Baseline Definitions

Let’s first take a step back and establish a baseline set of definitions:

  • Harm: Damage to health, including the damage that can occur from loss of product quality or availability.
  • Hazard: The potential source of harm
  • Risk: The combination of the probability of occurrence of harm and the severity of that harm
  • Severity: A measure of the possible consequences of a hazard
  • Occurrence: the likelihood of the events occurring (that result in the realization of the risk)

How to Visualize

A good way to try to visualize this is:

  • Ice on the sidewalk is a hazard
  • Harm can occur when walking on ice on the sidewalk, slipping, and falling
  • The severity could include broken bones, contusions, concussions, etc
  • Likelihood of occurrence might involve where the sidewalk is located (high-traffic area?)
  • The risk then is a factor of all these considerations

Always keep in mind that critical systems are used pretty much from cradle to grave for products in the life sciences.

Critical Quality Attributes

CQAs (Critical Quality Attributes) of drug development and manufacture will influence the understanding of the impact of the business process, while Critical Process

Parameters will influence the impact of specific computerized functions.

There are really two aspects of risk we want to consider.

First is the aspects of where are the risks in the software.

We do this to ensure we can, to the best of our ability, control (or mitigate) those risks.

The second is what the overall risk is. This helps us determine the approach and rigor to validation.