实验室质量手册.doc

1 目的Objective为保证检验和试验数据的准确性，对测试全过程实行严格控制。The objective of this procedure is to strictly control the whole test process in order to ensure the exactness of inspection and test data.2 适用范围Applicable Scope 适用于对本公司实验室的控制。This is applicable to the control over AICQ laboratory.3 职责Responsibility3.1 技术工程部负责实验室的日常管理，实验室设备的维护、修理、校正和测试控制。The Technical & Engineering Department is responsible for the routine management of the laboratory, and the maintenance, repair, calibration and test control of the lab equipment.3.2 人力资源部负责组织实验室人员的培训。The Human Resource Department is responsible to organize the training of the lab staffs.4 工作程序Work Procedure4.1 实验室业务范围 business scope for lab质量部编制实验室业务范围清单，列出实验室能从事的实验项目，实验方法或标准，实验设备等。The Quality Department compiles the Business Scope List for Lab to show experiment projects, methods or standards and equipment.4.2 测量设备的检定Calibration of Measurement Equipment4.2.1 工程技术部负责按检验、测量和试验设备控制程序规定要求校准实验设备。The Engineering & Technical Department is responsible to calibrate the test equipment according to the “Inspection, Measuring and Test Equipment Control Procedure”.4.2.2 根据测试设备的使用频次、制造商建议和运行状况和国家检定规程由工程技术部制定测试设备的校准周期，并按校准周期实施校准。According to the usage frequency of test equipment, manufacturer proposals, operating status and applicable national standards on calibration. the Engineering & Technical Department shall specify the calibration cycle of test equipment and conduct the calibration per the specified cycle 4.2.3 本公司无校准能力的测试设备由工程技术部负责委托经ISO/IEC导则25注册或顾客认可以及国家技术监督部门授权的检定机构，来现场对测试设备进行周期校准，如该设备没有经过有资格的检定机构进行校准，可以委托设备原制造商实施。For the test equipment beyond the company calibration ability, the Engineering & Technical Department is responsible to entrust an inspection organization accredited per ISO/IEC guideline 25, or recognized by the customer, or authorized by national technical supervising authority, to periodically calibrate the test equipment at site. The equipment may be entrusted to the original manufacturer if it has not been calibrated by the authorized inspection organization yet.4.2.4 对于尚无国际/国家基准可追溯的非标测试设备，可由工程技术部负责制订相应校准规程，校准规程须包括适用范围、使用设备、追溯标准、校准地点、校准周期、校准方法、验收准则以及发现问题采取措施等，校准规程编号、审批按文件和资料控制程序执行，校准规程须符合顾客要求。For the non-standard test equipment that has no applicable international/national standards, the Engineering & Technical Department is responsible for formulating corresponding calibration specifications. The calibration specification should include the applicable scope, equipment in use, traceability standard, calibration site, calibration cycle, calibration method, and acceptance principles, as well as the actions in case of problems. The numbering and auditing of calibration specifications shall follow the “Document & Data Control Procedures”. The calibration specification should satisfy the customer requirements. 4.2.5 测试设备的计量状态标识按检验、测量和试验设备控制程序规定执行，禁止使用未经标识的测试设备，如发现核准数据遗失或标准破坏时，应立即停止使用该台。The measurement status of test equipment should be labeled in line with the Inspection, Measuring and Test Equipment Control Procedure. It is forbidden to use the inspection equipment without labels. In case the calibration data is lost or the standard is destroyed, immediately stop using this equipment. 4.2.6 按检验、测量和试验设备控制程序规定建立每台测试设备的档案，包括校准记录、检定证书、校准规程等。Follow the “Inspection, Measuring and Test Equipment Control Procedure” and set up the historic records for each test equipment, including calibration record, verification certificate, calibration specifications, etc. 4.2.7 校准设备和测试设备需按检验、测量和试验设备控制程序规定进行预防、搬运、储存。