UC-421
Design History File Traceability Matrix
Links every user need to its requirement, verification test and design change, and shows which links break when a change is approved.
TBDBuild Duration
XXXXIndicative ROI
XXXXBuild Cost
XXXXValue
The Challenge
Design controls get rebuilt for the audit rather than maintained, so engineers spend weeks proving links that already existed. Requirements, tests and change orders live in three separate tools.
How It Works
- Reads requirements, verification and validation records, risk files and change orders.
- Links each user need through requirement to test evidence and flags links a change broke.
- Shows the design assurance engineer a live matrix with broken links before a change closes.
What It Removes
- Manual rebuilds of the traceability matrix before audit
- Chasing engineers for the test behind a requirement
- Reading change orders to find affected verification
Input Data RequirementsRequirement specifications, verification and validation reports, risk management files, engineering change orders, design review minutes
Output FormatLive traceability matrix, broken-link list per change order, gap report per design review, indexed design history file ready for audit
“We can build the matrix for an audit, but we cannot keep it true on a Tuesday when three change orders land”