2008-03-10_GENERAL DOCUMENTS - M1977247

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1 ACZ Laboratories, Inc. August 10, 2007 Quality Assurance Plan Version 12 SOPAD018.08.07.12 Page 12 of 96 2.5 Corrective Action When any problem, deviation or failure is identified within the Quality System or when any change is made to a previously documented company-wide protocol, a corrective action must be initiated. Corrective actions are a fundamental element of ACZ's QA/QC Program, as a successful Quality System requires the identification of , deficiencies and depends on the development, implementation, and documentation of effective contingency plans and resolutions to effectively address the deficiencies. Problems can ordinarily be classified two ways: 1) undesirable but not critical or 2) critical and requiring immediate action. To this extent, ACZ utilizes two types of corrective actions: Minor and Major. A minor corrective action pertains to any temporary deviation from a policy or procedure and may be initiated by any ' employee in order to resolve an immediate problem that is isolated or may impact only one workgroup or several related workgroups. Minor corrective actions do not require QA/QC follow-up. Major corrective actions address system-wide errors or failures and require the root cause(s) of the error or failure to be determined and the resolution to be documented and implemented. 2.5.1 Minor Corrective Action The minor corrective action report (FRMQA001) allows for complete documentation of any temporary deviation from the SOP or other protocol. The employee who initiates the corrective action will complete Section 1 of the report. Documentation must be accurate and must provide a complete detailed explanation of the situation for future reference. The department supervisor should always be informed of the need for a minor corrective action and may provide additional information in the appropriate section. The project manager may also provide additional information in the appropriate section if necessary. QA/QC does not need to close a minor corrective action; however, the employee may review the report with QA/QC personnel and request their signature in the appropriate section. Complete documentation may be provided either on the workgroup bench sheet or on the data review checklist in lieu of using FRMQA001 if the deviation applies to a limited number of workgroups. Use FRMQA001 if the deviation applies to many workgroups and attach a copy of the completed form to each workgroup before the workgroup is scanned. If the report is generated after the workgroups have been scanned, then the workgroup must be retrieved and rescanned with the report include as part ' of the data package. In this case, a note is made on the front page of the workgroup package indicating the reason the workgroup was rescanned (i.e. "CAR attached, WG rescanned"). If appropriate, a minor corrective action will be addressed in the case narrative of the client report. ' 2.5.2 Major Corrective Action It is the responsibility of the QA/QC Officer to notify laboratory management in writing of departures , from the Quality System, and it is the responsibility of the laboratory management to ensure that any , corrective action that arises is discharged within the time frame indicated on the corrective action report, or additional communication must be provided to the QA/QC Officer (see item 3 below). ' A major corrective action is initiated whenever a system failure has been identified or whenever an audit finding or other circumstance casts doubt on the correctness or validity of the analysis result(s). The client must be notified in writing if their work is affected. The QA/QC department will work with the ' Project Manager to determine if a revised report must be issued to the client. See ACZ's SOP Client Service Policies and Procedure (SOPAD043) for details. A major corrective action may also be initiated when the need for preventive action has been identified (refer to section 2.5.4). 2773 Downhill Drive Steamboat Springs, CO 80487 970-879-6590 www.acz.com n