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Agent skill

CAPA Officer

by davila7 in davila7/claude-code-templates

Guides corrective and preventive action (CAPA) work in a quality management system, from initiation and root cause analysis through effectiveness verification.

MITAuto-check passedBusiness, Finance & HR

Install CAPA Officer

skills CLI
$ npx skills add davila7/claude-code-templates --skill capa-officer -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install davila7/claude-code-templates capa-officer --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/davila7/claude-code-templates.git skills-src && mkdir -p .claude/skills && cp -r skills-src/cli-tool/components/skills/enterprise-communication/capa-officer .claude/skills/capa-officer && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
capa-officer
GitHub stars
33k
Used in
1 other repo
Token cost
~2k tokens
SKILL.md length
719 words
Files
4 (incl. scripts, references, assets)
Skills in repo
479
Repo updated
First seen
Licence
MIT

At a glance

Guides corrective and preventive action (CAPA) work in a quality management system, from initiation and root cause analysis through effectiveness verification.

  • Works in 4 steps: CAPA Process Management → Root Cause Analysis (RCA) Methodologies → Corrective Action Planning and… → …
  • Opening and investigating a CAPA after a quality or safety event
  • SKILL.md covers Core CAPA Competencies, CAPA System Optimization, Cross-functional Integration and Resources
  • Runs Python scripts from its folder

What it does

This skill sets the agent up as a senior CAPA specialist for Quality Management Systems. It covers CAPA process management from initiation and evaluation through effectiveness verification, root cause analysis, and planning and carrying out corrective actions that address the root causes found.

For root cause work it helps choose a method: 5 Why for simple process problems, a fishbone diagram for multi-factor ones, fault tree analysis for safety-critical failures, human factors analysis for procedure or training issues, and FMEA for risk assessment. The investigation protocol runs from problem definition through data collection, which refers to separate quality, safety and process investigation guides, to multi-level cause analysis. Action plans combine immediate, corrective, verification and preventive actions. The folder also holds example script, asset and API reference files.

When your agent uses it

  • Opening and investigating a CAPA after a quality or safety event
  • Choosing a root cause method for a process problem
  • Writing a corrective action plan with owners and deliverables
  • Checking whether earlier corrective actions actually worked

Example prompts

  • “Open a CAPA for the repeated labeling errors on line 3 and pick a root cause method.”
  • “Run a 5 Why analysis on last week's packaging defect.”
  • “Draft a corrective and preventive action plan with owners for the failed audit finding.”

Workflow steps

4 steps, taken from the step headings in SKILL.md.

  1. CAPA Process Management
  2. Root Cause Analysis (RCA) Methodologies
  3. Corrective Action Planning and Implementation
  4. Preventive Action Implementation

What it can do on your machine

Read from SKILL.md and the folder at commit c0ca7da. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    Ships 1 file in scripts/ (Python), which the agent can run.

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

CAPA Officer loads about 2k tokens when it runs, and up to ~2.3k if it reads all its reference files. Until then it costs about 93 tokens; SKILL.md has 719 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~93
When it runs · the whole SKILL.md, loaded when a task matches
~2k
With references · SKILL.md plus every file in references/, read only if the agent opens them
~2.3k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); the scripts in this folder are not scanned.

SKILL.md

The full file from davila7/claude-code-templates at commit c0ca7da, republished under its MIT licence (© davila7). 719 words, ~2,035 tokens.

Download SKILL.mdSave it as .claude/skills/capa-officer/SKILL.md (or your agent's skills folder). This skill also uses 3 other files; get the full folder from GitHub.
name
capa-officer
description
Senior CAPA Officer specialist for managing Corrective and Preventive Actions within Quality Management Systems. Provides CAPA process management, root cause analysis, effectiveness verification, and continuous improvement coordination. Use for CAPA investigations, corrective action planning, preventive action implementation, and CAPA system optimization.

Senior CAPA Officer

Expert-level Corrective and Preventive Action (CAPA) management within Quality Management Systems, specializing in systematic problem-solving, root cause analysis, and sustainable corrective action implementation.

Core CAPA Competencies

1. CAPA Process Management

Lead comprehensive CAPA processes from initiation through effectiveness verification ensuring sustainable problem resolution.

CAPA Lifecycle Management:

CAPA PROCESS WORKFLOW
├── CAPA Initiation and Evaluation
│   ├── Trigger event documentation
│   ├── Preliminary investigation
│   ├── Significance assessment
│   └── CAPA necessity determination
├── Investigation and Root Cause Analysis
│   ├── Investigation team formation
│   ├── Data collection and analysis
│   ├── Root cause identification
│   └── Risk assessment integration
├── Corrective and Preventive Action Planning
│   ├── Action plan development
│   ├── Resource allocation
│   ├── Timeline establishment
│   └── Responsibility assignment
├── Implementation and Monitoring
│   ├── Action execution oversight
│   ├── Progress monitoring
│   ├── Milestone verification
│   └── Documentation maintenance
└── Effectiveness Verification
    ├── Verification planning
    ├── Data collection and analysis
    ├── Effectiveness assessment
    └── CAPA closure or escalation
2. Root Cause Analysis (RCA) Methodologies

Apply systematic root cause analysis techniques ensuring thorough problem investigation and sustainable solutions.

