MEITEK TECHNOLOGY (QINGDAO)CO. ,LTD.
十萬分之一電子天平再驗證方案
One hundred thousandth electronic balance Validation Protocol

 

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

 
 
 
 

驗證*導小組會簽 Validation Leading Group Countersignature
方案審核 Protocol Review	簽   名 Signature	審核日期 Review Date
檢測中心主管 Testing Center  Department Manager
計劃采購部主管 Planing and Purchasing Department Manager
動力保障部經理 Power Supply Department Manager
方案批準 Protocol Approval	簽   名 Signature	批準日期 Review Date
驗證負責人 Validation Principal

 
 
目 錄
Table of Contents
1  概述Overview  …………………………………………………………………………… 3
2  再驗證目的Validation Purpose s  ………………………………………………………  3
3  再驗證要求Validation Conditions… ……………………………………………………… 3
4  再驗證合格標準Validation Criterion ……… ……………………………………  ……  3
5  方案實施Implementation of the protocol   …………………………………… ………  3
6  采用文件Reference Documents…………………………………………………… ……… 3
7  再驗證內容與方法Contents and Methods of Validation ………………………… ……… 3
8  再驗證數據分析The analysis of validation data  …………………………………………4
9  驗證結果與結論Result and conclusion of validation  …………………………  ……… 5
10 附件Appendix  ………………………………………………………………  ………… 5
 
 
1.概述Overview
1.1電子天平型號Electronic Balance Model：BT25S    設備編號Equipment No.：QC62Y011
1.2該設備由德G賽多利斯股份公司制造，安裝在天平室。
This equipment which Installed in the balance room is produced by Germany Sartorius AG
2.再驗證目的Validation Purposes
確認該儀器的稱量示值誤差、重復性、及其自動校準功能等技術指標經過一年的使用后仍舊能夠符合要求。
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#分頁標題#e#
3.再驗證要求Validation requirements
3.1驗證前檢查該設備的使用記錄及其日常維護保養測試記錄。
Before the validation, Confirm the equipment documents and spare parts are complete.
3.2驗證前必須對BT25S型電子天平進行每年一次的校驗。
Before the validation, Confirm the installation, operation of BT25S-type electronic balance and in accordance with the requirements of inspection weighing .
3.3驗證前必須對所用的校準砝碼確定有效。
Before the validation, Confirm the process of calibration weight of the trial used to effective
4.再驗證合格標準The validation Criterion
4.1BT25S型電子天平的稱量示值誤差范圍為20.0000g±1mg。
BT25S-type electronic balance sensitivity test weight is 20.0000g ± 1mg.
4.2BT25S型電子天平的重復性實驗合格標準：標準偏差≤0.02mg
BT25S-type electronic balance's eligibility criteria of reproducibility experimental: standard deviation is not more than 0.02mg.
4.3BT25S型電子天平的自動校準功能正常。
5.方案實施Implementation of the protocol
本驗證方案計劃于2010年01月04日－01月 05日進行驗證
The validation program is planned for verifying in December 21, 2008 to December 24 
由驗證小組：楊平、鐘迪仕、李霄、吳曉飛負責實施。
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.再驗證內容與方法Contents and Methods of Validation  
7.1日常使用記錄檢查及運行測試。
7.1.1目的：根據設備SOP-SB-QC022進行操作，確認該設備運行正常。 
Objective: operate the equipment in accordance with the equipment SOP-SB-QC022 。
7.1.2檢查項目（檢查結果在□劃“√”）Check the item (the results in the □ zoned "√")
7.1.2.1按鍵功能、顯示器Button functions, display

