Risk Management

 

⏤aligned with leadership risk strategy 

Risk Management Tools

Effective risk management in an organization can be realized with best practice risk management processes and organizational risk-based culture. Risk management tools to address enterprise, organizational and product risks include:

  • Risk Register

  • Risk Matrix

  • SWOT

  • Probability & Consequence Matrix

  • Data Analysis

  • Risk Data Quality Assessment

  • Root Cause Analysis

  • Interviewing and Surveys

  • Brainstorming

  • Bowtie Analysis

  • Fault Tree Analysis

  • Decision Tree

  • FMEA

Risk Assessment

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.).

 

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Risk Assessment | Guidelines | 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

 

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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

 

 

Risk Assessment | Guidelines | ISO 14971 Medical Devices

 

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