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ADVANCED PRODUCT QUALITY PLANNING

APQP 2nd Edition:-

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APQP 2nd Edition:-

2nd Edition launched – on 1st Nov.2008

 Incorporation of the customer focused process approach.


 Updated terminology and concepts consistent with ISO 16949 2009 and other
Chrysler, ford and General Motors core tool manuals.
 Appropriate references to customer specific provided without the full text.

This Manual Continues to provide general guidelines for ensuring that the
advance product quality planning is implemented in accordance with the
requirements of the customer.

3
REVISION IN APQP 2ND EDITION
 Aligned with ISO/TS-16949:2009 (Clause – 7.1,7.2,7.3)
 FMEA revised in June 2008.
 TGR & TWR replaced with knowledge management.

KNOWLEDGE MANAGEMET
Knowledge about
Appreciation for system Variation
(Statistical Tolerance)

Knowledge about Knowledge about


Variation Variation
(Statistical Tolerance) (Statistical Tolerance)

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APQP IS A SUPPLY CHAIN IMPROVEMENT
Automotive Consulting Group 2000  $6.2 billion per year in supply chain labor costs to prepare documentation

AMR Research 2001  $6.0 billion per year moving quality documents throughout the supply chain.

 $16.5 billion every year due to a critical lack of communication around new
PWC 2003
product development.
 $8.0 billion Warranty costs
North America –AMR Research 2000

SUPPLY CHAIN IMPROVEMENT

2nd – TIER 1ST – TIER GLOBAL OEM CUSTOMER


SUPPLIER SUPPLIER

Supplier internal PPM Receipt PPM In process PDI Customer Warranty


PPM PPM Complaints
Return

QGMS/QS-APQP 5
SUPPLY CHAIN IMPROVEMENT
1. Waste is shuttling in supply chain. Only name change for waste.
2. Ex. – Supplier Return – No Supply chain imp.
Inventory – Total waste in supply chain.
Who is customer for inventory ?
Production, PPC …
There is no ROI on it totally money block. Finance is the customer.

APQP IS A SUPPLY CHAIN IMPROVEMENT.

About the product development process ….

Advanced Product Quality Planning (APAP) was designed to help deliver benefits to the entire
supply chain.
 Promote early identification of required changes
 Avoid late changes.
 Provide Quality Product on time at lowest cost.
 Design to be a “ before-the-event” action, not an “after-the-fact” exercise.

QGMS/QS-APQP 6
Goal: Reduce Time to Market (Supply Chain Improvement…. )

Targe
Target
t
Supply Chain Readiness

Launch 5

4 Goal: Improved Visibility through


the network of supply chain
which allows the identification of risk
3 (quality, timing) much earlier in the
process.
 CRITICAL PATH METHOD
 PERT METHOD
 PROGRAM EVALUATION AND
2 REVIEW TECHNIQUE.

1
OEM

Integrated
System
system

Design
Concept to Production
Released
Component Sub System Sub System Sub System

Component Component

Material

QGMS/QS-APQP 7
VERSATILE SKILL VENTURE

History
ISO 9000
BS 5750
series Based ISO 9001 ISO 9001
upon
ISO
: 2000 : 2008
Ford Motor IATF
9001:1994
Gen. Motor QS 9000 was
Established
Dem. Chrysler To
represent Ist Edition
ISO /TS ISO /TS
European & of ISO/TS
16949 16949
France EAQF North 16949
: 2002 : 2009
VDA 6.1 :1999
Germany American
Italy AVSQ

ISO (International Organization for Standardization) came in 1947.


PRODUCT QUALITY PLANNING CYCLE

PLAN – Technology and concept Development

DO – Product and Process Development and


Proto Type Verification

CHECK - Confirm Product and Validation Process

ACT – Continual Improvement

The Purpose of the Product Quality Planning Cycle to emphasize the ……


1) Up - front Planning – The first Three Quarters of the cycle are devoted
to up – front Product quality planning through Product / Process
Validation.

2) The act of implementation – The fourth quarter is the stage where the
importance of evaluating the outputs serves two functions –

a) To determine if customers are satisfied,


b) And to support the pursuit of continual improvements.

PRODUCT QUALITY PLANNING CYCLE IS THE NEVER


ENDING PURSUIT OF CONTINUAL IMPROVEMENT
THAT CAN ONLY BE ACHIEVED BY TAKING THE
EXPERIENCE IN ONE PROGRAM AND APPLYING THAT
ACQUIRED KNOWLEDGE TO THE NEXT PROGRAM.

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QGMS/QS-APQP 10
QGMS/QS-APQP 11
APQP KEY ELEMENT

QGMS/QS-APQP 12
John Dewey once said, "A problem
well-defined is half solved."

QGMS/QS-APQP 13
QGMS/QS-APQP 14
QGMS/QS-APQP 15
QGMS/QS-APQP 16
QUALITY SYSTEM REQUIREMENT

QGMS/QS-APQP 17
Why Plan
 Identify ways to improve  Continual improvement

 Means for tracking and  Reduction in time cycle by up


checking front planning

 Contingency Planning  Better communication

 Anticipate problems in advance  Do it right first time


Many project we  On time outputs
accomplished in day to
day
QGMS/QS-APQP 18
What gets in the way of planning
• Lack of management • Personal egos
commitment • Lack of team spirit
• Lack of discipline • Adhock approach
• Time management issues
• Lack of knowledge
• Unclear priorities
• Lack of resources
• Unclear responsibilities
• Unclear directions
• Lack of accountability
• Lack of faith in systematic • Non-competitive operating
approach environment

QGMS/QS-APQP 19
APQP
• APQP is project , related to product Design to manufacturing ( project
planning & execution)
• APQP is a integral part of TS requirement – clause 7
• Organizations requirement , not a customer requirement but we will
implement as per customer’s guideline (if any), Customer specific
requirement.
• Organizations will implement as per AIAG Manual or customized way,
own way. Format are given only for reference only
• APQP is a process, process required Input and Output (results),
Objectives & continual improvements
• We will discuss in simplest way – transform technical word in the our way
of working
• APQP is a flexible process, is a customer style , not a rigid, fixed.
• APQP comprised with 05 individual subject matter & AIAG Manuals
• > APQP Manual > MSA Manual
• > SPC Manual > PPAP
• > FMEA
What is Quality Planning
• Product Quality Planning is a structured method of defining
and establishing the steps necessary to assure that a
product satisfies the Customer requirements.
• It’s a P-D-C-A Approach
• APQP – project planning started since conceptualization of
product .
• In your case – these stages are not applicable – we are not
designing any product , we develop the product as per
customer design / drawing / specification
• Customer wise – rewording, additional requirement
QGMS/QS-APQP
Objectives of APQP

Some of the bottom line goals of product quality


planning are...
• effective communications with all those who are involved
in the implementation scheme.
• timely completion of required goals.
• No quality problems.
• Minimal risks related to quality during product launch.
More technical word, not able to digest in a certain training time, If few word
not in network range or in daily use – don’t stress, don’t worry . Could be
became simple in future ….career..
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Advanced Product Quality
Planning requires ..
• Total integration of quality tools with management functions
• Multi-disciplinary team approach to quality planning
• It not only to meet requirements , should exceed customer
requirements
• To promote early identification of required changes
• To avoid late changes
• To provide a quality product on time at the lowest cost
• Facilitate communication with everyone involved
• Developing easily understandable formats for use.

