纠正和预防措施控制程序(1).doc

1 目的Objective 为了消除实际或潜在的不合格而采取纠正和预防措施，以防止不合格品发生和再发生，特制定本程序。The objective of this procedure is to eliminate the actual or potential defects through corrective and preventative actions and to avoid the occurrence and reoccurrence of nonconforming products.2 适用范围Applicable Products 适用于公司质量体系全过程中已出现的不合格或潜在的不合格的控制。This is applicable to the control of actual or potential defects in the whole process of AICQ quality system.3 职责Responsibility3.1 质量部负责纠正和预防措施的归口管理。The Quality Department is responsible for the total management of corrective and preventative actions.3.2 各相关部门负责本部门纠正和预防措施的制定、实施。Other relevant departments are responsible to formulate and accomplish the corrective and preventative actions concerned.3.3 各主管经理负责对所管部门制定的纠正和预防措施的审批。The supervisory managers are responsible to examine and approve the corrective and preventative actions formulated by relevant supervisee departments .3.4 管理者代表负责跨部门纠正、预防措施的审批和协调实施。The management representative is responsible to approve and coordinate the implementation of the corrective and preventative actions across departments.4 工作程序Work Procedures4.1 纠正措施Corrective Actions4.1.1 采取纠正措施的不合格质量信息。Quality Defects Requiring Corrective Actionsa） 生产过程中产品同一质量特性重复出现不合格；In production process, the product is repeatedly found of defects in the same quality characteristics;b） 生产过程中半成品发现致命不合格品，成品出现致命或重不合格品；In production process, the semi-finished products are found of fatal defects, and the finished products are found of fatal or heavy defects.c） 生产过程中发现的质量异常；In production process, the quality is found abnormal;d） 质量体系运行中发生的不符合项；The quality system is found of nonconformance during operation;e） 顾客对产品质量、服务质量的投诉；The customer complains the product quality and service quality;f） 服务人员反馈的不合格信息。“Quality nonconformance” information feedback from the service people.4.1.2 质量信息的传递Transmission of Quality Information4.1.2.1 检验员在检验产品时发现产品不合格，应立即填写质量信息反馈单报送质量部。If inspector finds defects in inspection, it shall immediately fill in “Quality Information Feedback Sheet” and report it to the Quality Department.4.1.2.2 制造部操作工在生产过程中发现质量异常，应立即报班组长、生产主管及时处理，若确属制造部不能解决时，应立即填写质量信息反馈单报送质量部。If operator of manufacture department finds quality abnormality in production process, it shall immediately report to the shift leader and production supervisor for prompt treatment. In case the manufacture department is not able to solve, immediately fill in “Quality Information Feedback Sheet” and report it to the Quality Department.4.1.2.3 市场销售部收到顾客对产品质量、服务质量的投诉后，应在小时内填写质量信息反馈单，报送质量部。Within 2 hours after receipt of customers complaints about product quality and service quality, the Marketing Department shall fill in “Quality Information Feedback Sheet” and report it to the Quality Department.4.1.2.4 服务人员收到产品质量、服务质量不合格信息后，应立即电话、电报、传真报送质量部。At receipt of quality nonconformance information about products and services, the service people shall immediately report the case to the Quality Department by telephone, telex, or telefax.4.1.2.5 各部门在质量体系运行中，发现不符合项，应及时填写质量信息反馈单报送质量部。The department finding any nonconformance in quality system operation shall duly fill in “Quality Information Feedback Sheet” and report it to the Quality Department.4.1.3 调查分析原因，采取纠正措施，验证实施效果。Investigate the reason, take corrective actions and verify the effects of implementation.4.1.3.1 质量部收到不合格质量信息后，应立即组织调查、分析产生原因，确定责任部门，质量部根据不合格的严重程度，下发纠正/预防措施表到相关责任部门。At receipt of the quality nonconformance information, quality department should organize investigation, analyze the reason and identify responsible departments, and should immediately, according to how serious the nonconformity is, issue “Corrective & Preventative Action Sheet to relevant departments. 4.1.3.2 责任部门接到纠正/预防措施表后，应立即制定纠正措施，填写纠正/预防措施表，报主管经理审批后组织实施。