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APQP - Advanced Product Quality Planning - In Consonance with the AIAG's APQP Manual

Rendered on 3/28/05





Click here to start the APQP Presentation


Table of Contents

APQP - Advanced Product - Quality Planning - In Consonance with the AIAG's APQP Manual

Files Included In This Package

The Red Road Graphics

About .swf Files - 1

About .swf Files - 2

Each APQP Is Unique!

What Is APQP?

What is the AIAG's APQP Reference Manual?

Basics

The Target & Goal

Advanced APQP Section

APQP - Advanced Product Quality Planning - In Consonance with the AIAG's APQP Manual

Meeting the Intent

What Is APQP?

The TS 16949 'Quality' System

What is the AIAG's APQP Reference Manual?

Advanced Product Quality Planning

APQP Phases

APQP Team

'Phase' Inputs & Outputs

Inputs / Outputs - Phase 1

Inputs / Outputs - Phase 2

Inputs / Outputs - Phase 3

Inputs / Outputs - Phase 4

Inputs / Outputs - Phase 5

Phase 1 Inputs

Voice of the Customer

Inter-Relationships

Relationships

Typical Automotive Trilogy Development

Document Links

Document Critical Paths

Automotive Process FMEA

Effects of Changing the Process FMEA

A Corrective Action System

Product Specific FMEA Approach

Current Control Plans & FMEAs

One Proposed Terminology

FMEA White Space Issues

Discrete Documents

Automotive Documentation Development

Base Documentation

Early Process Flow Diagram

The Control Plan

Example Control Plans

Control Plan Data Sources

End Advanced APQP Section

Relationships

Advanced Product Quality Planning

Ford's Concept to Customer (CTC)

Simplicity

A Simple APQP Sequence

QS 9000

A Word About Design

PPAP

Typical Automotive Trilogy Development

Automotive Documentation Development

APQP Design & Process Controls

Product Quality Planning Responsibility Matrix

Product Quality Planning Checklists

Benefits of APQP

Each APQP is Unique

Progressive Fundamentals

Teams

Team Organization

Natural Work Group vs. Team

Roles In A Team

Team Experience

Team Experience (continued)

Team-to-Team Communication

Define Project Scope

Simple Responsibilities Matrix Example

APQP Documents and Elements

Training

Recommended Statistical Courses

Customer and Supplier Involvement

Simultaneous (Concurrent) Engineering

Customer Requirements

Base Documentation

Inter-Relationships

Chicken or Egg

Typical Automotive Trilogy Development

The Links

Document Links

Document Links II

One Document? Or More?

Example Discussion

Registrar Responses

Current Control Plans & FMEAs

One Proposed Terminology

FMEA White Space Issues

Example Discussion I

Example Discussion II

Example Discussion IIa

Example Discussion IIb

Registrar Interpretations

Registrar Interpretations

The Control Plan

QS-9000:1998 Now TS 16949:2008

QS-9000:1998 - Control Plans Now TS 16949:2008

Semiconductor Supplement

APQP Manual : 1995 (this is an old presentation, there is a newer manual)

FMEA Manual

Concern Resolution

Timing Plan

Product Quality Planning Timing Chart

Timing Plan Contents

Project Plan Elements

Project Plan Definitions I

Project Plan Definitions II

Project Plan Summary Sheet

Analytical Techniques

APQP Phases

APQP Manual Appendix A - Check Lists

APQP Phase 1: Plan and Define Program

Phase 1 Inputs

Phase 1 Outputs

Voice of the Customer

Voice of the Customer

Market Research

Historical Warranty and Quality Information

Business Plan - Marketing Strategy

Product - Process Benchmark Data

Product - Process Assumptions

Product Reliability Studies

Customer Inputs

Critical Characteristics Matrix

Characteristics I

Characteristics II

Characteristics III

Characteristics IV

Characteristics V

Design Verification Plan and Report

Phase 1 Project Review

Phase 1 Responsibility Matrix

APQP Phase 2: Product Design and Development

Phase 2 Outputs

Outputs by Design Responsible Activity

Additional Outputs by Design Responsible Activity

FMEAs

DFMEA

DFM and DFA

Design Verification

Design Reviews - Evaluations

Design Review Tracking

Process Flow Diagram Example

PFMEA Example

Control Plan Methodology

Control Plan Use

Control Plan

Prototype Build Control Plan

Standard Control Plan Example

Ford's Dimensional Control Plan (DCP)

Control Plan Example (GM)

Prototype Build

Customer or Supplier Engineering Drawings - (including math data)

Customer or Supplier Engineering Specifications

Material Specifications

Drawing and Specifications Changes

APQP Team Outputs

New Equipment, Tooling and Facilities Requirements

Special Product and Process Characteristics List

Gage and Testing Equipment Requirements

Team Feasibility, Commitment and Management Support

Subcontractor Pilot Build

Supplier Pilot Sample Build

Phase 2 Responsibility Matrix

Phase 2 Project Review

APQP Phase 3: Process Design and Development

Phase 3 Outputs

Typical Design Responsibility Outputs

Typical APQP Team Outputs

Process Design and Development Outputs

Packaging Standards

Product and Process Quality System Review

Process Flow Chart

Process Flow Diagram Example

Floor Plan Layout

Characteristics Matrix

Process FMEA

Automotive Process FMEA

Pre-launch Control Plan

Automotive Control Plan

Additional Phase 3 Outputs

Updated Tool, Equipment and Facilities Lists

Quoting In-House Tooling, Equipment and Gages

Selecting Potential New Subcontractors

Subcontractor Pilot Sample Build

Supplier Pilot Build

Project Review III

Phase 3 Responsibility Matrix

Phase 3 Project Review

APQP Phase 4: Product and Process Validation

Phase 4 Outputs

Process Instructions

Measurement Systems Analysis (MSA)

MSA Studies

Measurement Systems Analysis Plan Ensures Gage:

Measurement Precision

Measurement Bias & Repeatability

Preliminary Process Capability Study Plan

Packaging Evaluation

Packaging Specifications

Production Part Approval Process

Purpose of PPAP

Production Part Approval Process (PPAP)

PPAP Review Checklist

PPAP Scope

Application

Methodology

Supplier Data Received

Flow Chart

DFMEA

PFMEA

Pre-Launch Control Plan

Production Control Plan

Production Validation Testing

Production Trial Run

Production Trial Run Product Used For:

Ppk vs. Cpk

Preliminary Process Capability Studies

Process Analysis Animation

Histogram Animation

Process Capability Animation

Process Capability Animation

Process Capability Studies

Part Submission Status Possibilities

Interim Part Classes

Review and Sign-Off

Phase 4 Project Review

Phase 4 Responsibility Matrix

APQP Phase 5: Feedback, Assessment and Corrective Action

Continuing Production

Phase 5 Outputs

Reducing Variation

Customer Satisfaction

Customer Satisfaction Metrics

Delivery and Service

Phase 5 Responsibility Matrix

Phase 5 Project Review

Summary

Home Page: Elsmar.com

Editable Powerpoint file available. Details HERE.

Also see this LIST.

APQP discussion threads in the Elsmar Cove forums.

NOTE: This is an old presentation so you may see QS-9000 mentioned in places in this web output. However, the APQP process has not substancially changed over the years.

APQP
Advanced Product Quality Planning

Phase 1
Plan & Define Program - determining customer needs, requirements & expectations using tools such as QFD review the entire quality planning process to enable the implementation of a quality program how to define & set the inputs & the outputs.

Phase 2
Product Design & Development - review the inputs & execute the outputs, which include FMEA, DFMA, design verification, design reviews, material & engineering specifications.

Phase 3
Process Design & Development - addressing features for developing manufacturing systems & related control plans, these tasks are dependent on the successful completion of phases 1 & 2 execute the outputs.

