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1、 Procedure 程序程序 Issue 版本版本：1QF-QA-026/01TITLE：Corrective 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
2、.数据分析的输出；Outputs of data analysis;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 managemen
3、t review, internal/external 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 i
4、nstruct the related dept to 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
5、QF-QA-004 中記錄調查不合格產生的原因,由審核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
6、QF-QA-004 while the auditor or 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.Procedure 程序程序 Issue 版本：版本：1QF-QA-027/01TITLE：Corrective & Preventive Action Control 标题：糾正和
7、預防措施控制标题：糾正和預防措施控制 DOC No. Rev 文件文件編號編號： FQP-CAR01 版次：版次： A Pages: 4 of 6Confidential & Proprietary Information of ZJKC5.2.1.3 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 improvement actions from management review, ISO will fill ou
8、t (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 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
9、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 verbal complaint from customer, management representative will a
10、ct 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 to paragraphs requirement of the control of nonconformin
11、g 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
12、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 opinion column of the report and follow up and verif
13、y 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 effective of the corrective and preventative actio
14、ns by QC.5.2.5 遇到的品質系統問題/Quality system problem encounteredProcedure 程序程序 Issue 版本：版本：1QF-QA-027/01TITLE：Corrective & Preventive Action Control 标题：糾正和預防措施控制标题：糾正和預防措施控制 DOC No. Rev 文件文件編號編號： FQP-CAR01 版次：版次： A Pages: 5 of 6Confidential & Proprietary Information of ZJKC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
15、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 filled 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 im
