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1. 目的Purpo
消除实际或潜在的不合格因素,及时采取有效的纠正和预防措施,并确保类似问题不再重复发生,以达到自我完善﹑自我提高的目的。
Eliminating the cau of actual and potential nonconformities, carrying out effectively corrective and preventive actions in time to ensure against the occurrence of similar problem to make lf-improvement and development.
2.范围 Scope
适用于本公司对不合格品及不合格项采取的纠正和预防措施的控制。Apply for the control to the corrective and preventive action to the nonconforming product and items. 英语四级
3.定义Definitions
3.18D: 8个遵循条款eight disciplines.
3.2CAPA：纠正预防措施。CAPA is the short form of Corrective Action and Preventive Action.
4.职责Responsibilities
4.1各部门经理负责采取纠正和预防措施的管理和监督工作,以及联系和本部门有关的跨部门的纠正和预防措施的组织实施，确保改进行动可达到目标。
The managers 丰溪里 of department are responsible to manage and supervi the corrective and preventive action and communicate with related dept to arrange and perform the corresponding corrective and preventive action to meet the goals and strategies of the unit.
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4.2各部门人员负责职权范围内纠正和预防措施的实施。hump
Personnel in his own department/ction are responsible for executing the corrective and preventive action within his/her authority.
4.3总经理或管理者代表负责重大的纠正和预防措施的审批工作以及协调和监督工作。
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General manager or management reprentative is in charge of the review and approval of important corrective and preventive action and related coordination, supervision action.
4.4对于8D所提出的行动，小组负责人应负责及时执行。
For 8Ds, the team leader is responsible for timely execution of 8D actions.
5.作业程序 General Procedure
5.1纠正预防实用情况 Corrective and preventive action application
5.1.1任何为消除现有不合格的纠正预防措施,其实施程度应需与问题的重要性及所承受的风险程度相适应，并采用适当的防错技术。
Executing all of any corrective and preventive action to eliminate the existing nonconformity shall depend on the nature and risk of problem and taking mistake proofing where applicable.
5.1.2当采取措施时，需强调过程的有效性和效率，所确定的纠正和预防措施需注重消除不合格或预防潜在不合格产生的根源，以避免其再发生。
When take the actions, shall be emphasized its effectiveness and efficiency, and stress to avoid the actual or potential nonconforming occurring once again according to the confirmed root cau.
5.1.3致我们终将逝去的青春经典台词纠正预防措施考虑的信息来源包括以下，但不限于：
The corrective and preventive actions considered can from below information, but not only be limited to them:
a. 管理评审的输出；The outputs of management review;
b.内、外部质量审核发现的不符合项或问题点; Nonconformance or problems discovered during internal/external audits;
c.客户报怨Customer complains;
d.客户退货 Customer returned goods;
e.客户满意度调查的输出Outputs of customer satisfaction survey;
f.不合格报告/趋势；Nonconforming reports/Trends
g.数据分析的输出；Outputs of data analysis;
namerichh.质量目标考核结果。Quality targets achievements.
英文在线翻译
j.程序运作中的不符合项。The NG items to the operational procedures
k.不符合相关法律法规要求。Against some related statutes and regulations
5.2 当同一个问题在CAPA关闭后又出现，则这个问题需再开一个CAPA，并在新的
CAPA中提
doma及先前的CAPA编号或相关信息。
If the same issue was found after the closure of CAPA, this issue should be documented in a new CAPA and refer to the previous CAPA No. or related information.
5.3对出现不合格品和不合项采用的纠正措施及其实施控制，应能举一反三同时消除在其他类
似的过程和产品中存在不合格原因。
Where applicable the corrective actions taken and control implemented shall be eliminate the cau of a nonconformance to other similar process and products.
5.4永久性措施的巩固Permanent action consolidation
5.4.1随着纠正和预防措施的实施,对于涉及永久性的措施,按《文件控制程序》修改相关文件加以巩固。
With the implementation of corrective and preventive action, the permanent action is to be consolidated by amending related documents in accordance with “Document control procedure “.
5.4.2质量部确保将采取纠正和预防措施的有关信息提交管理评审。
Quality department ensure the information about carrying out corrective and preventive action be submitted for management review.
6．记录 Records
纠正预防措施报告 Corrective & Preventive Actions Report EKCQA-004
