ISO纠正与预防措施流程图英文版

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纠正和预防措施标准管理规程SMP for Corrective and Preventive Actions中英文双译

纠正和预防措施标准管理规程SMP for Corrective and Preventive Actions中英文双译

1.目的Purpose本文件规定企业纠正预防措施系统(CAPA)如何建立,通过对纠正措施的制订和实施进行有效的控制,消除产生问题的实际原因,防止再次发生不合格/不符合,以达到持续改进的目的。

This document defines how the company creates CAPA system and then effectively controls it by making and implementing corrective and active actions to eliminate the real reasons of problem, prevent against disqualification and non-compliance and reach the goal of continuous improvement.2.适用范围Scope本文件适用于全公司所有部门和场所对有关产品、过程及质量管理体系纠正和预防措施的控制。

This document applies to the control of corrective and preventive actions regarding products, process and quality management system .3.职责Responsibility3.1.责任部门为CAPA的发起人。

发起人负责发起CAPA,填写CAPA来源,描述事件,识别根本原因,写出采取的纠正与预防措施,预计的时限,CAPA人员的姓名并获得责任部门负责人的批准。

Responsible department is the initiator of CAPA. Initiator is responsible to raise CAPA, write the source of CAPA, description of incident, Identify the root cause, write CAPA to be taken, write estimated timeline, write the responsible person’s name for CAPA completion and take approval from the head of the responsible department.3.2.CAPA责任人负责CAPA的延期申请并在措施完成后通知QA。

纠正和预防措施控制程序(英文版)

纠正和预防措施控制程序(英文版)
5.1.2Inspector should inform operators to correct and to meet quality requirement if any F G is out of spec and not meet customer requirement. Quality abnormal feedback form should be issued to responsible department for discussion and follow up.
4.2.QA Department is the direct responsible department of this procedure.
5.Procedure
5.1Corrective actions as follows:
5.1.1Rejected raw material should be dealt according toControl of InspectionandControl of Abnormal Events.
5.1.3.1First piece quality confirmation.
5.1.3.2Quality confirmation after corrective actions taken.
5.1.3.3In process quality confirmation.
5.1.3.4Quality confirmation for finished goods after actions taken.
5.1.3.5Others.
5.1.4 In order to prevent the recurrence of similar quality issue, design, spec, work instruction etc should be revised to solve the quality issues thoroughly.

纠正与预防措施控制程序(中英文)

纠正与预防措施控制程序(中英文)

纠正与预防措施控制程序Corrective and Preventive Action Control Procedure1.目的Purpose:及时发现不符合,并采取有效的纠正和预防措施,以消除存在或潜在的不符合原因,实现管理体系的不断完善和持续改进。

To found non-conformity in time, and to take effective corrective and preventive action, that remove the actual or potential non-conformity reasons, to realize the management system is constantly improved and continually improved.2.范围Scope:适用于管理体系运行过程中的改进、纠正和预防措施的制定、实施和验证。

This document applies to the improvement in the process of management system, formulation, implementation and verification of corrective and preventive action.3.术语Terms:纠正—为消除已发现的不符合所采取的措施。

Corrective - the action taken to remove the non-conformity founded.纠正措施—为消除已发现的不合格或其他不期望情况的原因所采取的措施。

Corrective action - the action taken to remove the reason of the non-conformity founded or other not expected situation.预防措施—为消除潜在的不合格或其他潜在不期望情况的原因所采取的措施。

CorrectiveandPreventiveActionProcess纠正和预防措施过程

CorrectiveandPreventiveActionProcess纠正和预防措施过程

纠正和预防措施过程GT001, rev. 2 Document # GOP210 Release Date: 25-AUG-2017 Page 1 of 7Document Owner: Director – Internal Audit Approvals: VP – Technical Management & QualityPurpose目的The purpose of this document is to describe the process for handling actual and potential non-conformances to the certification program, and determining and implementing necessary corrective and preventive action.该文件的目的是描述认证项目实际以及潜在的不符合的处理过程,以及决定和实施必要的纠正和预防措施。

