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.

Quality

78%

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Quality

Content

68%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.

The body is a well-structured, actionable audit-prep skill with concrete commands, thresholds, and an output template. Its main weakness is workflow clarity: the tooling sequence lacks explicit validation/feedback checkpoints between steps.

Suggestions

Add explicit validation/feedback checkpoints to the Workflow section (e.g., 'Verify compliance_state.json output before proceeding to submission tracking') so each step's output is checked before the next.

Insert a brief decision/feedback loop for the inspection verdict (e.g., if 🔴 NOT-READY, loop back to the failing question's corrective actions with an owner and timeline).

Tighten minor over-explanations such as the containment/correction/corrective-action distinction and '5 Why minimum' to one-line checks where possible.

Dimension	Reasoning	Score
Conciseness	Dense checklists with CFR citations assume domain competence rather than padding; regulatory specifics (DHR, MDR timelines) are legitimate non-common knowledge, with only minor over-explanation ("5 Why minimum", containment distinction).	4 / 5
Actionability	Concrete bash commands and specific thresholds (30-day, 15 working days, >90-day aging CAPAs) plus a full output template; the template uses placeholders and referenced scripts are not inlined, leaving minor gaps.	4 / 5
Workflow Clarity	A clear sequence exists (triggers -> six questions -> tooling commands -> verdict), but the bash workflow lacks explicit validate->fix->retry feedback loops and checkpoints are only implicit.	3 / 5
Progressive Disclosure	Well-organized sections with clearly signaled external script and related-skill paths; no bundle files exist to offload into, and the inline six-question checklists are core content, leaving only minor organization gaps.	4 / 5
	Total	15 / 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 that concretely states both the skill's purpose (FDA QSR forcing-question interrogation) and its use triggers, with a clear regulatory niche. Minor gains possible from adding a few more trigger synonyms.

Dimension	Reasoning	Score
Specificity	Names the domain and concrete mechanism ("6-question forcing interrogation", "FDA 21 CFR 820 (QSR / QMSR)") with several specific elements, but covers a single interrogation action rather than comprehensive multi-action coverage.	4 / 5
Completeness	Explicitly answers both what ("FDA 21 CFR 820 ... audit 6-question forcing interrogation") and when ("Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response") with concrete trigger phrases.	5 / 5
Trigger Term Quality	Strong natural terms a regulatory-affairs user would say ("QSR audit", "internal QSR audit", "pre-FDA-inspection readiness", "Form 483", "ISO 13485"), though a few synonyms like Warning Letter, MDR, or 510(k) are absent.	4 / 5
Distinctiveness Conflict Risk	Clear FDA-QSR niche explicitly distinguished from the ISO 13485 cross-walk pair, with regulation-specific triggers that minimize conflict risk with other skills.	5 / 5
	Total	18 / 20 Passed

Validation

93%

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 — 15 / 16 Passed

Validation for skill structure

Criteria	Description	Result
relative_links	Relative link issues: 2 suspicious	Warning

	Total	15 / 16 Passed

Repository: alirezarezvani/claude-skills
Path: compliance-os/skills/fda-qsr-audit-prep/SKILL.md
Commit: 19392f7

Reviewed: ~10 hours ago

Table of Contents

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