Corrective & Preventive Action (capa) 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 LaboratoryCorrective & Preventive Action (capa) Form | YL-QM-FRM-07-F01 (CAPA v1.0
Record: Corrective & Preventive Action (capa) Form — October 2026
Section 1 — Identification & Classification
CAPA Reference No. (QO assigns)CAPA-26-001
Date Identified2026-10-01
Date Assigned to Investigator2026-10-01
Identified by (Name / Section)T. Moyo
Date Assigned to Investigator2026-10-01
Department / Process AffectedHaematology
Lab Head Notified? (Y/N)Y
CAPA TypeCorrective Action (CA)
Source of NC/IssueInternal Audit
Severity / Risk LevelHigh — Patient/Safety Risk
Priority1 — Immediate (24 hrs)
Section 2 — Description Of Nonconformity / Issue
| Describe the problem precisely: WHAT happened, WHEN, WHERE, WHO was involved, how many times, what was the impact on patients/quality? |
|---|
Was the issue isolated or has it occurred before?Isolated — First occurrence
Were any patient results affected?5.09
If yes, how many?
Were results recalled / amended? (Y/N)5.03
Was clinician/patient notified? (Y/N)Y
Section 3 — Immediate Containment Action
| Describe any immediate action taken to contain or limit the impact of the nonconformity (e.g. quarantine samples, suspend testing, notify clinician). |
|---|
Date/Time of Containment Action2026-10-01T08:30
Completed byT. Moyo
Section 4 — Root Cause Analysis
RCA Method Used5-Why Analysis (PR07-F03a)
Root Cause CategoryHuman Error
| ROOT CAUSE STATEMENT (state the confirmed root cause — use RCA tool worksheets) |
|---|
Section 5 — Corrective / Preventive Action Plan
| No. | Action Description | Action Type (CA/PA) | Responsible Person | Target Date | Completed Date | Evidence of Completion | Status |
|---|---|---|---|---|---|---|---|
| 1 | None required | None required | T. Moyo | 2026-10-01 | 2026-10-01 | Within limits | Closed |
| 2 | None required | None required | R. Naidoo | 2026-10-08 | 2026-10-08 | In progress | |
| 3 | None required | None required | S. Dlamini | 2026-10-15 | 2026-10-15 | Open | |
| 4 | Investigated and repeated: within limits | Investigated and repeated: within limits | A. Mensah | 2026-10-22 | 2026-10-22 | Within limits | Closed |
| 5 | None required | None required | L. Banda | 2026-10-29 | 2026-10-29 | Closed | |
| 6 | None required | None required | K. Otieno | 2026-11-05 | 2026-11-05 | In progress |
Section 6 — Effectiveness Verification
Effectiveness Review Date2026-10-01
Review Method (see PR07-F04)
Reviewer NameR. Naidoo
EFFECTIVENESS VERDICTEffective — Close CAPA
CAPA Closure Date2026-10-01
CAPA Reference to Quality Indicators?CAPA-26-001
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 6 of 6 rowsExactly as LabToolkit Pro prints it — with your logo and colours
What it records
- Action Description
- Action Type (CA/PA)
- Responsible Person
- Target Date
- Completed Date
- Evidence of Completion
- Status
Sign-off
- Completed by
- Reviewed by
Related templates
- Nonconformity & Corrective Action Form (PR07-F01)
- 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)
- CAPA Effectiveness Review Form (PR07-F04)
- 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.