Identifying Critical Requirements Using FMEA

[article]
Summary:

Engineers in other specialties have adopted the FMEA to analyze all sorts of manufacturing processes and products. The FMEA process allows a development team to identify potential product related process failure modes and assess the effects these failures might have.

Engineers in other specialties have adopted the FMEA to analyze all sorts of manufacturing processes and products. The FMEA process allows a development team to identify potential product related process failure modes and assess the effects these failures might have.

About the author

Edith Maverick-Folger's picture Edith Maverick-Folger

Edith Maverick-Folger is a software engineer with LifeScan, Inc. She has 10 years’ experience in medical biotech development, QA, and validation under FDA cGMP’s and ISO 9000 guidelines. At LifeScan, she tests software for the automated test and assembly stations on blood glucose meter manufacturing lines. As a V&V professional, her overriding goal is to bring a focus on quality, from requirements to test, for system development. To build in quality, an organization needs to find problems early in the development cycle. This minimizes the time and cost of a project. Biotechnology’s diverse engineering teams share their different quality assurance methods to achieve this goal; consequently, at LifeScan, Edith was introduced to Failure Mode and Effects Analyses (FMEA’s). Edith has a B.A. in computer science. She added QA laboratory work, electronics, and manufacturing statistics skills through work experience and further education.

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