ABSTRACT

This study aimed to assess the global mapping risk of human islet isolation, using a failure mode and effect analysis (FMEA), and highlight the impact of quality assurance procedures on the risk level of criticality. Risks were scored using the risk priority number (RPN) scoring method. The risk level of criticality was made based on RPN and led to risk classification (low to critical). A raw risk analysis and a risk control analysis (with control means and quality assurance performance) were undertaken. The process of human islet isolation was divided into 11 steps, and 230 risks were identified. Analysis of the highest RPN of each of the 11 steps showed that the 4 highest risks were related to the pancreas digestion and islet purification stages. After implementation of reduction measures and controls, critical and severe risks were reduced by 3-fold and by 2-fold, respectively, so that 90% of risks could be considered as low to moderate. FMEA has proven to be a powerful approach for the identification of weaknesses in the islet isolation processes. The results demonstrated the importance of staff qualification and continuous training and supported the contribution of the quality assurance system to risk reduction.

摘要

本研究旨在使用失效模式和影响分析 (FMEA) 评估人体胰岛隔离的全局映射风险，并强调质量保证程序对临界风险级别的影响。使用风险优先级数 (RPN) 评分方法对风险进行评分。关键性的风险级别是基于 RPN 并导致风险分类（低到关键）。进行了原始风险分析和风险控制分析（包括控制手段和质量保证绩效）。人胰岛隔离过程分为11个步骤，识别出230个风险。对 11 个步骤中每个步骤的最高 RPN 的分析表明，4 个最高风险与胰腺消化和胰岛纯化阶段有关。在实施减排措施和控制措施后，严重和严重风险分别降低了 3 倍和 2 倍，因此 90% 的风险可以被认为是低到中度的。FMEA 已被证明是识别胰岛隔离过程中弱点的有效方法。结果证明了员工资格和持续培训的重要性，并支持质量保证系统对降低风险的贡献。