Scope范围This process applies to corrective/preventive actions within Business Assurance identified as a result of:该过程适用于商业保障部(BA)在以下方面所识别出的纠正/预防措施:a) Findings from internal and external audits来自内部和外部审核的发现b) Other CARs其他CARi) Results of analysis of trends indicating action is needed趋势分析的结果所需的措施ii) Results of activities indicating internal concerns exist (proposal review, technical review, etc.) 存在的相关活动的内部问题的结果(合同评审,技术评审等)iii) Requests for corrective/preventive action issued提出的纠正和预防措施要求(1) by any personnel (permanent or contractual) of Intertek由任何Intertek人员(包含长期合同或临时合同)提出的(2) by the Impartiality Committee由公正性委员会提出的Note: All Opportunities For Improvement (OFIs) shall be considered but only those where action has been determined to be necessary are to be entered in the CAPA database.备注:需要考虑到所有的改进机会(OFIs),只有在被认定必须采取措施时才会录入在CAPA数据库。

纠正预防措施程序 Corrective and Preventive Action Procedure

纠正预防措施程序 Corrective and Preventive Action Procedure

1目的和范围1.1目的:本程序的目的是明确如何启动和实施纠正/预防措施过程以及相关部门在纠正/预防措施过程中的职责。

及时发现潜在风险并采取预防性行动,减轻已发生问题如召回等所产生的影响,降低产品缺陷率,并发生偏差时及时采取措施纠正,提高客户满意度。

1.2范围:包括客户投诉、召回、生产、自检、外部审计、产品年度回顾等一切与产品质量相关的活动中,预先发现问题或发生偏差后所采取的措施。

2定义纠正为了消除已经出现的不合格而采取的措施。

纠正措施对出现的不符合的原因采取的措施,防止问题的再发生。

预防措施对潜在的不合格原因采取的措施,预防问题的发生。

纠正/预防措施报告用于调查产品、制程、质量体系不合格的产生/潜在原因,记录纠正和预防措施内容及实施效果等。

不符合违背定义的要求,隐含的要求,法定要求。

不符合分析针对不符合事件的评审和分析,确定问题根源。

CAPA 纠正预防措施的泛称。

根本原因可导致不合格,或不良趋势结果的原始来源。

趋势分析评估数据来确定是否有任何趋势存在的过程。

影响评估判定不合格影响程度的过程。

CAPA负责人负责组织调查和完成CAPA报告,通常是一个流程或部门或领域的负责人。

行动负责人纠正预防措施过程中某个具体行动的负责人。

验证通过提供客观证据对规定要求已经满足的认定。

确认通过提供客观证据对特定的预期用途或应用要求已经满足的认定。

3职责和权限质量部当产品、制程及/或质量体系的不符合确实需要调查时,发出纠正/预防措施;负责本程序的履行和维护,登记并跟踪纠正/预防措施过程;组织相关部门进行初步的调查,原因分析,确定主要责任部门;负责维护所有纠正/预防措施报告的记录,验证纠正/预防措施的实行情况及效果;确保其合理性、有效性、充分性。

质量经理负责批准涉及产品召回、药品监督管理部门检查发现等风险级别较高问题的整改措施。

管代审批风险评估表,对于意见不一致的问题,对CAPA关闭有最终决定权。

其他部门审批本部门相关的影响评估表,部门经理指定CAPA 负责人;提供适当的资源和指导来实施调查;提供适当的资源和指导来实施调查;审批根本原因及相应的行动计划(医疗相关的CAPA);CAPA措施负责人负责定期检查整改措施计划的实施及完成。

纠正和预防措施程序中英文版本

纠正和预防措施程序中英文版本
当生产过程(从原材料到半成品、成品及交付)及质量管理体系(含危害物质过程管理体系)、环境管理体系运行过程出现不合格项或潜在不合格项时,发现者须提出此不合格项,并由责任部门采取纠正或预防措施。
5.1.1 Inthe incoming material inspection process, if it is inspected to be defective material by MRB, IQC should issueDefective Material Improvement Notification.
5.1.4生产过程中巡检检验不合格,不合格率超出5%时,由PQC发出《品质异常反馈报告》给责任单位。
5.1.5 If batch reject are detected in final quality control inspection, FQC issuesQuality Abnormity Feedback Report.
3.1各职能部门负责纠正预防措施中问题的提出,责任部门制订相应的纠正措施、预防措施的评估。
3.2 Management personnel affirm the effectiveness of corrective and preventive action.
3.2管理层对纠正预防措施有效性进行肯定。
4.4不合格:未满足明示的,通常隐含的或必须履行的需求或期望,即未满足要求。本程序中的“不合格”为不符合、不合格品、不合格项的统称。
4.5 Major reject: defect more than 5%.
4.5严重不合格:超过5%的不良。
5、Procedure Content /程序内容
File name文件名称
5.1.3制程生产中出现技术或工艺导致严重或批量不合格产生,由生产部门发出《品质异常反馈报告》给中央研究院、工程部。

