2008-03-10_GENERAL DOCUMENTS - M1977247

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ACZ Laboratories, Inc. August 10, 2007 Quality Assurance Plan Version 12 SOPAD018.08.07.12 Page 14 of 96 4) Project Manager Review: If necessary, the PM will determine whether affected data will be accepted or rejected, contact the client, and reissue a revised report if necessary. Project Manager review may not be required for every major corrective action. 5) Conduct additional training if necessary. Training must be documented using the appropriate form and must include a description provided by the person who conducts the training. All trainees are required to sign and date the form to acknowledge he/she has received training, understands the change(s) and agrees to adhere to any change(s) in a policy or procedure. 6) Revise SOP(S). Proposed revisions must be documented on the SOP Revision form (FRMQA030) and approved by QA/QC before trained personnel initial / date and implement the changes. Use FRMQA023 if the changes are incorporated into the SOP and a new effective version is issued. 7) Submit all supporting documentation to QA/QC to be attached to the hard copy of the report. 8) QA/QC reviews the corrective action. If satisfactory, the corrective action is closed and the implementation date is documented in the space provided. 9) If necessary, QA/QC conducts follow-up within two (2) weeks from the implementation date. If the corrective action is determined to be ineffective, then a new major corrective action will be initiated and the process repeated. 2.5.3 Technical Corrective Actions Technical corrective actions apply to departures or deviations from the quality control parameters stated in individual test SOPs. Each test SOP must include all required quality control that applies to the procedure (as stipulated by the method and other regulatory agencies) as well as the performance frequency, acceptance criteria and corrective action for handling failed quality control measurements. Each SOP must describe the procedures to be followed for reviewing and assessing data, including corrective action for handling out-of-control or unacceptable data. The required protocol for technical corrective actions is summarized below. ACZ's protocols are included within the [ ]. I 1) identify the individual responsible for assessing each nonconformance and initiating or recommending corrective action [analyst who performs AREV] 2) define how the analyst must treat data if associated quality control measurements are unacceptable [section 12 of SOP] 3) specify how non-conformance and subsequent corrective actions are to be documented [data review checklist] 4) specify how management reviews the corrective actions [reviewed during SREV] To the extent possible, samples shall be reported only if all quality control measures are acceptable. If a quality control measure is found to be out of control then the corrective action described in the SOP must be performed. Alternatively, report data with the appropriate qualifier if reprocessing and reanalysis is not possible. The qualifier must be assigned to any sample(s) associated with the failed quality control measure. A current list of all extended qualifiers is available in the LIMS database and may be accessed by all employees. 2773 Downhill Drive Steamboat Springs, CO 80487 970-879-6590 www.acz.com