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.
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