Risk Analysis

Risk Analysis is the estimation of the possible risk to the product quality attributes if those components, functions, and processes fail. There are three parameters to consider during the Risk Analysis process:

  • 1. Probability of Occurrence (O) – refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as:
    • high (will probably occur)
    • medium (may occur at some time), or
    • low (unlikely to occur in most circumstances).
  • 2. Severity (S) – the measurement of the possible consequences of a hazard. The Severity is evaluated and graded as:
    • high (very significant non-compliance with GMP or injury to patients),
    • medium (significant non-compliance with GMP or impact on patients), or
    • low (minor infringement of GMP and no impact on patients).
  • 3. Probability of Detection (D) – the ability to discover or determine the existence, presence, or fact of a hazard.


Following the Risk Analysis, the Risk Level is evaluated and graded as:

  • High (unlikely to be detected in most circumstances – detection Low)
  • Medium (may be detected at some time – detection Medium)
  • Low (will probably be detected – detection High)