某外资企业天平的校验与维护规程.doc

标准操作程序Standard Operating Procedure文件编码Doc. No.:颁发日期：Issue Date:生效日期：Effective Date:替代 ： Supersedes:复审日期：Review Date:页码：第1页共8页Page No.: 1 of 8标题：分析天平的操作，校验和维护程序TITLE: PROCEDURE FOR OPERATION, PERFORMANCE CHECK & MAINTENANCE of ANALYTICAL BALANCE1.0 目的 Purpose:描述了分析天平的操作与校验的程序。To describe the procedure for operation and performance check of Analytical Balance.2.0 范围 Scope:适用于下表所列的分析天平的操作与校验：This procedure appliestooperation and performance check of analytical balance of the following:生产厂家Make仪器编号I.D. NO型号Model序列号Sr no量程Capacity最大称样量Maximum Wt最小称样量Minimum Wt210g 0.1 mg 41g 0.01 mg200 g10 mg位置：检测中心天平室Location : Quality Control Department (Balance Room)3.0 定义 Definitions: 无 Nil4.0责任 Responsibility:分析天平的操作与校验由检验员负责。The responsibility of operation and to verify the performance check of Analytical balances lies with QC .Analyst.5.0 程序 Procedure:5.1操作 Operation:5.1.1观察水平仪的气泡是否处于中心确认天平是否处于水平。如果没有，通过调节天平后方的地脚螺钉直至气泡处于中心位置。Ensure that the balance is leveled by observing the air bubble is in the center of level indicator. If not, adjust the leveling by turning foot screws at the rear side of the balance housing until the bubble is in the center of the level indictor.5.1.2打开天平电源开关。Switch ON the main switch of the balance.5.1.3按“ON/OFF”键。Press “ON/OFF” key.5.1.4等30秒天平初始化后，天平显示0.00000 g。否则按 0 键。Wait for about 30 seconds for the initialization of the balance. After initialization the balance displays 0.00000 g . Otherwise, press 0 key5.1.5当天平显示0.00000 时，可以对天平开始操作。When 0.00000 is displayed, the balance is ready for operation.5.1.6将称量纸或称量瓶置于称量盘中心，关上天平玻璃门。Place the empty container / butter paper on the center of the pan and close the sliding glass doors.5.1.7等读数稳定。Wait till the balance shows stable reading.5.1.8按T 键清零，显示变为 0.00000 g 。称量纸或称量瓶的重量被去皮重了。Tare the weight by pressing T key briefly. The display changes to 0.00000 g. Now the weight of the container /paper is tared.5.1.9加入称量样品达到规定量。Add weighing sample to the container / paper till the required weight is displayed.5.1.10等读数稳定。记录数据为总重量g。Wait until the balance shows stable reading. Record the weight as “Gross Wt in g”.5.1.11 小心将样品移入量瓶后,将称量纸或称量瓶小心放置在称量盘中。Transfer the sample carefully into the flask and place the butter paper or weighing object on the pan carefully.5.1.12关上天平玻璃门等读数稳定，记录数据为皮重g。Close the doors and wait till the balance shows stable reading. Record the weight as “Tare Wt in g”.5.1.13称量mg样品，按天平右边的 F键。显示变为 0.00 mg，接着按照5.1.6步骤进行称量。To weigh the sample in mg, press F key in the right side of the balance. The display converts into0.00 mg and continue from step 5.1.6 for to weigh.5.2 提示 Precautions:5.2.1天平必须避免振动、风吹、高温、高湿。 The balance should be free from vibration, air thrust, strong heat and moisture.5.2.2AG245天平称量范围不得超过200g。Do not weigh beyond the weighing 200g on AG245 balance for the analytical work.5.2.3读数稳定后再确认数据。Consider weight readings of the observations till constant reading is displayed.5.2.4称量之前确保称量盘是干净的。用软毛刷清洁称量盘。Ensure the pan is cleaned before weighing .Clean the pan with soft brush.5.3校验 Performance check5.3.1 分析天平的日校 Daily Performance check Analytical Balance5.3.1.1 去除称量盘负载，清洁称量盘及其周围。Remove any load from the weighing pan, clean the pan and area.5.3.1.2 持续按右上角的“Cal”键至显示“Calibration Internal”。