《整改与预防措施》由会员分享，可在线阅读，更多相关《整改与预防措施（8页珍藏版）》请在金锄头文库上搜索。
1、Page: SOP#: Eff. Date: Supersedes:STANDARDSTANDARDSTANDARD OPERATINGOPERATINGOPERATING PROCEDUREPROCEDUREPROCEDURE题目： Title整改措施和预防措施 CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) PROGRAM起草/修订人： Author日期： Date部门主管审查： Dept. Head Approval日期： DateQA 批准： Approved by QA日期： Date分 发： Distribution:QA、QC、生产、
2、工程、仓库、采购 QA, QC, Production, Engineering, Warehouse, Purchasing目的：制订用于监控“整改措施/预防措施”（CAPA）的方法。 PURPOSE:To define the method used to monitor the “Corrective Actions / Preventive Actions” (CAPAs) program.范围：适用于公司内所有与 CAPA 系统的启动、跟踪、延期或完成有关的人员。 SCOPE:This procedure shall apply to all site personnel invol
3、ved in the initiation, follow-up, extension or closure of a CAPA program.参考文件： REFERENCE AND ATTACHMENT: SOP/题目 SOP/TITLE记录/附件/题目 FORMS/ATTACHMENTS/TITLE定 义： DEFINITIONS:整改措施为消除已存在的不符合规定、问题或其他不希望有的情形而采取的措施；以允许某一 批或某一工艺能够继续生产直至放行。整改措施应在调查报告最终批准前完成。由于预防措施通常需要比较长的时间才能完成，所以在进一步的预防措施尚未最终完 成前，整改措施可由 QA 确定
4、是否已经完成。 Corrective ActionAn action taken to eliminate the cause(s) of existing nonconformities or other undesirable situations in order to release the lot or process.Corrective actions are completed prior to the final approval of the investigation reports.Corrective actions may be closed by QA with
5、or without further preventive actions, since preventive actions normally require longer time to implement.定义：（续） DEFINITIONS: (Cont.)Page: SOP#: Eff. Date: Supersedes:STANDARDSTANDARDSTANDARD OPERATINGOPERATINGOPERATING PROCEDUREPROCEDUREPROCEDURE题目： Title整改措施和预防措施 CORRECTIVE ACTION AND PREVENTIVE A
6、CTION (CAPA) PROGRAM预防措施为消除潜在的不符合规定或问题而采取的措施，以防止再次发生。预防措施通常与特定产品的放行没有关系。 Preventive ActionsAn action taken to eliminate the cause(s) of potential nonconformities or problems in order to prevent recurrence. Preventive actions are generally not related to specific product release activities.调查报告在本 SOP
7、 中，主要是指对偏差、用户投诉、年度产品评价、化验室调查、 OOS、OOT 和异常结果等的调查。 Investigation ReportThis term in this SOP refers to investigations of deviations, customer complaints, APR, LIR, OOS, OOT and aberrant results.CAPA 报告收集与 CAPA 有关的信息，并对整改/预防措施的状态进行跟踪以确保完成的报告。 CAPA ReportA report that captures the basic information rega
8、rding a CAPA and tracks the status of the corrective / preventive action to assure closure.规 程： PROCEDURE:责 任 人操 作 RESPONSIBILITY ACTION1.一般指南 GENERAL GUIDANCE1.1QA 负责制订公司的 CAPA。通过下面这些调查报告文件（父）来确定 CAPA（子）： The QA department is responsible for the generation of site CAPAs. A CAPA (child) is identifie
9、d in an investigation report document (parent) such as:1.1.1偏差调查（SOP 1-3002） Deviation Investigations (SOP 1-3002). 1.1.2化验室调查（SOP 3-0002） LIR (SOP 3-0002). 1.1.3用户投诉 （SOP 1-4002） Customer Complaint (SOP 1-4002). 1.1.4年度产品报告（SOP 2-0003） Annual Product Report (SOP 2-0003). 1.1.5其他确定预防或整改措施的系统 Any oth
10、er system that identifies a preventive or corrective action.1.2CAPA 系统还适用于跟踪自查所列出的预防或整改措施。 The CAPA system is also used to track preventive or corrective actions that are identified in self-inspections.责 任 人操 作 RESPONSIBILITY ACTIONPage: SOP#: Eff. Date: Supersedes:STANDARDSTANDARDSTANDARD OPERATING
11、OPERATINGOPERATING PROCEDUREPROCEDUREPROCEDURE题目： Title整改措施和预防措施 CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) PROGRAM1.3可以通过下面的方法将 CAPA 信息传递至 QA： Information that a CAPA exists is communicated to QA by the following methods:1.3.1偏差调查报告、化验室调查报告、用户投诉报告、年度产品评价。 In Deviations, LIR, Customer Complaints
12、, APRs. 1.3.2QA 保存一份递交文件的复印件并启动 CAPA。 QA maintains all hard copy paperwork submitted to create a CAPA. 1.3.3QA 通过 CAPA 来保存这些文件。 QA will maintain files to store such information by CAPA number. 1.3.4QA 对 CAPA 进行审核，并有权根据准确性和完整性来接受或拒绝 CAPA。所有的 CAPA 必须包括预防措施的说明、责任人和完成日期。 对于要求再培训或文件审核的预防措施，必须提供受影响的人员清单。Q
13、A reviews the CAPA and has the authority to accept or reject based upon accuracy and completeness. All CAPAs must include a description of the preventive action, the person responsible for its completion and the target completion date. For preventive actions requiring retrain / review of a document,
14、 a list of the affected individuals must be provided.QA 经理或其 指定人员2.CAPA 启动QA manager or DesigneeCAPA INITIAITON2.1定义 CAPA 的范围。 Define scope of the CAPA.2.2根据 QA 审核的情况，如果不需要 CAPA，则 QA 将取消 CAPA，不再采取进一 步的动作。 Based on QA review, if the CAPA is not required, QA cancels CAPA, and no further action is take
15、n.2.3为启动一个新的 CAPA，给定连续的 CAPA 号（注：可用年月日加流水号表示） ，同时在 CAPA 状态报告上记录下面的信息： In order to initiate a new CAPA, assign the sequential CAPA # (note: indicated by year and month and date, and sequence number) and enter the following information in the assigned CAPA log book:2.3.1责 任 人：完成 CAPA 的责任人。 Assigned to
16、: The person responsible for completing the CAPA. 2.3.2相关记录：确定 CAPA 的文件（父）数。 Related record(s): The number of the parent document that identified the CAPA. 2.3.3类 型：确定 CAPA 的文件（父）类型。 Type: The category of parent document that identified the CAPA.责 任 人操 作 RESPONSIBILITY ACTIONPage: SOP#: Eff. Date: Supersedes:STANDARDSTANDARDSTANDARD OPERATINGOPERATINGOPERATING PROCEDUREPROCEDUREPROCEDURE题目： Title整改措施和预防措施 CORRECTIVE ACTION AND PREVENTIVE AC