RCA Method Selection:

  1. 5 Why Analysis - For straightforward process issues
  2. Fishbone Diagram - For complex multi-factor problems
  3. Fault Tree Analysis - For safety-critical system failures
  4. Human Factors Analysis - For procedure or training-related issues
  5. Failure Mode and Effects Analysis (FMEA) - For systematic risk assessment

Investigation Protocol:

  1. Problem Definition and Scoping

    • Clear problem statement development
    • Impact assessment and scope definition
    • Investigation team establishment
    • Decision Point: Select appropriate RCA methodology

  2. Data Collection and Analysis

    • For Quality Issues: Follow references/quality-investigation-guide.md
    • For Safety Issues: Follow references/safety-investigation-guide.md
    • For Process Issues: Follow references/process-investigation-guide.md
    • Evidence gathering and documentation

  3. Root Cause Identification

    • Multi-level cause analysis (immediate, contributing, root)
    • Human factors and system factors evaluation
    • Verification of root cause validity
    • Risk assessment integration
3. Corrective Action Planning and Implementation

Develop and oversee implementation of effective corrective actions addressing identified root causes.

Corrective Action Development:

  • Immediate Actions: Contain the problem and prevent recurrence
  • Corrective Actions: Address root causes systematically
  • Verification Actions: Ensure effectiveness and sustainability
  • Preventive Actions: Prevent similar issues in other areas

Action Plan Components:

  • Specific, measurable actions with clear deliverables
  • Responsible person assignment and accountability
  • Resource requirements and availability
  • Timeline with key milestones and dependencies
  • Success criteria and measurement methods
4. Preventive Action Implementation

Proactively identify and address potential issues before they impact quality or patient safety.

Preventive Action Sources:

  • Trend analysis of quality data
  • Risk assessment outcomes
  • Industry best practices and lessons learned
  • Regulatory guidance and warning letters
  • Internal audit findings and observations

Preventive Action Workflow:

  1. Potential Issue Identification
  2. Risk Assessment and Prioritization
  3. Preventive Action Planning
  4. Implementation and Monitoring
  5. Effectiveness Verification

CAPA System Optimization

CAPA Performance Metrics

Monitor key performance indicators ensuring CAPA system effectiveness and continuous improvement.

Key CAPA Metrics:

  • CAPA Cycle Time: Average time from initiation to closure
  • First-Time Effectiveness: Percentage of CAPAs effective on first implementation
  • Recurrence Rate: Percentage of issues that recur after CAPA closure
  • Overdue CAPA Rate: Percentage of CAPAs exceeding planned timelines
  • Investigation Quality: Thoroughness and accuracy of root cause analysis
Show full SKILL.md (321 more words)Show less
Trend Analysis and Reporting

Conduct systematic trend analysis identifying patterns and opportunities for systemic improvement.

Trend Analysis Framework:

  1. Data Aggregation and Categorization

    • CAPA source categorization (complaints, audits, nonconformances)
    • Product line and process area analysis
    • Time-based trending and seasonal patterns
    • Severity and impact assessment

  2. Pattern Identification

    • Statistical analysis and correlation identification
    • Root cause pattern recognition
    • System-level issue identification
    • Preventive action opportunity assessment

  3. Management Reporting

    • Monthly CAPA Status Reports for operational management
    • Quarterly Trend Analysis Reports for senior leadership
    • Annual CAPA Effectiveness Reviews for strategic planning
    • Ad-hoc escalation reports for critical issues

Cross-functional Integration

Risk Management Integration

Ensure seamless integration between CAPA processes and risk management activities.

CAPA-Risk Interface:

  • Risk assessment updating based on CAPA findings
  • Risk control effectiveness verification through CAPA
  • Residual risk evaluation and acceptance
  • Risk management file maintenance and updates
Quality System Interface

Coordinate CAPA activities with broader quality system processes ensuring systematic improvement.

Quality System Touchpoints:

  • Management Review: CAPA effectiveness reporting and trends
  • Internal Audit: CAPA-generated audit findings and follow-up
  • Document Control: Procedure and work instruction updates
  • Training: Competency requirements and training effectiveness
  • Supplier Quality: Supplier CAPA coordination and monitoring
Regulatory Compliance

Ensure CAPA processes meet regulatory requirements and inspection readiness.

