2008-03-10_GENERAL DOCUMENTS - M1977247

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ACZ Laboratories, Inc. August 10, 2007 Version 12 Quality Assurance Plan SOPAD018.08.07.12 Page 1 1 of 96 2.4.3 Electronic Data Audits Periodically ACZ hires a third parry auditing firm to perform a full level audit of analytical data, either on-site or off-site. The auditing firm provides ACZ management with a report citing the deficiencies 1 and recommendations. After review of these findings by management, the QA/QC Officer, and the production supervisor, corrective actions are initiated to ensure that any deficiencies are rectified. 2.4.4 Proficiency Testing [PT] Program ACZ is required to participate in a formal Proficiency Testing Program at the frequency stipulated by ' regulating agencies. These "performance audits" are facilitated through the introduction of blind samples, purchased from approved vendors. ACZ analyzes PT samples for most accredited parameters twice in a calendar year, with each study being approximately six (6) months apart. These tests are analyte, matrix, and technology specific, but are not method specific, and provide useful information regarding the accuracy of the analytical data being produced. ACZ participates in the Water Supply (WS) study for SDWA, the Water Pollution (WP) study for CWA, the Soil and Underground Storage Tank studies for RCRA, and Radiochemistry PT study for Drinking Water. Following log-in, the PT sample is prepared by the analyst according to the vendor's instructions and is then analyzed in the same manner as client samples as described by the test SOP. NOTE: Analysts must record the date of preparation (and time of preparation if the holding time is < 72 hours) on the subsample container and on the associated workgroup bench sheet(s). Analysis must be performed as soon as possible after diluting the concentrate, as indicated in the vendor's instruction pamphlet. Metals analyses must be completed within 48 hours of diluting the concentrate, as indicated in ACZ CAR519. Data is compiled by the QA/QC department and reported to the vendor no later than the study close date. The vendor evaluates the data as "acceptable," "not acceptable," or "check for error" by comparing the reported values to statistically derived acceptance criteria and issues a report within 21 days from the study close date. Upon receipt of the report, the QA/QC department initiates a major corrective action for the PT study if any "not acceptable" results were reported. Each production supervisor must investigate all "not acceptable" results for their department, indicate possible causes and determine the appropriate corrective action(s) by the designated due date. If necessary, the QA/QC department will order follow-up samples to confirm the system deficiency has been corrected. Refer to ACZ's SOP ' Proficiency Testing Program (SOPADO11) for additional information. Strict rules apply regarding the exchange of information for any PT sample: ' ACZ shall not send any PT sample, or a portion of a PT sample for accrediting purposes to another laboratory for any analysis. ' ACZ shall not knowingly accept any PT sample or a portion of a PT sample for accrediting purposes from any other laboratory. ¦ Employees of ACZ shall not discuss PT data results with any other person outside of the ' laboratory, in particular any person associated with another laboratory. ¦ Employees of ACZ shall not attempt to obtain the results or assigned values of any PT sample ' from our PT Provider prior to the close of the study. 2773 Downhill Drive 970-879-6590 Steamboat Springs, CO 80487 www.acz.com ? 11