十万分之一电子天平再验证方案

MEITEK TECHNOLOGY (QINGDAO)CO. ,LTD.
十万分之一电子天平再验证方案
One hundred thousandth electronic balance Validation Protocol

 

方案起草 Draft Protocol	签   名 Signature	起草日期 Draft Date
质量管理部 Quality Management Department

 
 
 
 

验证*导小组会签 Validation Leading Group Countersignature
方案审核 Protocol Review	签   名 Signature	审核日期 Review Date
检测中心主管 Testing Center  Department Manager
计划采购部主管 Planing and Purchasing Department Manager
动力保障部经理 Power Supply Department Manager
方案批准 Protocol Approval	签   名 Signature	批准日期 Review Date
验证负责人 Validation Principal

 
 
目 录
Table of Contents
1  概述Overview  …………………………………………………………………………… 3
2  再验证目的Validation Purpose s  ………………………………………………………  3
3  再验证要求Validation Conditions… ……………………………………………………… 3
4  再验证合格标准Validation Criterion ……… ……………………………………  ……  3
5  方案实施Implementation of the protocol   …………………………………… ………  3
6  采用文件Reference Documents…………………………………………………… ……… 3
7  再验证内容与方法Contents and Methods of Validation ………………………… ……… 3
8  再验证数据分析The analysis of validation data  …………………………………………4
9  验证结果与结论Result and conclusion of validation  …………………………  ……… 5
10 附件Appendix  ………………………………………………………………  ………… 5
 
 
1.概述Overview
1.1电子天平型号Electronic Balance Model：BT25S    设备编号Equipment No.：QC62Y011
1.2该设备由德G赛多利斯股份公司制造，安装在天平室。
This equipment which Installed in the balance room is produced by Germany Sartorius AG
2.再验证目的Validation Purposes
确认该仪器的称量示值误差、重复性、及其自动校准功能等技术指标经过一年的使用后仍旧能够符合要求。
Confirm that the largest weighing range, repeatability, error range of the equipment meet the required technical specifications and in accordance with the inspection requirements.#p#分页标题#e#
3.再验证要求Validation requirements
3.1验证前检查该设备的使用记录及其日常维护保养测试记录。
Before the validation, Confirm the equipment documents and spare parts are complete.
3.2验证前必须对BT25S型电子天平进行每年一次的校验。
Before the validation, Confirm the installation, operation of BT25S-type electronic balance and in accordance with the requirements of inspection weighing .
3.3验证前必须对所用的校准砝码确定有效。
Before the validation, Confirm the process of calibration weight of the trial used to effective
4.再验证合格标准The validation Criterion
4.1BT25S型电子天平的称量示值误差范围为20.0000g±1mg。
BT25S-type electronic balance sensitivity test weight is 20.0000g ± 1mg.
4.2BT25S型电子天平的重复性实验合格标准：标准偏差≤0.02mg
BT25S-type electronic balance's eligibility criteria of reproducibility experimental: standard deviation is not more than 0.02mg.
4.3BT25S型电子天平的自动校准功能正常。
5.方案实施Implementation of the protocol
本验证方案计划于2010年01月04日－01月 05日进行验证
The validation program is planned for verifying in December 21, 2008 to December 24 
由验证小组：杨平、钟迪仕、李霄、吴晓飞负责实施。
By the validation team: Yang Ping, Liu Qiang,Liu Xiangwen,WuXiaofei, is responsible to implement.
6.采用文件Reference Documents
SOP-SB-QC022
7.再验证内容与方法Contents and Methods of Validation  
7.1日常使用记录检查及运行测试。
7.1.1目的：根据设备SOP-SB-QC022进行操作，确认该设备运行正常。 
Objective: operate the equipment in accordance with the equipment SOP-SB-QC022 。
7.1.2检查项目（检查结果在□划“√”）Check the item (the results in the □ zoned "√")
7.1.2.1按键功能、显示器Button functions, display

检查项目Inspection Items	合格标准 Eligibility criteria	检查方法Inspection method	检查结果 Inspection results
Tare	除皮后显示 In addition to skin revealed 0.00000g	按键检查 Key check	□符合Matched  □不符合Unmatched
1/	开关 power	开机运行Switched	□符合Matched  □不符合Unmatched
CAL	调校 Adjustment	开机运行Switched	□符合Matched □不符合Unmatched
F	功能 Function	开机运行Switched	□符合Matched  □不符合Unmatched
CF	清除 Clear	按键检查 Key check	□符合Matched  □不符合Unmatched
水平仪the level of instruments	气泡位于圆环中央 Bubble is located in the central ring	现场观察 Site observation	□符合Matched □不符合Unmatched
检查人Check：                  复核人：Reviewer              日期：Date

