Risk Analysis Study Protocol cum Report of Instruments of Purified Water System for Injection Pure Steam Generation System

There are different instruments attached with water system which helps in operation of equipment, these instruments are helpful in providing data at each stage, for the proper working these instruments are regularly calibrated by the external agency, this Calibration of the instruments is a scheduled activity. Calibration is done to check the efficiency of the instruments attached with the equipment, as after a period of time the instruments efficiency may drop down. There are 235 number of instruments related to utility, which are calibrated on yearly basis. Instruments are calibrated by the vendors approved by CQA. As per the calibration planner SOP, the calibration shall be done within ±1 month from the scheduled date.Risk shall be identified if Instrument gets malfunctioned. For that, all instruments shall be identified along with their role &risk.