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Office of Quality Management

Spotlight

Office of Quality Management's successes, showcasing its commitment to quality improvement within USAMMDA:

  • Established a centralized records system for USAMMDA personnel training regulated by the U.S. FDA, which included creating standardized training folders, developing training checklists for over 70 personnel, and reviewing the records for internal consistency and completeness.
  • Performed a risk-based internal assessment of USAMMDA's processes to identify gaps in medical product sponsor responsibilities as regulated by the U.S. FDA.
  • Finalized annual Managers' Internal Control Program (MICP) evaluations and provided USAMMDA's Annual Statement of Assurance.
  • Reinitiated the performance of internal audits to confirm compliance with USAMMDA Standard Operating Procedures, and reintegrated corrective / preventative action (CAPA) into the continuous improvement process.
  • Hosted a site qualification visit for the Bacteriophage Clinical Study conducted by Ampliphi Biosciences that qualified USAMMDA to fulfill all the requirements as outlined for the clinical trial.
  • Hosted the auditing of the Intravenous Artesunate protocol conducted by the Army Human Research Protections Office, Office of the Surgeon General.
  • Collaborated with Regulatory Submissions on a process improvement initiative that created an updated, leaner submission process.
  • Contributed to the development and implementation of process flows and quality tools.

Mission/Vision

Mission: To provide quality management support to all USAMMDA divisions, staff, and integrated product teams by functioning as an independent and objective entity that reviews and evaluates work product for the organization.

Vision: To work cross-functionally with customers to provide more efficient and effective systems that allow products to reach the Service Member more rapidly.


Office of Quality Management

Who we are:

  • Established in January of 2009, the office has developed and maintained a quality management system that services all divisions within the USAMMDA Command.
  • We facilitate the use of quality standards and tools such as document development and control, the accurate maintenance of training records for regulated activities, internal auditing, corrective action and preventive action tracking, risk analysis, process mapping, and strategy development and implementation.
  • We support the OTSG's Sponsor Representative and USAMMDA by ensuring the fulfillment of regulatory requirements and adherence to written procedures and guidelines.
  • We work closely with USAMRMC Headquarters and subordinate commands by providing technical support, regulatory training, and assisting in the development of support systems to meet our common goals.

What we provide the command:

Structure and stability -

  • We standardize the training and tracking of required personnel based on personnel roles and responsibilities.
  • We audit, identify, analyze, and recommend corrective measures to structural weaknesses to ensure adherence to policies and procedures, and to ensure continuous improvement.
  • We recommend trainings that would enhance the command's knowledge-base and reinforce established procedures.

Office of Quality Management Taskers

  • FDA Audit Management
  • Development and Management of a USAMMDA wide Quality Management System
  • Internal/External Audit Program Management
  • Corrective Action/Preventative Action (CAPA) Program Management
  • Continuous Improvement Program Management
  • Working with USAMRMC Quality Management Office, Policy Makers and Sub-Commands to Support Mission
  • Management Control Plan Program
  • Balance Scorecard
  • Operational Inspection Program/Staff Assistance Visit Management
  • Quality Support for OTSG's Sponsor Representative as requested
  • Review of Clinical Monitoring Report relating to CAPA
  • USAMMDA SOP Document Control Management
  • SOP Technical Writing/Review Support
  • Regulated and Professional Development Training Management and Support
  • Managers' Internal Control Program (MICP) evaluations
Last Modified Date: 10-Feb-2016