The Food and Drug Administration (FDA), a major agency under the Department of Health and Human Services (DHHS), is one of the nation's oldest and most respected consumer protection agencies.  The FDA’s mission is to promote and protect the public health by helping safe and effective products reach the market in a timely manner.  The FDA is also responsible for monitoring products for continued safety after they are in use or post market.

The FDA recognized the need to facilitate the development of an IT Capital Investment Management Process, including project management, to ensure that IT projects and resources were managed effectively.  The process was needed to focus on solving specific federal business problems:  a growing number of “data calls,” the Clinger Cohen Act of 1996, OMB Circulars A-11, A-94, A-30, the CIO Council Federal Enterprise Architecture Framework, and the Government Performance Results Act of 1993.

The FDA’s decentralized Centers/Offices made it difficult to gain consensus on common processes, templates, and tools.  In addition, the Office of the Chief Information Officer (OCIO) encountered turnover of its leadership four times in the last four years.

Repeatable project management tools and techniques at all levels of the Agency, including the decentralized eight Centers/Offices, needed to be put in place to ensure consistent compliance with these federal business requirements. A phased approached was used to implement the project management office; the first phase consisted of programs to establish discipline expertise in Portfolio Management/Investment Management and Project Management/System Development Lifecycle (SDLC) Management. Below are several milestones that supported the successful implementation of the project life cycle and other policies:

• Rewrote the FDA SDLC Document, called the FDA IT Investment Life Cycle Document, and later updated it to align with the Department of Health and Human Services Enterprise Project Lifecycle (EPLC)
• Authored the FDA Project Stage Gate and Operational Review Process and Templates
• Conducted Project Management Coaching and Mentoring Sessions with each Center/Office
• Developed and updated the IT Governance Framework Poster, a communication tool that allowed the Project Management Office (PMO) to demonstrate in simple terms Capital Planning, Project Management, and Enterprise Architecture (EA) to each project team
• Developed and drafted an FDA Earned Value Management (EVM) Policy

The second phase was to refine the processes developed using lessons learned specifically at the FDA and educate/mentor staff within the IT organization through training. 

• ITSolutions developed a Process Asset Library (PAL) to enable the FDA to collaborate while developing policy and procedures.  ITSolutions researched, developed and obtained approval for each of the FDA IT PMO project processes and templates.  The PAL contained the documentation for the IT Governance Framework, best practice information, and project archives accessible by all project and investment managers.   
• The training and mentoring included: deploying a formal project management training program; providing all graduates with a Project Management Master's Certificate from George Washington University; organizing the IT Project Management Steering Committee; one-on-one mentoring with project managers (PM's); facilitating and coaching lessons learned sessions for center projects; and holding monthly Brown Bag sessions to provide an informal environment for project specific questions and answers.

Phase three is ongoing and consists of an internal assessment leveraging the successes, reflecting the total IT portfolio, providing support and guidance for FDA’s overall project management structure, cultivating informal relationships with Agency Centers, the implementation of the Stage Gate Process, and providing tools to complete the implementation of EVM.

The benefits from developing an IT Capital Investment Management Process have been vast at the FDA. There are now over 200 certified PM's, one-third of whom have their Project Management Professional (PMP) certification. The PM's have repeatable processes to follow, and technology enablers have matured the process capability, including ProSight Portfolio Management Tool. Processes were integrated across EA, Capital Planning, and Project Management to improve project performance, promote information reuse, improve data integrity, and reduce data entry.

The FDA was recognized by the PMO Executive Board, a subsidiary of Corporate Executive Board.  A case study, "End-to-End Portfolio Documentation Control," was prepared and shared with the membership. The case study was highlighted in a best practice teleconference on March 23, 2006.  PMO Executive Board titled the teleconference, “Experience Using Portfolio Management Software Tools.”  The ITSolutions on-site team is the subject matter expert and administrator of the ProSight Software tool.