Article

Quality risk management of purified water generation system using failure mode and effect analysis as risk assessment tools

Author : Adarsh Sahu, Prafull Yawatkar, Mahendra Prasad Jatav, Garima Jain and Shweta Mishra

The quality risk management study is an important quality assurance tool for threat identification, assessment and extenuation of threats. The objective of current research was to resolve potential disappointment associated with purified water generation system. It includes profound and through study of purified water generation system, steps involved in water purification process, identification of potential disappointment and detection of their brutality, incidence and detection ratings, determining risk significance numbers of each failure mode, classification of risk on the basis of risk significance numbers and finally give the reduction rheostat measure for harmful disappointment modes. Analysis was conducted to identify the potential significance modes associated with purified water generation system and no major stark failure mode associated with purified water generation system was detected. Use of quality risk management and application of failure mode and effect analysis (FMEA) on pharmaceutical water system was a pivotal point of this research work.


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