RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 20

and the severity of the harm. Risk acceptance is decided and documented on a
case-by-case basis. It can be a formal decision or it can be passive. It may be
automatic acceptance based on meeting predefined criteria.
2.3.3 Risk Review/Communication
Decisions reached regarding risk identification, evaluation, mitigation, and accep-
tance need to be communicated throughout the entity. This most often is per-
formed through the report that documents the process, findings, and conclusions
of the risk management process. This communication step is important for man-
agement to understand the risk associated with the product, process, or project.
Depending on the product, process, or project, the communication step may also
be important for health care professionals, patients, caretakers, regulators, stake-
holders, or other workers involved in understanding the associated risks identified
and the mitigations employed. It is also important to document and communicate
the process so that during evaluation of residual risk later in the project life cycle,
information is available to assess the effectiveness of the mitigating actions and
to understand what was known, what was considered, and what decisions were
made during the risk assessment process to accept the risk.
It is important to note that writing the risk assessment report is not the end
of the risk management process. Throughout the product life cycle, the risk
assessment must be monitored and reviewed to ensure that mitigating actions
remain effective. Also, as additional information is collected or as events unfold,
it will be necessary to reevaluate the risk to determine if new hazards are identified
and to verify that the new information or events do not change the risk conclusions
previously established.
2.4 RISK ANALYSIS/ASSESSMENT TOOLS
Decisions are necessary as part of the quality risk management process. These
decisions are based on probability, severity, and, sometimes, the detectability
of risk. There are various risk management tools that can be used for the
risk management process. Risk management tools can be arranged into three
categories: (1) risk analysis/assessment tools, (2) basic facilitation tools, and (3)
decision-making, and statistical tools.
In using a risk analysis/assessment tool, the objective is to identify hazards and
analyze and evaluate the risk. Once the risks are identified, risk control is used to
reduce risk or to manage risk to acceptable levels. To determine the appropriate
risk analysis/assessment tool, it is necessary to have a well-defined description
of the risk. It is helpful in defining risk with the use of three questions: what
might go wrong, what is the probability or likelihood that the event will occur,
and how severe are the consequences of the event?
Risk assessment can be categorized as inductive risk assessment (looking for-
ward in time), deductive risk assessment (looking backward in time), or both.