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.

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

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	____________________