Phase 4
Product & Process Validation - validation of the selected manufacturing process & its control mechanisms through production run evaluation outlining mandatory production conditions & requirements identifying the required outputs.

Phase 5
Launch, Feedback, Assessment & Corrective Action - focuses on reduced variation & continuous improvement identifying outputs & links to customer expectations & future product programs.

Control Plan Methodology
discusses use of control plan & relevant data required to construct & determine control plan parameters stresses the importance of the control plan in the continuous improvement cycle.

APQP
Advanced Product Quality Planning
In Consonance with the AIAG’s APQP Manual
Files Included In This Package
The Red Road Graphics
• Files with the extension .swf are Macromedia Flash files (http://macromedia.com). They are Courtesy of The Red Road (http://www.sci.fi/~leo/). I have included them as I am a graphics ‘nut’ and I really believe they help a lot of text challenged people, myself included, understand several basic concepts.
• I develop on a Macintosh using Office 98. Work is checked for compatibility on a Compaq PC running Windows 98 and Office 2000. The free download version of Quicktime (http://www.apple.com/quicktime/) plays .swf files on both my Compaq peecee and on my Macintosh. The latest version of Quicktime is a ‘beta’ release of version 5 in which Flash is incorporated.
• Both computers have Shockwave and the Flash player installed, as well as the latest Quicktime. All are free downloads. There is a Quicktime Pro edition for sale, but you only need the free downloadable version.
• On the Macintosh platform, the files ‘play’ in Powerpoint like movies when in the SlideShow mode. On the PeeCee platform they do not. The Macintosh version of Powerpoint handles .swf files as ‘movies’ while the PeeCee does not appear to.
About .swf Files - 1
• If you have the Shockwave Flash plug-in for Internet Explorer installed, you can see these files online at: http://Elsmar.com/pdf_files/. All the .swf files are there (look by name). Using Explorer on both my PeeCee and my Mac, clicking on the file in my browser opens and allows you to ‘play’ the file. I don’t have Netscape for the PeeCee so I can’t check that, but on my Mac I cannot get the Netscape browser to play the file even though the plug-in is installed - so I doubt it will play with Netscape on the PeeCee.
? NOTE: Microsoft’s Photo Editor does not ‘play well’ with animated gif files. It is not animated gif ‘aware’. You can see the first frame, but that’s it.
About .swf Files - 2
• To Play Animations From Within Powerpoint on a PeeCee
? Except for the Histogram animation, I have included a .gif file as a counterpart to each .swf file. Any program which will play animated gif files will play these files. You can make the animations play in SlideShow mode in Powerpoint by first setting up the file links. Go to each presentation slide which contains an animation and delete the animation. Then, go to the Insert / Picture / From File… menu cascade. Releasing the mouse on the From File… menu line item will bring up a file browser. Browse to and click on the appropriate .gif file for that slide. The animation will now play (continuous looping) in the SlideShow Mode.
ß The controls on the files only work if you are viewing the Flash files!!! The controls on the gif files do NOT work!!!
• The location of .mov (Quicktime movie) and .ani (Windows animation/movie) versions of these .swf files:
http://Elsmar.com/pdf_files/Red_Road_Graphics/
Each APQP Is Unique!
What Is APQP?
• APQP is a ‘defined’ process for a product development ‘system’ for Ford, GM, Chrysler and their suppliers.
• APQP is an attempt to provide a common path and synchronization of product development activities.
• APQP is an attempt to ensure communication both within a company and between a company and their customer.
What is the AIAG’s APQP Reference Manual?
• It Is General Information
• It Does Not Address Specific Manufacturer Information or Requirements
• It is NOT Auditable
• It Does Attempt To Give Guidance
• It Does NOT Address Any Specific Industry or Manufacturer
Basics
• Do NOT try to write a procedure just like the APQP reference manual.
• Look at what YOU are doing and relate it to the APQP process described by the reference manual.
• Be ready to explain ‘Equivalencies’ - Where and How and What your system does which fulfills APQP timeline elements.
The Target & Goal
Advanced APQP Section
APQP
Advanced Product Quality Planning
In Consonance with the AIAG’s APQP Manual
Meeting the Intent
• It is important to interpret APQP requirements in terms of the documentation and systems within your company. You also have to understand that when the APQP manual talks about a link via a process operation number on the control plan to the process number on the process flow diagram it may be that the control plan and the process flow diagram within your company is one and the same - a single, discrete document.
• It is important to look at what they are attempting to do. In this case they are using the process number as a linkage between two or more documents as a way to ensure that ‘counterpart information’ is easily visible. This control is for this process step in the process flow which was evaluated for risk in this process FMEA line item.
• In this presentation we will first be looking at the base requirements - mainly inputs and outputs to and from ‘Phases’ of the APQP process. From there we will go to looking closely at the control plan and related ‘required’ documentation. You will find that a number of times within this presentation I will be reinforcing the fact that there is as low probability that your company’s systems and documentation will exactly reflect what is in the APQP and Control Plan manual text. You have to look at the intent and you must identify ‘equivalencies’ within your company’s systems and documentation.
What Is APQP?
• APQP is a ‘defined’ process for a product development ‘system’ for Ford, GM, Chrysler and their suppliers.
• APQP is an attempt to provide a common path and synchronization of product development activities.
• APQP is an attempt to ensure communication both within a company and between a company and their customer.
The TS 16949 ‘Quality’ System
What is the AIAG’s APQP Reference Manual?
• It Is General Information
• It is Not a specification
• It is a Customer Requirement
• It Does Not Address Specific Manufacturer Information or Requirements
• It is Not Auditable
• It Does Attempt To Give Guidance
• It Does Not Address Any Specific Industry or Manufacturer
Advanced Product Quality Planning
APQP Phases
• Phase 1: Plan & Define Program
° Where do we want to go?
• Phase 2: Product Design & Development Verification
° Can we design one?
• Phase 3: Process Design & Development Verification
° Can we make one?
• Phase 4: Product & Process Validation
° Proof of Phases 2 and 3.
• Phase 5: Feedback Assessment & Corrective Action
° Production, Continuous Improvement, Prevent Recurrence
APQP Team
‘ Phase’ Inputs & Outputs
Inputs / Outputs - Phase 1
Inputs / Outputs - Phase 2
Inputs / Outputs - Phase 3
Inputs / Outputs - Phase 4
Inputs / Outputs - Phase 5
Phase 1 Inputs
• Voice of the Customer
Market Research
Historical Warranty and Quality Information
Team Experience
• Business Plan and Marketing Strategy
• Product/Process Benchmark Data
• Product/Process Assumptions
• Product Reliability Studies
• Customer Inputs
• Service
Voice of the Customer
• External and Internal Customers
• Stated, Real and Perceived Needs
• Cultural Needs
• Unintended Uses
• Functional Needs vs. Technical Features
Inter-Relationships
Relationships
Typical Automotive Trilogy Development
Document Links
Document Critical Paths
Automotive Process FMEA
Effects of Changing the Process FMEA
A Corrective Action System
Product Specific FMEA Approach
Current Control Plans & FMEAs
One Proposed Terminology
FMEA White Space Issues
Discrete Documents
Automotive Documentation Development
Base Documentation
• Critical Characteristics Matrix
• Process Flow Diagram
• Design FMEA
• Process FMEA
• Control Plan
Early Process Flow Diagram
The Control Plan
• A Control Plan is a written description of systems for parts and processes
• It is Process Dominated
• Three ‘Types’ or Phases
Prototype *A Design Output
• Used During Prototype Build
• Dimensional Measurements
• Material and Performance Tests
Pre-Launch
• Update After Prototype and Before Production
