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Description
Introduction to APQP
© 2013 Eaton. All Rights Reserved.
Des
Lau nch
Plan
ign
A ve ro pp
e
at il d Va
Maintain high quality products while keeping projects on schedule with transparent task management and collaboration tools.
APQP – Advanced Product Quality Planning overview © 2013 Eaton. All Rights Reserved.
Presentation Overview
Scope of Training What is APQP Project Requirements Detail on APQP phase – inputs and outputs Why Do APQP Lessons learned Key Take Aways
© 2013 Eaton. All Rights Reserved.
3
Training Scope – Need to accomplish Introduces the concept of Advanced Product Quality Planning (APQP) process. Defines a typical program management phase review discipline (PRD)
Highlights the Inputs/Outputs of each stage Details process interfaces Relates importance of each element to the whole Steps through APQP Tool Kit Explains Levels and Elements of PPAP Highlights Eaton’s expectations for external suppliers.
© 2013 Eaton. All Rights Reserved.
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What is APQP? Advanced Product Quality Planning Cycle
Advanced Product Quality Planning method to assure that a product satisfies the customer (both internal and external). The goal of APQP is to facilitate communication with everyone and to assure that all required steps are completed on time
Each Advanced Product Quality Plan is unique and is a living document. Particular emphasis must be placed on identifying high risk long lead requirements or items which require focused upfront, effort.
© 2013 Eaton. All Rights Reserved.
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APQP Background Automotive industry
Automotive industry challenges: Innovation, more complex product Reduce NPD times
Complicated Supply chain Automotive Industry Action Group
Increasing customer and quality requirements
Solution: Ford, GM, Chrysler APQP Task Force jointly developed in the late 80’s to standardize their respective supplier quality systems. © 2013 Eaton. All Rights Reserved.
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APQP – timing chart and phases - AIAG The Advanced Product Quality Planning process consists of four phases and five major activities and has some 20+ supporting tools (e.g. DFMEA, PFMEA, CTQ, Special Characteristics, Control Plan, SPC) along with ongoing feedback assessment and corrective action.
© 2013 Eaton. All Rights Reserved.
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APQP Inputs and Outputs Product Design & Dev
Process Design & Dev
Product & Process Validation
• Process Flow Chart
Output
• Product/Process Quality System Review
Output
Output
• Packaging Standards
Feedback, Assessment & Corrective Action
Input
Plan & Define Program
Input
Prepare for APQP
• Production Trial Run • Measurement Systems Evaluation
• Floor Plan Layout
• Preliminary Process Capability Study
• Characteristics Matrix
• Production Part Approval
• Process Failure Mode and Effects Analysis (PFMEA)
• Production Validation Testing
• Pre-Launch Control Plan
• Production Control Plan
• Process Instructions
• Quality Planning Sign-Off and Management Support
• Reduced Variation • Customer Satisfaction
• Delivery and Service
• Packaging Evaluation
• Measurement Systems Analysis Plan • Preliminary Process Capability Study Plan • Packaging Specifications • Management Support
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The key to success is the development of a comprehensive project quality plan: • Identify all tasks;
• Assure the effort for all tasks is planned for all functions involved; • Monitor progress and effort against the plan.
© 2012 Eaton Corporation. All rights reserved.
APQP – timing chart in relation to Phase Gate Review Discipline Phase 0 Initiation Phase 1
Phase 3 Phase 2 Definition
Design and Development
Phase 4 Validation
Concept
Phase 5 Launch
Phase 6 Project Close
Market analyses / VOC Market Launch Product Design Process Design Supplier Validation
Production
Business Plan Project Management
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1. Plan and Define Program OUTPUTS:
INPUTS: • Voice of the Customer • Market Research
• Reliability & Quality goals
• Historical Warranty and Quality Information
• CONC* targets
• Team Experience
Assure that customer needs and expectations are clearly understood.
• Design Goals
• Preliminary Bill of Materials
• Business Plan/Marketing Strategy
• Preliminary Process Flow Chart
• Product/Process Benchmark Data
• Preliminary list of Special Product and Process Characteristics
• Product/Process Assumptions • Product Reliability Studies
• Product Assurance Plan • Management Support
• The inputs and outputs applicable to the process may vary according to the product process and customer needs and expectations. • *CONC = Cost of Nonconformance – New with Eaton Integration © 2013 Eaton. All Rights Reserved.
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2. Product Design and Development - 1 OUTPUTS:
INPUTS: • Design Goals
•
Design Failure Mode and Effects Analysis (DFMEA)
• Reliability & Quality goals
•
Design For Manufacturability and Assembly
• Preliminary Bill of Materials
•
Design Verification
•
Design Reviews
•
Prototype Build – Control plan
•
Engineering Drawings (Including Math Data)
•
Engineering Specifications
•
Material Specifications
•
Drawing and Specification Changes
•
New Equipment, Tooling and Facilities Requirements
•
Special Product and Process Characteristics
•
Gages/Testing Equipment Requirements
•
Team Feasibility Commitment
•
Management Support
• Preliminary Process Flow Chart • Preliminary list of Special Product and Process Characteristics *
Develop design into • Product Assurance Plan a near final form. Prototype and feasibility studies – volumes, schedule, manufacturing.
* New with Eaton Integration – Added granularity around Critical To Quality (CTQ) special characteristics – Two Types now available to select from Required Control Dimensions (RCD) and Statistically Toleranced Dimensions (STD). © 2013 Eaton. All Rights Reserved.
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3. Process Design and Development INPUTS:
Develop a manufacturing system and its related control plans to achieve quality products.
OUTPUTS: • Packaging Standards
•
Design Failure Mode and Effects Analysis (DFMEA)
•
Design For Manufacturability and Assembly
• Product/Process Quality System Review
•
Design Verification
•
• Process Flow Chart
Design Reviews
•
Prototype Build – Control Plan
• Floor Plan Layout
•
Engineering Drawings (Including Math Data)
•
Engineering Specifications
•
Material Specifications
•
Drawing and Specification Changes
•
New Equipment, Tooling and Facilities Requirements
•
Special Product and Process Characteristics
•
Gages/Testing Equipment Requirements
•
Team Feasibility Commitment
•
Management Support
• Characteristics Matrix • Process Failure Mode and Effects Analysis (PFMEA) • Pre-Launch Control Plan • Process Instructions • Measurement Systems Analysis Plan • Preliminary Process Capability Study Plan • Packaging Specifications • Management Support
© 2013 Eaton. All Rights Reserved.
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4. Product and Process Validation INPUTS: • Packaging Standards • Product/Process Quality System Review • Process Flow Chart
Validate manufacturing process through production trial run.
• Measurement Systems Evaluation • Significant Production Run
• Floor Plan Layout
• Preliminary Process Capability Study
• Characteristics Matrix
• Production Part Approval
• Process Failure Mode and Effects Analysis (PFMEA)
• Production Validation Testing
• Pre-Launch Control Plan
• Production Control Plan
• Process Instructions
• Measurement Systems Analysis Plan Validate that the control plan and process flow • Preliminary Process Capability chart are effective and Study Plan that the product meets customer expectation.
OUTPUTS:
• Packaging Evaluation
• Quality Planning Sign-Off formal • Management Support
• Packaging Specifications • Management Support © 2013 Eaton. All Rights Reserved.
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Feedback, Assessment, Corrective actions INPUTS: • Production Trial Run • Measurement Systems Evaluation
• Preliminary Process Capability Study • Production Part Approval
Evaluate outputs, effectiveness of the product quality planning efforts.
OUTPUTS: • Reduced Variation • Improved Customer Satisfaction • Improved Delivery and Service
• Effective use of best • Production Validation Testing practice, lessons learned • Packaging Evaluation • Maximum ROI • Production Control Plan
• Minimum Waste
• Quality Planning Sign-Off and Management Support
• Minimum CONC
© 2013 Eaton. All Rights Reserved.
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APQP Summary: What we do: o
Design Quality o
o
o
o
How we do it: Phase Review Discipline
DFMEA / PFMEA / DFM/A
o Defect Free Launches
Up
Manufacturing Quality o
Control Plans
o
Process Flows
o
Measurement System Analysis
o
Capability Analysis
o
Process Validation
o
Run at rate
Supplier Qualification & Quality Requirements
o Reduced Warranty Claims
Front
PRD Process Detailed
1st Article Inspection
o
PPAP
o
Tooling & Gauges
o
Testing
o Zero Spills o Customer Satisfaction o Robust Products o Greater Supplier Control
Quality
Product Qualification o
What we get:
o Reduced supplier cost
Planning
APQP…… Leadership Engagement is Critical 1 © 2013 Eaton. All Rights Reserved.
