5. Predictions and Prevention of Quality Problems
To insure that quality is consistently built into products, quality problems must be accurately predicted and predicted and prevented during the development stages.
Potentially degrading elements to production quality must be eliminated during the product design stage, selection of processing methods, and production planning.
Design reviews are very important. They predict and prevent design quality problems at the time of product development.
Through these reviews the supplier is expected to gain a better definition of the overall product reliability and quality performance. This information will highlight difficult or control characteristics to be used in the Process FMEA.
A Design or Product FMEA is not mandatory however a Design Review must be conducted.
Process Failure Mode and Effects Analysis (Process FMEA)
The Process FMEA is intended to point out process activities that have potential for causing parts to be produced that do not meet ISUZU’s specifications. The Process FMEA in no way replaces engineering drawings of specifications but enables the supplier to design a process for the prevention of potential problems.
To predict and prevent quality problems, ISUZU requires a Process FMEA be submitted per product.
Sample of Process FMEA is follow AIAG Manual, supplier is required to use this or similar format. (Recommend use attachment B-4: Process Failure Mode and Effects Analysis)
Note: These are the minimum requirements of ISUZU. The supplier shall also take every possible voluntary action to predict and prevent quality problems. If an alternate method to a Process FMEA is preferred, obtain approval prior to use.