Press “Cal” key at the right top for a while to perform “Calibration Internal”.5.3.1.3 天平显示自校：开始显示+ 200.00000g 结束显示0.00000g 。 Balance shows calibration internal, then + 200.00000g and finally 0.00000g.5.3.1.4 将10mg标准砝码置于称量盘中央，记录读数。Place 10 mg standard weight at the center of the pan and record the display reading.5.3.1.5 将100mg标准砝码置于称量盘中央，等显示稳定记录读数。Place 100 mg standard weight at the center of the pan and record the display reading till constant reading is displayed.5.3.1.6 将200g砝码置于称量盘中央，将读数记录在天平校验记录里。Place the weight 200 g at the center of the pan and record the observed reading in Performance check Record of Analytical Balance.5.3.1.7 将校验细节记录在如附录I所示分析天平校验记录里。Record the Performance check details in the Performance check Record of Analytical Balance as shown in Annexure - I.5.3.2月校验（多个标准砝码）Monthly performance check (with multiple standard weights)准确度Accuracy:5.3.2.1 用标准砝码校验天平。Check the performance check of the balance by using standardweights.5.3.2.2 将200 mg, 500 mg, 1g, 2 g, 5 g, 10 g, 20 g, 50 g, 100 g, 200 g标准砝码置于称量盘中央，记录读数。并奖结果记录在附录II所示的表格里。Place 200 mg, 500 mg, 1g, 2 g, 5 g, 10 g, 20 g, 50 g, 100 g, 200 g, standard weights at the center of the pan and record the observed readings. Tabulate the results in Monthly Performance check record of Analytical balance as shown in Annexure - II.5.3.3 标准限度Acceptance Criteria:标准砝码重量Standard Weight限度范围Acceptance RangeUSP等级Class as per USP10 mg+ 0.05 mg1100 mg+ 0.10 mg1200 mg+ 0.12 mg4500 mg+ 0.10 mg11 g+ 0.20 mg42 g+ 0.20 mg45 g+ 0.30 mg410 g+ 0.50 mg420 g+ 0.70 mg450 g+ 1.20 mg4100 g+ 2.0 mg4200 g+ 4.0 mg45.3.4 重复性实验 Measurement of Repeatability:5.3.4.1 确保标准砝码使用前已校验合格。 Ensure that the standard weights are calibrated prior to their use.5.3.4.2 确保天平做重复性实验前已校验合格。Ensure that the balance is checked for performance check prior to the repeatability study.5.3.4.3 将100mg标准砝码置于分析天平称量盘中央。 Take the100mg standard weight and place it at the center of the pan of the analytical balance.5.3.4.4 记录读数。用同一标准砝码重复称10次，计算标准偏差值。 Record the reading on the display. Repeat the step for ten times with the same standard weight and calculate the standard deviation of the display weights.5.3.4.5 用1 g和100g标准砝码重复5.3.4.3和5.3.4.4的步骤，计算标准偏差值。 Repeat 5.3.4.3 and 5.3.4.4 with 1 g and 100g of the standard weights, calculate the standard deviation of the weights.5.3.4.6 将重复性数据记录在附录III所示的表格里。Record the Repeatability data in the Performance check record as shown in Annexure - III.5.3.4.7 如果重复性实验中出现任何偏差，必须对偏差进行调查，而且必须进行内部或代理商的校正。In case of any deviation found during Repeatability, deviation should be investigated and should be corrected by in-house or by external agency.5.3.4.8 校正后，天平必须进行机能检查和重复性实验。 After correcting, the balance should be tested for Performance check and tested for repeatability. 5.3.5 置信度 Uncertainty, precision (repeatability):5.3.5.1 用100 mg、1 g and 100 gm的重复性数据计算不可信度Calculate the uncertainty value for 100 mg、1 g and 100 gm standard weights under measurement of repeatability. 3 x 标准偏差 计算公式： - 标准砝码重 3 x Standard Deviation Calculation: - Standard Weight 5.3.5.2 限度范围：0.001Acceptance Criteria: Should not be more than 0.001. 5.4 校验周期 Frequency for Calibration:5.4.1 用指定标准砝码进行每日校验。Daily performance check to be done by using specified standard weights.5.4.2 多标准砝码校验周期：一个月+ 2 天。