Fifteen Concepts for Improving Project Management

PRODUCT DEVELOPMENT INSIGHT

Your team starts a project that has five key milestones. Things are going great as the team completes the first three milestones on time. Then, without much advance notice, the team completely misses the fourth and fifth milestones' deadlines. The overall timeline, budget, and end goal for the project are not met. How did this happen? According to the Gartner Group, “A full 66% of large-scale projects fail to achieve their stated business objectives, are delivered late, or are substantially over budget.” The reason is that many projects are executed in a linear fashion when, in fact, nonlinear, asymmetric execution is required in order to succeed.¹

The linear project management approach is most likely a by-product of the command-and-control business model that was put in place during the industrial revolution. One major tenet of this model is the assumption that you can treat human resources as interchangeable, with each producing a constant output over time. For example, a person working on a production line can make three widgets in an hour. Therefore, he or she will make 12 widgets in four hours and 24 widgets in eight hours. It is further assumed that another person can produce the widget just as effectively as the first person and that two resources (people) will produce 48 widgets in eight hours. The application of this linear logic in the business and project management domains is flawed. Yes, to some extent it is feasible to make general extrapolations to determine how much work can be completed over the duration of a project based on what can be completed by a single resource in a unit of time. But the key error in this thinking is the attempt to also execute a project in a linear fashion without taking into account the project's complexity.

For example, let's say that in order to roll out a quality system at a medical device company, 20 procedures must be created. It is estimated that, on average, one procedure can be completed every two days and, therefore, the project can be completed in 40 days. Starting on day one, one procedure is developed every two days. Things go well until Day 30, when the 15 completed procedures can be reviewed collectively. Although each procedure is adequate independently, there are inconsistencies in common content and the documents are not properly integrated (e.g., the trigger for retraining does not take into account the document approval and release process). The documentation set is not cohesive, and changes must be made.

The updates are made to the procedures to bring them into alignment, but the target project completion date is missed and the budget is exceeded because of the required rework activities. This project failed because the approach to execution was purely tactical. It was executed linearly and didn't adequately account for the documents' interdependencies.

Assume instead that the project manager had spent several days extensively planning the project, assessing how the documents would fit together, and identifying the elements of commonality, points of integration, and potential hurdles to surmount. The project manager created relational diagrams for the documents, and built out templates. By developing this type of strategic overlay for the execution of the project, the tactical steps in the project can be performed more efficiently and more effectively. Such a leveraged approach could allow for the completion of the procedures in one and one-half days on average, which would bring the tactical project execution time to 30 days total and therefore allow for up to 10 days of strategic planning and management. The result is a better overall outcome—higher-quality work outputs and on-time project completion. However, to achieve such improvements, it is critical to understand the key elements of a strategic project. This article describes 14 critical steps to avoiding the problems outlined above.

Concept 1: Own It

First and foremost, the project needs a true owner. One of the most common problems with failed projects is that there is no clear project owner. Not to be confused with the project champion (the person who wants to see the project completed), the project owner is the one person who is ultimately responsible for the success or failure of the project. Often there are multiple functional groups that contribute to a project, and this situation can cloud the lines of ownership. Whether unintentional or by design, the lack of a clear project owner is the single biggest reason that projects fail. As described below, be sure to create an owner in each identified subproject. Top-level project ownership is the most critical.

Concept 2: Identify Project Genus and Species

What type of project do you have? Projects vary from the simple to the ultracomplex. In general, complexity is added as the volume of work increases, the variety of work increases, the disparity in the variety of work increases, oversight resources increase, and project resources (i.e., time, people, money) decrease. The more complex a project is, the more dependencies it will have and the more likely it is that unforeseen hurdles will be presented. For example, a simple project would be validation of a simple off-the-shelf software system. By contrast, a complex project would entail design, development, approval, and production of an integrated system of medical devices (e.g., a cardiovascular perfusion system). The project timeline should take into account the loss of efficiencies and increase in project management time as complexity increases, as well as the increased likelihood of the unforeseen. My experience is that timelines for highly complex projects may require up to twice as many hours as those for projects where each activity is separately estimated and then all estimates are summed.

An assessment of the type of project will help determine the extent of planning required as well as the content of the project plan. A project plan for a simple project could be a one-page document that calls out the objectives, deliverables, resources, and timeline. A complex project could have a detailed plan, including Gantt charts for project execution timeline and spreadsheets for cost estimating, as well as dedicated plans for project phases such as development, test, approvals, etc.

