# AI Change Assessment

Version 2.0 · Updated 2026-09-21 · Operations

Determine whether an AI model, prompt, source, retrieval, parser, guardrail, workflow, or role change affects approved use or demonstrated performance.

Adapt this template to your intended use, applicable requirements, and approved procedures.

## When to use it

For planned and supplier-managed AI changes before release.

## Information needed before starting

- Authoritative AI change and version/configuration baseline
- Source, retrieval, model, prompt, parser and workflow dependencies
- Previous evaluation results, acceptance criteria and rollback/monitoring plan

## Field instructions

- **Change and authoritative information:** Identify the authoritative change, affected configuration and dependencies. Trace the impact to approved use, controls, evidence and the local change/approval process.
- **Approved intended use:** Describe the specific task, users, outputs and decisions supported. Identify the assessed environment and limits of reliance.
- **Affected AI and GxP functions:** Identify the function or requirement and its controlled reference. Explain the regulated process or record that depends on it.
- **Prompt, source, retrieval, or parser impact:** Identify the applicable retention basis, accountable record owner and retrieval method. Confirm obligations and test retrieval before deletion or ending supplier access.
- **Model or version impact:** Identify the authoritative change, affected configuration and dependencies. Trace the impact to approved use, controls, evidence and the local change/approval process.
- **Guardrail, workflow, tool, or role impact:** Identify the authoritative change, affected configuration and dependencies. Trace the impact to approved use, controls, evidence and the local change/approval process.
- **Acceptance-criteria impact:** Define the measures, denominators and risk-based acceptance criteria before execution. Report critical misses separately and explain dataset limitations.
- **Regression and critical-miss evaluation:** Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- **Human-review impact:** Define the reviewer’s independent checks, source access, competence and escalation route. Reference evidence that the review detects important errors.
- **Rollback, monitoring, and stop criteria:** State what will be compared or monitored, against which baseline, by whom and how often. Define discrepancy thresholds and the response.
- **Release decision:** Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.
- **Revalidation criteria and approval:** Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.

Define the specific system, service, change, population, and intended use.

Complete each field from available records and accountable interviews; record unknowns rather than guessing.

Link conclusions to affected GxP functions, failure scenarios, controls, evidence, and approval.

Adapt the structure to the organization’s approved procedures and document-control process.

## Blank template

System / record ID: ____________________

Prepared by / date: ____________________

Required review / approval under local procedure: ____________________

| Field | Your entry |
| --- | --- |
| Change and authoritative information | ____________________ |
| Approved intended use | ____________________ |
| Affected AI and GxP functions | ____________________ |
| Prompt, source, retrieval, or parser impact | ____________________ |
| Model or version impact | ____________________ |
| Guardrail, workflow, tool, or role impact | ____________________ |
| Acceptance-criteria impact | ____________________ |
| Regression and critical-miss evaluation | ____________________ |
| Human-review impact | ____________________ |
| Rollback, monitoring, and stop criteria | ____________________ |
| Release decision | ____________________ |
| Revalidation criteria and approval | ____________________ |

## Related guidance

- [Read the related practical guide](https://csvtocsa.com/learn/guidance/ai-supplier-and-change-assessment)

Canonical page: https://csvtocsa.com/templates/ai-change-assessment