Building and Sustaining a Culture of Quality

Concurrent Session

W17 - Auditing Your Risk Management System

Primary Presenter(s)

• 

  Barrett Craner, MS+, MBA (with distinction), CQE, CRE, CQA, CBA, RAC(US), ASQ Fellow

  Principal Consultant
  CQA Associates
  Manteca, California

Moderator(s)

• LG

  Lisa Grosskopf

Level: Intermediate

Division: Biomedical Division

All major quality system standards call for risk-based decision making and a risk management system, and as such, many auditors are practicing auditing aspects of risk management, including hazard identification, hazard analysis, failure mode and effects analysis (product and process), risk management file, risk management reporting, risk management planning, and even other less commonly used risk management tools like fault tree analysis and hazard analysis and critical control point. Are you ready for an audit of your risk management system and your analysis tools? One way to find out is to attend this informative session and check off the thoughts discussed, and during the Q&A, share your own additional thoughts. Attendees should include management, engineering, QA, regulatory, manufacturing, and project management, and attendees at all levels will benefit from this presentation and discussion.

Learning Objectives:

• Prepare for an audit of your organization's risk management system, including its processes, procedures, planning, reporting, risk management analysis tools, and risk management file completion.
• Understand specific aspects of many risk management analysis tools potentially audited (hazard identification, hazard analysis, FMEA (product, process, and use), fault tree analysis (product and process), and others.
• Learn the "whys" of being audited on this major product and process development tool, including regulatory emphasis and direction.
• Gain a full grasp of a the consequences of a risk management system under audit, and gain ideas for a risk management program structure.
• Get several sample workshops to take back to your company for use as actual workshops or as examples to create your own workshops to prepare for a risk management audit.