Practice tool
Change Impact Review
Version 1.0 · Tool & checklist
Assess the effect of a proposed change on requirements, evidence, approvals and released supply.
Describe the change precisely
Use technical differences rather than a conclusion such as equivalent or minor. Include software, materials, location and process changes where relevant. Define the existing and proposed configurations so the review can be repeated.
Working record
| Change subject | Information to record | Required decision |
|---|---|---|
| Existing baseline | Configuration and controlling requirements | What is currently authorized? |
| Proposed change | Technical before-and-after description | What actually changes? |
| Affected population | Models, lots and versions | Where does the change apply? |
| Requirement impact | Regulatory, adopted and contract provisions | Which obligations depend on the change? |
| Evidence impact | Tests, analyses and certificates | What remains applicable and why? |
| External action | Notification, approval or additional submission | What must precede release? |
| Supplier interface | Lower-tier changes and records | Are dependencies controlled? |
| Information impact | Labels, instructions and technical data | Which claims or documents change? |
| Implementation | First affected lot and inventory treatment | Can configurations be distinguished? |
| Verification | Defined questions and acceptance criteria | What evidence closes the review? |
| Authorization | Responsible authority and conditions | Who permits implementation? |
Assess the evidence
Identify which assumptions in earlier reports depend on the changed feature. Record the rationale for retaining evidence and the questions that require new analysis or testing. Keep regulatory and contractual actions explicit.
Control implementation
Coordinate purchasing, drawings, software releases, labels and inventory. Establish the first affected lot or version. Do not allow a changed configuration to become indistinguishable from the one covered by earlier evidence.
Close on demonstrated results
Retain verification and authorized disposition of open conditions. Read Assessing Product and Process Changes.