The FMEA is considered a living document because throughout the product development cycle, change and updates are made to the product and process. These changes can introduce new failure modes if they are not fully investigated. It is therefore important to review and/or update the FMEA when the following events occur:
• A new product or process is being initiated (at the beginning of the cycle).
• Changes are made to the operating conditions in which the product or process is expected to function.
• A change is made to either the product or the process design. The product and process are inter – related. When the product design is changed, the process is impacted and vice versa.
• New regulations are instituted.
• Customer feedback indicates problems in the product or process.

Manufacturing engineers write the product’s manufacturing procedures for their department. When completed; it should be trialed to ensure all operations are performed correctly, work instructions are accurate, and anticipated results are obtained. Also, the trial should ensure that the product meets the necessary specifi cations for this point in its manufacture. At this point, an FMEA is conducted to ensure the quality department has not missed any unknown problems; the quality department is assisted by the department’s engineers who are knowledgeable of the product and operation. Knowledgeable personnel must be used here to ensure no operation or item is left unanswered in the FMEA. The FMEA is the responsibility of the department where the operation is performed with a team composed of personnel who have a stake in the process.

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