Performance check with multiple standard weights shall be carried out once in a month + 2 days.5.4.3 重复性实验周期：一个月+ 2 天。Repeatability shall be done once in a month + 2 days.5.5 维护计划 Maintenance Program :5.5.1 当天平观察到需要维修/未通过校验时，应贴上“维修”标签（附件V），同时向QC经理报告。Put “UNDER MAINTENANCE ” label (Annexure-V) on the instrument when it was observed breakdown / or out of calibration, intimate to Q.C. Manager.5.5.2 QC经理通知仪器售后服务工程师，经修理后需校验仪器，检查是否正常工作并记录。（注意：本次校验为额外校验，应按照校验日程计划照常进行每月的校验）。Q.C. Manager informs to the Instrument service engineer. After maintenance, calibrate the instrument to check its satisfactory functioning and record the readings. (Note: Calibrate the instrument as per the monthly calibration schedule, this calibration is an additional)5.5.3 将仪器维修报告附在仪器维护历史文件中，按照附件VI的格式填写仪器故障的详细情况。Retain service report copy attached in the Instrument Maintenance History File and enter the breakdown details in the enclosed format as Annexure-VI.6.0 相关文件 Related Documents:6.1 分析天平日校验记录（附录-I）Daily calibration record of analytical balance (Annexure-I)6.2分析天平月校验记录（附录-II）Monthly calibration of record of Analytical Balance (Annexure-II)6.3分析天平重复性实验记录（附录-III）Precision (repeatability) of analytical balance (Annexure-III)6.4 校验状态标签（附录-IV）Calibration status label (Annexure-IV)6.5 “维修”标签（附录-V）“UNDER MAINTENANCE” label (Annexure-V)6.6 仪器维修记录（附录-VI）Maintenance Record (Annexure-VI)6.7 仪器使用记录（附录-VII）INSTRUMENT USAGE LOG BOOK (Annexure-VII)7.0 修订记录 Revision Record:序号Sl. No版本号Revision Status修订内容Details of Revision备注Remarks*文件终结符END OF DOCUMENT附录IANNEXURE-I分析天平每日校验记录DAILY PERFORMANCE CHECK RECORD OF ANALYTICAL BALANCE参照文件编码Doc. Ref. No. : 表格号Form No.: 生效日期 Effective Date:第1页共1页Page 1 of 1仪器编号ID.No. 序列号S/N: 生产厂家 型号Model: MAX：200g MIN：10mg日期Date水平SpiritLevel内校Internal Calibration砝码重量Standard Weight读数Display Reading误差Difference限度范围Acceptancecriteria备注Remarks校验人Calibrated by复核人Checked by10.00 mg0.05 mg100.00 mg0.10 mg200.0000 g4.0 mg10.00 mg0.05 mg100.00 mg0.10 mg200.0000 g4.0 mg10.00 mg0.05 mg100.00 mg0.10 mg200.0000 g4.0 mg附录II ANNEXURE-II分析天平每月校验记录MONTHLY PERFORMANCE CHECK RECORD OF ANALYTICAL BALANCE参照文件编码Doc. Ref. No.: 表格号Form No.: 生效日期Effective Date:第1页共1页Page 1 of 1仪器编号 序列号S/N: 生产厂家Make: 型号Model: MAX：200g MIN：10mg 准确度 Accuracy日期Date水平Spirit Level内校Internal Calibration标准砝码重量Standard weight读数Display Reading误差Difference限度范围Acceptance Criteria备注Remarks校验人Calibrated by复核人Checked by200.00 mg0.12 mg500.00 mg0.10 mg1.00000 g0.20 mg2.00000 g0.20 mg5.00000 g0.30 mg10.00000 g0.50 mg20.00000 g0.70 mg50.0000 g1.20 mg100.0000 g2.0 mg200.0000 g4.0 mg下次校验日期Next Calibration due date : _附录III ANNEXURE-III分析天平重复性(精密度) 每月实验记录PRECISION (REPEATABILITY) OF ANALYTICAL BALANCE参照文件编码Doc. Ref. No.: 表格号Form No.: 生效日期Effective Date:第1页共1页Page 1 of 1 校验日期 calibration on: 仪器编号ID.No. 序列号S/N: 生产厂家 型号Model: MAX：200g MIN：10mg 精密度 (Balance Uncertainty)水平Spirit Level内校Internal Calibration标准砝码重量Standard weight读数Display readings3SDstd wt限度范围AcceptanceCriteria备注Remarks校验人Calibrated by复核人Checked by1st2nd3rd4th5th6th7th8th9th10th100.00 mg0.0011.00000g100.0000 g根据准确度和精密度来确认上述天平性能是否合格。Remarks: The performance of the above balance is satisfactory/Not Satisfactory in term of Accuracy and Precision are within the Limit下次校验日期Next Calibration due date : _附件IVANNEXURE IV校准状态标签CLIBRATION STATUS TAG参照文件编码Doc. Ref. No.: 标签号Label No.: 生效日