Projects and Solutions

FMEA Settings

OVERVIEW

FMEA Settings in Admin panel allows configuring Default Risk Settings for the newly created Projects. In order to configure your default FMEA settings, Click on FMEA Settings in Admin

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 P-Harm  and P-Hazard. User can set the Probability values which would be used to calculate the Tabular RPN Values
  • Risk probability, severity, detectability layout settings – User has to set any one option among Code, Description or Both. Based on that the values for FMEA will be displayed in the item details.
  • Change Reason – Add note when updating the FMEA settings

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 detectability as well.

Calculated RPN Settings will have 4 different ranges for 4 Acceptability levels.

P-HAZARD P-HARM MATRIX

Use this matrix to set the probability based on Hazard and Harm values

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 (X axis) Sometimes
The result is suppose Continually
So, the P1 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 Scalar zone labels, acceptable Tabular zone labels and risk categories by clicking on the hyperlink where user will be navigated to System tables to add/update new values.

User can now update the values for Risk Acceptability i.e. Scalar Risk Level & Tabular Risk Level on respective System tables page.

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