Production
• Comprehensive
• Process Controls
• Test and Measurement Systems Used
• Reaction Plan
• Sampling Plans
• SPC Requirements
Example Control Plans
Example Control Plans included in the APQP Manual (starting on page 47):
Equipment
Set-Up Dominant Process
Machine Dominant Process
Fixture/Pallet Dominant Process
Tooling Dominant Process
People
Operator Dominant Process
Material
Material or Component Dominant Process
Methods
Preventive Maintenance Dominant Process
Environment
Climate Dominant Process
Control Plan Data Sources
End Advanced APQP Section
Relationships
Advanced Product Quality Planning
Ford’s Concept to Customer (CTC)
Simplicity
• Do not make your system overly complex
• Don’t try to copy the APQP manual, just Meet the intent with your system
A Simple APQP Sequence
TS 16949
APQP Involves:
4.1 Management Responsibility
4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document and Data Control
4.9 Process Control
4.10 Receiving (Incoming)
4.11 Inspection, Measuring and Test Equipment
4.12 Inspection and Test Status
4.13 Control of Nonconforming Product
4.14 Corrective Action
4.15 Handling, Storage, Packaging and Delivery
4.16 Quality Records
4.18 Training
4.19 Servicing
4.20 Statistical Techniques
A Word About Design
If you design it in, it’s there to stay!
You will constantly be waiting for the next problem to surface!
PPAP
The End Product of APQP!
Typical Automotive Trilogy Development
Automotive Documentation Development
APQP Design & Process Controls
• Design Reviews
• Design Verification
• Design Validation
• Process Validation
• Design FMEA
• Process FMEA
• Prototype Validation
Product Quality Planning Responsibility Matrix
Product Quality Planning Checklists
• Design FMEA
• Design Information
• New Equipment, Tooling and Test Equipment
• Product/Process Quality
• Flow Plan
• Process Flow Chart
• Process FMEA
• Control Plan
Benefits of APQP
• Ensures early planning takes place
• Directs resources to the customer
• Identifies required changes early in the process
• Provides quality product on time and at lowest cost
• Enables cross-functional inputs and outputs
• Addresses potential problems early in
Design
Manufacturing
Each APQP is Unique
• Because of product and program differences
• Timing and sequence are dependent upon customer needs and expectations
• Product complexity
Stamping
Sub-assembly
• New
• Modification
Progressive Fundamentals
• KEY** Organize a Cross-Functional TEAM
• Define the scope
• Team-to-team communications
• Training
• Simultaneous (concurrent) engineering
• Control Plan Phases
Prototype
Pre-Launch
Production
• Concern resolution
Includes analytical techniques
Teams
Team Organization
Cross-functional
• Engineering (Typically the leader)
• Quality Assurance
• Purchasing
• Manufacturing Engineering
• Material Control
• Sales/Marketing
• Etc.
• Participation appropriate for phase being conducted
• Resources - Team defines ‘Needs’
• *Should* involve customer or subcontractor participation (not always feasible)
Natural Work Group vs. Team
Roles In A Team
Several roles need to be established for the team. These roles are: Leader, Champion, Record Keeper (Recorder), Participants and (if needed) Facilitator.
Team Experience
• Input from higher system level or past QFD projects
• Media commentary and analysis
• Customer letters and suggestions
• Things gone Right/Wrong reports
• Dealer comments
• Fleet operator comments
Team Experience (continued)
• Field service reports
• Problems and issues reported from Internal customers
• Internal evaluations using surrogate customers
• Road trips (e.g.: Struts)
• Management comments and/or direction
• Government requirements and/or regulations
• Contract review
Team-to-Team Communication
• Manage using the APQP process
• Understanding of ‘How We Work As A Team’
• Should have a Focus Person & Distributed Minutes
• Customer teams
• Internal teams
• Supplier teams
• Sub-Teams
• Subcontractors should be encouraged to embrace APQP and QS 9000
Define Project Scope
• Select team members and functions
• Define roles and responsibilities
• Identify external customer needs, expectations and requirements
• Identify internal customer needs, expectations and requirements
• Complete preliminary feasibility study
• Identify costs, timing and constraints
• Identify documentation process and method
• Develop program plan (if project is a go)
Simple Responsibilities Matrix Example
APQP Documents and Elements
• Action Plan
• Product / Process Assumptions
• Product Reliability studies
• Product / Process Characteristics
• Cross Functional Team Members
• Design FMEA
• Design Verification Plan and Report
• Design FMEA checklist
• Design Information Checklist
• New equipment tooling and Equipment checklist
• Team feasibility Commitment
• Process Flow
• Manufacturing Process Flow Chart Checklist
• Process FMEA
• Control Plan
• Product / Process Quality checklist
• Floor plan checklist
• Process Flow Chart checklist
• Process FMEA checklist
Training
Customer Needs and Expectations
Working as a Team
Group process skills
Development skills
Requirements of APQP
FMEA
APQP
PPAP
Recommended Statistical Courses
Customer and Supplier Involvement
Customer may initiate the planning process
Supplier has the obligation to establish cross-functional team to manage process
Supplier should expect the same performance from their subcontractors
Simultaneous (Concurrent) Engineering
• Requires cross-functional team participation
• Replaces prior system of sequential phases and pass-off (old method)
• APQP team ensures that other functions and teams plan and execute support activities
Customer Requirements
Ways to Determine Customer Requirements
• Print
• Purchase Request or Request for Quotation
• QFD - Quality Function Deployment
• Service Engineers
• Verbal Communications
• Development Engineers
• Product Check List
• Customer’s Customer Requirements Review
Base Documentation
• Critical Characteristics Matrix
• Process Flow Diagram
• Design FMEA
• Process FMEA
• Control Plan
Inter-Relationships
Chicken or Egg
• Which is First? Second? Third?
Control Plan?
Process Flow Diagram?
Project Plan?
Design FMEA?
Process FMEA?
Process Documentation (‘Work’ Instructions)?
• Why Does it Matter?
Relationship to Product Planning
Typical Automotive Trilogy Development
The Links
• Each Flow Chart ‘element’ must have a matching FMEA element. As a ‘trilogy’, remember - the links must all match.
• The ‘trilogy’ documents must precisely link to your process documentation (work instructions or however your company addresses this issue)
Document Links
Document Links II
One Document? Or More?
Example Discussion
Issues in the interpretation of QS 9000 and the Semiconductor Supplement:
1. Control Plans must address the flow of received materials and parts from receiving, through manufacturing and on to shipping and to warehouses.
2. Control Plan content must contain as a minimum all customer and Company X ‘critical’ characteristics.
3. Impact of Flow Diagram being incorporated into the Control Plan, if any.
The questions are:
1. What must be on a Control Plan (content)? --> Every process in accordance with corporate procedure?
2. Does each ‘responsibility’ have to have * both * Control Plan(s) and FMEA(s)???
(e.g.: Receiving has only Control Plans)
3. What must be on an FMEA (content)? Every process that is on the Control Plan?
4. White Space - Does every move have to be on the Control Plan &/or FMEA?
Terminology!
° Technology Control Plan (Language used in FABs) vs. Device FMEA
° Process Control Plan (Various places) vs. Process FMEA
° Machine/Equipment FMEA (Definition from corporate procedure)
° Family Control Plan (See Definition for Control Plan in company procedure)
Registrar Responses
• 1. QUESTION: What must be on a Control Plan? -- Every process?
ANSWER: Only the major processes are required on the control plan. Critical processes alone are not sufficient.
• 2. QUESTION: Does each 'responsibility" have to have *both* Control Plan(s) and FMEA(s)? (e.g.: Receiving has only Control Plans).
ANSWER: Yes, both the Control Plan(s) and FMEA(s) are required.
• 3. QUESTION: What must be on an FMEA? Every process that is on the Control Plan?
ANSWER: Only the major processes are required on the FMEA. (technology based)
• 4. QUESTION: White Space - Does every move have to be on the Control Plan &/or FMEA?
ANSWER: Yes, there should be a block on the Control Plan to indicate a transfer.
Current Control Plans & FMEAs
One Proposed Terminology
FMEA White Space Issues
