CAPA Effectiveness Review Form template
A form in the Nonconformity and Corrective Action procedure (PR07), mapped to ISO 15189:2022 clause 8.7. Fill it in whenever the task occurs. Used by the quality-management team.
FormISO 15189 · 8.7As needed
Calculated automaticallyRed = outside limits
Your LaboratoryCAPA Effectiveness Review Form | YL-QM-FRM-07-F04 v1.0
Record: CAPA Effectiveness Review Form — October 2026
CAPA Reference No.CAPA-26-001
Original Issue / NC DescriptionMonthly QC review
Root Cause Identified
Date CA Implemented2026-10-01
Review Date2026-10-01
Reviewer Name / DesignationT. Moyo
| No. | Effectiveness Criterion | Verification Method | Evidence Reviewed | Finding | Criterion Met? (Y/N) | Reviewer Initials | Comments |
|---|---|---|---|---|---|---|---|
| 1 | Has the original nonconformity recurred since CA implementation? | Document / observation review | S. Dlamini | Within limits | Y | TM | Within limits |
| 2 | Is the corrective action still in place and being followed? | SOP review / observation | A. Mensah | Y | RN | ||
| 3 | Have staff been informed and trained on the new process? | Training records | L. Banda | Y | SD | ||
| 4 | Has the relevant SOP been updated if required? | Document control review | K. Otieno | Within limits | N | AM | Within limits |
| 5 | Are IQC/EQA or other monitoring indicators showing improvement? | IQC/EQA trend review | T. Moyo | Y | LB | ||
| 6 | Are quality indicators for this area showing improvement? | PR25-F01/F02 review | R. Naidoo | Y | KO | ||
| 7 | Have any new risks been introduced by the corrective action? | Risk register review | S. Dlamini | Within limits | Y | TM | Within limits |
| 8 | Are audit findings in this area showing improvement? | Audit records | A. Mensah | Y | RN | ||
| 9 | Is customer / user feedback improved? | Complaint log review | L. Banda | Y | SD | ||
| 10 | K. Otieno | Within limits | Y | AM | Within limits |
% Criteria Met0.0
EFFECTIVENESS VERDICTEffective — Close CAPA
CAPA Closure NotesWithin limits
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Completed by | |||
| Reviewed by |
Shaded cells are calculated automatically. Values in red are outside their limits. † marks a corrected value (see Corrections).
Controlled document. Printed copies are uncontrolled unless stamped.Page 1
A4 portrait · first page · showing 10 of 10 rowsExactly as LabToolkit Pro prints it — with your logo and colours
What it records
- Effectiveness Criterion
- Verification Method
- Evidence Reviewed
- Finding
- Criterion Met? (Y/N)
- Reviewer Initials
- Comments
Sign-off
- Completed by
- Reviewed by
Related templates
- Nonconformity & Corrective Action Form (PR07-F01)
- Corrective & Preventive Action (capa) Form (PR07-F01 (CAPA-FORM))
- Nonconformity Log (PR07-F02)
- CAPA Register & Status Tracker (PR07-F02 (CAPA-LOG))
- 5-why Root Cause Analysis Worksheet (PR07-F03a)
- Fishbone / Ishikawa Cause Analysis Worksheet (PR07-F03b)
- Failure Mode & Effect Analysis (fmea) Worksheet (PR07-F03c)
- Nonconformity Trend Analysis Dashboard (PR07-F05)
- Guide: ISO 15189 documentation checklist
Clause references are to ISO 15189:2022; check them against your licensed copy of the standard.