Risk Management

  1. Click the Project Dashboard tab in the top header bar.

  1. Click the current context button.

  1. Click the dropdown button to see the recently used and favorite configurations.

  1. Click Infusion Pump Base under Favorite Global Configurations.

  1. Notice the FMEA and Operational Hazard Analysis tabs on the Infusion Pump Requirements Project Dashboard.

There are many similarities between operational hazard analysis and Failure Modes and Effects (FMEA). Both examine functions, failure ‘modes’ (equipment failures or incorrect operations), effects, and causes. The primary difference is that operational hazard analysis focuses on what could go wrong if the device is not used correctly. FMEA focuses on identification of potential hazards in the design. Additionally, a hazard analysis focuses solely on safety hazards, whereas the scope of an FMEA covers safety as well as performance, quality, and reliability.

  1. Click the FMEA tab.

  1. Explore the FMEA page.

Note that this tab is surfacing analysis reports such as traceability from System Requirement to Failure Mode to the Safety Requirement that mitigates it – and metrics such as how many Failure modes have mitigations versus those that do not.

  1. Right-click the first Failure Mode box and click Open Artifact.

  1. Click FMEA View in the Views panel.

  1. Explore the various columns in the analysis.

  1. Click the current context button.

  1. Click Create Change Set....

  1. Enter RPN in the Name field and click Create.

  1. Double-click in the Risk Priority Number field of the first row of the table.

  1. Delete the value 12 and click OK so the cell is empty.

  1. Expand the Mini Dashboard and pin it open.

  1. Expand the FMEA-RPN widget in the Mini Dashboard.

  1. Scroll down in the FMEA-RPN widget and click the Calculate RPN button.

  1. Notice that the correct value is re-inserted into the RPN cell.

  1. Click the current context button.

  1. Click Discard Change Set...

  1. Click Discard the Change Set in the pop-up dialog.

  1. Click the Unpin icon in the Mini Dashboard and click away from the Mini Dashboard.

  1. Switch back to Infusion Pump Base under Favorite Global Configurations in the current context button.

  1. Click the Project Dashboard in the top header bar.

  1. Click the Operational Hazard Analysis tab.

  1. Explore the Operational Hazard Analysis tab.

Note, the tab has a table of hazards containing their possible causes, actions, and the safety requirements that mitigate the hazards. The analysis is done in a similar way as FMEA, so no need to dive into this one.

  1. Click the Risk Management File link in the Generated Documentation widget.

Birds-eye view

  1. Explore the Risk Management File generated document.

This document was generated from the platform by Document Builder and delivered in Portable Document Format (PDF) for convenience. The Risk Management File combines both types of fault and hazard analysis into a single document and includes both tables and metric graphs.

  1. Close the Risk Management File and Requirements Management (RM) browser tabs.