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Abstract：
In our study, a food safety management system was developed for a chaga mushroom biotechnology product manufacturer, with the purpose of meeting the quality demands of customers and enhancing the manufacturer\'s reputation. The study focused on identifying the potentially significant hazards present at each stage of the production process for chaga mushroom capsule products, and on ensuring that the biotechnology company in question has fully implemented ISO22000:2018 and the HACCP methodology. The results indicate that, in the 1 year following the implementation of ISO 22000:2018, there was a statistically significant drop (P < 0.05) in the coliforms level of the tested biotechnology product samples that started in the ninth month following implementation. The rapid screening of mycotoxin, heavy metal, and pesticide residue levels also increased monitoring intensity and strengthened the periodic rotation plan, enabling control over potential problems relating to raw materials and ensuring product quality. This finding reveals the importance and necessity of rapid screening for small- and medium-sized food industry enterprises. Furthermore, 1 year after the system\'s implementation, the defect rate for chaga products was also observed to have declined, and the number of process flow anomalies requiring correction was also found to have decreased significantly (P < 0.05), indicating that safety and quality levels were improving and stabilizing. If implemented over a longer period of time, the food safety management system\'s benefits would stand out even more, and significant improvements would be observed for more monitored items. PRACTICAL APPLICATION: Few studies have touched on food safety management systems (FSMSs) developed for capsule health food products. The enterprise examined in this study had actively worked to improve its quality system and meet its customers\' needs through the implementation of the FSMSs.
摘要：
在我们的研究中,为Chaga蘑菇生物技术产品制造商开发了食品安全管理系统，以满足客户的质量要求和提高制造商的声誉为目的。该研究的重点是确定在chaga蘑菇胶囊产品生产过程的每个阶段存在的潜在重大危害，并确保相关生物技术公司全面实施ISO22000：2018和HACCP方法。结果表明,在实施ISO22000:2018后的1年内,在实施后的第9个月开始,测试的生物技术产品样品的大肠杆菌水平有统计学意义的下降(P<0.05).霉菌毒素的快速筛查,重金属,农药残留水平也加大了监测力度，加强了定期轮换计划，能够控制与原材料有关的潜在问题并确保产品质量。这一发现揭示了对中小型食品工业企业进行快速筛查的重要性和必要性。此外，系统实施后1年，Chaga产品的缺陷率也有所下降，需要纠正的工艺流程异常数量也显著减少(P<0.05)，表明安全和质量水平正在提高和稳定。如果在更长的时间内实施，食品安全管理体系的好处将更加突出，和显着的改善将观察到更多的监测项目。实际应用：很少有研究涉及为胶囊保健食品开发的食品安全管理系统（FSMS）。在这项研究中检查的企业积极致力于改善其质量体系，并通过实施FSMS来满足客户的需求。
