The application of FMEA should be an act before the incident, not a relief afterwards. To achieve the best results, the earlier you apply, the better. The application of FMEA in product design stage can find problems early and prevent "congenital bad design". Design FMEA is an activity carried out in the design process. At all stages of product development, design changes or other change information should be revised in time. Therefore, it is a dynamic process for factories to do DFMEA. The object of DFMEA evaluation and analysis is the final product and each related system, subsystem and parts, and the quality, environment, safety and hygiene problems that may occur during product manufacturing and product use are evaluated, thus providing a good foundation for process control. In the process of developing FMEA, the design defects cannot be solved by the control of the subsequent manufacturing or service process, and the restrictive conditions in the manufacturing and service process must be considered.
PFMEA should start at or before the stage of process feasibility analysis in production preparation, and consider all manufacturing processes from a single part to an assembly from the perspective of products, process characteristics and process flow charts. The objects of its evaluation and analysis are new processes, changed processes and processes with changed applications or environments. Therefore, it is also a dynamic process for factories to do PFMEA.
Because of DFMEA and FMEA, you can find out the key quality parts and processes and the size of the risk priority number (RPN). Then, according to the requirements of the company or customers, you can judge that the parts and processes with key quality characteristics and the size of RPN must be controlled by the factory, so the control plan comes out. Specifically, in the subsequent sample trial production, small batch trial production and mass production, there must be a specific "control plan" for parts with key quality characteristics identified by FMEA and processes with RPN greater than a certain value (generally RPN greater than 80).
The monthly quality report generally made by factories is actually the monthly statistics of control index data formulated by various departments and processes. Only by perfecting the five tools of TS can we have a convincing monthly quality report. Deming, a world-class quality master, once said: Except God, everyone else must use data and facts. Otherwise, the monthly quality report will have no reference value, and even affect the factory's decision-making mistakes.
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