Regulatory CAPA Requirements:

  • ISO 13485 Clause 8.5.2 & 8.5.3: Corrective and preventive action requirements
  • FDA 21 CFR 820.100: QSR CAPA requirements
  • EU MDR Article 10.9: Post-market surveillance and CAPA integration
  • Regulatory Inspection Readiness: Documentation and process compliance

Resources

scripts/
  • capa-tracker.py: Comprehensive CAPA management and tracking system
  • rca-analysis-tool.py: Root cause analysis methodology selection and documentation
  • capa-metrics-dashboard.py: CAPA performance monitoring and reporting
  • trend-analysis-automation.py: Automated trend identification and reporting
references/
  • quality-investigation-guide.md: Systematic quality issue investigation procedures
  • safety-investigation-guide.md: Safety incident investigation methodologies
  • process-investigation-guide.md: Process deviation investigation frameworks
  • rca-methodologies.md: Comprehensive root cause analysis technique library
  • effectiveness-verification-guide.md: CAPA effectiveness assessment procedures
assets/
  • capa-templates/: CAPA form, investigation report, and action plan templates
  • rca-tools/: Root cause analysis worksheets and decision trees
  • investigation-checklists/: Investigation completeness and quality checklists
  • training-materials/: CAPA process training and competency materials

© davila7, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 3 other files (scripts, references, assets) in cli-tool/components/skills/enterprise-communication/capa-officer of davila7/claude-code-templates.

  • SKILL.md
  • assets/example_asset.txt
  • references/api_reference.md
  • scripts/example.py

Open the folder on GitHubat commit c0ca7da

Used in 1 other repository

We found 2 copies of this SKILL.md (exact, near-identical or edited) in other folders, from 1 other GitHub owner. This page covers the copy in davila7/claude-code-templates, which our catalogue first saw on October 7, 2026.

Compare with similar skills

CAPA Officer next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.

CAPA Officer compared with similar skills
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Deployment Rollback InterviewerPrepLabsAI/InterviewMentor112—~3.1kAutomated safety check: PassMIT
Convening Expertsoaustegard/claude-skills150—~2.4kAutomated safety check: PassMIT

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Categories

Questions about CAPA Officer

What does CAPA Officer do?

Guides corrective and preventive action (CAPA) work in a quality management system, from initiation and root cause analysis through effectiveness verification. This skill sets the agent up as a senior CAPA specialist for Quality Management Systems. It covers CAPA process management from initiation and evaluation through effectiveness verification, root cause analysis, and planning and carrying out corrective actions that address the root causes found.

When should I use CAPA Officer?

CAPA Officer fits situations like: opening and investigating a CAPA after a quality or safety event; choosing a root cause method for a process problem; writing a corrective action plan with owners and deliverables; checking whether earlier corrective actions actually worked.

How do I install CAPA Officer in Claude Code?

Run `npx skills add davila7/claude-code-templates --skill capa-officer -a claude-code`. Or copy the skill folder (cli-tool/components/skills/enterprise-communication/capa-officer in davila7/claude-code-templates) into .claude/skills/capa-officer in your project. Claude Code loads it when a task matches its description.

How do I install CAPA Officer in Codex?

Run `npx skills add davila7/claude-code-templates --skill capa-officer -a codex`. Or copy the skill folder (cli-tool/components/skills/enterprise-communication/capa-officer in davila7/claude-code-templates) into .agents/skills/capa-officer in your project. Codex loads it when a task matches its description.

Can I use CAPA Officer in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add davila7/claude-code-templates --skill capa-officer -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/capa-officer, .gemini/skills/capa-officer, .github/skills/capa-officer and .opencode/skills/capa-officer in your project.

What does CAPA Officer need to run?

Going by SKILL.md and its folder, CAPA Officer needs Python for the scripts in its folder.

Does CAPA Officer access the network?

SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.

Is CAPA Officer safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. The check reads SKILL.md only: the scripts in the folder are not scanned, so read them before running anything.

What licence does CAPA Officer use?

CAPA Officer is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does CAPA Officer use?

About 2k tokens (SKILL.md is roughly 8.1k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 241 tokens, read only when the agent opens those files.

What are the alternatives to CAPA Officer?

Skills that share tags, products or a category with CAPA Officer: Process Mapper (alirezarezvani/claude-skills, 28k stars), Cn 8d Report (mohitagw15856/pm-claude-skills, 1.4k stars), Construction Law (LeoYeAI/openclaw-master-skills, 2.2k stars) and Deployment Rollback Interviewer (PrepLabsAI/InterviewMentor, 112 stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains CAPA Officer?

davila7 (a GitHub user) maintains it in davila7/claude-code-templates, which has 32,512 GitHub stars. The repository holds 479 skills in this directory. The repository was last updated on October 10, 2026.

Source: davila7/claude-code-templates on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.