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Service Design Review: Forensic engineering audits that protect margins,
scale field operations, and lock down regulatory compliance prior to design transfer.
Without a forensic Service Design Review (SDR), prototypes scale into the field with hidden mechanical dependencies and digital blocks.
This oversight forces simple interventions into expensive, depot-level repairs, driving unacceptable warranty drain and destroying commercial margins before the first unit is even sold.
Intake verification against CAD and RMF. Execution of baseline IEC 62353 safety tests.
Deep disassembly to calculate MTTR, Service Priority Numbers, and mechanical blocks.
Validation of fastener lifecycles (torque limits) and isolation of cable pinch-hazards.
Audit of digital service logic, functional load testing, and global regulatory labelling.
Traditional design reviews rely on subjective engineering opinions (e.g., "The pump is too hard to reach"). Subjective feedback is easily dismissed by R&D teams pushing for rapid launch deadlines, leaving field service exposed.
Schema Technical replaces opinion with hard math. We calculate the Service Priority Number (SPN) for every primary assembly:
We do not just report mechanical frustrations; we translate them into strict QARA mandates.
An unkeyed ribbon cable or a blind fastener isn't just a service nuisance—it is a latent patient safety hazard (Use Error). We tie every physical design flaw directly to ISO 13485 (DfS), ISO 14971 (Risk Management), and IEC 62366-1 (Usability).
By mapping physical teardown findings directly to regulatory hazard codes, we provide Quality Directors with the objective, auditable data required to block flawed hardware from reaching the field.
We validate fastener thread lifecycles using calibrated torque limits and inspect internal routing for cable strain and crush hazards upon reassembly.
We audit the software environment for hardware pair-locking, latency, diagnostic code granularity, and Bare Metal OS recovery speed.
We perform IEC 62353 safety tests before and after the teardown to ensure field interventions do not compromise Earth Continuity or Leakage limits.
| Asset Type | Deliverable Content | Primary Value |
|---|---|---|
| Formal Audit Report(PDF Document) | A regulatory-grade document detailing SPN metrics, identified gaps, and specific ISO 14971 hazard traceability links. | Provides R&D leadership with objective data to justify BOM changes before tooling locks. |
| HTM Delta Export(.csv / .xlsx Data) | A raw data export mapping physical serviceability flaws directly to the client's internal Hazard Traceability Matrix. | Allows QARA to immediately ingest findings into their CAPA systems, satisfying Notified Body requirements. |
| Executive Debrief(Video Conference) | A comprehensive presentation with R&D and QARA leadership to review physical findings and prioritize mitigations. | Aligns cross-functional teams and accelerates the Engineering Change Request (ECR) pipeline. |
Audit the prototype before the BOM locks.