ISO 14971 PFMEA Manufacturing Risk

Apex Hao

Starting to get Involved
Hi all, a quick question.

Latest edition of iso 14971 refers the risk management throughout the whole lifecycle.. may i confirm if the corresponding risk is referring solely to the risk created by the device on its actual user/customer?

How about the risk of manufacturing operator injury (while manufacturing this device) which is typically covered by pfmea?

Thanks in advance.


Quite Involved in Discussions
PFMEA is a tool used within an overall risk management process. Typically, safety is a consideration that orgs include as part of equipment control and process validation. Many orgs integrate team member health and safety requirements into these processes. Depending on the organization, they may have a dedicated EHS department that partners with engineering on production and process control. Bottomline, including certain safety controls within your device QMS is commonly done but 14971 is not the driver. Depending on your geography, you will have local requirements to comply with.


Involved In Discussions
I would agree with William. while 14971 does require you to consider harm to operators (since the definition does not exclude your own personel) the View point of those organizations who assess your files will not be from Occupational Health and Safety, they will instead be looking at the patient, user of the device etc...

If you do want to insert those risk controls, I would suggest you are correct in the PFMEA beign the place to put them. But you would have to be very careful as you could not use those line items in overall residual risk or risk benefit analysis. You would then need to subtract them later.

For example you can't say I won't put a guard rail on this bed because my operator may pinch his finger while installing it, thus the risk of my operator pinching his finger outweighs the risk of the patient falling out of the bed.
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