Example Discussion I
Example Discussion II
Meeting Objective:
• Develop Recommendation for a "Standard FMEA Approach"
The team defined two different types of Process FMEAs as defined below:
Device FMEA (a single FMEA that defines a single Device Flow (from start to completion).
Process FMEA, which defines the process for either an equipment set or a "Cost Block" (e.g., probe).
Example Discussion IIa
Device FMEA "PRO's":
° Defines a single flow.
° Allows identification of Process Interaction Failure Modes.
° Allows identification of "Critical Processes".
° Opens communication between Device and Process Engineers.
Device FMEA "CON's":
° Less detail on Process Failure Modes.
° Document control is unmanageable.
° Diffuses ownership responsibilities.
Process FMEA "PRO's":
° More user friendly.
° More detailed.
° More manageable.
° TPM/Cross Functional Team Enabler.
Process FMEA "CON's":
° Doesn't exhibit Process Interaction Failure Modes.
° More difficult to identify critical processes.
Example Discussion IIb
RECOMMENDATIONS
Based on this information the team made the following recommendations:
° As a minimum, Process FMEAs should be used.
° Device FMEAs should be used as tool to introduce new Platforms to manufacturing.
CONCERNS
FMEAs must be reviewed and updated as detailed below:
° Process Changes.
° Customer Incidents (IFAR/EFAR).
° Annually.
° Whenever the process produces significant line scrap as determined by each manufacturing site.
° Ensure that the FMEAs links with the Control Plans.
Registrar Interpretations
Q5 1/12 (AEC-A100)
Are control plans developed to the...and/or material....level?
• Control plans are required at the system, subsystem, component, and/or material level. Suppliers may not need a separate and distinct control plan for components such as wafers, gases, and chemicals. However, existing control plans must cover receiving through shipment of materials, parts, components, and assemblies. So in effect, supplier's control plans will include wafers, gases, and chemicals. The Semiconductor Supplement supports this!
Registrar Interpretations
Q8 2/18 (Rev 1) QS9000 Page 13, Production Control Plans:
• "Comprehensive" requires the company to duplicate all inspections and tests already called out in shop orders and specifications into the control plan. Our company document requires inclusion of all customer-identified special characteristics and company identified important characteristics. Other inspections and tests are optional in the control plans.
• Control plans should be comprehensive including all processes, inspection, tests, methods & include special characteristics but can reference existing inspection/ test procedures.
The Control Plan
• A Control Plan is a written description of systems for parts and processes
• Process Dominated
• Prototype *A Design Output
Used During Prototype Build
Dimensional Measurements
Material and Performance Tests
• Pre-Launch
Update After Prototype and Before Production
• Production
Comprehensive
Process Controls
Test and Measurement Systems Used
Reaction Plan
Sampling Plans
SPC Requirements
QS-9000:1998
4.2.3.1 - Advanced Product Quality Planning
• The supplier shall establish and implement an advanced product quality planning process. The supplier should convene internal multi-disciplinary teams to prepare for production of new or changed products. These teams should use appropriate techniques identified in the Advanced Product Quality Planning and Control Plan reference manual. Similar techniques that accomplish the intent are acceptable.
• Team actions should include:
∑ Development/finalization of special characteristics (see Appendix C)
∑ Development and review of FMEAs
∑ Establishment of actions to reduce the potential failure modes with high risk priority numbers
∑ Development or review of control plans
QS-9000:1998 - Control Plans
4.2.3.5 - Process Failure Mode and Effects Analysis (Process FMEAs)
• Process FMEAs shall consider all Special Characteristics. Efforts shall be taken to improve the process to achieve defect prevention rather than defect detection. Certain customers have FMEA review and approval requirements that shall be met prior to production part approval (see Section II). Refer to the Potential Failure Mode and Effects Analysis reference manual.
Semiconductor Supplement
Quality Planning - 4.2.3.S
During the advanced quality planning processes, the supplier shall include all processes from the incoming material through shipping and warehousing
Failure Mode and Effects Analysis and Control Plan documents shall include these processes.
The Intent:
The supplier shall *consider* all processes. But - does it mean that all process shall be included in the FMEA and Control Plan?
APQP Manual : 1995
6.2 Overview
• “A control plan is a written description of the system for controlling parts and processes”
• “In effect, the Control Plan describes the actions that are required at each phase of the process including receiving, in-process, out-going, and periodic requirements to assure that all process outputs will be in a state of control”
FMEA Manual
“ Process Potential FMEA”
Is “...a summary of engineer’s/team’s thoughts (including an analysis of items that could go wrong based upon experience and past concerns) as a process is developed.”
“A process FMEA should begin with a flow chart / risk assessment of the general process. This flow chart should identify the product characteristics associated with each operation.”
Concern Resolution
Design or Process concerns
Responsibility matrix
Disciplined problem solving methods
Use analytical techniques (*as appropriate)
(See AIAG’s APQP & Control Plan reference manual page 4 and appendix B, page 81)
Timing Plan
Depends upon
• Product complexity
• Customer expectations
Team plan for
• Training
• Event
• Action
Framework for tracking
Basis for status reporting
Prepare a timing chart using available project or similar software
Product Quality Planning Timing Chart
Timing Plan Contents
Identify individual tasks
Track resources by task
Establishes dependencies between tasks
Determine critical path
Track specific tasks or groups of tasks
Status reports
Project Plan Elements
Mission
Scope
Objectives
Requirements
• How to measure
Definitions and specifications
Market analysis
Feasibility
• Time
• Resources
• Plant space
• Etc.
Timeline
Control system
Team
Cost Estimate
Project Plan Definitions I
• Mission - Goal, customer and approach
• Scope - What will and will not be included (with consideration to available technology)
• Objectives - Technical, profit, performance, quality, etc.
• Requirements - Deliverables
• Definition and specification - Criteria it must meet
• Market analysis - Expected annual production volume, length of run, start (delivery) target date, target price (Japan), key sales points, key competitors, etc.
Project Plan Definitions II
• Preliminary Feasibility - Degree to which current tooling and equipment can be used
• Timeline - Major milestones and detail task schedule
• Control system - Answers questions such as:
How will progress be measured?
Who will receive reports?
How are changes handled?
What limits are there on authority, responsibility, and accountability?
• Team - Who, from where and who is the team leader?
Beware of Turf Wars!
• Cost estimate - Estimate with assumptions. Often ‘all’ information is not available.
Project Plan Summary Sheet
Analytical Techniques
• Assembly Build Variation Analysis
• Benchmarking
• Cause & Effect Diagram
• Characteristics Matrix
• Critical Path Method
• Design of Experiments (DOE)
• Design for Manufacturability & Assembly (DFM & DFA)
• Design Verification Plan & Report (DVP&R - Chrysler & Ford)
• Dimensional (Dynamic) Control Plan (DCP)
• Mistake Proofing (Poka-Yoke)
• Process Flow Charting
• Quality Function Deployment (QFD)
• System Failure Mode & Effects Analysis (SFMEA)
APQP Phases
• Phase 1: Plan & Define Program
• Phase 2: Product Design & Development Verification
• Phase 3: Process Design & Development Verification
• Phase 4: Product & Process Validation
• Phase 5: Feedback Assessment & Corrective Action
APQP Manual Appendix A - Check Lists
A-1 Design FMEA Check List
A-2 Design Information Checklist
A-3 New Equipment, Tooling and Test Equipment Checklist
A-4 Product / Process Quality Checklist
A-5 Floor Plan Check List
A-6 Process Flow Chart Checklist
A-7 Process FMEA Checklist
A-8 Control Plan Checklist
APQP Phase 1: Plan and Define Program
Phase 1 Inputs
• Voice of the Customer
Market Research