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APQP Benefits: Manufacturing process functions that are clearly planned, validated, documented and communicated will result in:
Improved Customer satisfaction Improved Delivery and Service Maximum ROI
CONC
$$ Total Cost of Quality
Robust and reliable designs Reduced process variation Enhanced confidence in supplier’s capabilities Better controlled process changes Defect free launches
Redesign Re-qualifications Escape Investigations
Prevention through APQP Current state
Minimum Waste Minimum CONC
Development
© 2013 Eaton. All Rights Reserved.
Production
Time
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Phase/Gate Process What is a phase/gate process? • Process steps are organized into phases • Decision gates are used to prevent later phase steps from being executed before earlier phase steps are complete and the project is ready
• What is the responsibility of a Reviewers? • Stop the project from advancing if current phase activities are not done, or not done well
• Who should participate in the review? • Senior functional and business leaders that are not directly involved in the program
• How can a reviewer understand the status of Phase deliverables prior to the gate review? • Typically requires an expert to review deliverable details and report on quality and completion of deliverables
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DA1 IP20 – Variable Frequency Drive (Phoenix) 12.04.2013 – Invertek DS Supplier, ICD, EMEA - Electrical P. Raas = +49 151 161-67329
Lessons Learned
Incident description: On receipt of the initial batch of product it was found that the alignment of the external housing with the internal connectors was out of position. Investigation findings: • The buttons are too loose in the recesses in the plastics.
Alignment issues
• The control PCB clip is not holding the control PCB close enough to the front plastic. • Clip design for holding PCB to housing not correct Root Causes and Management System Gaps: • Design error on the plastic housing not identified through risk assessment. • No sign off from Eaton on plastic housing or final unit sample.
Preventive & corrective actions: How would APQP have prevented this incident ? • DFMEA of the new PCD and housing assed the risk • PPAP/FAI – dimensional checks of the key dimensions • Finalised samples for approval • PSW sign off and PPAP approval • Run at Rate analysis at supplier
• The plastic clip design has been changed. The holes for the buttons have been reduced in size to more closely match the button shapes: this reduces button wobble and secures housing correctly.
Quality and Engineering Lessons Learned 19
© 2013 Eaton. All Rights Reserved.
Direct Source Supplier Circutor – NZM-XMC-MB (measurement device) 19.04.2012 – PDCD, EMEA – Electrical 20.01.2013 – PDCD, EMEA – Electrical D. Schwellenbach = +49 151 277- 45370
Lessons Learned Incident description: Two issues reported from this direct source supplier. 1. Incorrect component used causing a defect with the component memory. 5v used instead of the required 3.3v component. Resulting in a field campaign to update the firmware. 2. Potential of an arc caused by reversed polarity on the 24DCconnection and the inner insulation concept of the product (intolerable wiring) does not fulfill the required double insulation standard. Field campaign initiated to exchange products. Investigation findings: • Integration of the product line quality manager for brand products not completed • Supplier not qualified correctly prior to supplying products to Eaton.
How would APQP have prevented this incident ? • CTQ analysis of key components. • DFMEA risk assessment • Prototype samples and product qualification • PPAP and FAI • Supplier Qualification • Validation of design and test results • Sample testing
• No test plan or product qualification completed. Root Causes and Management System Gaps: • Validation of key components • Supplier R&D wrongly classified the terminals of the equipment as not accessible, but in fact the terminals are accessible. • Design failure unfortunately not been detected during the conformity testing in the lab in Circutor. Preventive & corrective actions: • Design improvement to ensure correct components used. • Extra control point added into the testing and qualification • Updated build instructions and training
Quality and Engineering Lessons Learned20
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Expectations: Supplier: • Understand Eaton APQP / Phase Review Discipline requirements. • Attend web overview training sessions. • Review AIAG manuals for APQP & PPAP and work accordingly. •
www.aiag.org
• Submit PPAP’s on required product, parts, products or components. • Focus on up front quality planning. • Follow Supplier Excellence Manual dictates • Provide PPAP submissions compliant with the Latest CPSD PPAP Manual (Level 3 is default!)
• Be a part of our team! © 2013 Eaton. All Rights Reserved.
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Key Take Aways: APQP is cross-functional planning and execution to produce product that fully meets the customer’s expectations the first time. AIAG APQP phases are Planning, Product Design, Process Design, Validation, Production. PRD phases are Concept, Definition, Design, Validation, Launch, Close. Cross-functional – means multiple functions input requirements Marketing/Design/Manufacturing/SCM/Quality.
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APQP: Process Design/Development and Validation
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APQP: Key Elements For Our Training
Process Design
• PFC (Process Flow Chart) • FMEA (Failure Mode Effects Analysis) • Control Plan
Process Validation
• MSA (Measurement System Analysis) • Process Capability Study © 2013 Eaton. All Rights Reserved.
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PROCESS FLOW DIAGRAM
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Process Flow Diagram What is It? • A visual diagram of the entire process from receiving through shipping, including outside processes and services
Purpose? • To help people “see” the real process. Process maps can be used to understand the following characteristics of a process: • Set-by-step process linkage • Offline activities (measurement, inspection, handling) • Rework, scrap
When to Use It? • To understand how a process is done • Prior to completing the PFMEA
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Process Flow Diagram
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Preparing the Process Map • Team Effort: • • • •
Manufacturing engineers Line operators Line supervisors Maintenance technicians
• Possible Inputs to Mapping: • • • • •
Brainstorming Operator manuals Engineering specifications Operator experience 6M’s • Man, Machine (Equipment), Method (Procedures), Measurement, Materials, Mother Nature (Environment) © 2013 Eaton. All Rights Reserved.
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Process Map Summary • Process Mapping Provides Inputs to • Potential Failure Mode Effect Analysis • Control Plan • Capability Studies • MSA
Process Mapping helps us gain process knowledge!
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Process Flow Diagrams • Reviewers Checklist
Process Flow must identify each step in the process Should include abnormal handling processes Scrap Rework Extended Life Testing Process Flow must include all phases of the process Receiving of raw material Part manufacturing Offline inspections and checks Assembly Testing Shipping Transportation
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PROCESS FMEA
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FMEA Origin Created by NASA following Apollo 1 mission failure Allows us to take a proactive approach to what can go wrong in a process and manage our risks better
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Process FMEA (PFMEA)
What is It? A tool used to identify and prioritize risk areas and their mitigation plans.
Purpose Identifies potential failure modes, causes, and effects. Inputs come from the process flow diagram. Identifies key inputs which positively or negatively affect quality, reliability and safety of a product or process. Denotes Special Characteristics of Product/Process that impact the ultimate safety/performance of the end product.
When to Use It After completion of the process flow diagram. Prior to tooling for production
© 2013 Eaton. All Rights Reserved.
IMPORTANT! The PFMEA should be completed using a cross-functional team!
33
Process FMEA (PFMEA)
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Potential Failure Mode Discuss with the team all credible Potential Failure Modes. Team should be able to pose and answer the following questions: − How can the process/part fail to meet requirements? − Regardless of Eng specs, what would a customer consider objectionable?
