Project planning is not only the first step in managing a new project, but a continual process. To successfully plan a project, there are 8 critical plans/processes that must be completed to ensure proper steps are executed during the project’s development phase. When questioning the value of project planning, consider the following questions:

• Does project planning guarantee success?
• What successful projects have I worked on without a plan?
• What are the key reasons plans fail?
• Would you enter the world’s tallest building knowing there was no architectural plan prior to its construction?

Projects fail for several reasons, including:

• Lack of planning
• Unreliable estimates
• Poor requirements
• Poor change control
• Weak management
• Lack of defined processes
• Lack of risk management
• Insufficient resources
• Unclear objectives
• Lack of documentation
• Scope creep
• Over-allocated resources
• Lack of monitoring and control
• Company culture / politics
• Poor communication
• Stakeholder conflicts

Creating plans and processes for reference throughout the product development life cycle can save time and money in the long run often lessening, even eliminating, project rework. Planning up-front provides project stakeholders with a clear plan on where you will be at each stage of development, and the dates associated with each delivery.

Master Project Plan
Within the master project plan, several items must be defined. First, define and describe the plan’s components, approval process, product components, and goals and objectives. Establish a project management process in which outlines management and stakeholder responsibilities, a comprehensive project schedule and maintenance, and communications and reporting protocols. Additionally, define configuration management, standards requirements, change management, problem reporting, and goals for project completion. Establishing this process from the start will ensure all stakeholders are on the same page.

Risk Management Plan & Mitigation Report
Defining a risk management plan includes a few essential pieces: management procedures, roles + responsibilities, identification + analysis, and risk planning, monitoring, control, and reporting. Analysis early-on is critical as risks and hazards to end-users and users in development as well as those validating the device during clinical trials must be evaluated. To mitigate potential risk occurrence, a risk mitigation report should be developed. Developing a report that brings attention to various options and actions to reduce risk allows project stakeholders to identify potential root causes, assess and prioritize, and implement a sound plan for mitigation.

Product / Software Requirements
To create requirements that accurately define the product’s needs, closely consider what the project’s goals are versus the product’s requirements. There is a difference!  A product that was developed with a dedicated requirement process will reap many added benefits. Products with well-written requirements will have fewer defects and cleaner designs. Identifying essential requirements from the start of the project will significantly reduce project rework and mitigate technical risks prior to the product’s release. As the project successfully passes through each state of the product development life cycle, the overall cost will be reduced and the product’s speed to market will greatly increase..

Project Schedule and Budget
Project managers can build an appropriate budget for each phase of the project once resources are defined. Start by creating a work breakdown structure (WBS) to accurately define your product, for example: system startup & shutdown, system protection & security, user interface, control system, algorithms & formulas, communications, external interfaces, configuration, data & databases, and performance. Once the WBS is complete, work to establish a project scope and traceability. Traceability will be important throughout the project, allowing any stakeholder to quickly determine where a requirement originated, and what testing was performed. It can identify what document, software version, and test equipment was utilized, as well as the test’s result. Ultimately, traceability provides a means of accountability for all stakeholders.

Quality Assurance Plan
Quality assurance is a major part of the product development process, especially when engineering a mission- or safety-critical embedded system. Within the quality assurance plan, management procedures must be defined as it relates to configuration management, change control, and problem reporting. Outlining a plan to design and develop the system to various high-quality standards, whether that be FDA 510(k) for medical devices, MILSPEC for military systems, or ISO 9001 for industrial control systems, a quality plan and review process is a must. To create a solid quality control process, several key items must be included. Identifying the roles that each stakeholder will play as they relate to risk and quality management is the first piece of a quality control process. In addition to assigning stakeholder roles, a quality control process must include resource qualifications, a method to support various test features, and design processes for verification, clinical trials, development of standards, and test processes.

Architectural Design
An architectural design can make or break the system. All the more important to create a design that demonstrates a high-level structure of the system. Developing an architectural design from the start of the project provides a more realistic way to manage risk as well as managing cost expectations by supporting design decisions early on. Laying the entire system out in front of each stakeholder encourages communication and smart choices, such as re-using pieces of the design without having to rewrite or rework areas that may duplicate throughout the project.

Development Plan
As with many of the project sub-plans and processes, the development process must also include a definition of management responsibilities as well as what development environment the system will utilize. In terms of development, a focus on documentation is highly encouraged. Creating a process surrounding development, design documents, project reporting, project management, and test documents can be extremely beneficial throughout the duration of the project. When information is requested pertaining to these subjects, the documentation can easily be located. Standard documentation processes set expectations for every phase of the project. For software-related projects, it is critical that a software development plan be completed during this planning phase. Elements of the software plan should include identification of the hardware components, any commercial off-the-shelf (COTS) products, various support systems, software under development, software of unknown pedigree (SOUP), and various simulators, installers, and downloaders to be utilized.

Master Test Plan
Constructing a testing methodology will allow the engineers a concise and speedy means of testing the system. Defining the types of testing methods and testing goals and exceptions will provide the test engineers a basis of what is expected from the test, keeping cost of testing and budget constraints in mind. Recommendations for testing should include: requirements testing, stress testing, testing unique to product, security testing, and performance testing. Thorough testing during development will reduce the time it takes to test once development is complete; therefore, increasing speed to market.

Taking the time to solidify the above plans will ensure a smooth transition from each stage of the product development process. Defining roles and processes each step of the way mitigates any risk of uncertainty. Utilizing project plans allows you to envision what can be achieved when project objectives are realized.

WHAT’S NEXT?
Stay tuned for the second part of our 9 week blog series on project management. Next week we will dive deeper into the master project plan.