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Session Topic: 1A, Quality Management

   

Paper Title: You’ve Found The Cure For Cancer…But Can't Reproduce Your Results! Could Your Test Equipment Be the Weakest Link?

   

Date & Time: MONDAY, August 5, 2002

 

10:45am - 12:15pm PARALLEL SESSIONS - SESSION 1

   

Speaker: Jay L. Bucher Promega Corporation

Email: jbucher@promega.com

   

Most in the Metrology community are familiar with calibration laboratories, and how they function and operate. What about companies that want to meet Good Manufacturing Practices (GMP) or the International Organization for Standardization (ISO) requirements, manufacture products worldwide, or are trying to find the cure for cancer? How can they guarantee their products and/or results are reproducible, at home or abroad, without sending all their test equipment off-site for calibration? To paraphrase from a compliance guide covering GMP: "Manufacturers are responsible for ensuring the establishment of routine calibration on their test equipment so it will be suitable for its intended use". Not only is this true for GMP, but also ISO, and any manufacturer or research facility requiring reproducible results or products. The core requirements for establishing and maintaining an in-house metrology department can be found in various regulations and recommended practice guidelines. Putting these requirements and recommendations into a useable, viable calibration program that meets your individual needs, while being fiscally responsible, can be a daunting task. This paper explains how the Metrology Department at Promega Corporation, a biotechnology company, 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.

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