Historical Warranty and Quality Information
Team Experience
• Business Plan and Marketing Strategy
• Product/Process Benchmark Data
• Product/Process Assumptions
• Product Reliability Studies
• Customer Inputs
• Service
Phase 1 Outputs
• Design Goals
• Reliability and Quality Goals
• Preliminary Bill of Material
• Preliminary Process Flow Chart
• Preliminary Listing of Special Product and Process Characteristics
• Product Assurance Plan
• Management Support
Voice of the Customer
• Market research
• Historical warranty and quality information
• Team experience
• Complaints
• Recommendations
• Data and/or other information
Voice of the Customer
• External and Internal Customers
• Stated, Real and Perceived Needs
• Cultural Needs
• Unintended Uses
• Functional Needs vs. Technical Features
Market Research
• Customer interviews
• Customer questionnaires and surveys
• Marketing test and positioning reports
• New product quality and reliability studies
• Competitive product quality studies
• “Things Gone Right” reports
Historical Warranty and Quality Information
• “Things gone Wrong” reports
• Warranty reports
• Capability indicators
• Supplier plant internal quality reports
• Problem resolution reports
• Customer plant returns and rejections
• Field return product analysis
Business Plan - Marketing Strategy
• Framework for quality plan
• May place constraints on timing, cost, investment, positioning, R&D resources
• Strategy defines target customer, key sales points, key competitors
• SWOT
Strengths
Weaknesses
Opportunities
Threats
• Old vs. New
How deep and how far to go
Product - Process Benchmark Data
• A requirement of QS 9000 para. 4.1
• Provides inputs to establish performance targets
• Must address key process(es)
• Must be measurable
• Methods for successful benchmarking:
Identify appropriate benchmark(s)
Find reason for gap between your status and benchmark
Develop a plan for closing gap, meeting or exceeding benchmark
Product - Process Assumptions
• Assumptions
Features
Design
Process concepts
Technical innovations
Advanced materials
Reliability assessments
New technology
• Document assumptions as part of project plan
• Utilize as inputs to plan
• Consider alternate paths in case assumptions do not play out
Product Reliability Studies
• Frequency of repairs or replacements within designated time period(s)
Repair or Throw-away?
LRU Level (Line Replaceability Unit)
• Long range reliability and/or durability tests
• Studies can be VERY costly and lengthy
EDCTP (Environmental Design Criteria Test Plan)
Customer Inputs
• Next users provide information about needs and expectations
• Possibility of previous conducted reviews and studies
• Used to develop measure of customer satisfaction
Critical Characteristics Matrix
Characteristics I
• CHARACTERISTIC: A distinguishing feature, dimension or property of a process or its output (product) on which variable or attribute data can be collected. (P39 APQP)
• CHARACTERISTIC, CRITICAL, CHRYSLER DEFINITION: Characteristics applicable to a component, material, assembly, or vehicle assembly operation which are designated by Chrysler Corporation Engineering as being critical to part function and having particular quality, reliability and/or durability significance. These include characteristics identified by the shield, pentagon, and diamond. (49 PPAP)
• CHARACTERISTIC, CRITICAL (INVERTED DELTA), FORD DEFINITION: Those product requirements (dimensions, performance tests) or process parameters that can affect compliance with government regulations or safe vehicle/product function, and which require specific supplier, assembly, shipping, or monitoring and included on Control Plans. (P49 PPAP)
• CHARACTERISTIC, CRITICAL, GM DEFINITION: See Key Product Characteristic. (P49 PPAP)
• CHARACTERISTIC, KEY CONTROL (KCCs): Those process parameters for which variation must be controlled around a target value to ensure that a significant characteristic is maintained at its target value. KCCs require ongoing monitoring per an approved Control Plan and should be considered as candidates for process improvement. (P49 PPAP)
• CHARACTERISTIC, KEY PRODUCT (KPC): Those product features that affect subsequent operations, product function, or customer satisfaction. KPCs are established by the customer engineer, quality representative, and supplier personnel from a review of the Design and Process FMEA’s and must be included in the Control Plan. Any KPCs included in customer-released engineering requirements are provided as a starting point and do not affect the supplier’s responsibility to review all aspects of the design, manufacturing process, and customer application and to determine additional KPCs. (P49 PPAP)
Characteristics II
• CHARACTERISTIC, PROCESS: Core team identified process variables (input variables) that have a cause and effect relationship with the identified Product Characteristic(s) which can only be measured at the time of occurrence. (6.3 #20 APQP)
• CHARACTERISTIC, PRODUCT: Features or properties of a part, component or assembly that are described on drawings or other primary engineering information. (6.3 #19 APQP)
• CHARACTERISTIC, PRODUCT, CRITICAL (D), CHRYSLER DEFINITION: A defect which is critical to part function and having particular quality, reliability, and durability significance. (QS-9000)
• CHARACTERISTIC, PRODUCT, MAJOR, CHRYSLER DEFINITION: A defect not critical to function, but which could materially reduce the expected performance of a product, unfavorably affect customer satisfaction, or reduce production efficiency. (QS-9000)
• CHARACTERISTIC, PRODUCT, MINOR, CHRYSLER DEFINITION: A defect, not classified as critical or major, which reflects a deterioration from established standards. (QS-9000)
• CHARACTERISTIC, PRODUCT, SAFETY/EMISSION/NOISE (S), CHRYSLER DEFINITION: A defect which will affect compliance with Chrysler Corporation and Government Vehicle Safety/Emission/Noise requirements. (QS-9000)
• CHARACTERISTIC, SAFETY, CHRYSLER DEFINITION “Shield <S>: Specifications of a component, material, assembly or vehicle assembly operation which require special manufacturing control to assure compliance with Chrysler Corporation and government vehicle safety requirements. (QS-9000)
Characteristics III
• CHARACTERISTIC, SAFETY, CHRYSLER DEFINITION: Specifications which require special manufacturing control to assure compliance with Chrysler or government vehicle safety requirements. (P50 PPAP)
• CHARACTERISTIC, SIGNIFICANT, CHRYSLER DEFINITION: Special characteristics selected by the supplier through knowledge of the product and process. (QS-9000)
• CHARACTERISTIC, SPECIAL: Product and process characteristics designated by the customer, including governmental regulatory and safety, and/or selected by the supplier through knowledge of the product and process. (P104 APQP)
• CHARACTERISTIC, SPECIAL, CHRYSLER DEFINITION “Diamond” <D>: Specifications of a component, material, assembly or vehicle assembly operation which are designated by Chrysler as being critical to function and having particular quality, reliability and durability significance. (QS-9000)
• CHARACTERISTIC, SPECIAL, CHRYSLER DEFINITION “Diamond” <D>: Specific critical characteristics that are process driven (controlled) and therefore require SPC to measure process stability, capability, and control for the life of the part. (Appendix C QS-9000) & (Appendix C APQP)
• CHARACTERISTIC, SPECIAL, CHRYSLER DEFINITION “Pentagon” <P>: Limited to highlighting Critical characteristics on (Production) part drawings, tools and fixture, and tooling aid procedures where ongoing process control is not automatically mandated. (Appendix C QS-9000) & (Appendix C APQP)
• CHARACTERISTIC, SPECIAL, CHRYSLER DEFINITION “Shield” <S>: Engineering designated specifications or product requirements applicable to component material, assembly operation(s) which require special manufacturing control to assure compliance with governmental vehicle safety, emissions, noise, or theft prevention requirements. (Appendix C QS-9000) & (Appendix C APQP)
Characteristics IV
• CHARACTERISTIC, SPECIAL, FORD DEFINITION “Critical Characteristic” <Inverted Delta>: Those product requirements (Dimensions, Specifications, Tests) or process parameters which can affect compliance with government regulations or safe Vehicle/Product Function and which require specific producer, assembly, shipping or monitoring actions and inclusion on the Control Plan. (Appendix C QS-9000) & (Appendix C APQP)
