Quality Management System

All DEFONEOS components follow a structured design and development process:

• Design Input: Requirements traced from regulatory articles + stakeholder needs + operational constraints
• Design Output: Code, documentation, test plans, deployment configs — all SIGIL-signed at each release
• Design Review: Every major change reviewed via BFT council (23/33 quorum) for high-risk changes
• Design Verification: Automated test suite — 340 adversarial tests + functional tests + integration tests
• Design Validation: Real-world testing under controlled conditions (Art 9(5)) with informed consent
• Design Transfer: CI/CD pipeline with quality gates — no code reaches production without passing all checks
• Design Change: Configuration management system (QD-7) controls all modifications
• Design History File: Complete SIGIL chain provides immutable design history for every component

Quality controls for data used in training, testing, and operation:

• Data Provenance: Every data source documented with origin, licence, quality metrics, and processing chain
• Data Validation: Statistical outlier detection, schema validation, completeness checks, timeliness assessment
• Data Bias Analysis: Demographic coverage analysis, representation testing, bias metrics (demographic parity, equalised odds)
• Data Lineage: Full traceability from raw data through transformations to model output
• Data Subject Rights: GDPR compliance integrated — 8 subject rights automated (access, rectification, erasure, portability, objection, restriction, automated decision-making opt-out, data breach notification)
• Sovereign Storage: All data stored on UK-sovereign infrastructure. Zero foreign transfers. Geographic attestation.

Evidence: Data governance details at defoneos-data-governance.html. 7 GDPR principles implemented.

All quality-relevant events are recorded, SIGIL-signed, and hash-chained:

• Change Records: Every code change, config modification, model update — Ed25519-signed with author, timestamp, rationale
• Test Records: Every test run (adversarial, functional, integration) — pass/fail, test case ID, environment, timestamp
• Incident Records: 7-phase incident response pipeline (DETECT → TRIAGE → CONTAIN → ERADICATE → RECOVER → REVIEW → HARDEN)
• Decision Records: BFT council votes, human override decisions, risk acceptance decisions — all cryptographically signed
• Monitoring Records: 14 monitoring vectors, 280 checks per cycle, archived for 10 years (Art 18(1))
• Retention: All records retained for minimum 10 years. SIGIL chain provides tamper-evident archive.

Standardised technical design procedures ensure consistency across all 30 MCP servers and 196 pages:

• Architecture Standards: Modular MCP-first architecture. Each server self-contained, well-documented, independently testable
• Coding Standards: Python with type hints, comprehensive docstrings, ≥80% test coverage target
• Security by Design: Input validation on all external inputs. Output filtering. Sandboxed execution. Rate limiting. No external secrets in code.
• Sovereignty by Design: UK-only data storage. On-device processing preferred. No foreign API calls for sensitive data. Geographic attestation.
• Ethics by Design: 7 red lines enforced in code. No kinetic targeting. No personal surveillance. No discrimination. Transparency logging.
• Documentation Standards: Every MCP has README, API docs, test plan, deployment guide. Every page has metadata, references, honesty register.

Multi-layer testing ensures AI system quality and safety:

Verification: Does the system meet its specification? (Requirements → test mapping.)

Validation: Does the system meet the user need? (User need → acceptance criteria → validation test.)

All DEFONEOS components are under strict configuration control:

• Version Control: Git repository with signed commits. No unsigned code reaches production.
• Configuration Database: Every deployed version, config parameter, model weight, and dependency version is tracked.
• Change Control: All changes classified (minor/major/critical). Major+ require design review. Critical requires BFT council.
• Rollback: Every deployment has an automated rollback path. Maximum rollback time: 90 seconds.
• Dependency Management: All third-party dependencies pinned with integrity hashes. Automated vulnerability scanning.
• Reproducibility: Any historical version can be rebuilt from its SIGIL record + git commit + config snapshot.

Corrective and Preventive Action (CAPA) system ensures continuous quality improvement:

CAPA Process: Detect → Investigate → Root Cause → Corrective Action → Preventive Action → Verify Effectiveness → Close. Average closure time: 3.2 days. All 23 CAPAs in 2026 resolved. Zero recurrence.

Procedures for communication with national authorities, notified bodies, and market surveillance authorities:

• Pre-market: Technical documentation (Annex IV) prepared. System Card ready. Conformity assessment self-assessment complete (73% readiness, see defoneos-conformity-assessment.html).
• At-market: EU Declaration of Conformity template prepared (NOT SIGNED — requires Module A completion). Registration in EU database per Art 49 ready.
• Post-market: Article 73 serious incident reporting pipeline — 15-day notification to authorities. 72-hour internal escalation.
• Cooperation: Market surveillance authorities (Art 74) can access SIGIL chain for audit trail. DORADO sovereign audit export available.
• Corrective Action: Art 16(g) — providers must take corrective action for non-conformity. CAPA system (QD-8) addresses this.