In each instance, the assumption is made that the failure could occur, but will not necessarily occur: – Each failure mode should be credible – Do not list acts of God or freak accidents – A description of non-conformance – Assume incoming parts are correct – Remember to consider subsequent operations – Examples of failure modes include:
Potential failure modes should be described in “physical” or technical terms, not as a symptom noticeable by the customer. Burred
Bent
Hole off location
Cracked
Hole to shallow
Hole missing
Handling Damage
Dirty
Hole to deep
Surface too rough
Corrosion
Open circuit
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Potential Effect(s) of Failure Potential effects of failure are defined as the effects of the failure on the customer(s) o o
Describe in terms of what the customer might notice or experience State clearly if the failure mode could impact safety or cause noncompliance to regulations
For the end user the effects should always be stated in term of product or system performance such as: Noise
Rough
Erratic Operation
Excessive
Effort
Inoperative
Unpleasant Odor
Unstable
Operation Impaired
Draft
Intermittent Operation
Poor Appearance
Leaks
Control Impaired
Rework Repairs
Scrap
If the customer is the next operation the effects should be stated in terms of process/operation performance, such as: Cannot fasten
Does not fit
Cannot bore/tap
Does not connect
Cannot mount
Does not match
Cannot face
Causes Excessive tool wear
Damages Equipment
Endangers Operator
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Potential Cause(s) of Failure Potential causes are defined as how the failure could occur, and described in terms of something that can be corrected or controlled. Only specific errors should be listed, ambiguous phrases such as “operator error”, “machine malfunction”, etc., should be avoided. Acceptable alternatives would be operator failed to install seal, or over temperature set incorrectly. The causes should be described so that remedial efforts can be aimed at those causes which are pertinent. Typical failure causes may include but are not limited to: Improper torque – over/under
Improper weld current, time, pressure
Inaccurate Gauging
Improper Heat Treat – time, temperature
Inadequate gating/venting
Inadequate or no lubrication
Part missing or mislocated
Worn locator
Worn Tool
Chip on locator
Broken tool
Improper Machine Setup
Improper programming
Incorrect Software version
Non validated test system
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PFMEA - Definition of Terms • Severity (of Effect) - severity of the effect on the Customer and other stakeholders (Higher Value = Higher Severity)
• Occurrence (of Cause) - frequency with which a given Cause occurs and creates Failure Mode. (Higher Value = Higher Probability of Occurrence)
• Detection (Capability of Current Controls) ability of current control scheme to detect the cause before creating the failure mode and/or the failure mode before suffering the effect (Higher Value = Lower Ability to Detect)
Caution: Notice the scale difference for Detection!
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Analyzing the PFMEA • Once the RPN Numbers are determined, they can be used to prioritize the most significant failure modes.
Sort by RPN to determine
the most significant failure modes
• Sort the FMEA by the RPN numbers. Graphical and statistical tools can help the team to continually improve.
?
How many items should be the focus of the next steps?
RPN’s • DO NOT set a threshold for RPN. • Focus on Continuous Improvement. • DO NOT forget to address high Severity scores first. © 2013 Eaton. All Rights Reserved.
Pareto Chart
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PFMEA – Remediation Guidelines • Severity – can only be improved by a design change to the product or process
• Occurrence – can only be reduced by a change which removes or controls a cause. Examples are redundancy, substituting a more reliable component or function or mistake-proofing.
• Detection – can be reduced by improving detection.
Examples are mistake-proofing, simplification and statistically sound monitoring. In general, reducing the Occurrence is preferable to improving the Detection
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Summary Steps To Complete a FMEA 1.
For each Process Input, determine the ways in which the Process Step can go wrong (these are Failure Modes). 2. For each Failure Mode associated with the inputs, determine Effects on the outputs. 3. Identify potential Causes of each Failure Mode. 4. List the Current Controls for each Cause. 5. Assign Severity, Occurrence and Detection ratings after creating a ratings key appropriate for your project. 6. Calculate RPN. 7. Determine Recommended Actions to reduce High RPNs. 8. Take appropriate Actions and Document. 9. Recalculate RPNs. 10. Revisit steps 7 and 8 until all the significant RPNs have been addressed.
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Example
Process Step/Input
Potential Failure Mode
What is the Effect on the Outputs? Potential Failure Effects
What is the In what ways does the process step/ Key Input go wrong? Input under investigation?
What is the impact on the Key Output Variables (Customer Requirements) or internal requirements?
Grind (12)
Irregular contact surface, plating surface rough
Sanding disk grit incorrect
epoxy build up on parts due to drag out not being blown off Masking (2)
De Masking (8)
rough surface where failed visual or high pot the part will be coated test w/epoxy Equipment failure, pins bar falls off carrier, break, welds break on possible to damage tank rack or other equipment, or damage bar Tape not removed Epoxy on contact correctly surfaces, damaged epoxy from contact
How well ?
Prepared by: D. Yount
What are the Causes? S E V
5
Potential Causes
What causes the Key Input to go wrong?
Vendor supplied incorrect disk
O C C
9
What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? Should include an SOP number.
OJT for operator 7
poor sanding, weld slag, weld splatter, metal chips on bars
operator training OJT, visual 10 inspection , (SOP ?)
part fatigue, part failure 10
9
Current Controls
Supervisor inspects incoming material, then 1 releases for use
operator error 8
loader visual inspection 4
bars hung to close together, too many bars on a rack, not enough resources demasking, bars hung incorrectly
5
Page ____ of ____
How are What can FMEAthese Date (Orig)found _July 99__ (Rev) 2, Nov 99___(Rev 3), Nov 99_ be done? or prevented? D R
operator training OJT, work instruction for masking SOP
© 2013 Eaton. All Rights Reserved.
E T
P N
Actions Recommended
How well can you detect cause or FM?
What is the Input
How Often?
How often does cause or FM occur?
What can go wrong with the Input?
Low Voltage Busway Epoxy Insulation GF&P Mario Seppulveda Responsible: GF&P, Ladd Kelly C-H
How Severe is the effect to the
Process or Product Name:
How Bad?
What are the actions for reducing the occurrence of the Cause, or improving detection? Should have Need to create work instruction to 4 20 document inspection Re train operators 9 504 both shifts, review deisgn & operation of air hammer Define causes, 5 450 train Fab, Epoxy and Plating operators New racks, re train 7 280 operators to inspect, review PM schedule review modified rack design, 6 270 elimintae demask where possible, replve tape with
S E V
O C C
8
3
M. Target complete 1/00 Sepulveda, 10 L. Kelley
4
Resp.
Actions Taken
Whose What are the Responsibl completed actions e for the taken with the recommend recalculated RPN? ed action? Be sure to include completion month/year M. Target complete Sepulveda 11/99
Ladd Kelley Target complete 11/99 L. Kelley, Target complete M. 11/99 Sepulveda
M. Target complete Sepulveda, 11/99 L. Kelley
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Process FMEA (PFMEA) Reviewers Checklist
Verify there is a system for prioritizing risk of failure such as high RPN numbers
Make sure that high RPN process concerns are carried over into the control plan
Make sure that all critical failure modes are addressed
Safety Form, fit, function Material concerns
See AIAG Core Tools for detailed checklist © 2013 Eaton. All Rights Reserved.
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Control Plan
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Process Control Plan (PCP)
What is It?
Objective or Purpose
A tool used to define the operations, processes, material, equipment, methodologies and special characteristics for controlling variation in key product or process characteristics within the manufacturing process. Communicates the supplier's decisions during the entire manufacturing process from material receipt to final shipping. Verifies existence of production controls at each step defined in the Process Flow/PFMEA Defines reaction plans at each step should a nonconformance be detected Denotes Special Characteristics of Product/Process that impact the ultimate safety/performance of the end product.
When to Use It After completion of the process flow diagram/pFMEA. At Prototype, Prelaunch and Production
Implementation of new process Implementing a process change
IMPORTANT! Since processes are expected to be updated as changes are made Control Plans are LIVING documents that need to be changed in step with manufacturing
© 2013 Eaton. All Rights Reserved.
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Control Plan Tool Interaction Department/Group Project High Level Process Map
Project Idea
6 Sigma Project High Level Process Map
Process Step Fill Out Master Form with Initial Information
Get WO Assigned
Begin/Work Project Follow DMAIC or DFSS process
6 Sigma Assigns Project Number
Monitor Progress through Power Steering and Monthly Financial Reviews
Other Required Signatures: Segment CEO Champion Process Owner BB or GB
No
Yes Finance Approval and Signature
Finance Approval and Signature No
Master Form Will Generate Contract
Complete Project (Has to be fully Documented
Enter Remaining Information on Master Form
Do you have BB/GB to Assist/Work the project?
Monitor Progress through BiWeekly Updates and Monthly Reviews
6 Sigma Project
Does the Project Involve >2 Groups in Eng?
Yes
Department or Group Project
Does the Project Involve >3 Depts. outside Eng?
