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Risk assessment workspace

RA-AIV-0001 — FMEA per ICH Q9(R1)

FMEA risk assessment — the assurance pipeline itself. Scores are computed server-side. A risk is lowered by applying a named measure, never by typing a smaller number.

Working as Guest viewer. You are a read-only guest. Sign in to apply measures or sign off residual risk.

#	Key input	Failure mode	S	O	D	RPN	Q9	Measures	Escalation
1	Sovereign RAG corpus	Superseded document version retrieved	4	2	2	16	C3	—	Awaiting signatureReport ↗
2	Assurance rule library	Encoded rule incorrect or incomplete	4	2	2	16	C3	—	Awaiting signatureReport ↗
3	Risk-tiering module	Output mis-tiered as low risk	4	2	2	16	B3 !	—	Awaiting signatureReport ↗
4	Audit-trail service	Audit record not written	4	1	1	4	B1	—	—
5	E-signature workflow	Signature by unauthorised user	3	1	2	6	B1	—	—
6	Human review workflow	Reviewer approves without adequate review	3	2	3	18	C3	—	Awaiting signatureReport ↗
7	Change management	Model update without re-validation	4	2	2	16	C3	—	Awaiting signatureReport ↗
8	Sovereignty boundary	Data leaves validated environment	4	1	2	8	B2	—	—

A risk goes down by applying a named measure, with a note of what was done, never by typing a smaller number. RPN and the Q9 score recompute from the real backend, and every change is saved together with its audit record: both happen, or neither does. Severity is locked. Accepting residual risk is an electronic signature.

Checks & approval

Draft

✕Formality commensurate with risk on every item (Q9(R1) principle 2)

✕No unresolved escalations (residual risk accepted for every item that ever reached the QA threshold)