quality-manager-qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
74
42%
Does it follow best practices?
Impact
95%
1.26xAverage score across 6 eval scenarios
Passed
No known issues
Optimize this skill with Tessl
npx tessl skill review --optimize ./ra-qm-team/quality-manager-qmr/SKILL.mdQuality
Discovery
50%Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.
The description is strong in specificity and distinctiveness, clearly identifying a niche role within MedTech quality management under ISO 13485. However, it critically lacks a 'Use when...' clause, which would help Claude know when to select this skill from a pool of options. The trigger terms are domain-appropriate but could be expanded to cover more natural user language variations.
Suggestions
Add an explicit 'Use when...' clause, e.g., 'Use when the user asks about medical device quality systems, ISO 13485 compliance, management reviews, or quality management representative responsibilities.'
Include additional natural trigger terms users might say, such as 'QMS', 'medical device', 'CAPA', 'audit readiness', 'FDA', 'CE marking', or 'quality manual'.
Consider adding common user scenarios like 'preparing for regulatory audits', 'setting up a quality management system', or 'conducting management reviews' to improve trigger matching.
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Lists multiple specific concrete actions: 'quality system governance', 'management review leadership', 'regulatory compliance oversight', and 'quality performance monitoring per ISO 13485 Clause 5.5.2'. These are distinct, named capabilities. | 3 / 3 |
Completeness | The description answers 'what does this do' reasonably well but completely lacks a 'Use when...' clause or any explicit trigger guidance for when Claude should select this skill. Per the rubric, a missing 'Use when...' clause caps completeness at 2, and since the 'when' is entirely absent (not even implied through context), this scores a 1. | 1 / 3 |
Trigger Term Quality | Includes relevant domain keywords like 'ISO 13485', 'HealthTech', 'MedTech', 'quality system', 'management review', and 'regulatory compliance'. However, it misses common user variations like 'QMS', 'medical device quality', 'CAPA', 'audit', or 'FDA compliance' that users might naturally say. | 2 / 3 |
Distinctiveness Conflict Risk | The description is highly specific to a niche domain — QMR role for HealthTech/MedTech under ISO 13485 Clause 5.5.2. This is unlikely to conflict with other skills due to its narrow regulatory and industry focus. | 3 / 3 |
Total | 9 / 12 Passed |
Implementation
35%Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.
This skill reads more like a comprehensive quality management reference manual than a focused skill file for Claude. It is extremely verbose with extensive tables, templates, and matrices that largely describe standard ISO 13485 quality management concepts Claude would already understand. The content would benefit significantly from moving detailed templates and reference tables into the referenced files and keeping only concise, actionable guidance in the main skill.
Suggestions
Move the detailed templates (Management Review Input Template, Quality Objective Structure), KPI tables, culture survey content, and compliance matrices into the referenced files (management-review-guide.md, quality-kpi-framework.md) and keep only a brief summary with links in the main skill.
Remove or drastically condense tables that describe standard quality management concepts (QMR responsibilities, ISO 13485 clause requirements) that Claude already knows — focus only on organization-specific decisions and thresholds.
Add concrete error recovery steps to workflows — e.g., what specifically to do when a management review input is missing, when KPIs are below critical threshold, or when regulatory compliance gaps are found.
Include at least one concrete, executable example of using the management_review_tracker.py script with sample input/output rather than just pointing to --help.
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | This is extremely verbose at ~400+ lines. Much of the content consists of reference tables (compliance matrices, KPI tables, culture survey questions, checklists) that Claude already understands conceptually. The management review input template, quality objective structure template, and numerous matrices could be drastically condensed or moved to reference files. The skill explains standard quality management concepts at length rather than providing only what Claude wouldn't already know. | 1 / 3 |
Actionability | The workflows provide numbered steps and templates with fill-in-the-blank structures, which give some concrete guidance. However, there is no executable code shown (the script reference just points to a file), templates are text placeholders rather than executable artifacts, and much of the content is descriptive tables rather than specific instructions Claude can act on. The guidance is more of a reference manual than actionable instructions. | 2 / 3 |
Workflow Clarity | Multiple workflows are presented with numbered steps and each ends with a validation checkpoint, which is good. However, the validation steps are fairly generic (e.g., 'Each KPI has owner, target, data source, and escalation criteria') and lack specific error recovery or feedback loops. For a role involving regulatory compliance and quality decisions, the workflows don't adequately address what to do when validation fails or how to handle exceptions beyond the basic escalation decision tree. | 2 / 3 |
Progressive Disclosure | The skill does reference external files (management-review-guide.md, quality-kpi-framework.md, scripts/) and related skills, which is good. However, the main file itself is a monolithic wall of tables and templates that should largely be in those reference files. The table of contents helps navigation, but the sheer volume of inline content undermines the progressive disclosure pattern — most of the templates and matrices should be in the referenced documents. | 2 / 3 |
Total | 7 / 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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