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ACZ Laboratories, Inc. August 10, 2007 <br />Version 12 <br />Quality Assurance Plan <br />SOPAD018.08.07. 12 Page l9 of 96 <br />4.2 QA/QC Officer <br />The QA/QC Officer reports directly to the President; however, the QA/QC department is considered a separate <br />entity from operations in order to assure data is evaluated objectively and assessments are performed without <br />outside (i.e. managerial) influence. The QA/QC Officer has direct access to the President, and is therefore able to <br />discuss and/or resolve all concerns, policies, etc. related to quality assurance or quality control. The primary <br />responsibility of the QA/QC Officer is to develop, implement, and manage all aspects of ACZ's Quality System, <br />and he/she may take any action necessary to ensure all ACZ employees adhere to all policies, procedures, and <br />objectives documented in ACZ's QAP, SOPs, memorandums, entails, etc. If warranted, the QA/QC Officer has <br />the authority to halt the performance of a single method or the production of a department, and if necessary, the <br />operations of the entire laboratory, and will grant permission to resume when satisfied that the issue(s) have been <br />resolved. Additional responsibilities include but are not limited to those stated in FRMAD060 and the following: <br />• Review and revise ACZ's QAP and provide training for all employees following approval of a new version. <br />• Provide QA/QC orientation to new employees. <br />• Meet quarterly (or more often) with the President and Production Manager. <br />• Work with department managers to develop and improve training protocols. <br />• Conduct department training sessions as needed to address specific problems and questions. <br />• Arrange for or conduct internal audits; notify management of deficiencies; and track corrective actions. <br />1 • Organize all external audits; notify management of deficiencies; and assign and track corrective actions. <br />• Review and approve SOPs (may designate responsibilities to QA/QC Coordinator). <br />• Meet at least quarterly with Production Supervisors to provide information, respond to questions, etc. <br />• Manage Proficiency Testing (PT) program (may designate responsibilities to QA/QC Coordinator). <br />• Coordinate and maintain all regulatory and client certification programs. <br />• Review and validate a determined percentage of all data packages from Log-in to Reporting. <br />• Work with marketing/client service representatives on QA/QC aspects of proposals. <br />1 Work with Project Managers and the Production Manager to resolve client feedback regarding data quality. <br />1 • Review and maintain records and documentation for audits, certifications and all other QA/QC issues. <br />• Schedule electronic data audits with third-party. <br />Qualifications: <br />• General knowledge of the analytical test methods <br />• Documented training and/or experience in QA/QC procedures <br />. Knowledge of the Quality System as defined under NELAC <br />2773 Downhill Drive 970-879-6590 <br />Steamboat Springs, CO 80487 www.acz.conn <br />