QGMS/QS-APQP 23
Fundamentals of Product Quality
Planning
• Organize the team - Multi-disciplinary team from Engineering, Manufacturing,
Quality, Materials, Sales, Service, Sub-contractors and Customers
• Define the Scope - Team Leader, Roles and Responsibilities, Customer (Internal /
External), Customer Requirements, Additional Members, Cost , Timings,
Constraints, Customer Assistance & documentation.
• Team-To-Team - Establish line of communication with customer team and other in-
house teams & responsibility of communication
• Training - Identifications and organizing for providing training
• Customer and Supplier Involvement - Identification of issues needs interaction
with customer / sub-contractor and resolution
• Timing plan and sub plan
• Decide the review frequency with CFT member
• Support where lacking the time plan
• Responsible person should inform , if chances of lacking

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QGMS/QS-APQP
Fundamentals of Product
Quality Planning (Cont’d.)
• Simultaneous Engineering - A process where CFT strive for a common
goal and executing related activities parallel & met the common time line.
• Control Plans - Prototype, pre-launch and production
• Concern Resolution - Documenting, responsibility assigned. Use of
disciplined problem solving method in difficult situations
• Product Quality Timing Plan - Developing activity plan for all activities.
Review of activities and corrective actions
• Plans Relative to the Timing Chart - Sub plans for associated activities!
Simultaneous Engineering : Concurrent engineering is a method by
which several teams within an organization work simultaneously to
develop new products and services.
QGMS/QS-APQP 25
Phases of APQP
They include...
• Plan and define the program
• Product design and development
• Process design and development
• Product and process validation
• Feedback assessment and corrective action

QGMS/QS-APQP 26
Product Quality Planning Timing Chart

• When is APQP appropriate?


• For development of new product
• Incorporating changes in the product

QGMS/QS-APQP

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APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design and Product and Feedback,
Development Development Process Assessment and
Validation Corrective Action

OUTPUT

OUTPUT

OUTPUT

OUTPUT

OUTPUT
INPUT

INPUT

INPUT
INPUT

INPUT
• Organize the Team • Voice of the • Design Goals • Design Failure Mode • Packaging Standards • Production Trial Run • Reduced Variation
Customer and Effects Analysis
• Define the Scope • Reliability and • Product/Process Quality • Measurement • Customer Satisfaction
(DFMEA)
• Business Quality Goals System Review Systems Evaluation
• Establish Team-to- • Delivery and Service
Plan/Marketing • Design for
Team Communication • Preliminary Bill of • Process Flow Chart • Preliminary Process
Strategy Manufacturability and
Material Capability Study
• Provide Core Tools Assembly • Floor Plan Layout
• Product/Process
Training • Preliminary Process • Production Part
Benchmark Data • Design Verification • Characteristics Matrix
Flow Chart Approval
• Involve Customers
• Product/Process • Design Reviews • Process Failure Mode
and Suppliers • Preliminary Listing of • Production Validation

MSA
Assumptions and Effects Analysis
Special Product and • Prototype Build – Testing
• Implement (PFMEA)
• Product Reliability Process Characteristics Control Plan
Simultaneous • Packaging Evaluation
Studies • Pre-Launch Control
Engineering • Product Assurance • Engineering Drawings
Plan • Production Control
• Customer Inputs Plan (Including Math Data)
• Develop Control Plan Plan
• Process Instructions
Format • Management Support • Engineering
• Quality Planning
Specifications • Measurement Systems
• Decide on Concern Sign-Off and
Analysis Plan
Resolution • Material Specifications Management Support
• Preliminary Process
• Develop Product • Drawing and
Capability Study Plan
Quality Timing Plan Specification Changes
• Packaging Specifications

PPAP
• New Equipment,
Tooling and Facilities • Management Support
Requirements
• Special Product and
Process Characteristics

FMEA • Gages/Testing
Equipment Requirements
• Team Feasibility

SPC
Commitment and
Management Support

APQP 28
Customized requirements -APQP
• Product Design & Development : a project start right from Vehicle concept and
subsequent part
• Concept model , Horse power , BHP, Fuel efficiency/ mileage, speed, sitting
capacity .
• Design through the use of Engineering Software and Calculation for all the
parts and Engines and complete vehicles
• Simulates the ‘Design Calculation’ through Simulation Software and Review
the Design & change the Design where ever required.
• Finalyse Drawing and approve Drawing / Design
• Prepare a Model – Prototype – Use of Off tooling and machines
• Validation and Verification , review & Changes , if required
• Final Drawing / Design - Child parts & Vehicles
• Process Design & Development : Receive Drawing from Customer & initiates
• CFT , Drawing Review, Feasibility study , Risk assessment , Contract review
• Timing Chart , Responsibility, Project Review schedule.
• Tool , Mould, Fixture, Gauge, Supplier Development
• Floor plan, Machine plan, PPAP submission and date and Approval.
Phase -01

Planning and defining


the program

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Phase -01
Planning and defining the program
Prepare for Plan and Define Program Product Design Process Design Product and Feedback,
APQP Or and Development and Process Assessment and
Fundamentals for Development Validation Corrective Action
Product Quality
planning

OUTPUT
INPUT

• Organize the • Voice of the • Design Goals


Team Customer
• Reliability and
• Define the • Business Quality Goals
Scope Plan/Marketing
• Preliminary
Strategy
• Establish Bill of Material
Team-to-Team •
• Preliminary
Communication Product/Process
Process Flow
Benchmark Data
• Provide Core Chart
Tools Training •
• Preliminary
Product/Process
• Involve Listing of
Assumptions
Customers and Special Product
Suppliers • Product and Process
Reliability Characteristics
• Implement
Studies
Simultaneous • Product
Engineering • Customer Assurance Plan
Inputs
• Develop • Management
Control Plan Support
Format
• Decide on
Concern
Resolution
• Develop
Product Quality
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Timing Plan
QGMS/QS-APQP 32
Planning and defining the program

This stage is designed to ensure that customer needs & expectations


are clearly understood. The input of this phase is furnished by the
contract review for full service suppliers.
Inputs : Example for a Vehicle Launch
• Voice of Customers : End User requirement / complaints, which Segments to target, Cost , speed, Mileage
• Business Plan / Marketing Strategy : Could be a Brand image
• Product / Process Benchmark Data
• Product / process assumptions
• Product Reliability Studies
• Customer Inputs

Organization can consider this phase of APQP equivalent to Design and


Development Planning and Design Input in ISO/TS 33
Planning and defining the program

Outputs Include : Output of the Planning phase are :


• Design goals
• Reliability & Quality Goals
• To prepare Preliminary bill of material
• Preliminary process flow chart
• Preliminary listing of special product and process characteristics
• Product assurance plan
• Management Support

Final Goal of Design is similar as a Goal of Process Development ,


During Design -take care for manufacturing also
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Notes : to participants help, if required
Reliability is … the ability or capability of the product to perform the specified function in the designated
environment for a minimum length of time or minimum number of cycles or events.
Note this definition has four elements:
• Function • Environment • Duration • Probability

## A Example of well stated reliability goal is : MTBF, “as good as or better than…” or ‘a 5 year product’.
“Reliability (MTBF) is time based specification but under some circumstances. So Reliability is quality
over a period of time”
Durability - Degree to which it can bear stresses and environmental factors without failure. Example -
Watch - 2points - water resistant and shock resistant, Example - one man arrowed exactly on target , do
come other work and then again arrowed but now position was not in centre. i.e.
“durability issue not reliability. Durability is not time based specification , Basically this is condition
based requirement.”
Maintainability ( MTTR ) - Probability that a device has failed or functioning abnormality and it will be
restored back to its operational efficiency within a a given time period.
Examples - projector fail every month but repair time is 2 minutes, other case projector fail once / year
and repair time is 7 days. 1st case reliability is poor but maintainability was ok & 2nd case is reverse.
NASA needs only reliability.

