OMB Winter Mtg.-February 5-6, 2015

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Draft 6. Note: This document is a draft suggestion only and is not an approved document. Please do not distribute to laboratory staff for use. additional performance checks. Examples include the consistency of retention times and resolution of analytes in a chromatographic system, the stability and linearity of a detector, and the resolution, alignment and wavelength accuracy of spectrometers. Results of these performance checks shall be documented. The frequency of such performance checks shall be specified in manuals or operating procedures based on manufacturer requirements, lab experience, equipment type, and/or previous performance of the equipment. Intervals for performance checks should be shorter than the time the equipment has been found, in practice, to take to drift outside acceptable limits. The performance checks shall be satisfactorily completed before the equipment is used. The manufacturer of the instrument may be consulted and should offer a program to ensure proper instrument performance. Many types of equipment can affect a test result and thus will require calibration or verification as well as maintenance. The laboratory shall have a plan and/or procedure for the calibration or verification and maintenance of the equipment listed in Appendix A, Table 1. Appendix A, Table 1 provides minimum requirements for the calibration and verification of critical equipment; regulations and accrediting bodies may specify additional requirements. 5.6 Measurement Traceability According to 5.6.1 and 5.6.2 of ISO/IEC 17025 and the ILAC Policy on the Traceability of Measurement Results (ILAC-P10:01/2013), if the calibration of instruments used in testing contributes significantly to the overall uncertainty of the measurement result the requirements of traceability to the International System of units should be met. Further information about meeting the requirements for traceability are available in ILAC P10 and policy documents provided by the individual accrediting bodies. If the equipment or instrument does not contribute significantly to the overall uncertainty, demonstrated by calculation of a full uncertainty budget, the traceability to the SI may not be required. Note : Depending on regulations, the frequency of verifications or calibrations may need to be increased; in these cases, laboratories shall always follow the most stringent requirements to remain in compliance with their specific programs. The following guides and policy are useful when developing and maintaining the program and procedure for establishing trace ability: EURACHEM/CITAC Guide: Traceability in Chemical Measurement—A guide to achieving comparable results in chemical measurement (2003) http://www.eurachem.org/ Meeting the traceability requirements of ISO/IEC 17025: An Analyst’s Guide, 3rd Edition ILAC-P10 International Laboratory Accreditation Cooperation (2013 ILAC) Policy on Traceability of Measurement Results, 5.6.3 Reference Standards and Reference Materials 5.6.3.1 Reference Standards Reference Standards shall be stored according to the documentation supplied, unless valid reasons exist for not doing so. Deviations from documentation should be recorded and justified appropriately. Documentation accompanying the reference standard shall be stored in the laboratory’s record management system and available at all times. Reference standards shall not be used past their expiry date without requalification demonstrating that they are still suitable for use. 5.6.3.2 Reference Materials All Reference Materials shall be labeled using an identification scheme that allows the laboratory to trace the lot of Reference Material used in any analysis. In addition, each Reference Material shall be labeled with the date received and expiration date. Upon receipt of the Reference Material, records shall also be kept to include name or description, manufacturer’s lot number, assigned laboratory number, date received, manufacturer’s expiration date if