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CAPA Officer · alirezarezvani | DecimalAI

industryby alirezarezvani

CAPA Officer

alirezarezvani/capa-officer

Source alirezarezvani/claude-skills ↗License MIT

CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics.

SkillScore91Maintained

Automatic

QA & Test Engineering pack

Last verified 8/4/2026

What it changes

Passed 20 of 22 test cases with the skill, and 11 of 22 without it.

Without skill50%

With skill91%

Checks it passed that the model alone missed

Classifies the 75-day open CAPA as Warning status.
Includes `--output json` in the command invocation.
Defines corrective action timeline as 30 to 90 days.

and 12 more in the full report

10 fixed10 passed either way1 still failing1 broke

Pass-rate lift: +41 pp
Tokens: +145%
Agent turns: 0%
Response time: -28%

Model gemini-3.6-flashMeasured 8/4/2026v120 of 22 cases passed with skill

Tokens, turns and time describe resource use, not a dollar price.

Use this skill

Save it into your project's skills folder. Claude Code picks it up in its next session.

curl -fsSL --create-dirs -o .claude/skills/alirezarezvani-capa-officer/SKILL.md https://app.decimal.ai/s/alirezarezvani-capa-officer/SKILL.md

Want it pinned and updatable? pip install "decimalai>=0.15", then decimalai skills add alirezarezvani-capa-officer, and start Claude Code with claude --plugin-dir "$(git rev-parse --show-toplevel)/.agents"

1 · One-time — install the CLI (docs ↗)

pip install "decimalai>=0.15"

2 · Get the skill — writes .agents/skills/alirezarezvani-capa-officer/ and pins it in .decimal/skills.lock

decimalai skills add alirezarezvani-capa-officer

No CLI? Get the same file — curl · raw file

curl -fsSL --create-dirs -o .claude/skills/alirezarezvani-capa-officer/SKILL.md https://app.decimal.ai/s/alirezarezvani-capa-officer/SKILL.md

Raw file: /s/alirezarezvani-capa-officer/SKILL.md ↗ · machine-readable summary at /s/alirezarezvani-capa-officer.json ↗

Safety checks: 3 of 3 passed

Code scan CleanIntent PassedContent Clean

See it in action

One of 10 test cases the skill fixed. Same model, same prompt, with and without the skill.

1 of 10

Prompt

Our quality team needs to generate a sample JSON datafile to test our local CLI tracking scripts. Which command-line flag generates sample data directly to standard output?

What was checked, without and with the skill
Checked	Without skill	With skill
Includes the `--sample` flag in the command-line usage.	Missed	Passed

case-13 · gemini-3.6-flash · 8/4/2026 · answers are capped and redacted

What's inside

The instructions your model reads when the skill loads.

SKILL.md420 linessingle file

CAPA Officer

Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification.

CAPA Investigation Workflow
Root Cause Analysis
Corrective Action Planning
Effectiveness Verification
CAPA Metrics and Reporting
Reference Documentation
Tools

CAPA Investigation Workflow

Conduct systematic CAPA investigation from initiation through closure:

Document trigger event with objective evidence
Assess significance and determine CAPA necessity
Form investigation team with relevant expertise
Collect data and evidence systematically
Select and apply appropriate RCA methodology
Identify root cause(s) with supporting evidence
Develop corrective and preventive actions
Validation: Root cause explains all symptoms; if eliminated, problem would not recur

CAPA Necessity Determination

Trigger Type	CAPA Required	Criteria
Customer complaint (safety)	Yes	Any complaint involving patient/user safety
Customer complaint (quality)	Evaluate	Based on severity and frequency
Internal audit finding (Major)	Yes	Systematic failure or absence of element
Internal audit finding (Minor)	Recommended	Isolated lapse or partial implementation
Nonconformance (recurring)	Yes	Same NC type occurring 3+ times

Track record

Benchmark

20 / 22

test cases passed, vs 11 / 22 without

Adoption

Users: 0
Times used: 0

Safety and source details

SkillSafety

✓ 3 of 3 passed

Code scan15 of 15 checks clean

0 critical · 0 warning · 0 info — scanner v4 — 8/3/2026

View 15 scanner checks

live_secretremote_code_executionreverse_shelldata_exfiltrationssrf_metadataagent_snoopinganti_refusaldestructive_commandsobfuscated_unicodeunicode_homoglyphopaque_blobsuspicious_urltool_overreachtrigger_abuseprompt_injection_phrasing

IntentSafe

LLM judge · does the skill do what it claims

ContentClean

LLM judge · policy & harmful-content review

Source

Imported

alirezarezvani / claude-skills

.gemini/skills/capa-officer/SKILL.md

View on GitHub ↗

License MITImported 8/3/2026Version v1

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See it in action

What's inside

CAPA Officer

Table of Contents

CAPA Investigation Workflow

CAPA Necessity Determination

Track record

Benchmark

Adoption

SkillSafety

Source

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