FAILURE MODE AND EFFECT ANALYSIS Sample Clauses

FAILURE MODE AND EFFECT ANALYSIS. Introduction Failure Mode and Effect Analysis (FMEA) is an analytical technique used to ensure that all recurrence prevention items, previous concerns and potential concerns have been considered and addressed during the development of a product or process. The FMEA identifies high-risk items for improvement activities or special controls. In order to anticipate and prevent concerns during the production preparation activity, the supplier should actively involve representatives from all affected areas in the completion of an FMEA. A FMEA should be completed for each part (where practicable) or by generic process and should form the basis for the Quality Control Plan. Submission The FMEA should be started at the outset of the Project and should be reviewed at each parts submission stage. The FMEA should be reviewed and updated as required after any customer concern. With agreement from Nifco UK QA, the suppliers own format may be used. Completion The document should be completed detailing each stage of process and manufacture and for each stage detail the following:  Potential Failure Modes (consider previous concerns on similar products)  The Potential Effects of these failures on the customer (internal as well as external)  The Potential Causes of the failure  The current controls already existing within the process (if any)  Any recommended actions detailing when they will take place and by who  A review of these actions  Each potential failure should be graded according to the scoring system detailed in QS 9000.  Update FMEA copies may be requested following a parts concern