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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.

Note: For laboratories testing samples as received, laboratories should communicate with the sample submitter to minimize factors that can contribute to sampling error.

7.3.3 (a)

Note: Whatever strategy is used for the sampling, it is vitally important that the sampler keeps a clear record of the procedures followed to the degree needed to repeat the sampling and trace the sample to the lot sampled. “If the laboratory has conducted or directed the sampling stage, it should report the procedures used and comment on any consequent limitations imposed on the results” (CITAC/Eurachem Guide to Quality in Analytical Chemistry: An Aid to Accreditation ).

7.3.3 (g)

Note: “Where more than one sample is taken from the original material it may be useful to include a diagram as part of the documentation to indicate the pattern of sampling. This will make it easier to repeat the sampling at a later date and also may assist in drawing conclusions from the test results” (CITAC/Eurachem Guide to Quality in Analytical Chemistry: An Aid to Accreditation ).

7.4

Handling of test or calibration items

7.4.1 When not specified by the customer or regulations, minimum sample retention periods shall be communicated to customers so that all parties are aware of how long the sample will be available for retesting or retrieval.

Many laboratories do not test the entire sample as received, but instead perform testing on a sub-division of a sample (i.e., sub-sample, portion, aliquot, etc.). This portion will be identified in such a way that it is unmistakably associated to the original sample.

The laboratory shall have documented procedures for sub-dividing, compositing, and/or homogenizing to ensure that a representative test portion is used for analysis.

Note: Sample identification is particularly important as a sample progresses further into the analytical process where the sample may be sub-divided or modified in some way. In such instances, additional information may be appropriate, such as references to the main sample and to any processes used to extract or sub-divide the sample. If the sample identification is irrecoverably separated from the sample, then traceability is lost. Note: Appropriate considerations should be made for multi-phase and labile samples, aseptic handling, cross- contamination, and other issues to reduce the known errors associated with sample heterogeneity . Note: There are many documents that provide guidance for sample preparation and handling by the lab such as GOOD Test Portions.

Good Samples:

https://www.aafco.org/Publications/GOODSamples

Good Test Portions:

https://www.aafco.org/Publications/GOODTestPortions

08/09/2018