risk-management-specialist
tessl i github:alirezarezvani/claude-skills --skill risk-management-specialistSenior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control verification, and risk management file maintenance.
Validation
75%| Criteria | Description | Result |
|---|---|---|
description_trigger_hint | Description may be missing an explicit 'when to use' trigger hint (e.g., 'Use when...') | Warning |
metadata_version | 'metadata' field is not a dictionary | Warning |
license_field | 'license' field is missing | Warning |
body_output_format | No obvious output/return/format terms detected; consider specifying expected outputs | Warning |
Total | 12 / 16 Passed | |
Implementation
20%This skill reads as a comprehensive ISO 14971 reference document rather than actionable guidance for Claude. It extensively explains risk management concepts Claude already understands while failing to provide concrete, executable examples or specific templates. The referenced scripts and templates would add value but are not included, leaving the skill as abstract description rather than practical instruction.
Suggestions
Replace abstract process descriptions with concrete examples: show a sample hazard identification table, a completed risk matrix entry, or actual risk control verification criteria
Include actual code for the referenced scripts (risk-assessment-automation.py, etc.) or remove the references if they don't exist
Move the detailed framework diagrams and hierarchical lists to referenced files, keeping only a concise quick-start workflow in the main skill
Add specific validation checkpoints with concrete criteria (e.g., 'Verify risk acceptability by checking: [specific checklist items]') rather than abstract statements
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | Extremely verbose with extensive explanations of ISO 14971 concepts that Claude already knows. The content reads like a textbook chapter rather than actionable guidance, with excessive framework diagrams and hierarchical lists that pad the token count without adding unique value. | 1 / 3 |
Actionability | Despite referencing Python scripts, no actual executable code is provided. The content describes processes abstractly ('Conduct systematic risk analysis', 'Apply systematic risk estimation methodologies') without concrete commands, specific examples, or copy-paste ready templates. | 1 / 3 |
Workflow Clarity | Steps are listed in logical sequences with some decision points indicated, but validation checkpoints are vague ('Decision Point: Define scope') and there are no explicit feedback loops for error recovery. The workflows describe what to do conceptually but lack verification steps. | 2 / 3 |
Progressive Disclosure | References to external files (scripts/, references/, assets/) are present and organized, but the main content is a monolithic wall of text that should be split across multiple files. The overview section contains far too much detail that belongs in referenced documents. | 2 / 3 |
Total | 6 / 12 Passed |
Activation
85%This is a strong description that clearly defines a specialized niche (ISO 14971 medical device risk management) with specific capabilities and explicit usage triggers. The main weakness is the trigger terms lean toward formal/technical language that may not match how users naturally phrase requests. The description uses proper third-person voice throughout.
Suggestions
Add more natural user language variations like 'hazard analysis', 'FMEA', 'safety risk', 'device hazards', or 'risk-benefit analysis' that users might actually say
Consider including file types or deliverables users might mention, such as 'risk management report', 'hazard log', or 'risk matrix'
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Lists multiple specific concrete actions: 'risk analysis, risk evaluation, risk control, and post-production information analysis' plus 'risk management planning, risk assessments, risk control verification, and risk management file maintenance.' | 3 / 3 |
Completeness | Clearly answers both what ('risk analysis, risk evaluation, risk control, post-production information analysis') AND when ('Use for risk management planning, risk assessments, risk control verification, and risk management file maintenance'). | 3 / 3 |
Trigger Term Quality | Includes relevant domain terms like 'ISO 14971', 'medical device', 'risk management', 'risk assessment' but uses somewhat technical/formal language. Missing common variations users might say like 'hazard analysis', 'FMEA', 'safety analysis', or simpler terms. | 2 / 3 |
Distinctiveness Conflict Risk | Very clear niche with distinct triggers: specifically targets ISO 14971 for medical devices, which is a specialized regulatory domain unlikely to conflict with general risk management or other compliance skills. | 3 / 3 |
Total | 11 / 12 Passed |
Reviewed
Table of Contents
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