Product and Process Validation

It is important to evaluate the manufacturing process. This can be through a production trial run. 

The product quality planning team must validate the control plan and process flow chart and ensure that customer requirements are accomplished. 

The inputs of this phase were the outputs of the process design and development stage. 

Outputs

• Production Trial Run

The effectiveness of the manufacturing process depends on the production trial run. 

The output of this will provide useful to other processes such as preliminary process capability study, measurement systems evaluation, final feasibility, process review, and many more. 

• Measurements System Evaluation

The specified measurement devices and methods must go through a systems evaluation to confirm the control plan characteristics.   

• Preliminary Process Capability Study

This study provides an assessment of the readiness of the processes identified by the control plan. 

• Production Part Approval

This study offers an assessment of the readiness of the processes identified by the control plan. 

• Production Validation Testing

This refers to engineering tests that validate the products.

• Packaging Evaluation 

This is necessary to assure the customers that products are protected from normal transportation and other external factors. 

• Production Control Plan 

This extends the pre-launch control plan. It is a living document that describes the systems controlling the parts and the processes. It must be updated from time to time. 

• Quality Planning Sign-off and Management Support

The team must ensure that all control plans and process flow charts are being followed. 

Control plans must always be available for all operations.

Process instructions must contain all the special characteristics specified in the control plan. 

Gage and equipment must be tested prior to their use. 

It is important for the team to gain commitment from the top management to assist them in any open issues.