ISO13485纠正和预防措施控制表格汇编(中英文)

ISO13485纠正和预防措施控制表格汇编(中英文)

文件制修订记录目录1、纠正预防措施报告单Report of Corrective and Preventive Action 2、纠正预防措施状态报告CAPA Status Report3、纠正预防措施有效性核查报告CAPA Effectiveness Verification Report4、8D纠正预防措施报告8D Report5、内部质量审核不合格报告Non-conforming Report纠正预防措施报告单Report of Corrective and Preventive Action 编号:Section A 不合格(潜在不合格)来源及情况描述(Source and Description of the issue)[ ]外部审核External Audit; [ ] 内部审核Internal Audit; [ ]管理评审Management Review; [ ]客户投诉Customer Complaint; [ ] 生产异常Production abnormity; [ ]不合格品控制Non-Conforming Product; [ ] 其它Other提出人Initiator:日期Date:Section B调查分析Investigation调查部门(人)Investigator: QA:Section C 纠正/纠正(预防)措施的制订Proposed Correction/Corrective(Preventive) Actions纠正Correction:纠正(预防)措施Corrective(Preventive) Actions:改进部门Improvement Department预计完成时间Due Date 制定人/时间Prepared by/DateSection D纠正预防措施审批Approval of Proposed Corrective and Preventive Actions部门主管Department Supervisor 日期DateQA经理QA Manager 日期Date其他Others()日期Date()日期DateSection E纠正预防措施的实施CAPA implementation记录人Recorded by:日期Date:QA确认QA Confirm:日期Date::纠正预防措施状态报告CAPA Status ReportSection A 纠正预防措施通知(Notification of CAPA due)纠正预防措施编号CAPA Ref: ___________ 预计完成时间Due Date: _______________ 调查人/制定人Investigator/Owner: _________________以上涉及的纠正预防措施必须在预定的时间内完成、关闭。

Corrective Action纠正和预防措施程序(中英文)

Corrective Action纠正和预防措施程序(中英文)

1.0 PURPOSE 目的1.1 The procedure defines the process for Corrective &Preventive Action and ContinuousImprovement and makes sure quality and environment management system is on continuingimprovement and continuously meets customer requirements.确定纠正预防和持续改进的流程,确保公司的质量管理体系和环境管理体系是处于持续改进的,不断满足客户需要。

2.0 SCOPE 范围2.1 Apply to the products and processes which are related with quality management system andenvironment management system, such as internal products or processes required correctiveaction or improvement, customer complaint, internal/external audit and environmentnonconformity, KPI over target, and etc.适用于公司内质量管理体系和环境管理体系所涉及的产品和过程。

比如要求纠正或改进的产品、过程,客户投诉,内/外部审核和环境不符合,目标未达成,数据分析等。

3.0 DEFINITIONS定义3.1 Correction: action to eliminate a detected nonconformity. A correction can be, for example,rework or re-grade.纠正:为消除已发现的不合格所采取的措施,如返工,降级等。

ISO9001 纠正预防措施程序

ISO9001 纠正预防措施程序

4.7 QP-4.16-1
Records Control Procedure 记录控制程序
4.8 QP-4.17-1
Internal Quality Audit 内部审查程序
4.9 QP-4.14-7
Environmental Information Communication Procedure 环境信息沟通程序
3.3 DG - refers to Aztech Communication Device (DG) Ltd DG – 指 Aztech 通信设备(东莞)有限公司
3.4 PQM – refers to Product Quality Management in DG PQM – 指产品质量管理(东莞)
Quality Manual 质量手册
4.2 QP-4.1-1
Management Review
Form # : 03-2 [QP-4.5-1]
CORRECTIVE AND PREVENTIVE ACTIONS PROCEDURE
DOC NO. REV PAGE DATE
: QP-4.14-1 : 08 : 2 OF 8 : 21-Apr-2014
相关环境管理不符合的纠正预防措施,各责任部门依据相关程序文件要求执行。
7
PROCEDURE
程序
7.1 PQM personnel, upon receiving feedback from the Sales personnel or directly from the customer, shall review the contents of the issue reported. 从销售人员或直接从顾客接收反馈后,PQM 人员应评审问题报告的内容。

