Quality Assurance

MRIGlobal’s policy is to meet or exceed client expectations. We listen to our clients and translate their needs into action. We continually improve our skills and processes in order to ensure excellence and efficiency in our work and to achieve sustainable growth. We nurture spirited interaction and open-mindedness in our search for new and better ways to solve client problems. Honesty and good judgment are imperative in our interactions with our clients and each other.

MRIGlobal’s quality system consists of its organizational structure policies, procedures, processes, and resources needed to implement and continuously improve quality management in its technical and business operations. Details on the operation of the quality system are given in the MRIGlobal Quality Manual. The goal of MRIGlobal’s quality system is to meet or exceed client expectations while increasing our competence, size, and financial viability. MRIGlobal’s Kansas City and National Capital Region facilities are ISO 9001:2008 certified, and the Florida Division facility is ISO 17025 certified, indicating that the quality management system meets specific requirements that demonstrate MRIGlobal’s ability to consistently provide products and services that meet client and applicable regulatory requirements.

Executive management has designated and appointed at each facility an MRIGlobal ISO Management Representative who has the authority to ensure that the quality system is maintained. The management representative reports on the performance of the quality system to executive management for its review. Management is responsible for ensuring the effectiveness of the quality system and for the continual improvement in MRIGlobal’s operation.

MRIGlobal’s Quality and Regulatory Systems operates independently of MRIGlobal’s technical divisions, reporting directly to the Senior Vice President and Director of Technical Operations. The Quality Assurance Unit (part of Quality and Regulatory Systems) assists technical management in ensuring that the work performed by the technical staff meets MRIGlobal quality requirements as well as client requirements and those of applicable government regulatory groups. This endeavor is principally done by internal and external audits, both announced and unannounced; review of project work; review of MRIGlobal SOPs and other quality documents; and staff training in quality control and quality assurance.

Corporate management has overall responsibility for quality assurance at MRIGlobal. Corporate management reviews and resolves QA problems reported by division or project management or the QA Unit.

Division management is responsible for all QA aspects of projects conducted within the division. It has the authority to override project management and review project QA plans, protocols, and reports to ensure that client and QA requirements have been addressed. It can review project status reports and QA audit reports and ensure that appropriate corrective actions have been taken. Division management reports to corporate management any problems that cannot be resolved at the division level.

Project management is responsible for conducting work in accordance with the QA requirements and has authority over staff and supervisors on QA matters. Project managers coordinate the development of the project QA plan, ensuring that project QA requirements are addressed. They report project status, problems, and corrective actions as required by the contract, division QA plan, or project QA plan, and review work products to ensure that QA goals were met. Project managers ensure that staff is trained for the required work and that the training is documented.

Project staff and supervisors are responsible for conducting work in accordance with division and project QA requirements. They may request information and help in problem resolution from project or division management and the QA Unit. They are responsible for following division and QA plans and SOPs and for reporting QA problems immediately to project management, the QA Unit, and any project-designated auditor. Project staff help resolve problems as they are identified.

Project Management

Project management at MRIGlobal encompasses processes to provide clear and thorough communications with clients, perform balanced responses to cost and schedule demands, and deliver exceptional products and services. Our proven methods and skills are the result of more than 65 years of success and continuous improvements. Over the past three years, MRIGlobal has applied these tools to successfully manage more than $1.1 billion of client services for research and development, management, and operations. MRIGlobal currently employs over 20 PMP certified staff, with additional staff obtaining certification each year.

Structured project management disciplines at MRIGlobal encompass all tasks required to initiate, plan, execute, control, and close projects. The specific steps include: defining key stakeholders, project scope, and a work breakdown structure (WBS); assigning and loading resources to scheduled tasks; and managing changes to scope, costs, and schedules. Particular outputs include the project execution plan, (integrated) master schedule or IMS, WBS, staffing plan, risk management plan, and earned value measurements.

MRIGlobal lays the groundwork for successful projects by developing an initial WBS for every proposed project assignment. Upon award of new contract work, the project manager and principal investigator will apply the client-accepted proposal and associated statement of work to create the project execution plan. Generally this plan includes an expanded WBS; detailed resource-loaded master schedule; definitions of all milestones and deliverables; description of steps to execute each scope element; a review of risks; and the methods to manage safety, security, and quality outcomes. Whenever changes affect project-staffing assignments, the project manager re-negotiates staff commitments to ensure the work is completed as defined.

MRIGlobal uses clear objectives, milestones, and specific deliverables to govern project management. The client, the project team and other critical stakeholders agree on measurable performance parameters. We maintain the successful client relationship by clearly translating requirements into objectives, engaging client approval of original and updated plans, and accurately reporting progress.

Our project management is a powerful assurance that work will be completed on-time and on-budget. Complex work with challenging goals and aggressive targets can increase the risk for delays and cost overruns. To mitigate this risk, we regularly communicate with project team members–including subcontractors and client contacts. During project meetings, we review the financial status and earned value metrics as forms of leading indicators. We initiate preventative and corrective actions by early detection of deviations between progress and targets and by control gate decisions between project phases.

Risk management steps encompass several components, and the approach applied will be proportional to the complexity of assignments. Risk subjects may include technology challenges, schedule and cost demands, systems engineering, Earned Value Management, logistics, quality, and safety. We understand and reduce risks to acceptable levels of probability and of impact by using technology tradeoff analyses and mitigation steps.

MRIGlobal prepares periodic reports to communicate the status of work performed, associated costs, significant accomplishments, and measures taken to eliminate obstacles that influence technical, schedule, and cost performance. Accurate and thorough reports will clearly indicate progress toward contract deliverables and avoid unexpected conditions.