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1、Revision 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:_Program Director: _PM: _Store Mgr:_Purchasing Mgr:_PMC Sup:_Shipping Sup:_Facility Mgr: _Review x x x x x x x x x Signature
2、 / 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:Effective 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
3、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。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. 2.0 范圍 Scope:適用於本公司對不合格品及不合格項采取的糾正和預防措施的控制。
4、Apply for the control to the corrective and preventive action to the nonconforming product and items. 3.0 定义Definitions:3.1 8D: 8个遵循条款eight disciplines.3.2 CAPA：纠正预防措施。CAPA is the short form of Corrective Action and Preventive Action.4.0 职责Responsibility:4.1 各部門主管/經理負責采取糾正和預防措施的管理和監督工作,以及聯系和本部門有關的跨部
5、門的糾正和預防措施的組織實施，确保改进行动可达到目标。The supervisors/managers are responsible to manage and supervise 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. 4.2 各部門人員負責職權范圍內糾
6、正和預防措施的實施。Personnel in his own department/section are responsible for executing the corrective and preventive action within his/her authority.4.3 厂长或管理者代表負責重大的糾正和預防措施的審批工作以及協調和監督工作。Plant manager or management representative is in charge of the review and approval of important corrective and preventi
7、ve 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.5.0 程序 Procedure:5.1 糾正預防實用情況 Corrective and preventive action application5.1.1 任何為消除現有不合格的糾正預防措施,其實施程度應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。 Execu
8、ting 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 effec
9、tiveness and efficiency, and stress to avoid the actual or potential nonconforming occurring once again according to the confirmed root cause.5.1.3 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. 管理評審的输出；The outpu
10、ts of management review;B. 內、外部質量審核發現的不符合項或問題點; 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/TrendsG. 数据分析的输出；Outputs of data anal
11、ysis;H. 品質目標考核结果。Quality targets achievements.I. 程序运作中的不符合项。The NG items to the operational proceduresJ. 不符合相关法律法规要求。Against some related statutes and regulations5.2 糾正預防措施控制方式 Control methods to corrective and preventive action5.2.1 管理評審、內外審核發現的問題。Problems found by management review, internal/exter
12、nal audit5.2.1.1 客户审核及第三方审核发现的不符合项和提出的观察项，由 ISO专案科填写外部审核发现及其改善计划一览表QF-QA-040分发给责任部门，責成责任部門調查分析并予以糾正或预防,并組織跟进落實。若客户或第三方所发现的不符合项报告有自己的格式，则采用客户或第三方的格式。For the problems or observation found in customer audit or the third part audit, ISO office should fill out and issues it to instruct the related dept t
13、o analyze and correct. ISO Office arranges the follow up action. If customers or the third parties have their own format about the nonconformance and corrective action report, then we follow it. .5.2.1.2 內部質量審核中發現的不符合項,由審核小組發行不符合項報告QF-QA-004, 審核員要求責任單位采取糾正措施,責任單位負責人在 不符合項報告QF-QA-004中記錄調查不合格產生的原因,由審核
14、組成員或被審核方提出具體的糾正預防措施并落實完成期限。由ISO專案科或審核成員負責對糾正预防措施的跟蹤驗証。 Audit group issues QF-QA-004 to problems found in internal audit and auditor requests the related dept to carry out corrective action. The head of related dept records and investigates the causes of nonconformity in QF-QA-004 while the auditor o
15、r the audited dept issue corrective and preventive action in place and completion deadline. ISO Office or audit members are required to follow up and verify the corrective actions.5.2.1.3 管理评审有关纠正改善行动的输出，由ISO专案科填写管理评审输出及其跟进状况一览表(QF-QA-039)并责成责任部门调查分析并以糾正或预防，及每月組織跟蹤及更新管理评审输出及其跟进状况一览表(QF-QA-039)。For i
16、mprovement actions from management review, ISO will fill out (QF-QA-039) and issue it to all related department/section to analyze and correct and arranges the following-up and update (QF-QA-039) every month.5.2.2 客戶反饋：即：投訴、退貨、滿意度調查結果 Customer feedback including Customer complaint and rejection and
17、customer satisfaction survey results：客戶抱怨、退貨處理、满意度调查依分設的的運作程序執行。詳見 FQP-CFR01 客戶抱怨處理程序 、FQP-CFR02 客戶退貨處理 & FQP-CFR04 客户满意度调查 Customer Satisfaction Survey.5.2.3 客戶向厂长或管理者代表提供有參考意義的建議或口頭抱怨時,由管理者代表參照本程序第5.2.2條執行。When plant manager or management representative receives the worthwhile suggestions or verba
18、l complaint from customer, management representative will act according by per item5.2.2.5.2.4 不合格品/趋势Nonconforming product/Trend5.2.4.1 进料品质异常(含生产线发现)，由IQC依不合格品管制FQP-NCP01 的“来料不合格品管制”章节的要求以及供应商纠正行动要求FQW-IQC01 跟踪纠正或预防行动。Incoming material problems (including the problems found on-line), IQC according
19、 to paragraphs requirement of the control of nonconforming incoming material of FQP-NCP01 and FQW-IQC01 to follow up the corrective & preventive actions.5.2.4.2 对于塑胶类产品，制程中的品质异常、最终品质查核异常/库存品品质查核异常/出货品质查核异常/趋势异常时，QC必须发行不合格报告QF-QC-005，若不良率超过5%，责任部门必须作原因分析，QC必须跟进及验证责任部门采取纠正或预防措施的有效性；若同一个月内同一产品因同一问题被QC连
