Design Control overview
Design Control manages the chain from stakeholder needs to requirements to specifications to tests. Every item is a native Jira work item on a Design Control tab in your project’s Jira space, so the traceability between them is a property of the data itself, not a matrix somebody maintains by hand.
The point of design control is to prove that what got built meets the intended use and the needs of the people who will use it. Each requirement traces back to a need, each specification traces back to a requirement, and each test proves that the link held. That proof is what an auditor asks to see.
What you can do
Capture stakeholder needs
Record what each named stakeholder needs from the product, ready for review and approval.
Derive requirements and specifications
Turn each approved need into requirements, then into the specifications that implement them.
Verify and validate with tests
Cover every requirement and specification with a test, and every stakeholder need with a validation test.
Export into controlled documents
Release the finished set of needs, requirements, specifications, and tests through Document Control.
How the pieces connect
Design Control starts from four documents already released through Document Control: an Intended Use, a Concept Document, a Use Specification, and a Business Case. Stakeholder needs come from the stakeholders named in the Use Specification, and everything downstream traces back to them.
The order of work
The steps run in a fixed order, because each one needs the last to have reached a certain point first.
- Elaborate a stakeholder need into requirements only once that need is approved.
- Find requirements in two passes: work top down from each stakeholder need first, then bottom up from the list of requirement categories to catch anything the first pass missed.
- Build a system architecture once the first wave of requirements exists. The architecture usually generates a second wave of requirements, plus requirements for each sub-system.
- Draft specifications only once the requirements are far enough along and the system architecture exists.
The guides follow the order of the views in the app, so working through them in sequence walks the chain. Start with Key concepts and Manage stakeholder needs.
Standards it supports
Design Control supports the design control requirements of ISO 13485, and, for products with a software component, the lifecycle requirements of IEC 62304. Every approval is signed with a passcode sent by email, so the record shows who approved what and when.