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 6 of 96 2.2 Standard Operating Procedures , A documented procedure is required for all phases of ACZ's business operations, from sample log-in through sample disposal. A Standard Operating Procedure (SOP) is a written document that details the manner in which an operation, analysis, or action is performed and thoroughly prescribes the techniques and procedures, which ' are the accepted process for performing certain routine or repetitive tasks. Analytical SOPS must be written with adequate detail to allow someone similarly qualified, other than the analyst(s) who routinely performs the procedure, to reproduce the procedure used to generate the test result. To the extent possible, administrative ' SOPs [non-technical] must include specific requirements pertaining to the process; however, the procedure itself may be a more general description so as to lend a degree of necessary flexibility to account for client requests and other circumstances, which may be outside of ACZ's control. W Proposed revisions to any test SOP must be noted on the SOP Revision Form (FRMQA030). Proper use of FRMQA030 ensures the SOP continues to include all requirements of the procedure. All procedural revisions must be reviewed and approved by QA/QC prior to implementation. Changes to provide additional clarification, ' correct typographical errors, etc. do not need to be approved but need to be noted on the revision form to ensure the changes are included during the next revision. Analytical SOPS must be reviewed annually using the SOP Review Form (FRMQA035), and Administrative SOPS must be reviewed regularly and revised if necessary to ensure the information is accurate and reflects current practice. Documenting changes in the ' controlled copy of any SOP is not permitted. Refer to section 10.5.1 for additional information on SOPs. SOPs are proprietary documents and ACZ does not distribute them freely. Any copy sent electronically or ' otherwise to an outside party is considered uncontrolled, and the recipient understands that additional changes can be made without prior notification. The use of uncontrolled copies of SON is not permitted on site unless approved by QA/QC, and such documents will be initialed and dated by QA/QC personnel when issued. ' Before a new procedure, application, or instrument can be implemented, an SOP must be developed. Following QA/QC review, an effective "working draft" will be issued to allow the user(s) to "fine-tune" the document. If a client requests a procedure for which there is not a published method or an existing SOP, ACZ will utilize the ' process described in the SOP Client Service Policies and Procedures (SOPAD043). Analytical SOPs are written in accordance with the NELAC Standards and must include or reference the following items, where applicable: , 1) identification of the test method 2) summary, scope & application of the test method, including matrices & components to be analyzed 3) references, including documents provided by instrument / equipment manufacturer 4) sample collection, preservation, & storage ' 5) equipment & supplies 6) reagents & standards, including storage conditions & shelf-life for each 7) safety ' 8) interferences 9) complete procedure, including details and acceptance criteria for initial & continuing calibration 10) data review & assessment, including protocols for handling out-of-control or unacceptable data ' 11) quality control, including acceptance criteria & corrective action for handling failed quality control 12) calculation equations (dilution factors, RPD, % recovery, etc.) & calibration formulas 13) method detection limit & reporting limit 14) method performance, including Demonstration of Capability and Method Detection Limit procedures ' 15) pollution prevention & waste management 16) definitions 17) tables, diagrams, flowcharts , 2773 Downhill Drive 970-879-6590 Steamboat Springs, CO 80487 www.acz.com ,