FMEA is an explicit requirement of ISO TS 16949 standard.
Process FMEA is used to assess the efect of possible process failure on product quality. Process FMEA should be performed for any new process or for a current process which was programmed to produce a new product to make sure they are taken into account all the possible failures and implemented all necessary remedial measures. Process FMEA is a useful tool used to investigate the root cause of defective products in the current process.
This P-FMEA (Process Failure Mode & Effect Analysis) workshop provides a common structure for the development of the activities designed to recognize and evaluate the failure potential of a product or process design and associated effects. Moreover, it seeks to identify actions that could eliminate or reduce the possibility of occurrence of failures and the development of process document to ensure that a design or process does exactly what it takes to satisfy customers.
Through this P-FMEA workshop – Process Failure Mode and Effect Analysis, Exegens® provides you the approach of the breakdowns in the system. P-FMEA is an engineering technique used to define, identify and remove the breakdowns from the system, the potential and/ or known errors or problems. FMEA direction is to design processes so that customers are not affected.
All standards of Advanced Product Quality Planning provide structured methods for defining and establishing the necessary steps to ensure that the product meets the requirements of the customers. The Control Plans help products′ quality being consistent with customer requirements and apriori standards. The Control Plans provide the structural approach for design, selection and implementation of control methods for the added value in the whole system. A company that targets a high level of quality must use FMEA in the Advanced Quality Planning Processes and in the development of their control plans.
The main objective of this FMEA workshop is approaching ways in which a product or a process could “fail”. A “failure” of a product or a process is when this can not work as default. In the real life of the companies there are a multitude of “opportunities” for the system to “fail”.
FMEA is a group of activities designed to:
– Recognize and assess the potential “failure” of the products or processes and its effects;
– Identify actions that could eliminate or reduce potential “failure”;
– Document the processes.