偏差处理程序

目的确立偏差处理程序，加强对于生产过程、检验过程、管理过程的控制，及时有效处理偏差，并及时采取有效的整改措施和预防措施，杜绝有意偏差的发生。PURPOSE To establish the procedure of deviation treatment, make good control during manufacturing and testing, handle the deviations in time and take the corrective and preventative action to prevent their recurrence, to avoid intentionally deviation happening.

范围适用于生产、检验、管理等全过程中发生的偏差。

SCOPE It applies to all of the deviations during manufacturing and testing etc.

责任

RESPONSIBILITY

●发生偏差的部门应发出并填写偏差记录，对偏差展开调查或必要时会同其他部门展开调

查。

●Any deviation should be recorded and explained by deviation occurring department, if

necessary, it should be investigated by its department or with other departments.

●发生偏差的部门应制定合适的整改措施和行动，对相关部门进行通报，并经质量管理部

审核批准。

●Acceptable correct actions should be established by the department concerned,

reported to relevant departments and approved by QA department.

●与偏差相关的其它部门根据实际的偏差情况，也应采取相应的合适措施。

●Other relevant departments with deviations should adopt appropriate correct action

according to the deviations.

●质量管理部负责监督本程序的执行和修订，确保关键偏差已被调查和解决，非关键偏差

已被解释说明。

●QA should supervise the implementation and updating of the procedure, make sure

that critical deviations have been investigated and resolved and non-critical deviations have been explained.

1 定义

1 DEFINITION

对于批准的程序或确立的标准产生的偏离情况均为偏差。

Any instance deviated from established procedures is deviation.

2 偏差分类

2 CLASS OF DEVIATIONS

关键偏差：对产品质量有影响或可能产生不良影响的偏差视为关键偏差。

Critical deviation: Deviation which will impact the product quality is regared as critical deviation.

非关键偏差：对产品质量不会产生影响即关键偏差以外的其他所有偏差视为非关键偏差。

Non-critical deviation: Deviation which won’t impact the product quality is non-critical deviation, that is, other deviations excluded from critical deviation.

3处理程序

3 HANDLING PROCEDURE

3.1 生产过程、检验过程、管理过程的偏差一旦发生（发现），操作人员应立即记录并报告。

如是正常白班时，应立即（1小时内）报告车间主任（部门经理）或临时授权人员，上述人员应在立即（1小时内）填写《偏差处理报告》交给对口QA，根据偏差情况判断偏差级别（关键偏差或非关键偏差）。

3.1 Once occurring the deviation during the manufacturing, analysis and management, the deviation

should be recorded and reported immediately. If it happens in daytime, workshop manager (department manager) or temporary authorized person should be reported within 1 hour, people mentioned above should fill the to relevant QA within 1 hour. The Deviation should be identified, whether it’s critical and non-critical.

如是中班、夜班或节假日，当班人员应立即（1小时内）电话通知车间主任（部门经理）或临时授权人员，上述人员立即（1小时内）电话通知对口QA，根据偏差情况判断偏