Conciseness

The body is dense and substantive — risk matrices, P/S criteria tables, AFAP requirements — with no concept over-explanation (it never explains what ISO 14971 or FMEA 'is' at tutorial length). However, detailed reference material (the full 5x5 matrix, probability/severity criteria, two ASCII decision trees) is inlined in SKILL.md when equivalent tables exist in the reference files, so some content could be trimmed or pushed down; this fits 'efficient; minor instances that could be trimmed' (4) rather than the lean 5 anchor.

Actionability

Every workflow is a numbered, concrete procedure (e.g., "Define probability categories (P1-P5)", "Select optimal control following hierarchy"), backed by specific decision tools: a method-selection table (component failures → FMEA, system-level → FTA), a filled-in 5x5 acceptability matrix, a copy-paste risk control option analysis template, and a runnable script invocation (`python risk_matrix_calculator.py --help`). For an instruction-only skill this is fully actionable guidance covering the common cases, matching the 5 anchor; no code absence penalty applies per the scoring notes.

Workflow Clarity

All five workflows are clearly sequenced and each ends with an explicit bolded validation checkpoint (e.g., "**Validation:** Control implemented; verification passed; residual risk acceptable; no unaddressed new hazards"). Feedback loops are present for error recovery — the evaluation decision tree branches on "Further reduction possible? Yes/No" and residual risk "Still unacceptable → Additional control or design change" — matching the 5 anchor (explicit validation steps, feedback loops, checklists).

Progressive Disclosure

Structure is good: a table of contents, clearly signaled one-level-deep references (all three referenced files verified to exist), and a scripts table. But two gaps hold it below 5: scripts/fmea_analyzer.py is bundled yet never mentioned anywhere in SKILL.md (undiscoverable), and several reference-file topics (method selection, criteria tables) are substantially duplicated inline rather than split out. This fits 'good structure; most content appropriately placed; minor organization gaps' (4).

Specificity

"Provides risk analysis, risk evaluation, risk control, and post-production information analysis" lists multiple concrete actions that comprehensively cover the ISO 14971 lifecycle stages, matching the 5-anchor pattern (multiple specific concrete actions, comprehensive coverage). The named domain ("medical device risk management specialist implementing ISO 14971 throughout product lifecycle") pins the scope precisely.

Completeness

Both questions are explicitly answered: 'what' via "Medical device risk management specialist implementing ISO 14971... Provides risk analysis, risk evaluation, risk control, and post-production information analysis" and 'when' via "Use when user mentions risk management, ISO 14971, ..." with concrete trigger phrases. Voice is third person ("Provides"), matching the 5 anchor exactly.

Trigger Term Quality

The 'Use when' clause enumerates twelve natural trigger terms — "risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk" — including synonyms (fault tree analysis spelled out, post-market risk). Only trivially less common variants (FTA acronym, hazard analysis) are absent, which still fits comprehensive coverage with synonyms.

Distinctiveness Conflict Risk

The niche (medical device ISO 14971 risk management) is clear and mostly distinct, but several trigger terms are domain-generic — "risk management", "risk analysis", "risk matrix" — which could also fire for project/financial risk questions or the sibling skills it itself lists (capa-officer, quality-manager-qms-iso13485). This fits 'mostly distinct; minor overlap risk with closely related skills' (4) better than 5, since the triggers are not exclusively medical-device-flavored.