RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 44

• Test data.
• Clinical evidence.
• Use and user data.
• Expert opinion.

In addition, a number of government agencies such as the Department of
Energy and National Aeronautics and Space Administration have routinely con-
ducted risk assessments on a number of projects. Some of these studies are
available publicly.

2.9 CONCLUSION

This chapter has attempted to introduce a number of risk analysis tools that are
appropriate for use in risk management within the pharmaceutical and biological
manufacturing industries. It is important to note that there is not one tool that fits
all situations. It should also be noted that the selection of an appropriate tool, a
particular tool, or the “correct tool” is not as important as following a methodical
approach to management of risk and consistently employing risk management
throughout the project or product life. As indicated throughout, numerous tools
may be used for a particular situation with similar results achieved in identifying
hazards and evaluating their respective risk. The authors' advice is to select a
tool that works for the application, use it well, do not presume to know the results
before they are achieved, be faithful to the process, be robust in documentation,
and ensure the results are communicated to the stakeholders. Finally, remember
that this is not a one-time process, but rather a life cycle activity.

DEFINITIONS

Risk Combination of the frequency or probability of occurrence

and the consequence of a specified hazardous event.
IEC 300-3-9

Harm Physical injury or damage to health, property, or the envi-

ronment. ISO/IEC Guide 73

Hazard Potential source of harm. ISO/IEC Guide 51; ICH Q9

Risk analysis Systematic use of available information to identify hazards

and to estimate risk

Risk assessment Overall process comprising a risk analysis and a risk eval-

uation

Risk control Process through which decisions are reached and protec-

tive measures are implemented for reducing risks to, or
maintaining risks within, specified levels