Design Validation

1. If not already there, return to the FMEA tab of the Project Dashboard.

2. Right-click on one of the System Requirements and click Open Artifact.

3. Click 6. Validated by Test Method in the Views panel.

4. Notice the linked test cases, link validity, and also the current status of the linked text case execution.

5. Click the failed test case link to open the test case.

6. Notice the right-hand sidebar.

Notice this test case is part of a Test Plan and that it validates a requirement. It has a related test script, a link to the most recent test execution result, and also a linked defect which was raised when the last test execution failed.

Birds-eye view

7. Hover the the mouse over the linked requirement to show rich hover information.

Engineering Test Management (ETM) provides a collaborative hub for systems and software quality across virtually any platform and type of testing. Teams can collaborate and share information easily and seamlessly. Here for example, a tester can see the requirement they are testing without the need to open the requirements tool or refer to a spreadsheet. Test Plans, Test Cases, Test Scripts are all traced to developments, requirements, and designs really help when you’re trying to prove compliance to industry standards.

8. Click the stacked menu icon and then click the Infusion Pump Testing option.

9. Explore each of the dashboard tabs to show the test-specific data.

10. Click the Planning tab.

11. Click the System Test Protocol test plan.

12. Click Test Objectives in the sidebar.

13. Click the ISO 13485 for quality management link in the Test Objectives widget.

14. Close the new browser tab opened to iso.org.

15. Click Risk Assessment in the sidebar.

16. Explore the content in the Risk Assessment widget.

17. Click Requirement Collection Links in the sidebar.

18. Click Coverage in the View As pull-down menu.

19. Click the Reconcile requirements icon above the Links table.

20. Click 3 of the requirements checkboxes.

21. Click the menu pulldown icon, but do not click any of the Generate ... actions.

22. Click Cancel.

23. Click Development Plan Links in the sidebar and explore the page.

24. Click Test Cases in the sidebar and explore the page.

25. Click Formal Review in the sidebar and explore the page.

26. Click Test Case Results in the sidebar and explore the page.

27. Notice the test has a test script called Maximum Flow Rate Test.

28. Click 109: Each pump channel shall... link in the Test Case column.

29. Click Test Scripts in the sidebar.

30. Notice that this is a manual test script.

31. Click Manual Steps in the sidebar.

32. Notice this is a manual test script, and the steps and expected results are displayed.

Test Cases can be manual or automated. For automated test cases, RQM can invoke the test and gather the results here in the hub. Automated tests could be executed by testing tools like those National Instruments.

Manual tests may be performed in the lab using the web browser, but may also be exported out so that the tester can use a smart device like an iPad to perform the tests in the field – and then upload the results when they come back to the office or lab.

33. Click the Run pulldown at the top of the page, but do not click Run.

Birds-eye view

34. Click Test Case Execution Records in the sidebar.

35. Notice this shows all the execution runs of this test case, which test script was executed, and the result of the test.

37. Click the Failed symbol in the most recent test record.

38. Scroll down and note the steps taken by the tester and the results.

39. Click the defect labeled 392: Failing Test case....

40. Click the Links tab.

41. Notice the links to the artifacts affected by the defect.

42. Close the Problem 392 browser tab.

43. Click the Design Validation tab.

44. Explore the Design Validation analysis and reporting of the test data.