1) ""what factors""/""How to"" determine the suitability/fitness of a tool(cause-effect - DRBFM - FMEA - FMECA...) to your product/process/industry etc.,
1.1 Does the simplicity of the tool figure in the above factors. (simplicity - easy to implement/understand etc.,)
1.2 I have not much heard about DRBFM (Design Review Based on Failure Mode) in the regulatory circles, will it be accepted by FDA.
1.3 is it true that regulatory only accepts the tools which are somewhere used/cited in the rules/guidances!!!
2) Do you use mutilpe tools based on the stage of product development; If yes, how do you maintain the continuity of risk assessment between multiple tools.
1.1 Does the simplicity of the tool figure in the above factors. (simplicity - easy to implement/understand etc.,)
1.2 I have not much heard about DRBFM (Design Review Based on Failure Mode) in the regulatory circles, will it be accepted by FDA.
1.3 is it true that regulatory only accepts the tools which are somewhere used/cited in the rules/guidances!!!
2) Do you use mutilpe tools based on the stage of product development; If yes, how do you maintain the continuity of risk assessment between multiple tools.
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