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Original research IMPROVING THE INTEGRATED RISK IDENTIFICATION SYSTEM IN ANALYTICAL TESTING LABORATORIES BASED ON CLASSIFICATION AND PROCESS-ORIENTED METHODOLOGIESPages 285-292
Abstract
The accuracy and reliability of test results in analytical testing laboratories significantly depend on the correct and effective management of operational risks. This paper proposes a methodology to enhance risk identification efficiency by categorizing potential hazards into four primary classes: “Personnel”, “Management”, “Reagents and Equipment”, and “Environment and Samples”. Such an approach enables laboratory managers to conduct a systematic search for risks within specific operational domains. Furthermore, the identified risks are integrated into a three-stage functional flow model, wherein pre-testing, testing-period, and post-testing processes are analyzed independently. The proposed model simplifies the risk identification process and serves to improve the laboratory quality management system in accordance with international standards, specifically ISO/IEC 17025. Implementation of this integrated framework helps in minimizing human-related errors and optimizing resource allocation across different laboratory workflows. Application of the framework in an accredited laboratory environment resulted in the identification of previously unrecognized risk factors, demonstrating improved diagnostic coverage and enhanced structural consistency of the risk management process.
Keywords:
Quality management, risk-oriented approach, ISO/IEC 17025, analytical testing laboratory, process-oriented methodology, risk identification.
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