A product assurance plan is just the overall planning you do for inspection and test coupled with any
appropriate process controls. Typically this information goes in the control plan and in part is derived from
the Process FMEA. Many times some things are passed down to work instructions .
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Plan and Define

• Describes how to determine customer needs and


expectations
• All work done with customer in mind for providing
better product / service than competitor

• VOICE OF THE CUSTOMER


• Encompasses complaints, recommendations, data and
information obtained from Internal or External customers

QGMS/QS-APQP 36
Plan and Define (Cont’d.)

• MARKET RESEARCH
• Team obtains data and information reflecting the voice of customer
to identify concerns, wants for translating into product process
characteristics. Can be in the form of
• Customer interviews
• Customer questionnaire and surveys
• Market test and positioning reports
• New product quality and reliability studies
• Competitive product quality studies
• Things Gone Right (TGR) reports

QGMS/QS-APQP 37
Plan and Define (Cont’d.)

HISTORICAL WARRANTY AND QUALITY INFORMATION


 List of historical customer concerns / wants to assess the potential
for recurrence during design, manufacture, installation and use. The
following item can be used:
 Things Gone Wrong (TGW) reports
 Warranty reports
 Capability indicators
 Organization’s internal Corrective actions & Quality problems
 Internal quality reports
 Problem resolution reports
 Customer plant returns and rejections
 Field return product analysis
QGMS/QS-APQP 38
Plan and Define (Cont’d.)
TEAM EXPERIENCE
 The team may use other source of information such as:
 Input from higher system level or past Quality Function Deployment (QFD) projects
 Customer letters and suggestions
 TGR / TGW reports
 Dealer comments
 Field service reports
 Internal evaluations using surrogate customers
 Management comments or direction
 Problems and issues reported from internal customers
 Government requirements and regulations
 Contract review

QGMS/QS-APQP 39
Notes : to participants help, if required
Quality Function Deployment (QFD) is a structured approach to defining
customer needs or requirements and translating them into specific plans to
produce products to meet those needs.
The "voice of the customer" is the term to describe these stated and unstated
customer needs or requirements. The voice of the customer is captured in a
variety of ways: direct discussion or interviews, surveys, focus groups, customer
specifications, observation, warranty data, field reports, etc. This understanding of
the customer needs is then summarized in a product planning matrix or "house of
quality". These matrices are used to translate higher level "what's" or needs into
lower level "how's" - product requirements or technical characteristics to satisfy
these needs.
S.No. Customer Requirements Engineering Part Characteristics/system
Characteristics
1 Easy to store Accessible location ERP system in store, Location
decided
Easy to Handle Gripping, lifting, Part dimension
Maintenance Free Compact design Factor of safety
Reusable, recycle QGMS/QS-APQP
Use of material Material specification 40
Plan and Define (Cont’d.)
BUSINESS PLAN / MARKETING STRATEGY
 Customer business plan and marketing strategies will set the frame
work for APQP. Issues like timing, cost, investment, product
positioning, R&D may put constraints. The marketing strategies will
define the target customer, key sales point and key competitors
PRODUCT / PROCESS BENCHMARK DATA
 Benchmarking provides input for product / process performance
targets. R&D may provide benchmark and concept ideas. Methods
to successful benchmarking are:
 Identify appropriate benchmark
 Understanding the reasons for gap between current status and the benchmark
 Develop a plan to either close the gap, match the benchmark or exceed the
benchmark
Positioning is also defined as the way by which the marketers attempt to create a distinct
impression in the customer's mind; specifically, "the place a product, brand, or group
of products occupies in consumers' minds relative to competing offerings". 41
Plan and Define (Cont’d.)

PRODUCT / PROCESS ASSUMPTION


 Certain assumptions about product feature, design or process
concept become inputs for planning. These includes:
 Technical innovations
 Advanced Materials
 Reliability assumptions and
 New Technology
PRODUCT RELIABILITY STUDIES
 Data related to frequency of repair, replacement of components
within specified period, long term reliability / durability tests

QGMS/QS-APQP 42
Plan and Define (Cont’d.)

CUSTOMER INPUTS
 User of product provides valuable information relating to the needs and
expectations of customers.
 Additionally, user may have conducted various studies and reviews on
the product.
DESIGN GOALS
 A translation of the voice of customer into tentative and measurable
design objectives. Assures that voice of customer is not lost
RELIABILITY AND QUALITY GOALS
 Reliability goals are established based on customer wants and
expectations, programe objectives and reliability benchmarks.
 Quality goals are targets based on continual improvement

QGMS/QS-APQP 43
Plan and Define (Cont’d.)

PRELIMINARY BILL OF MATERIAL


• To prepare a bill of material based on product / process assumptions and early
sub-contractors list
PRELIMINARY PROCESS FLOW CHART
 To prepare a pre. Process flow chart
PRELIMINARY LISTING OF SPECIAL PRODUCT & PROCESS
CHARACTERISTICS
 Customer and team identify based on knowledge of product and process. List
could be developed from
 Based on Product assumptions, analysis of customer needs and expectations
 Based on Identification of reliability goals / requirements
 Based on Identification of special process characteristics from the anticipated
manufacturing process
 Consider the ‘similar part FMEAs’ if any

QGMS/QS-APQP 44
Plan and Define (Cont’d.)

PRODUCT ASSURANCE PLAN


 Translate design goal into design requirements. Should include:
 Outlining of program requirements
 Identification of reliability, & durability
 Assessment of new technology, complexity, materials, application, environment,
packaging, service and manufacturing requirements or any other factor that may place
the program at risk
 Development of Failure Mode Analysis (FMA)
 Development of preliminary engineering standards requirements
MANAGEMENT SUPPORT
 One of the key to the APQP teams success is interest, commitment and support
of top management. Team should update management at the conclusion of every
product quality planning phase.