Checks
Identify Customer
Wire Transfer reference line
Identify Invoice Checks
Enter Remaining Information on Master Form Finance Approval and Signature
Other Required Signatures: Champion: Dir T&E Process Owner Project Owner Dept BB or MBB
No
Yes
Yes
Process Steps
Receive Payment
Potential Potential Failure Mode Failure Effects Delay internal mail
AR balance does not go down
Information not AR balance is supplied past due
S O E Potential Causes C V C Inadequate staffing in mail 7 room Customer or bank did not include name and/or 10 account info on wire transfer
Current Controls
D E T
R P N
None 7
5
10 490
Acct identifies problem when trying to apply payment
E O C
Actions Recommended Investigate mail room staffing and associated processes Poka-Yoke wire transer process
5 250
Final Project Review
No
No
Close Project
Follow DMAIC or DFSS process
Is Hard Savings > $???
Does the Project Involve Only Your Group?
Other Required Signatures: Champion: Dir T&E Process Owner Project Owner Dept BB or MBB
Get DLN Assigned
Begin/Work Project
Complete Project (Has to be fully Documented)
Master Form Will Generate Contract
Finance Approval and Signature
Complete all Documentation including a (1) Page Closeout Sheet
Group Assigns Project Number
Yes
Yes
Final Project Review
Other Required Signatures: Champion: Process Owner Project Owner Dept GB/BB/MBB
Prefer to work this project within your area?
Key Process Input
No
Close Project
Complete all Documentation including a (1) Page Closeout Sheet
New/Revised Process Steps
Identify Invoice Checks
Incorrect invoice supplied
Invoice shows outstanding (AR balance does go down)
5
Invoice number Invoice shows not supplied outstanding (AR balance does go down)
5
Customer error
Customer might catch it when reviewing the 5 next statement 10 250
Provide payment stub with statement for each invoice
Customer error
Acct identifies problem when trying to apply 10 payment 5 250
Provide payment stub with statement for each invoice
Process FMEA
Process Flowchart
Control Plan © 2013 Eaton. All Rights Reserved.
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The Control Plan Form
© 2013 Eaton. All Rights Reserved.
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Control Plan Sections - 1
Administrative: Identifies part number and description, supplier, required approval signatures, and dates.
Phases:
Prototype – a description of the dimensional measurements and material and performance tests that will occur during Prototype build.
Pre-Launch – a description of the dimensional measurements and material and performance tests that will occur after Prototype and before full Production.
Production – a comprehensive documentation of product/process characteristics, process controls, tests, and measurement systems that will occur during mass production
© 2013 Eaton. All Rights Reserved.
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Control Plan Sections - 2
Body of Document: Since the Control Plan is Keyed to the Flow Chart and pFMEA, replication of the steps listed in those documents is done as the first step in producing your control plan. Each step, in the same order, listed in the pFMEA is documented on the Control Plan In addition any Special Characteristics listed on the pFMEA are replicated in the control plan as individual line items
For each step you determine the characteristics of either the product or the process or both that need to be controlled in order to repeatedly and reproducibly manufacture the component. If the feature has been denoted on the drawing or specification as a Special Characteristic by Eaton or your internal analysis place the required symbol in the Spec Char Column
© 2013 Eaton. All Rights Reserved.
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Control Plan Sections - 2
Body of Document: List the Product Specification tolerance required by the drawing or the process specification required to produce the product specification. List how you will measure or evaluate your product/process to determine if specification has been met. Specify the sample size and the frequency at which you will monitor the product produced at each step. List what documents the control. This could be a work instruction, a control chart, material certificate, set-up sheet, log sheet etc. AVOID statements such as, OPERATOR TRAINING, UNKONWN or BLANKS Provide specific guidance for the operator to carry out if a defect or issue is detected. Typical Reaction Plans include, Segregate Product, Stop Process, Contact Supervisor, Scrap, Contact Engineering, Rework, No Blanks. © 2013 Eaton. All Rights Reserved.
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Control Plans: Audit Plans – WALK THE WALK Audit plans can be included in the control plan as a separate line. Auditing is an important tool for control. Process auditing should be a key element of the quality system of a business. Audits generally cover: • Effectiveness of controls • Control plan (say) vs. what is actually done (do) Audits should be objective (done by internal or external third parties if possible). Audit frequencies should be based on balancing level of risk (FMEA) and cost.
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Control Plan – Example A supplier manufactures a circuit board with electronic components soldered on the board. Properly soldered connections are the major product characteristics. Two major process characteristics for the wave solder machine are solder level and flux concentration. An automated feeder controls the solder level by sensing the level of solder and feeding in additional solder as the level is reduced. This characteristic is measured 100% by checking electrically for continuity. The flux must be sampled and tested for the concentration level.
CONTROL PLAN Prototype
Pre-Launch
Control Plan Number 002 Part Number/Latest Change Level 54321231 / D Part Name/Description Electronic Circuit Board Supplier/Plant Supplier Code ACR Control 439412 Part / Process Number
2
Machine, Process Name Device, / Operation Jig, Tools, Description for MFG.
Soldering Connections
Wave solder machine
Production Key Contact/Phone T. Smith / 313-555-5555 Core Team Erin Hope, Alan Burt, Ken Light Supplier/Plant Approval/Date
Date:(Org.) Date (Rev.) 11/29/2009 2/20/2010 Customer Engineering Approval/Date (If Req'd.)
Other Approval/Date (If Req'd.)
Other Approval/Date (If Req'd.)
Characteristics No.
Product
Customer Quality Approval/Date(If Req'd.)
Methods
Process
Wave solder height
Special Char. Class
Product/Process Evaluation / Specification/ Measurement Tolerance Technique
2.0 +/- .25 mc Flux concen tration
Standard #302B
© 2013 Eaton. All Rights Reserved.
Sensor continuity check Test sampling lab environment
Sample Size
100%
1 pc
Freq.
Control Method
Automated inspection (error Continuous proofing)
4 hours
Reaction Plan
Adjust and retest
Segregate x-MR chart and retest
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Control Plan: Reviewer’s Checklist Remember the Control Plan is a planning tool – • •
Use it to decide what you should be doing The AIAG format will help make sure the plan makes sense and is complete
Use process flow diagram and PFMEA to build the control plan; keep them aligned Controls should be effective. Keep it simple. Ensure that the control plan is in your document control system Good control plans address: • •
All testing requirements - dimensional, material, and performance All product and process characteristics at every step throughout the process
The control method should be based on an effective analysis of the process •
Such as SPC, Error Proofing, Inspection, Sampling Plan
Control plans should reference other documentation •
Specifications, tooling, etc.
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Measurement System Analysis (MSA)
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Measurement System Analysis (MSA) What is It? An MSA is a statistical tool used to determine if a measurement system is capable of precise measurement. Objective or Purpose
When to Use It • On the critical inputs and outputs prior to collecting data for analysis. • For any new or modified process in order to ensure the quality of the data. Who Should be Involved Everyone that measures and makes decisions about these measurements should be involved in the MSA.
• To determine how much error is in the measurement due to the measurement process itself. • Quantifies the variability added by the measurement system. • Applicable to attribute data and variable data. IMPORTANT! Measurement System Analysis is an analysis of the measurement process, not an analysis of the people!!
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Two Types of Study - Attribute and Variable MSA Attribute Data Examples: Count, Pass/fail, yes/no, red/green/yellow, timekeeping buckets
Variable Data Examples: Physical measurement (length, width, area, …) Physical conditions (temperature, pressure…) Physical properties (strength, load, strain…) Continuous or non-ending
Unless approved by Eaton, attribute data is not acceptable for PPAP submission
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Inspection – what do you really see?
57
57
Measurement System Analysis (MSA) Measurement The observed variation in process output measurements is not simply the variation in the process itself; it is the variation in the process plus the variation in measurement that results from an inadequate measurement system.
System Variation
Observed Variation
Process Variation
Conducting an MSA reduces the likelihood of passing a bad part or rejecting a good part
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Measurement System Analysis (MSA) Observed Variation Measurement
System Variation
Observed Variation Differences between individual parts – often caused by: Process
• Material variation
Variation
• Machine variation • Set-up variation
• Operator variation © 2013 Eaton. All Rights Reserved.
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Measurement System Analysis (MSA)
Observed Variation Resolution Precision (Variability)
Repeatability
Reproducibility Measurement
System Variation Linearity Accuracy
Observed
(Central Location)
Variation
Bias Stability
Process
Variation
Calibration addresses accuracy © 2013 Eaton. All Rights Reserved.
