capa-officer
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
96
92%
Does it follow best practices?
Impact
99%
1.06xAverage score across 6 eval scenarios
Passed
No known issues
Quality
Discovery
100%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 skill description that clearly defines its domain (CAPA system management for medical device QMS), lists specific concrete capabilities, and includes an explicit 'Use for...' clause with rich trigger terms. The description is concise, uses third-person voice appropriately, and would be easily distinguishable from other skills in a large skill library.
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Lists multiple specific concrete actions: root cause analysis, corrective action planning, effectiveness verification, CAPA metrics, 5-Why analysis, fishbone diagrams, corrective action tracking, and CAPA program optimization. | 3 / 3 |
Completeness | Clearly answers both 'what' (CAPA system management covering root cause analysis, corrective action planning, effectiveness verification, and metrics) and 'when' (explicit 'Use for...' clause listing specific trigger scenarios like CAPA investigations, 5-Why analysis, fishbone diagrams, etc.). | 3 / 3 |
Trigger Term Quality | Excellent coverage of natural terms a user in medical device QMS would use: 'CAPA', 'root cause analysis', '5-Why analysis', 'fishbone diagrams', 'corrective action tracking', 'effectiveness verification', 'CAPA program optimization'. These are all terms practitioners would naturally use. | 3 / 3 |
Distinctiveness Conflict Risk | Highly distinctive with a clear niche in medical device QMS CAPA management. The specific domain terminology (CAPA, 5-Why, fishbone diagrams, effectiveness verification) makes it very unlikely to conflict with other skills. | 3 / 3 |
Total | 12 / 12 Passed |
Implementation
85%Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.
This is a well-structured, highly actionable CAPA management skill with excellent workflow clarity, complete templates, worked examples, and appropriate progressive disclosure to reference documents. Its main weakness is moderate verbosity—some sections (regulatory requirements, generic CAPA concepts) could be trimmed since Claude likely knows standard QMS/FDA requirements. Overall it's a strong skill that would effectively guide CAPA investigations and management.
Suggestions
Consider trimming or removing the Regulatory Requirements section (ISO 13485, FDA 21 CFR 820.100) as Claude already knows these standards, or reduce to a brief checklist of key compliance points rather than full tables.
The Investigation Team Composition and CAPA Necessity Determination tables, while useful, could be condensed—these are organizational decisions that vary by company and may not need this level of generic detail.
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | The content is reasonably well-organized but includes some material Claude would already know (e.g., general CAPA concepts, ISO/FDA requirements that are standard knowledge). The tables and templates are useful but the overall document is quite long, and sections like Regulatory Requirements and some of the more generic guidance could be trimmed significantly. | 2 / 3 |
Actionability | The skill provides highly concrete, actionable content: complete 5-Why analysis templates with worked examples, decision trees for method selection and effectiveness determination, specific checklists, action plan templates with fields, CLI commands for the CAPA tracker tool, and JSON input schemas. Nearly everything is copy-paste ready. | 3 / 3 |
Workflow Clarity | Multi-step workflows are clearly sequenced with numbered steps and explicit validation checkpoints (marked with **Validation:** at key stages). The investigation workflow, corrective action planning, and effectiveness verification all include clear sequences with decision trees for error recovery (e.g., ineffective CAPA → re-investigate). The effectiveness determination includes a feedback loop for failed verifications. | 3 / 3 |
Progressive Disclosure | The document has a clear table of contents, well-structured sections, and appropriately references external files (references/rca-methodologies.md, references/effectiveness-verification-guide.md) for detailed content. References are one level deep and clearly signaled with descriptions of what each contains. The main document serves as a comprehensive but navigable overview. | 3 / 3 |
Total | 11 / 12 Passed |
Validation
90%Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.
Validation — 10 / 11 Passed
Validation for skill structure
| Criteria | Description | Result |
|---|---|---|
frontmatter_unknown_keys | Unknown frontmatter key(s) found; consider removing or moving to metadata | Warning |
Total | 10 / 11 Passed | |
- Repository
- alirezarezvani/claude-skills
- Commit
f567c61
- Reviewed
Table of Contents
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