1、APQP,Product and Process Validation,Jan (“Yon“) Roovers President JAN ROOVERS ASSOCIATES, INC. Charlotte, North Carolina USA,Presented by:,1,Purpose: To validate the manufacturing process through an evaluation of a production trial run. Considerations: During the production trial run, the APQP Team
2、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.,4.0 Product and Process Validation,74,INPUTS Packaging Standar
3、ds 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
4、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,4.0 Product and Process Validation,75,Definition/Purpose: To validate the effectiven
5、ess 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 - Prod
6、uction validation testing - Production part approval - Packaging evaluation - First time capability - Quality planning sign-off,4.1 Production Trial Run,76,Definition/Purpose: To evaluate the stability of the specified measurement devices and methods used to check the characteristics identified on t
7、he control plan. Action Items: - Evaluate the measurement system - Refer to the MSA Manual,4.2 Measurement Systems Evaluation,77,Definition/Purpose: To determine the readiness of the process for production. Action Items: - Include all characteristics identified in the control plan for the capability
8、 study - Refer to the PPAP Manual - Refer to the SPC Manual,4.3 Preliminary Process Capability Study,78,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,4.4 Production
9、 Part Approval,79,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 16949:2002,4.5 Production Validation Testing,80,Definition/Purpose
10、: 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 Teams involvement in evaluating the packaging method.,4.
11、6 Packaging Evaluation,81,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 cha
12、nges (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),4.7 Production Control Plan,82,Definition/Purpose: To inform Top Management of the program status and gain their commitment to assist in (or r
13、esolve) 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),4.8 Quality Planning Sign-off and Management Support,8
14、3,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
15、 - 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),4.8 Quality Planning Sign-off and Management Support (Contd),84,
