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QUALITY ASSURANCE (QA) PROCEDURES
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Over the last 20 years the reliability of data produced by analytical laboratories has increased dramatically. Strict requirements have ensured that the data were produced under de ned standards of quality with a stated level of con dence. The routine day-to-day activities (e.g., matrix forti cations) to control, assess, and ensure the quality of generated data are the quality controls associated with analytical processes. The management of the system that ensures that these processes are in place and functional is the quality assurance portion of the laboratory program to produce reliable data. Quality assurance (QA) is an essential part of analytical protocols. Each laboratory is required to detect and correct problems in analytical processes and to reduce errors to agreed-upon limits. To produce data that have acceptable quality, all laboratory members must follow established guidelines and protocols. Some of the essential elements that must be included in a QA program are as follows: 1. Laboratory practices (e.g., glass washing protocols) must be developed, reviewed, and updated with the staff s participation on a scheduled basis and followed strictly by all laboratory members; 2. Operating procedures (e.g., SOPs monitoring freezer temperatures daily) must be standardized, documented, and supplied to each member of the laboratory staff and updated on a set schedule; 3. Monitoring programs (e.g., surface water monitoring of supplies furnishing public drinking water) must be carefully designed. 4. Maintenance of equipment and instruments must be documented in LIMS or appropriate maintenance books kept with the equipment. 5. Expiration dates of analytical standards, chemicals, and solvents must be observed and replacements made prior to their expiration date. 6. Good laboratory practices (GLPs) must be implemented as needed. 7. Audits must be performed on a scheduled basis to verify that all aspects of the QA program are operating suf ciently.
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QUALITY CONTROL (QC) PROCEDURES
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Quality control (QC) concerns procedures that maintain a measurement system in a state of statistical control. This does not mean that statistics control the analytical
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TOXICANT ANALYSIS AND QUALITY ASSURANCE PRINCIPLES
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procedures but that statistical evidence is used to ensure that the procedure is working under the conditions set by protocol. The accuracy of an analytical method depends on statistical control being conducted prior to determining any other parameter. How well the basic method will work with the sample matrix being evaluated will depend on the way the QC samples are examined. A comprehensive QC analytical procedure would include the following: 1. Replicated environmental samples to test the precision of the sampling or analytical procedures. 2. Replicated analyses conducted on the same sample multiple times in order to determine analytical precision. 3. Trip blanks to determine if contaminants are introduced the processes of collecting, shipping, or storing of samples. 4. Matrix-forti ed laboratory blanks consisting of solvent and reagent blanks to determine levels of bias due to matrix effects or analytical method problems. 5. Sample blanks (a sample matrix that does not contain the toxicant, although this is sometimes dif cult to obtain) to ensure no extraneous or interfering peaks; the peaks indicate where a problem might exist in the method used. 6. Forti ed eld blanks to determine the effects that the matrix might have on analyte recovery.
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Planning the essential elements of an analytical protocol is critical to ensuring that the data generated answer what is requested, provide information affecting regulatory action, or enable some decision affecting environmental or human welfare. Essential decision criteria must be included in the protocol that describes the analytical process in detail, including the objective(s) of the study, the QA/QC requirements, the sample plan, methods of analysis, calculations, documentation, and data reporting. Meaningful data can only be generated with the proper method of analysis.
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