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

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