- Sampling Plan and AQL
采样计划有助于定义您的样本量或从每批传入材料中检查的物品数量。当您选择一个采样计划时，就像常用的ANSI/ASQ Z1.4一样，您将设置一个基线水平，以供您愿意容忍每个测量特征的缺陷百分比。该百分比可能为0％，这意味着对您最关键的产品特征的100％检查。对于不太关键的特征，您可以选择不同的百分比来测量（通常在2.5-4.0％之间）。
此级别称为您的接受质量水平或AQL。根据您的AQL，采样计划定义了要检查给定批量尺寸的项目。通常，AQL越低，您需要的样本量就越高，以确保对材料质量的统计信心。
传入的检查采样计划还定义了允许批次进行多少缺陷，以便进行检查。
- 跳过批次时间表
A skip lot schedule details how many lots need to be inspected out of the total number of lots that you receive. Just like the sampling plan, your skip lot schedule can vary based on past supplier performance or based on a material’s risk. You may decide to vary the inspection schedule for certain raw materials, while you may have other materials that need no incoming inspection at all.
- Switching Rules
Switching rules are a third component of risk-based incoming inspection. These rules take ongoing inspection results into consideration and tell you how your sample size and skip lot schedule should change as a result. For sampling systems like ANSI/ASQ Z1.4, switching rules govern changes between the following states:
- 普通的- 样本量和要检查的批次数的基线
- 减少– Fewer lots are inspected and fewer samples are taken for each lot. This state is reached based on good results in previous incoming inspections.
- Tightened– More lots are inspected and more samples are taken for each lot. This state is reached based on poor results in previous incoming inspections.
Stick with the Standards
Switching rules are also based on a statistical plan that modifies the inspection schedule while maintaining confidence that incoming quality will remain high. For this reason, you should try and stick with an industry-standard plan rather than creating your own skip lot schedule.
基于风险检查的挑战
在基于风险的检查环境中，采样系统可能很难跟踪。行业标准抽样表可以详细且复杂。手动检查管理流程可能会使了解每种材料的质量性能随着时间的流逝而具有挑战性。这些因素可能使得为组织的许多供应商和原材料确定样本量，跳过批次频率以及切换时间表变得困难。
幸运的是，电子检查管理解决方案可以完全自动化基于风险的检查过程。类似的工具SmartSolve®供应商质量管理from IQVIA combine industry-standard sampling systems with your ongoing supplier performance data to notify your team when inspection is needed. You can have all the benefits of risk-based inspection without the administrative and statistical headaches.
采样系统和合规性
在生命科学行业中，合规性应处于每个传入质量决策的最前沿。请记住考虑采样选择的合规性方面。至关重要的是，您必须清楚地记录您决定使用的采样系统，并统计验证您使用的采样系统。同样重要的是要记住，只有在您对供应商以前的质量性能有信心时，才应实施采样系统。确保您记录了任何审核，检查，不合格历史记录或其他记录，以支持质量管理系统中的此决定。
SmartSolve® Supplier Management
尽管影响每个设备制造商的供应商运营的业务和监管要求越来越严格，但SmartSolve QMS为合规且成功的供应商质量管理计划不可或缺的流程提供了支持。借助供应商质量模块的生态系统，SmartSolve正在授权组织评估，跟踪，报告和评价供应商，以应对复杂供应链带来的挑战。
