FMEA is a Reliability Analysis tool, and like all tools it has limitations along with its benefits, and is defined in IEC 60812. If you are discussing it's use in medical device risk management, it does not, by itself, fully cover the requirements of
ISO 14971:2018 5.4 Identification of hazards and hazardous situations. The standard requires more than single-fault be covered which is a limitation of FMEA. 14971 also requires that normal condition hard be covered, which is not possible with FMEA.
So, if you are only using FMEA as your risk analysis, you are not meeting the requirements of ISO 14971, you must cover all the requirements in the above mentioned Clause 5.4.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.comPrincipal Consultant
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Original Message:
Sent: 17-Dec-2021 08:43
From: Anonymous Member
Subject: FMEA
This message was posted by a user wishing to remain anonymous
I would like to know how the industry integrates FMEA (process, design etc.) of line extension of a product which is in the development phase to the current FMEA of the product while the product is in process of submitting registration documents in Asia. What are the risks of integration before line extension development is complete