Conciseness

Dense, checklist-driven body that assumes regulatory competence — e.g., "MDR-reporting decision tree applied: death OR serious injury OR malfunction-that-could-cause = MDR" with no basic-concept padding. Minor trimming is possible (the Routing and Related sections overlap; "FDA-specific overlay not in ISO 13485" is repeated in the output template), which keeps it just below the lean score-5 anchor.

Actionability

Mostly executable: concrete commands with script paths ("python ${CLAUDE_PLUGIN_ROOT}/vendor/.../qsr_compliance_checker.py compliance_state.json"), specific regulatory timelines ("30-day timeline for most MDR reports; 5 days for certain serious events", "Response within 15 working days"), and a full output template. Minor gaps: the workflow scripts' input files (compliance_state.json, submissions.json, phi_inventory.json) are never explained, and the scripts live outside this skill's bundle.

Workflow Clarity

The Workflow section is a numbered list of four commands with no validation checkpoints — nothing tells Claude how to interpret checker output, what to do if a script fails or returns gaps, or how findings feed the verdict (🟢/🟡/🔴). This matches the score-3 anchor ("Steps listed but validation gaps; sequence present but checkpoints missing or implicit"); score 4 would require most checkpoints present, and there are none between the four commands.

Progressive Disclosure

No bundle files exist (no references/, scripts/, assets/), and the body is well-sectioned (When to Run, Six Questions, Workflow, Output Format, Routing, Related) with one-level-deep, clearly labeled cross-references ("../../agents/cs-fda-qsr-auditor.md", vendor SKILL.md). Minor gaps: the six questions' inline checklists are long enough to belong in reference files, and several links point outside the skill (../../skills/..., vendor paths) that cannot be verified from this bundle.

Specificity

The description names the domain precisely ("FDA 21 CFR 820 (QSR / QMSR) audit") and one concrete action ("6-question forcing interrogation"), but stops short of listing several specific actions like the score-4/5 anchors (e.g., what the six questions actually cover — complaints/MDR, CAPA, DHR, labeling). Not score 2, because the action named is concrete and domain-specific rather than generic.

Completeness

Explicitly answers both: what ("FDA 21 CFR 820 (QSR / QMSR) 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, matching the score-5 anchor. The "Use before..." clause is present and specific with three concrete scenarios.

Trigger Term Quality

Good natural keyword coverage: "internal QSR audit", "pre-FDA-inspection readiness", "Form 483" — phrases a regulatory-affairs user would actually say. Missing a few common variations/synonyms (e.g., "warning letter", "MDR", "medical device quality system", "inspection"), which keeps it below the comprehensive score-5 anchor.

Distinctiveness Conflict Risk

A clear niche — US medical-device QSR audit prep — with distinct triggers (FDA 21 CFR 820, QSR/QMSR, Form 483) and an explicit differentiator from ISO 13485 ("substantially harmonized with ISO 13485" signals the adjacent skill without competing with it). Minimal conflict risk.