Transcript No Slide Title

APQP
Product and Process Validation
Presented by:
Jan ("Yon") Roovers
President
JAN ROOVERS ASSOCIATES, INC.
Charlotte, North Carolina • USA
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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
OUTPUTS
• 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
• 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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