by complianzworld.com 2014 - Efficient Failure Mode And Effects Analysis

Description:
It's not enough to do your best. You must first know what to do, and then do your best. The FMEA methodology is so structured; it forces you to identify the right things to do. One of the right things to do is to not repeat the problems of the old designs into the new devices. Why companies are prone to having past problems in new devices? One of the main reasons seems to be the "weak cognition." It is usually the result of short term memory, inattention to details, insufficient vigilance, or multitasking
Course Objective:
The ISO 14971 and its risk analysis tool FMEA has been recognized by FDA, and in Europe, for risk mitigation of medical devices. Compliance with ISO 14971 will therefore be crucial not in meeting regulatory requirements but also as a most important part of design control. The FDA reviews the results of the FMEA as preview to device recalls, during adverse event analysis, and complaint investigations. FMEA may be very difficult and tedious for the case of complex systems which have multiple functions consisting of a high number of components. This difficulty can be increased by the number of possible operating modes, as well as by including consideration of repair and maintenance policies. Therefore a thorough understanding by the entire staff is critical in efficient FMEAs.
Course Outline:
FMEA process fundamentals
Frequent mistakes in FMEA
Scoping the FMEA for efficiency
Identifications for traceability
Multiple effects for each failure mode
Multiple causes for each effect
Evaluation criteria
Severity rating scale
Probability rating scale
Detectability rating scale
Risk assessment
Risk mitigation
Post control risk evaluation
Example of a good FMEA
Reporting the results of FMEA
Using FMEA as a living document
Target Audience:
R&D and Engineering Managers
Design and Development
Quality Engineers
Manufacturing Engineers
Quality Auditors
Manufacturing Managers
Medical staff evaluating risk, safety or effectiveness
Quality or regulatory staff assigned to complaint, CAPA or MDR management
Marketing Managers
Training Personnel
General/corporate counsel
Speaker : Dev Raheja
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to come up with elegant solutions using creativity and innovation.
Price List:
Live : $199.00
Group : $799.00
Recorded : $249.00
Training CD-DVD :$ 399.00
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