T16 (PM Only)

Healthcare Metrology Program Documentation Best Practices-An Industry Perspective

Author/Presenter: MARCUS B. MCNEELY

Courtesy of: MMc Consulting Services, Inc.

 

Abstract(s): Overviews current practices on Calibration Master Plans and Sub- Documentation

  • Quality System Inspection Technique
  • Equipment / Process Relationship
  • A Typical System Lifecycle
  • The Calibration Program
  • Calibration Master Plans
  • Equipment Categorization
  • Equipment Registration
  • Numbering and Labeling
  • Equipment IDs
  • Process Versus Calibration Limits
  • Guard banding Process Limits (graphic)
  • Calibration Frequencies
  • Calibration SOPs
  • Master History Records
  • Calibration Certificates
  • Tolerance Logs
  • Calibration Frequency Logs
  • Calibration Failures of Critical Instruments
  • OOT Impact on Business
  • Out of Tolerance Investigations Change Control SOPs