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%

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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: ~1 hour ago

Table of Contents

Discovery Implementation Validation

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