RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 17

standardize on using certain tools exclusively or may leave it to the project team
to select an appropriate tool. In certain cases, a company may choose an infor-
mal risk analysis process to meet their risk management requirements, whereas
in other circumstances, a very rigorous, quantitative, and involved risk analysis
will be required. In utilizing risk management tools for managing the risks of the
quality of a product (drug, biotechnological products, combination products, etc.),
the risks to the patient should be the most important consideration for which tool
or tools to use. The product manufacturer has the best information and the most
at stake, so they are the best positioned to identify the scope and selection of the
tools for their risk management approach. Also, keep in mind there is no “one
size fits all” approach to risk management. Each situation must be evaluated on
the basis of facts present at the time in the specific project that is being evaluated.
2.2 RISK MANAGEMENT
Risk management is an ongoing process of minimizing risks throughout a project,
process, or product's life cycle to maximize its benefit and reduce its risk to
individuals or the environment. Risk information will emerge throughout the
product life cycle. This information combined with risk management tools makes
it easy for the application of quality risk management principles. When the risk
cannot be eliminated, it must be determined at each decision point if the currently
identified risk level can be reasonably reduced further or not and if the current
level of risk is acceptable to the company.
2.3 RISK MANAGEMENT PROCESS
The quality risk management process includes the assessment, control, commu-
nication, and review of risks associated with a product, project, or process (i.e.,
drug) throughout its life cycle. The use of risk management tools can provide
documented and reproducible methods for accomplishing the risk management
process. The flow chart shown in Figure 2.1 is an example of a typical quality
risk management process [1].
2.3.1 Risk Assessment
As you see in Figure 2.1, the first process is assessing the risk. This has three
components: risk identification, risk analysis, and risk evaluation. Each of these
is discussed later. This is a systematic process to understand risk: (i) what can
go wrong, (ii) how likely is it, and (iii) what are the impacts?
A risk assessment is conducted on the basis of historical experience, analytical
methods, knowledge, and sometimes intuition.
2.3.1.1 Risk Identification In order to address risk, the hazards leading to harm
must be identified. This process requires subject matter experts knowledgeable
and experienced with the product or process to “brain-storm,” use checklists,