Calibration in Regulated Industries: Federal Agency use of ANSI Z540.3 and ISO 17025

摘要

ANSI/NCSL Z540.3-2006 and ISO/IEC 17025:2005 are voluntary consensus standards which prescribe requirements for the calibration of measuring and test equipment and for the technical competency of the performing laboratories. Many agencies in the U.S. which are part of, or regulated by, the Federal Government are required to use instruments which have been calibrated in accordance with one or both of these standards. The National Technology and Transfer Advancement Act (NTTAA) of 1995 encourages all federal agencies to use technical standards that are developed by consensus standards bodies, in lieu of "government-unique" standards. ISO 17025 and ANSI Z540.3 have evolved over a half-century of metrological advancement, drawing upon expertise in the public and private sector. They are now supported by a mature infrastructure of third party assessment and accreditation that facilitates mutual recognition and global trade, ensuring calibrations are accepted worldwide. However, some federal agencies and regulatory bodies in the U.S. do not yet recognize these standards. Calibrations are commonly performed which may not conform to these requirements. This paper discusses the history of risk mitigation techniques applied to products and processes when declaring in-or-out of tolerance conditions. Particular focus is given to the Food and Drug Administration's (FDA) regulation of calibration requirements in the Quality System Regulation (QSR) found in Title 21 Part 820 of the Code of Federal Regulations (CFR). Currently, a paucity of official guidance exists with respect to what constitutes an acceptable calibration program in medical device and pharmaceutical industries. Ambiguities may persist due to lack of recognition of consensus standards such as ISO 17025 and Z540.3 as guidance documents. Fundamental requirements such as traceability, measurement uncertainty, measurement decision-rules, as well as basic metrological definitions are somewhat ill-defined in the CFR. The objective of this paper is to provide relevant background information and to encourage constructive dialogue between government agencies, standards writing committees, industry partners, and third party assessment/accreditation bodies. Cooperation of this type is consistent with public law and White House policy objectives. Ultimately, such dialogue may foster recognition of these voluntary consensus standards as guidance documents for calibration in regulated industries, resulting in regulatory efficiencies, improved quality, and reduced risk to consumers and patients.