The calibration and test equipment shall be preserved, handled and stored in accordance with the “Inspection, Measuring and Test Equipment Control Procedure”.4.3 测试控制Test Control4.3.1 由工程技术部编制各项试验规程，其内容包括适用范围、使用设备、试验流程、试验性能标准等，由工程技术部制定每台测试设备的操作规程。试验规程必须符合顾客要求（包括抽样方法 ），并采取现行的国际/国家标准，当使用标准以外方法时须征得顾客认可。The Engineering & Technical Department shall compile various test procedures, including applicable scope, equipment for use, test process, and test performance standards, etc, while formulating operation regulations for each test equipment is made by the Engineering & Technical Department. The test procedures must conform to the customer requirements (including the sampling method), and the prevailing international / national standards shall be adopted as the test procedures. Approval must be obtained from the customer in case the methods other than the standards are adopted.4.3.2 所有试验规程、操作规程以及所需技术规范等均须在测试现场易于得到，供试验人员使用。All the test procedures, operation regulations and necessary technical specifications must be easily available at the test site. 4.3.3 实验室接到试验申请单和试验件后进行登记，在试验件上标识送验日期、委托部门和试验申请单编号或试件批号，并对来样进行编号，放在待验区内，对于有存放条件限制的试件须按规定的存放条件储存，试件应注意防护不得损坏腐蚀。At receipt of the “Test Request” and the test part, the lab shall make record properly, and label the test part with delivery date, entrustment department and the number of “Test Request” or the lot number of the test part . Meanwhile, niumber tha sample and place it in the Awaiting-Inspection area. The test part with storage restrictions must be stored in the prescribed way. All test parts must be prevented from damage or corrosion.4.3.4 根据试验申请单的测试要求进行测试并作好原始记录，测试完成后填写试验报告，报告中注明试件批号/送验单编号，送验日期/部门，以便报告可追溯原始记录和试件，并将试件放置在已验区域内。Conduct the test according to the requirements as stated in the “Test Request” and make original records properly. After completing the test, it is required to write “Test Report”, in which the test part lot No. / delivery No. and delivery date/department shall be indicated, so as to use the Test Report to trace the original records and test part. Meanwhile, place the test part in the area for tested part.4.3.5 测试试件在测试完毕后可由实验室通知送验部门取走，如送验部门不来领取则试件由实验室保存15天以便复检，保存期过后由实验室负责处理，在保存期须对试件进行必要的防护。After completing the tests, the lab may inform the delivery department to take back the test part. In case the delivery department does not take the test part back, the lab may retain it for 15 days for re-inspection. After the retention period, the lab may dispose the test part, but during retention period, the test part must be properly preserved.4.3.6 试件经测试不合格则由实验室出具试验报告交送验部门，由送验部门按不合格品控制程序处置。The lab will issue a test report to the delivery department if the test part fails the test. The delivery department will dispose per the “Nonconforming Product Control Procedures”.4.3.7 试验报告按质量记录控制程序规定保存期保存。The test report will be retained for a length of time as required in “Quality Record Control Procedure”.4.3.8 在日后发现测试数据有误，则立即通知工程技术部，工程技术部应及时通知车间隔离，如已发运，则由市场销售部负责与顾客联系追回产品，并进行重新测试。If the data was found wrong later, the Engineering & Technical Department should be informed immediately to isolate the parts from the workshop. The Marketing Department is responsible to call back the products for re-test if the products have been shipped out.4.3.9 对于测试数据由试验室进行统计、分析产品性能波动情况，采取适当的统计技术。The test lab shall adopt proper statistical techniques to make statistics of the test data and analyze the product performance fluctuation.4.3.10 对于本实验室无法开展项目，则由工程技术部委托ISO/IEC导则25注册或顾客认可以及国家认可机构进行测试，并出具报告。