APQP

Product and Process Validation

Presented by:

Jan ("Yon") Roovers

President
JAN ROOVERS ASSOCIATES, INC. Charlotte, North Carolina USA

4.0 Product and Process Validation

Purpose:
To validate the manufacturing process through an evaluation of a production trial run.

Considerations:
During the production trial run, the APQP Team must validate that the control plan and process flow chart are being followed and that the product meets the customer requirements. Additional concerns must be identified for investigation and resolution prior to regular production runs.
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4.0 Product and Process Validation

INPUTS
Packaging Standards Product/Process Quality System Review Process Flow Chart Floor Plan Layout Characteristics Matrix PFMEA Pre-Launch Control Plan Process Instructions Measurement System Analysis Plan Preliminary Process Capability Study Plan Packaging Specifications Management Support

OUTPUTS
Production Trial Run Measurement System Evaluation Preliminary Process Capability Study Production Part Approval Production Validation Testing Packaging Evaluation Production Control Plan Quality Planning Sign-Off and Management Support

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4.1 Production Trial Run

Definition/Purpose:
To validate the effectiveness of the manufacturing process.

Action Items:
Conduct the production trial run using all planned resources and cycle time Determine minimum quantity for the trial run Use output for:
- Preliminary process capability study - Measurement systems evaluation - Final feasibility - Process review - Production validation testing - Production part approval - Packaging evaluation - First time capability - Quality planning sign-off

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4.2 Measurement Systems Evaluation

Definition/Purpose:
To evaluate the stability of the specified measurement devices and methods used to check the characteristics identified on the control plan.

Action Items:
- Evaluate the measurement system - Refer to the MSA Manual
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4.3 Preliminary Process Capability Study

Definition/Purpose:
To determine the readiness of the process for production.

Action Items:
- Include all characteristics identified in the control plan for the capability study - Refer to the PPAP Manual - Refer to the SPC Manual
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4.4 Production Part Approval

Definition/Purpose:
To validate that products made from production tools and defined processes meet engineering requirements.

Action Items:
- Conduct PPAP - Refer to the PPAP Manual

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4.5 Production Validation Testing

Definition/Purpose:
Engineering tests that validate that products made from production tools and defined processes meet engineering requirements.

Action Items:
- Conduct required engineering tests. - Refer to ISO/TS 16949:2002

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4.6 Packaging Evaluation

Definition/Purpose:
To assess the protection of the product from normal transportation damage and adverse environmental factors.

Action Items:
- Conduct test shipments - Select specified test methods

NOTE:
Customer specified packaging does not preclude the APQP Team's involvement in evaluating the packaging method.
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4.7 Production Control Plan

Definition/Purpose:
A written description of the systems for controlling parts and processes. A logical extension of the Pre-Launch Control Plan.

Action Items:
- Develop the Production Control Plan - Evaluate process output, review the control plan, and make appropriate changes (Customer approval may be required) - Refer to Section 6 (Page 31) and A-8 (Page 79) - Refer to the Ford DCP in Appendix B (Page 83) and G (Pages 95-101)

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4.8 Quality Planning Sign-off and Management Support

Definition/Purpose:
To inform Top Management of the program status and gain their commitment to assist in (or resolve) any open issues.

Action Items:
- Ensure that all control plans and process flow charts are being followed - Perform the review at the manufacturing location(s) and coordinate a formal sign-off - Review the following items: (See next page)

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4.8 Quality Planning Sign-off and Management Support (Cont'd)

Action Items:
Review the following items:
- Control Plans: Existence and availability at all times for all affected operations - Process Instructions: Must contain Special Characteristics; all PFMEA recommendations addressed; compare process instructions and process flow charts to the control plan - Gage and Test Equipment: Verify GR&R for all special gages, fixtures, and test equipment

Be able to show that all requirements are met and concerns documented Schedule a management review Refer to, and utilize Appendix F (Pages 93-94)
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