# AI monitoring and change assessment

Connect signals and changes to impact, containment, evidence and continued-use decisions.

Adapt this worksheet to your applicable procedures, intended use and requirements. Fictional examples are teaching material, not execution evidence.

## Field instructions

- **Use and baseline:** Record current intended use, configuration and evidence basis.

- **Signal or change:** Describe observed error, model/source/interface change or changed user reliance.

- **Affected requirements and risks:** Identify what claims or controls might no longer be supported.

- **Impact and containment:** Identify affected outputs/decisions and any temporary restrictions.

- **Evidence and retest:** Specify targeted regression, source, permission and reviewer evaluation needed.

- **Monitoring owner and frequency:** Name responsible roles and a risk-appropriate review schedule.

- **Incident / deviation / CAPA:** Link the applicable procedure and actual investigation/action records.

- **Periodic review and conclusion:** Reconcile trends, changes and open issues; state continued-use disposition.

- **Approval and reassessment trigger:** Identify local approval responsibilities and future triggers.

## Completed fictional example

Fictional restricted pilot controls. Frequencies are teaching choices, not universal requirements.

| Signal / change | Impact and action | Evidence and owner |
| --- | --- | --- |
| New parser proposed | May omit or reorder requirement-table content; hold affected use | Compare supported formats and rerun affected detection/reviewer cases; application owner |
| Wrong-version source found | Restrict affected retrieval; assess outputs since last confirmed refresh | Source versions, refresh logs, impacted decisions and recovery checks; source owner |
| Critical final-review miss | Do not expand reliance; investigate workflow and interface | DEV-02, revised procedure/interface and fresh reviewer evaluation; process owner |
| Periodic pilot review | Weekly result summary and monthly scope review during this pilot | Errors, actual use, supplier changes, open deviations and continue/stop decision; Quality/process roles |

## Blank worksheet

System / record ID: ____________________

Prepared by / date: ____________________

Required review / approval under local procedure: ____________________

| Field | Your entry |
| --- | --- |
| Use and baseline | ____________________ |
| Signal or change | ____________________ |
| Affected requirements and risks | ____________________ |
| Impact and containment | ____________________ |
| Evidence and retest | ____________________ |
| Monitoring owner and frequency | ____________________ |
| Incident / deviation / CAPA | ____________________ |
| Periodic review and conclusion | ____________________ |
| Approval and reassessment trigger | ____________________ |

### Blank results or assessment rows

| Signal / change | Impact and action | Evidence and owner |
| --- | --- | --- |
| ____________________ | ____________________ | ____________________ |
| ____________________ | ____________________ | ____________________ |
| ____________________ | ____________________ | ____________________ |