cs-quality-regulatory

Quality & Regulatory agent for ISO 13485 QMS, MDR compliance, FDA submissions, GDPR/DSGVO, and ISMS audits. Orchestrates ra-qm-team skills. Spawn when users need regulatory strategy, audit preparation, CAPA management, risk management, or compliance documentation.

Quality

70%

Does it follow best practices?

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Securityby

Passed

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tessl review fix ./.gemini/skills/cs-quality-regulatory/SKILL.md

Quality

Content

53%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 well-structured orchestration skill that maps regulatory/quality tasks to named sub-skills with clear sequenced workflows. Its main weaknesses are missing validation checkpoints in the workflows, high-level step descriptions, and a non-actionable Success Metrics section.

Suggestions

Add explicit validation/verification checkpoints to each workflow (e.g. after generating an audit checklist or CAPA, a 'Verify evidence completeness before proceeding' step) so workflow_clarity can exceed the batch-operation cap of 3.

Tighten step descriptions with concrete acceptance criteria or output artifacts instead of abstract verbs like 'Identify' or 'Generate', improving actionability.

Remove or relocate the aspirational 'Success Metrics' section; it does not guide Claude's execution and dilutes the token budget.

Dimension	Reasoning	Score
Conciseness	The body is mostly lean (skill maps, numbered workflows, output standards) and avoids explaining concepts Claude already knows, but the 'Success Metrics' section ("Zero critical findings", "95%+", "first-time acceptance rate >90%") is non-actionable aspirational fluff that does not guide Claude and could be trimmed.	3 / 5
Actionability	It gives concrete routing to named sub-skills (e.g. "Run gap analysis via `qms-audit-expert`") and clear step lists, but the individual steps ("Identify audit scope", "Generate checklist with evidence requirements") stay high-level and lack the specific detail needed to execute without further interpretation.	3 / 5
Workflow Clarity	Four workflows are clearly sequenced as numbered 1-6 lists, but none include validation/verification checkpoints or feedback loops; per the destructive/batch cap this compliance work cannot score above 3 without explicit validation steps.	3 / 5
Progressive Disclosure	Well organized into clear sections with one-level-deep references to sibling skills (ra-qm-team/* and ../engineering-team/*) clearly signaled; no bundle files exist to split further, and the inlined skill list is appropriately placed, leaving only minor organization gaps.	4 / 5
	Total	13 / 20 Passed

Description

87%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, specific description with an explicit 'Spawn when...' trigger clause and concrete regulatory/quality capability areas. The only weakness is that capabilities are framed as responsibility domains rather than tightly enumerated concrete actions.

Dimension	Reasoning	Score
Specificity	Lists several concrete capability areas ("audit preparation, CAPA management, risk management, or compliance documentation") and named standards (ISO 13485, MDR, FDA, GDPR/DSGVO, ISMS), with only minor gaps in coverage; not a 5 because the phrasing names domains/responsibilities rather than multiple distinct concrete actions.	4 / 5
Completeness	Explicitly answers both what ("Quality & Regulatory agent for ... Orchestrates ra-qm-team skills") and when ("Spawn when users need regulatory strategy, audit preparation, CAPA management, risk management, or compliance documentation") with concrete trigger phrases, in third person.	5 / 5
Trigger Term Quality	Good coverage of natural terms a practitioner would say ("regulatory strategy", "audit preparation", "CAPA management", "risk management", "compliance documentation") plus standard names; a few natural synonyms are missing, so it sits below the comprehensive anchor 5.	4 / 5
Distinctiveness Conflict Risk	A clear niche (medical-device quality/regulatory with named standards and the ra-qm-team skill family) gives it distinct triggers and minimal conflict risk with other skills.	5 / 5
	Total	18 / 20 Passed

Validation

87%

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 — 14 / 16 Passed

Validation for skill structure

Criteria	Description	Result
frontmatter_unknown_keys	Unknown frontmatter key(s) found; consider removing or moving to metadata	Warning
relative_links	Relative link issues: 2 suspicious	Warning

	Total	14 / 16 Passed

Repository: alirezarezvani/claude-skills
Path: .gemini/skills/cs-quality-regulatory/SKILL.md
Commit: 19392f7

Reviewed: ~3 hours ago

Table of Contents

Discovery Implementation Validation

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