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<br />ACZ Laboratories, Inc. August 10, 2007 <br />i Quality Assurance Plan Version 12 <br />SOPAD018.08.07. l2 Page 33 of 96 <br />9 MAINTENANCE & CALIBRATION OF INSTRUMENTATION & EQUIPMENT <br />9.1 Maintenance of Instruments and Support Equipment <br />The best protocol for producing quality work is to prevent errors and non-conformances rather than to react <br />to and correct problems after they occur. An essential part of this protocol is ensuring that all laboratory <br />instrumentation and equipment used for the generation of data has been optimized and is functioning properly <br />before commencing work on client samples. Performing routine maintenance and optimizing instrument- <br />operating conditions prior to sample analysis minimizes instrument downtime, thereby improving productivity <br />and ensuring quality of the data. It is the responsibility of the designated analyst(s) to perform and properly <br />' document daily and routine maintenance, instrument optimization, troubleshooting, any instrument servicing or <br />repair, and any repair or replacement of parts. <br />All manufacturer-prescribed inspection and maintenance must be performed according to the schedule <br />indicated in the operator's manual (or similar) provided by the manufacturer and must be documented either in <br />the instrument logbook or a separate maintenance logbook or on the instrument maintenance checklist (available <br />' in LabWeb). ACZ management recognizes that performing all maintenance procedures at the frequency <br />indicated by the manufacturer may not be economically feasible or a significant increase in workload may <br />require the maintenance be performed at a later time if instrument performance is deemed to be acceptable; <br />therefore, at a minimum, the instrument part(s) must be inspected regularly according to the schedule. The <br />analyst must use their professional judgment to determine if maintenance or replacement is necessary at that <br />time. Refer to ACZ's SOP Control, Calibration and Maintenance of Measuring and Test Equipment <br />(SOPAD013) for details for each specific instrument or instrument type. <br />' Additionally, all support equipment (any device that may not be the actual test instrument, but is necessary to <br />support laboratory operations) must be monitored regularly to confirm proper functioning. The temperature of <br />all drying ovens, refrigerators, freezers, and incubators must be checked each working day (except Sundays or <br />holidays) and each check recorded on the associated Temperature Logsheet. Refer to SOPAD013 for more <br />detail. <br /> <br />Equipment that has been subjected to overloading or mishandling, gives suspect results or has been shown to <br />be defective or outside specified limits must be taken out of service and FRMAD029 attached to indicate the <br />instrument or equipment is waiting for repair and cannot be used. During this downtime the department <br />supervisor, Production Manager, and Project Manager may collectively determine it is necessary to sub- <br />contract samples until correct performance of the repaired instrument or equipment has been demonstrated by <br />a successful calibration or other suitable test. Document all contact with the manufacturer, as well as all <br />repairs and other services, in the instrument or maintenance logbook to be used as a reference for solving <br />future instrument problems. Additionally, when instrumentation or equipment goes outside of the direct <br />control of the laboratory, the functioning and calibration status must be checked and shown to be satisfactory <br />before it is returned to service. Refer to SOPAD013 for additional information. <br />To minimize downtime, each laboratory should maintain an adequate inventory of reagents, stock standards, <br />glassware, etc. and should keep a sufficient supply of extra "critical" parts in-house rather than possibly delay <br />sample analysis while waiting for parts to arrive. Keep in mind that parts from a vendor may be back-ordered <br />and will not be available for immediate shipment. Additionally, an MDL study, MDL verification, calibration <br />range determination, etc. must be performed for all methods on each instrument used to analyze client samples. <br />This ensures any "backup" instrument can be utilized for analysis of client samples as soon as needed, rather <br />than delaying production to first successfully complete any QC requirement(s). <br />2773 Downhill Drive 970-879-6590 <br />Steamboat Springs, CO 80487 www.acz.com