不合格品的处理

10.1 Rejected finished products, bulk products, raw materials and packaging materials

不合格的成品，半成品，原料，包材

10.1.1 Investigations of rejected product or materials should be performed by personnel authorized to do so

应由被授权的人来对这些不合格品进行分析。

10.1.2 Decisions to destroy or to reprocess should be approved by the personnel responsible for quality.

销毁或再加工的决定应由质量负责人员的批准。

10.2 Reprocessed finished products and bulk products

成品和半成品的返工

10.2.1 If all or part of a batch of finished product or bulk product does not meet the defined acceptance criteria, a decision to reprocess in order to obtain the defined quality should be approved by personnel responsible for quality.

质量负责人员决定对全部或者部分成品和半成品的返工。

10.2.2 The method of reprocessing should be defined and approved.

要对返工方法进行界定和批准。

10.2.3 Controls should be performed on the reprocessed finished products or bulk products. Results should be reviewed by authorized personnel in order to verify the conformity of the finished product or bulk product with the acceptance criteria.

应对成品和散装产品的返工实施控制。对返工的成品和散装产品是否符合验收标准的验证结果应经授权人员审核。

11 Wastes 废弃物

11.1 Principle 条例

Wastes should be disposed of in a timely and sanitary manner.废物应及时地以及时和卫生的方法处理

11.2 Types of waste 废物类型

Using findings from production and quality control laboratories, the company should define the different types of waste that could affect the quality of the product.

根据对生产和实验室调查的结果，公司应明确可能影响产品质量的不同类型的废弃物类型。

11.3 Flow 流动

11.3.1 The flow of waste should not impact on the production and laboratory operations.废弃物的流动不能对产品和实验

室操作产生不利影响。

11.3.2 Appropriate measures should be taken concerning collection, transportation, storage and disposal of wastes.

对收集，运输，储存和废弃物要有适当的处理措施

11.4 Containers 容器

Containers of waste should be properly identified as to contents and other information, as appropriate.

适用时，废弃物的容器内合所装的废弃物的成份和其它住息应正确的识别。

11.5 Disposal 处理

The disposal of waste should be performed in an appropriate way with an adequate level of control.

采取合适的方法和恰当的途径对废弃物进行处理。