20、续发出3次要有原因分析的不合格报告，则QC部必须发出8D报告QF-QC-022给责任部门及跟进和验证责任部门采取的纠正和预防措施的有效性。When nonconforming product was found in process / final inspection / storage inspection / outgoing inspection，QC should issue QF-QC-05. If the rate of defect is more than 3%, root cause analysis is to be given in the analysis opini
21、on column of the report and follow up and verify the effective of the corrective or preventative actions. When for the same part, that defect rate more than 3%, is issued consecutive 3 times in one month, QF-QC-022 is to be issued to responsible department/person and followed up and verified the eff
22、ective of the corrective and preventative actions by QC.5.2.5 遇到的品質系統問題/Quality system problem encountered各部門在遇到與品質系統有關的問題(程序文件的不適應之處教育訓練不足等)時,應填寫品質系統問題通知單 QF-QA-015交給ISO專案科，ISO專案科對這些潛在不合格因素進行分析 ，必要時簽發糾正和預防措施要求書QF-QA-016,責成有關單位制訂纠正或預防措施实施，消除潛在的不合格原因,ISO專案科跟蹤預防措施實施,以保证预防措施的有效性。 QF-QA-015 shall be fil
23、led and pass to ISO Office if any problem found on quality system. ISO Office should analyze the problems and issue a QF-QA-016 if required, instruct related dept to issue preventive action to perform and eliminate the potential cause to nonconformity. ISO office follows up preventive action impleme
24、ntation to ensure the effectiveness of preventive action.5.2.6 品質目標的考核/Quality targets assessment由各职能部门依质量目标、指标及其跟进责任& 监测方法总表FQP-QIP02进行考核，如未达到目标或趋势异常时 ，发行糾正和預防措施要求書QF-QA-016，谋求改进。The functional dept measures the yearly objectives & targets according to Summary List of Quality Objectives & Targets a
25、nd Following Responsibilities & Measurement Methods and issues FQP-QIP02 to make improvement if failed to achieve the targets.5.2.7 采购部必须发放8D报告给不良绩效的供应商。When the performance of supplier was poor must issue the vendor to take corrective and preventive action by purchasing department.5.2.8 其它 Other其它情
26、況由發現問題部門負責人簽發糾正和預防措施要求書QF-QA-016責成有关责任单位調查分析原因,并制訂糾正措施和落實期限,由責任單位主管跟蹤實施情況。 If any other problem found, the head of finding dept shall and issue a QF-QA-016 and instruct related department to investigate and analyze the cause, determines the corrective action and implementation due date. Relevant sup
27、ervisors shall follow up its application.5.3 所有的纠正或预防措施必须在计划的完成期限或客户规定的完成期限内完成。如果纠正或预防措施未在规定的完成期限内完成，则跟进人需将CAPA报告给管理者代表和责任部门经理以谋求进一步的解决。All corrective actions or preventive actions are required to complete within the set period. The CAPA report that are open longer than this period of time shall be
28、reported to management representative and responsible department head for further solution.5.4 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
29、 information.5.5 对于同一个不合格项连续反复出现3次时，则第三次必须发8D报告（ 8D CAR report）给责任部门/人。由8D报告发出者跟进及验证纠正和预防措施的有效性。The same nonconforming items are consecutive 3 times, then must be issue to the responsible department / person on the third time5.6 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
30、 the corrective actions taken and control implemented shall be eliminate the cause of a nonconformance to other similar process and products.5.4 永久性措施的鞏固/Permanent action consolidation 5.4.1 隨著糾正和預防措施的實施,對於涉及永久性的措施,按文件和資料控制FQP-DOC01修改程序文件加以鞏固。With the implementation of corrective and preventive acti
31、on, the permanent action is to be consolidated by amending procedure documents in accordance with FQP-DOC01.5.4.2 质量部確保將采取糾正和預防措施的有關信息提交管理評審。Quality department ensure the information about carrying out corrective and preventive action be submitted for management review.6.0 相關文件和資料 Relevant document
32、and data6.1 FQP-DOC01 文件和資料控制 6.3 FQP-CFR01 客戶抱怨處理程序 6.4 FQP-CFR02 客戶退貨處理 6.5 FQP-CFR04 客户满意度调查 Customer Satisfaction Survey6.6 FQP-NCP01不合格品管制6.7 FQW-IQC01供应商纠正行动要求6.8 FQP-IQA01內部品质系统審核6.9 FQP-MGR01管理评审 7.0 品质记录Quality Records:Record Description记录名称Form No记录的表格编号Keep by保管人Retention Time(Min)保存期限Obs
33、olete Disposition过期处理办法糾正和預防措施要求書Corrective and preventive action requirementQF-QA-016發出/跟蹤單位The issued Deptand following up Dept.3年3年书面记录撕掉电子档删除Tear the hardcopy and delete the softcopy不符合項報告Nonconformance and corrective action ReportQA-QA-004ISO Office品質系統問題通知單 Quality system problem notificationQ
34、F-QA-015外部审核发现及其改善计划一览表Improving actions for external audit findingsQF-QA-040管理评审输出及其跟进状况一览表Management review output follow up action Tracking logQF-QA-039客户审核和第三方审核颁发的“纠正预防措施要求报告”CAPA request report issued by customer or the third partyN/A8D 报告8D CAR reportQF-QC-022QC/IQC/Purchasing1年不合格报告Nonconforming ReportQF-QC-005IQC/QC1年8.0 流程图 Flow Chart: N/A
