CAPA Officer (Corrective & Preventive Action)

What it does

• 8-step CAPA investigation workflow: document the trigger event, decide whether a CAPA is required (criteria table for safety complaints, Major/Minor audit findings, recurring NCs), staff the team by severity, and work through an evidence-collection checklist.
• RCA method selection: a decision tree routing you to Fault Tree Analysis (safety-critical), Human Factors Analysis, 5 Why (1–2 linear causes), Fishbone/6M (3–6 systemic factors), or FMEA (proactive). Includes a fill-in 5 Why template plus a complete worked example on an overdue pH-meter calibration.
• Action planning: Containment (24–72h) / Correction (1–2 weeks) / Corrective (30–90 days) / Preventive (60–120 days) taxonomy, an action-plan template with owners, success criteria and sign-off lines, and an effectiveness red-flag table.
• Effectiveness verification: wait periods and verification windows by severity, a verification-method matrix, and a decision tree for effective vs. ineffective closure.
• Metrics and reporting: cycle time, overdue rate, first-time effectiveness, recurrence rate targets, aging buckets with escalation triggers, and monthly management-review inputs.
• Regulatory grounding: ISO 13485:2016 §8.5.2/8.5.3, a clear warning that the QMSR final rule (effective 2026-02-02) removed 21 CFR 820.100, and common FDA 483 observation patterns.

Who it's for

• QA/RA staff and CAPA owners at medical device and IVD manufacturers
• Teams preparing for ISO 13485 certification or an FDA inspection
• Quality professionals in other regulated industries (pharma, food) who need a rigorous RCA framework
• Groups whose 5 Why / fishbone work has become a box-ticking exercise

Examples

1. Closing out a Major internal audit finding: say "equipment found 2 months overdue for calibration" and the skill confirms CAPA necessity, builds an evidence-backed 5 Why chain, drafts SOP-revision corrective actions, and schedules verification at 60 days.
2. Monthly CAPA status report: run python scripts/capa_tracker.py --capas capas.json to get open/overdue counts, aging buckets and cycle-time trends for management review.
3. Handling a failed verification: if the issue recurs inside the verification window, the decision tree marks the CAPA ineffective and lays out the re-investigation steps.

⚠️ The skill explicitly does not certify CAPA closure or compliance. Final effectiveness and closure decisions must be signed off by the named CAPA owner and Quality function, and reportability/recall questions go to Regulatory Affairs.

Read the instructions in this file and follow them to help me:
https://raw.githubusercontent.com/alirezarezvani/claude-skills/HEAD/.gemini/skills/capa-officer/SKILL.md

What I want: (describe your task here)

Install the skill I found on AI Skill Mart.
Copy the .gemini/skills/capa-officer folder from the GitHub repo alirezarezvani/claude-skills into my ~/.claude/skills/capa-officer/.
When it's done, tell me in one line what this skill can do.