品質保証

Quality assurance comprises three cyclical activities: quality control, quality assessment, and internal corrective measures. Quality control is performed before and during analysis to prevent issues. Quality assessment occurs during and after analysis to evaluate results. Internal corrective measures are implemented based on assessment findings to improve future analyses.

Quality assessment is performed during and after the analysis to evaluate whether results meet specifications and use objectives. The outcome of quality assessment determines whether analysis modifications are needed. This timing allows analysts to identify issues while data is still being collected or immediately after completion.

Before analysis begins, specifications must include sampling protocols, blank tests, calibration checks, quality control checks, accuracy, precision, detection limit, selectivity, sensitivity, robustness, and the rate of false results. These specifications establish expected performance standards and ensure consistent, reliable analytical outcomes across all measurements.

Clear and concise use objectives define the intended application of analysis results and serve as the foundation for quality assurance. All specifications, quality control checks, and assessment criteria are designed to ensure results meet these objectives. The final quality assurance step confirms whether results align with both specifications and the original use objectives.

Internal corrective measures are implemented based on quality assessment findings to address identified issues. These corrections can occur after analysis to improve future procedures or before analysis begins to prevent known problems. They close the quality assurance cycle by translating assessment results into actionable improvements.

Sampling is a critical component of quality assurance specifications because it directly affects data quality and representativeness. Proper sampling protocols ensure that analyzed samples accurately reflect the population being studied. Including sampling in specifications guarantees consistent, reliable sample collection that supports valid analytical results.

Quality control is a specific preventive activity performed before and during analysis to maintain method performance. Quality assurance is the broader term encompassing quality control, quality assessment, and corrective measures. While quality control focuses on preventing problems during analysis, quality assurance manages the entire cycle of planning, monitoring, and improvement.