How Will You Manage?

Quality professionals should hone their project management skills

by Les Schnoll

While the required skill sets of quality and regulatory professionals are constantly changing, and capability upgrades must be ongoing to ensure success, it was hard to predict that branching out into project management would be the next hurdle to overcome.

In the not-too-distant past, if someone needed help managing a project, they contacted their friendly IT department and, via begging or threats, compelled them to help. Today, the response is, "I’m too busy. You’re going to have to manage your own project."

For many functions, that was a no brainer. For the quality and regulatory professional, it meant entering uncharted waters and taking on an activity about which they had no clue.

So, to assist my fellow quality professionals in tackling this project, I thought a short course—let’s call it "Project Management for Dummies"—would make their lives easier.

The basics

Let’s start with a couple of definitions. A project is "a temporary endeavor undertaken to create a unique product, service or result."1 Projects end when their objectives have been reached or the project has been terminated. Projects can be large or small and take any length of time to complete.

Among a project’s many characteristics, it:

  • Has a unique purpose.
  • Is temporary.
  • Involves uncertainty.
  • Is developed using progressive elaboration.
  • Requires resources  (often from various areas).
  • Should have a primary customer or sponsor.

Project management is defined as "the application of knowledge, skills, tools and techniques to project activities to meet project requirements."2 Advantages of a formal project management system include:

  • Better control of financial, physical and human resources.
  • Improved customer relations.
  • Shorter development times.
  • Lower costs.
  • Higher quality and increased reliability.
  • Higher profit margins.
  • Improved productivity.
  • Better internal coordination.
  • Higher worker morale.

Project managers strive to meet the triple constraint of balancing project scope, time and cost goals. They typically work with project sponsors, the project team and others involved in a project to meet project goals.

The people involved in or affected by project activities are the stakeholders:

  • The project sponsor.
  • The project manager.
  • The project team.
  • Support staff.
  • Customers.
  • Users.
  • Suppliers.
  • Opponents of the project.

Knowledge is power

The fourth edition of A Guide to the Project Management Body of Knowledge categorizes the overall project management process into nine knowledge areas that describe the key competencies project managers must develop.3 Four of the knowledge areas lead to specific project objectives:

  1. Project scope management includes the processes required to ensure the project includes the work required—and only the work required—to complete the project successfully.
  2. Project time management includes processes required to manage the timely completion of the project.
  3. Project cost management includes processes involved in estimating, budgeting and controlling costs so the project can be completed within the approved budget.
  4. Project quality management includes processes and activities of the performing organization that determine quality policies, objectives and responsibilities so the project will satisfy the needs for which it was undertaken.

Another four knowledge areas are referred to as facilitating knowledge areas and are the means through which project objectives are achieved:

  1. Project HR management includes processes that organize and manage the project team.
  2. Project communications management includes processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval and ultimate disposition of project information.
  3. Project risk management includes processes concerned with conducting risk management planning, identification, analysis, responses, and monitoring and control of a project.
  4. Project procurement management includes processes to purchase or acquire the products, services or results needed from outside the project.

The final knowledge area is one that affects and is affected by all the other areas:

  1. Project integration management includes processes and activities needed to identify, define, combine, unify and coordinate the various processes and project management activities within the project management process groups.

Figure 1 depicts the interaction among these processes. A further breakdown results in 42 discrete processes in five groups:

  1. An initiating process group includes processes performed to define a new project or new phase of an existing project by obtaining authorization to start the project or phase.
  2. A planning process group includes processes required to establish the project scope, refine the objectives and define the course of action required to attain the project objectives.
  3. An executing process group includes processes performed to complete the work defined in the project management plan to satisfy the project specifications.
  4. A monitoring and controlling process group includes processes required to track, review, and regulate the progress and performance of the project, identify any areas in which changes to the plan are required and initiate the corresponding changes.
  5. A closing process group includes processes performed to finalize all activities across all process groups to formally complete the project or phase.

Figure 1

Sharpen your skills

The complete process is too large and complex to summarize in one article, but suffice it to say that being an effective project manager doesn’t come easy and can’t be learned by reading one or two articles. Still, there are certain skills and techniques that can ensure a successful project.

Success means the project met scope, time and cost goals; satisfied the customer or sponsor; or achieved the main objective, such as making or saving a certain amount of money, providing a good return on investment or simply making the sponsors happy.

Project managers need a wide variety of skills. They should be comfortable with change, understand the organizations they work in and with, and be able to lead teams to accomplish project goals. To that end, the 10 most critical skills and competencies a project manager must have are:

  1. People skills.
  2. Leadership.
  3. Listening.
  4. Integrity, ethical behavior and consistency.
  5. Trustworthiness.
  6. Verbal communication.
  7. Team building.
  8. Conflict resolution and management.
  9. Critical thinking and problem solving.
  10. Ability to understand and balance priorities.

Different skills are needed for different situations. For example, large projects require leadership, prior experience, planning, people skills, verbal communication and team-building skills. High-uncertainty projects need risk management, expectation management, leadership, people skills and planning skills. Unique projects demand leadership, people skills, vision, self-confidence, expectations management and listening skills.

Effective project managers provide leadership by example. A leader focuses on long-term goals and big-picture objectives while inspiring people to reach those goals, while a manager deals with the day-to-day details of meeting specific goals.

Project management is rapidly becoming a required ability for quality and regulatory professionals. While mastery of the process is time-consuming, having a basic understanding of the knowledge areas and process groups will go a long way to making a positive impact on your project.

Armed with that knowledge, working on a project team and being mentored by a skilled project manager will be a rewarding experience.


  1. Project Management Institute, A Guide to the Project Management Body of Knowledge, fourth edition, 2008.
  2. Ibid.
  3. Ibid.

Les Schnoll is principal of Quality Docs LLC, which provides quality and regulatory consulting services to industries regulated by the Food and Drug Administration. He earned a doctorate in health law from Concord University School of Law. He is a senior member of ASQ and an ASQ-certified quality engineer, auditor and manager. A member of the U.S. technical advisory group to ISO 9000 technical committee 176, Schnoll wrote The Regulatory Compliance Almanac.

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