How far is possible?

We have been following an interesting discussion on Linked In "How far is possible"  (this link can only be viewed if you are a group member: Medical Devices: QA / RA discussion 'How far is possible?') as a result of the 14971:2012 Annex ZA deviation #3.

In this discussion mr Singh linked to an informative presentation on the subject.

Most companies that participated in the discussion have updated thier processes to avoid the term ALARP, usually also no longer identifying any 'Acceptable' ranges of risks. The driver seems rather to be to comply with what notified bodies expect to see. All still acknowledge that there will always be the notion of an economical parameter when deciding on risk mesures. The arguments backing why the risk measures weren't taken even further where recommended to be an analysis of Risk vs Benefit and caliming that the risk measures are 'State of the Art'







googleplus facebook