Compass' Failure Mode and Effect Analysis (FMEA) Templates
Compass’ Failure Mode and Effect Analysis (FMEA) Templates guide teams through completion of FMEA tasks for dFMEA and pFMEA. It allows teams to configure risk score calculations using either simple scoring thresholds or user-defined color lookup matrices. Compass’ FMEA templates also support risk libraries commonly used in product development and post-market surveillance.
Compass’ FMEA Templates are configurable to support EN ISO 14971:2012 – Application of Risk Management to Medical Devices.
Failure Modes Effect Analysis (FMEA) “… provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance” – Section I.2, Annex I: Risk Management Method and Tools, Q9 Quality Risk Management. Failure mitigation through FMEA reduces or controls potential failures by breaking down complex systems into manageable steps. It is an effective tool for identifying important failure modes, contributing factors/causes, failure effects, and mitigations.
FMEA promotes safety by identifying elements and operations within a system that render it vulnerable; outputs of FMEA tasks can be utilized for further risk analysis or design change. As each FMEA task is completed, users define controlling requirements for all mitigations to tie risks into requirements in Cockpit.
Product development teams can set and define scores and ranges for risk severity, probability of occurrence, and detectability. Matrices or straight threshold calculations can be configured to reflect scores.
Compass includes several pre-populated risk libraries to guide teams through FMEA exercises. Set up your own risk libraries or modify pre-configured ones within Compass. The platform support libraries for failures, hazards, harms, complaints, etc..
SUPPORTED FMEA TEMPLATES
- dFMEA — Apply FMEA method specifically to device or product design
- pFMEA — Identify and evaluate potential process failures
Develop multiple risk exercises for use cases and human factors, functional studies including connections to system BOM and mapping out app process definitions to predict risk of failure and identify appropriate mitigations.
CONNECTING RISKS TO REQUIREMENTS AND TESTS
Implement mitigations by designating controlling requirements to show interactions between risks and requirements; verify implementation through Compass’ testing features. Out of box templates empower dynamic connections between all design controlled documents, meaning risks can be tied back to requirements in a real-time, dynamic environment.
Field complaints can be fed back into FMEA templates as actual occurrences of a failure to help support post market surveillance and the Corrective and Preventive Action (CAPA) process. Templates support both pre-and post-mitigation scoring algorithms.