QGMS/QS-APQP 45
Plan and Define –TS Requirements

 TS Requirement :
 7.2.1 : Determination of requirement related to the product
 7.2.2
 7.3.1 - Design & Development Planning
 6.2.2 – Competence , Training & Awareness
 5.4.1.1 – Quality Objective

QGMS/QS-APQP 46
Phase -02
Product Design &
Development
a. Product Design
b. Product Development

47
Product Design & Development
• Product design & Development - a one word
• Design is the act of planning and creating artistically i.e.
• mathematically calculation We discussed if
• by use of design software previous slides
• Design prepares a preliminary sketch of the form and function of
something, Mathematically Data
• Development - makes the calculated design parameters into the
functional, prototype , or Model
• A developer will work within the design framework and actually
create the functional elements.
• Many Organization are implemented Product Design &
development along with Process Design & development
QGMS/QS-APQP 48
Product Design & Development
Product
Design & Development Input s Design – Clause 7.3.2

• Functional and Performance requirements


• Applicable Statutory & Regulatory requirements
• Information derived from Previous Similar design
• Other essential requirement for Design & Development
• Customer Specific requirement - Contract review – special
characteristics, identification, Traceability & Packaging.
• Supplier input, Field Data, Competitor analysis
• Target for conformity to product requirement, Life, Reliability,
Durability, maintainability, Timing & cost, durability -the ability to withstand
wear, pressure, or damage Requirement shall be completed & review prior to use.
QGMS/QS-APQP
Product Design & Development
This area encompasses a thorough review of product design (engineering) requirements and
concludes with a sign-off on the design reliability
Outputs by Design Responsible Activity
• Design failure mode and effects analysis
• Design for manufacturing and assembly Product Design
• Design verification & Validation
• Design reviews
• Prototype build-control plan
• Engineering drawings (including math data) Detail of each in
• Engineering specifications & Material Specifications Subsequent Slides
• Drawing and specification changes
Outputs by Advanced Product Quality Planning Team
• New equipment, tooling and facilities requirements
• Consensus on key/critical product and process characteristics? Responsibility
for each item
• Gages/testing equipment requirements
• Team feasibility commitment and management support
QGMS/QS-APQP
Product Design and Development
• Organization Manufacturing Feasibility : Feasibility study is carried out during the
product design stage in view of safety , manufacturing & cater to customer .
• Feasible design includes the following :
TS Clause – 7.2.2.2
• production volumes,
• ability to meet engineering requirements with quality,
• reliability, Safety
• investment cost,
• weight, unit cost and timing and objectives
• Design planning process to assure comprehensive and critical review
• To conduct Risk analysis – consider Quality , Safety & Environments

Note : Team Feasibility is required for Product D&D and process D&D
51
Team Feasibility

98
QGMS/QS-APQP 52
Critical Design Review (CDR):The CDR demonstrates that the
maturity of the design is appropriate to support proceeding with full-
scale fabrication, assembly, integration, and test. CDR determines that
the technical effort is on track to complete the development and
operations, meeting mission performance requirements within the
identified cost and schedule constraints.
The following are typical objectives of a CDR:
Ensure that the "build-to" baseline contains detailed hardware and
software specifications that can meet functional and performance
requirements
Ensure that the design has been satisfactorily audited by production,
verification, operations, and other specialty engineering organizations
Ensure that the production processes and controls are sufficient to
proceed to the fabrication stage
Establish that planned Quality Assurance (QA) activities will establish
perceptive verification and screening processes for producing a quality
product
Verify that the final design fulfills the specifications established at PDR
QGMS/QS-APQP 53
Product Design and Development
 Design Failure Mode and Effect Analysis - DFMEA
 A disciplined analytical technique to assess the probability of
failure and effect of such failures
 DFMEA provides an opportunity to review the previously
selected process and product characteristics. Make
necessary additions, changes and deletion
 Use DFMEA checklist to assure appropriate design
characteristics are considered
01 Separate session
QGMS/QS-APQP 54
Product Design and Development
 Design for Manufacturability and Assembly
 DFMA is a simultaneous engineering process to optimize the
relationship between design function, manufacturability and ease
of assembly
 The scope of customer needs and expectations determine the
extent of the activity. The following shall be considered:
 Design, concept, function and sensitivity to manufacturing variation
 Manufacturing and / or assembly process
 Dimensional tolerances
 Performance requirements
 Number of components
 Process adjustments
 Material Handling
 Teams knowledge, experience, the product / process, government regulations
and service requirements are other factors
QGMS/QS-APQP 55
Product Design and Development
 Design Verification
 Verifies that product design meets the customer requirements
 Design Review
 Regularly scheduled meeting led by design engineering activities
and must include other affected area
 An effective method to prevent problems, misunderstandings and
provide mechanism to monitor progress
 Design reviews are a series of verification activities that are more
than an engineering inspection

QGMS/QS-APQP 56
•Verification and validation are independent procedures that are used
together for checking that a product, service, or system
meets requirements andspecifications and that it fulfills its intended
purpose
Verification :
Verification is intended to check that a product (or portion thereof)
meets a set of design specifications. To verify the Design specification-
strength , Dimension,
• verification procedures involve performing special tests to model or
simulation
• In the post-development phase, verification procedures involve
regularly repeating tests devised specifically to ensure that the product,
service, or system continues to meet the initial design requirements,
specifications, and regulations as time progresses
Validation :
Validation means endurance test – Test for actual condition ,Road test,
Mud test , SST
Validation is intended to ensure a product, service, or system (or portion
thereof, or set thereof) result inQGMS/QS-APQP
a product, service, or system (or portion 57
thereof, or set thereof) that meets the operational needs of the user
Product Design and Development
 Design Review (Contd.)
 Shall evaluate
 Design / Functional requirement(s) considerations
 Formal reliability and confidence goals
 Component / subsystem / system duty cycles
 Computer simulation and bench test results
 DFMEA(s)
 Review of the Design for Manufacturability and Assembly effort
 Design of Experiments (DOE) and assembly build variation results (Refer
to Appendix B)
 Test failures
 Design Verification progress
 A major function of design review is the tracking of design verification
progress
QGMS/QS-APQP 58
Product Design and Development
 Engineering Drawings
 Customer design do not preclude the responsibility to review the
following in the engineering drawings
 Special characteristics (Governmental, Regulatory and Safety)that must
be shown on the control plan
 In case customer drawings do not exist, review which characteristic affect
fit function durability and/or governmental, regulatory and safety
requirements
 Drawing should be reviewed to determine
• adequacy of informations for dimensional layout of the individual part
• control / datum services / locators clearly identified
• dimensional evaluation to assure feasibility and compatibility with
manufacturing and measuring standards
• In case of math data, it has two way communication compatibility
QGMS/QS-APQP 59
Product Design and Development
 Engineering Specifications
 Specification review helps to identify functional durability and
appearance requirements
 Sample size frequency and acceptance criteria generally
identified in the specifications otherwise establish in the control
plan
 Determine which characteristics affect or control the results that
fulfill functional durability and appearance requirements
 Material Specifications
 Material specifications should be reviewed for special
characteristics relating to physical properties, performance,
environmental, handling and storage requirements
 These characteristics should be included in control plan
QGMS/QS-APQP 60
Product Design and Development
 Drawing and Specification Changes
 Where changes required in drawings & specifications, team must
ensure that the changes are
 promptly communicated to all affected areas and properly
documented
 New Equipment, Tooling and Facilities Requirements
 DFMEA, product assurance plan, design reviews may identify new
equipments and facilities requirements
 Should address the items in the timing chart
 Ensure new equipment, tooling is capable and delivered on time
 Facilities progress should be monitored to assure completion before
the production tryout

