The CAPA Toolkit.
The root-cause worksheet, effectiveness-check template, and closure checklist our customers run — usable on paper or in any QMS.
1 · Root-cause worksheet (Five Whys)
Problem statement (what happened, where, when, detected how): ________________________________________
Why 1: ____________________________ · Why 2: ____________________________
Why 3: ____________________________ · Why 4: ____________________________
Why 5 → root cause: ________________________________________
Root cause is systemic (process/system), not a person. If your answer names a person, ask why the system let it happen.
2 · Action plan
Correction (immediate containment): ____________________ · Owner: ________ · Due: ________
Corrective action (removes the root cause): ____________________ · Owner: ________ · Due: ________
Scope check: does the same root cause exist in other processes, sites, or products? ____________________
3 · Effectiveness check
Metric that proves the fix worked: ____________________ · Target: ________
Check date (allow enough cycles to be meaningful — typically 30–90 days): ________ · Result: ________
4 · Closure checklist
- ☐ Root cause documented and systemic
- ☐ All actions completed with objective evidence attached
- ☐ Affected documents revised and retraining completed
- ☐ Effectiveness check passed against the stated metric
- ☐ Similar-event review done (no recurrence elsewhere)
- ☐ Closure approved by quality with e-signature and date
In Kintavo, every field above is a structured record with owners, due-date escalation, and an immutable audit trail — see it at kintavo.com/demo.