Failure Modes and Effects Analysis (FMEA) is a proactive risk assessment method designed to identify potential failures in manufacturing processes, products, or systems before they occur. By systematically evaluating failure modes, their causes, and their effects, FMEA helps manufacturers prioritize risks, implement preventive measures, and improve overall product and process reliability.
Digitized and integrated directly into MBrain, this feature enhances traditional FMEA methodologies by adding the possibility to leverage actual production data, to for instance continuously update probability of occurrence for your various failure modes. This allows you to gain insights enabling you to reduce defects, optimize processes, and ensure compliance with industry standards such as IATF 16949, ISO 9001, and Six Sigma.
Key Capabilities of MBrain’s FMEA:
Structured Failure Mode Analysis: Identify and categorize potential failure modes across products, components, or processes.
Risk Prioritization with RPN (Risk Priority Number): Calculate RPN based on Severity, Occurrence, and Detection, and allow teams to focus on high-risk areas.
Data-Driven Decision Making: Use historical interference and test reports, machine logs, and sensor data to enhance failure mode predictions.
Dynamic & Continuous Updates: Ensures that FMEA is not a static document but a live risk management tool that evolves with process changes.
Collaboration & Documentation: Provides a centralized platform for teams to work on risk assessments, ensuring traceability and compliance.
How FMEA Works in MBrain
System, Design, or Process Breakdown The product, component, or process is divided into subsystems and functions to systematically analyze potential failure points.
Identification of Failure Modes Teams document all possible failure modes (e.g., material defects, machine malfunctions, incorrect assembly). MBrain’s AI suggests failure modes based on historical scrap reports, downtime events, and quality trends.
Effects & Severity Rating (S) Each failure mode’s impact on safety, performance, and production efficiency is assessed and assigned a Severity (S) score (1-10 scale).
Cause Analysis & Occurrence Rating (O) Identifies potential causes (e.g., human error, equipment wear, incorrect setup) and assigns an Occurrence (O) score based on likelihood. MBrain integrates data from maintenance logs, operator feedback, and historical production failures to refine occurrence ratings.
Detection Controls & Detection Rating (D) Evaluates current detection methods (inspections, sensors, AI monitoring) and assigns a Detection (D) score based on effectiveness. MBrain’s predictive analytics enhances detection by analyzing live machine conditions and quality data.
Risk Priority Number (RPN) Calculation RPN = Severity (S) × Occurrence (O) × Detection (D)Higher RPN values indicate higher-risk failure modes, which require immediate action.
Risk Mitigation & Action Plan Failure modes with high RPN are addressed through preventive measures, such as process adjustments, better training, improved materials, or automated quality controls. MBrain links FMEA results to corrective action tracking and process control updates.
Implementation & Monitoring Corrective actions are tracked in MBrain, with automated alerts ensuring follow-ups and effectiveness verification. Continuous monitoring and periodic FMEA reviews keep risk assessments up to date.
Benefits of MBrain’s FMEA
Proactive Quality Control: Helps prevent defects before they impact production, reducing scrap, rework, and warranty claims.
Enhanced Reliability & Safety: Improve product and process robustness by systematically eliminating failure risks.
Data-Driven Insights: Use production data to refine risk assessments and corrective actions.
Continuous Improvement: Let your FMEAs evolve dynamically, ensuring alignment with process updates, new failure trends, and evolving risks.
Regulatory & Industry Compliance: Meet the requirements of IATF 16949, ISO 9001, Six Sigma, and Lean Manufacturing.
Why Use FMEA?
Unlike traditional spreadsheet-based FMEA, MBrain digitizes and partly automates risk assessment, ensuring that failure mode analysis is a real-time, continuously improving process. MBrain empowers manufacturers to eliminate risks, enhance quality, and drive continuous improvement across their operations.