Quality Control Plan and Process FMEA

After the recognition of potential risk in the manufacturing procedure through process FMEA, it is necessary that appropriate measures & actions be incorporated in the process quality control plan. For instance, a process has recognized an X-ray inspection to be performed after a specified process step to reduce the RPN to an acceptable level.

Now It becomes imperative that the quality engineer ensures that the X-ray inspection be installed & carried out at the desired location in addition to on the quality control plan. Thus, the process FMEA shall always drive the quality control plan and the two documents would be closely associated to each other. With the passage of time as manufacturing engineers gain experience, they shall incorporate changes in the process to make it more risk free and less prone to producing defects. Accordingly, both the process FMEA and the control plan get modified simultaneously to reflect the changes and improvements made. The process FMEA and the Quality Control plan both are living documents for reference on the factory floor. They must be kept on the factory floor readily accessible to factory personnel when needed. The continual updating of these documents contributes considerably in maintaining a healthy manufacturing process flow.