This is a ready-to-use register for tracking CAPA effectiveness checks to completion. Its single job is to make sure every scheduled effectiveness check has a due date, an owner, and a status, so none silently lapses, because an overdue or missing effectiveness check on a closed CAPA is one of the most common findings. Replace every <<FILL: ...>> placeholder, set your document number, and route through your normal document control. A filled specimen follows. Confirm each cited regulation against the current source before you rely on it.
Log control header
| Field | Entry |
|---|---|
| Log title | CAPA Effectiveness Check Tracking Register |
| Log number | <<FILL: LOG-ID, e.g. LOG-QA-021>> |
| Version | <<FILL: version, e.g. 1.0>> |
| Governing SOP | <<FILL: SOP-ID for CAPA effectiveness verification>> |
| Maintained by | <<FILL: role, e.g. QA CAPA coordinator>> |
| Review frequency | <<FILL: e.g. monthly, in the CAPA review meeting>> |
1. Field definitions
| Field | Format | Required | Who enters | When |
|---|---|---|---|---|
| CAPA ID | Text | Yes | CAPA owner | At effectiveness-check scheduling |
| Effectiveness criterion (short) | Text | Yes | CAPA owner | At scheduling |
| Metric | Text | Yes | CAPA owner | At scheduling |
| Window start trigger | Text/date | Yes | CAPA owner | When implementation is effective |
| Due date | Date | Yes | CAPA owner | At scheduling |
| Owner | Name/role | Yes | QA | At scheduling |
| Status | Scheduled / In window / Data under review / Effective / Not effective / Overdue | Yes | Owner | Ongoing |
| Result (actual numbers) | Text | Yes at closure | Owner | At evaluation |
| Overdue flag | Yes/No | Yes | System or QA | Ongoing |
| Closure date | Date | Yes at closure | QA | At closure |
| Linked record | Text | Yes | QA | At closure |
2. Register
| CAPA ID | Criterion (short) | Metric | Window start | Due date | Owner | Status | Result | Overdue | Closure date |
|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Yes/No>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Yes/No>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Yes/No>> | <<FILL>> |
3. Instructions
- Add a row when an effectiveness check is scheduled (at CAPA action approval), not when it becomes due.
- Set the due date from the window design, not a fixed calendar offset; a low-volume process may need an occurrence trigger (“30 operations or 90 days, whichever is later”).
- Review the register at the defined frequency; every row past its due date with status not yet Effective/Not effective is flagged Overdue and escalated.
- On evaluation, record the actual result (numbers), set the status to Effective or Not effective, and link the completed effectiveness-check record.
- A Not effective result does not close the CAPA; it triggers reopening and a new scheduled check (a new row).
- Trend the register: count of overdue checks, and the ratio of Effective to Not effective, as a quality metric that sits next to on-time-closure. See quality-metrics-and-kpis.
4. Retention
Retain per the records retention schedule, not less than <<FILL: retention period>>. The register is a controlled quality record; entries are never overwritten, only updated with a traceable history.
5. References
21 CFR 820.100 (CAPA, including effectiveness); 21 CFR 211.192 (follow-up); ICH Q10 (CAPA and management review).
Confirm the current version of each reference before issue.
6. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Filled specimen
The following shows the register with three entries. Details are illustrative.
| CAPA ID | Criterion (short) | Metric | Window start | Due date | Owner | Status | Result | Overdue | Closure date |
|---|---|---|---|---|---|---|---|---|---|
| CAPA-2026-041 | Zero mis-weigh deviations; 12/12 obs compliant | Mis-weigh recurrence + observation | 20-Apr-2026 (SOP effective) | 19-Jul-2026 | Dispensing lead | Effective | 0 in 34 ops; 12/12 obs compliant | No | 22-Jul-2026 |
| CAPA-2026-052 | Access/audit-trail controls hold over 3 cycles | Control-state review | 05-May-2026 | 05-Aug-2026 | System owner | In window | 2 of 3 cycles reviewed, both clean | No | (open) |
| CAPA-2026-033 | Zero recurrence of label mix-up | Recurrence count | 01-Mar-2026 | 30-May-2026 | Packaging lead | Overdue | pending | Yes | (open) |
The third row is the value of the register: CAPA-2026-033’s effectiveness check is overdue, it is flagged, and it surfaces in the monthly review for escalation, instead of being discovered by an inspector on a record marked closed.
Common inspection findings this log prevents
- Overdue or missing effectiveness checks on closed CAPAs, discovered by the inspector rather than the firm.
- A CAPA closed with the effectiveness check “to be completed” and no follow-through.
- No systemic view of how many effectiveness checks are pending or overdue.
- On-time-closure reported as healthy while effectiveness checks quietly lapse.
How to adapt this log
- Build it into your CAPA system as an alerting, tracked list rather than a standalone spreadsheet if you can; the point is that due dates cannot be forgotten.
- Add columns your governance needs (site, event classification, root-cause type).
- Review it in your CAPA or quality council meeting and act on the overdue count.
- Confirm the references in section 5 against the current published version before issue.