ICH Q9(R1) — Quality Risk Management — 75% covered.

4 requirements · 3 enforced · 0 designed · 0 advisory · 0 deferred.

Source: ICH Q9(R1) Quality Risk Management provides principles and tools for a systematic process for the assessment, control, communication and review of risks to the quality of a medicinal product across its lifecycle. It anchors risk-based decision-making (formality of the risk assessment, subjectivity of risk decisions, and the role of risk in supply chain and product availability). KYE Protocol™ governs whether an AI-generated QRM output (a risk assessment, a risk-based decision, an FMEA record) may PROCEED to a consequential action — Quality-Unit approval, reliance in a dossier, or use to release a lot — under a named Quality Unit / QP authority, with the risk-decision justification recorded before the action and replay-provable provenance. KYE does not perform the risk science, set the risk thresholds, or judge whether the risk decision is correct. · License: ICH guidelines are published by the International Council for Harmonisation; KYE registry paraphrases each requirement's intent and cites the official identifier for mapping purposes only.

By category

Category	Reqs	Enforced	Coverage
Risk-based decision authority at the action boundary	1	1	100%
Risk-decision justification recorded before the action	1	1	100%
Replay-provable QRM provenance	1	1	100%
Risk-assessment science & control-strategy selection	1	0	0%

Every requirement → the KYE™ artefact that enforces it

ID	Title	Status	KYE™ enforcement
`ich-q9.qrm-decision-authority`	Risk-based decision by an AI QRM output proceeds only under a recorded named-authority decision	enforced	audit_events: `kye.purpose.request.v1`, `kye.purpose.admissibility.v1`, `kye.evidence.decision_map.v1` engines: `internal`, `internal` rule_packs: `kye:rule-pack:ich-authority` dictionaries: `internal` constitution_refs: `constitution/12-PURPOSE-PERMISSION.md`
`ich-q9.risk-decision-justification`	An AI risk-based decision proceeds only with its risk-decision justification recorded before the action	enforced	audit_events: `kye.evidence.decision_map.v1`, `kye.evidence.pack.v1` engines: `internal` rule_packs: `kye:rule-pack:ich-authority` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`ich-q9.qrm-provenance`	Replay-provable provenance pin for an AI QRM output relied on in a consequential action	enforced	audit_events: `kye.evidence.tool_call.v1`, `kye.replay.context_seal.v1` engines: `internal` rule_packs: `kye:rule-pack:ich-authority` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`ich-q9.risk-assessment-science`	Hazard identification, probability / severity scoring and control-strategy selection	out-of-scope	(no enforcement cited)