we have started implementation of risk management system...(FMEA as primary tool) and we are quite in evolving stages. the reason i say that ''évolving stages'' is that, we get to updating/documenting the risk assessment (FMEA) at the end of stages. (i.e., before manufacturing)...ideally it must be done pro-actively...(design/development to flow from FMEA to address the potential failure modes / causes)!!!
but more frequently (wittingly and seriously) we get the question of
has FMEA made any difference to product - process?
typically, regulatory industries undertake any system (especially in development) ...only if its mandated by authorities (submission requirement) and moreover ..even if it was otherwise,, the above question is legitimate...
how to answer that question;....where to start....how to establish and demonstrate the real value...
but more frequently (wittingly and seriously) we get the question of
has FMEA made any difference to product - process?
typically, regulatory industries undertake any system (especially in development) ...only if its mandated by authorities (submission requirement) and moreover ..even if it was otherwise,, the above question is legitimate...
how to answer that question;....where to start....how to establish and demonstrate the real value...