# CAPA Report > Corrective and Preventive Action reports for audit non-conformities. Enforces 5 Whys root cause analysis and a future Effectiveness Check date (ISO 9001 / ISO 13485). Tags: CAPA, Quality, ISO 9001, ISO 13485, Audit, Non-conformity ## Example Prompts - Document a CAPA for the non-conformity from the internal audit - Complete root cause analysis with 5 Whys and define corrective actions - Set the Effectiveness Check date and verify the CAPA is ready to close URL: https://rakenne.app/skills/capa-report/index.md Try this skill: https://rakenne.app/a/?skill=capa-report ## Overview Corrective and Preventive Action reports for audit non-conformities, aligned to ISO 9001:2015 (clause 10.2) and ISO 13485:2016 (8.5.2, 8.5.3). The skill enforces a strict sequence: complete a 5 Whys root cause analysis before proposing solutions, and set a mandatory future date for the Effectiveness Check so the CAPA cannot be closed prematurely. Two built-in validation tools run on the CAPA document to enforce these gates. ## Example Conversation > **You:** We have a non-conformity from the internal audit — calibration records for the packaging scale were not updated for 6 months. Can you draft a CAPA and run the validations so we can close it properly? > **Agent:** I'll draft the CAPA with containment, root cause (5 Whys), corrective actions, and verification of effectiveness. I'll create `capa-packaging-scale-2024.md` and run the logic gate after the root cause section; then we'll set the effectiveness check date and run the timer. > **Agent:** I've written the non-conformity and containment. Now I'm adding the Root Cause section with 5 Whys. *(Adds Why 1 … Why 5.)* Running `root_cause_logic_gate` on the draft... > **Agent:** Result of `root_cause_logic_gate`: > > --- ROOT CAUSE LOGIC GATE (5 WHYS) --- > Result: PASS > Root cause / 5 Whys section: found. Why levels detected: 5/5. You may proceed to define corrective and preventive actions. > > I'll add the corrective and preventive actions and the Effectiveness Check section with a target date of 2025-04-15. Then I'll run `verification_of_effectiveness_timer`. > **Agent:** Running `verification_of_effectiveness_timer`... > > --- VERIFICATION OF EFFECTIVENESS TIMER --- > Result: PASS > Effectiveness Check date found: 2025-04-15. Date is in the future. Effectiveness Check may be scheduled. > > The CAPA is structurally complete and passes both validations. You can assign owners and implement the actions; the effectiveness check is scheduled for 15 April 2025. ## Output Excerpt After the agent drafts the CAPA and runs both tools, a typical document includes the non-conformity, containment, a complete 5 Whys section, actions, and a future effectiveness check date. Excerpt: ```markdown # CAPA — Packaging scale calibration records (NC-2024-08) ## 1. Non-conformity and containment **Finding:** Internal audit found that calibration records for the packaging scale (ID: PKG-01) were not updated for 6 months. Last calibration date documented: 2024-02-15; next due 2024-05-15. **Containment:** Scale locked out from use for weighing until calibration is performed and records updated. All batches weighed on PKG-01 in the gap period are under review for impact. ## 2. Root cause analysis (5 Whys) - **Why 1:** Why were calibration records not updated? — Because the calibration was not performed by the due date. - **Why 2:** Why was calibration not performed by the due date? — Because the reminder in the QMS calendar was missed. - **Why 3:** Why was the reminder missed? — Because the responsible technician was on leave and no backup was assigned. - **Why 4:** Why was no backup assigned? — Because there is no documented delegation or backup role for calibration tasks. - **Why 5:** Why is there no documented delegation? — Because the calibration procedure does not require a designated backup and handover was informal. **Root cause:** Lack of documented backup/delegation for calibration tasks when the primary responsible person is absent. ## 3. Corrective and preventive actions - **Corrective:** Perform calibration of PKG-01; update records; release scale. Owner: Quality. Due: 2024-03-01. - **Preventive:** Update calibration procedure to define designated backup and handover; add to training. Owner: Quality. Due: 2024-03-15. ## 4. Verification of effectiveness **Effectiveness Check date:** 2025-04-15. Review: (1) No recurrence of missed calibration for PKG-01 or similar equipment; (2) Backup role in use and records complete. ``` The root cause logic gate would pass on this text (5 Whys section with levels 1–5); the effectiveness timer would pass if the check date is in the future. ## Extension Tools and Validations The skill includes two validation tools that run on the CAPA document (Markdown or text). **`root_cause_logic_gate`** enforces completion of a 5 Whys analysis before corrective/preventive actions are proposed: - **Section detection** — Looks for a heading such as "Root Cause", "5 Whys", or "Why analysis" and restricts checks to that section. - **Why-level count** — Detects at least five distinct levels (e.g. "Why 1" … "Why 5", or "Level 1" … "Level 5", or numbered lines "1. Why/Because" … "5. Why/Because"). - **Result** — PASS only when both a root-cause section exists and at least 5 distinct levels are present. FAIL otherwise, with a message to complete the 5 Whys before proposing solutions. Run this tool after drafting the root cause section and before finalising corrective/preventive actions. **`verification_of_effectiveness_timer`** prevents premature closure by requiring a future Effectiveness Check date: - **Section detection** — Finds the block under "Effectiveness Check", "Verification of effectiveness", or "Effectiveness verification". - **Date parsing** — Reads the first date in that section (ISO 20XX-MM-DD or DD/MM/20XX). - **Future-date check** — Compares the parsed date to today; PASS only if the date is strictly in the future. - **Result** — FAIL if no date is found or the date is today or in the past, with a message to set a mandatory future date for the effectiveness check. Run this tool before closing the CAPA or marking effectiveness verification as done. ## Getting Started Add your audit finding or non-conformity details to the project workspace and activate the *CAPA Report* skill. The agent will guide you through containment, 5 Whys, actions, and effectiveness check. Run `root_cause_logic_gate` after the root cause section and `verification_of_effectiveness_timer` before closing the CAPA. --- Back to [Skill Library](https://rakenne.app/skills/index.md)