agile-v/agile_v_skills/agile-v-compliance

Instructions

Compliance protocols for Agile V. Requires agile-v-core loaded first.

Risk Management (ISO 9001 6.1 / AS9100D 8.1.1)

Append-only, cycle-tagged register in .agile-v/RISK_REGISTER.md: RISK-ID | Cycle | Level(L0-L4) | Category | Description | Likelihood | Impact | Controls | Residual Decision | Owner | Status. Apply docs/agile-v-runtime/04_RISK_CLASSIFICATION.md; legacy R0-R3 maps only as documented there.

Categories: Technical, Process, Compliance, Security. Severity matrix: High x High = Critical, High x Med = High, High x Low / Med x Med = Medium, rest = Low. Critical risks require Human resolution or documented acceptance before Gate 2.

Residual-risk acceptance is an exception decision: a documented risk acceptance is a residual_risk_acceptance under docs/agile-v-runtime/09_EXCEPTION_AND_WAIVER_CONTRACT.md — it requires scope, owner, expiry, and monitoring, not a bare "accepted" note. It does not override a separate mandatory technical failure unless a valid, permitted exception independently resolves that failure too.

When: draft persisted = Req Architect identifies; independent findings = Logic Gatekeeper flags constraints; Stage 4 = Red Team finds residual; cycle boundary = Compliance Auditor reviews. Baselining requires Gate 1 approval and no unresolved mandatory finding.

CAPA Protocol (ISO 13485 8.5 / ISO 9001 10.1-10.2)

Triggers: CRITICAL finding, recurring NC across cycles, regression FAIL with no CR, 3-attempt escalation.

Record in .agile-v/CAPA_LOG.md: CAPA-XXXX with Cycle, Trigger, Nonconformity, Root Cause (5-Whys), Corrective Action, Preventive Action, Effectiveness Verification, Status (open -> corrective-complete -> preventive-complete -> verified-effective -> closed), Owner.

Workflow: Detect -> Record -> Analyze -> Correct -> Prevent -> Verify effectiveness. Compliance Auditor tracks open CAPAs at Gate 2, flags overdue (>2 cycles).

Governance conversion: when the preventive action is a new or changed control (not a one-off fix), record it as a GOVERNANCE_CONVERSION (docs/agile-v-runtime/12_GOVERNANCE_CONVERSION.md) linked to the originating CAPA. It follows proposed -> approved -> deployed -> validated; the CAPA owner proposing it is not the approving authority, and activation does not retroactively change the frozen baseline of the task that motivated it.

Human Gate Approval Records (21 CFR Part 11 / Annex 11)

Append-only in .agile-v/APPROVALS.md: GATE-XXXX with Gate type, Cycle, Scope, Decision (Approved/Conditional/Rejected), Conditions, Approver (full name), Role/Authority, Timestamp (ISO 8601), Signature Method, Evidence Reference (commit hash). Durable HITL (Phase 2): when closing a pending interrupt, include resume_token=[value] and INTERRUPT-ID=[INT-XXXX] matching .agile-v/CHECKPOINTS.md; Compliance Auditor verifies token pairing on Gate 2.

Rules: Name + role required (not just "Human"). Authority from matrix in config.json. Rejected = pipeline halts.

Checkpoint SLA: If CHECKPOINTS.md shows due_at passed with PENDING, escalate per project policy; append ESCALATED or EXPIRED row before forcing resume.

AI Agent Security Controls (ISO 27001 A.5.23 / A.8.3)

LLM Provider Registry in config.json: per provider record name, models, data_residency, retention, api_data_usage, approved_for classifications, review_date. Verify input classification vs provider approval before sending. Never send credentials/patient data unless provider approved. Least privilege per agent. Context sanitization on session end.

File Integrity: Git-tracked = verify clean status. Store hashes in STATE.md at Gates; verify before next stage. Flag unverifiable files to Human.

Periodic Review & Revalidation (GxP / GAMP 5)

Triggers: LLM model change, runtime/platform major update, skill file change, >5 CRs since last revalidation, 12-month interval.

Record in .agile-v/REVALIDATION_LOG.md: REVAL-XXXX with Date, Trigger, Scope, Results, Decision, Reviewer. Regression failure = new cycle trigger.

Model Tracking in config.json: model_versions with tier IDs + last_validated + validated_by. Any change triggers revalidation.

Qualification Deviations and Requalification (GxP / GAMP 5)

For GxP computerized-system qualification, DQ/IQ/OQ/PQ are evidence stages, not agent names; see agile-v-gxp-qualification. red-team-verifier owns OQ execution; validation-agent owns any PQ/intended-use mapping.

Qualification deviation handling reuses the CAPA and Periodic Review workflows above: a rejected pipeline halts, and stage/gate records remain consistent with matching agile v checkpoints md.