To create an enterprise project management (EPM) system to support the rigor and discipline necessary to manage over 200 Consent Decree (CD) projects across several sites. Each project’s scope and due date were submitted to the FDA and was subjected to daily fines if not delivered on time. The projects’ objectives included creating new processes for nineteen quality systems spanning key areas such as manufacturing, facilities, quality assurance, quality control, laboratories, and validation. Moreover, the massive undertaking included hiring nearly 1000 team members, 50 of them being project managers. Disparate project processes, inconsistent use of tools, and subjective reporting were not realistic options.
The projects’ fine-punishable deadlines propelled the client to create an infrastructure for project managers to plan, execute, and control the work with extraordinary precision and accuracy. A CD PMO was formed that was led by a core leadership team, with one of the key members being our PMO Lead who specializes in implementing EPM systems. During the first six months of the CD, the core leadership team developed new processes and systems, as well as hired, trained, and developed 50 project managers. These solutions included management processes, project templates, scorecards and histograms, compliance metrics, and an entire suite of management tools for risks, interdependencies, and documents, all of which resided in a centralized repository. Furthermore, the entire system was designed to be managed at the client’s home office by the PMO Lead and a local support team, without requiring the client’s enterprise IT or any external partners. During the three-year duration of the CD work, the system continued to evolve with the organization while providing the vital governance and visibility that was so desperately needed.
Even with over 200 hundred projects, every single project was completed on-time, and often months ahead of schedule. Essentially, the client was able to successfully deploy hundreds of improved processes and procedures while avoiding FDA penalties. The client’s leadership attributes the CD PMO’s systems as a significant reason for the 100% success rate. Other business units within the client’s organization have followed suit by embracing an EPM solution to be the fundamental system used to manage project work. To date, led by the same core leadership team, five additional EPM systems have spawned; each leveraging many lessons learned and best practices from the CD PMO implementation.