实验室质量综合手册.doc

1 目Objective
为确保检验和试验数据正确性, 对测试全过程实施严格控制。
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
适适用于对本企业试验室控制。
This is applicable to the control over AICQ laboratory.
3 职责Responsibility
3.1 技术工程部负责试验室日常管理, 试验室设备维护、 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试验室人员培训。
The Human Resource Department is responsible to organize the training of the lab staffs.
4 工作程序Work Procedure
4.1 试验室业务范围 business scope for lab
质量部编制《试验室业务范围清单》, 列出试验室能从事试验项目, 试验方法或标准, 试验设备等。
The Quality Department compiles the Business Scope List for Lab to show experiment projects, methods or standards and equipment.
4.2 测量设备检定Calibration of Measurement Equipment
4.2.1 工程技术部负责按《检验、 测量和试验设备控制程序》要求要求校准试验设备。
The Engineering & Technical Department is responsible to calibrate the test equipment according to the “Inspection, Measuring and Test Equipment Control Procedure”.
4.2.2 依据测试设备使用频次、 制造商提议和运行情况和国家检定规程由工程技术部制订测试设备校准周期, 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 本企业无校准能力测试设备由工程技术部负责委托经ISO/IEC导则25注册或用户认能够及国家技术监督部门授权检定机构, 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检定机构进行校准, 能够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/国家基准可追溯非标测试设备, 可由工程技术部负责制订对应校准规程, 校准规程须包含适用范围、 使用设备、 追溯标准、 校准地点、 校准周期、 校准方法、 验收准则以及发觉问题采取方法等, 校准规程编号、 审批按«文件和资料控制程序»实施, 校准规程须符适用户要求。
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 测试设备计量状态标识按《检验、 测量和试验设备控制程序》要求实施, 严禁使用未经标识测试设备, 如发觉核准数据遗失或标准破坏时, 应立刻停止使用该台。
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》要求建立每台测试设备档案, 包含校准统计、 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》要求进行预防、 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 Control
4.3.1 由工程技术部编制各项试验规程, 其内容包含适用范围、 使用设备、 试验步骤、 试验性能标准等, 由工程技术部制订每台测试设备操作规程。试验规程必需符适用户要求（包含抽样方法 ）, 并采取现行国际/国家标准, 当使用标准以外方法时须取得用户认可。
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 全部试验规程、 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 试验室接到《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试件须按要求存放条件储存, 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 依据《试验申请单》测试要求进行测试并作好原始统计, 测试完成后填写《试验汇报》, 汇报中注明试件批号/送验单编号, 送验日期/部门, 方便汇报可追溯原始统计和试件, 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 测试试件在测试完成后可由试验室通知送验部门取走, 如送验部门不来领取则试件由试验室保留15天方便复检, 保留期过后由试验室负责处理, 在保留期须对试件进行必需防护。
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试验室出具试验汇报交送验部门, 由送验部门按《不合格品控制程序》处理。
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 试验汇报按《质量统计控制程序》要求保留期保留。
The test report will be retained for a length of time as required in “Quality Record Control Procedure”.
4.3.8 在以后发觉测试数据有误, 则立刻通知工程技术部, 工程技术部应立刻通知车间隔离, 如已发运, 则由市场销售部负责与用户联络追回产品, 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, 采取合适统计技术。
The test lab shall adopt proper statistical techniques to make statistics of the test data and analyze the product performance fluctuation.
4.3.10 对于本试验室无法开展项目, 则由工程技术部委托ISO/IEC导则25注册或用户认能够及国家认可机构进行测试, 并出具汇报。
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 试验室人员培训Training of Lab Staff
4.4.1 试验/校准人员培训工作按《培训控制程序》要求实施, 当实施新测试程序或新设备操作规程时, 由工程技术部提出培训申请, 由人力资源总务部组织实施, 全部试验/校准人员必需含有对应专业技术和经验, 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 Equipment
4.5.1 由工程技术部负责按《设备管理控制程序》要求进行一、 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立刻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 试验室环境控制Control of Lab Environment
4.6.1 试验室环境控制须符合试验规范和操作规范要求环境要求。
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, 须由试验室人员做好统计, 并在试验汇报上注明测试时环境条件。
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 试验人员须按试验室规章制度做好试验室清洁工作。
The lab staff shall keep the lab clean according to the lab rules and regulations.
4.7 处理用户埋怨要求Regulations on Settlement of Customer Complaints
4.7.1 处理用户埋怨按《纠正和预防方法控制程序》要求实施。
The customer complaint will be settled per the Corrective & Preventative Action Control Procedures”.
4.7.2 当埋怨或其她信息对试验室是否符合测试标准要求, 或对其她试验室校准或质量提出疑问, 工程技术部应立刻按本程序要求对相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 Audit
4.8.1 试验室内部质量审核按《内部质量审核控制程序》实施。
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试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 Documents
5.1 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 《质量统计控制程序》
AICQ/QP-1601 “Quality Record Control Procedure”
5.7 AICQ/QP-1401 《纠正和预防方法控制程序》
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 质量统计Quality Record
6.1 AICQ/QR-1002-01A 《试验汇报》
AICQ/QR-1002-01 “Test Report”
6.2 AICQ/QR-1002-02A 《试验申请单》
AICQ/QR-1002-02 “Test Request”