What JIRA Software workflows you use for your software lifecycle?

#1
Hi everybody.

I work to a company that will produce software for medical devices. We are at the stage trying to understand and incorporate the I.E.C 62304 to our day to day actions. By reading on the internet is seems that JIRA Software is a good candidate for managing the whole software lifecycle.

So far I have made a specific JIRA workflow for the problem reporting/resolution (see below) procedure.

JunXLnO.png

I was wondering now what kind of workflow will I need to develop for the development part. By default JIRA provides you with the following workflow for the development board.
x0CzYHi.png
According to your experience, is this sufficient or should be more complex (i.e add code-review, verification steps )? What kind of workflows do you use for that case?
 
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shimonv

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#2
My two cents:
Jira should be aligned with your software development procedure.
The screenshot below (from IEC 62304) describes the software development procedure as a whole.
Some things can be done in Jira and some are best handled as QA documents (e.g. development handling, and software release).

Shimon

Screen Shot 2022-03-26 at 18.20.55.png
 
#3
Thanks for the prompt reply.
I suppose you mean that except from JIRA Software one might need to use either Confluence (for the documents) or Office Word etc. Sure I totally agree. But based on the image you posted, I'm wondering what kind of workflow do you use for the 5.5 Clause. I mean, ok, I got that 5.1-5.4 clauses are more document based but in my opinion 5.5 needs to be transformed into a JIRA workflow because it's the implementation stage of the software. Am I missing something here?
 

yodon

Leader
Super Moderator
#4
A lot depends on your team culture. For example, we have a fairly small team with pretty deep experience in software development for medical devices. They know to do things like the code reviews and unit (re)verification and do these things without prompting. If you have a large team with not much medical device experience, you may well want to put triggers in to help ensure those things are done.

One thing to note is that the basic Jira workflow as you show is development-centric. If you look at section 6 in the standard, it is at a little higher level. I think many companies have an ECO process to cover section 6 and then the software change control process (per the Jira workflow) to cover section 9

One other note: between 62304 and 13485 (and possibly other standards / regulations you're under), you will likely need to update Jira to collect more data than what is provided out of the box.
 

shimonv

Trusted Information Resource
#5
Section 5.5 (software unit implementation and verification) is more suited for Jira and the workflow is straightforward.
The acceptance criteria and the results can be logged in Jira.
 
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