Quality Management Office Introduction Briefing Mr. Kelly E. Garrett Director, Quality Management Office

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Quality Management Office Introduction Briefing Mr. Kelly E. Garrett Director, Quality Management Office 2011 UNCLASSIFIED

PURPOSE: To inform and educate our partners about the role of the Quality Management Office. 1. Overview 2. Quality Management 3. Strategy Deployment and Automation 4. Process Improvement/Innovation 5. Licensing Credentialing Program 6. Conclusion Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 2 of 14 10-Nov-11

What Does QMO Do? The Quality Management Office (QMO) serves as the Sponsor's and Commander's quality representative to coordinate and guide quality assurance, Food and Drug Administration (FDA) regulated compliance, strategy deployment, and business process improvement activities throughout USAMRMC and its subordinate commands. Our mission is to promote a culture of quality that enhances the USAMRMC mission. Collaborating with our partners at subordinate commands ensures success by efficiently and effectively maximizing resources. Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 3 of 14 10-Nov-11

What Does QMO Do? The Quality Management Office assures that nothing is done, or fails to be done, which will get anyone fired or sent to jail. Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 4 of 14 10-Nov-11

QMO Leadership Philosophy The role of QMO within the command is to: Inform, Educate, and Assist We need to be Consistent with our message and Persistent in our approach Communication is key Communication = Information = Knowledge = Influence Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 5 of 14 10-Nov-11

QMO Leadership Approach Stakeholder Analysis helps to: Identify Priority Targets of Influence and Influence Areas of Interest so that we may better: Solve Problems Make (& Influence) Decisions Achieve Results Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 6 of 14 10-Nov-11

QMO Current Organizational Structure USAMRMC Quality Management Office Organizational Structure DIRECTOR, QMO Mr. Kelly E. Garrett QUALITY ASSURANCE SPECIALIST/OFFICE MANAGER Ms. Elaine English QU REGULATORY AFFAIRS SCIENTIST/QA Dr. Tibor Tuzson QUALITY ASSURANCE SPECIALIST/STRATEGIC PLANNER Mr. John C. Kreitz PROCESS IMPROVEMENT SPECIALIST/LSS MBB VACANT LEAN SIX SIGMA ADMIN SUPPORT Ms. Pam Sardelis QU REGULATORY AFFAIRS SCIENTIST/QA Mr. Paul Lomax QUALITY ASSURANCE SPECIALIST/STRATEGY ANALYST Ms. Jane Wingate PROCESS IMPROVEMENT SPECIALIST/LSS BB VACANT QU REGULATORY AFFAIRS SCIENTIST/QA Ms. Cynthia Barlow TDA POSITIONS 7 Requirements MEDCOM PROPOSED TDA POSITIONS STRATEGY & INNOVATION CONTRACTOR POSITIONS Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 7 of 14 10-Nov-11

Quality Management Serve as the Sponsor s Quality Representative for FDA-regulated activities Advisor to the CG, HQ staff, and subordinate commands on quality processes Support USAMRMC Staff Assistance Visit /Organizational Inspection Program (SAV/OIP) Quality Assurance Representative on Integrated Product Teams (IPT) Proponent for USAMRMC policies and pamphlets as related to Quality in FDA-regulated activities and other areas Plan and conduct for cause and scheduled audits for FDAregulated activities and other areas Inform, educate, and assist USAMRMC subordinate commands and functional areas Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 8 of 14 10-Nov-11

Strategy Deployment and Automation Roles within HQ USAMRMC, at subordinate commands, and at OTSG/MEDCOM Strategy deployment (strategic planning and execution) Strategy automation (Strategic Management System) Organizational assessments Balanced Scorecard Institute Certified Professionals Strategy Deployment and Automation workshops SMS training and helpdesk support Interactive Customer Evaluation (ICE) Strategic performance reporting Strategic human capital management Sustainability Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 9 of 14 10-Nov-11

Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 10 of 14 10-Nov-11

Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 11 of 14 10-Nov-11

Process Improvement/Innovation Serve as the USAMRMC Deployment Director Office for Continuous Process Improvement/Lean Six Sigma (LSS) Synchronize process improvement efforts with Strategy Deployment and Balanced Score Card Support process improvement efforts throughout USAMRMC utilizing LSS methodology for Rapid Improvement Events (RIE) Facilitate Quick Wins throughout USAMRMC by assisting subordinate command with process improvement events Mentor LSS Green Belt and Black Belt Candidates Conduct LSS Yellow Belt training for team members Regularly report LSS project updates, training, and other accomplishments to USAMRMC Executive Steering Committee and Commanding General Report LSS Deployment Progress to MEDCOM via Balance Score Card Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 12 of 14 10-Nov-11

Licensing & Credentialing Program QMO manages the Licensing & Credentialing Program at HQ USAMRMC and the subordinate commands. Army Regulation 40-68, 4-4. Professional disciplines requiring license, certification, and /or registration. The following health care providers/professionals must possess and maintain a current, active, valid and unrestricted license from a U.S. jurisdiction before practicing independently within the defined scope of practice their specialty (list not all inclusive): APRNs, audiologist, behavioral health practitioners, chiropractors, clinical pharmacists, clinical psychologist, clinical social workers, counseling psychologist, dental hygienists, dentists, dietitians, occupational therapists (OTs), optometrists, physical therapist, PA, physicians, podiatrists, practical/vocational nurses, psychological associates, registered nurses, substance abuse counselors, and speech pathologist. Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 13 of 14 10-Nov-11

CONCLUSION The goal of the Quality Management Office is to earn your trust and respect through collaboration. Kelly E. Garrett/MCMR-QM/(301)619-8088(DSN 343) / kelly.e.garrett@us.army.mil UNCLASSIFIED Slide 14 of 14 10-Nov-11