Building and Sustaining a Culture of Quality
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.