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Measurement System Analysis (MSA)
Elements of Precision
Resolution Error in Resolution The inability to detect small changes.
Possible Cause Wrong measurement device selected divisions on scale not fine enough to detect changes.
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Elements of Precision Repeatability Error in Repeatability The inability to get the same answer from repeated measurements made of the same item under absolutely identical conditions.
Possible Cause Lack of standard operating procedures (SOP), lack of training, measuring system variability.
Equipment Variation
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Elements of Precision Reproducibility Error in Reproducibility The inability to get the same answer from repeated measurements made under various conditions from different inspectors.
Possible Cause Lack of SOP, lack of training.
Appraiser Variation
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Variable MSA – Gage R&R Study Gage R&R is the combined estimate of measurement system Repeatability and Reproducibility
• Typically, a 3-person study is performed Each person randomly measures 10 marked parts per trial
Each person can perform up to 3 trials
• There are 2 key indicators % P/T or Measurement System or Equipment Variation
% R&R or Process Improvement or Appraiser Variation
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Variable MSA – AIAG GR&R VAR(Tol) GAGE REPEATABILITY AND REPRODUCIBILITY DATA SHEET VARIABLE DATA RESULTS Part Number
Gage Name
Appraiser A
GAGE REPEATABILITY AND REPRODUCIBILITY DATA SHEET VARIABLE DATA RESULTS Part Number
NUMBER
Gage Name
Appraiser A
Gage Number
Appraiser B
Characteristic
Gage Type
Appraiser C
Characteristic Classification
Trials
NUMBER
Part Name
Gage Number
Appraiser B
Part Name
NAME
NAME
Characteristic
Specification
Gage Type
Appraiser C
Lower Upper Characteristic Classification
Trials
Parts
APPRAISER/
Appraisers
Date Performed
PART
Included in AIAG Core Tools TRIAL #
1
1. A
1
2.
2
2
3
4
5
6
7
8
9
EV
K1
2
0.8862
=
=
3
0.5908
=
3
5.
R
6. B
1
=
7.
2
=
8.
3
9.
AVE
10.
R
11. C
1
12.
2
13.
3
14.
AVE
15.
R
xc = rc = X=
AVERAGE
Rp=
(ra +
R=
xa= ra=
18. 19.
rb + rc ) / (# OF APPRAISERS) = x DIFF = (Max x - Min x) = * UCLR = R x D4 =
xb= rb=
xDIFF =
% EV
=
100 (EV/Tol)
Reproducibility - Appraiser Variation (AV) AV
=
{(xDIFF x K 2)2 - (EV 2/nr)}1/2
% AV
2
3
K2
0.7071
0.5231
Parts
K3
=
=
2
0.7071
=
=
3
0.5231
4
0.4467
5
0.4030
=
6
0.3742
=
=
7
0.3534
=
8
0.3375
=
r = trials
{(EV2 + AV 2)}1/2
Part Variation (PV) =
RP x K3
Tolerance (Tol) Tol
% GRR
=
Upper - Lower / 6
9
0.3249
=
( Upper - Lower ) / 6
10
0.3146
=
100 (AV/Tol)
= A p p r aiser s
n = parts
PV
= =
Repeatability & Reproducibility (GRR) GRR
UCLR =
R x K1
Trials
AVE
17.
% Tolerance (Tol)
=
=
4.
16. PART
Date Performed
Repeatability - Equipment Variation (EV)
3.
Automatically calculates %GRR and %PV
Appraisers
Measurement Unit Analysis
AVERAGE
10
Parts
% PV
ndc
=
=
=
100 (GRR/Tol)
100 (PV/Tol)
1.41(PV/GRR)
= =
* D4 =3.27 for 2 trials and 2.58 for 3 trials. UCLR represents the limit of individual R's. Circle those that are beyond this limit. Identify the cause and correct. Repeat these readings using the same appraiser and unit as originally used or discard values and re-average and recompute R and the limiting value from the remaining observations.
For information on the theory and constants used in the form see MSA Reference Manual , Fourth edition.
Notes:
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Measurements Systems Analysis MSA Tips and Lessons Learned Important: An MSA is an analysis of the process, not an analysis of the people. If an MSA fails, the process failed.
A Variable MSA provides more analysis capability than an Attribute MSA. For this and other reasons, always use variable data if possible.
The involvement of people is the key to success. Involve the people that actually work the process Involve the supervision Involve the suppliers and customers of the process
An MSA primarily addresses precision with limited accuracy information.
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MSA: Reviewer’s Checklist If the gage/inspection measures a special characteristic or other important feature, then conduct a Gage R&R Make sure the study is recent - less than 1 year Compare the control plan gages against the Gage R&Rs
% R&R and %P/T must be less than 30% If you question that gage, then Question the technique and part sampling Ask for additional studies
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MSA Summary Measurement systems must be analyzed BEFORE embarking on process improvement activities MSA helps understand how much observed variation is from the measurement system MSA will tell you about the repeatability, reproducibility and discrimination Sample selection is very important – sample during normal production to capture total range of process variation MSA assessors should be operators that would normally use the measurement system MSA should be done on a regular basis © 2013 Eaton. All Rights Reserved.
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Initial Process Study
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Purposes of Initial Process Study To evaluate how well a process can produce product that meets specifications To provide guidance about how to improve capability • better process centering • reduced variation
Capability studies can be used to define a problem or to verify permanent corrective actions in the problem solving process.
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Initial Process Studies Is the process employed Stable and Capable? MSA before Cpk • MSA must be acceptable and should represent tools used for Initial Process Studies
How many samples? What frequency? • Recommend minimum 30 pieces per cavity, line, etc • Data should be time based sequential when possible − (2 each hr/line) • Where to look for opportunities • Cpk & Ppk minimums are higher for initial release vs. ongoing
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Capability Studies Capability studies are measures of how well the process is meeting the design requirements. In performing a capability study, the team determines from sample data the process average and a spread (capability) of the process, and compares this variation with the specifications.
The normal distribution is the voice of the process—it’s how the process behaves.
The goal posts are the voice of the customer. They’re our spec limits.
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Capability Studies Proces s Data for Co2 15 UCL=14.18
Individual Value
14 13
X=12.64
12 LCL=11.10
11 10 9 0
50
100
150
A short-term capability study covers a relative short period of time during which extraneous sources of variation have been excluded. (Guideline: 30-50 data points.)
Observation Number
Proces s Data for Co2 15 UCL=14.18
Individual Value
14 13
X=12.64
12 LCL=11.10
11 10 9
0
50
100
A long-term capability study covers a longer period of time in which there is more chance for a process shift. (Guideline: 100-200 data points.)
150
Observation Number
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Capability versus Performance Capability Ratios (CP and CPK) • use a short-term estimate of sigma (s) obtained from the withinsubgroup variation • show what the process would be capable of if it did not have shifts and drifts between subgroups
Performance Ratios (PP and PPK) • use a long-term estimate of sigma (s) obtained from withinsubgroup plus between-subgroup variation
• Show what the overall variation is
Performance ratios will be worse (smaller) than the corresponding capability ratios if the process has shifts and drifts
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Acceptance Criteria Acceptance criteria for critical vs. non-critical characteristics
Red (Bad) Yellow (Marginal) Green (Good)
Critical
Non-Critical
<1.33
<1.00
1.33-1.67
1.00-1.33
>1.67
>1.33
Decision
Cpk must be greater than or equal to 1.67 for critical processes Cpk must be greater than or equal to 1.33 for non-critical processes
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Capability Summary Capability ratios are used to compare the Voice of the Customer (specs) to the Voice of the Process (natural process limits).
For a capability ratio to be a good predictor of future performance, the process must be stable. Otherwise, the ratio is just a descriptor of past performance! The two key ways to improve process capability are to reduce variation and to improve centering. A capability ratio should never be interpreted without also looking at a control chart to verify stability and a histogram of the process to ensure normality. The supplier should set warning tolerances and track changes – to give a pre-emptive warning © 2013 Eaton. All Rights Reserved.
