รายละเอียดเอกสาร

Quality control (QC) is an important attribute of any laboratory’s quality assurance (QA) program. Without QC, there is no confidence in the results of analytical tests. As described in Part 1000, essential QC measures include method calibration, reagent standardization, assessment of each analyst’s capabilities, analysis of blind check samples, determination of the method’s sensitivity [method detection level (MDL) or quantification limit], and regular evaluation of bias, precision, and the presence of laboratory contamination or other analytical interference. The details of these procedures, their performance frequency, and expected ranges of results should be formalized in a written QA manual and standard operating procedures. In addition, it is the laboratory’s responsibility to qualify and report data values not meeting QC or other method-defined requirements with sufficient information so the client or end user can determine the usability of the qualified data...