Compass' Template for PHA Exercises
The PHA template allows teams to create a Preliminary Hazard Analysis by defining a list of perspectives and questions proposed by the guiding EN ISO 14971:2012 standard. The PHA Template supports pre-populated Harm and Hazard libraries.
Compass’ PHA templates are configurable to support EN ISO 14971:2012 – Application of Risk Management to Medical Devices and the IEC 62366-1:2015 Medical devices –Part 1: Application of usability engineering to medical devices.
It promotes “inherent safety by design” by guiding users through detailed risk analysis early in the design phase of the system. It reduces development costs and time to market by minimizing system redesigns in the later stages of product development.
DEVELOPER PERSPECTIVES
The template comes preconfigured with perspectives (User, Maintainer, Patient), but more may be added as required
HAZARDS LIBRARY
The template comes preconfigured with a hazards library. Hazards and categories may be added as required.
HARMS LIBRARY
The template comes preconfigured with a harms library and associated severities. Harms may be identified and severities assigned as required.
GUIDED Q&A: APPLICATION OF RISK MANAGEMENT TO THE MEDICAL DEVICE
The template comes preconfigured with a non-exhaustive list of questions identified in Annex C of EN ISO 14971:2012 to assist with “identifying the characteristics of the medical device that could affect safety”. Additional questions may be added as required.
AUTO GENERATE PHA TABLE
The template automatically inserts the hazards identified as a part of answering the risk management and usability questions into the PHA table. The user is then prompted to identify hazardous situations, sequences of events, harms, and risk (severity and occurrence) for each hazard, before defining mitigations and residual risk for each overall risk.
COMPLETE RISK CONTROL MATRIX
The template automatically inserts the mitigations identified in the PHA table into the risk control trace matrix. The user is then prompted to link mitigations to existing requirements.
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