The PDMA Handbook of New Product Development

28.5. References

AIAG, Potential Failure Mode and Effects Analysis (FMEA) Reference Manual. 3rd Ed., 2001.

ANSI/AAMI/ISO 14971:2000, "Medical devices—Application of risk management to medical devices," Arlington, VA: Association for the Advancement of Medical Instrumentation (AAMI), 2000.

IEC 812, "Analysis techniques for system reliability—Procedure for failure mode and effects analysis (FMEA)," Geneva, Switzerland: Bureau Central de la Commission Electrotechnique Internationale (CEI), Geneva, Switzerland, 1985.

Stamatis, D. H., Failure Mode and Effect Analysis: FMEA from Theory to Execution. ASQ, Milwaukee, WI: Quality Press, 1995.

Tan Hiap Keong, Risk Analysis Home Page, http://homel.pacific.net.sg/~thk/, downloaded on 7/8/2003.

Steven R. Nelson

has 25 years of experience leading commercial and government projects ranging in size from $5000 to $5 million. For 16 years, he has worked to transition the very formal and expensive government risk analysis and management tools into the commercial product development environment. He founded Decision Support to assist and train commercial clients in the use of these techniques. Mr. Nelson has a degree in mechanical engineering from the Ohio State University.

Fritz Eubanks

is a mechanical engineer at Battelle Memorial Institute involved in system-level design and analysis of both medical and commercial products, with emphasis on hardware and software risk assessment activities, such as safety hazard analyses and failure mode and effects ...