质量异常纠正及预防改善措施流程图

质量异常纠正及预防改善措施流程图

继续生产 Continue Production
YES
效果验证 Effect Confirmation
Novatron
来料质量异常纠正及预防改善措施流程图 Incoming material quality deviation corrective and preventive action flow chart
来料
Incoming
整批不合格 Total Defect Lot
《供应商纠正/预防措施联络单 Send VCAPAN
NO
入库
Stocking
Novatron
质量异常纠正及预防改善措施流程图 Quality Deviation Corrective and Preventive Action Flow Chart
制程质量异常纠正及预防改善措施流程图 Production process quality deviation corrective and preventive action flow chart
质量异常 Quality Deviation
QC确认 QC Confirm
NO
记录/反馈 Record/Feedback
技术部确认 Tech Confirm
NO
〈品质异常联络单〉 Quality Deviation Notice
YES YES
原因分析 Cause Analysis
纠正/预防措施 CAPA
IQC check
NO
物料评审会议 MRB
不良原因分析 Cause analysis
YES
合格标识 Qualified label
让步接收 Waive
挑选 Select

ISO9001:2015监视测量分析改进控制程序英文版(含流程图)

ISO9001:2015监视测量分析改进控制程序英文版(含流程图)

MRF Name / LogoQP10 – Monitoring, measurement andimprovementApproved:Management RepresentativeNote:Within this manual template, red italic text should be replaced by MRF specific information and any guidance in ‘text boxes’ should be implemented.1 PurposeThis procedure describes the processes for customer satisfaction monitoring, the monitoring and measurement of processes, the implementation of corrective and preventive actions (including the management of customer complaints) and the continual improvement of Quality Management System (QMS) effectiveness.2 ScopeThis procedure contains the following sections:5.1 Customer satisfaction5.2 Process monitoring5.3Analysis of data5.4Control of non-conformity5.5 Continual improvement5.6 Corrective action5.7 Preventive action6Related documentsAppendix A – Customer Complaints FlowchartAppendix B – Corrective Action, Improvement and Customer Satisfaction Flowchart3Definitions and glossaryMR - Management RepresentativeQA - Quality AuditorQMS - Quality Management SystemCSAT - Customer SatisfactionNC - Nonconformity4 ResponsibilityThe MR is responsible for the overall implementation of this procedure, including the gathering of customer satisfaction data and the implementation of improvement activity.The Quality Auditor (QA) is responsible for the monitoring of QMS effectiveness through audit and process review.5 Procedure5.1 Customer satisfactionAll feedback from customers is monitored and analysed to ascertain customer satisfaction. Any service problems or improvement suggestions can be received by any member of staff. A record of correspondence related to significant feedback is maintained on a Quality Report / customer compliant form (QFyy).All customer feedback resulting from perceived dissatisfaction in relation to the supply of services is recorded on a Quality Report form and is identified as a customer complaint.Appropriate information is recorded on the Quality Report form to identify the customer, problem type and initial corrective action.The Quality Report form is completed with corrective and preventive actions resulting from the analysis of the issue raised. Results of the investigation and where required, subsequent corrective action is fed back to the customer. All corrective action is to be reviewed by the MR before full implementation.feedback and suggestions, including those received through CustomerSatisfaction Surveys (CSS) QFxx. All customer related Quality Reports arereviewed at least quarterly to ascertain whether customer requirements arebeing met and to identify possible opportunities for improvement.The CSS may be sent to various customers / customer organisations onconclusion of a significant supply activity. Customer satisfaction feedback isalso obtained through the company website via email. The method for analysing the results from the CSS will be defined in associated data analysis reports.5.2 Process monitoring and measurementQuality processes and procedures are verified by internal audit and process monitoring. These measures are used to monitor quality and operational processes to determine that planned results have been achieved including conformity with MRF Name’s quality objectives and targets. Audit non-conformities and their associated corrective actions are recorded onan Audit Report form (QFaa). Further details are given in the management procedure, QP09 Internal Auditing.Where process monitoring and review identify that planned results are not being achieved or performance could be improved, the NC or improvement suggestion is recorded on a Quality Report form (QFyy). Where appropriate, corrective or preventive action is taken to ensure continued conformity of service.5.3 Analysis of dataAppropriate data is determined, collected and analysed to demonstrate the effectiveness of the MS and operational processes. This data is then used to evaluate where improvements in management system effectiveness can be made.The data generated from monitoring and measurement or other relevant sources is analysed to provide performance information relating to:•Customer satisfaction.•Conformity of service requirements.•Trends/ characteristics of processes and services, and opportunities for preventive action.•Sub-contract / service provider performanceResults of data analyses are reviewed at six monthly Management Review meetings.5.4Control of non-conformityWhere a non-conformity is identified with the activities and services provided by MRF Name, this will be recorded on a Quality Report for QFyy, investigated and acted upon as appropriate. All such instances are subject to review in line with the degree of concern. Records of non-conformity are maintained and analysed as part of Management Review. Products or services are reviewed by authorised staff in order to determine any remedial action and any remedial work is subsequently inspected.In the unlikely event that a service may not fully meet specified requirements, but is still acceptable to the client, this will be reported on a concession (Quality Report QFyy) as appropriate. Records of any concessions will be held by the Management Representative.5.5 Continual improvementThe effectiveness of the MS is continually improved through the review of Quality Policy Statement and Quality Objectives, the analysis of audit results, corrective and preventive actions, customer feedback and associated data.Improvement suggestions can also be documented by any member of staff on a Quality Report form (QFyy). Improvement actions are also reviewed and documented as an output of the Management Review.If Quality Objectives have been reached and can be maintained, then the targets are stretched to ensure that the company meets its objective of continual improvement and performance growth.5.6 Corrective actionAny non-conformities are analysed to develop corrective actions which eliminate root cause and prevent re-occurrence. This reporting procedure includes the activities and requirements for:•Reviewing NCs, including customer complaints.•Determining the cause of an NC.•Evaluating the need for action to prevent re-occurrence.•Determining and implementing action needed.•Recording results of action taken.•Review of corrective action implemented.。

