Is PFMEA (Process FMEA) for OEM sufficient to address Risk?

Hi All,

I am wondering if PFMEA is sufficient for the OEM who is responsible for manufacture only, although ISO 14971 is given in the note of clause 7.1.

Regards,
Roland

Roland chung said:

Hi All,

I am wondering if PFMEA is sufficient for the OEM who is responsible for manufacture only, although ISO 14971 is given in the note of clause 7.1.

Regards,
Roland

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Is the OEM being certified to ISO 13485, or does that question relate to certification of the entity purchasing from the OEM?

Further, under clause 7.1 (ISO 13485:2016) - Planning of product realization - the requirements for risk management aren't too specific: documenting a process (ie creating a procedure) and maintaining activity records.

NOTE Further information can be found in ISO 14971.

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I don't see any requirement in that note. Furthermore, ISO 14971 is quite flexible with regards to the method of risk analysis.

Cheers,
Ronen.

Thanks, Ronen.

The OEM is being certified to ISO 13485. For sure, FMEA is just a technique for risk analysis which can be used to identify the hazards. It seems that clause 7.1 cannot be fulfilled unless ISO 14971 is employed.

Roland chung said:

It seems that clause 7.1 cannot be fulfilled unless ISO 14971 is employed.

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Not sure how you reached that conclusion.

I like this article on why the FMEA is not risk management here.

The PFMEA can be a component of risk management that addresses the manufacturing process but there could be other things that the manufacturer does that might need to be considered. Depends upon how you draw the circle around the scope. For instance, who decides upon and sources the materials?

Also, if you're using EN ISO 13485:2012 and/or this is CE marked, you can't use PFMEA's they way they've been traditionally used. I won't elaborate unless you want me too.

What are you doing for risk management overall?

@ Ronen
FMEA can be very helpful for R&D and production. But FMEA is more of a reliability tool rather than a risk management.

@ QA-man
Thanks for your input.
For sure, FMEA is not RM defined in ISO 14971. I am just not sure if a contract manufacturer or medical components manufacturer needs a complete RM as well.

Roland chung said:

@ Ronen
FMEA can be very helpful for R&D and production. But FMEA is more of a reliability tool rather than a risk management.

@ QA-man
Thanks for your input.
For sure, FMEA is not RM defined in ISO 14971. I am just not sure if a contract manufacturer or medical components manufacturer needs a complete RM as well.

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I didn't advocate the use of FMEA (or any other specific technique) and didn't state that FMEA equals risk management. FMEA might be used as a reliability tool or as a risk management tool. In itself, it is a risk analysis technique that might be more or less effective in any given set-up. Further, it is one of the techniques mentioned (not required) in ISO 14971 for that purpose.

I thought that my responses were consistent with your questions and with the standards, but apparently I don't understand what you're aiming at.

Dear all

Note that the use of the standard EN ISO 14971:2012 does not comes from the EN ISO 13485 in which only appears as a note as indicates Ronen

The need for the application is related to their publication as harmonized standard with the european directives.

To obtain the CE mark of your device you must justify any not application of an harmonized standard. In this case please do not loss time to justify that, apply EN ISO 14971

This requirement is only for the final medical device manufacturer

regards

Xavier