Design reviews are an integral part of managing a development project, as per the regulatory requirements of IEC 62304. Not only must each specification item be reviewed (i.e., a user need, a functional specification), but design review documentation needs to exist as ‘evidence for compliance’.
Luckily, the documentation process for design reviews doesn’t have to be time-consuming or complicated. There are a couple of easy ways to get the job done. To illustrate, we’ll use a fictional product manager, Julia, and the medtech company for whom she works, SmashMed Ltd. Both the company and Julia are based on real-life businesses and stakeholders we’ve consulted with to create quality management systems that ace audits and make it possible for every “Julia” to sleep easy at night.
In a previous post, we provided details about how traceability items are connected to stories. Now we’ll cover another piece of the puzzle that relates the product manager’s responsibility to process each user need and functional specification through a documented design review.
The good news is that regulators give product managers the flexibility to tailor-make their own design reviews process. So, for example, Julia could take the whole list of user needs for a certain product version, compile it into one document, and put it into review. All pertinent discussions would be documented, making it simple for stakeholders to sign off on the design review in minutes — providing necessary evidence for auditors that the design review was completed.
If that method doesn’t make sense, Julia could instead decide that she’d prefer to have each design specification reviewed separately.
This article will provide details about how to configure Jira and Confluence to support either of these two approaches. The following configurations are extensions of items we’ve already covered in this article about connecting requirements to stories.
How to use Jira and Confluence to do specifications design reviews in a bulk
The first step in using Jira and Confluence for a bulk design review system is to clarify for each specification in Jira if it is:
- Not ready for design review
- Ready for design review
The best way to do this is directly via the workflow. For example, a workflow for a specification item can consist of the following statuses:
When the specification lands on the status “pending design review,” it will remain there until a review is conducted.
The design review is performed in Confluence and consists of the following:
- Date and list of reviewers
- Discussion notes
- A Jira Snapshot macro with a filter set to retrieve all specifications that are “pending design review” and may be filtered to include only those specifications relating to a specific component (i.e., the ones pertaining to users management)
- A signature/approval setup which will allow reviewers to officially sign the document (be sure to check out how to configure Confluence for approvals)
Once the design review is complete, Julia can now “bulk edit” all the reviewed issues in Jira. She will transition them into the next status in the process and also link them to review pages in Confluence.
Notes about the Confluence configuration:
This flow will require the following configurations on Confluence:
How to do a design reviews for each specification item separately
To document a design review for each specification item, all Julia needs is a workflow similar to the one above, along with the Speedy PDF for Jira app installed on her Jira. With this app, the review and the official signature process can happen without leaving Jira:
- A specification enters into the “pending design review” status.
- Using the Speedy PDF app, Julia generates a PDF with all the specification information and assigns the reviewers to sign it.
- Once all of the reviewers have signed, Julia moves the specification to the next step.
- Conveniently, the signed reviews are archived automatically in the designated external storage and are ready for any future review.
And voilà! Design reviews are properly documented according to regulatory standards, and Jira and Confluence have made the process pain-free. If any of this seems easier said than done, don’t hesitate to reach out. We’re always here to make life easier for you!