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Field Reliability Analysis: Forensic root cause execution to eliminate
"No Fault Found" loops and close regulatory CAPAs with objective physics.
When field hardware fails, depots often strip and rebuild units until the symptom disappears. This destroys the forensic evidence required to find the true root cause.
Returning an unverified unit to the clinical field drives up "No Fault Found" (NFF) rates, erodes patient trust, and leaves your ISO 13485 Quality Management System dangerously exposed to recurring hazards.
Securing the Failed-From-Field (FFF) unit and extracting telemetry prior to any physical disturbance.
Comparative disassembly against a Known Good Unit (KGU) to capture torque metrics and isolation data.
Translating physical metrology into the 5-Whys and Ishikawa methodologies to classify the fault.
Safe reassembly and definition of the exact Verification of Effectiveness (VoE) metric for QARA.
Attempting to diagnose a complex failure by analyzing a single broken unit in isolation. Without a baseline, thermal deformations or torque backouts are impossible to mathematically verify.
Schema Technical never audits in isolation. We strictly mandate a Known Good Unit (KGU) for every investigation to lock the comparative delta:
We do not deliver speculative opinions. We deliver the definitive engineering data required for your QARA team to formally close Corrective and Preventive Actions.
Every FRA report clearly defines whether the root cause originates from Design (DfM), Manufacturing Process, Service Protocol, or Clinical Use-Error—allowing precise routing of Engineering Change Orders (ECO).
We supply the strict Verification of Effectiveness (VoE) metric. We tell your Quality team exactly what measurable test must be passed (e.g., 60-second pressure decay < 0.1 mbar) to legally prove the CAPA is mitigated.
Execution of baseline IEC 62353 safety tests and thermal imaging to capture electrical and hardware states before geometry is broken.
Using calibrated torque drivers, digital calipers, and UV markers to identify fastener backout, fluid ingress, and compromised isolation barriers.
Mapping physical evidence into structured 5-Whys and Ishikawa (Fishbone) models to prevent the investigation from terminating at "Human Error".
| Asset Type | Deliverable Content | Primary Value |
|---|---|---|
| Formal Audit Report(REP-FRA-001) | A regulatory-grade document detailing physical failure modes, Ishikawa analysis, and the required VoE metric. | Provides QARA and R&D with the objective, physics-based evidence required to formally close the CAPA. |
| Spoliation Control(Chain of Custody) | Strict inbound triage enforcing baseline safety and forbidding unapproved depot-level cleaning or resets. | Protects forensic evidence from being accidentally destroyed by well-meaning technicians. |
| Executive Debrief(Video Conference) | A comprehensive presentation with R&D and Quality leadership to present the forensic findings. | Aligns cross-functional teams immediately on whether the fix requires an ECO, a software patch, or a training update. |
Find the root cause. Engineer the fix.