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Abstract:This article proposes the use of failure mode and effects analysis (FMEA) as a dynamic tool ("dynamic FMEA") rather than a static operation. As a complementary risk management tool, FMEA is used widely in medical device and pharmaceutical design or processes. It is initiated and completed prior to the product's commercialization or process validation. There are no requirements, guidelines, or practices in this industry that an organization must keep the FMEA document open or to reevaluate after release of product. Neither are there links among corrective and preventive action (CAPA), nonconforming material reports (NCMR) and an FMEA saying that issuing a CAPA or NCMR precludes review of the closed FMEA to determine whether the failure and control were addressed. Generally, a product development team owns the FMEA. It will request the input of people from quality, regulatory, marketing, sales, logistics, and customer services groups for input. Unfortunately, after a product is developed or the …

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I will use this as a reference for a book on risk-based thinking, and the role of FMEA.
--Bill Levinson, 06-11-2015


FMEA is a underused tool. This approach may help to gain traction in implementing them with additional benefits.
--Gilles Belanger, 04-16-2015


I fully agree with you. FMEA is a document that is based on the estimation in the initial stage based on the past knowledge gained. Hence as the knowledge about the customer requirements change so also the severity factor changes. Also the field returns or internal failures also refine the estimates of the occurance. These need to be drilled back into FMEA to make it more closer to reality. The more accurate an FMEA is more accurate a tool it will be.
--Rajan Bhagwat, 04-10-2015


Found it enlightening. I did work for a company that used a dynamic FMEA and CAPAs/NCMRs were sources that fed into revisions of the FMEA. They could indicate mitigation/verification/validation activities.
--Elisa Ortiz, 04-08-2015


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