2008-03-10_GENERAL DOCUMENTS - M1977247

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r ACZ Laboratories, Inc. August 10, 2007 Quality Assurance Plan Version 12 SOPAD018.08.07.12 Page 26 of 96 5.9 A thorough review of the raw data is performed as part of initial method training and should include particular attention to details not presented in LIMS or on the final report, such as generating final sample concentration from the instrument response provided in the raw data (if applicable) and verifying correct standard and reagent traceability. 5.10 Where specified by the method or a regulating entity, and as stated in the test SOP, successful demonstration of performance such as Linear Calibration Range determination (LCR) or Method Detection Limit (MDL) study must be completed prior to independent analysis of client samples. 5.11 All initial training documentation must be submitted to the QA/QC department as a complete package. At a minimum, the package must include: r 1) Initial Method Training form (FRMQA004), signed by the trainee and instructor (or department supervisor). 2) IDOC documentation: ? Completed and signed certification statement (FRMAD023) ' ? Workgroup bench sheet, raw data, and all supporting documentation 3) If applicable, MDL study for each instrument. Complete FRMAD031 and attach all related raw data and supporting documentation. 4) If applicable, calibration range study for each instrument. Complete FRMQA029 and attach all related raw data and supporting documentation. 5.12 Following review of all pertinent training documentation, QA/QC will issue procedure-specific clearance for the trainee to independently generate and review data for client samples. This permission is tracked and may be viewed on a designated location on the public network drive. , 1) Approval for preparation procedures is granted after the instrument data has been reviewed and approved. 2) An unapproved analyst who is "shadowing" the trainer (observing, learning the organization of the lab, reagent room, etc.) may not assisting with the procedure, and the workgroup documentation must bear only the initials of the trainer, who is fully responsible for the data. 3) If the analyst has completed training for a procedure and generates client data or reviews client data prior to QA/QC approval, then any workgroup(s) or data review checklist must also bear the initials of a proficient analyst, with current approval for the method, who oversees the analyst's work for the procedure and assumes full responsibility for the data. The primary analyst must always be aware that he/she is responsible for the workgroup. The use of another employee's initials without their explicit approval is not permitted. 5.13 The supervisor is responsible for ensuring the training of each analyst is kept up-to-date. Each analyst must read, understand, and agree to follow the effective version of the SOP and continued proficiency must be demonstrated and documented annually for each analyst. 5.14 Each production supervisor routinely conducts department meetings to discuss procedures, work schedules, resources, questions and concerns, problems, QA/QC, etc. , 2773 Downhill Drive 970-879-6590 Steamboat Springs, CO 80487 www.acz.com '