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BC quality-documentation-manager

Document control for medical device QMS, covering numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflows, and electronic signature compliance.

borghei/Claude-Skills Agent Skills author: borghei 4 files · 1 script body ≈ 4 971 tokens Open the sourcegithub.com↗ analyzed 7 h ago

Document control for medical device QMS, covering numbering, version control, change management, and 21 CFR Part 11 compliance.

As a process C 56/100 · Has gaps — References files that are not bundled: ../quality-manager-qms-iso13485/, ../qms-audit-expert/, ../quality-manager-qmr/

ProcedureQuality controlSecurityWriting and documentstype and topics are labelled automatically from the skill text
Runs in: Claude / Claude Code ChatGPT / Codex Gemini CLI Cursor GitHub Copilot / VS Code Qwen Code Kimi Code CLI Z.ai (GLM) DeepSeek (Deep Code) Mistral Vibe LangChain (deepagents) OpenClaw Goose OpenCode
JSON
Technical rating
B
93/100
safety, quality, tests
Safety 60%
100
Quality 40%
83
Run on models
none yet
Process rating
C
56/100
Has gaps
References files that are not bundled: ../quality-manager-qms-iso13485/, ../qms-audit-expert/, ../quality-manager-qmr/
Tools and files w 18
0
Inputs and preconditions w 11
0
Progress reporting w 2
0
the three weakest of ten parameters · all ten

How to improve

  1. The text references files that are not there: add them or drop the references.
For the model run — optional
  • Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
  • A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.

Guard findings · 0

✓ No critical or high findings

Files scanned: 4. Evidence is masked. Grey chips explain why severity was lowered.

Against the Agent Skills spec

  • warning missing-ref reference to a missing file: ../quality-manager-qms-iso13485/
  • warning missing-ref reference to a missing file: ../qms-audit-expert/
  • warning missing-ref reference to a missing file: ../quality-manager-qmr/
  • warning missing-ref reference to a missing file: ../fda-consultant-specialist/
  • warning missing-ref reference to a missing file: ../capa-officer/
  • note edit-residue the text marks something as outdated (lines 40, 51, 425, 443, 463): check that old rules are not kept next to new ones — the full check reads the text for contradictions

Process rating: all ten parameters 56/100

Will not run. References files that are not bundled: ../quality-manager-qms-iso13485/, ../qms-audit-expert/, ../quality-manager-qmr/
  • 0Tools and files. 5 referenced file(s) missing: ../quality-manager-qms-iso13485/, ../qms-audit-expert/, ../quality-manager-qmr/
  • 0Inputs and preconditions. Does not say what the process needs to start
  • 0Progress reporting. Says nothing while it works
  • 30Running it twice. 6 mutating operations with no state check
  • 50When it triggers. No condition that starts the skill
  • 70Execution cost. Instruction body is 4971 tokens
  • 85Steps. 97 steps, 1 vague phrases
  • 100Result and completion. Output format and completion criterion are stated
  • 100Failures and branches. 1 branches, has a failure section
  • 100Consistency. Name and required fields are in place
  • low 16 top-level sections: this looks like several domains in one skill

Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.

Quality signals

  • +5Description has no quoted example phrases that should trigger the skill
  • +4Description does not say when NOT to use the skill (false activations)
  • +2Single-language instructions
  • +3Description length 227: enough signal without eating the budget
  • +4Structure: 48 headings
  • +3Step-by-step instructions: 97 items
  • +3Output format is stated explicitly
  • +4Has examples (5 code blocks)
  • +4Reference files are cited in the instructions (2 of 2)
  • +3All 1 scripts are documented
  • +1License stated

Quality base 70; lint remarks subtract, signals add up to 100. Result: 83.