Concept 3: Create a Project Plan

A project plan should be used to set expectations. It should communicate the following points:

A project plan should focus on answering this question: “Is the timeline feasible given the objectives to be met and the resources available?” The plan should be as detailed and granular as is necessary to help identify major challenges that could significantly affect the project timeline before project execution begins. The plan can also help identify areas in which efficiencies can be realized. An efficiency is where you can leverage work in one area toward completion of work in another (i.e., it takes less time to complete Step Z because you completed Step A. An efficiency could be realized in the form of templates. For example, if you have to validate five similar systems, focus on the first system and solidify the approach and deliverables. Then, replicate the approach for the remaining four systems. This process avoids addressing the same problems five times in parallel and can create significant efficiency and improve consistency and quality of deliverables. An efficiency can also be realized if you don't have to create content from scratch. If you spend time thoroughly describing a project, its importance, and why it is being executed during planning, this content can often be used in an associated regulatory submission or communication.

Strategic thinking in this vein is especially important when a project timeline is tight. Because of time pressure, the impulse is to want to begin work as soon as possible. However, a little extra effort spent on planning can help identify areas where resources can be leveraged. The plan should be sized appropriately for the project: a simple project should have a basic plan, and a complex project requires more detail. After the project plan is approved, it should only need to be updated if a major shift in scope or resource availability occurs. The associated timeline should require only minimal updates. If there are no major changes to the project, periodic checks against and updates to the project timeline should be sufficient.

Concept 4: Identify the Critical Constraints

Critical constraints are those activities that will serve as a gating factor during the execution of the project.² They have the potential to stall both the completion of the project phases and progress of adjacent activities. Critical constraints occur in areas where there are heavy workloads, where the timeline is long and can't be reduced simply by adding additional resources, or where multiple resource groups are involved in the activity. Critical constraints merit significantly more attention during the course of the project so that they are addressed before they adversely affect the project outcome. For example, a manufacturer may perform equipment operational qualifications (OQs) on a microscope measuring system, a package sealer, and a refrigerator as part of a project. The first two items involve activities that can be performed within a few hours. The refrigerator, however, requires that temperature mapping be performed over a period of 24 hours. Of the three activities, the refrigerator OQ is the critical constraint. It takes the longest and there is no opportunity to reduce the time required to complete the activity by applying additional resources.

Concept 5: Create a Strategic Overlay

If a project is executed as a series of independent tactical activities, it is lacking a strategic overlay. A strategic overlay, or framework, is created when the interrelationships of the project activities are well understood and accounted for in the execution of the project. A strategic overlay can be invisible or it can manifest in relational diagrams, process flowcharts, or textual descriptions. An overlay aligns with the goals of the project and ensures that the pieces will fit together to achieve them.

One way to create a strategic overlay is to break up the project activities into discrete modules. The modules can then be organized to demonstrate sequential dependencies, which take into account the inputs and outputs of each module. The overlay identifies leveraging opportunities and organizes resources for efficient project execution. It is customized for each project and, similar to selecting the right tool from the toolbox for a particular task, comprises the specific project management elements that are needed to complete the project per the established plan.

Concept 6: Use Resources Effectively

Successful project execution is about having the right people in the right roles at the right times. A well-functioning team is apparent when each person plays his or her role and trusts that others are playing their roles as well. Roles may be changed or swapped during the course of the project, and the transitions need to be made cleanly to avoid having multiple team members unknowingly perform redundant work. The project manager performs such coordination, including ongoing communications with the project team members and project stakeholders to ensure that resources (individuals) have the best chance of completing their assigned work.

Concept 7: Couple Authority and Accountability

Resources need both authority and accountability to be effective. Authority and accountability can be conveyed during the project in the form of work assignments. Setting expectations for what is to be completed by each given team member and then measuring performance against those expectations helps achieve accountability. Authority means providing team members with an appropriate level of autonomy to complete their assigned tasks. To determine the appropriate level for each team member, project managers must make sound initial judgments and then monitor outputs closely.

For example, a person who is new to the company and freshly out of school should be given work with a shorter completion horizon and lesser complexity than a seasoned engineer with a proven track record of success. If young engineers deliver on initial work assignments successfully, expand their autonomy by giving them larger assignments. Add autonomy incrementally until a person's appropriate level is determined.