• CHARACTERISTIC, SPECIAL, FORD DEFINITION “Significant Characteristic - SC” <None>: Those product, process, and test requirements that are important to customer satisfaction and for which quality planning actions shall be included in the Control Plan. (Appendix C QS-9000)
• CHARACTERISTIC, SPECIAL, FORD DEFINITION “Significant/Characteristic - S/C” <None>: Characteristics that are important to the customer and that must be included on the Control Plan. (Appendix C APQP)
• CHARACTERISTIC, SPECIAL, GM DEFINITION “Fit/Function” <F/F>: Product characteristic for which reasonably anticipated variation is likely to significantly affect customer satisfaction with a product (other than S/C) such as its fits, function, mounting or appearance, or the ability to process or build the product. (Appendix C QS-9000) & (Appendix C APQP)
• CHARACTERISTIC, SPECIAL, GM DEFINITION “Safety/Compliance” <S/C>: Product characteristic for which reasonably anticipated variation could significantly affect customer the product’s safety or its compliance with government regulations (such as: flammability, occupant protection, steering control, braking, etc. . .), emissions, noise, radio frequency interference, etc. . . (Appendix C QS-9000)
• CHARACTERISTIC, SPECIAL, GM DEFINITION “Safety/Compliance” <S>: Product characteristic for which reasonably anticipated variation could significantly affect customer the product’s safety or its compliance with government regulations (such as: flammability, occupant protection, steering control, braking, etc. . .), emissions, noise, radio frequency interference, etc. . . (Appendix C APQP)
Characteristics V
• CHARACTERISTIC, SPECIAL, GM DEFINITION “Standard” <None>: Product characteristic for which reasonably anticipated variation is unlikely to significantly affect a product’s safety, compliance with governmental regulations, fit/function. (Appendix C QS-9000) & (Appendix C APQP)
• CHARACTERISTIC, SPECIAL, PROCESS (e.g., CRITICAL, KEY, MAJOR, SIGNIFICANT): A process characteristic for which variation must be controlled to some target value to ensure that variation in a special product characteristic is maintained to its target value during manufacturing and assembly. (P57 FMEA)
• CHARACTERISTIC, SPECIAL, PRODUCT: Core team compilation of important product characteristics from all sources. All Special Characteristics must be listed on the Control Plan. (6.3 #19 APQP)
• CHARACTERISTIC, SPECIAL, PRODUCT (e.g., CRITICAL, KEY, MAJOR, SIGNIFICANT): A product characteristic for which reasonably anticipated variation could significantly affect a product’s safety or compliance with governmental standards or regulations, or is likely to significantly affect customer satisfaction with a product. (P55 FMEA)
• CHARACTERISTIC, SPECIAL, TOOLING, CHRYSLER DEFINITION “Pentagon” <P>: Critical tooling symbol used to identify special characteristics of fixtures, gages, developmental parts, and initial product parts. (QS-9000)
• CONTROL ITEM PART, FORD DEFINITION: Product drawings/specifications containing Critical Characteristics. Ford Design and Quality Engineering approval is required for changes to Control Item FMEA’s and Control Plans. (QS-9000)
Design Verification Plan and Report
Phase 1 Project Review
Phase 1 Responsibility Matrix
APQP Phase 2: Product Design and Development
Phase 2 Outputs
• Outputs by Design Responsible Activity
• Outputs by Advanced Product Quality Planning Team
Outputs by Design Responsible Activity
• Design FMEA
• DFM and DFA
Design for Manufacturability
Design for Assembly
• Design Verification
• Design Reviews
• Prototype Build - Control Plan
• Engineering Drawings (including Math data)
• Engineering Specifications
• Material Specifications
• Drawing and Specification Changes
Additional Outputs by Design Responsible Activity
• Updated special characteristics list
• Prototype parts build
Make - Buy decisions
Parts inspection
Assembly of prototype(s)
Preferably manufacturing, not model shop
Inspection layout
Prototype validation testing
• Redesign as required and design review
• Update DFMEA (and System Level FMEA if appropriate)
• Feasibility report
FMEAs
DFMEA
• Disciplined analytical tool
Assess probability of failure
Effect of failure
• Must be continually updated
• Causes changes and/or additions to previously selected special product and/or process characteristics
• If you do not have design control, you MUST (should) have customer DFMEA
• Check list (AIAG APQP Manual Appendix A-1)
DFM and DFA
• Design, concept, function and sensitivity (tolerancing) to manufacturing variation
• Manufacturing and/or assembly process
• Dimensional tolerances
• Performance requirements
• Number of components (complexity)
• Process adjustments
• Material handling
Design Verification
• Inspection methods
• Testing methods
• Ensure that all design outputs meet design input requirements
Alternate calculations
CAD/math data
Review design stage documents before release
Design Reviews - Evaluations
• Design/functional requirement(s) and considerations
• Formal reliability and confidence goals
• Component/subsystem/system duty cycles
• Computer simulation and bench test results
• DFMEA(s)
• Review of the DFM and DFA
• Design of experiments (DOE) and assembly build variation results
• Test failures
• Design verification progress
• Max/Min builds
Design Review Tracking
• Track verification progress using a design verification plan and report (DVP&R - Ford & Chrysler)
• Product/process validation of components
Process Flow Diagram Example
PFMEA Example
Control Plan Methodology
• Aids in the manufacturing of products according to customer requirements
• Provide structured approaches
• Contain a written summary of the system used in minimizing process and product variation
• Forms provided in the AIAG handbook are examples of how to document
• Alternate formats can be used if they contain necessary information
• Must be maintained and used throughout the product life cycle
Control Plan Use
• Initial: To document and communicate initial process control
• Next: Guidance in controlling processes and to ensure product quality
• Last: A living document reflecting current methods of control and measurement systems used
Control Plan
• Ensure Control Plan is aligned to, and correlates with, DFMEA, Process Flow, PFMEA
• Control Methods appropriate to variation type(s)
• Incorporates Lessons Learned, Statistical Data
• Use A-8 Control Plan checklist in APQP manual to evaluate
Prototype Build Control Plan
• A description of the dimensional measurements
• Material tests
Functional tests that will occur during prototype build
Depending upon product complexity, several prototype builds may be necessary and may require updates to the control plan
Standard Control Plan Example
Ford’s Dimensional Control Plan (DCP)
Control Plan Example (GM)
Prototype Build
• Make -buy decisions
• Part inspections
• Assemble prototypes
• Perform layout inspection
• Validation testing (Who will do testing?)
• Redesign as required
• Update DFMEA and SFMEA if required
Customer or Supplier Engineering Drawings
(including math data)
• Review for special and/or critical characteristics
• Review controlling drawings when engineering drawings are nonexistent
• Review drawings for:
Dimensions for form, fit, function, durability, government S&R
Control or datum surfaces/locators for function gages and equipment
Feasibility/compatibility with industry standards
• Compatibility of math data with two-way communications (Written waivers acceptable)
Customer or Supplier Engineering Specifications
• Review and understand controlling specifications
• Identify functional, durability and appearance requirements
• Should define:
Sample size
Frequency
Acceptance criteria
• Otherwise, determined by supplier and included in control plan
Material Specifications
• Review Material Specifications for Special Characteristics
Physical properties
Performance
Environmental
Handling
Storage
• Include in Control Plan
Drawing and Specifications Changes
• Change control requirement applies
• Ensure proper communication
• QS 9000 Element 4.5 ‘Document and Data Control’ applies (requires a Change Control system)
APQP Team Outputs
• New equipment, tooling and facilities requirements
• Special product and process characteristics
• Gage and testing equipment requirements
• Team feasibility commitment and management support
• Subcontractor build
• Supplier build
New Equipment, Tooling and Facilities Requirements
• Preliminary identification of new equipment, tooling and facilities
• Address these items on the timing chart
