Organizational performance depends on established operational
systems, and successful performance depends on systems that are
synergistic and function together smoothly. At Keathley and Company, we view the
organization as a whole with multiple interdependent parts, and we focus
on ensuring those parts work together as effectively as possible. Case Studies
Cybersecurity and QMS- Led improvement team to incorporate security management system into company quality management system, based on NIST Cybersecurity Framework
Quality Management System deployment, Drug Development Real World Experience (RWE) Industry- Conducted gap analysis on QMS compliance for innovative drug development company managing RWE studies
- Established QMS integration project plan after meeting with key stakeholders and reviewing QMS environment
Quality Management System deployment, Medical Device Software Industry
- Created QMS for innovative entrepreneurial company that had matured to a point where standardization was needed for efficiencies and regulatory compliance was required by primary vendor partner
- Established project plan after meeting with key stakeholders and conducting initial gap analysis
- Executed plan to satisfaction of company management and vendor partner
- Continued to maintain and improve system
- Multiple vendor partner and regulatory audits completed with minor or no findings
ISO 9001 Quality Management System implementation, Clinical Research Industry- Co-chaired ISO9001 deployment project for international clinical research organization that resulted in successful ISO registration
- Standardized processes throughout offices in multiple countries and ensured alignment and integration across all facets of clinical trial services, including:
- Clinical study start-up and documentation
- Trial execution, monitoring, and clinical data collection
- Data management
- Statistical analysis and reporting
- Safety monitoring
- Oversaw updates of company’s QMS processes to consistent format, ensured key process metrics established for all processes, developed reporting system for monitoring process performance
Performance Feedback Reporting, Baldrige Criteria
- Examiner for Baldrige Performance Excellence Program (sponsored by National Institutes for Standards and Technology, Department of Commerce)
- Participated on multiple Baldrige teams at Virginia state and national level; served as Examiner, Team Leader, Trainer, and Editor
- Evaluated organization applications against Baldrige Performance Excellence criteria
- Developed feedback reports identifying performance strengths and opportunities
- Participated on multiple site visits and feedback visits
- Reviewed applications from a variety of sectors, including healthcare, manufacturing, government/non-profit, small business, and education
Quality Control System deployment, Biopharmaceutical Manufacturing- Upgraded
and enhanced quality control system for manufacturer of bulk tissue
culture products sold to pharmaceutical companies, including:
- Development of standardized quality control procedures
- Refinement of processes for key tests, such as endotoxin detection
- Training of quality control staff
- System
met FDA GMP requirements, as evidenced by successful FDA audit, and was
developed under Corning Total Quality Management program
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