Design and Validation of a Safety Risk Assessment Checklist for Food and Drug Quality Control Labs

Abstract

Background: Food and drug quality control laboratories operate with complex chemical, biological, and procedural hazards that necessitate structured safety monitoring, yet validated tools tailored to these environments remain limited. A standardized risk assessment checklist can strengthen hazard identification, enhance regulatory compliance, and support safer laboratory operations. Objective: To design and validate a comprehensive safety risk assessment checklist specifically for food and drug quality control laboratories and evaluate its content validity, reliability, and underlying domain structure. Methods: A methodological cross-sectional study was conducted using expert-driven item generation, a two-round Delphi process, and psychometric evaluation across 96 checklist applications. Content validity indices (I-CVI, S-CVI/Ave) were calculated, followed by reliability testing using Cronbach’s alpha, inter-rater reliability, and test–retest stability. Exploratory factor analysis assessed construct validity and domain structure. Results: The expert panel achieved strong consensus, yielding a final 44-item checklist with an S-CVI/Ave of 0.94. Internal consistency was high across all domains (Cronbach’s alpha 0.87–0.91), with overall alpha of 0.92. Inter-rater reliability was substantial (κ = 0.83), and test–retest reliability demonstrated excellent stability (ICC = 0.89). Five domains emerged, explaining 89% of total variance. Conclusion: The validated checklist demonstrates strong psychometric performance and offers a reliable, domain-specific tool for improving safety assessment in food and drug quality control laboratories.