5-why Root Cause Analysis Worksheet 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 Laboratory5-why Root Cause Analysis Worksheet | YL-QM-FRM-07-F03a v1.0
Record: 5-why Root Cause Analysis Worksheet — October 2026
CAPA Reference No.CAPA-26-001
FacilitatorS. Dlamini
PROBLEM STATEMENT (clear, factual description of the nonconformity):
5-Why Analysis:
Confirmed Root Cause:
CONTRIBUTING FACTORS (other factors that enabled or worsened the problem):
SYSTEMIC FACTORS (are there similar risks elsewhere in the laboratory)?:
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
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What it records
- CAPA Reference No.
- Facilitator
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))
- 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.