可以参照GMP指南做灯检资质确认，资质确认可以考虑最差条件，如人员疲劳状态、最长灯检时长、最短灯检时限等。

下面是最新的ECA Questions and Answers on Manual Visual Inspection上两个相近的Q&. 

Q: There's currently a lack of clarity concerning the required number of qualification runs for qualification of inspectors. How many runs are recommended?  目前对于检验人员资质确认所需的确认运行次数尚不明确。建议进行多少次运行？

A:  You should conduct standardized training for your employees, then it is sufficient to carry out the qualification once. If employees pass, they prove that they have completed the training and are approved for routine inspections. So it is perfectly fine to carry out this qualification only once.  您应对员工进行标准化培训，然后只需进行一次资质确认即可。如果员工通过了，就证明他们已完成培训，并被批准进行常规检查。因此，仅进行一次这种资质确认是完全可以接受的。

Q: Should the annual qualification / requalification be conducted using the worst-case product and performed at the end of the production shift? 年度资质确认/再确认是否应使用最差情况的产品进行，并在生产班次结束时进行？

A:  The annual qualification or requalification of manual visual inspectors should be performed using the defined qualification kit, not the "worst-case product." EU GMP Annex 1 and USP require requalification to be conducted on a specific commercial product presentation. Instead, both require qualification using appropriate samples from the manufacturer's defect library, considering worst-case conditions such as inspection time, fatigue, container size, and defect difficulty. A: 手工目检人员的年度资质确认或再确认应使用定义的资质确认工具包进行，而不是使用“最差情况产品”。欧盟GMP附录1和美国药典（USP）要求再确认应针对特定的商业产品规格进行。相反，两者均要求使用生产商缺陷库中的适当样品进行资质确认，并考虑最差情况条件，例如检查时间、疲乏、容器尺寸和缺陷难度。

The qualification kit serves as a standardised reference set, ensuring reproducibility and comparability of performance over time. It should be designed to represent worst-case detectability scenarios (e.g. smallest or lowest-contrast particles, borderline defects). Consistency of the qualification kit is essential to allow meaningful performance trending. 资质确认工具包作为标准化参考集合，确保随时间推移性能的重现性和可比性。其设计应代表最差情况的可检测性场景（例如最小或最低对比度的颗粒、临界缺陷）。资质确认工具包的一致性对于实现有意义的绩效趋势分析至关重要。

Regarding timing, Annex 1 (8.31) requires consideration of factors such as fatigue. Conducting requalification at the end of a production shift can therefore be considered a realistic approach, as it reflects routine operating conditions. However, the regulation does not explicitly mandate this. 关于时间安排，附录1（8.31）要求考虑疲乏等因素。因此，在生产班次结束时进行再确认可以被视为一种现实的方法，因为它反映了常规操作条件。然而，法规并未明确要求这样做。

• ✅ 缺陷对照品占混合包 不超过10%~20%
• ✅ 缺陷对照品的 QN值（质量数）应≥0.7（即经有经验人员验证可稳定检出）
• ✅ 混合包总量应具有统计代表性，足以评估检出率
• ✅ 考核需包含所有已知缺陷类型
• ✅ 需制定明确的可接受标准（检出率 + 误剔率≤5%

3）每一次灯检时限（检查速度）是公司自行规定吗？——检查速度由企业自行规定，但必须经过确认。（EU GMP Annex 1 §8.31 ："检查率（Inspection rates）应经适当控制和确认（appropriately controlled and qualified）"）。

4）是否需要在人员疲劳的状态下，进行灯检考核？——GMP指南倾向于在疲劳状态下考核；欧美指南将疲劳作为"最差条件"考虑，但认为不必刻意模拟。建议按国内GMP指南执行。