For the projects beyond the lab ability, the Engineering & Technical Department shall entrust an organization accredited per ISO/IEC guideline 25, or approved by the customer, or certified by the state, to carry out tests and require it to issue test report.4.4 实验室人员的培训Training of Lab Staff4.4.1 试验/校准人员的培训工作按培训控制程序规定执行，当实施新的测试程序或新设备的操作规程时，由工程技术部提出培训申请，由人力资源总务部组织实施，所有试验/校准人员必须具备相应的专业技术和经验，取得资格证书方可上岗。The training of the test/calibration staff will be carried out per the “Training Control Procedure”. The implementation of new test program or operation procedure of new equipment will be put forward by the Engineering & Technical Department and organized by the Human Resource & General Affair Department. All the test/calibration staff must possess corresponding special technique and experience, and can only be allowed to work on post after obtaining qualification certificate.4.5 测试设备保养Maintenance of the Test Equipment4.5.1 由工程技术部负责按设备管理控制程序规定进行一、二级保养。The Engineering & Technical Department is responsible to perform 1st Level & 2nd Level maintenance according to the Equipment Management Control Procedures.4.5.2 试验人员在完成测试后及时对设备进行日常保养。After completing the tests, the test staff shall duly perform routine maintenance of test equipment.4.6 实验室环境控制Control of Lab Environment4.6.1 实验室环境控制须符合试验规范和操作规范规定的环境要求。The control of lab environment l must accord with the requirements as stipulated in the test and operation specification.4.6.2 对于有温度、湿度要求时，须由实验室人员做好记录，并在试验报告上注明测试时的环境条件。If it is required to perform the test under certain temperature and humidity, the lab staff shall make records properly and note the environment conditions in the test report. 4.6.3 实验人员须按实验室规章制度做好实验室清洁工作。The lab staff shall keep the lab clean according to the lab rules and regulations.4.7 处理顾客抱怨的规定Regulations on Settlement of Customer Complaints4.7.1 处理顾客抱怨按纠正和预防措施控制程序规定执行。The customer complaint will be settled per the Corrective & Preventative Action Control Procedures”.4.7.2 当抱怨或其他信息对实验室是否符合测试标准要求，或对其他实验室校准或质量提出疑问，工程技术部应立即按本程序要求对有关工作或职责进行审核。In case of any complaints or other messages on if the lab meets the test requirements, or any doubts on calibration or quality of other labs, the Engineering & Technical Department shall immediately conduct audits on related work or responsibilities per the requirements of this procedure. 4.8 内部审核Internal Audit4.8.1 实验室的内部质量审核按内部质量审核控制程序执行。The internal audit of the lab is per the Internal Quality Audit Control Procedures.4.8.2 由管理者代表组织对实验室进行内部质量审核，审核按年度内审计划实施。The management representative will organize the lab to perform internal quality audit according to the annual internal quality audit plan. 5 相关文件Specific Documents5.1 AICQ/QP-1101 检验、测量和试验设备控制程序 AICQ/QP-1101 “Inspection, Measuring and Test Equipment Control Procedure”5.2 AICQ/QP-1701 内部质量审核控制程序 AICQ/QP-1701 “Internal Quality Audit Control Procedure”5.3 AICQ/QP-1801 培训控制程序AICQ/QP-1801 “Training Control Procedure”5.4 AICQ/QP-1301 不合格品控制程序 AICQ/QP-1301 “Unacceptable Parts Control Procedure”5.5 AICQ/QP-0904 设备管理控制程序 AICQ/QP-0904 “Equipment Management Control Procedure”5.6 AICQ/QP-1601 质量记录控制程序 AICQ/QP-1601 “Quality Record Control Procedure”5.7 AICQ/QP-1401 纠正和预防措施控制程序 AICQ/QP-1401 “Correction and Prevention Measure Control Procedure”5.8 AICQ/QP-0501 文件和资料控制程序 AICQ/QP-0501 “Files and Materials Control Procedure”6 质量记录Quality Record6.1 AICQ/QR-1002-01A 试验报告 AICQ/QR-1002-01 “Test Report”6.2 AICQ/QR-1002-02A 试验申请单 AICQ/QR-1002-02 “Test Request”