QGMS/QS-APQP 61
Product Design and Development
 Special Product and Process Characteristics
 Preliminary special characteristics identified through voice of
customer
 Team should build on this listing and reach consensus during the
review and development
 Special characteristics must be documented in the control plan
 Gauge / Testing Equipment Requirements
 Gauge / Testing equipment requirements is also identified and
added in the timing chart
 Monitor progress to assure the meeting of required timings
QGMS/QS-APQP 62
Product Design and Development
 Team Feasibility Commitment and Management Support
 Team must assess feasibility of the proposed design
 Customer design ownership does not preclude the obligation to
assess design feasibility
 Team must be satisfied that the proposed design can be
manufactured, assembled, tested, packaged and delivered in
sufficient quantity at an acceptable cost to the customer on
schedule
 Design feasibility should be documented along with all open
issues that require resolution and presented to the management
for their support
QGMS/QS-APQP 63
Product D&D –TS Requirements

 TS Requirement :
 7.3.2.1 - Product Design Input
 7.3.2.3 – Special Characteristics
 7.3.3.1 – Product Design Output
 7.3.4 – Design & Development Review
 7.3.5 - Design & development Verification
 7.3.6 - Design & development validation

QGMS/QS-APQP 64
Phase -03
Process Design &
Development
a. Process Design
b. Process Development

65
Fundamentals of Product Quality
Planning
• Organize the team - Multi-disciplinary team from Engineering, Manufacturing,
Quality, Materials, Sales, Service, Sub-contractors and Customers
• Define the Scope - Team Leader, Roles and Responsibilities, Customer (Internal /
External), Customer Requirements, Additional Members, Cost , Timings,
Constraints, Customer Assistance & documentation.
• Team-To-Team - Establish line of communication with customer team and other in-
house teams & responsibility of communication
• Training - Identifications and organizing for providing training
• Customer and Supplier Involvement - Identification of issues needs interaction
with customer / sub-contractor and resolution
• Timing plan and sub plan
• Decide the review frequency with CFT member
• Support where lacking the time plan
• Responsible person should inform , if chances of lacking

66
QGMS/QS-APQP
Process Design and Development
Introduction
• This section discusses the major features of developing a
manufacturing system and its related control plans to achieve
quality products
• The manufacturing system must assure that customer
requirements, needs and expectations are met
• Product Design and Development output are used as Input
for Process D & D
• Used CSR as a Input requirements – CSR Manual
QGMS/QS-APQP 67
Process Design and Development
Inputs : Derived from output of previous chapter (Product D&D)
• DFMEA
• Design Verification
• Design Review
• Prototype - Control Plan
• Engineering Drawing & spec change
• Engineering Specification
• Material Specification
• Design for manufacturability & assy.
• New equipment, Tooling and facilities requirement
• Special Product & process Characteristics
• Gauge / Testing equipment Requirements
• Team Feasibility Commitment & management Support

QGMS/QS-APQP 68
Process Design and Development
Outputs :
• Process Flow chart
• Floor plan layout
• Characteristic Matrix – relation between Process parameters & Operations
• PFMEA
• Product & process Quality System review
• Process Instruction
• Pre Launch Control Plan
• MSA Plan
• Preliminary Process capability Study Plan
• Packaging Standards & Specification
• Training Plan & management Support

QGMS/QS-APQP 69
Activities & Timings are depends
on..

Supplier
Tool in house or Outsource

QGMS/QS-APQP 70
Process Design and Development
 Process Flow Chart
 Process flow chart is a schematic representation of current /
proposed process flow
 Used to analyze sources of variation of machines, materials,
methods and manpower from the beginning to end
 Used to emphasize impact of sources of variation on the
processes
 Help to analyze the total process rather than individual steps
 Assist to focus on process when conducting PFMEA and
designing control plan
QGMS/QS-APQP 71
Process Design and Development
 Process Failure Mode and Effects Analysis (PFMEA)
 Should be conducted during product planning and before
beginning production.
 A disciplined review and analysis of a new / revised process and
conducted to anticipate, resolve, or monitor potential process
problems.
 Is a living document and needs to be reviewed and updated as
new failure modes are discovered

Refer AIAG FMEA Manual – 4th Edition


01 Day Training Session 72
QGMS/QS-APQP
Process Design and Development
 Pre-launch Control Plan
 A description of the dimensional measurements, material and
functional tests that will occur after prototype and before full
production. Should include additional product / process controls to
be implemented until the production process is validated. The
purpose is to contain potential non-conformances during or prior
to initial production runs. Examples
 More frequent inspection
 More in-process and final check points
 Statistical evaluations
 Increased audits

QGMS/QS-APQP 73
Process Design and Development
 Floor Plan Layout
 The Floor Plan should be developed and reviewed to determine
the acceptability of inspection points, control chart location,
applicability of visual aids, interim repair stations, and storage
areas to contain defective material.
 All material flow should be keyed to the process flow chart and
control plan. – Consider to avoid mixing, ergonomic, optimize
material travel
 Characteristics Matrix
 Recommended analytical technique for displaying the relationship
between process parameters and manufacturing stations
QGMS/QS-APQP 74
Process Design and Development
 Process Instructions / WI /OPS/PQCS
 Ensure that understandable process instructions, provide
sufficient detail for all operating personnel who have direct
responsibility for the operation of the processes. These should be
developed from the following sources:
 FMEAs and Control plan(s)
 Engineering drawings, performance specifications, material specifications,
visual standards and industry standards
 Process flow chart
 Floor plan layout
 Characteristics matrix
 Packaging standards

QGMS/QS-APQP 75
Process Design and Development
 Process Instructions (Contd.)
 Process parameters –OPS/ PQCS
 Handling requirements
 Operators of the Process
 Should include set-up parameters such as: machine speeds,
feeds, cycle times, etc., and should be accessible to the operators
and supervisors.

QGMS/QS-APQP 76
Process Design and Development

 Measurement Systems Analysis Plan


 Ensure that a plan to accomplish the required measurement
systems analysis is developed. This should include, at a
minimum; the responsibility to ensure gage linearity,
accuracy, repeatability, reproducibility. Correlation for
duplicate gages

AIAG Manual – Edition -04


TS Standards – Clause :7.6.1
QGMS/QS-APQP 77
Process Design and Development

 Preliminary Process Capability Study Plan


 Ensure the development of a preliminary process capability
plan. The characteristics identified in the control plan will
serve as the basis for the preliminary process capability study
plan.

AIAG Manual – SPC, Edition -02


TS Standards – Clause : 8.1.1- Identification of Statistical
Tools, 8.2.3.1- Monitoring & measurement of manufacturing processes
QGMS/QS-APQP 78
Process Design and Development
 Packaging Specifications
Ensure that individual product packaging (including interior
partitions) is designed and developed.
 Customer packaging standards or generic packaging
requirements should be used when appropriate.
 In all cases the packaging design must assure that the
product performance and characteristics will remain
unchanged during packing, transit and unpacking.
The packaging should have compatibility with all material
handling equipment including robots
 Refer CSR for Packaging
QGMS/QS-APQP 79
Process Design and Development
 Packaging Standard
 Incorporate customer packaging standard into packaging
specifications for the product. If not provided packaging design
should ensure product integrity at point of use
 Product / Process Quality System Review
 Team should review the quality system. Additional controls /
procedural changes should be updated. Also an opportunity to
improve the existing quality system based on customer input,
team expertise, previous experience

QGMS/QS-APQP 80
Process Design and Development
 Management Support
 Management Feed and Support - Resources

QGMS/QS-APQP 81
Activities & Timings are depends
on..

