ENSURİNG LABORATORY QUALİTY THROUGH RİSK MANAGEMENT
DOI:
10.32010/EBGB8804
Abstract
This paper explores the implementation of risk management systems in calibration laboratories and evaluates their impact on the accuracy of measurement results. According to ISO 31000, risk is defined as the effect of uncertainty on objectives, and in this context, the probability of erroneous results is a critical factor. In calibration processes, risks often arise from improper execution of measurement procedures, equipment malfunctions, human error, and environmental conditions. Timely identification and effective management of these risks enable laboratories to ensure quality performance and meet accreditation requirements. The application of modern technologies, automated control systems, and structured quality plans are key tools in achieving this objective. The paper also examines the development of a risk-based quality control plan and continuous improvement mechanisms supported by monitoring. One of the core elements discussed is the CLSI EP23 guideline, which provides a framework for designing risk-based quality control (QC) plans tailored to each laboratory setting. These plans are constructed using manufacturer data, regulatory requirements, and user feedback to assess and control potential risks. A key feature of EP23 is the use of risk matrices—such as a simple 3x3 model—to evaluate both the likelihood and severity of harm. The article illustrates this with a scenario where an untrained operator uses a point-of-care testing device, showing how environmental factors and access control mechanisms affect overall risk assessment. Moreover, the paper emphasizes the need for continuous improvement of the QC plan through post-implementation monitoring. Any increase in error rates, device malfunctions, or clinician complaints should prompt re-evaluation of existing control measures. If manufacturerprovided safeguards are insufficient, laboratories must implement additional layers of protection to ensure the risk remains clinically acceptable. In conclusion, risk management is not merely a set of preventive actions but a systematic approach to maintaining laboratory quality. By integrating the principles of ISO 31000 and CLSI EP23, laboratories can construct scientifically sound and adaptable QC plans. These plans do not aim to eliminate traditional QC measures but rather to balance them with engineering controls and contextual risk factors. This integrated approach enables laboratories to achieve consistent, high-quality outcomes while protecting patient safety. The ongoing assessment and refinement of risk controls support a culture of continuous quality improvement and strengthen the laboratory’s compliance with accreditation and regulatory standards.
Keywords
risk management
calibration laboratory
quality control
uncertainty
ISO 17025
measurement results
technical competence