Conciseness

The body is lean and checklist-driven with no re-teaching of concepts Claude already knows — every line carries domain-specific value (MDR 30-day/5-day timelines, DHR retention rules, 5-Why minimum, >90-day CAPA flag). Minor deductions: the 'When to Run' section duplicates the frontmatter description's triggers, and time-sensitive date references ('post-Feb 2026') appear inline rather than isolated in a dedicated section, so anchor 4's 'minor instances that could be trimmed' fits better than anchor 5.

Actionability

Each of the six questions is a concrete document request with verifiable acceptance criteria, and the Workflow section provides four copy-paste-ready python commands with named input files (e.g., 'python ra-qm-team/skills/fda-consultant-specialist/scripts/qsr_compliance_checker.py compliance_state.json'). The Output Format is a complete fill-in template. This matches anchor 5: fully executable commands plus specific coverage of the common audit cases.

Workflow Clarity

A clear macro-sequence exists: When to Run → six question checklists → numbered 4-step workflow (compliance state → submission tracking → HIPAA overlap → mock inspection) → Output Format with a gated verdict (INSPECTION-READY / GAPS-IDENTIFIED / NOT-READY) and Top 3 Actions. However, there are no explicit validate-and-retry feedback loops (e.g., what to do when a checker script fails or reveals gaps), so anchor 4's 'most checkpoints present, minor validation gaps' fits; anchor 5 requires explicit validation steps and error-recovery loops.

Progressive Disclosure

The single-file body (~150 lines) is well-organized into clearly headed sections (When to Run, Six Questions, Workflow, Output Format, Routing, Related) with clearly signaled cross-links to sibling skills, and no bundle files exist to score against. It sits above the under-50-line exception for a solo-file 5, and the 54-line Output Format template plus per-question checklists are detail that could be offloaded to reference files, so anchor 4's 'good structure, minor organization gaps' is the best fit rather than anchor 5's fully split content.

Specificity

The description names the domain precisely ("FDA 21 CFR 820 (QSR / QMSR)") and one concrete action ("6-question forcing interrogation"), but does not list several specific actions (e.g., complaint/MDR review, process validation, DHR sampling, CAPA health). This matches anchor 3 ("names domain and 1-2 concrete actions, but not comprehensive") rather than anchor 4, which requires several enumerated actions.

Completeness

Both questions are answered explicitly: what ("audit 6-question forcing interrogation" of FDA 21 CFR 820) and when ("Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response") — an explicit trigger clause with multiple concrete scenarios, matching anchor 5. The 'when' is specific and multi-trigger, so anchor 4's 'could be more explicit' caveat does not apply.

Trigger Term Quality

Natural user phrases are present — "annual internal QSR audit", "pre-FDA-inspection readiness", "Form 483 response", "ISO 13485" — giving good keyword coverage. A few natural terms are missing (e.g., "FDA audit", "quality system audit", "Warning Letter", "recall"), so it falls short of anchor 5's comprehensive synonym coverage but is clearly above anchor 3's partial coverage.

Distinctiveness Conflict Risk

FDA-specific triggers (Form 483, FDA inspection, 21 CFR 820) carve a clear niche, but the description itself states it is "substantially harmonized with ISO 13485", implying overlap with a closely related sibling ISO 13485 audit skill. Minor overlap risk with a closely related skill matches anchor 4; anchor 5's 'minimal conflict risk' is not met given the acknowledged harmonization.