ASQ--611 Risk Management,
The quickest way to find out information about, and/or registering for the upcoming ASQ sponsored biomedical classes is to visit the section’s web site as described below.
Go to the section’s web site at asq-silicon-valley.org Then select “Education” from the column at left. Then select “Courses” from the column at left. A list of courses will appear. Scroll down until you come to the course of interest to you. Then select that course. A course description and registration instructions will appear on the screen. Follow the prompts to register for the course(s) of interest.
If you have difficulty registering using this information, please call me and I will help you out.
Jim Bischof 408-972-8852.
This course will provide a work-shop setting in which the major risk-identification and risk-reducing methods will be characterized o
Failure Modes and Effects Analysis – FMEA,
Fault Tree Analysis – FTA,
Hazard and Critical Control Point Analysis – HACCP
* Analysis will be performed real-time in class in order to experience practical implementation of these processes.
• Examples will be worked on in class
Identifying product and process hazards,
Evaluating the hazards for possible level of risk,
Ways to creatively brainstorm on reducing (mitigating) the risk.
• The course will also review recently enacted standards relevant to medical device risk management.
• Applicability of these analytical processes to the product development cycle will be explained The transfer to production
Production phases,
Examples of the use of such tools, many from the instructor’s work experience, will be explained and used in class
*Identifying and minimizing risk impact during production
* Critical process point identification / mitigation •
* How to adapt many of these skills and processes for your specific needs,
In or out of the medical device development and manufacturing environments.
• Examples also provided: Determining risk-level, Assignment of risk-impact, How to implement both predictive and preventive processes.
• Summary and introduction of the issues facing the FDA and Europe early on, which moved them toward the focus of requiring risk management in all aspects of product development and manufacturing, including mechanical, electrical, software, and disposable products.
•Full, usable procedures on Risk Management, Fault Tree Analysis, and Failure Modes and Effects Analysis •
CD with ~60 public and original resources for Risk Management in medical devices
Binder with >100 pages of material, including all class presentation notes, procedures, worksheets, etc.
Instructor: Barry Craner
