FMEA Settings

FMEA Settings in Admin panel allows configuring Default Risk Settings for the newly created Projects
In order to configure your default FMEA settings, please follow the next steps

In Admin, Click on FMEA Settings in FMEA Section to change default FMEA settings (used in new projects) or select a specific project.

Note: These settings will not affect existing projects!In order to change FMEA settings for specific project, go to Admin->Projects & Solutions -> Projects ->Open project->Select “FMEA Settings” tab

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)
  • RPN Range – the Severity/Probability range (1-5, 1-10)
  • Same Severity For Initial/Residual RPN – means the severity of residual RPN cannot be edited and is equal to initial severity
  • Use ALAP – According to ISO 14971 recent updates, ALAP is no longer acceptable, so its user choice whether to use it or not
  • Use P-hazard * P-harm = P-total – In order to use P-Hazard P-Harm Matrix to set the final P, select this checkbox. When selected, a new matrix will appear, showing the Pharm  and Phazard. User can set the Probability values which would be used to calculate the Tabular RPN Values

Use P-hazard * P-harm = P-total is enabled only for the Tabular RPN Calculation Method

SCALAR RPN SECTION

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

P-HAZARD P-HARM MATRIX

Use this matrix to set the probability based on Phazard and Pharm

TABULAR RPN CALCULATION 

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 as (Low, Acceptable, ALAP, Unacceptable) of the selected cells

For example:
User select P hazard (Y axis) Probable, and P harm Sometimes (X axis)
The result is Continually
So, the P total displayed is Continually
Then based on that, Tabular RPN will be automatically updated as today

LIST VALUES

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

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