ASQ Phoenix January 9, 2025 Virtual Program Meeting
6:00pm – 8:00pm Phoenix (UTC: -7)
AGENDA: All times are Phoenix (MST):
6:00 pm Welcome
6:05 pm Brief Announcements
6:15 pm Guest Speaker
7:15 pm Q&A and Networking
7:45 pm Phoenix Section business
8:00 pm Adjourn
TITLE: Building Quality from Within: Our Continuous Process Improvement Journey
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Introduce the Super Office within the Center for Device and Radiological Health (CDRH) called the Office of Product Evaluation & Quality (OPEQ) and the OPEQ Quality Management (QM) Program
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Quality Challenge / Journey
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Current state of the OPEQ QM Program
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Continued normalizing after restructuring from 4 offices into 1 super office
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Continuous Process Improvement and streamlining of procedures
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Further development and monitoring of key performance metrics & initiatives
Our team is from Food and Drug Administration in the Center for Devices and Radiological Health (CDRH). Within CDRH we are a super office, formed in 2018, after combining 4 smaller offices and designed to create a Total Product Life Cycle (TPLC) culture within the center. Our team is the Quality and Analytics Staff for the super office.
The Quality Management Program within OPEQ currently oversees the continuous improvement projects, the document control, and performance monitoring for the super office programs. Our focus for this presentation will include an overview of our organization, QM function, and current efforts to work with leadership on our Organizational Excellence journey. There will be several instances shared with participants that we have encountered so far on this quality journey.
Sharing our organizational excellence journey with other organizations allows dialogue and sharing of practices to be leveraged by all in attendance.
Continuous feedback, performance monitoring, internal audits, and Lean methodologies are used to analyze our processes. We will share both quantitative and qualitative data from our continuous improvement journey.
We will provide practical takeaways to participants from lessons learned to include:
--How we drive improvement through our organization’s key performance metrics/measures for key business processes,
--How our continuous process improvement efforts help our organization engage with stakeholders and partners thus, enabling leaders and staff to take ownership of their programs and process areas; and,
--How our Quality Practitioners engage Leadership during our journey.
Speaker: Cherron “Lu” Blakely, DBA, MBA
Dr. Cherron “Lu” Blakely is a member of a senior leadership team in the Office of Product Evaluation & Quality (OPEQ), Center for Devices & Radiological Health (CDRH), Food & Drug Administration (FDA) where she leads the quality team that supports the Super Office and continues research about how leaders use QM tools and techniques to achieve business excellence. Cherron has served as a National Baldrige Examiner and is currently an Adjunct Faculty in the University of Maryland Global Campus (UMGC) MBA Program. Cherron has over 26 years of federal service which began in the United States Army. Prior to joining the FDA, she served in several positions in hospital operations, quality management, and healthcare compliance with the Veterans Health Administration in Dublin Georgia, Duluth (Atlanta), Georgia, and the VA Central Office in Washington, D.C. She also worked for several years as a Laboratory Manager in a VA medical center. Cherron has a diverse background of training including certifications as a Medical Laboratory Scientist (ASCP), Project Management, Mentor (Fellow), Quality Improvement Associate, Quality Auditor, and Lean Six Sigma Green & Black Belt training. During her military career as a Medical Service Corps Officer and Enlisted Administrative Specialist, she was awarded the Army Meritorious Service Medal (MSM), the Army Commendation Medal (4 times), and the Army Achievement Medal (4 times). Cherron has a Doctorate in Business Administration (DBA), a master’s degree in Business Administration (MBA), and a bachelor’s degree in Clinical Laboratory Science. Cherron and her husband, John, have two daughters, Brittany and Tiffany, and they reside in Howard County, Maryland.
LOCATION: via Zoom
COST: Free. Open to all.
We will be using Zoom Meeting to broadcast the January 9, 2025, ASQ Phoenix monthly Program meeting. Register in advance for this meeting:
Zoom registration link:
https://us02web.zoom.us/meeting/register/tZIod-qpqz8vEtFYBJ-Hb6hBB3gLupnqrlFg
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