Quality Assurance

OpTech recognizes that Quality is achieved by maintaining repeatable, scheduled, documented, and managed processes and by properly managing and assigning responsibility and oversight. Adherence to these standards is managed via the OpTech Project Management Office methodology, a blending of best practices taken from CMMi, ITIL and PMI methodologies, which are currently applied to both Federal and Commercial projects globally.

Process Overview

The project management methodology adopted by the OpTech PMO should be followed for every project managed through this department. Some smaller projects may be managed by Project Leaders, but a Project Manager should always be assigned to assist and support the Project leader as needed.

Each project will be managed through the phases of the project, from Initiating through Planning, Executing and Controlling to Closing. The amount of time spent on each phase will vary based on the size and complexity of the project. If the project involves a clinical system purchased from a vendor, IV&V needs to be involved. Other projects may involve IV&V as needed.

PMO Roles and Responsibilities

Director PMO

Provides leadership, direction and support for all projects ensuring they have clear goals, objectives, timelines and measurable milestones. The Director oversees the development and management of the Project Office as well as the education, coaching and mentoring of all staff related to project management. The Director provides a regular status update for all ongoing projects to the CIO. This person may also assume the Project Manager or Project Team Leader role on projects.

Project Manager

Manages cross functional teams responsible for delivering defined project outputs on time, within budget and with quality results. Responsible for all project related activities as identified below in Initiating, Planning, Executing and Controlling and Closing phases. Ensures all project documentation is completed.

Project Leader

Leads a sub-project group and represents the team within the larger project. Responsible for all project related activities, as identified below, for their portion of the larger project. Ensures all project documentation is completed for their portion of the larger project. This person may also assume the Project Manager role on smaller projects.

Project Budget Coordinator

Tracks project performance against budgets, plans and schedules. Maintains accurate records of committed, expensed and forecast costs and monitors project costs and EVM measurements.

Project Planner/Scheduler

Works with Project Managers and Project Leaders to develop and manage all project plans, schedules and resource forecasts. Prepares and keeps the master project plan.

IV&V

Works with Project Managers and Project Leaders to assess, identify, monitor and/or mitigate project risks, and review deliverables, throughout the project lifecycle.

Project Office Administrator

Provides supports to the Project Office staff. Assists with meeting planning, documentation and communication related to projects. This person maintains the repository of all project historical documents.

Contract Officer

Responsible for all contract negotiation and coordination along with all contract documentation.

Business Analyst

Develops business needs, requirements and business cases for all projects assigned.

Systems Analyst

Develops technical requirements and supports the information systems used by the project management staff.

Project Management Process

Initiation

It is important to have a project manager identified as early as possible once the project is identified. During the initiation phase, the Project Manager should do the following:

Determine the business need for the project
Determine goals and objectives of the project
Determine the high level deliverables
Determine any constraints and assumptions
Review any historical information
Determine high level resource needs
Identify IV&V resource for project, if appropriate
Create the Business Requirements, if new development (template available)

Once the project requirements are defined, you move on to the planning phase of the process.

Planning

In the planning phase, the project continues to be defined including what work needs to be completed, when and by whom. During the planning phase, the Project Manager should do the following;

Create the Project Scope document (template available)
Create Technical Requirements, if new development (template available)
Document any changes in workflow that will be a result of this project
Create the Project plan, including tasks, duration, work effort, dates and resources
Identify and document any risks, begin documenting mitigation strategies
Complete the Roles and Communication document (template available)
Complete the Communication Plan document (template available)
Complete IV&V Expectations document, if necessary (template available)

The project scope document may include the risks identified as well as known mitigation strategies for smaller projects. For larger projects, the risk plan may be a separate document. A Scope document is to be completed for every project. The Scope document, Project plan, Risk plan and Communication plan should be reviewed with, and signed off by, the Project Sponsors. Project Sponsors include the CIO along with the senior representative from the customer’s department or institute. At the end of the planning phase, a project kick-off meeting is held with all stakeholders to review the approved Scope and plans for the project.

Execution and Control

The project work begins right after the kick-off meeting at the end of the planning phase. The Executing and Controlling phases are done concurrently. The Project Manager’s role during these two phases is to keep the project on task and moving towards an on-time completion. The executing phase relates to completing the tasks on the project plan, identifying any requested changes and sharing of information. The controlling phase relates to the management of risks, changes, schedule and ensuring compliance to all plans. During these phases, the Project Manager should do the following;

Manage any issues as well as track their resolution (template available)
Facilitate regular status meetings including documentation of minutes (template available)
Prepare and send regular status reports to the Director PMO (template available)
Manage any requested changes to scope or requirements according to the documented Project Change Management process
Provide weekly project plan updates to the Project Planner/Scheduler
Monitor any risks identified and update the Risk plan as needed with new risks or mitigation strategies
Monitor resource allocation
Escalate any unresolved issues to the Director PMO

The project remains in this phase until all project work is complete.

Closure

This is the final phase of a project where all documentation is finalized and archived. The Project Manager should do the following;

Create the Project Completion document (template available)
Facilitate the documentation of lessons learned, include all team members
Archive all project documentation, at a minimum include initial and final project plans, scope document, risk plan, communication plan, roles and contact document, completion document and lessons learned document

The Project Completion document should be should be reviewed with, and signed off by, the Project Sponsors. Once all documents are archived, the project is officially completed.

Glossary

IV&V Independent Verification and Validation – An independent entity that verified appropriate processes have been followed and ensures that the product, or service, complied with the contractual requirements. IV&V provides objective assessment that requirements are accurate, complete, consistent and testable. They work with the PM to assess, identify, monitor and mitigate project risks and review project deliverables.

PMO Project Management Office – A formal structure that supports project management within an organization. It provides policies, methodologies and templates for managing projects within the organization. It also provides support and guidance to others on how to manage projects, training others in project management.

Project Sponsor This is the person, or people, who have the authority to approve the scope and completion documents and have ownership for the project. This is the CIO for technology projects and also includes the business owner, from a department or institute, for whom the project is being done.

Project Stakeholders

This is someone whose interests may be positively or negatively impacted by the project such as the project manager, sponsor, project team and representatives of the end users.

Please contact OpTech for details on how OpTech institutes a specific quality assurance PMO for each task order and on key components of OpTech’s Quality Assurance approach.