发生偏差的原因是验证人员在设置采样频率时由于鼠标滑轮滚动导致其操作失误,同时第二人未复核出相关错误。1.偏差只是Setup Report中的的英语翻译

发生偏差的原因是验证人员在设置采样频率时由于鼠标滑轮滚动导致其操作失误

发生偏差的原因是验证人员在设置采样频率时由于鼠标滑轮滚动导致其操作失误,同时第二人未复核出相关错误。1.偏差只是Setup Report中的采样频率设置错误,不涉及后续设备确认中参数采集的正确性。2.本次偏差涉及脉动真空灭菌柜最大装载模式的确认,相关验证数据合格。该设备发生偏差期间,不涉及相关产品批次,故不会对生产产生影响。3.偏差发生后重新设置探头采样频率,详见调查报告-附件05“重新进行脉动真空灭菌柜最大装载模式的温度验证”,测试结果合格,对后续生产无影响。4.为了防止后续发生类似的风险,需对验证人员进行H0-TM-22206 Validator“温度验证仪操作规程”培训,强调设置Setup Report后需与对应的验证方案进行核对。1.重新设置采样频率,进行脉动真空灭菌柜最大装载模式的温度验证。2.对验证人员进行H0-TM-22206 Validator“温度验证仪操作规程培训”的培训,强调设置Setup Report后需与对应的验证方案核进行核对。
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结果 (英语) 1: [复制]
复制成功!
The reason for the deviation is that the verification personnel set the sampling frequency due to the mouse wheel rolling, which caused the operation error, and the second person did not review the relevant error. <br><br>1. The deviation is just the wrong setting of the sampling frequency in the Setup Report, and does not involve the correctness of the parameter collection in the subsequent device confirmation. 2. This deviation involves the confirmation of the maximum loading mode of the pulsating vacuum sterilizer, and the relevant verification data is qualified. During the deviation of the equipment, the relevant product batches are not involved, so there will be no impact on production. 3. Reset the sampling frequency of the probe after the deviation occurs. For details, please refer to the investigation report-Annex 05 "Re-perform the Temperature Verification of the Maximum Loading Mode of the Pulsating Vacuum Sterilizer". The test result is qualified and has no effect on subsequent production. 4. In order to prevent subsequent similar risks, the verification personnel should be trained in H0-TM-22206 Validator "Operating Procedures for Temperature Validator", emphasizing that after setting up the Setup Report, it is necessary to check with the corresponding verification scheme. <br><br>1. Reset the sampling frequency and verify the temperature in the maximum loading mode of the pulsating vacuum sterilizer. <br>2. Train the verification personnel with H0-TM-22206 Validator "Temperature Verifier Operation Procedure Training", emphasizing that after setting up the Setup Report, check with the corresponding verification scheme.
正在翻译中..
结果 (英语) 2:[复制]
复制成功!
The deviation occurs because the validator made a misoperation when setting the sampling frequency due to the mouse sheave rolling, and the second person did not review the error.<br><br>1. The deviation is only an error in the sampling frequency setting in Setup Report, and does not involve the correctness of parameter acquisition in subsequent equipment confirmation. 2. This deviation involves the confirmation of the maximum loading mode of the pulsating vacuum sterilization cabinet, and the relevant verification data are qualified. The equipment does not involve the relevant product batch during deviation, so it does not affect production. 3. After the deviation occurs, reset the probe sampling frequency, see the investigation report - Annex 05 "Re-testthe temperature verification of the maximum loading mode of the pulsating vacuum sterilization cabinet", the test results are qualified, no impact on subsequent production. 4. In order to prevent similar risks in the future, the validator H0-TM-22206 Validator "temperature validato" training, emphasizing the setup Report after the need to check with the corresponding verification program.<br><br>1. Reset the sampling frequency to verify the temperature of the maximum loading mode of the pulsating vacuum sterilization cabinet.<br>2. The certification personnel to H0-TM-22206 Validator "temperature validato" training, emphasizing that the setup Report after the setting up with the corresponding verification program nuclear check.
正在翻译中..
结果 (英语) 3:[复制]
复制成功!
The reason for the deviation is that the verifier made an operation error due to the mouse pulley rolling when setting the sampling frequency, and the second person did not check out the relevant error.<br>1. The deviation is only the sampling frequency setting error in the setup report, and does not involve the correctness of parameter collection in subsequent equipment confirmation. 2. This deviation involves the confirmation of the maximum loading mode of the pulsating vacuum sterilization cabinet, and the relevant verification data are qualified. During the deviation period of the equipment, the relevant product batches are not involved, so the production will not be affected. 3. Reset the probe sampling frequency after the deviation. For details, see the investigation report - Annex 05 "temperature verification of maximum loading mode of pulsating vacuum sterilizer". The test results are qualified and have no impact on subsequent production. 4. In order to prevent similar risks in the future, it is necessary to conduct h0-tm-22206 validator "operating procedures for temperature validator" training for the verifier, emphasizing that after setting up the setup report, it is necessary to check with the corresponding verification scheme.<br>1. Reset the sampling frequency to verify the temperature of the maximum loading mode of the pulsating vacuum sterilization cabinet.<br>2. Carry out h0-tm-22206 validator "temperature verifier operation procedure training" for the verifier, and emphasize that after setting up the setup report, it is necessary to check with the corresponding verification scheme.
正在翻译中..
 
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