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1 <br />ACZ Laboratories, Inc. August 10, 2007 <br />Quality Assurance Plan Version 12 ' <br />SOPAD018.08.07.12 Page 52 of 96 <br />13 VALIDATION & REVIEW OF ANALYTICAL DATA <br />ACZ has the responsibility to always provide the best data possible to ensure our clients can make sound and <br />cost-effective decisions regarding public health and the environment. In order to generate and report reliable <br /> <br />data, the analytical systems used need to be properly functioning, and the review process must be conducted in a , <br />manner that is logical and reasonable and would be defensible if subjected to legal scrutiny. Decisions regarding <br />data quality must be meaningful and must be backed by good science and sound professional judgments. <br />' <br />The entire validation and review process encompasses more than solely evaluating the final results for client <br />and quality control samples. To this extent, the necessary steps must also be performed prior to sample <br />preparation or analysis to ensure the quality of the data. Following sample analysis, data is uploaded to the , <br />LIMS database and then submitted to a variety of process chains such as calculations, rounding, application of <br />qualifiers, etc. A multi-level data review process is utilized to verify the uploaded analytical data meets all <br />documented ACZ requirements as well as any client-specific quality objectives. For additional details of the <br /> <br />data reduction, review, and validation process, refer to ACZ's SOP Data Review Process (SOPAD032). At a ' <br />minimum, the validation process must include the following steps, as applicable: <br />• Monitor the expiration dates for all stock, intermediate, and working standards, reagents, and chemicals. , <br />• Prior to analysis, determine that holding times have not been exceeded. Unless otherwise specified by <br />the test SOP, sample preparation and analysis must be completed within the holding time. , <br />• Prior to analyzing samples, verify the correct set-up and operation of the instrument or equipment. <br />Perform calibration, maintenance, and optimization as necessary to ensure proper functioning. <br />• In general, for QC frequency of 1 per10 or less client samples, the first set of QC is associated with <br />samples 1 - 10. If there are fewer than 20 samples in the workgroup, then the remaining client samples <br />are associated with the second set of QC. <br />• Before completing workgroup creation, verify the correct PCNs and/or SCNs have been entered. <br />Percent recovery for control samples and spikes is calculated using the information in LIMS for each. <br />• Verify the proper sub-sample (green dot, yellow dot, etc.) is being used for preparation or analysis. <br />o Notify the supervisor or Production Manager as soon as possible if a sample cannot be located. ' <br />o Document on the bench sheet if a sub-sample other than the type indicated in the SOP is used. <br />• Compare the Log-In number on the sample container to the Log-In number on the bench sheet and make <br />a visible mark next to each sample on the workgroup to indicate the check has been performed. <br />• Clearly label tubes, beakers, autosampler cups, etc. to identify the sample (and dilution factor, if applicable). ' <br />• Manage sample volume to ensure all analyses from a bottle type can be completed. <br />• Document all dilution factors on the bench sheet at the time the dilution is performed. <br />• Record complete and accurate observations, as necessary, when an analysis, sample preparation, or <br />sample matrix is unusual or problematic. ' <br />2773 Downhill Drive 970-879-6590 <br />Steamboat Springs, CO 80487 www.acz.com <br />