中英文纠正预防措施程序文件

中英文纠正预防措施程序文件

Procedure 程序Issue版本:1TITLE:Corrective & Preventive Action Control 标题:糾正和預防措施控制DOC No.文件編號:FQP-CAR01 Pages: 1 of 6Revision History 更改记录Issue 版本Page#页码Rev版次CHANGE更改內容WRITTEN BY编写DATE日期Review and Approval審查和批准Review [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] Signature / DateISO Officer:________________________QC Sup:_____________________________QE Sup: ____________________________QA Mgr&MR:__________________________ProgramDirector: __________________________PM: ________________________________Store Mgr:_________________________Purchasing Mgr:______________________PMC Sup:_____________________________Shipping Sup:________________________Facility Mgr: ______________________Review[ x ][ x ][ x ][ x ][ x ][ x ][ x ][ x ][ x ]Signature / DateFacility Engineering Mgr:___________________________________ME Mgr:____________________________1st process Mgr:______________________2nd Process Mgr:______________________PPC Mgr: ____________________________Tooling Repair & Maintenance Mgr:___________________________________HR Mgr: ________________________ADM Mgr:_____________________________MIS Mgr:_____________________________APP[ x ]Signature / DatePlant. Manager:____________________Checked by DCC / Date: 文控審核/日期:TITLE:Corrective & Preventive Action Control 标题:糾正和預防措施控制DOC No. Rev文件編號: FQP-CAR01 版次: A Pages: 2 of 6Effective date Expiry date文件生效日期:____________________ 文件失效日期:_________________1.0目的Purpose:消除實際或潛在的不合格因素,及時采取有效的糾正和預防措施,并確保類似問題不再重复發生,以達到自我完善﹑自我提高的目的。

