Customers considering the use of Design Controls in Qualio to track their product requirements, risks, and test cases can benefit from the customer webinar below where we discuss some common start up questions and scenarios to think about. Watch the webinar or view the highlights and Q&A generated during the webinar below.
(Recorded September 28, 2022. Runtime 45:57)
Access & Permissions
First and foremost, Design Controls is disabled, by default, for all users and must be enabled by request to Qualio Support on a per-user basis. Qualio can only grant access to users after they have accepted their invite to Qualio.
Next, determine what user role your Product Managers & Developers should be in. Often, Product Managers are granted the Normal User role but this role does not allow them to create and manage their Product in Design Controls as well as approve Reviews related to their Product. As a work around Product Managers can work closely with Quality Users to create Products and when it comes time to approve Reviews, their signature can be captured with the related Design Review Record document. Also note, if a user’s role changes, Design Controls will need to be re-enabled for that user, so it is helpful to determine what role they should be in ahead of time.
Learn more about Design Controls access and permissions here.
Create and Configure a Product
During the webinar, Dave demonstrated the complete Product creation and configuration process. But the key takeaway is that Qualio Design Controls uses the model displayed below to enable customers to develop, verify and validate product requirements. It allows up to three levels of requirements with v&v test cases where applicable. The labels can be customized.
Migrate Requirements and Risks into Design Controls
If you’ve already documented product requirements and risks outside of Qualio, you’ll need to migrate that documentation into Design Controls. To help prepare for this manual process, here are some tips and guidance.
Some customers have already documented requirements in a spreadsheet format. This makes copying and pasting content go very quickly. But one ‘gotcha’ with this scenario to look out for is the fields in your spreadsheet may not directly align with the fields in the Requirement form. Some cells may need to be condensed, while some cells may need to be divided.
Another gotcha that we often see is the merging of the processes around Hazard Analysis and FMEA. These will also need to be separated when you input risks into Qualio Design Controls. This separation may also require organizations to update their associated risk procedures.
And lastly, if your organization has used more than three levels of requirements, you’ll want to take the time to condense down to three levels prior to beginning your data migration.
Linking to External Evidence
When creating a requirement or a test case that needs to reference relevant evidence outside of Design Controls, you can use the ‘insert link’ button to reference a Qualio Document or other source outside of Design Controls.
Webinar Questions & Answers
Do we need to validate Design Controls before we can use it or grant access to users?
Yes. Customers should validate Design Controls before using Design Controls to create requirements, risks etc.. Tip: Use your sandbox for validation activities and the Validation Support tools Qualio provides for a “least burdensome approach”.Once a product is created, can you use it as a template to create additional products?
Not currently, but a great suggestion. We will submit that suggestion to our ProductBoard.
Will Basic users have access to Design Controls in the future?
That is not on the roadmap, nor advised for that level of user. Basic users can initiate an Event that may be related to a Requirement or Risk in Design Controls.Is there a way to assign a priority to a requirement?
Not currently, but a great suggestion. We will submit that suggestion to our ProductBoard.
Can Design Controls track two overlapping projects for a software system that may need to incorporate patches on a frequent basis? (In other words, maintain requirements for different versions linked to a correct project.)
Design Controls does not support requirements overlapping multiple products. However, if the requirements are in Jira, the Jira project(s) can feed multiple products in Qualio. With that said, the same version of a requirement will display in each product.
Does the Risk Management Matrix take into consideration P1 & P2 as defined in ISO 14971: 2019 & ISO?
Design Controls does not currently support the optional P1 & P2 approach for determining probability outlined in Annex 3 but our Product team is investigating.
For Reviews, does Design Controls generate a report of all the requirements for a “Phase Review / Design Review”?
Upon approval of a Design Control Review, reports containing all released user needs, inputs, and outputs are generated to support Phase/Design Reviews. If the question is in regards to the requirements of Phase/Design Reviews, those additions (Independent Reviewer, attendees, etc.) would need to be added to the Review’s Description, or handed over to a templatized document.
How does Qualio handle the quality records created when manufacturing products?
Manufacturing records (e.g. DHRs, inspection records) should be documented in the Documents area of Qualio and can subsequently be hyperlinked in Design Controls for reference to certain design elements if/where applicable.
Will the upcoming Attachments enhancement include/allow CAD format files to be attached?
Yes. However, there is a known limitation with CAD files where the internal references/links break when opened from a source other than where they were saved.
What does the interaction between regular documents and e.g. FMEA object look like? Can one link to the other similarly as with regular documents linking to one another?
FMEA objects can link to design elements only (i.e. needs / inputs / outputs / verification / validation elements). Design elements can link to documents via attachments/hyperlinks.Are all items accessible via the REST API?
Not currently.
Can Design Controls demonstrate one trace matrix for all user needs?
As Dave demonstrated in the webinar, yes, the trace matrix collates all User Needs (level 1 requirements) into one report. It is a cumulative report. A separate report for both Level 2 and Level 3 requirements is also produced.
Right now we can link to outside documents. How will the new functionality highlighted in the webinar be different from current functionality?
Existing functionality will remain. The new functionality will add an option to attach files.
Where would a bug log be kept?
Bugs may be treated as non-conformances and recorded in Events.
If a specification changes, are we alerted to other documents that need to be considered for change (are documents linked within the system)?
The system will not alert for the impacted documents based on the revised document. Thus, when they make a change they need to perform an impact assessment to list out the documents that are impacted. The impact assessment can be a simple table in the change control tab to list the documents/processes.If we have a user needs/ requirement document that is translated to a design specification, are there templates that can be adapted to test whether a built prototype/ product meets the design specification?
With our Plus Content (upgrade to the current plan), we can provide a document template or they can build it/customize it per your needs. A document template for design specifications can be a simple document with the requirements/specs listed. But it also depends on their product/device, accordingly you may have to add more details to it.
Can we use Qualio for post-market fault reporting?
If expecting to have an autogenerated reporting system via Qualio to FDA or other Regulatory authorities, this is not possible at this time. But for Post Market Surveillance reporting or any Adverse event reporting you can document in Qualio using a Quality Event template, but you will need to use the electronic reporting system provided by the regs. For Example, for FDA they need to use the suggested forms for reporting.