**12. References**

[1] FDA (2004) Pharmaceutical CGMPS for the 21st century - A risk-based approach. Final report.

**Chapter 18** 

© 2012 Maria-Sanchez, licensee InTech. This is an open access chapter distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

© 2012 Maria-Sanchez, licensee InTech. This is a paper distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

**Project and Enterprise Risk Management** 

Pedro Maria-Sanchez

http://dx.doi.org/10.5772/51442

**1. Introduction** 

Additional information is available at the end of the chapter

enterprise risk management in the real world.

performing a sound and trusted risk management exercise.

**at the California Department of Transportation** 

A better understanding of risk management processes and practices within a government agency is crucial for enhancing the project delivery process and for implementing formally risk management. This chapter outlines the whole implementation process carried out with the risk management team formed from different functional units and backgrounds. In addition, a discussion is held over the critical steps and aspects for performing project and

Risk management is not new for the transportation industry in the United States, specifically in highway projects. The California Department of Transportation (Caltrans), a leading authority in public transportation projects in the US, has used basic project management principles along its statewide Districts offices. Risk management has been part of the project management menu; nevertheless its application was limited only to developing a risk register and a qualitative analysis at the most. The Office of Statewide Project Management Improvement (OSPM), has developed a Project Risk Management handbook which is a guide for project managers at Caltrans for using risk management. Unfortunately, the latest version of the manual which is from 2007, did not included a detail explanation of the benefits for performing quantitative risk analysis while determining the risks impacts into the project objectives, in terms of cost and time. The term quantitative risk analysis is merely described, lacking a sound description of the tools and methodologies that have been in place and use in the industry for many years and even with other government agencies around the world. Cost overruns caused by a lack of using risk management in the practice for infrastructure and transportation projects, has been mentioned in the literature for many years. However, only few examples of how risk management can be use in the real life are available, including how can a risk team be formed and how to educate the team for

