You've Found The Cure For Cancer... But Can't Reproduce Your Results! Could Your Test Equipment Be The Weakest Link?

摘要

To paraphrase from a compliance guide covering Good Manufacturing Practices (GMP): "Manufacturers are responsible for ensuring the establishment of routine calibration on their test equipment so it will be suitable for its intended use". The core requirements for establishing and maintaining an in-house metrology department can be found in various regulations and recommended practice guidelines. This paper explains how the Metrology Department at Promega Corporation meets all these requirements. Topics covered include identifying test equipment, writing procedures, training technicians, recording data, traceability of measurement and standards, uncertainty budgets, and scheduling practices. Also covered are some valuable lessons learned that might help you establish, improve, or maintain a metrology program that instills confidence in your measurements, and test equipment.