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AF fda-qsr-audit-prep

/cs:fda-qsr-audit-prep <scope> — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.

alirezarezvani/claude-skills Agent Skills author: alirezarezvani MIT 1 file body ≈ 1 525 tokens Open the sourcegithub.com↗ analyzed 2 d ago

/cs:fda-qsr-audit-prep <scope> — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation.

As a process F 51/100 · Will not run — References files that are not bundled: ../../agents/cs-fda-qsr-auditor.md, ../../../ra-qm-team/skills/fda-consultant-specialist/SKILL.md

AnalyzerCustomer supportData and analyticsSecuritytype 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
A
91/100
safety, quality, tests
Safety 60%
100
Quality 40%
78
Run on models
none yet
Process rating
F
51/100
Will not run
References files that are not bundled: ../../agents/cs-fda-qsr-auditor.md, ../../../ra-qm-team/skills/fda-consultant-specialist/SKILL.md
Tools and files w 18
0
Inputs and preconditions w 11
0
Failures and branches w 10
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: 1. Evidence is masked. Grey chips explain why severity was lowered.

Against the Agent Skills spec

  • warning missing-ref reference to a missing file: ../../agents/cs-fda-qsr-auditor.md
  • warning missing-ref reference to a missing file: ../../../ra-qm-team/skills/fda-consultant-specialist/SKILL.md

Process rating: all ten parameters 51/100

Will not run. References files that are not bundled: ../../agents/cs-fda-qsr-auditor.md, ../../../ra-qm-team/skills/fda-consultant-specialist/SKILL.md
  • 0Tools and files. 2 referenced file(s) missing: ../../agents/cs-fda-qsr-auditor.md, ../../../ra-qm-team/skills/fda-consultant-specialist/SKILL.md
  • 0Inputs and preconditions. Does not say what the process needs to start
  • 0Failures and branches. Linear process with no failure handling
  • 20When it triggers. No condition that starts the skill
  • 100Steps. 40 steps
  • 100Result and completion. Output format and completion criterion are stated
  • 100Consistency. Name and required fields are in place
  • 100Execution cost. Instruction body is 1525 tokens
  • 100Running it twice. No mutating operations
  • 100Progress reporting. Reports progress

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)
  • +1No license
  • +2Single-language instructions
  • +3Description length 245: enough signal without eating the budget
  • +4Structure: 13 headings
  • +3Step-by-step instructions: 40 items
  • +3Output format is stated explicitly
  • +4Has examples (2 code blocks)

Quality base 70; lint remarks subtract, signals add up to 100. Result: 78.