Concept 8: Set Up the Guardrails

Project guardrails serve intertwined purposes. Picture guardrails as the bumpers that keep a car heading down the correct path. First, they set the boundaries inside which resources can act autonomously. Second, they help to prevent adverse effects on the project scope and timeline. Guardrails can be tacit or explicit. A tacit guardrail can be created by a well-defined work assignment. The work assignment for a given resource should match the worker's level of authority to enable autonomous decisions. Guardrails can be constructed for a project subteam as well.

For example, a software development project includes requirements definition, software development, system testing, and operation and maintenance. To keep it simple, assume subject matter experts are responsible for the requirements definition, developers are responsible for code creation, quality assurance is responsible for testing, and technical services is responsible for system deployment. A few examples of guardrails for the resource groups are the following:

Such guardrails are typically explicitly stated in procedures that govern the area involved.

Guardrails applied to individual people are often ad hoc and rely on the expertise of the project manager. In general, tighter guardrails are required for inexperienced or unproven resources. Keep in mind that a resource proven in one domain could be unproven in another. A technical person who is adept at troubleshooting may not be good at creating technical documentation. If this person is responsible for producing such documents, ensure the guardrail is initially tight by setting detailed expectation and by reviewing work frequently.

Guardrails can and should change during the course of the project. As a team member develops a pattern of success in a particular domain, expand the level of autonomy so that the benefits to the project can be maximized. The ideal is to have only a few guard-rails for a project and to have those rails set as far out as possible.

A project manager does not typically discuss guardrails because they are the unnoticed combination of the procedural and project management techniques employed.

Concept 9: Find the Levers

The natural progression in increasing work output is illustrated in Figure 1. Most people are intimately familiar with the first four parts of this chart. The fifth area, “Leverage the Work,” is where the greatest benefits in work output can be realized. Projects are successful when device makers can find the levers that create work multipliers. If a project involves repeating the same activities (i.e., for different product lines, different equipment lines, etc.) there is an opportunity to leverage such work. For example, rather than simultaneously deploying several resources to independently create work product for the different pieces of equipment, first perform the process for one piece of equipment (ideally the most complex). Then take those outputs and create guidelines and templates that can be followed for each of the other pieces of equipment. Although more time is spent on the initial pilot, such effort eliminates the need to address the same challenges for each piece of equipment. In addition, the process creates a more consistent set of deliverables for the overall project.

Concept 10: Manage the Configuration

Configuration management is often associated with software development activities, but it is an activity that can make or break a project. Configuration management is especially important when various resources contribute to the completion of project deliverables. Simply, it is the actions performed to ensure that project deliverables are tracked and controlled in such a way that they can be easily located, identified, and revised.

Commercial tools are available to assist with configuration management, but basic processes instituted by the project manager can also have the desired effect. For instance, during the project you want to avoid having multiple project resources updating the same document deliverable at the same time. As part of configuration management, you can phase the updates to the document so that no two resources are performing updates to it at the same time. You arrange to have Resource A update the document and then pass it to Resource B. If time constraints exist and you need to update the document more quickly, you could divide up the document into sections and ask the two resources to update only their designated sections of responsibility and track changes when doing so.

Deciding on a file naming convention can also lend to effective configuration management. For example, all project resources can agree to append a date and revision to the end of each file name, with the revision number corresponding to revisions on that particular date, e.g., “Visual Measurement System Operational Qualification 5Jul2007 R1.” If the document is updated the following day, the file name will then become “Visual Measurement System Operational Qualification 6Jul2007” and if it's modified yet again on the July 6, the file name will become “Visual Measurement System Operational Qualification 6Jul2007 R1.”

Focus configuration management efforts based on risk. Microsoft Word's “Compare and Merge Documents” functionality makes it fairly easy to identify changes made in a document. Microsoft Visio, however, has no such functionality, so it would be more time consuming to recover from a configuration management problem. Therefore, you may want to exercise tighter controls on the Visio files than on the Microsoft Word files.

Concept 11: Decouple Urgency and Importance

One of the most common mistakes made during the execution of a project is to treat important activities as though they are urgent.³ Urgency and importance should be independently evaluated, beginning with importance. An effective project plan encompasses all project activities to allow a natural, logical flow of execution. Important project activities will likely occur throughout the duration of the project in a sequential manner. An important activity could be related to the provision of the specific project deliverable. Examples include the following:

Important activities require additional attention to ensure that they are completed as planned, but project managers should avoid the tendency to allow important activities to dictate the sequence of execution of the project, especially when new important activities are identified during the course of the project.

