Agile-V 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.
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).
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.
| Regulatory Context | Minimum Signature |
|---|---|
| Non-regulated | APPROVALS.md entry with name + timestamp |
| ISO 9001/27001 | + Git commit attribution |
| GxP / 21 CFR Part 11 | + Signed commit + authority verification |
| ISO 13485 | + Digital signature + authority matrix + retention |
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.
| Concern | Record / Action |
|---|---|
| Qualification deviations | Record QDEV-XXXX in .agile-v/QUALIFICATION_DEVIATIONS.md: Stage (IQ/OQ/PQ), Description, Impact, Disposition, Approver, linked RISK-XXXX/CAPA-XXXX. Open critical deviation blocks stage release. |
| Stage release | Release an IQ/OQ/PQ stage only when its evidence is complete, deviations are dispositioned, and required Human Gate approval is recorded in APPROVALS.md. |
| Requalification assessment | On qualification-relevant change, assess scope of requalification (which stages must be re-executed) and record the decision and rationale in REVALIDATION_LOG.md. |
| Periodic-review triggers | Trigger requalification review on the Periodic Review triggers above plus: qualified-baseline change, infrastructure/environment change, or a critical qualification deviation. |
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.