At the receipt of Corrective & Preventative Action Sheet, the responsible department shall immediately formulate corrective actions, fill in “Corrective & Preventative Action Sheet”, and prior to implementation, report them to the supervisory manager for approval.4.1.3.3 若是涉及几个部门的纠正措施，由质量部协调，各责任部门分工，制定各自的纠正措施，报管理者代表审批后组织实施。If the corrective action involves several departments, the Quality Department is responsible to harmonize relevant departments to formulate respective corrective actions. Prior to implementation, the corrective actions shall be reported to the management representative for approval.4.1.3.4 纠正措施实施后，由质量部组织相关人员验证实施效果。After completing the implementation of corrective actions, the Quality Department shall organize relevant personnel to verify the results.4.1.3.5 纠正措施若验证不合格，由责任部门重新制定纠正措施，按4.1.3.24.1.3.4执行。若连续多次整改不合格，由质量部组织有关单位进行质量攻关，直到验证有效为止。If the corrective actions are verified to be nonconforming, the responsible departments shall formulate new corrective actions in accordance with the procedures in 4.1.3.2 4.1.3.4. If the corrective actions are repeatedly nonconforming, the Quality Department shall organize relevant departments to tackle the quality problems, until achieving an effective verification.4.2 预防措施Preventative Actions4.2.1 质量部负责收集预防措施的信息，包括： The Quality Department is responsible to collect the information about preventative actions, including: ）市场信息反馈； Market Information Feedback; ）同行业动态分析； Industrial Status Analysis; ）各相关过程控制中统计技术的结果； The results of statistical techniques for each process control; ）质量分析例会提供的信息； Information Provided in Quality Analysis Meeting; ）月质量报告、报表。 Monthly Quality Report and Statement.4.2.2 质量部根据上述信息，分析潜在不合格的原因，确定责任部门，下发纠正/预防措施表。Based on the above information, the Quality Department shall analyze the potential reasons of defects, identity the responsible departments, and issue “Corrective & Preventative Action Sheet”.4.2.3 责任部门接到通知书后，应立即制定预防措施，填写纠正/预防措施表，报主管经理审批后组织实施。At receipt of the notification, the responsible departments shall immediately formulate the preventative actions, fill in “Corrective & Preventative Action Sheet”, and prior to implementation, report them to the supervisory manager for approval.4.2.4 若属跨部门的预防措施，由质量部协调，各责任部门分工，制定各自的预防措施，报管理者代表审批后实施。If the preventative action involves several departments, the Quality Department is responsible to harmonize relevant departments to formulate respective corrective actions. Prior to implementation, the preventative actions shall be reported to the management representative for approval.4.2.5 预防措施由质量部监督实施并组织效果评审。The Quality Department is responsible to supervise the implementation of preventative actions, and to organize the effect analysis.4.2.6 预防措施的实施结果，提交管理评审，执行管理评审控制程序。The results of preventative actions shall be submitted to the management for audit. Implement “Management Audit Control Procedures”.4.3 管理说明Notes to Management4.3.1 对于产品/过程出现与规范和要求不符合时(包括本公司内部和顾客处)，有要求时必须采用顾客指定的解决问题技术作反应。If the product/process is found of incompliance with the specifications and requirements (of both AICQ and the customer), the technologies designated by the customer must be adopted to solve the problems.4.3.2 对从顾客制造厂、技术工程部门及其代理商退回产品，由质量部组织有关部门按要求进行检验、分析并保留分析结果。并采取纠正措施和可能工艺更改以防止再发生，顾客要求时须提供所有记录。The Quality Department shall organize relevant departments to make inspection, analysisand maintain analysis results when receiving products returned from customers manufacturing site, engineering department and their agents. Corrective actions and possibly process changes are to be made as to prevent reoccurrence. Whenever customers require, all records should be provided to them.4.3.3 公司在纠正和预防措施的过程中应考虑防错技术的应用，采用防错技术时应考虑成本。In the process of c