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Initial Process Study: Reviewer’s Checklist Ensure that the results are acceptable, and that the process is stable and capable of producing a quality part PPAPs should only be approved if the capability is greater than 1.67 for critical dimensions and greater than 1.33 for non-critical dimensions Capability template is in the AIAG Core Tools
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Des
Lau nch
Plan
ign
A ve ro pp
e
at il d Va
Maintain high quality products while keeping projects on schedule with transparent task management and collaboration tools.
“Production Part Approval Process (PPAP)” APQP TEAM 2013
© 2013 Eaton. All Rights Reserved.
What is PPAP? Production Part Approval Process Standard used to formally reduce risks prior to product or service release, in a team oriented manner using well established tools and techniques Initially developed by AIAG (Auto Industry Action Group) in 1993 with input from the Big 3 - Ford, Chrysler, and GM
AIAG’s 4th edition effective June 1, 2006 is the most recent version PPAP has now spread to many different industries beyond automotive
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Purpose of PPAP Provide evidence that all customer engineering design record and specification requirements are properly understood by the organization
To demonstrate that the manufacturing process has the potential to produce product that consistently meets all requirements during an actual production run at the quoted production rate
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When is PPAP Required? New part Engineering change(s) Tooling: transfer, replacement, refurbishment, or additional Correction of discrepancy
Tooling inactive > one year Change to optional construction or material Sub-supplier or material source change Change in part processing Parts produced at a new or additional location PPAP is required with any significant change to product or process!
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Benefits of PPAP Submissions Helps to maintain design integrity Identifies issues early for resolution Reduces warranty charges and prevents cost of poor quality Assists with managing supplier changes Prevents use of unapproved and nonconforming parts Identifies suppliers that need more development Improves the overall quality of the product & customer satisfaction
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Paying for PPAPs? • What is wrong with paying a PPAP charge? • 2 primary cost drivers with APQP • Process design • Process validation
• Are these 1 time expenses? • Consider year over year cost out • Process maintenance
• Other continuous improvement activities
• Where does overhead belong in a quote?
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Full Level Official PPAP Requirements 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18.
Part Submission Warrant Design Records & Bubbled Print(s) Approved Engineering Change Documentation, if any Customer Engineering Approvals Design FMEA Process Flow Diagrams Process FMEA Control Plan Measurement System Analysis (MSA) Dimensional Results Material, Performance Test Results Initial Process Study (CPK) Capability studies Qualified Lab Documentation Appearance Approval Report Sample Product Parts Master Samples Checking Aids Customer Specific Requirements a. b. c. d. e.
Tooling Information Form Packaging Form Inspection Plan (ASC ONLY) Specification Deviation Form Supplier PPAP Checklist
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PPAP Submission Levels Level 1
Warrant Only and Appearance Approval Report as requested. Applied to: Noncritical parts, Non-critical raw/bulk material or catalog/commodity parts for electrical applications and recertification of existing parts previously approved at levels 3, 4 or 5.
Level 2
Warrant with product samples and limited supporting data. Applied to: Critical bulk products such as Paint/Resin/Chemicals, critical fasteners, simple material changes, simple revision level only changes or simple print updates not impacting form-fit-function. This level can also be applied to low risk parts within a product family.
Level 3
Default Submission Level: Warrant with product samples and complete supporting data. Applied to: New parts, changes affecting form-fit-function, reliability or performance. All products resourced to new suppliers, serial production parts, and existing high risk parts undergoing a part number change.
Level 4
Warrant and other requirements as specified by CPSD. This level is reserved for special applications only . Applied to: This level can only be applied with prior approval from Supplier Quality Management.
Level 5
Warrant with product samples and complete supporting documentation reviewed at the supplier’s manufacturing location. On-Site Level 3 PPAP!! Applied to: This level is used at the discretion of Supplier Quality for urgent or large components only.
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PPAP Submission Requirements Requirement 1. Part Submission Warrant 2. Design Record & Bubbled Print(s) 3. Approved Engineering Change Documentation 4. Customer Engineering Approvals 5. Desgin FMEA 6. Process Flow Diagrams 7. Process FMEA 8. Control Plan 9. Measurement System Analysis (MSA) 10. Dimensional Results 11. Material, Performance Test Results 12. Initial Process Study (Cpk) Capability Studies 13. Qualified Laboratory Documentation 14. Appearance Approval Report 15. Sample Product Parts 16. Master Samples 17. Checking Aids 18. Customer Specific Requirements 18a. Tooling Information Form 18b. Packaging Form 18c Inspection Plan (ASC Only) 18d. Specification Deviation Form 18e. Supplier PPAP Checklist
1 S NR NR NR NR NR NR NR NR NR NR
2 S S NR NR NR NR NR NR NR AR AR
Level 3 S S S NR AR S S S S S S
NR NR AR NR NR NR AR NR NR NR NR S
NR NR AR AR NR NR AR NR NR IA IA S
S S AR S NR R AR S S IA IA S
4 AR AR AR NR AR AR AR AR AR AR AR
5 S S AR NR AR S S S S S S
AR AR AR AR NR AR AR AR AR IA IA S
S S AR S R R AR S S IA IA S
Symbol Key S Submit NR Not Reuired AR As Requested IA If Applicable R Retain LEVEL 3 is DEFAULT Items in Light Blue are Mandatory at the listed level
S = Supplier MUST submit and retain a copy of records or documetantion items R = Supplier MUST retain and make available to customer upon request
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Definition of Risk High Risk Parts associated with multiple critical features, complex design, or high end technology that is not yet established in the general manufacturing environment Supplier’s quality system and/or quality performance is not to Eaton satisfaction Critical process being conducted e.g. heat treatment, leak proof welding Parts that impact the safety performance of the final product Medium Risk Parts that have at least one critical feature Parts that impact functional performance of the final product Low Risk
Parts that have no critical features and can be manufactured by any manufacturer in the commodity category Catalogue Parts Supplier’s quality system is acceptable and Supplier’s quality performance can be demonstrated over time
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PPAP Status Approved The part meets all Eaton requirements Supplier is authorized to ship production quantities of the part
Interim Approval Permits shipment of part on a limited time (90 days) or piece quantity basis Submission must have a specification deviation identifying permanent corrective action to achieve full approval within 90 day period.
Rejected The part does not meet Eaton requirements, based on the production lot from which it was taken and/or accompanying documentation Production quantities may not be shipped before Eaton Approval is provided!!!! © 2013 Eaton. All Rights Reserved.
89
Supplier Excellence Manual © 2013 Eaton. All Rights Reserved.
Welcome to the Eaton Electrical Sector Eaton Corporation is a Diversified Power Management Company, who in 2012 acquired all of Cooper Industries. As of 2015 we will be fully integrated into the Eaton Supplier Quality Requirements and enforcing the policies set forth in the Global Supplier Excellence Manual. Eaton has in excess of 100,000 employees and sells products to customers in more than 170 countries. For more information, visit www.eaton.com. To learn more about doing business with Eaton, please access our website at: http://www.eaton.com/Eaton/OurCompany/DoingBusiness/SellingtoUs/i ndex.htm
© 2013 Eaton. All Rights Reserved.
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Purpose of the Manual The purpose of this manual is to communicate expectations to our suppliers and the core set of tools, processes and systems that are to be used in the manufacture, design and development of parts, products and services supplied to Eaton and its business locations. In this manual, the terms ‘shall’ and ‘must’ mean that the described requirement is mandatory, while the term ‘should’ means that the described requirement is needed and expected with some flexibility in how it can be completed.
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Supplier Responsibilities To understand and ensure compliance with this manual, quality policies, procedures and work instructions of Eaton Corporation and any business specific requirements.
To cascade requirements to your sub-tiers. To Abide by the Supplier Code of Conduct regarding workplace standards and business practices. Compliance Monitoring Acknowledgement of Acceptance http://www.eaton.com/Eaton/OurCompany/DoingBusiness/SellingtoUs/SupplierCodeofConduct/index.htm
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Quality Management System Major change as we move to Eaton SEM
expectations. As of Jan 1, 2014 all new suppliers to Eaton MUST hold a valid third party registration certifying their quality system at minimum meets all requirements of ISO 9001 or above. If you are being considered for new business and do not hold a QMS certification at minimum an On Site Assessment MUST occur.
