APQP Five Phase Process
Concept Program
Initiation/Approval Approval Prototype
Pilot Launch
Planning Planning
Product Design and Development
Process Design and Development
Product and Process Validation
Production
Feedback Assessment and Corrective Action
Phases 2 and 3
• Phase 2 - Design • Phase 3 - Process
– Objectives – Objectives
• Develop design features and • Develop a comprehensive and
characteristics effective manufacturing system
• Critically review engineering • Ensure that the manufacturing
systems meet customer
requirements
requirements
• Assess potential manufacturing
problems – Outputs
– Outputs by Design
Responsibility Activity
– Outputs by Advanced Product
Quality Planning Team
Links Between the Tools
Contract Review Determine Customer Expectations and Plan for Quality
Program Plan
Phase I
DFMEA Identify Key Characteristics Phase II
DVP&R and Team Feasibility Determine Risk and Feasibility
Commitment
Phase II
Produce Process
Flow Diagrams Associate Characteristics with Process Steps and Identify Key Characteristics Phase III
Conduct Process Expose Sources of Variation and Finalize Key Characteristics
FMEA
Phase III
Develop Determine Methods to Improve Process and Control Variation
Control Plan
Phase III
Work Instruction Implement Control Plan and Standardize the Process
Development
Phase III
Product and Ensure Customer Expectations are Met
Process Validation
Phase IV
Ensure Continuous Exercise Management Oversight
Improvement
Phase V
How a PFMEA Works
• Where does the data for the PFMEA come
from?
• What types of people are a part of the
PFMEA team?
• What types of activities should we spend a
lot of time on?
Link Between the Documents
Process Flow PFMEA Control Plan
Operation Number
Product/Process
Characteristic
Incoming Sources Variation Class
of Variation
Work Instructions
APQP Links to PFMEA
PFMEA Control Plan Work Instructions
Change in detection
or
Change in occurence
Change in severity
or
or or
Design Change Other Action
APQP Links to Control Plan
Control Plan
Quality Checklist
First/Last Piece
Yearly Layout
Mistake Proofing
P/M Checklist
PFMEAs/Control Plans and 8-Ds During APQP
• PFMEAs should be driven by real data, including 8-Ds
(internal and external), warranty and returned pat analysis
• PFMEAs should be completed by process experts and
should be a driver of the control plans and work
instructions
• Work instructions (Post control log, process parameter
logs, preventive maintenance, etc.) implement the control
plan in the process
• When there is a quality problem there is an opportunity to
improve the control plan and the work instructions
Quality Problems
Quality Problem Occurs
Customer Problem
no yes
no
Cause known? Conduct Disciplined Problem Solving
yes yes
Revisit PFMEA Cause known?
no
Corrective Action yes Conduct D.O.E.
n
Update Control Plan and Plant Work Instructions Cause known? o
Cause unknown
• Use PFMEA
Note: When a customer problem occurs, follow customer prescribed methodology
When to use 8-D
• When the cause is unknown
• When you need to get input from several
parties
• When customers dictate use
Note: We use voting techniques, X to Y variable testing, and IS/IS Not to determine the root cause.
However, you still may not know what the root cause is?
When to use Designed Experiments or
Regression
• After using 8-D, the cause is still unknown
• Designed experiments between cause and
effect voted by team could identify the vital
few root causes
• Semi-conductor companies collect product
and process information that could be used
to identify root cause using regression
QS-9000 Semi-Conductor Supplement
• Conduct containment in 24 hours, electrical
verification in 48 hours and root cause and
corrective identification in ten days
• Complete returned product analysis
• Analyze the product in a qualified laboratory
• Make sure the corrective actions are effective
• Use the knowledge gained in similar processes
and products
Update the PFMEA & Control Plans
Scrap, Rework Data
Process PFMEA Control Work
Flow Plan Instruction
Warranty & Assembly Plant Data
After the 8-D is completed, the PMEA and the control plan should be revised and updated as
applicable