Supplier
Tool in house or Outsource

QGMS/QS-APQP 82
Phase -04
Product and Process
Validation

83
Product and Process Validation
 Introduction
 This section discusses the major features of validating the
manufacturing process through an evaluation of a
production trial run. During a production trail run, the
Product Quality Planning Team should validate that the
control plan and process flow chart are being followed and
the products meet customer requirements. Additional
concerns should be identified for investigation and resolution
prior to regular production runs.
 Out of Process Design and Development phase should be
used as Inputs

QGMS/QS-APQP 84
Product and Process Validation
 Production Trial Run
 The validation of the effectiveness of the manufacturing
process begins with the production trial run. The minimum
quantity for a production trial run is usually set by the
customer but can be exceeded by the Product Quality
Planning Team. Output of the production trial run (product) is
used for:
 Preliminary process capability study
 Measurement system evaluation
 Final feasibility, if gap any
 Process review
 Production validation testing
 Production part approval –PPAP Manual Documents & submission
 Packaging evaluation
 First time capability (FTC)
 Quality Planning sign-off
QGMS/QS-APQP 85
Product and Process Validation
 Production Trial Run (Contd.)
 Conduct Trial Run by using:
 Production Tooling
 Equipment
 Environment
 Operators
 Facilities
 Cycle Time

QGMS/QS-APQP 86
Product and Process Validation
 Measurement Systems Evaluation
 Evaluate the measurement devices and methods used to
check the characteristics specified in the Control Plan
 Preliminary Process Capability Study
 Perform preliminary process capability studies on the
characteristics specified in the control plan (Preliminary
process capability study plan). This assessment help to
evaluate process readiness for production

QGMS/QS-APQP 87
Product and Process Validation
 Production Part Approval
 The intent of product part approval is to validate that products
made from production tools and processes, meets
engineering requirements.
 Production Validation Testing
 Production validation testing refers to engineering tests that
validate that products made from production tools and
processes meet engineering standards.

QGMS/QS-APQP 88
Product and Process Validation
 Packing Evaluation
 Assess the protection of the product from normal
transportation damages and adverse environmental factors.
Use test shipments & methods where feasible
 Production Control Plan
 A written description of the systems for controlling parts and
processes.
 A living document and should be updated to reflect the
addition / deletion of controls based on experience gained by
producing parts (Approval of the procuring organization(s)
may be required).
 Logical extension of the pre-launch control plan.
 Mass production provides the producer the opportunity to
evaluate output, review the control plan and make
appropriate changes.
QGMS/QS-APQP 89
Product and Process Validation
 Quality Planning Sign-off and Management Support
 Ensure that all control plans and process flow charts are
being followed. It is suggested that the Product Quality
Planning Team performs its review at the manufacturing
location(s) and coordinates a formal sign-off. A review of the
following items prior to first production shipment is required:
 Control Plans. Exist and be available at all times for all affected
operations
 Process Instructions. Verify that these documents contain all the
Special Characteristics specified in the control plan and that all
PFMEA recommendations have been addressed. Compare the
process instructions and process flow chart to the control plan
 Gage and Test Equipment. Where special gages, fixtures, or test
equipment are required per the control plan, verify gage repeatability
and reproducibility (GR&R) and proper usage
QGMS/QS-APQP 90
Product and Process Validation
 Quality Planning Sign-off and Management Support (Contd.)
 Management support is necessary prior to the quality planning
sign-off.
 The team should be able to show that all planning requirements
are met or concerns documented and schedule a management
review.
 The purpose of this review is to inform upper management of
program status and gain their commitment to assist in any open
issues.
 The Product Quality Planning Summary and Sign-Off required to
support an effective quality planning sign-off
QGMS/QS-APQP 91
Phase -05
Feedback,
Assessment and
Corrective Action

92
Feedback, Assessment and
Corrective Action
 Introduction
 Quality planning does not end with process validation and
installation
 It is the component manufacturing stage where output can be
evaluated when all special and common causes of variation are
present
 This is also the time to evaluate the effectiveness of the product
quality planning effort
It is the obligation of all suppliers to meet customer requirements
on all characteristics. Special Characteristics must meet the
indices specified by the customer
 Inputs & outputs of all previous phases used as inputs
QGMS/QS-APQP 93
Feedback, Assessment and
Corrective Action
 Reduced Variation
 Use Production Control Plan as the basis to evaluate product
or service. Use both variable and attribute data for evaluation
 Supplier must ensure that
 All characteristics meeting the requirements
 Special characteristics meet the indices specified by the customer
 Use control chart and other statistical technique to identify
process variation
 Use analysis and corrective actions to reduce variation
 Reduce continually variation because of special causes and
common causes
 Develop proposal for improvement in cost, timing and other
area for customer review
QGMS/QS-APQP 94
Feedback, Assessment and
Corrective Action
 Reduced Variation (Contd.)
 Reduction / Elimination of common cause results into lower
cost
 Prepare proposal based on value analysis, reduction of
variation
 Decisions to implement, negotiate or progress to the next
product design level is customer prerogative

QGMS/QS-APQP 95
Feedback, Assessment and
Corrective Action
 Customer Satisfaction
 Detailed planning activities and demonstrated process capability
of a product or service do not always guarantee customer
satisfaction. The product or service must perform in the customer
environment. The product usage stage requires supplier
participation. It is in this stage where the most can be learned by
both the supplier and customer. The effectiveness of the Product
Quality Planning efforts can be evaluated in this stage. The
supplier and customer must be partners in making the changes
necessary to correct deficiencies to achieve customer satisfaction

QGMS/QS-APQP 96
Feedback, Assessment and
Corrective Action
 Delivery and Service
 The delivery and service stage of quality planning continues the
supplier / customer partnership in solving problems and continual
improvement. The customer’s replacement parts and service
operations always merit the same consideration in quality, cost
and delivery. Failure to correct a problem the first time always
damages the supplier’s reputation and customer partnership. It is
important that both supplier and customer listen to the Voice of
the Customer
 The experience gained in this stage provides the customer and
supplier with the necessary knowledge to recommend price
reductions achieved by reducing process, inventory and quality
costs and to provide the right component or system for the next
product

QGMS/QS-APQP 97
PRODUCT QUALITY PLANNING RESPONSIBILITY MATRIX
Service organization .i.e. heat
Design Manufacturing
Phase treatment, warehousing,
Responsibility only
transportation
Define the Scope
O O O

Plan and Define program 1.0


O
Product Design and Development 2.0
O
Feasibility section 2.13
O O O

Process Design and development 3.0


O O O
Product and Process validation 4.0
O O O
Feedback assessment and corrective action 5.0
O O O

Control plan Methodology


O O O
98
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design and Product and Feedback,
Development Development Process Assessment and
Validation Corrective Action

