quality-documentation-manager
Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.
86
73%
Does it follow best practices?
Impact
94%
1.17xAverage score across 6 eval scenarios
Passed
No known issues
Optimize this skill with Tessl
npx tessl skill review --optimize ./ra-qm-team/quality-documentation-manager/SKILL.mdQuality
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 (medical device QMS document control), lists specific capabilities, and provides explicit trigger guidance via a 'Use for...' clause. The regulatory specificity (21 CFR Part 11) and domain terms (QMS, change control workflow) make it highly distinctive and easy for Claude to select appropriately.
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Lists multiple specific concrete actions: document numbering, version control, change management, and 21 CFR Part 11 compliance. These are clearly defined capabilities within a well-scoped domain. | 3 / 3 |
Completeness | Clearly answers both 'what' (document control system management covering numbering, version control, change management, Part 11 compliance) and 'when' (explicit 'Use for...' clause listing six specific trigger scenarios). | 3 / 3 |
Trigger Term Quality | Includes strong natural keywords users would say: 'document control', 'change control', 'document numbering', 'version management', 'electronic signature', '21 CFR Part 11', 'regulatory documentation', 'QMS'. These cover common variations a user in this domain would naturally use. | 3 / 3 |
Distinctiveness Conflict Risk | Highly distinctive with a clear niche: medical device QMS document control with 21 CFR Part 11 compliance. The regulatory and domain-specific terms make it very unlikely to conflict with generic document or version control skills. | 3 / 3 |
Total | 12 / 12 Passed |
Implementation
47%Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.
This skill is well-structured with clear workflows and validation checkpoints, but suffers significantly from verbosity. It includes extensive reference tables and regulatory details inline that Claude either already knows or that belong in the referenced companion files. The actionability is moderate—process workflows are clear but mostly describe organizational procedures rather than providing executable technical guidance.
Suggestions
Move regulatory reference tables (ISO 13485 clauses, FDA 21 CFR 820 sections, common audit findings) into the referenced companion files to reduce the main skill from ~350 lines to under 150
Remove explanatory content Claude already knows (e.g., what document lifecycle stages mean, basic definitions of electronic signature requirements) and keep only the specific organizational rules and constraints
Add the actual document_validator.py script content or at minimum provide the validation logic inline so the tool reference is actionable rather than just a CLI invocation of an unavailable script
Consolidate the multiple detailed tables (comment disposition, signature requirements, approval matrix) into more compact formats since many contain only 3-4 rows of straightforward information
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | The skill is extremely verbose at ~350+ lines, with extensive tables covering information Claude already knows (what ISO 13485 clauses say, what 21 CFR 820 sections require, basic definitions of document lifecycle stages). Much of this is reference material that could be in separate files rather than inline. The regulatory requirements section and many tables add bulk without adding actionable guidance. | 1 / 3 |
Actionability | The skill provides structured workflows with numbered steps and includes a concrete tool example (document_validator.py with sample JSON input and CLI commands). However, the tool script is referenced but not provided, and much of the content is descriptive tables rather than executable guidance. The workflows describe what to do at a process level but lack specific implementation commands or code for most steps. | 2 / 3 |
Workflow Clarity | Each major process (document control, numbering, approval, change control, Part 11 compliance) has clearly sequenced numbered steps with explicit validation checkpoints at the end. The change control workflow includes classification-based routing and an impact assessment checklist. The document lifecycle stages table provides clear state transitions. | 3 / 3 |
Progressive Disclosure | The skill references external files (references/document-control-procedures.md, references/21cfr11-compliance-guide.md) and has a table of contents, which is good. However, the main file is monolithic with extensive inline content that should be in those reference files instead. The regulatory requirements section, detailed compliance checklists, and KPI tables would be better placed in referenced documents. | 2 / 3 |
Total | 8 / 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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