Risk Assessment

ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.

/cs:caio-review <plan> — Eval-demanding Chief AI Officer interrogation of any plan that involves AI: model selection, risk classification, cost economics, or AI hiring.

Observe and assess a garden using a structured sensory protocol adapted from Coordinate Remote Viewing. Covers pre-entry clearing (meditate checkpoint), Stage I gestalt impression, Stage II sensory layer (leaf, stem, root, soil), Stage III pattern recognition with AOL management, and garden health triage matrix (heal checkpoint). Use before any intervention, when plants show stress symptoms, at seasonal transitions, when evaluating a new garden site, during regular health monitoring, or after extreme weather events such as frost or heat waves.

Run the AgentRC readiness assessment on the current repository and produce a static HTML dashboard at reports/index.html. Wraps `npx github:microsoft/agentrc readiness` and hands off rendering to the @ai-readiness-reporter custom agent. Supports policies (--policy) for org-specific scoring. Use when asked to assess, audit, or score the AI readiness of a repo.

Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (FDA, EMA, MHRA). Covers warning letter and 483 theme analysis, mock inspection protocols, document bundle preparation, inspection logistics, and response template creation. Use when a regulatory inspection has been announced or is anticipated, when a periodic self-assessment is due, when new systems have been implemented since the last inspection, or after a significant audit finding that may attract regulatory attention.

Design and operate a data integrity monitoring programme based on ALCOA+ principles. Covers detective controls, audit trail review schedules, anomaly detection patterns (off-hours activity, sequential modifications, bulk changes), metrics dashboards, investigation triggers, and escalation matrix definition. Use when establishing a data integrity monitoring programme for GxP systems, preparing for inspections where data integrity is a focus area, after a data integrity incident requiring enhanced monitoring, or when implementing MHRA, WHO, or PIC/S guidance.