99
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

• Organize the Team


• Define the Scope
• Establish Team-to-
Team Communication
• Provide Core Tools
Training
• Involve Customers
and Suppliers
• Implement
Simultaneous
Engineering
• Develop Control Plan
Format
• Decide on Concern
Resolution
• Develop Product
Quality Timing Plan

100
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

INPUT
• Organize the Team • Voice of the
Customer
• Define the Scope
• Business
• Establish Team-to-
Plan/Marketing
Team Communication
Strategy
• Provide Core Tools
• Product/Process
Training
Benchmark Data
• Involve Customers
• Product/Process
and Suppliers
Assumptions
• Implement
• Product Reliability
Simultaneous
Studies
Engineering
• Customer Inputs
• Develop Control Plan
Format
• Decide on Concern
Resolution
• Develop Product
Quality Timing Plan

101
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

OUTPUT
INPUT
• Organize the Team • Voice of the • Design Goals
Customer
• Define the Scope • Reliability and
• Business Quality Goals
• Establish Team-to-
Plan/Marketing
Team Communication • Preliminary Bill of
Strategy
Material
• Provide Core Tools
• Product/Process
Training • Preliminary Process
Benchmark Data
Flow Chart
• Involve Customers
• Product/Process
and Suppliers • Preliminary Listing of
Assumptions
Special Product and
• Implement
• Product Reliability Process Characteristics
Simultaneous
Studies
Engineering • Product Assurance
• Customer Inputs Plan
• Develop Control Plan
Format • Management Support
• Decide on Concern
Resolution
• Develop Product
Quality Timing Plan

102
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

OUTPUT

OUTPUT
INPUT

INPUT
• Organize the Team • Voice of the • Design Goals • Design Failure Mode
Customer and Effects Analysis
• Define the Scope • Reliability and
(DFMEA)
• Business Quality Goals
• Establish Team-to-
Plan/Marketing • Design for
Team Communication • Preliminary Bill of
Strategy Manufacturability and
Material
• Provide Core Tools Assembly
• Product/Process
Training • Preliminary Process
Benchmark Data • Design Verification
Flow Chart
• Involve Customers
• Product/Process • Design Reviews
and Suppliers • Preliminary Listing of
Assumptions
Special Product and • Prototype Build –
• Implement
• Product Reliability Process Characteristics Control Plan
Simultaneous
Studies
Engineering • Product Assurance • Engineering Drawings
• Customer Inputs Plan (Including Math Data)
• Develop Control Plan
Format • Management Support • Engineering
Specifications
• Decide on Concern
Resolution • Material Specifications
• Develop Product • Drawing and
Quality Timing Plan Specification Changes
• New Equipment,
Tooling and Facilities
Requirements
• Special Product and
Process Characteristics
• Gages/Testing
Equipment Requirements
• Team Feasibility
Commitment and
Management Support

103
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

OUTPUT

OUTPUT

OUTPUT
INPUT

INPUT

INPUT
• Organize the Team • Voice of the • Design Goals • Design Failure Mode • Packaging Standards
Customer and Effects Analysis
• Define the Scope • Reliability and • Product/Process Quality
(DFMEA)
• Business Quality Goals System Review
• Establish Team-to-
Plan/Marketing • Design for
Team Communication • Preliminary Bill of • Process Flow Chart
Strategy Manufacturability and
Material
• Provide Core Tools Assembly • Floor Plan Layout
• Product/Process
Training • Preliminary Process
Benchmark Data • Design Verification • Characteristics Matrix
Flow Chart
• Involve Customers
• Product/Process • Design Reviews • Process Failure Mode
and Suppliers • Preliminary Listing of
Assumptions and Effects Analysis
Special Product and • Prototype Build –
• Implement (PFMEA)
• Product Reliability Process Characteristics Control Plan
Simultaneous
Studies • Pre-Launch Control
Engineering • Product Assurance • Engineering Drawings
Plan
• Customer Inputs Plan (Including Math Data)
• Develop Control Plan
• Process Instructions
Format • Management Support • Engineering
Specifications • Measurement Systems
• Decide on Concern
Analysis Plan
Resolution • Material Specifications
• Preliminary Process
• Develop Product • Drawing and
Capability Study Plan
Quality Timing Plan Specification Changes
• Packaging Specifications
• New Equipment,
Tooling and Facilities • Management Support
Requirements
• Special Product and
Process Characteristics
• Gages/Testing
Equipment Requirements
• Team Feasibility
Commitment and
Management Support

104
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

OUTPUT

OUTPUT

OUTPUT

OUTPUT
INPUT

INPUT
INPUT

INPUT
• Organize the Team • Voice of the • Design Goals • Design Failure Mode • Packaging Standards • Production Trial Run
Customer and Effects Analysis
• Define the Scope • Reliability and • Product/Process Quality • Measurement
(DFMEA)
• Business Quality Goals System Review Systems Evaluation
• Establish Team-to-
Plan/Marketing • Design for
Team Communication • Preliminary Bill of • Process Flow Chart • Preliminary Process
Strategy Manufacturability and
Material Capability Study
• Provide Core Tools Assembly • Floor Plan Layout
• Product/Process
Training • Preliminary Process • Production Part
Benchmark Data • Design Verification • Characteristics Matrix
Flow Chart Approval
• Involve Customers
• Product/Process • Design Reviews • Process Failure Mode
and Suppliers • Preliminary Listing of • Production Validation
Assumptions and Effects Analysis
Special Product and • Prototype Build – Testing
• Implement (PFMEA)
• Product Reliability Process Characteristics Control Plan
Simultaneous • Packaging Evaluation
Studies • Pre-Launch Control
Engineering • Product Assurance • Engineering Drawings
Plan • Production Control
• Customer Inputs Plan (Including Math Data)
• Develop Control Plan Plan
• Process Instructions
Format • Management Support • Engineering
• Quality Planning
Specifications • Measurement Systems
• Decide on Concern Sign-Off and
Analysis Plan
Resolution • Material Specifications Management Support
• Preliminary Process
• Develop Product • Drawing and
Capability Study Plan
Quality Timing Plan Specification Changes
• Packaging Specifications
• New Equipment,
Tooling and Facilities • Management Support
Requirements
• Special Product and
Process Characteristics
• Gages/Testing
Equipment Requirements
• Team Feasibility
Commitment and
Management Support