7.2 维修保养情况。
7.3 日常测试记录情况及其性能测试。
7.3.1校准砝码信息： Information of weight calibration

标准器Standards	测量范围Measuring range	等级 Grade	出厂厂家 Factory	校验日期 Calibration Date
砝码 Weight	1g～100g	F1

7.3.2 日常测试周期为：

测试项目 Test items	周期
校验 Calibration	每年一次 Yearly
重复性 Repeatability	每月一次 Monthly
示值误差 Sensitivity	每天一次 Daily

#p#分页标题#e#7.3.3调整校准：Adjust the calibration
内部校准：当显示0时，用         键激活校正功能。
Internal calibration: When the 0, use To activate the Calibration function
检验结论Test conclusions_____________________________________________________       
_________________________________________________________________________        
检查人Inspector：                  复核人Reviewer：               日期Date：           
7.3.4 示值误差测试：该天平zui大称量为21g，使用20g的标准砝码进行称量测定，天平仪表显示值应为20.00000g±1mg。
Sensitivity test weight: the scales for the largest weighing of the balance is 21g, the use of the standard weight to 20g weigh measuring , weighing instrument shows the value of the balance should be 20.00000g ± 1mg.
7.3.5 重复性试验：取1g的标准砝码进行称量测定10次，记录称量时电子天平仪表所显示的数值，其标准偏差应≤0.02mg。
Repeatability test: respectively 1g standard weight weigh for 10 times, recording when electronic balance 's weighing instrument shown values.
8.再验证数据分析The analysis of validation data
验证结果均应符合再验证合格标准。如有数据超过上述标准，则应由动力保障部、质量管理部共同进行分析，找出不合格原因，再实施验证，直至符合再验证合格标准。
The results of validation should be in accordance with the standards for validation Criterion of four. If few amount of data over the above criteria, this should be analysis by the power protection Department and the Department of Quality Management , identifying the reasons for failure , amending the verification program and till compliance with validation Criterion of four set forth in subparagraph.
9.验证结果与结论  Result and conclusion of validation
9.1检测中心负责收集各再验证试验结果记录，根据再验证试验结果起草验证报告，报告验证委员会。验证委员会根据再验证方案的内容，对验证报告进行核对和审查，然后批准并签署，并由各成员会签。验证报告审批通过后，由验证委员会的总负责人签署验证合格证书，说明该再验证工作完成，已验证的项目及相应的管理文件可交付正常使用。
Testing Center is responsible for collecting records of the verification test results, according to the test results of validation to draft, reporting to the Commission . the Commission will in accordance with the contents of the report of validation program to verify the check and review, and then approved and signed, and countersigned by the members. After the certification report for approval ,by the general in charge of the Commission sign on the certificate ,it is proven that the work of verification has been completed  ,the management of projects and corresponding documents may pay to use normally.
9.2结果评价The results of the evaluation

项目 Items	评   价 Evaluation	评价人Evaluator	评价日期Evaluation Date
日常使用情况
维修保养情况
日常测试
运行确认 runing confirm
性能确认 Function confirm
结论 Conclusion

10.附件Annex
附件1：BT25S型电子天平验证方案试验记录
Annex 1: Test records of BT25S-type electronic balance validation program 

附件Appendix 1:            
BT25S型电子天平验证方案试验记录
The record of BT25S type electric balance validation program test
 

标准器 Standards		测量范围 Measuring range		等级 Grade			出厂厂家 Factory			校验日期 Calibration Date
砝码 Weight		1g～100g		F1#p#分页标题#e#
室温room temperature：          湿度humidity：          仪器编号the equipment code
1.重复性称量测试记录 1.Repeatability weighing test record
1:	2:		3:					4:	5:
6:	7:		8:					9:	10:
平均值: Average Value:						标准偏差（mg）: Standard Deviation:
结论: Conclusion：
操作人/operator： 日期/date：					复核人/recheck man： 日期/date：
2.示值误差测试记录 2.Sensitivity test weight record
测量值: measure value:              g					真实值: true value:                    g
结论conclusion：
操作人/operator： 日期/date：					复核人/recheck man： 日期/date：