What Is a Quality Issue
TMF documents can develop defects over their lifecycle: missing pages, incomplete signatures, wrong content, version confusion. A Quality Issue records these defects, links them to a specific document, and tracks remediation from discovery to closure — the core tool of the TMF quality loop, also used to record inspection findings.
State Flow
| State | Meaning | Available actions |
|---|---|---|
| Initiated | Recorded, not yet assigned/followed up | Open |
| Open | In progress, awaiting remediation | Close |
| Closed | Resolved / verified | Deactivate |
| Inactive | Archived (hidden from default lists) | Read-only |
Typical flow: Initiated → Open → Closed; use Deactivate afterwards if you want it out of active views.
Note
Close vs Deactivate: Close means the issue is resolved and the record stays visible in active views; Deactivate archives it into Inactive.
Creating a Quality Issue
Creating from the document is recommended (links are pre-filled):
- Open the document detail page → Quality Issues related section → Create (Related Document / Study are pre-filled when created from a document).
- Fill in:
| Field | Notes |
|---|---|
| Quality Issue ID | Auto-numbered QI-{######} |
| Study | The owning study |
| Related Document | The defective document |
| QC Issue Type | Missing / Inaccurate Content / Duplicate / Expired / Incomplete Metadata / Misclassified / Signature Not Present |
| Assigned To | The remediation owner |
| Due Date | The required resolution date |
| QC Issue Comments | Description of the defect |
Two-Way Linkage
QIs and documents are linked in both directions: from a QI's detail page, click Related Document to jump to the defective document; on the document detail page you can see its attached quality issues — the full traceability chain for audits.
Viewing on the TMF Homepage
The TMF Homepage → Quality Issues widget groups issues by type, filterable by Open / Closed / All / Assigned to me. QIs you create and Open appear in the Open view.
Note
Quality issues only appear on the Homepage for document types configured with the Quality Issue field.
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Quality Issue: Create, Read, Edit | Creating and maintaining quality issues |
| Lifecycle action | Quality Issue: Open, Close, Deactivate | Advancing the remediation loop |
| Object | Document: Read | Creating QIs from documents and viewing the two-way link |
The QI creation entry usually lives in the related-object section of the document detail page; Read access to a document lets you see the quality issues attached to it.