Capa Officer
Plan and document CAPA effectiveness verification so corrective actions in regulated products are proven closed with evidence, not hope.
Overview
Capa-officer is an agent skill most often used in Ship (also Operate) that guides CAPA effectiveness verification planning, methods, criteria, and closure documentation.
Install
npx skills add https://github.com/alirezarezvani/claude-skills --skill capa-officerWhat is this skill?
- Verification planning required before corrective action implementation, with owner matrix by CAPA stage
- Severity-based wait windows: Critical 30 days, Major 60 days, Minor 90 days before effectiveness checks
- Documents verification methods, effectiveness criteria, closure requirements, and ineffective-CAPA escalation
- Includes verification plan and documentation templates for QA sign-off
- Verification timelines: Critical 30-day minimum wait, Major 60 days, Minor 90 days
- Verification planning must occur before corrective action implementation
Adoption & trust: 730 installs on skills.sh; 17.5k GitHub stars; 2/3 security scanners passed (skills.sh audits).
What problem does it solve?
You closed a corrective action in your tracker but have no defined wait period, verification method, or evidence standard to prove the fix stuck.
Who is it for?
Small teams in regulated or quality-system environments using agents to draft CAPA verification plans and closure packets.
Skip if: Pure software teams with no CAPA or QMS process, or builders seeking automated penetration testing or code review only.
When should I use this skill?
When planning, executing, or closing CAPA records and you need effectiveness verification methods, timelines, and closure criteria.
What do I get? / Deliverables
You produce a verification plan and effectiveness assessment aligned to severity timelines, with clear closure or re-open criteria for the CAPA record.
- CAPA verification plan document
- Effectiveness assessment with closure or re-open decision
- Completed documentation templates for QA archive
Recommended Skills
Journey fit
Spans multiple journey phases - primary shelf plus alternate fits below.
CAPA closure is a ship-time quality gate before you treat fixes as done; it also resurfaces in Operate when incidents recur. Effectiveness verification is structured review of whether corrective actions worked—aligned with Ship/review, not greenfield build work.
Where it fits
Draft the verification plan and 60-day effectiveness window before implementing a major manufacturing CAPA fix.
Re-open an ineffective CAPA and document escalation steps when post-implementation data shows recurrence.
How it compares
Quality-system workflow skill for CAPA evidence—not a generic bug-fix or SRE incident postmortem template.
Common Questions / FAQ
Who is capa-officer for?
Solo operators and lean quality leads who must verify corrective actions under CAPA programs and want agent help drafting consistent verification and closure docs.
When should I use capa-officer?
Use it in Ship/review when planning or closing CAPAs, and in Operate when re-verifying ineffective actions or extending monitoring after production incidents.
Is capa-officer safe to install?
It is procedural documentation guidance; review the Security Audits panel on this page and keep regulated records and PHI out of shared agent logs.
SKILL.md
READMESKILL.md - Capa Officer
# Effectiveness Verification Guide CAPA effectiveness assessment procedures, verification methods, and closure criteria. --- ## Table of Contents - [Verification Planning](#verification-planning) - [Verification Methods](#verification-methods) - [Effectiveness Criteria](#effectiveness-criteria) - [Closure Requirements](#closure-requirements) - [Ineffective CAPA Process](#ineffective-capa-process) - [Documentation Templates](#documentation-templates) --- ## Verification Planning ### When to Plan Verification Verification planning must occur BEFORE corrective action implementation: | Stage | Planning Activity | Owner | |-------|-------------------|-------| | CAPA Initiation | Define preliminary verification approach | CAPA Owner | | Root Cause Analysis | Refine criteria based on root cause | Investigation Team | | Action Planning | Finalize verification method and timeline | CAPA Owner | | Implementation | Schedule verification activities | Quality Assurance | ### Verification Timeline Guidelines | CAPA Severity | Minimum Wait Period | Verification Window | |---------------|---------------------|---------------------| | Critical (Safety) | 30 days | 30-90 days post-implementation | | Major | 60 days | 60-180 days post-implementation | | Minor | 90 days | 90-365 days post-implementation | **Rationale**: Waiting period ensures sufficient data collection and accounts for process variation. ### Verification Plan Components ``` VERIFICATION PLAN TEMPLATE CAPA Number: [CAPA-XXXX] Problem Statement: [Original issue] Root Cause: [Identified root cause] Corrective Action: [Implemented action] VERIFICATION METHOD: [ ] Data Trend Analysis [ ] Process Audit [ ] Record Review [ ] Testing/Inspection [ ] Interview/Observation [ ] Multiple Methods (specify) EFFECTIVENESS CRITERIA: 1. [Measurable criterion 1] 2. [Measurable criterion 2] 3. [Measurable criterion 3] SUCCESS THRESHOLD: - [Quantitative threshold, e.g., "Zero recurrence for 90 days"] - [Qualitative threshold, e.g., "Procedure followed correctly 100%"] DATA COLLECTION: - Source: [Where data will come from] - Sample Size: [Number of records/instances to review] - Time Period: [Start and end dates] - Responsible: [Who collects data] VERIFICATION SCHEDULE: - Implementation Complete: [Date] - Waiting Period Ends: [Date] - Verification Start: [Date] - Verification Complete: [Date] - Report Due: [Date] APPROVAL: CAPA Owner: _____________ Date: _______ Quality Assurance: _____________ Date: _______ ``` --- ## Verification Methods ### 1. Data Trend Analysis **Best for:** Quantifiable issues with measurable outcomes (defect rates, cycle times, complaint trends) **Procedure:** 1. Collect post-implementation data for defined period 2. Compare to pre-implementation baseline 3. Apply statistical analysis if sample size permits 4. Document trend direction and magnitude **Example Criteria:** - Defect rate reduced by ≥50% from baseline - Zero recurrence of specific failure mode - Process capability (Cpk) improved to ≥1.33 **Evidence Required:** - Pre-implementation baseline data - Post-implementation trend data - Statistical analysis (if applicable) - Trend charts with annotation ### 2. Process Audit **Best for:** Procedure compliance issues, process control failures, systemic problems **Procedure:** 1. Develop audit checklist based on corrective action 2. Conduct unannounced process audit 3. Interview operators and supervisors 4. Review records generated since implementation 5. Document compliance percentage **Example Criteria:** - 100% compliance with revised procedure - All operators demonstrate competency - No deviations observed during audit **Evidence Required:** - Audit checklist completed - Interview notes - Record samples reviewed - Photos/observations (if applicable) ### 3. Record Review **Best for:** Documentation issues, completeness problems, traceability failures **Procedure:** 1. Define sample size based on volume (minimum 10 or 10%, whichever greate