Welcome back to Morris Medical Monday: a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.
Today we will continue on the subject of Polarion's MedPack extension, and have a look into MedPack's Software System Test type Work Item.
Software System Test
A system test description according to clause 5.7.1 of the IEC 62304:2006. Any issue of this type either describes the test completely or links to test procedure descriptions or code to perform the test. It must be linked to the software system(s) and software item(s) covered by the test as well as the software requirement(s) that is tested. System tests must only be performed in case of a class B or class C project.
The Software System Test Work Item uses the standard Full Workflow.
Traceability & Impact
A Software System Test Work Item must be traceable to a Software Requirement Work Item and has an impact on an Anomaly.
For more information on traceability and impacts, see the Traceability wiki page.
Work Item Attributes
The following custom fields must be filled out before verification can be requested:
Establish tests for software requirements: Input value (as required by IEC 62304:2006->5.7.1).
Establish tests for software requirements: Expected outcomes (as required by IEC 62304:2006->5.7.1).
Establish tests for software requirements: Pass/Fail criteria (as required by IEC 62304:2006->5.7.1).
Establish tests for software requirements: Procedure used.
This enumeration has to be filled out from the administrator. The procedure has to be explained in Integration Test Plan. (as required byIEC 62304:2006->5.7.1).
(as required by IEC 62304:2006->5.7.5c/9.8g).
Relevant test tool(s) used
(as required by IEC 62304:2006->9.8e).
Test parameters to ensure repeatability
(as required by IEC 62304:2006->5.7.5 NOTE/9.8d).
Preset values for the "Procedure used" enumeration
Blackbox test using equivalence classes
A blackbox test is performed, test values are determined using equivalence classes.
Blackbox test, boundary based
A blackbox test is performed, test values are determined using boundaries of equivalence classes.
Blackbox test using decision tables
A blackbox test is performed, test values are determined using decision tables.
A stress test ist performed, making the system crash and see how well it recovers.
Long term test
A long term test is performed to check for long-time performance, memory leaks etc.
Error based test
The system is fed with unexpected input values.
A load test is performed to check the system's behaviour under heavy load.
The system is fed with a huge amount of input data.
A group of usability experts perform a usability inspection on the system.
The system is tested in a usability lab.
Users are given a questionnaire.
Users are interviewed about their experience with the system.
The following custom fields must be filled out before verification/evaluation can be finshed and the work item can be closed:
Person(s) to perform, performing or have performed a review.
Short summary of the review. Attachments should be used for additional information.
Last review date
Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.
The following checklist must be filled out before evaluation can be finshed and the work item can be closed:
(as required by IEC 62304:2006->5.7.4d).
The following table shows the possible resolution values when the work item is closed:
The software system test has been executed and successfully evaluated.
The software system test has become obsolete and is no longer needed.
The work item entry has been discarded. No further attention is needed.