ISO14001:2015纠正与预防措施程序英文版

ISO14001:2015纠正与预防措施程序英文版

1. Contents1.Contents2.Scope and application3.Introduction4.Definitions and abbreviations5.Responsibilities6.Procedures7.Interacting Procedure8.Supporting form9.Flow chart of Procedure2. Scope and applicationAll issues where non-conformances are identified to ISO 14001, non-compliance to regulations, complaints from third parties and customers. This procedure is applicable for ShenZhen Factory.3. IntroductionThis procedure defines responsibilities and methods for registration, corrective and preventive action relating to an environmental non-conformance and remarks of internal and external environmental audits.4. Definitions and AbbreviationsEIRF Environmental Incident Registration FormCAR Corrective Action RequestThe concerned department Department wherein a non-conformance is first observed.The action department Department which physically implements the agreed correctiveand preventive action5. ResponsibilitiesEMS Officer -to maintain CAR, correspondences and complaintsDept. Head -to establish what corrective action is required and establish if changesare required to existing procedures.-to monitor the follow-up details of corrective action6. Procedures6.1 All information relating to an environmental non-conformance and remarks of internaland external environmental audits shall be documented on a Corrective Action Request(CAR).6.2 Any system deficiencies identified, which may cause adverse effects on environmentother than internal and external audits, shall be entered onto an Environmental IncidentRegistration Form (EIRF).6.3 Where a non-conformance relates to an off-site release potentially resulting innon-compliance to environmental legislation and regulations, reference should be madeimmediately to emergency response and communication (external) by the concerneddepartment and action department. Any environmental incidents shall be documentedon Environmental Incident Registration Form (EIRF) by department head of theconcerned department.6.4 All issues raised on environmental performance shall be provided to the DepartmentHead on a CAR. The CAR shall be issued within 2 weeks from the time of anon-conformance is identified. The CAR shall be collected from the Department Head 2weeks from date of issued.6.5 The Department Head shall :6.5.1 investigate the cause of non-conformance.6.5.2 establish what corrective action is required and establish if changes are requiredto existing procedures.6.5.3 acknowledge any complaint from a third party and respond in writing detailingwhat actions are to be taken and who will be responsible.6.5.4 document the modified procedure.6.6 The corrective action shall be authorized by Department Head who shall sign theCorrective Action Request (CAR).6.7 Where a serious defect in the system or legal issue is identified, an unscheduled auditmay be considered in accordance with Management Review. Any change in auditfrequency shall be determined by the Department Head.6.8 The Department Head shall ensure action taken is effective from any CAR raised anddecide whether a preventive action is needed.6.9 Copies of CAR, correspondence and complaints shall be maintained by EMS Officer.7. Interacting ProcedureQKW-666-QA10001 Corrective and Preventive Action ProcedureQKW-666-EMS0003 Environmental Incident Registration Procedure8. Supporting formQKW-666-EMS0004 Form 1 Corrective Action Request (CAR) Appendix I9. Flow chart of procedureN/AAppendix I Corrective Action Report for EMS。

纠正和预防措施控制程序(中英文)

纠正和预防措施控制程序(中英文)

质量管理体系程序文件QUALITY SYSTEM PROCEDURE编制Initiated by:审核Reviewed by:批准Approved by:发放范围(applied for):生效日期(Effective Date):2022年05月10日文件修改履历Document History Summary目录Ta b l e o f C o n t e n t序号名称页码Item #Title Page1 目的(Purpose) (2)2 范围(Scopes) (2)3. 定义(Definitions) (2)4 职责(Responsibilities) (2)5 工作流程(Working procedures) (3)6 相关文件(Relevant Documents) (8)7 相关记录(Relevant Records) (8)8 附件(Appendixes) (8)Document History Summary (1)1 目的(Purpose)本程序规范了为消除实际或潜在的不合格而采取纠正预防措施的流程,以确保类似或潜在不合格不再发生,促进质量管理体系的持续改进。

The procedure clarifies the process to adopt corrective and preventive action to eliminate the existing or potential non-conforming and prevent similar non-conforming in the future and promote the sustained improvement of the quality management system.2 范围(Scopes)本程序适用于本公司质量管理体系范围内纠正措施和预防措施的制定、实施与有效性验证。

The procedure is applicable to the establishment, implementation and validation of corrective and preventive action within the quality management system.3. 定义(Definitions)3.1 纠正:为消除已发现的不合格所采取的措施;Correction: Action to eliminate a detected nonconformity.3.2 纠正措施:为消除已发现的不合格或其他不期望情况的原因所采取的措施;Corrective action: Action to eliminate the cause(s) of a detected nonconformity or other undesirable situation. 3.3 预防措施:为消除潜在不合格或其他潜在不期望情况的原因所采取的措施;Preventive action: Action to eliminate the cause of a potential nonconformity or other undesirable potential4 职责(Responsibilities)4.1 质量管理体系内各部门负责将质量管理体系持续改进的机会,包括不合格情况、潜在不合格情况、改进机会反馈至QA。

