Laserfiche WebLink
analyze; and any other information required to perform the analysis <br /> accurately and consistently. <br /> Instrument Standardization -- This includes concentration(s) and frequency <br /> of analysis of calibration standards, linear range of the method, and <br /> calibration acceptance criteria. <br /> Sample Data -- This includes recording requirements and documentation in- <br /> cluding sample identification number, analyst, data verification, date of <br /> analysis and verification, and computational method(s) . <br /> Precision and Bias -- This includes all analytes for which the method is <br /> applicable and the conditions for use of this information. <br /> Detection and Reporting Limits -- This includes all analytes in the <br /> method. <br /> Test-Specific QC -- This describes QC activities applicable to the <br /> specific test and references any applicable QC procedures. <br /> 4.3.5 Equipment Calibration and Maintenance <br /> The procedures describing how to ensure that laboratory equipment and <br /> instrumentation are in working order should be specified. These procedures <br /> include calibration procedures and schedules, maintenance procedures and <br /> schedules, maintenance logs, service arrangements for all equipment, and spare <br /> parts available in-house. Calibration and maintenance of laboratory equipment <br /> and instrumentation should be in accordance with manufacturers' specifications <br /> or applicable test specifications and should be documented. <br /> 4.3.6 OC <br /> The type, purpose, and frequency of QC samples to be analyzed in the <br /> laboratory and the acceptance criteria should be specified. Information should <br /> include the applicability of the QC sample to the analytical process, the <br /> statistical treatment of the data, and the responsibility of laboratory staff and <br /> management in generating and using the data. Further details on development of <br /> project-specific QC protocols are described in Section 4.4. -- <br /> 4.3.7 Corrective Action <br /> The procedures describing how to identify and correct deficiencies in the <br /> analytical process should be specified. These should include specific steps to <br /> take in correcting the deficiencies such as preparation of new standards and <br /> reagents, recalibration and restandardization of equipment, reanalysis of <br /> samples, or additional training of laboratory personnel in methods and <br /> procedures. The procedures should specify that each corrective action should be <br /> documented with a description of the deficiency and the corrective action taken, <br /> and should include the person(s) responsible for implementing the corrective <br /> action. <br /> ONE - 17 Revision 1 <br /> July 1992 <br />