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风险评估和缓解计划 - 您有保障吗? | china
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风险评估和缓解计划 - 您有保障吗?

随着食品和制药法规在本质上越来越接近,与风险规避和风险缓解规划相关的总体指导方针正在出现。

对于这两种垂直行业来说,都可以通过查看关键控制点并确定“假设”以及如何使这些假设成为潜在的非问题来实现这一点。

在食品和农产品法规方面,这些被称为 HACCP(关键控制点危害分析),而在食品安全和现代化法案(FSMA)下,这些被广泛定义为所有关键控制点。

在制药和生物制剂领域,风险评估多年来一直是良好分销规范 (GDP)、良好供应规范 (GSP) 和良好生产规范 (GMP) 所要求的。然而,在许多专门涉及药品和生物制剂产品的全球法规以及现行良好规范中,风险评估和风险缓解规划现在正成为任何现场审计的一部分。

那么,哪些常见因素应被视为潜在风险领域?

  1. 到目前为止,人为因素是主要因素。只要有人为接触点,就有发生错误的可能性。一些团体估计,冷链物流错误中人为“影响”因素占冷链错误主要原因的 99%。
  2. 多式联运。运输过程中,只要有交接点,就有可能发生错误——尤其是在使用新的承运人或运输方式时。
  3. 单一供应商策略——这是人们容易忽视的一个重要因素,所以永远不要忘记,正如那句老话提醒我们的那样:“不要把鸡蛋放在一个篮子里”。如果某个供应商无法提供您常规订单所需的必要组件,那么从该供应商采购的特定纸箱、温度监控设备或解决方案可能会让您面临风险。
  4. 定期对关键人员进行培训并记录在案。如果员工没有定期更新,新员工也未接受并完成新员工培训计划,那么标准操作程序和工作指导 (WI) 可能会发生变化,与变化相关的关键点可能会被忽略。
  5. 定期进行自我审计,查看所有潜在风险领域,并根据需要更新您的缓解计划。
  6. 忘记启动或激活随货运输的温度监控设备是上述第 1 项中提到的常见人为错误之一。DeltaTrak 多年前就认识到这种错误很常见,我们所有的一次性数据记录器都配有我们专利的 Shadow Log™ 功能,该功能可确保您获得相关货件的温度日志,即使记录器在运输时没有实际启动。

那么您对您的风险评估和缓解计划是否是最新的有多大信心,或者更确切地说——“您有多确定您的物流人员在关闭纸箱之前激活了数据记录器?”

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风险评估和缓解计划 - 您有保障吗? | china