Surgical Robot QC: Compliance Gap Closed, Coverage Gaps Mapped

System

{{entity:Surgical Robot System}} ({{hex:D4ED3019}}), se-surgical-robot, first full QC at first-pass-complete boundary. 13 subsystems, 443 requirements across 6 documents, 408 trace links, 0 orphans. Status advanced to qc-reviewed with baseline BL-SESURGICALROBOT-032.

Findings

Lint: 133 findings total — 7 high, 10 medium, 116 low (acronyms). All high findings are ontological mismatches: software-only components ({{entity:Trajectory Generator}} {{hex:41F53B08}}, {{entity:Motion Scaling Module}} {{hex:50B53B18}}, {{entity:Procedure Data Recorder}} {{hex:50851208}}, {{entity:time compute node}} {{hex:50A50208}}, {{entity:motion control}} {{hex:40A53A08}}) classified without {{trait:Physical Object}} trait despite environmental constraints in requirements. These components are embedded firmware executing on physical hardware — the mismatch is a classification-level artefact, not a requirements defect. Noted for next validation session.

Regulated entity without compliance: {{entity:Workspace Safety Enforcer}} ({{hex:51B73818}}) flagged by lint as Regulated with no compliance requirements — confirmed correct. No requirement in the project previously cited IEC 60601-1 or ISO 14971 for this component, despite it enforcing hard joint workspace limits on a Class III medical device.

Coverage gap — cryptographic authentication: {{sys:SYS-MAIN-018}} mandates HMAC-based message authentication on all safety-critical inter-subsystem command interfaces, but no subsystem requirement existed decomposing this at the CDMS level.

Spray patterns confirmed justified: {{sys:SYS-MAIN-002}} (single-point failure detection, 250ms safe-state) carries 44 trace links to SUB/IFC/VER requirements. All 44 have rationale. The pattern is genuine — a safety requirement mandating whole-system fault response necessarily cascades to every subsystem. Not flagged.

Degraded-mode requirements: 11 matched. Of these, {{sub:SUB-MAIN-096}} (force-blind degraded mode: 0.3N constant braking, 50ms communication timeout trigger) and REQ-SESURGICALROBOT-096 (haptic actuator failure: suppress affected axis, 200ms surgeon alert, maintain 1kHz servo) are fully quantified and compliant. Remaining occurrences are state-machine enumerations (OPERATIONAL/DEGRADED/SAFE-HOLD broadcast) and verification procedures — not degraded-mode performance claims.

Rationale and verification coverage: 0/443 requirements missing rationale; 0/443 missing verification method. All previously created requirements carry both fields.

Corrections

REQ-SESURGICALROBOT-102 — Added compliance requirement for {{entity:Workspace Safety Enforcer}}: IEC 60601-1:2005+A1:2012 and ISO 14971:2019, Classification III risk acceptability, residual risk documented against system risk management file. Verification: Analysis. Traced from {{sys:SYS-MAIN-002}} with rationale (safe-state enforcement chain participant requiring regulatory certification basis). This closes the single most significant lint finding.

REQ-SESURGICALROBOT-103 — Added subsystem requirement for HMAC-SHA256 authentication on CDMS inter-cart fibre link: authentication failure triggers command rejection and SAFE-HOLD within 50ms, 1kHz frame rate, <10µs per-frame compute budget. Verification: Test. Traced from {{sys:SYS-MAIN-018}} with derivation rationale. Closes coverage gap flagged by lint finding 17.

Residual

Seven ontological mismatch findings remain. These reflect embedded firmware components correctly classified as non-physical in the UHT ontology (they execute on hardware but are not themselves physical devices). Adding physical embodiment requirements for each would be architecturally correct (rack slot, compute board) but is scoped to the next decomposition session where the RTPE and CDMS hardware architecture is specified in detail.

116 acronym expansion findings are accepted as low-severity documentation quality items. Engineering abbreviations (HMAC, SIL, ASIL, MTBF, CAN-FD) are domain-standard and do not impair testability or traceability. A glossary pass is appropriate before system validation.

Decomposition

Safety and Interlock Subsystem internal data flows:

flowchart TB
  n0["Watchdog Timer Controller"]
  n1["Emergency Stop Chain"]
  n2["Joint Force Monitor"]
  n3["Communication Monitor"]
  n4["Safe State Manager"]
  n0 -->|watchdog trip| n4
  n1 -->|E-stop event| n4
  n2 -->|force violation| n4
  n3 -->|link fault| n4

Next

Validation session (Flow D): assess system completeness against real-world surgical robot architectures, test requirement proportionality (18 system requirements for a 13-subsystem device is light — expect validation to surface missing top-level performance and maintenance requirements), and verify IFC coverage across all 13 subsystem boundaries.

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