J
Hello to you all,
I'm working at a company that makes Class IIa medical devices. By the Medical Device Directive we are obliged to do a Risk analysis of each product (classified as MD). I've been hired (since a short period) to improve the technical documentation and while doing so I found out that FMEA is widely recognized.
Though my colleague did some earlier work using the ALARP (as low as reasonably possible) principe. He likes that way and wants to stick to it.
I'm not yet that convinced and haven't got that much experience (yet) in this area.
Since 1. I'm fairly new to this form of risk analysis and 2. I'm the 'new' guy at work, and nobody likes the new guy to tell you how to do your work (stubburn old colleague), I was wordering if anybody has experience with changing from ALARP or even using ALARP. I like to make a good case defending FMEA in my next duscussion (
) or maybe even merging both FMEA and ALARP.
Who can help me out here :truce:
Kind regards
,
Jerome
I'm working at a company that makes Class IIa medical devices. By the Medical Device Directive we are obliged to do a Risk analysis of each product (classified as MD). I've been hired (since a short period) to improve the technical documentation and while doing so I found out that FMEA is widely recognized.
Though my colleague did some earlier work using the ALARP (as low as reasonably possible) principe. He likes that way and wants to stick to it.
I'm not yet that convinced and haven't got that much experience (yet) in this area.
Since 1. I'm fairly new to this form of risk analysis and 2. I'm the 'new' guy at work, and nobody likes the new guy to tell you how to do your work (stubburn old colleague), I was wordering if anybody has experience with changing from ALARP or even using ALARP. I like to make a good case defending FMEA in my next duscussion (
) or maybe even merging both FMEA and ALARP.Who can help me out here :truce:
Kind regards
,Jerome