Risk Management Process in Quality & GMP

Risk Management Process

• The Risk Management process involves three steps: Risk Assessment & Prioritization, Risk Treatment, and other steps (not specified).

Risk Assessment & Prioritization

• Rate the Severity (S) of the injury outcome.
• Rate the likelihood (L) that the hazard may cause the injury.
• Multiply S and L to get the Risk Prioritization Number (RPN).
• Compare the RPN against the Risk Matrix to determine the risk level.
• Take action based on the current risk level.

Risk Matrix

• The Risk Matrix helps determine the risk level based on Severity (S) and Likelihood (L) of the injury.
• Severity scoring:
  • Negligible (1): Minor injury not requiring first aid treatment.
  • Minor (2): Minor injury or illness, first aid treatment required.
  • Moderate (3): Significant injury requiring treatment and/or counseling.
  • Major (4): Major injuries/long-term treatment and/or counseling.
  • Extreme (5): Incident leading to death or permanent psychosocial impairment.

Risk Treatment

• Step 3 of the Risk Management process involves identifying and implementing risk treatment options.
• Risk treatment options include:
  • Risk Financing: Utilizing funds to pay for the financial impact of unexpected losses or adverse events.
  • Risk Control: Reducing or eliminating risks through control measures.

Risk Financing

• Risk Financing involves using internal or external funding sources to cover financial losses.
• Internal funding sources include self-retention or shared retention/captive programs.
• External funding sources include commercially available insurance.