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Strip-chart recorder printouts should be signed by the person who performed <br /> the instrumental analysis. If corrections need to be made in computerized data, <br /> a system parallel to the corrections for handwritten data should be in place. <br /> Records of sample management should be available to permit the re-creation <br /> of an analytical event for review in the case of an audit or investigation of a <br /> dubious result. <br /> Laboratory records should include, at least, the following: <br /> Operating Procedures -- Procedures should be available to those performing <br /> the task outlined. Any revisions to laboratory procedures should be <br /> written, dated, and distributed to all affected individuals to ensure <br /> implementation of changes. Areas covered by operating procedures are <br /> given in Sections 3.3 and 4.3. <br /> Quality Assurance Plans -- The QAPjP should be on file. <br /> Equipment Maintenance Documentation -- A history of the maintenance record <br /> of each system serves as an indication of the adequacy of maintenance <br /> schedules and parts inventory. As appropriate, the maintenance guidelines <br /> of the equipment manufacturer should be followed. When maintenance is <br /> necessary, it should be documented in either standard forms or in <br /> logbooks. Maintenance procedures should be clearly defined and written <br /> for each measurement system and required support equipment. <br /> Proficiency -- Proficiency information on all compounds reported should be <br /> maintained and should include (1) precision; (2) bias; (3) method detec- <br /> tion limits; (4) spike recovery, where applicable; (5) surrogate recovery, <br /> where applicable; (6) checks on reagent purity, where applicable; and <br /> (7) checks on glassware cleanliness, where applicable. <br /> Calibration Records & Traceability of Standards/Reagents -- Calibration is <br /> a reproducible reference point to which all sample measurements can be <br /> correlated. A sound calibration program should include provisions for <br /> documenting frequency, conditions, standards, and records reflecting the <br /> calibration history of a measurement system. The accuracy of the <br /> calibration standards is important because all data will be in reference <br /> to the standards used. A program for verifying and documenting the <br /> accuracy and traceability of all working standards against 'appropriate <br /> primary grade standards or the highest quality standards available should <br /> be routinely followed. <br /> Sample Management -- All required records pertaining to sample management <br /> should be maintained and updated regularly. These include chain-of- <br /> custody forms, sample receipt forms, and sample disposition records. <br /> Original Data -- The raw data and calculated results for all samples <br /> should be maintained in laboratory notebooks, logs, benchsheets, files or <br /> other sample tracking or data entry forms. Instrumental output should be <br /> stored in a computer file or a hardcopy report. <br /> ONE - 22 Revision 1 <br /> July 1992 <br />