Risk Management is necessary to ensure device usability, safety, and regulatory compliance. FDA’s quality system regulation is intended to give manufacturers “the flexibility to determine the controls that are necessary to be commensurate with risk.” The template provides numerous methods for risk analysis including, but not limited to, Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA), numerous forms of Failure Mode Effects Analysis (FMEA) and Use Error Analysis (UEA) following the guidance given in EN ISO 14971:2012.
Risk Management Methods with Compass
The template provides a number of risk management methods that are approved for use in EN ISO 14971:2012 and IEC 62366-1:2015.
Preliminary Hazard Analysis is easy with Compass. The template guides product teams through the process of fully completing a PHA exercise, jump-starting them on the path to submission.
According to FDA, Usability Engineering is the idea of understanding “how people interact with technology and studying how user interface design affects the interactions people have with technology.”
Compass provides mechanisms for completing numerous types of Failure Mode Effects Analysis depending on the product team’s needs. We provide pFMEA, dFMEA, and many others out-of-the-box.
Fault Tree Analysis is a probabilistic risk analysis used during product development. Compass supports this analysis by providing a built-in, graphical method. FTA handles both pre- and post-mitigation probabilities and supports numerous calculation methods including, but not limited to, basic-gates, AND, and OR gates.
Compass provides multiple templates to ensure regulatory compliance.
Compass' powerful guided approach to regulatory compliance is a combination of the base Cockpit Platform and a specialized set of templates created for specific standards. Compass includes a template to complete the PHA exercise recommended in ISO 14971. Download our white paper to learn more:
Risk Management Features
Compass provides configurable risk settings out-of-the-box. Change severity, detectability, and occurrence values for the entire site or for an individual project. Teams can also configure whether to use simple calculations for both color and score or they can configure custom matrices based on company standards. The configurable settings include:
- Detection Levels
- Occurrence (Probability) Levels
- Severity Levels
- Score Settings: Simple Calculations vs. Configurable Score Matrix
- Color Settings: Simple Threshold vs. Configurable Color Matrix
Compass provides the powerful ability to create libraries to use among product development lines. These libraries can contain any sort of object, such as Harms and Hazards for risk management processes. These libraries are configurable by your organization and are access controlled, only allowing those authorized to access and edit the libraries.
Compass provides a number of out-of-box and configurable risk analysis tools, such as FMEA (d/p), PHA, and FTA. In all formats, the platform will automatically calculate risk scores within the table based on the settings configured during the platform initialization. The team can choose which scoring method to use during risk analysis. Some out-of-box scoring methods for FMEA and PHA include, but are not limited to: RPN, SxO, Mitigation Benefit, and Residual Risk. FTA calculations include pre- and post-mitigation risk.
Connect other programs to Compass to transfer data between the two.
Easily allocate design inputs, user needs, etc. to sub-systems of the design.
Compass’ built-in reporting and report creation abilities allow teams to gather information on anything.
EVERYTHING IS LINKED
From risks to mitigations to requirements to tests and more. Everything is linked and stored in the same Compass database.
Manage all aspects of requirements for your project in Compass.
VERIFICATION & VALIDATION
Manage all verification and validation tests for your design. All tests are dynamically linked to one or more requirements, creating a documented trace.