AS9100纠正和预防措施程序英文版

AS9100纠正和预防措施程序英文版

1.0 PURPOSE1.1. The purpose is to provide a procedure for ide ntify ing Noncon forma nces and pote ntial Noncon forma nces,in vestigat ing the cause, determ ining and tak ing actions to elimi nate the cause and follow-up activities to en sure agreed actions were take n and effective.2.0 SCOPE2.1 This procedure applies to all Noncon forma nces and pote ntial Noncon forma nces ide ntified withinthe Quality Man ageme nt Systems.3.0 RESPONSIBILITY3.1 The Man ageme nt Represe ntative, or delegate, is resp on sible for:*Assig ning CAR nu mbers *Assig ning resp on sibility to inv estigate the cause and recomme nd acti on to be take n *Review ing cause, recomme nded acti on and impleme ntati on schedule for adequacy *Assig ning In ternal Auditors to verify impleme ntati on and effective ness of CARs *Forwardi ng copy of closed CARs to the Observer *Mai ntai ning CAR database and copies of CARs * An alyz ing appropriate in formati on in order to detect opport un ities for preve ntive acti on3.2 The appropriate personnel are responsible for investigating the cause of noncon forma nce/pote ntialnoncon forma nee, record ing the results of the inv estigatio n, recommending appropriate action, implementing agreed action and applying sufficie nt con trols to en sure acti on is effective.3.3 The Observer of a noncon forma nce/pote ntial noncon forma nee is resp on sible for origi nati ng aCAR and forwardi ng to the Man ageme nt Represe ntative.3.4 The Internal Auditor is responsible for verifying that agreed action has been impleme nted and iseffective.4.0 GENERAL4.1 The Manageme nt Represe ntative forwards a CAR to the supplier whe n it is determ ined that the supplieris resp on sible for the root cause. If the supplier is intern al, the CAIR process is used.5.0 DEFINITIONS5.1 Pote ntial Noncon forma nee: The predictio n that con diti ons exist which may lead to a noncon formanee uni ess acti on is take n.5.2 Noncon forma nee: The non fulfillme nt of a requireme nt. Examples in clude:5.2.1The abse nee of a procedure required by the Quality Man ageme nt System.522 Failure to effectively impleme nt a procedure required by the Quality Man ageme nt System.5.2.3 A con firmed customer compla int.5.2.4An out of calibration instrument or measuring device.5.2.5 A rejected product.5.2.6 A quality systems violation.5.3Corrective Acti on: acti on take n to elimi nate the cause of a detected noncon forma nee or other undesirable situati on. Corrective actions preve nt recurre nee.5.4Preve ntive Actio n: actio n take n to elimi nate the cause of a pote ntial noncon forma nee or otherun desirable pote ntial situati on. Preve ntive actions preve nt occurre nee.5.5Observer: anyone observ ing a noneon forma nce/pote ntial noneon forma nee or recei ving a customercompla int.5.6Immediate Action: corrective or preve ntive as appropriate to elim in ate the cause of a noneon formance/pote ntial noneon forma nee in order to preve nt recurre nce/occurre nee.5.7Root Cause: Underlying reason of why the discrepancy occurred, determined as results of an in vestigation of the product, process an d/or quality system.5.8Corrective Action Verification: Activity undertaken immediately after impleme ntati on of root causecorrecti on to verify impleme ntati on5.9Follow-Up: Planned activity to determine if implemented root cause corrective action is effective andbeing adhered to.5.10CAR -Corrective Actio n Request gen erated from any noneon forma nee.&0 PROCEDURE6.1The Observer of a noneon forma nce/pote ntial noneon forma nee orig in ates a QPF1400- 1 CAR form bycomplet ing the detail secti on of the CAR. The Observer provides sufficie nt details of the noneonforma nce/pote ntial noneon forma nee to permit an effective inv estigati on of the cause.6.2The Observer forwards the CAR to the Man ageme nt Represe ntative.6.3The Man ageme nt Represe ntative reviews the details provided to en sure they are sufficie nt and requestadditi onal details as appropriate.6.4The Man ageme nt Represe ntative assig ns a CAR nu mber and other in formatio n such as refere nee, procedurenu mber, requireme nt sect ion nu mber, etc. as appropriate in the database.6.5The Man ageme nt Represe ntative assig ns resp on sibility for inv estigati ng the cause of the nonconforma nce/pote ntial noncon forma nee and forward a copy of the CAR to that in dividual.6.6The assig ned in dividual inv estigates the cause of the noncon forma nce/pote ntial noncon forma nee,record the results of the inv estigati on, recomme nd appropriateacti on to be take n and forward the completed CAR to the Man ageme nt Represe ntative.6.7The Man ageme nt Represe ntative reviews the completed CAR to determ ine if the cause, recomme nded action and schedule for impleme ntati on are appropriate to the effects of the noncon forma nee encoun tered.The Man ageme nt Represe ntative reissues using QPF 1400-2 for additional effort if the cause, recommended actions or schedule for impleme ntati on are con sidered in adequate.6.8The Man ageme nt Represe ntative assig ns an In ternal Auditor to verify that the agreed acti on wastake n and was effective. The Man ageme nt Represe ntative closes the CAR if no action is recomme nded.6.8.1The Internal Auditor closes the CAR if the agreed action is verified as impleme nted andeffective and forwards the CAR to the Man ageme nt Represe ntative.6.8.2The Internal Auditor returns the CAR to the Management Representative if the agreed actionwas not implemented or could not be verified as effective.6.8.2.1 The Man ageme nt Represe ntative reassig ns the in effective CAR requesti ng additional in formati on.6.9The Man ageme nt Represe ntative forwards a copy of each closed CAR to the Observer and update the databaseto reflect the status of CARs.。