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Quality Management Systems QMS MUST encompass Supplier Confidentiality Quality Planning (APQP)
Business Changes – Continuity Planning
Material Identification
Electronic Communications
Lot Traceability
WISPER
Problem solving
Supplier Visualization
Internal Audits
EHS
Operator and Inspection Instructions
Product Stewardship
Packaging Plans
Supplier Diversity
Sub-tier Supplier Control
Conflict Minerals DUNS Number © 2013 Eaton. All Rights Reserved.
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Quality Management Systems - CPSD Additionally you will notice that the SEM manual has specifics for Aerospace Suppliers. In the case of Power Systems we have also adopted many if not all of those same requirements. The ones below are highlighted for your reference; Raw Material (Mill) certificates
Age-Sensitive Material Certificates Supplier Validation of raw Material Internal Audit Procedures
Distributors are treated as First Tier Suppliers and held responsible for the quality of products they distribute even if they don’t manufacture. Labs are expected to have ISO17025 or A2LA accreditation
© 2013 Eaton. All Rights Reserved.
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Supplier Assessment and Qualification Each Eaton business group maintains a supplier selection and sourcing process . Suppliers must be capable of meeting the specific groups’ quality, delivery, cost, environmental and health and continuous improvement requirements Acceptance for use by one Eaton business does not guarantee acceptance by all Eaton business groups.
© 2013 Eaton. All Rights Reserved.
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Quality Planning and Product Approval General requirements:
Suppliers MUST use APQP Suppliers MUST approve parts through PPAP
Suppliers MUST retain records Life of Product Suppliers MUST notify and obtain approval prior to implementing changes
© 2013 Eaton. All Rights Reserved.
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Supplier Assessment and Qualification The Supplier assessment and qualification process includes: Initial Supplier Profile – Accessed through WISPER Supplier Screening/Data Analysis Process Suppliers current delivery performance based on 100% OTD expectation Suppliers Quality performance for previous 12 – 24 months
Suppliers registration to an industry sector quality system Cost competitiveness Supplier’s financial strength for future growth
Supplier Assessment Typically consists of an On-Site Audit (OSA)
Assessment Results/Timely Corrective Actions Approvals Full Approval Conditional Approval Un-approved (approval can be lost to those previously approved) © 2013 Eaton. All Rights Reserved.
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Cost of Poor Quality Major change as we move to Eaton SEM expectations. All costs incurred by Eaton that are associated with the failure of a supplier to meet Eaton’s quality requirements will be charged back to the responsible supplier.
A DMR (Discrepant Material Report) Administrative Fee of $250/DMR shall be charged due to costs associated with dispositioning the DMR and managing the corrective actions process.
The following is a list of potential Cost of Poor Quality charges (NOT exhaustive!!!) Sorting Rework Line disruption
Premium Freight Cost of Increased inspection Premium product cost paid to support production
Downtime/Overtime Equipment Breakage Travel Warranty costs Containment Activities
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Appendix A Elements of PPAP
© 2013 Eaton. All Rights Reserved.
Element 1: Part Submission Warrant (PSW) What is It? • This is the form that summarizes the whole PPAP package. This form shows the reason for the submission (design change, annual revalidation, etc.) and the level of documentation submitted. Purpose Used to : • document part approval • provide key information
• declare that the parts meet specification When to Use It • Prior to shipping production parts Use Of CPSD specific format is MANDATORY, alternate forms are not accepted including the default AIAG format. © 2013 Eaton. All Rights Reserved.
103
Production Run PPAP data must be submitted from a production run using: Production equipment and tooling Production employees Production rate Production process All data reflects the actual production process to be used at start-up!
© 2013 Eaton. All Rights Reserved.
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Element 1: Part Submission Warrant (PSW) Reviewers Checklist
Must be on CPSD Specific Form Must be completely filled out Must be signed by the supplier P/N must match the PO Product family submissions allowed Submitted at the correct revision level Submitted at the correct submission level
Specify the reason for submission
© 2013 Eaton. All Rights Reserved.
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Element 2: Design Records & Ballooned Drawings What is It? A copy of the current released Engineering Drawing or Specification that documents the item being purchased and qualified. Purpose: To document and provide a formal part print and/or specification against which an items’ compliance can be determined.
Example of a Ballooned Drawing
When to use:
This element is required for any submission level 3 or higher.
A ballooned drawing must be submitted as part of every PPAP submission where dimensional confirmation is required.
© 2013 Eaton. All Rights Reserved.
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Element 3: Approved Engineering Change Documentation What is It? Evidence that any changes from part print or specification have been authorized by Engineering. Purpose: To capture approval of changes made through Emails, Supplier Change Requests (SCR), feasibility studies etc. When to use: When a change is pending and drawing has been marked up but not formally released into the CPSD SAP business system.
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Element 4: Customer Engineering Approvals Customer Engineering Approvals are used to demonstrate pre-approval of a design.
Customer Engineering Approvals are not required for supplier submissions. In the event that this would be required in the future we have maintained a placeholder within out requirements.
© 2013 Eaton. All Rights Reserved.
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Element 5: Design FMEA (DFMEA)
What is It? A risk analysis of the design for potential failure modes. Purpose: To highlight any product design issues that may cause malfunction of the component once industrialized. When to use: Used during the design phase. Typically the customer owns this element, unless the design is proprietary to the supplier or developed jointly. If the supplier does own the design their DFMEA is required to be reviewed to ensure that it addresses all Special Characteristics and any potential vice of the customer inputs identified in the Cooper Project Scope. © 2013 Eaton. All Rights Reserved.
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Element 6: Process Flow Diagram What is It? A visual map of the manufacturing process from Receiving to Shipping Purpose: To document and clarify all steps required to manufacture the part. When to use: As the first step in completing the risk analysis of the current process and prior to development of the control plan. For every step in the flow chart there should be a corresponding step in the pFMEA and Control Plan. The flow chart is the first document in the control documentation trilogy. Flow Diagram MUST include all key steps in the process and all offline activities (such as measurement, inspection and handling). In addition the flow of non-conforming parts MUST be included.
© 2013 Eaton. All Rights Reserved.
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Element 7: Process FMEA (PFEMA) What is It? A risk analysis of the manufacturing process for potential failure modes. Purpose: To highlight any process issues that may cause malfunction of the component once industrialized. When to use: Used prior to production release to determine potential failure modes that may occur during the manufacturing process that could impact the supplier or the end customer. pFMEA’s are constructed as the second phase of the control documentation tribology, immediately after the process flow has been determined. Important Things to Note in regards to PFMEA!!!!!!
PFMEAs are LIVING documents. They are born with award of new business They develop as the product manufacturing matures. They should be reviewed on regular basis and each and every time a new nonconformance type is identified by either the supplier or customer.
© 2013 Eaton. All Rights Reserved.
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Element 7: Process FMEA (PFEMA) Examples of common mistakes made on pFMEA: Misapplication of Severity, Occurrence and Detection Redefining Severity, Occurrence and Detection from AIAG standard Over estimating the effectiveness of a “recommended Action” Applying RPN thresholds arbitrarily Not recognizing all potential failure modes Failure to properly identify the customer Misapplication of the ranking scales Confusing effects with causes Allow the pFMEA to turn into a design review
© 2013 Eaton. All Rights Reserved.
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Element 7: Process FMEA (PFEMA) Important Requirements/Expectations: Ranking of Potential Failure Modes is per AIAG guidelines. Guidelines are published within the pFMEA Form in the CPSD PPAP Forms Kit. Anything that depends on visual inspection as the control method must be given at least an 8 on the detection scale Anything that is given a 1 in the occurrence field indicates that THIS WILL NEVER HAPPEN, think twice and have objective evidence to support this ranking Anything that will impact the safety of the end product and customer needs to carry a severity of either a 9 or 10. Anything that escapes your facility should be given a Severity of at least a 7 as it WILL cause customer dissatisfaction! Anything with a “built-in” rework loop should have an Occurrence ranking of either a 9 or 10. Rework/repair loops need to be eliminated at minimum as product matures. ALL SPEICAL CHARACTERISTICS listed on the print and/or material specification must have their own line(s) in the pFMEA!
