![]() NOTE: Control and monitoring procedures may include in-process and/or finished device acceptance activities as well as environmental and contamination control measures. Also confirm that the piece of inspection, measuring or test equipment was controlled and calibrated. Prior to concluding the inspection, confirm that applicable maintenance activities (preventive maintenance, cleaning, adjustment etc.) are performed as scheduled for the chosen piece of processing equipment. While on the shop floor, make note of one significant piece of process equipment and one significant piece of inspection, measuring or test equipment (preferably from a finished device acceptance activity). This should be done on the shop floor by reviewing work instructions, product acceptance criteria and results, control charts, etc. Verify that the control and monitoring activities demonstrate that the process is currently operating in accordance with the DMR. Verify that the building is of suitable design and contains sufficient space to perform necessary operations. This list can be verified against the DMR and brought to the shop floor to compare with the currently available documents. Most firms maintain a "Master List" of the most currently approved documents. Examples of some verification activities associated with validated processes include review of process parameters, dimensional inspections, package performance tests, sterility and EO residual testing.įor the process chosen, confirm that the established Process (and where applicable Environmental and Contamination) Control, Monitoring and Product Acceptance Procedures maintained by the shop floor are the most current approved revision contained within the Device Master Record (DMR). ![]() Just because a process is validated, does not mean verification activities utilized to monitor and control the process are unnecessary. Verify that the process is controlled and monitored.Īll processes that may cause a deviation to a device's specification and all validated processes must be monitored and controlled in accordance with established procedures. ![]() Review the specific procedure(s) for the manufacturing process selected and the methods for controlling and monitoring the process. The firm may accomplish this requirement via Product and Process Risk Analyses.Ģ. Discuss with the Management Representative (or designee) the firm's system for determining whether deviations from device specifications could occur as a result of the manufacturing process or environment. In order to meet the Production and Process Control requirements of the Quality System Regulation, the firm must understand when deviations from device specifications could occur as a result of the manufacturing process or environment. Note: If the process chosen is Sterilization, evaluate the process according to the "Sterilization Process Controls" chapter of this handbook. Variety in process technologies and profile classes.Verify that personnel have been appropriately qualified to implement validated processes or appropriately trained to implement processes which yield results that can be fully verified.If the process is software controlled, confirm that the software was validated.If the results of the process reviewed cannot be fully verified, confirm that the process was validated by reviewing the validation study.Evaluate the validation study in full to determine whether the process has been adequately validated.Review the equipment adjustment, calibration and maintenance and.Determine whether any nonconformances were handled appropriately.If review of the Device History Records (including process control and monitoring records, etc.) reveals that the process is outside the firm's tolerance for operating parameters and/or rejects or that product nonconformances exist:.Note: Control and monitoring procedures may include in-process and or finished device acceptance activities as well as environmental and contamination control measures. Verify that the process is controlled and monitored. Review the specific procedure(s) for the manufacturing process selected and the methods for controlling and monitoring the process.Note: If the process chosen is sterilization, evaluate the process according to the "Sterilization Process Controls" chapter of this handbook. Any other appropriate criterion as dictated by the assignment.Processes not covered during previous inspections.Variety in process technologies and Profile classes.Use of the process in manufacturing multiple devices. ![]()
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