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  • 1.  FMEA

    This message was posted by a user wishing to remain anonymous
    Posted 20-Dec-2021 10:41
    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

  • 2.  RE: FMEA

    Posted 21-Dec-2021 08:56
    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.

    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant

  • 3.  RE: FMEA

    Posted 21-Dec-2021 11:40
    Generally there are a few ways. If your company is great at configuration management (note that most aren't) you can simply use your tools to create a revision level for the new change that is still "unreleased" or "inactive" or even is "active" but for a new part number.

    For most systems, you need to use a 'work around" of which there are several and you need to pick what fits your processes. 1) work in redline for the new changes, and don't formally release the new documents until you have approval of the new changes, 2) create new part numbers/document numbers for the product line extension and tie all the updated documents only to those new part numbers, 3) create new document numbers for the changes, knowing you will "update" the finished good BoM at the same time you switch it over to the new model.

    Obviously, all of these have some risks, including in some instances having to update 2 sets of documents for changes in the interim period, or indefinitely if you sell both versions of the product line. However, all are better than trying to explain to an FDA inspector that your "current revision" documents reflect products (and risks) that don't exist yet and have no traceability to your currently marketed product. Don't go there.....


    Ginger Glaser RAC
    Chief Technology Officer