62304 code review, unit test, integration test example

[DesignAssurance]

The medical device company I work for uses Jira to develop, and maintain software used in the device. In terms of complying to IEC 62304, there needs to be code review, unit tests and integration tests along with requirements verification tests.

For the last one, we create a protocol with test cases, acceptance criteria, test results etc. But for the first three ( code, unit and integration) testing, how does one document them from Jira? Do you keep them within Jira and create a summary report within a word document to comply with IEC 62304? Or do you actually create a word document that identifies unit, test coverage ..... If so, would anyone be willing to share an example/template for these?

TIA

 

[Tidge]

I have only used JIRA for issue tracking (and resolution), and not project management (of deliverables). My teams have treated the test deliverables (code review, unit testing, integration testing) as stand-alone documents that get approved and then executed.

It should be possible to configure JIRA to manage these sorts of activities, but I haven't personally witnessed JIRA being used in a diligent enough way that would do this:

• record both pre-approval of test goals (with traceability) and post-execution review/approval of actual test results, and then a report summarizing results

I seem to recall that a default configuration for JIRA "sort of" has places were these hooks could exist, but there is (from my PoV) a lot of overhead that would have to be entered in each JIRA item, such that I'm not sure that this would be practical.

This may be just because I am somewhat set in my ways, but here goes: In my mind, JIRA is for "one-and-done" tasks, whereas formal testing is the sort of activity that can be revised... because of new implementations, new test methods, bug fixes, test setups, etc. JIRA tasks start to look really sloppy when things go wrong. This is fine for development, but when generating objective evidence to support 62304 required activities I think it would become a nightmare to untangle.

 

[mihzago]

You can attach things in JIRA, so you could add the protocol/results of each feature review/testing to the JIRA issue. If you don't want to clutter your JIRA issues, then you could create tasks where you could keep track and record testing activities.

Creating a summary report is also a good idea; at least that's what do in some cases.

You could also explore integrations with Confluence and Bitbucket/Github, or test case management tools (Using JIRA Software for Test Case Management | Jira | Atlassian Documentation)