2008-03-10_GENERAL DOCUMENTS - M1977247

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?l ACZ Laboratories, Inc. August 10, 2007 Quality Assurance Plan Version 12 SOPAD018.08.07.12 Page 25 of 96 5 TECHNICAL TRAINING Prior to the independent generation or review of data for client samples (including PT samples), all analysts must undergo a formal, documented training process. Technical personnel must be thoroughly trained in the analytical techniques and operating principles and procedures for the methods utilized by ACZ. This process includes but is not limited to: reading the associated published method, reading all related SOPS, improving laboratory skills, learning troubleshooting, maintenance, and operating procedures for pertinent equipment and 1 instruments, and creating workgroups and reviewing data through the LIMS database. It is the responsibility of the department supervisor to determine that a new analyst is properly trained, has successfully completed all initial training requirements and is prepared to commence work on client samples. Under no circumstances may any analyst independently generate client data before receiving the explicit approval of the QA/QC department. 5.1 The effective version of the test SOP provides the framework for training for all sample preparation and analysis. The SOP is typically based on published approved methodologies (EPA or other) and incorporates any necessary activities and protocols not included in the published method(s) as well as 1 requirements stipulated by other regulatory agencies. 5.2 Training for data AREV or SREV only must be documented as specified in section 2.3.6. 5.3 Each employee must be trained either by the department supervisor or by an analyst within the department who is proficient in the area of testing and has been designated by the supervisor. Anyone performing training must meet the following requirements: 1) Documentation of training on the effective version of the test SOP. 2) Documented approval for the analysis. I 3) A current IDOC or CDOC. 5.4 Initial training is documented using the Initial Method Training form (FRMQA004). Once training has been completed, the trainee and the instructor fill out the form together to ensure all pertinent information has been addressed and to ensure the trainee comprehends the material and is provided an opportunity to ask questions or request additional training. The trainee's signature is an attestation that he/she has read, understands, and agrees to always follow the effective version of the SOP. 5.5 To demonstrate an aptitude for the procedure, the analyst must perform a successful Initial Demonstration of Capability (IDOC) prior to independent preparation and/or analysis of client samples. Performance is documented using FRMAD023. The data is reviewed initially by the department supervisor and the analyst (AREV), and both individuals must initial and date the review checklist. 5.6 SREV for any preparation workgroup is performed by the department supervisor or a qualified analyst, and SREV for any analytical workgroup is performed by QA/QC. 5.7 Prior to performing an IDOL, a new analyst should be provided sufficient opportunity to practice the procedure. This confirms the analyst understands the procedure and feels comfortable performing the procedure independently. Data associated with any practice is not submitted to QA/QC. 5.8 It is not necessary for the first IDOC attempt to pass; however, the supervisor needs to review the ' analyst's techniques if multiple attempts do not pass. 2773 Downhill Drive 970-879-6590 Steamboat Springs, CO 80487 www.acz.com