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FMEA helps us to deal with the potential problematic situations that a process or product can have during manufacture so it helps the organisations to deal with these situations in advance based upon severity & detection criterias before they arise actually & hamper quality requirements of product or process.
ISO 9001:2015 is based upon risk assessments & this is vital tool for assessment purposes,hence it has been included in the new version .
FMEA in the quality management at FMEA you can analyze the situation inside the process and its study the possible failure and and planning of action in the future that will discuss to all concern party or management for immediate action.
FMEA increases the probability of detection and reduces probability of failure occurrence. It identifies biggest contributor to failures and eliminate them.