capa-officer

CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when running CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.

Quality

92%

Does it follow best practices?

Run evals on this skill

Adds up to 20 points to the overall score

View guide

Securityby

—

The risk profile of this skill

Quality

Content

85%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

The content is well-structured, actionable, and rich in validation checkpoints and feedback loops appropriate to a regulated CAPA process. It earns top marks on workflow clarity, with only minor conciseness and disclosure gaps (an unreferenced script, some lengthy templates).

Suggestions

Reference `scripts/root_cause_analyzer.py` from the Tools section with example invocations, so all bundled scripts are discoverable and the actionability gap is closed.

Trim or move the full worked 5-Why example and long action-plan template into `references/rca-methodologies.md`, keeping only a compact inline template in the body to improve token efficiency.

Confirm the QMSR/820.100 time-sensitive regulatory note lives in a clearly marked 'deprecated/historical' framing so the date-sensitive content does not penalize conciseness.

Dimension	Reasoning	Score
Conciseness	The body is mostly efficient and assumes domain competence (e.g. no explanation of what CAPA or a fishbone diagram is), but the worked 5-Why example and several full templates add length that could be trimmed; not quite a perfectly lean score-5.	4 / 5
Actionability	Provides executable tool invocations (`python scripts/capa_tracker.py --capas capas.json`, `--interactive`, `--output json`, `--sample`) and a copy-paste JSON input shape, plus templates; the analyzer script is never shown in the body, leaving a minor gap versus fully executable coverage.	4 / 5
Workflow Clarity	Each phase (investigation, RCA, corrective action, effectiveness verification) is a numbered workflow with explicit bold 'Validation:' checkpoints, decision trees, and a dedicated root-cause validation checklist, including feedback loops for ineffective CAPAs (re-investigate / revise actions).	5 / 5
Progressive Disclosure	Good one-level-deep structure with clearly signaled references (`references/rca-methodologies.md`, `references/effectiveness-verification-guide.md`) and a Reference Documentation section enumerating their contents; the bundle file `scripts/root_cause_analyzer.py` exists but is never referenced from the body, a minor organization gap.	4 / 5
	Total	17 / 20 Passed

Description

100%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

This is a strong description that clearly states what the skill does and when to use it, with concrete, domain-specific trigger phrases. It avoids vagueness and over-claiming while covering the CAPA workflow comprehensively.

Dimension	Reasoning	Score
Specificity	Lists multiple concrete actions — 'root cause analysis', 'corrective action planning', 'effectiveness verification', 'CAPA metrics' — with comprehensive coverage matching the score-5 anchor.	5 / 5
Completeness	Explicitly answers both 'what' (CAPA system management...covers root cause analysis, corrective action planning, effectiveness verification, CAPA metrics) and 'when' ('Use when running CAPA investigations, 5-Why analysis...') with concrete trigger phrases.	5 / 5
Trigger Term Quality	Natural trigger phrases users would say ('5-Why analysis', 'fishbone diagrams', 'CAPA tracking', 'effectiveness verification') are comprehensively covered including synonyms and variations.	5 / 5
Distinctiveness Conflict Risk	The CAPA/QMS niche is highly specific with distinct triggers (CAPA, 5-Why, fishbone, effectiveness verification) unlikely to collide with unrelated skills; minimal conflict risk.	5 / 5
	Total	20 / 20 Passed

Validation

93%

Warnings & errors only

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation — 15 / 16 Passed

Validation for skill structure

Criteria	Description	Result
frontmatter_unknown_keys	Unknown frontmatter key(s) found; consider removing or moving to metadata	Warning

	Total	15 / 16 Passed

Repository: alirezarezvani/claude-skills
Path: ra-qm-team/skills/capa-officer/SKILL.md
Commit: 19392f7

Reviewed: ~2 hours ago

Table of Contents

Discovery Implementation Validation

Is this your skill?

If you maintain this skill, you can claim it as your own. Once claimed, you can manage eval scenarios, bundle related skills, attach documentation or rules, and ensure cross-agent compatibility.