• Address capability requirements
• Establish delivery times
• Complete check list in AIAG APQP & Control Plan reference manual Appendix A-3
Special Product and Process Characteristics List
• Upgrade preliminary list started in Phase 1 from information gathered through review and development of design features
Additional sources
• DFMEA
• SFMEA if applicable
• PFMEA
• Previous history
• Must be on control plans for prototype, pre-launch and production
• Listing should be a team consensus
Gage and Testing Equipment Requirements
• Preliminary identification of inspection, test and measurement equipment
• Requirements on timing chart
Complete in time to conduct measurement systems analysis
Equipment builder
Pilot build
Production trial run
Team Feasibility, Commitment and Management Support
• Team feasibility commitment
• Complete program review check list, including:
Design feasibility
Can be manufactured, assembled, tested and packaged
Can be delivered in the right quantities on schedule at acceptable cost
Review design information check list in AIAG APQP Reference manual Appendix A-2 as part of feasibility inputs
• Open issues that require resolution with assigned responsibility and timing.
• Management Support
Report project status to management
Recommend continue or drop project depending on feasibility
Cover open issues and concerns
Management support as required
Subcontractor Pilot Build
• Supplier participated, if appropriate
• Sample quantity required
• Check that it is according to:
Work instructions
Control plan
• Where to be produced
Supplier Pilot Sample Build
• Parts availability
• Tooling and equipment availability
• Measurement equipment availability
Phase 2 Responsibility Matrix
Phase 2 Project Review
APQP Phase 3: Process Design and Development
Phase 3 Outputs
• Packaging Standards
• Product / Process Quality System Review
• Process Flow Chart
• Floor Plan Layout
• Characteristics Matrix
• Process Failure Mode and Effects Analysis
• Pre-Launch Control Plan
• Process Instructions
• Measurement Systems Analysis Plan
• Preliminary Process Capability Study Plan
• Packaging Specifications
Typical Design Responsibility Outputs
• DFMCA
• DFM/DFA
• DV
• Design Reviews
• Prototype Build
• Engineering Drawings
• Engineering Specifications
• Material Specifications
• Drawing and Specification Changes
Typical APQP Team Outputs
• New Equipment
• Facilities
• Etc.
Process Design and Development Outputs
• Packaging standards
• Product and process quality system review
• Process flow chart
• Floor plan layout
• Characteristics matrix
• PFMEA
• Pre-launch control plan
• Process instructions
• Measurement systems analysis plan
• Preliminary process capability study plan (Typically 100 Parts)
• Management support
Packaging Standards
• From customer
• Developed during prototype or pre-launch runs
Product and Process Quality System Review
• Team must review existing quality systems manual to ensure that changes resulting from APQP (if any) are reflected
• Must comply with QS 9000
• Changes must be reflected in control plan
• Reference AIAG APQP Reference manual Appendix A-4 check list
Process Flow Chart
• Update process flow chart
(Example in AIAG APQP Reference manual Appendix A-6)
• Describes current or proposed process flow
• Used to analyze sources of variation
• Helps analyze total process
• Needed for process FMEA, characteristics matrix and control plan
• Reference AIAG APQP Reference manual Appendix A-6 check list
Process Flow Diagram Example
Floor Plan Layout
• Determine acceptability of inspection and test points
• Control chart location(s)
• Visual aides
• Interim repair stations
(rework)
• Nonconforming material storage
• Keyed to material flow and control plan
• Reference AIAG APQP Reference manual Appendix A-5
Characteristics Matrix
• Displays relationship between:
Process parameter
Manufacturing stations
• Reference AIAG APQP Reference manual Appendix B, page 82
Process FMEA
• To the extent possible, potential failure modes have been considered and addressed
• May be started after design FMEA in Phase 2
• Needs to be updated regularly
• Must be done prior to committing new tools and equipment
• Living document
• Typically started too late!
• Reference AIAG APQP Reference manual Appendix A-7
Automotive Process FMEA
Pre-launch Control Plan
• Description of dimensional measurements, materials and functional tests
• Adds additional product and/or process controls
• Purpose is to contain potential nonconformities utilizing:
More frequent inspections and/or tests
More in-process and final inspection and/or check points
Statistical evaluations
Increased audits
Reference AIAG APQP Reference manual Appendix A-8 check list
Automotive Control Plan
Additional Phase 3 Outputs
• Updated equipment, tools and facility lists
• Updated process flow chart, PFMEA and control plan
• Quotes for in-house tooling, equipment and gages
• Selection of potential new subcontractors
• Quote and delivery of gages in time for MSA plan
• Equipment build and runoffs
• Generation of a subcontractor pilot build
• Generation of a supplier pilot build
Updated Tool, Equipment and Facilities Lists
• Information from PFMEA and other sources
• Address on timing chart
• Address capability requirements
• Reference AIAG APQP Reference manual Appendix A-3 check list
Quoting In-House Tooling, Equipment and Gages
• Delivery timing for pilot build or production trial run
• Include capability requirements
• Include trial run/runoff/prove-out requirements
• Gage delivery for MSA plan and runoff
• Reference AIAG APQP Reference manual Appendix A-3
Selecting Potential New Subcontractors
• Responsible for planning, tracking and follow-up for subcontracted work
• Provide technical resources for tool and gage design, fabrication and full dimensional inspection
Subcontractor Pilot Sample Build
• Supplier participation, if appropriate
• Build sample quantity required
Machine trial runs
Pilot run(s)
• In accordance with appropriate work instructions
• In accordance with control plan
• Production tooling and equipment, if possible
Supplier Pilot Build
• Provide for customer participation, if specified
• have process instructions in place
• Have control plan in place
• Provide required quantity
• Complete MSA
• Generate required documentation as planned
Project Review III
• Include in control plan
• Manufacturing location’s quality system manual should be reviewed
• Procedures and control plans to be updated to reflect changes
• Last chance to eliminate problems before ramp-up
Phase 3 Responsibility Matrix
Phase 3 Project Review
APQP Phase 4: Product and Process Validation
Phase 4 Outputs
• Production trial run
• Measurement system evaluation (complete)
• Preliminary process capability study
• Production part approval
• Production validation testing
• Packaging evaluation
• Production control plan
• Quality planning sign-off and management support
Process Instructions
• Work instructions for operating personnel
• Sources:
† FMEAs
† Control plans
† Engineering drawings and specifications
† Material specifications
† Visual standards
† Industry standards
† Process flow chart
† Floor plan layout
† Characteristic matrix
† Packaging standards
† Process parameters
† Producer expertise
† Handling requirements
† Operators of process
† Accessible operators
† Include set-up parameters
† Reference QS 9000 Element 4.9 ‘Process Control’
Measurement Systems Analysis (MSA)
• Complete studies as defined in the MSA plan
• Minimum are those identified in the control plan
• Subjected to evaluation prior to or during production trial
MSA Studies
• Measurement uncertainty determined
Gage R&R, Bias, Stability, and Linearity
• Gage R & R acceptance guidelines
< 10% acceptable
10-30% may be acceptable, evaluate total variation
> 30% unacceptable, measuring system needs improvement
• Verify study performed correctly
Measurement Systems Analysis Plan Ensures Gage:
• Linearity
• Accuracy
• Repeatability
• Reproducibility
• Correlation for duplicate gages
• Gages may be needed prior to gage sign-off at subcontractor plant or any in-house pilot runs
Measurement Precision
Measurement Bias & Repeatability
Preliminary Process Capability Study Plan
• Must include characteristics identified in control plan
• Few characteristics for simple component
• Many characteristics for complex product with many parts
• Reference AIAG Fundamental SPC Reference Manual
Packaging Evaluation
• Packaging must conform to specifications developed by customer or supplier
• Assess protection of product
