Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

wash/rinse glassware. Also, mold assessments, especially in microbiology labs, can be included.

6.3.4 c) Examples include, but are not limited to, areas for reagent preparation or trace analysis instrumentation where separation is necessary to avoid system contamination.

Note: Effective separation of incompatible laboratory activities could take the form of spatial or temporal separation. 6.4 Equipment

Note: Appendix A, Table 1 provides minimum requirements for the calibration and verification of critical equipment. Regulations and accrediting bodies may specify additional requirements.

6.4.3 Reference materials shall be handled and stored according to instructions provided by material supplier/producer, unless valid reasons exist for not doing so. Deviations from these storage instructions and justification for the deviation shall be recorded. If deviations occur, ensuring quality of reference materials shall be demonstrated. Documentation accompanying the reference material shall be stored and available at all times. 6.4.4 Reagents, reagent solutions, sample solutions, and internal reference materials (including certified reference materials (CRMs) used as internal reference materials) shall not be used past their expiry date without recorded verification that they are still suitable for use. Media and CRMs cannot be used beyond their expiration date.

Note: Expired CRMs can be qualified as Reference Materials

The laboratory must define the use of the water and ensure the water is fit for that use. There are various documents that state specifications for water, such as USP, EP, the Standard Methods for the Examination of Water and Waste Water (SMEWW), and ASTM Standard D1193-06 Standard Specifications for Water .

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6.4.8 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 when the date is used for determining the expiration date. For further guidance, refer to APLAC TC012- 09/10 Guidelines for acceptability of chemical reference materials and commercial chemicals for calibration of equipment used in chemical testing .

6.4.10

Note: Intervals between intermediate checks should be shorter than the time the equipment has been found, in practice, to take to drift outside acceptable limits. Examples of intermediate checks include the consistency of retention times and resolution of analytes in a chromatographic system, the stability and linearity (when applicable) of a detector, and the resolution, alignment and wavelength accuracy of spectrometers. The manufacturer of the instrument may be consulted and should offer a program to ensure proper instrument performance.

Note: When the detector response is inherently non-linear, check the proper response of the detector.

6.5

Metrological traceability

6.5.1

Note: The following guides and policy are useful when developing and maintaining the program and procedure for establishing traceability: EURACHEM/CITAC guide Traceability in Chemical Measurement - A guide to achieving comparable results in chemical measurement , LGC guide Meeting the traceability requirements of ISO/IEC 17025: An Analyst’s Guide , and ILAC Policy on Traceability of Measurement Results .

08/09/2018