Conciseness

The body is dense with non-generic operational data Claude would not reliably know ("First-time effectiveness | >90%", "Critical | 30 days | 30-90 days post-implementation", "8.5.2 Corrective Action | Eliminate cause of nonconformity"). Minor over-explanation keeps it from 5: the generic 5-Why template block ("WHY 1... EVIDENCE: [Supporting data]" x5) is immediately followed by a full worked example, and the 6M fishbone table largely restates standard categories. Not 3 because nearly every section is specific operational content rather than padding.

Actionability

Concrete fill-in templates ("ACTION 1: [Specific action description]... Success Criteria: [Measurable outcome]"), copy-paste commands ("python scripts/capa_tracker.py --capas capas.json"), a complete JSON input example, and ASCII decision trees make the guidance mostly executable. Not 5 because the tracker commands depend on scripts/capa_tracker.py, which is not present in the bundle, so they cannot actually run as packaged.

Workflow Clarity

Each phase is a numbered sequence with an explicit validation checkpoint ("**Validation:** Root cause explains all symptoms; if eliminated, problem would not recur"), evidence checklists ("Root cause can be verified with objective evidence"), and error-recovery feedback loops ("Yes → CAPA INEFFECTIVE (re-investigate root cause)"). This matches the top anchor: clear sequence, explicit validation, feedback loops, and checklists for a complex multi-phase process.

Progressive Disclosure

In-body structure is good — a table of contents and clearly signaled one-level-deep pointers ("See `references/rca-methodologies.md` for complete method details and templates"). However, none of the referenced files exist in the bundle: references/rca-methodologies.md, references/effectiveness-verification-guide.md, and scripts/capa_tracker.py are all missing, so the deeper disclosure levels are unreachable. Not 4 because dangling references to three files are more than a minor organization gap; not 2 because the body's own structure is well-organized and references are one level deep and clearly signaled.

Specificity

"Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics" lists multiple specific, concrete capabilities spanning the full CAPA lifecycle in "CAPA system management for medical device QMS". This matches the top anchor's comprehensiveness (comparable to "Extract text and tables from PDF files, fill forms, merge documents"); not 4 because there is no meaningful gap in coverage of the domain.

Completeness

"CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning..." clearly answers what, and "Use when running CAPA investigations, 5-Why analysis, fishbone diagrams..." explicitly answers when with concrete trigger phrases — matching the top anchor's structure exactly.

Trigger Term Quality

"Use when running CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization" gives good natural-keyword coverage including method synonyms. Not 5 because a few natural phrases this domain's users would say are missing from the description itself (e.g., "nonconformance investigation", "audit finding", "customer complaint"); not 3 because coverage clearly exceeds 'some relevant keywords'.

Distinctiveness Conflict Risk

"CAPA system management for medical device QMS" carves out a clear niche with distinct, domain-specific triggers (CAPA, 5-Why, fishbone, effectiveness verification) that no generic skill would claim. Conflict risk with closely related quality/audit skills is minimal; nothing pushes it below the top anchor.