RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 19

• intended use
• unintended use
• normal and fault conditions.
This process may be inductive or deductive and will be as exhaustive as
resources allow. The process examines the likelihood of the occurrence and sever-
ity of the harm as the result of the hazard. In some cases, the process looks at the
detectability of the harm as the result of a hazard in estimating the risk. At the
end of this, the identified risk will be scored for comparison with risk acceptance
criteria as described next.
2.3.1.3 Risk Evaluation In a quantitative, qualitative, or semiquantitative pro-
cess, each estimated risk is compared with defined risk criteria to determine the
significance of the risk. This allows the risk to be categorized as acceptable or
unacceptable. For those risks that are acceptable, the company is willing to accept
the risk. In some cases, it may not be possible to completely eliminate risk. For
those that are determined to be unacceptable, risk control must be employed to
achieve risk acceptance.
2.3.2 Risk Control
Risk control is the process through which decisions are reached to implement
protective measures to reduce risk or maintain risk within specified levels. It is a
balance between benefits, risks, and resources. Through this process, it must be
evaluated whether there are new risks introduced as a result of the risk control.
The objective is to reduce the risk to make it acceptable. If the risk cannot be
reduced to an acceptable level, the product or process should be abandoned or
more data must be obtained which allows the risk evaluation to be reexamined.
2.3.2.1 Risk Reduction Risk reduction is the process of identifying mitigating
approaches to address the identified risk. Risk can be reduced by mitigating the
severity of harm, reducing the likelihood of harm, or improving the detectability
of hazards. When applying risk reduction, the priority of approach should be
to make changes inherent in the design to remove the hazard without introduc-
ing new hazards. This may include protective measures or controls (i.e., barriers,
alarms), instituting administrative controls, and, only if no other approach is iden-
tified, including information regarding risk (labeling). It is important to include
validation and verification procedures for the mitigations in the qualification of
the product, process, or project.
2.3.2.2 Risk Acceptance As applied to the risk management process, risk
acceptance is the establishment of the level of risk that the entity is willing to
allow in the product, process, or project. This decision to accept risk is dependent
upon many parameters, some of which include an entity's overall risk tolerance,
the intended purpose for product or project, the ability to mitigate the risks,