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  • hm243 replied to the topic Maintenance & validation in the forum Process Validation and Process Risk 7 years, 11 months ago

    In a situation like this, it is primarily important to determine the factor that caused the failure. Once the reason for failure is found, then measures can be taken to fix the issue and possibly prevent the failure from occurring again. After the machine is repaired or a new machine is installed, the maintenance and calibration schedule might need to be updated. This may call for more frequent checkups to prevent from failure again. In addition, if the machine has been updated and modified from the original, then it can cause for an entirely new maintenance and calibration schedule.