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FA <br />1,; <br />Section 1 <br />Revision 1 II <br />Date: January 15, 1994 . <br />Page: 1 of 18 <br />Internal <br />requiresAn internal quality control program of routineinternal <br />that the ta <br />1 generated 1111 a measurement system meetsprescribedcriteria quality. <br />ata <br />An effective internal QC program must be capable of measuring and controlling the quality of <br />the data, in terms of precision, accuracy, and completeness (see sections 5 and 14 for these <br />r <br />This section identifies ,.:: protocols \ r <br />ciated with analytical procedures. Table 11-1 is a <br />general outline 1 quality1 r'. 1 parametersmonitored 1 <br />1 procedure. <br />specificcontrol provide <br />general quality control measures as well as <br />1 <br />continualf f andassessment <br />through FIgures 11-1 <br />FGL Control Charts. <br />FGL uses continuing calibration verifications (C and initial 6fibration verification (ICV) <br />for instrument quality control. The laboratory control sample (LCS) is used for sample <br />preparation quality control. 71be CCV standard only verifies continuing calibration. The ICV <br />standard is used to independently verify the calibration and may take the place of CCV when <br />used on a continuing basis during analysis. The LCS may take the place of both ICV and <br />CCV when prepared independently and used on a continuing basis during analysis. <br />11.1 Quality Control Parameters <br />11.1.1 Initial Demonstration of Capability <br />Before analyzing samples, the laboratory must prove proficiency in the method by <br />preparing a data package for certification. The laboratory normally provides the <br />following information: <br />calibration data <br />calibration n from an independentsource <br />methoddetection 11 data <br />4) detection limit verification data <br />accuracy and precision data <br />These must all be acceptable under the method QC criteria or, when requirements <br />am not specified, reasonably meet good laboratory practices and Department of <br />Health Services requirements. <br />11.12 Analysis Quality Controls <br />11.1.2.1 Instrument Blank <br />The instrument or calibration blank is used to calibrate the instrument. This <br />blank contains the same reagents used in the standards and samples. However, <br />the blank is prepared under controlled conditions and is not processed like all <br />samples. <br />IM <br />11.1.2.2 Detection I;imft Standard (DIS) <br />Normally, method detection limits Ls) are performed on an annual basis. <br />However, this doesn't adequately refl the day -today variations in the <br />analysis. FGL has taken a different approach. We perform what we call <br />detection limit standards on a daily basis. This gives more "representative" <br />method detection limits. Tracking the DLS using our IjMS allows us to monitor <br />instrument and method performance. Historically, we can also prove what our <br />L was at a particular time. <br />