FMEA — Failure Modes and Effects Analysis
Risk prioritization based on real dimensional data, structured QIF (ISO 23952) and full process traceability
IVR.FMEA connects failure modes to objective inspection results, nonconformities and historical measurement records. Using structured QIF (ISO 23952) data and automatic collection from IMTE — Inspection Measuring and Test Equipment — the analysis eliminates manual transcription and ensures every severity, occurrence and detection rating is supported by measurable evidence.
What IVR.FMEA Delivers
- Direct linkage between failure modes and dimensional characteristics
- Traceable connection to QIF-based structured data
- Integration with SPC capability indicators and trends
- Evidence-based detection ranking using real inspection data
- Full audit trail for revisions and risk re-evaluations
From Subjective Risk to Evidence-Based Prioritization
Traditional FMEA implementations often rely on subjective evaluations disconnected from actual process performance. IVR.FMEA transforms this approach by linking each failure mode to measurable characteristics defined in CAD models and structured through QIF (ISO 23952).
Severity, occurrence and detection ratings can be supported by real dimensional deviations, historical nonconformities and statistical indicators from IVR.SPC. This ensures that risk prioritization reflects the true behavior of the manufacturing process, not assumptions.
Every risk index can be traced back to measurable data and inspection evidence.
Integration with CAD, QIF and DMIS
Failure modes are associated with specific product characteristics derived from CAD models and structured via QIF (ISO 23952). Inspection programs generated through DMIS maintain alignment between design intent and measured results.
When dimensional characteristics are updated in engineering, the impact on risk analysis becomes immediately visible. This closed loop between CAD → QIF → DMIS → Measurement → FMEA guarantees structural consistency across engineering and quality.
- Bidirectional traceability between design and risk analysis
- Automatic update of affected risk items when characteristics change
- Alignment between inspection planning and risk controls
Detection Ranking Based on Real Inspection Capability
Detection ratings can be supported by Measurement System Analysis (MSA) results and SPC stability indicators. If the inspection system demonstrates limited capability or instability, the detection score reflects this condition objectively.
Automatic data acquisition from IMTE — Inspection Measuring and Test Equipment — eliminates manual data entry errors and preserves the integrity of measurement history used in the analysis.
Detection performance is evaluated using measurable system capability, not assumption.
Lifecycle Traceability and Audit Readiness
IVR.FMEA maintains a complete revision history of risk assessments, linking each change to process data, inspection results and corrective actions. This supports internal audits, customer requirements and regulatory compliance.
When integrated with IVR.DMS and IVR.Audit, the system ensures that risk mitigation actions are traceable to documented evidence and verified by measurable results.
- Revision history with timestamp and responsible user
- Link between corrective actions and measurable improvements
- Evidence export for customer and certification audits
Aligned with APQP and Continuous Improvement
Within the APQP framework, IVR.FMEA operates as a structured and data-driven risk control mechanism. Risk reduction actions are validated through dimensional reports, SPC trends and capability studies.
By connecting risk analysis to measurable process performance, organizations establish a continuous improvement loop where engineering, quality and production operate on the same structured data foundation.
Risk management becomes a measurable and auditable engineering activity.