Re: Would Design & Process FMEA (PCBA) be sufficient to fulfill requirement of Cl 7.1
It´s not enough. FMEA is generally used as a hazard identification/risk analysys tool. As such, it´s a small (albeit important) part of the whole risk management process. This generally comprises five phases (risk management planning, risk analysis, risk evaluation, risk control, and post-production information. FMEA generally comprises half of the risk analysis phase, meaning hazard identification and risk estimation (although the FMEA generally has more information, for example some part of the risk evaluation and risk control).
If you want to understand the process, you should read ISO 14971, as this is the best framework to used for risk management. You can also take a look at figure 1 from this link
http://www.devicelink.com/mddi/archive/01/03/002.html to see the process phases i mentioned before. You can also take a look at this thread
http://elsmar.com/Forums/showthread.php?t=21190, and there´s also other threads on the subject here on the Cove.
One reminder: take some care in using FMEA. There´s a lot of misuse of the FMEA technique simply because people rely too much on it. For example, FMEA is an approach that is best suited for use in the late development phases because it´s a bottom-up approach. For more info on this, you can read "The Use and Misuse of FMEA in Risk Analysis" from Mike Schmidt at this link:
http://www.devicelink.com/mddi/archive/04/03/001.html
