQ Inland Empire Section, ASQ Temecula Valley Section and ASQ San Gabriel Valley Section Joint Online Webinar

Surprising Mitigations from Fault Tree Analysis - Don't Stop Just with the Fault Tree! by Barry Craner

Help Designers! The Fault Tree Analysis (FTA) is a tool for any problem from an event or hazard when one desires to understand possible future or past causes. It can be used in Root Cause Analysis (like a Fishbone analysis), and in Risk Management in device design and process development. One starts with an event or hazard, then proceeds through a few levels of possible succeeding causes. However, if one stops there, the “product” is only a list of possible (even probable) potential causes one wants to avoid. So, “Where is the Beef?” The next step is where we create a list of potential “mitigations” that can be used in the product or process design process to ensure the probability of a future event is significantly lowered, or for a past event, we can see why it happened, and more importantly, likely prevent it from happening again. The speaker will also provide a blank template and an example completed template for “take-aways”.

Speaker: Barry Craner

Instructor Introduction

• Vice President, QA/RA, Stellartech Research Corporation (ret.)

• >40 years managing Engineers, Scientists

• MS + Scientific Language Cert - Biology (Cardiac Contractility Physics)

• MBA (with distinction - emphasis Computer Information Systems)

• Biological Sciences, Electrical Eng., Chemistry, Aerospace, InfoSystems

• White House and HIMA - Y2K ask Forces (1998-2000)

• Wrote ASQ Y2K “2-digit year” letter to FDA (FDA then approved 2-digit year)

• In 100 Notable People in Medical Device Industry – MDDI 2008

• Professor (Adjunct), Graduate MSQA Program, Calif State Univ (12 yrs - ret.)

• Instructor, UC Santa Cruz Extension, Grad Certificate Program (12 yrs - ret.)

• ASQ Lancaster Medal, 5/2025 (meritorious international teaching, mentoring)

• ASQ Wrote Risk Mgt Body of Knowledge for CQE Refresher Course (2016)

• ASQ Simon Collier Quality Award, (2008)

• ASQ Distinguished Service Award (2008)

• ASQ Stanley Marash Speaker Scholarship 2010 (speaker at Israel International Quality Congress (2010)

• ASQ Founding Member Medical Device Auditor Certification Program (2002)

• Chair, Impartiality Review Board – Major Notified Body since 2022, member since 2016

• Taught Risk Mgt to FDA, Fortune 500 companies, Startups, Aerospace

• Regulatory Affairs Certified (RAPS) – RAC(US)

• Fellow (ASQ 2008), Certifications (all current):

• Certified Quality Engineer (1985)

• Certified Reliability Engineer (1986)

• Certified Quality Auditor (1991)

• Certified Biomedical Auditor (2004)

Professional History

• Vice President, QA/RA, Stellartech Research Corporation (ret.)

• Director, Design Assurance, Boston Scientific Corporation

• Director, Quality Assurance, Lipid Science, Incorporated

• Director Technology, Synteleos, Inc.

• Director, Y2K Program, Mallinckrodt Corporation (Mfg, Prod Dev, Service, Suppliers, etc.)

• Director, Quality Assurance, Hospital Division, Tyco/Mallinckrodt/Nellcor Puritan Bennett

• Director, Quality Assurance, ACS/Guidant Corporation

• Manager, Reliability Engineering, Advanced Cardiovascular Systems

• Manager, Reliability Engineering, IMED Corporation

• Supervisor of Engineering, Scanivalve Corporation

• Research Associate, Biomathematics and Electrocardiographic Research Group

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