• Customer specified packaging must be evaluated by team
• Pilot or production trial run parts usually used in evaluation
Packaging Specifications
• For individual products
• Customer packaging
• Generic standards where appropriate
• Must ensure delivery quality
• Compatible with all material handling equipment used
Production Part Approval Process
PPAP
• Production parts are manufactured at the production site using production tooling, gaging, equipment, operators, etc
• Parts from production run are analyzed.
• Test results and records from APQP are submitted with Part Submission Warrant.
Purpose of PPAP
For the supplier to demonstrate:
° All design records and specification.
° Requirements are properly understood.
° The process has the capability to produce product that meets requirements.
Production Part Approval Process (PPAP)
• Production Part Approval Process
• Parts produced at production site using:
Production tooling
Production gages
Process
Operators
Environment
Process settings
• Feeds
• Speeds
• Cycle times
• Pressures
• Temperatures
• Intent is to validate (prove) that products made using production equipment meet engineering requirements
• If submission level is not known, contact customer
• Default level is 3
• Customer approval is required prior to quantity production
• Reference AIAG Production Part Approval Process reference manual
PPAP Review Checklist
• Checklist to assist with evaluation of PPAP package
• Action plan created with use of checklist
PPAP Scope
• Production parts - generally 300 ‘pieces’
• Service subcontractors - fulfill requirements
• Bulk material
• Includes internal and external sources for information
• Submission required prior to first production shipment
• PPAP Manual Section I.3 “Customer Notification and Submission Requirements” (starting on page 11) for guidance
Application
AIAG PPAP Manual Defines When PPAP Submission is Required
° New part
° Correction to discrepancy in previous submission
° Design or process change
° Change in source of subcontracted materials or services
° Transfer or rearrangement of tooling & equipment
Methodology
• Buyer enters PPAP submission date on purchase order.
• Approver determines submission level.
Default level 3
Default level 4 for raw material
• Supplier submits PPAP
PPAPALL.xls electronic submission (Delphi)
• Approver evaluates PPAP package.
Level 5 at supplier site
• Approver determine part submission status.
• Notify supplier and manufacturing of status.
Supplier Data Received
• Warrant
• Appearance Approval Report (AAR), as required
• Sample Parts
• Print/Design Record
• Engineering Change Documents
• Check fixtures/aids
• Process Flow Diagram
• PFMEA
• DFMEA
• Control Plan
• Early Production Containment Plan (Pre-Launch Control Plan)
• Process capability studies
• Gage Measurement System Analysis
• Lab Accreditation & scope
• Restricted & Reportable Materials form
• Interim Worksheet, if required
Flow Chart
• Linkage of Product Characteristics from DFMEA to Operational Steps.
• Operation numbers consistent with PFMEA, Control Plan, Operator Instructions.
• Ensure identification of inspection and rework.
• Use A-6 Process Flow Chart checklist in APQP manual to evaluate.
DFMEA
• Assess Feasibility, Risk, Design Intent Issues
• Confirm Manufacturing Process Capability Considered
• Focus on Critical Characteristics
• Lessons Learned Incorporated
• Use A-1 Design FMEA Checklist in APQP Manual to Evaluate
PFMEA
• Linkage with DFMEA, Process Flow, Control Plan, Operator Instructions, etc
• Degree to which high RPN’s are addressed with preventive strategies
• Action Plans assigned, implemented, effectiveness assessed and RPN recalculated
• Use A-7 Process FMEA checklist in APQP manual
Pre-Launch Control Plan
Early Production Containment Requirements
1. Additional controls included for proper duration or quantity.
2. PFMEA and statistical data used to determine what additional controls necessary.
• Short Term Capability
• Long Term Capability on similar process
Production Control Plan
• Update pre-launch control plan (living document)
• Add:
Sampling plans
Control method
SPC, inspection, attribute data and mistake-proofing
Reaction plan
• Nonconformances clearly identified, quarantined and disposition made
• Requires customer approval unless otherwise specified
• Reference AIAG APQP Reference manual Appendix A-8, B and G
Production Validation Testing
• Engineering tests validate products manufactured with:
Production tools
Production processes
Production operators
• Performed under end-use operating conditions
• Multiple validations for multiple intended uses
• Reference QS 9000 Element 4.4.8
Production Trial Run
• Production tooling, equipment, environment, facilities and cycle time
• Process instructions and control plans
• Minimum quantity set by customer
(Can be increased by team)
• Generally 300 parts
Production Trial Run Product Used For:
• Preliminary process capability studies
• MSA (if not completed earlier)
• Final feasibility
• Process review
• Production validation testing
• PPAP
• Packaging evaluation
• First time capability
• Quality planning sign-off
• Design changes (if required)
Ppk vs. Cpk
Preliminary Process Capability Studies
• Characteristics identified in the control plan
• Usually 100 pieces minimum
• May be 30 if run is less
• Ppk ≥ 1.67 is acceptable unless otherwise specified
• Ppk ≤ 1.67 requires action plan unless otherwise specified
• Reference AIAG Fundamental SPC Reference Manual
1.0 at spec limit
+-3 sigma = 1.67
Allows ‘flop’ within spec limit
Process Analysis Animation
Histogram Animation
Process Capability Animation
Process Capability Animation
Process Capability Studies
Part Submission Status Possibilities
• Full Production Approval
• Interim Approval
Authorize shipment to Delphi without Full Production Approval
Corrective Action Plan is required.
• Rejected
Corrected submission required before production quantities may be shipped.
Interim Part Classes
A Parts from production tooling and meet specs, not all PPAP requirements have been met.
B Parts from production tooling and require rework to meet specs.
C Parts not from production tooling, parts meet specs.
D Parts do not meet specs.
E Parts do not meet specs and vehicles with class E parts require retrofit to make them saleable.
Review and Sign-Off
• Process instructions in place and followed
• Flow charts in place and followed
• GR&R plans exist and are followed
• Publish final feasibility report
• Obtain formal sigh-off
• Schedule and conduct management review
• Obtain management commitment to assist in open issues
Phase 4 Project Review
Phase 4 Responsibility Matrix
APQP Phase 5: Feedback, Assessment and Corrective Action
• The results of continuing production are evaluated for common or special causes of variation during this phase to ensure that the products satisfy customer satisfaction requirements
• The effectiveness of the quality process should be evaluated during this process step
Includes continual improvement efforts
Includes delivery and service performance
Continuing Production
Phase 5 Outputs
• Reduced variation
• Customer satisfaction
• Delivery and service
Reducing Variation
• Identify process variation
• take corrective action to reduce variation
• Develop proposal for customer review
• Gain customer decision to implement, negotiate or change design
Customer Satisfaction
• Product or service must perform in customer’s environment
• Supplier must participate
• Supplier and customer must be partners
• Reference QS 9000 Element 4.1.6
Customer Satisfaction Metrics
• Warranty
• Labour claims
• Concerns reports
• Nonconforming material reports
• Corrective actions
• On time delivery
• Tech calls
Delivery and Service
• Continues the supplier - customer partnership in problem solving and continuous improvement
• Replacement parts and services are important
• Leads to possible price reduction from:
Inventory cost reduction
Process cost reduction
Cost of quality reduction
Reference QS 9000 Element 4.15
Phase 5 Responsibility Matrix
Phase 5 Project Review
Summary
• AIAG PPAP Manual Defines Requirements
• APQP Product and Process Validation
• Supplier submits PPAP to proper level
• PPAP package evaluated and status determined
• Supplier and customer manufacturing site notified of PPAP approval status


   

This page reviewed or revised: Wednesday, October 22, 2014 9:49 AM EST USA - GMT {Greenwich Mean Time} -5 hours

Marc Timothy Smith - Elsmar.com
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