This Risk Management Webinar/training will discuss how to use the 5 different tools which should be used in risk management process as per ISO 14971. It also emphasize on the documentation of results of the usage of tools.
Why Should You Attend:
An effective Risk Management process requires the use of more than one tool to identify hazards and estimate risks. The use of a single tool does not produce a complete risk analysis nor does it meet the requirements of the risk management standard and FDA regulations. The standard requires identification of hazards in the device normal and fault condition. Most tools identify fault condition hazards, but omit the normal condition hazard. ISO 14971 identifies five different tools, but many companies only use one. In addition, new requirements for product use were identified by FDA in guidance on human factors and risk management in 1999, and further explored in standards on usability and human factors. The documents provide additional tools for identification of normal and fault condition hazards.
This presentation will explore effective use of the various tools for identifying hazards, hazardous situations, and estimating risk as part of the risk management process. We will identify correct use of the tools and how the results of their use should be documented in such a way that it meets the requirements of a Risk Management File in ISO 14971. We will identify strengths and weaknesses of the various tools, as well as the proper use of each tool.
Areas Covered in the seminar:
- Regulatory and risk standards requirements and guidance.
- Identifying risk management tools and their use.
- How some tools are commonly misused in risk management.
- Explaining the strengths and weaknesses of the various risk management tools.
- Choosing the proper tools for risk management.
- How usability relates to risk management.
Who will benefit:
This webinar is appropriate for all medical device risk management team members who use the various tools to conduct risk analysis and risk assessment, both during product and manufacturing process design and in later phases when products and their manufacturing processes are changed. It is also appropriate for supplier quality engineers who work with suppliers in developing their manufacturing processes.
- Design Engineers
- Quality Engineers
- Risk Managers
- Process designers
- Process Validation Engineers
- Supplier Quality Engineers
Instructor Profile:
Edwin L. Bills, During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group.
Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.