檢查項目Inspection Items	合格標準 Eligibility criteria	檢查方法Inspection method	檢查結果 Inspection results
Tare	除皮后顯示 In addition to skin revealed 0.00000g	按鍵檢查 Key check	□符合Matched  □不符合Unmatched
1/	開關 power	開機運行Switched	□符合Matched  □不符合Unmatched
CAL	調校 Adjustment	開機運行Switched	□符合Matched □不符合Unmatched
F	功能 Function	開機運行Switched	□符合Matched  □不符合Unmatched
CF	清除 Clear	按鍵檢查 Key check	□符合Matched  □不符合Unmatched
水平儀the level of instruments	氣泡位于圓環中央 Bubble is located in the central ring	現場觀察 Site observation	□符合Matched □不符合Unmatched
檢查人Check：                  復核人：Reviewer              日期：Date

7.2 維修保養情況。
7.3 日常測試記錄情況及其性能測試。
7.3.1校準砝碼信息： Information of weight calibration

標準器Standards	測量范圍Measuring range	等級 Grade	出廠廠家 Factory	校驗日期 Calibration Date
砝碼 Weight	1g～100g	F1

7.3.2 日常測試周期為：

測試項目 Test items	周期
校驗 Calibration	每年一次 Yearly
重復性 Repeatability	每月一次 Monthly
示值誤差 Sensitivity	每天一次 Daily

#p#分頁標題#e#7.3.3調整校準：Adjust the calibration
內部校準：當顯示0時，用         鍵激活校正功能。
Internal calibration: When the 0, use To activate the Calibration function
檢驗結論Test conclusions_____________________________________________________       
_________________________________________________________________________        
檢查人Inspector：                  復核人Reviewer：               日期Date：           
7.3.4 示值誤差測試：該天平zui大稱量為21g，使用20g的標準砝碼進行稱量測定，天平儀表顯示值應為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 重復性試驗：取1g的標準砝碼進行稱量測定10次，記錄稱量時電子天平儀表所顯示的數值，其標準偏差應≤0.02mg。
Repeatability test: respectively 1g standard weight weigh for 10 times, recording when electronic balance 's weighing instrument shown values.
8.再驗證數據分析The analysis of validation data
驗證結果均應符合再驗證合格標準。如有數據超過上述標準，則應由動力保障部、質量管理部共同進行分析，找出不合格原因，再實施驗證，直至符合再驗證合格標準。
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.驗證結果與結論  Result and conclusion of validation
9.1檢測中心負責收集各再驗證試驗結果記錄，根據再驗證試驗結果起草驗證報告，報告驗證委員會。驗證委員會根據再驗證方案的內容，對驗證報告進行核對和審查，然后批準并簽署，并由各成員會簽。驗證報告審批通過后，由驗證委員會的總負責人簽署驗證合格證書，說明該再驗證工作完成，已驗證的項目及相應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結果評價The results of the evaluation

項目 Items	評   價 Evaluation	評價人Evaluator	評價日期Evaluation Date
日常使用情況
維修保養情況
日常測試
運行確認 runing confirm
性能確認 Function confirm
結論 Conclusion

10.附件Annex
附件1：BT25S型電子天平驗證方案試驗記錄
Annex 1: Test records of BT25S-type electronic balance validation program 

附件Appendix 1:            
BT25S型電子天平驗證方案試驗記錄
The record of BT25S type electric balance validation program test
 

標準器 Standards		測量范圍 Measuring range		等級 Grade			出廠廠家 Factory			校驗日期 Calibration Date
砝碼 Weight		1g～100g		F1#p#分頁標題#e#
室溫room temperature：          濕度humidity：          儀器編號the equipment code
1.重復性稱量測試記錄 1.Repeatability weighing test record
1:	2:		3:					4:	5:
6:	7:		8:					9:	10:
平均值: Average Value:						標準偏差（mg）: Standard Deviation:
結論: Conclusion：
操作人/operator： 日期/date：					復核人/recheck man： 日期/date：
2.示值誤差測試記錄 2.Sensitivity test weight record
測量值: measure value:              g					真實值: true value:                    g
結論conclusion：
操作人/operator： 日期/date：					復核人/recheck man： 日期/date：