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Element 8: Control Plan What is It? A tool to define the operations, processes, materials, equipment, methodologies and Special Characteristics for controlling variation during the manufacturing process. Purpose: To communicate the supplier’s decisions during the entire manufacturing process from materials purchase through final shipping. When to use: Used prior to production release to ensure that each step of the manufacturing process is governed or controlled for desired output. The control plan is prepared using the process flow and pFMEA as inputs. For every step in the process flow and pFMEA there is an identical step in the control plan. Important Things to Note in regards to Control Plan Control Plans are LIVING documents. They are synchronized with the Flow Diagram and pFMEA. As those documents change so does the Control plan. They can be prepared as a family document or by manufacturing FUNCTION or by individual part.
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Element 9: Measurement
System Analysis (MSA)
What is It?
A mathematical method of determining the contribution of variation within the measurement process to overall process variability. Purpose: To ensure the use of the right measurement system for running production. When to use:
For devices measuring data on special characteristics and each measurement device on all Level 3 and Level 5 submissions.
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Element 10: Dimensional Results What is It?
Unique Requirements for CPSD
Verification that the component was produced to required specifications
Must be submitted on CPSD Dimensional Analysis template
Purpose:
Measurements must be on the same parts submitted as formal samples
To ensure proper measurement techniques and analysis was performed to show conformance with all customer requirements When to use: Prior to release of production tooling/process to manufacturing
Measurements must be provided for a minimum of three unique parts or 1 part per cavity in the instance of multi-cavity or multi-processing paths. The report must address all dimensions and any notes that have variable dimensions included. Also all dimensions on reference prints. The method of measurement must be documented for every line item.
Any non-conforming items must list a corrective action and be covered in the specification deviation form. © 2013 Eaton. All Rights Reserved.
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Element 11: Material and Performance Test Results What is It? A place to report all other test results other than the dimensional results. Purpose: Primarily used to report conformance of material requirements and part functionality. Together with the dimensional data will provide a complete review of all product specifications and/or part print requirements. When to use: Prior to production release to confirm part is conforming in all respects.
Material and Performance Test Result FAQs COA Certificate of Analysis from an accredited lab should be used to confirm the composition of the material. A COC is not acceptable for initial submission. Performance testing can be done internally or externally but must be credible and conforming to the test requirements. Performance testing responsibility needs to be agree upon prior to PPAP submission. By default the supplier is responsible unless they have taken exception during the early design requirements review sessions or noted inabilities on the Production Feasibility Agreements.
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Element 12: Initial Process Study (Cpk, Ppk) What is It? A method to determine if the manufacturing process is repeatable and reproducible. Purpose:
To determine if the production process is likely to manufacture product that will meet requirements. When to use: At the start up of a new product/process and for all special characteristics indicated on the part print or specification.
Cpk Vs PpK CpK: CpK predicts future capability For new or revised parts Used when significant changes occur in process or material Ppk: Ppk predicts past performance Been manufacturing item for a significant time even if never supplied to CPSD Capability Thresholds: Special Characteristics >/= 1.33 or >/= 1.67 for any safety related special characteristics.
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Element 13: Qualified Laboratory Documentation What is It?
Internal Labs:
Evidence that the lab performing material or functional testing is qualified to perform the test per standard.
Documentation required to be submitted with PPAP: Scope of Testing Personnel’s competency to perform tests Test Equipment used
Purpose: To ensure that the testing completed to verify compliance of the component was done by individuals competent in the test methodology using properly calibrated equipment.
Calibration Certificates on equipment External Labs: Documentation required to be submitted with PPAP:
Copy of Lab’s third party accreditation + scope On company letterhead
When to use: As part of initial submission and on going verification of component material and performance properties
Name of Lab
Date of testing Standards used
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Element 14: Appearance Approval Report What is It? A method to document the cosmetic requirements of the component. Purpose: To ensure that identical methodologies and standards are used by both supplier/customer to evaluate subjective appearance items
When to use: Anytime there is an expectation that the part has to be free from contamination, dirt, rust, etc., or it has a specific color, gloss or texture defined on the print or specification
ALERT!!!!! This is one of the most overlooked areas of any submission. Many times cosmetic issues are not apparent until after the product has been released for production. All parties are cautioned to establish initial criteria at PPAP to avoid expensive rework, sorting or added operations that may become required at a latter date simply because the criteria had never been clarified during early design requirements review steps!
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Element 15: Sample Parts What is It? Actual samples that reflect the parts documented in the PPAP.
Objective or Purpose • Confirm cosmetic or functional part approval.
When to Use It • Sample parts should be delivered WITH the PPAP submission
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Element 16: Master Samples What is It? Original part used to determine conformance to part print/specification retained at the manufactures site for the life of the product
Purpose: To allow historical benchmarking of physical component over the course of product life. Becomes a “Go-by” sample for future production builds. When to use: Only required for Level 5 on-site PPAP’s, usually due to it’s extreme size or expense.
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Element 17: Checking Aids What is It? Any tool, gage or assembly equipment that verifies the physical or performance requirements of a part to print/specification.
Purpose: To provide evidence that the checking aids used to verify product exist and have been properly validated.
Checking aids must conform to the following requirements: Copy of controlled print that documents the design of the checking aid Third party certification if aid is used to confirm form or fit Verification of checking aid repeatability For PPAP Submission:
When to use:
1. Conformance to the design print
During component manufacturing to certify acceptance or compliance to specification.
2. Evidence of Repeatability 3. GR&R for all special characteristics
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Element 18: CPSD Specific Requirements What is It? CPSD has additional requirements based on product, IP and regional criteria that need to be addressed at time production of the component is approved.
CPSD Specific Requirements: Tooling Information Form Packaging Form
Purpose: To address CPSD specific requirements during PPAP submission
IQC Inspection Plan (ASC only) Specification Deviation Form Supplier PPAP Checklist
When to use: When Supplier Quality indicates a need to submit on the PPAP Checklist based on their understanding of the requirements and program.
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Element 18a: Tooling Form What is It? A method to document the condition of any CPSD owned tooling a the start of the program. Purpose:
To document critical information including, cost, dimensional, capacity and life expectancy as well as location of tooling. When to use: At time of production start-up and anytime a tooling update or maintenance is performed that would cause the initial information to change.
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Element 18b: Packaging Form What is It? A method to formally plan for the protection of the product during transportation from the supplier to CPSD or our customer.
Purpose: To pre-approve the packaging method and materials for the supplied product.
When to use: At time of production start-up and anytime a product change or customer issue is highlighted that may have been caused by shipment handling.
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Element 18c: IQC Inspection Form What is It? The inspection plan covers all planned inspection(s) for a specific part for lot sampling and is included with all submissions originating with suppliers located in Asia.
Purpose: To clarify inspection requirements in a central location that can be included with the work instructions. This is a common practice in China that predates Americanized control plans. When to use: Only required for suppliers located in Asia.
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Element 18d: Specification Deviation Form What is It? The Spec Deviation form documents variations in the product from the initial specification. Purpose: To highlight the variations and provide CPSD with corrective action plan(s) to address the variations so that a full submission approval can be obtained. When to use: Specification Deviation forms are submitted:
1. When an existing Production Deviation is in place to document a temporary condition. 2. When documenting issues with the PPAP requirements that are not attainable without print changes 3. To request print changes to accommodate manufacturability issues via capability or test results. This request for change is specifically documented on the Supplier Change Request form, but the specific dimensions in question are noted on the Specification Deviation Form.
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Element 18e: Supplier Checklist What is It? An organizational/communication aid for suppliers to use in preparing the PPAP for submission. Purpose:
To clearly list which elements of the PPAP are required to be submitted in order to gain full approval of the component for production. When to use: The supplier checklist is generated for every PPAP requested and is required regardless of which level of PPAP is requested.
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PPAP Summary The Production Part Approval Process is an extensive approval process for new or changed designs or processes
It is very formalized, so it inevitably causes some administrative work It can be used in both manufacturing and service industries. Later changes to the product or process can be expensive and time-consuming! © 2013 Eaton. All Rights Reserved.
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Key Take Away: • Production Part Approval Process is a game changer across the electrical sector. • AIAG PPAP expects the supplier to do all design and validation activities, regardless of PPAP level request • Used for both Internal and External Suppliers • Approval of PPAP submissions • AIAG Core Tools available to suppliers The PPAP elements are all requirements of Eaton Quality System. All internal suppliers should be able to give a full level 3 submission
For External suppliers some training may be required but early communication facilitates this and prevents delays to the project © 2013 Eaton. All Rights Reserved.
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