Be sure to assess the importance of an activity independent of its delivery mechanism. For instance, if the head of a department requests that a particular activity be completed during the project, resist the urge to restructure the project in an illogical fashion so that the request of this senior individual can be satisfied as quickly as possible. Such an activity might include a request for training material—it needs to be completed, but is best created after the system design is solidified. Instead, assess where the activity to satisfy the particular request naturally slots into the established project plan. If the activity is not accounted for in the plan, determine its most logical placement objectively. Then clearly communicate with the requesting party when the activity will be completed and why the selected approach was taken.

Concept 12: Delineate Decisions

Learn to quickly differentiate critical decisions from noncritical decisions. Critical decisions are those that have a significant influence on the scope, budget, gross resource allocation, or timeline of the project. Critical decisions therefore typically have an effect on the dependencies of the project. Make noncritical decisions as quickly as possible, but take the necessary time to determine the best course of action when a difficult, critical decision must be made.

Understanding the details of a project as much as possible can help speed this decision making. Don't be afraid to delay a critical decision to conduct further research or to enable time to think through things clearly.

A critical decision for a project may be whether to make a course correction. As a project is being executed, it may become apparent that the project activity order needs to change. This may be because a critical constraint is revealed that must be slotted into the project as quickly as possible. Ideally, the project timeline and activity phasing do not need to be adjusted during a project, but don't avoid updating the project timeline in the interest of achieving intermediate milestones if it means limiting the chances of completing the project successfully. Don't hesitate to adjust milestones to accommodate new critical constraints. Remember that the end goal is the successful completion of the project, not the achievement of intermediate milestones.

Concept 13: Escalate Effectively

It is important to recognize when it is appropriate to escalate issues during a project's execution. However, it is equally important to know when not to escalate. Escalation can take multiple forms: the type of communication; the level of management; and formally updating the key metrics of the project such as timeline, budget, and resources required. Escalation is all about getting the right resources involved at the right times through the right communication channels.

If a particular project task is critical, communicate directly with the person who is assigned the task to ensure that expectations are clear. If a problem involving one person occurs but other team members could repeat it, call a team meeting to discuss the problem and how to avoid it in the future.

Concept 14: Keep It Smooth

Project managers should work to keep the project disruptions, real or perceived, to a minimum. Momentum will be lost if the project team is frequently subjected to major shifts in the scope, timeline, or method of execution. Every project will require adjustments, but not all adjustments need to send a ripple through the project team. By identifying potential hurdles, a project manager can ensure that future activities are executed as effectively as possible.

A project manager must develop ways of tracking the project that enable understanding the important elements of the project and whether the project is on schedule. However, this method should not be so complex or detailed that it requires tedious, ongoing updates to be current. Tracking serves two purposes. One, it minimizes the time spent updating the project plan. Two, it prevents the perception that the project is unstable.

Concept 15: Be Okay with Ambiguity

Complex projects will naturally introduce areas of ambiguity. When ambiguity arises, check the project plan to understand whether it can be resolved during the natural execution of the project. Ambiguity is uncomfortable, but the urge to address each unknown situation as it arises will wreak havoc on the success of a project. The key is to understand whether the ambiguity will be addressed at some time during the course of the project and then rely on this planned activity to resolve it.

It's All About Style

Every project manager has a different style. Rather than prescribe specific tools for project management, this article discusses general topics in the hope that each manager can adapt the ideas into the project management framework and tool set that works best. Incorporating such concepts into a future project may present challenges to the individuals involved in the project. If used appropriately, these tools will help a project team achieve success.

The ability to effectively execute projects is a core competency of any successful organization. A typical medical device manufacturer is involved in business-critical projects in the areas of product design and development, FDA approval, and quality system rollout . It is also continually addressing product improvements, validation, manufacturing scale-up, and supporting infrastructure. With all of these critical activities, it will clearly thrive or fail based on its ability to successfully execute projects.

Bryan Chojnowski is director of quality at Reglera Corp., an organization specializing in quality and regulatory consulting and process outsourcing. He can be reached at [email protected].

References

1. Program Management [online], private research conducted by Gartner Group (San Jose) cited [25 October 2007] available from Internet: www.gartner.com/it/products/consulting/program_mgmt.jsp.

2. J Cox and EM Goldratt, The Goal: A Process of Ongoing Improvement (Great Barrington, MA: North River Press, 1992).

3. SR Covey, Seven Habits of Highly Effective People (New York City: Free Press, 1989).

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