The basic objective of the manufacturing process is to produce a product at a target rate, cost and yield that meets the Product Design Specifications without hurting anyone. When a manufacturing process fails to meet this basic objective in any manner, there is risk to the company.
The Quality Plus® Manufacturing Process Risk Management Module guides the manufacturing personnel through a structured decomposition of the process and enables them to capture critical information about the process. This information is placed in a Process Design Model for current use as well as for future use for processes of similar type. Using the information in the Process Design Model as well as information from the Requirements Risk Assessment® and Design FMEA, the Manufacturing Process Risk Management Module autogenerates a Process FMEA and supporting Process Validation Plan. After modifying the Occurrence Ratings of the Process FMEA with information gained from performance of the Process Validation Plan, the manufacturing personnel use the Process FMEA output in combination with risk-based thinking to prioritize which process failures and causes of process failure causes must be worked on to achieve the greatest risk/benefit ratio in the process.
The Process Design Model found in the Quality Plus® Manufacturing Process Risk Management Module must not be confused with the static Master Process FMEA templates offered many FMEA software vendors. The contents of the Quality Plus® Process Design Model are dynamically integrated with information in the Requirements Risk Management and Design Risk Modules. The amount of information used from the Process Design Model for a new process design is dependent on a customized description of the new process provided to the Manufacturing Process Risk Management Module as well as the product that is being produced using the process.
The Manufacturing Process Risk Management Module has many other important features including but not limited to autogenerated Process Control Plans, Process Check Sheets and Processing Instructions. A Process Bookshelf Technology option is included to capture manufacturing process lessons learned. The Process Design Model is linked to the FRACAS/CAPA Module.