1. Are customer approved specifications, drawings, standards and artwork incorporated into the facilities internal documentation-
顾客批准认可的规格，图纸，标准和艺术品是否纳入设施内部文件？
2. Is there assurance that current editions are utilized in the manufacturing process (double checks)-
是否可以保证目前的版本使用于生产过程中(再次确认)
3. Are customers testing procedures being utilized properly-
是否适当使用客户的测试程序
4. Has the organization established and maintained a documented feedback system to provide early warning of potential and actual quality problems and to facilitate customer input into Corrective and preventative actions- (CAPA)
是否有建立和维持文件反馈系统提供潜在的和实际的质量问题，方便客户输入纠正和预防措施的预警组织？（CAPA）
5. When required by the customer, does the organization agree with the customer, which changes require written confirmation prior to approval and which changes require notification only-
当顾客要求时，组织是否同意客户，这需要改变之前批准的书面确认，哪些变化只需要通知？
6. Are proposed changes communicated in a timely manner and the process for introducing changes agreed-
所提议的改变是否及时的进行沟通来介绍改变是否经过同意的
7. Is there between the organization and the customer, a documented technical/QA agreement that includes the action to be taken for nonconformities-
是否有机构和客户之间的技术和质量保证协议，文件，被视为不合格的行动？
雅诗兰黛验厂之质量管理系
A. QUALITY MANAGEMENT SYSTEM 雅诗兰黛验厂之质量管理系统
1. Is there a documented statement of the corporate Quality policy and Quality objectives-
是否有一个文件化的质量方针和质量目标？
2. Is this policy distributed and adhered to by all employees-
这项政策是否分发给所有员工并遵守？
3. Is there a published Quality Manual- And is this Manual updated regularly-
是否出版有质量手册？并且保持本手册定期更新？
4. Does the Quality Manual outline the structure of the documentation-
是否有文档化的质量手册大纲结构？
5. Control of documents:文件管理
Are available documents controlled, periodically reviewed and approved-
可用文件控制，是否定期审查和批准？
6 Do controlled documents have unique identification – e.g. title/number, issue & page number-
文件的管理是否有独特的识别号码（例如，标题和页号）
7. Control of records: 记录管理
Are all records controlled documents- (no use of uncontrolled records or notes)
是否都是受控记录文件？（不能使用不受控制的记录或笔记）
8. Are entries in records clear, indelible, made directly after performing the activity (in the order performed), dated, initialled or signed by the person making the entry-
正在执行的活动（在执行顺序）后，是否有记录清晰，不可磨灭的条目，还是直接进行日期，草签或使入境的人签署？
9. Are corrections to entries performed in the correct way and dated, initialled or signed-
是否以正确的方式进行修正和过时的条目，草签或签署？
10. Are all manufacturing, control, testing, distribution and investigation records retained for at least 5 years-
所有的生产，控制，检验，分布和记录至少保留5年？
11. Is the organization structure documented to define authority roles and responsibilities within the system- (organisation chart, job descriptions)
是否在组织结构文件系统内定义角色和责任？（组织结构图，岗位描述）
12. Is there evidence an adequate internal audit program is in place-
是否有证据充分的证明内部审计程序是否到位？
13. Is there a documented change control procedure-
是否有一个文件化的变更控制程序？
14. Does the change control procedure include the evaluation of effectiveness of the change-
变更控制程序是否包括改变效果的评估？
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