risk-management-specialist

Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.

Quality

91%

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Quality

Content

88%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.

A thorough, well-structured ISO 14971 implementation skill with explicit per-workflow validation checkpoints, copy-paste templates, and decision trees. Tightening would come from pushing inline criteria matrices into references and surfacing the unused fmea_analyzer.py script.

Suggestions

Move the inline 5x5 risk acceptability matrix and the P1-P5 / S1-S5 criteria tables into references/risk-assessment-templates.md or the implementation guide, keeping only a pointer in SKILL.md to reduce token cost and AFAP repetition.

Reference scripts/fmea_analyzer.py in the Tools and References table alongside the risk matrix calculator so the bundled FMEA tool is discoverable.

Consolidate the EU MDR AFAP guidance into one section (e.g. Risk Evaluation) and cross-reference it elsewhere instead of restating the rationale in three places.

Dimension	Reasoning	Score
Conciseness	The body is mostly efficient structured reference material with little concept-padding, but the inline 5x5 risk matrix and probability/severity criteria tables duplicate content that belongs in the reference files, and the AFAP/EU MDR rationale is restated across multiple sections, so it could be tightened further.	4 / 5
Actionability	Each workflow gives concrete numbered steps with sub-items, the Risk Control Option Analysis template is copy-paste ready, decision trees are explicit, and the calculator script is surfaced with usage ('python risk_matrix_calculator.py --help'), covering the common cases.	5 / 5
Workflow Clarity	Every workflow ends in an explicit 'Validation:' checkpoint, hazard-category checklists are provided, and decision trees (e.g. risk evaluation, risk control selection) supply recovery branches for error handling, satisfying the feedback-loop and checklist anchors.	5 / 5
Progressive Disclosure	A table of contents plus clearly signaled one-level-deep references (three reference docs and the calculator script) give good navigation, but the bundled scripts/fmea_analyzer.py exists and is never surfaced in the body, a minor organization gap versus the clean-split anchor 5.	4 / 5
	Total	18 / 20 Passed

Description

95%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.

A strong, well-constructed description that explicitly states both capability and trigger conditions with comprehensive natural keywords. Minor room to sharpen the 'what' from process-level activities toward more granular concrete actions.

Dimension	Reasoning	Score
Specificity	Names the domain and lists four concrete lifecycle activities ('risk analysis, risk evaluation, risk control, and post-production information analysis'), but the actions are domain-process names rather than granular operations, leaving minor coverage gaps versus the comprehensive anchor 5.	4 / 5
Completeness	It explicitly answers both 'what' (implements ISO 14971 throughout the lifecycle; provides the four risk activities) and 'when' (an explicit 'Use when user mentions...' clause with concrete trigger phrases), matching the top anchor.	5 / 5
Trigger Term Quality	The 'Use when...' clause packs comprehensive natural trigger terms including acronyms and synonyms (risk management, ISO 14971, FMEA, fault tree analysis, hazard identification, risk matrix, benefit-risk analysis, residual risk, risk acceptability, post-market risk), matching the comprehensive-coverage anchor.	5 / 5
Distinctiveness Conflict Risk	'Medical device risk management specialist implementing ISO 14971' carves a clear niche with highly specific triggers, giving minimal overlap risk with other skills.	5 / 5
	Total	19 / 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
relative_links	Relative link issues: 4 suspicious	Warning

	Total	15 / 16 Passed

Repository: alirezarezvani/claude-skills
Path: ra-qm-team/skills/risk-management-specialist/SKILL.md
Commit: 19392f7

Reviewed: ~24 hours ago

Table of Contents

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