纠正和预防措施控制程序(英文版)

1.0PURPOSE1.1.The purpose is to provide a procedure for identifying Nonconformances and potentialNonconformances, investigating the cause, determining and taking actions to eliminatethe cause and follow-up activities to ensure agreed actions were taken and effective.2.0SCOPE2.1This procedure applies to all Nonconformances and potential Nonconformancesidentified within the Quality Management Systems.3.0RESPONSIBILITY3.1The Management Representative, or delegate, is responsible for:∙Assigning CAR numbers∙Assigning responsibility to investigate the cause and recommend action to be taken∙Reviewing cause, recommended action and implementation schedule for adequacy∙Assigning Internal Auditors to verify implementation and effectiveness of CARs∙Forwarding copy of closed CARs to the Observer∙Maintaining CAR database and copies of CARs∙Analyzing appropriate information in order to detect opportunities for preventive action3.2The appropriate personnel are responsible for investigating the cause ofnonconformance/potential nonconformance, recording the results of the investigation,recommending appropriate action, implementing agreed action and applyingsufficient controls to ensure action is effective.3.3The Observer of a nonconformance/potential nonconformance is responsible fororiginating a CAR and forwarding to the Management Representative.3.4The Internal Auditor is responsible for verifying that agreed action has beenimplemented and is effective.4.0GENERAL4.1The Management Representative forwards a CAR to the supplier when it isdetermined that the supplier is responsible for the root cause. If the supplier isinternal, the CAIR process is used.5.0DEFINITIONS5.1Potential Nonconformance: The prediction that conditions exist which may lead to anonconformance unless action is taken.5.2Nonconformance: The nonfulfillment of a requirement. Examples include:5.2.1The absence of a procedure required by the Quality Management System.5.2.2Failure to effectively implement a procedure required by the QualityManagement System.5.2.3 A confirmed customer complaint.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 Action: action taken to eliminate the cause of a detected nonconformanceor other undesirable situation. Corrective actions prevent recurrence.5.4Preventive Action: action taken to eliminate the cause of a potential nonconformanceor other undesirable potential situation. Preventive actions prevent occurrence.5.5Observer: anyone observing a nonconformance/potential nonconformance orreceiving a customer complaint.5.6Immediate Action: corrective or preventive as appropriate to eliminate the cause of anonconformance/potential nonconformance in order to prevent recurrence/occurrence.5.7Root Cause: Underlying reason of why the discrepancy occurred, determined asresults of an investigation of the product, process and/or quality system.5.8Corrective Action Verification: Activity undertaken immediately afterimplementation of root cause correction to verify implementation5.9Follow-Up: Planned activity to determine if implemented root cause corrective actionis effective and being adhered to.5.10CAR – Corrective Action Request generated from any nonconformance.6.0PROCEDURE6.1The Observer of a nonconformance/potential nonconformance originates a QPF1400-1 CAR form by completing the detail section of the CAR. The Observer providessufficient details of the nonconformance/potential nonconformance to permit aneffective investigation of the cause.6.2The Observer forwards the CAR to the Management Representative.6.3The Management Representative reviews the details provided to ensure they aresufficient and request additional details as appropriate.6.4The Management Representative assigns a CAR number and other information suchas reference, procedure number, requirement section number, etc. as appropriate in the database.6.5The Management Representative assigns responsibility for investigating the cause ofthe nonconformance/potential nonconformance and forward a copy of the CAR to that individual.6.6The assigned individual investigates the cause of the nonconformance/potentialnonconformance, record the results of the investigation, recommend appropriateaction to be taken and forward the completed CAR to the Management Representative.6.7The Management Representative reviews the completed CAR to determine if thecause, recommended action and schedule for implementation are appropriate to the effects of the nonconformance encountered. The Management Representative re-issues using QPF 1400-2 for additional effort if the cause, recommended actions or schedule for implementation are considered inadequate.6.8The Management Representative assigns an Internal Auditor to verify that the agreedaction was taken and was effective. The Management Representative closes the CAR if no action is recommended.6.8.1The Internal Auditor closes the CAR if the agreed action is verified asimplemented and effective and forwards the CAR to the ManagementRepresentative.6.8.2The Internal Auditor returns the CAR to the Management Representativeif the agreed action was not implemented or could not be verified aseffective.6.8.2.1The Management Representative reassigns the ineffective CARrequesting additional information.6.9The Management Representative forwards a copy of each closed CAR to the Observerand update the database to reflect the status of CARs.。

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。

1.0 P URPOSE 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 S COPE 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 D EFINITIONS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。

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。

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。

Version: A0 Page: 1/7Status:PROCEDURE 程序文件Corrective and Preventive Actions ManagementProcedure 纠正和预防措施程序目的OBJECTIVE 2 范围SCOPE2 职责RESPONSIBILITY2 正文PROCEDURAL ELEMENTS2流程FLOW CHART 3 任务描述TASKS DESCRIPTION 4 参考文件REFERENCE DOCUMENTS 6 记录RECORDS7 定义与缩写DEFINITIONS/ ABBREVIATIONS 7___________________________________________________________________Version: A0 Page: 2/7Status:PROCEDURE 程序文件Corrective and Preventive Actions ManagementProcedure 纠正和预防措施程序Objective 目的To ensure continually improve the effectiveness of the quality management system through the use of corrective and preventive actions.利用纠正与预防措施，确保持续改进质量管理体系和环境管理体系的有效性。

__________________________________________________________Scope 范围Applied to the corrective , correction action and continual improvement. 适用于纠正、预防和持续改进。

__________________________________________________________Responsibility 职责It is the responsibility of the related departments to implement the corrective and preventive action in compliance with this procedure.相关部门负责按照此程序实施纠正与预防措施。

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。

1 目的 Purpose本程序规范了为消除存在或潜在的不合格而采取纠正预防措施的流程，以确保类似不合格不再发生或潜在不合格的发生，促进质量管理体系的持续改进。

This procedure define the process of taking corrective and or preventive actions toEliminate existing or potential non-conformity, to prevent similar non-conformity fromReoccurring or occurring of potential non-conformity. Promote continuousImprovement of quality systems.2 范围 Scope本程序适用于公司质量管理体系范围内纠正和预防措施的制定、实施与验证。

This procedure is applicable to the formulation, implementation and verification of Corrective action and preventive action in the company quality management systems3 定义 Definition3.1 不合格：未满足指定要求。

“要求”是指明示的、通常隐含的或必须履行的需求或期望，如法规、行业标准要求，公司文件要求等Non-conformity: Non-fulfillment of a specified requirement. “requirement” refers to the explic it, usually implicit, Or the need or expectation is a must to fulfill. Such as regulation,industry requirement,company documents etc.3.2 关键不符合：违反法定工艺、超出内控质量标准或违反生产相关法规规定，将会造成产品整批报废、产品召回、重大客户投诉.不符合关系到安全、企业的品牌形象和产品的市场影响。

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。

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。

1. 目的Purpose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 cause of actual and potential nonconformities, carrying out effectively corrective and preventive actions in time to ensure against the occurrence of similar problem to make self-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.3.定义Definitions3.18D: 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Responsibilities4.1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 of department are responsible to manage and supervise the corrective andpreventive action and communicate with related dept to arrange and perform the correspondingcorrective and preventive action to meet the goals and strategies of the unit.4.2各部门人员负责职权范围内纠正和预防措施的实施。