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.

This quiz covers the risk management process in Quality and Good Manufacturing Practice (GMP), focusing on risk assessment and prioritization. It includes steps to rate the severity outcome and likelihood of hazards.