Project Management: The Key to Successful FDA Remediation Activities

Most medical device companies have been in this position. The U.S. Food and Drug Administration (FDA) has spent days—in some cases weeks—on site at your organization conducting an audit. When they exit, they leave you with some “thoughts” in a form 483, which is what the agency uses to document its view of non-compliance with Current Good Manufacturing Practices regulations. In some cases, the fixes to address those observations are simple; in others, the solutions are more complex and require time, resources and detailed planning to execute.

Enter project management. Methodology and tools associated with succinct project management phases can be of great value to organizations—particularly those whose FDA remediation activities span departments, divisions, and/or international boundaries and require resources representing various levels and disciplines within the organization.

Fundamentally, project management is accomplished in five distinct phases: initiation, planning, execution, monitoring and control, and close. The project management body of knowledge (PMBOK)

provides a collection of internationally recognized processes, practices, tools and knowledge, including:

1. Project Charter. Once the project manager and team resources have been identified, it’s critical to complete the project charter. The charter is the team’s definition and documentation of the scope, objectives, timing, resources, identified stakeholders and associated risk for the project. The benefit of developing a charter at a project’s onset is that it can serve as the team’s reference point for defining project status, avoiding “scope creep,” and ensuring that all stakeholders in the process or project appropriately are considered throughout the course of the project. Most importantly, the charter helps to keep the team focused on the end result.

2. Work Breakdown Structure. The work breakdown structure (WBS) is a key project tool that organizes all of the project team’s work into manageable segments. PMBOK defines the WBS as a “deliverable oriented hierarchical decomposition of the work to be executed by the project team. Simply put, it helps the team to organize and describe the work required so that the team knows exactly what needs to be done to complete the project. It also facilitates easier management and control of the scope of work for the project. The WBS is intended to be hierarchical and define the “parent/child” or task/sub-task relationships of the work.

3. Project Schedule. The project schedule generally is used to assign resources and timing to the tasks identified in the WBS. This ensures that the team understands the overall timing allotted for each task or groups of tasks and the resources necessary to complete the tasks.

When developing the project schedule, it’s critical to apply realistic considerations to the timing for the tasks based on the nature of the tasks and the resources available to complete them. It’s also critical to determine predecessors (what tasks must be completed before) and successors (tasks that can’t start until after) to each task. The critical path of the task(s) also must be considered, meaning which tasks, if they fall behind, are critical to the completion of the project on time and on budget. The easiest way to do this is to consider the “float” or flexibility of the tasks relative to the completion timing and duration. Some tasks will have flexibility in their completion dates, while others will have “zero float”—meaning they’re the critical path tasks.

There are several tools available to assist with project schedule development,including those that (1) allow for allocation of resources in days, weeks and hours; (2) define associated costs; and (3) provide multiple views of the project status. These may be very helpful in creating a project schedule, especially for those projects that have considerable complexity. With the ability to show various views of the project status, more sophisticated tools also can minimize the time involved in preparing project status summaries and reporting.

Managing an organization-wide project with a high level of complexity can be an overwhelming task. Taking advantage of the PMBOK can help. Spending time at the beginning of the project to consider and document all of the key elements can promote better communication, ensure better control over physical, financial, and human resources, and provide what we all desire: a successful outcome.

Laurie Solotorow is a senior consultant with the Operations and Supply Chain Management Consulting Practice of Plante Moran, where she supports clients in the development of quality management systems. Laurie specializes in quality systems design and implementation, advanced product quality planning, just-in-time manufacturing, team problem solving and quality management system training. Plante Moran is one of the nation’s largest accounting and business advisory firms, providing clients with financial, human capital, operations improvement, strategic planning, and technology selection and implementation services.