Risk Assessment

 

...aligned with leadership risk strategy 

Momentum Risk Assessment captures risk ratings to maintain visibility of risk and the results of risk treatment plans. Risk Assessment is configured to meet risk management requirements specific to your organization (e.g., ISO 31000, ISO 14971 Medical Devices, FMEA, etc.).

 

 

 

Guidelines for Risk Assessment | ISO 31000

Top management leadership establishes guidelines for risk assessment, for example:

  • Extreme: Immediate action required

  • High: Senior management attention needed

  • Medium: Management responsibility must be specified

  • Low: Manage by routine procedures

 

 

 

Risk Assessment | Process

A risk assessment is completed in five steps:

  • Risk (Initial)​

  • Risk Response (Tolerate​Treat, Transfer, Terminate)

    • Extreme: Immediate action required

    • High: Senior management attention needed

    • Medium: Management responsibility must be specified

    • Low: Manage by routine procedures

  • Risk Treatment Plan

  • Risk (Final)

  • Risk Review

 

 

Guidelines for Risk Assessment | ISO 14971 Medical Devices

ISO 14971 risk assessment matrix:

 

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