Quality Assurance Oversight

The many QA practices discussed have been shown to improve the quality of laboratory testing, but they must be coordinated. As mentioned, this is accomplished in some laboratories by establishing a QA office that constantly inspects and reviews QA practices. Incidents that have an impact on quality and corrective actions are documented in a log book or computer file and all incidents are compiled in periodic reports given to the laboratory director. In some laboratories these actions are accomplished by a combination of personnel. Regardless of the organizational structure, the director is responsible for overall quality and must constantly monitor QA functions and document periodic review. Some requirements that have become standard practice include the director reviewing QC charts and incident summaries monthly with the QC supervisor conducting a similar review more frequently. The director approves all procedures and ensures they are revalidated annually. The director monitors laboratory practices for quality and corresponds with inspectors and certifying organizations regarding issues of qualifier. Each of these actions must be documented. The most important axiom of QA is that the process never ends but is a continuous quality improvement process.

Most informed individuals in the forensic laboratory community agree that a comprehensive QA program is essential. However, one must also recognize that programs can have a negative impact on quality if improvements are not balanced with the routine flow of work. For example, analysts make fewer errors when they are familiar with procedures, and too many changes to procedures can increase the number of errors. Also, analysts often detect errors by noticing that some part of the testing process is different than expected. They may not immediately recognize an error but find it by investigating why the procedure is different. With too many changes there is no expectation of normal operating procedures, and these errors go undetected. The QA challenge is to find a balance between changing procedures to improve quality and maintaining current procedures to ensure that workers are familiar with them.

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