FMEA Settings

FMEA Settings allow to configure Default Risk Settings for the newly created Projects

In order to configure your default FMEA settings, please follow the next steps

1.  Open Admin

2. Click on FMEA Settings to change default FMEA settings (used in new projects) or select a specifci project. In order to change FMEA settigns for specific project, go to Admin->Projects->Open project->Select “FMEA Settings” tab

3.  On the FMEA settings screen, setup your configuration:

General Settings

  • RPN calculation Method: Scalar (Severity x Probability), or tabular (based on RPN table – see RPN table below)
  • Range – the Severity/Probability range (1-5, 1-10)
  • Same Severity – means the severity of residual RPN cannot be edited and is equal to initial severity
  • Use ALAP – according to ISO 14971 recent updates, ALARP is no longer acceptable, so its user choice whether to use it or not

Scalar RPN Section

Setup value for acceptability zones by RPN value (Severity x Probability), and decide if you wish to use detectibility as well

Tabular RPN

Setup acceptability zone for tabular RPN calculation

You can click on a row to select/deselect entire row, or column to select/deselect entire column, click cell to select/deselect cell.

Then click on update button and change the value of the selected cells

List values 

Ability to change labels of severity, probability, detectability, acceptable zone labels and risk categories


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