Application of the quality control circle model to reduce non-conforming surgical instrument packaging and hospital-acquired infection risk: a pilot study

Background: Healthcare-associated infections (HAIs), particularly postoperative infections, remain a major global concern, and deficiencies in surgical instrument packaging represent an important and preventable risk factor. The Central Sterile Supply Department (CSSD) plays a critical role in maintaining sterile assurance; however, process-related packaging non-conformance can compromise patient safety. This pilot study aimed to apply the Quality Control Circle (QCC) model to reduce non-conforming surgical instrument packaging and strengthen infection prevention capability in a tertiary hospital CSSD. Methods: This prospective quality improvement study was conducted in the CSSD of a tertiary hospital. Baseline performance was assessed using routine quality monitoring data, with non-conforming packaging defined as missing instruments, incorrect instrument type, nonfunctional instruments, improper sealing, wet packs, labeling errors, or chemical indicator defects. QCC methodology was applied, incorporating Pareto analysis, root cause analysis, structured training, workflow optimization, equipment maintenance reinforcement, and strengthened verification systems. The primary outcome was the non-conforming packaging rate before and after intervention. Results: Baseline analysis identified missing instruments, incorrect instrument types, and incomplete or nonfunctional instruments as dominant contributors to packaging defects, with an overall baseline non-conformance rate of 0.213%. Following QCC implementation, the rate decreased to 0.199% during the initial assessment (May 2024; 19,060 packs inspected, 38 defective) and further declined to 0.106% during extended follow-up (June-October 2024; 82,182 packs inspected, 87 defective), achieving the predefined improvement target of a 50% reduction. Post-intervention Pareto analysis demonstrated a marked decrease in dominant defect categories, accompanied by strengthened process standardization and stability. Conclusion: Application of the QCC model significantly improved surgical instrument packaging quality, reduced non-conforming events, and enhanced operational reliability in the CSSD. These findings demonstrate that structured, team-based quality management is feasible, sustainable, and potentially beneficial for supporting infection risk reduction and perioperative safety. The model provides a replicable framework for broader implementation and future outcome-linked research.