(完整版)纠正和预防措施表(中英文)

(完整版)纠正和预防措施表(中英文)
XX有限公司XXCo Ltd
纠正和预防措施表corrective and preclude action table
编号NO.:QR-8.5-02序号Serial NO.:
不合格/体系(现在或潜在)缺陷描述Nonconformance/system (existing or potential) defect description:
日期Date:日期Date:
纠正和预防措施实施情况报告Progress report of corrective and preclude actions:
报告人Reporter: 部门经理Manager:
日期Date: 日期Date:
纠正和预防措施有效性验证Testing of Validity of corrective and preclude actions:
验证人Approved by: 日期Date:
调查人/日期Inspector/Date:
计划的纠正和预防措施: 预计完成/日期:
Planned corrective and preclude actions Planned action date
责任人:
Responsible person:
计划完成时间:
Actual action date:
编制D符合类型:
描述人Described by:日期Date:
责 任Responsibility
整改计划递交日期确认Date of corrective action confirmation
部门Department:
经理Manager:
完成日期Action date:
签 名Signature:
不合格原因调查Reasons of nonconformance:
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Raise an Action Report allocating the next number from the Action Report Register Distribute Action Report to named
person to implement the action
a) Action Report Number
b) Date of Issue
c) Type & summary of non-
conformance
d) Ref to any originating report
e) Actions to be implemented
f) Name of person responsible
g) Target Completion Date To Named Personnel to implement the action and return
report to the Management Representative
Actions satisfactorily completed
and effective?Management Representative to sign, date
and file completed report.
Update Action Report Register a) Date Complete
b) If further action is required
Update Action Report Register a) Report Number
b) Date Issued
c) Summary of Action
Yes
Is a follow up audit
required ?
No Further Action No
Carry out audit
Yes
May 2015Issue No: 1
ISO 9001 : 2008 Reference : 8.5 Improvement ISO 14001: 2004 Nonconformity,
Corrective and Preventive Action 4.5 ISO 18001: 2007 Nonconformity, corrective action
and preventive action 4.5Internal Audits
JHE Ltd CORRECTIVE / PREVENTIVE ACTION FLOW 02
Purpose : To define the methods to be used to implement appropriate corrective and / or preventive action to resolve or prevent non-conformances, or to identify where an action can be raised to improve a process or procedure.
Scope : This is applicable to all non-conformances noted as a direct result of the Management Review Meeting, Internal Audits, or any other failure analysis data. Additionally, this procedure covers events where actions are raised when an actual or potential improvement can be made to a process or procedure.
Responsibilities : Management Representative in conjunction with those personnel whose area requires the action.
Associated Records : Action Report, Action Report Register
Audit Findings
No
Corrective / Preventive Action is identified a) Internal Audit
b) Management Review
c) External Assessment
d) Other。

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