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  • bb254 replied to the topic Maintenance & validation in the forum Process Validation and Process Risk 7 years, 1 month ago

    When a fixture fails on the production floor at work, the priority is to determine if it affected any products what were in contact with that fixture. If so, then it can escalate to a CAPA through the development of a CRF. In terms of validation, it does not need to be revalidated unless it is moved from the production floor. If it is moved from its current location for fixing, the bare minimum to get it back onto the production floor for use would be an installation qualification, operational qualification and performance qualification. The maintenance procedure for that fixture might need to be updated based on the findings of why the fixture failed. The fixture will continue to require maintenance and calibration (if expired) to be able to check if the products being produced with the fixture match the specifications.