105
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

OUTPUT

OUTPUT

OUTPUT

OUTPUT

OUTPUT
INPUT

INPUT

INPUT
INPUT

INPUT
• Organize the Team • Voice of the • Design Goals • Design Failure Mode • Packaging Standards • Production Trial Run • Reduced Variation
Customer and Effects Analysis
• Define the Scope • Reliability and • Product/Process Quality • Measurement • Customer Satisfaction
(DFMEA)
• Business Quality Goals System Review Systems Evaluation
• Establish Team-to- • Delivery and Service
Plan/Marketing • Design for
Team Communication • Preliminary Bill of • Process Flow Chart • Preliminary Process
Strategy Manufacturability and
Material Capability Study
• Provide Core Tools Assembly • Floor Plan Layout
• Product/Process
Training • Preliminary Process • Production Part
Benchmark Data • Design Verification • Characteristics Matrix
Flow Chart Approval
• Involve Customers
• Product/Process • Design Reviews • Process Failure Mode
and Suppliers • Preliminary Listing of • Production Validation
Assumptions and Effects Analysis
Special Product and • Prototype Build – Testing
• Implement (PFMEA)
• Product Reliability Process Characteristics Control Plan
Simultaneous • Packaging Evaluation
Studies • Pre-Launch Control
Engineering • Product Assurance • Engineering Drawings
Plan • Production Control
• Customer Inputs Plan (Including Math Data)
• Develop Control Plan Plan
• Process Instructions
Format • Management Support • Engineering
• Quality Planning
Specifications • Measurement Systems
• Decide on Concern Sign-Off and
Analysis Plan
Resolution • Material Specifications Management Support
• Preliminary Process
• Develop Product • Drawing and
Capability Study Plan
Quality Timing Plan Specification Changes
• Packaging Specifications
• New Equipment,
Tooling and Facilities • Management Support
Requirements
• Special Product and
Process Characteristics
• Gages/Testing
Equipment Requirements
• Team Feasibility
Commitment and
Management Support

106
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

OUTPUT

OUTPUT

OUTPUT

OUTPUT

OUTPUT
INPUT

INPUT

INPUT
INPUT

INPUT
• Organize the Team • Voice of the • Design Goals • Design Failure Mode • Packaging Standards • Production Trial Run • Reduced Variation
Customer and Effects Analysis
• Define the Scope • Reliability and • Product/Process Quality • Measurement • Customer Satisfaction
(DFMEA)
• Business Quality Goals System Review Systems Evaluation
• Establish Team-to- • Delivery and Service
Plan/Marketing • Design for
Team Communication • Preliminary Bill of • Process Flow Chart • Preliminary Process
Strategy Manufacturability and
Material Capability Study
• Provide Core Tools Assembly • Floor Plan Layout
• Product/Process
Training • Preliminary Process • Production Part
Benchmark Data • Design Verification • Characteristics Matrix
Flow Chart Approval
• Involve Customers
• Product/Process • Design Reviews • Process Failure Mode
and Suppliers • Preliminary Listing of • Production Validation
Assumptions and Effects Analysis
Special Product and • Prototype Build – Testing
• Implement (PFMEA)
• Product Reliability Process Characteristics Control Plan
Simultaneous • Packaging Evaluation
Studies • Pre-Launch Control
Engineering • Product Assurance • Engineering Drawings
Plan • Production Control
• Customer Inputs Plan (Including Math Data)
• Develop Control Plan Plan
• Process Instructions
Format • Management Support • Engineering
• Quality Planning
Specifications • Measurement Systems
• Decide on Concern Sign-Off and
Analysis Plan
Resolution • Material Specifications Management Support
• Preliminary Process
• Develop Product • Drawing and
Capability Study Plan
Quality Timing Plan Specification Changes
• Packaging Specifications
• New Equipment,
Tooling and Facilities • Management Support
Requirements
• Special Product and
Process Characteristics

FMEA • Gages/Testing
Equipment Requirements
• Team Feasibility
Commitment and
Management Support

107
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

OUTPUT

OUTPUT

OUTPUT

OUTPUT

OUTPUT
INPUT

INPUT

INPUT
INPUT

INPUT
• Organize the Team • Voice of the • Design Goals • Design Failure Mode • Packaging Standards • Production Trial Run • Reduced Variation
Customer and Effects Analysis
• Define the Scope • Reliability and • Product/Process Quality • Measurement • Customer Satisfaction
(DFMEA)
• Business Quality Goals System Review Systems Evaluation
• Establish Team-to- • Delivery and Service
Plan/Marketing • Design for
Team Communication • Preliminary Bill of • Process Flow Chart • Preliminary Process
Strategy Manufacturability and
Material Capability Study
• Provide Core Tools Assembly • Floor Plan Layout
• Product/Process
Training • Preliminary Process • Production Part
Benchmark Data • Design Verification • Characteristics Matrix
Flow Chart Approval
• Involve Customers
• Product/Process • Design Reviews • Process Failure Mode
and Suppliers • Preliminary Listing of • Production Validation
Assumptions and Effects Analysis
Special Product and • Prototype Build – Testing
• Implement (PFMEA)
• Product Reliability Process Characteristics Control Plan
Simultaneous • Packaging Evaluation
Studies • Pre-Launch Control
Engineering • Product Assurance • Engineering Drawings
Plan • Production Control
• Customer Inputs Plan (Including Math Data)
• Develop Control Plan Plan
• Process Instructions
Format • Management Support • Engineering
• Quality Planning
Specifications • Measurement Systems
• Decide on Concern Sign-Off and
Analysis Plan
Resolution • Material Specifications Management Support
• Preliminary Process
• Develop Product • Drawing and
Capability Study Plan
Quality Timing Plan Specification Changes
• Packaging Specifications
• New Equipment,
Tooling and Facilities • Management Support
Requirements
• Special Product and
Process Characteristics

FMEA • Gages/Testing
Equipment Requirements
• Team Feasibility
Commitment and
Management Support

APQP 108
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

OUTPUT

OUTPUT

OUTPUT

OUTPUT

OUTPUT
INPUT

INPUT

INPUT
INPUT

INPUT
• Organize the Team • Voice of the • Design Goals • Design Failure Mode • Packaging Standards • Production Trial Run • Reduced Variation
Customer and Effects Analysis
• Define the Scope • Reliability and • Product/Process Quality • Measurement • Customer Satisfaction
(DFMEA)
• Business Quality Goals System Review Systems Evaluation
• Establish Team-to- • Delivery and Service
Plan/Marketing • Design for
Team Communication • Preliminary Bill of • Process Flow Chart • Preliminary Process
Strategy Manufacturability and
Material Capability Study
• Provide Core Tools Assembly • Floor Plan Layout
• Product/Process
Training • Preliminary Process • Production Part
Benchmark Data • Design Verification • Characteristics Matrix
Flow Chart Approval
• Involve Customers
• Product/Process • Design Reviews • Process Failure Mode
and Suppliers • Preliminary Listing of • Production Validation
Assumptions and Effects Analysis
Special Product and • Prototype Build – Testing
• Implement (PFMEA)
• Product Reliability Process Characteristics Control Plan
Simultaneous • Packaging Evaluation
Studies • Pre-Launch Control
Engineering • Product Assurance • Engineering Drawings
Plan • Production Control
• Customer Inputs Plan (Including Math Data)
• Develop Control Plan Plan
• Process Instructions
Format • Management Support • Engineering
• Quality Planning
Specifications • Measurement Systems
• Decide on Concern Sign-Off and
Analysis Plan
Resolution • Material Specifications Management Support
• Preliminary Process
• Develop Product • Drawing and
Capability Study Plan
Quality Timing Plan Specification Changes
• Packaging Specifications
• New Equipment,
Tooling and Facilities • Management Support
Requirements
• Special Product and
Process Characteristics

FMEA • Gages/Testing
Equipment Requirements
• Team Feasibility

SPC
Commitment and
Management Support

APQP 109
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design Product and Feedback,
Development and Process Assessment and
Development Validation Corrective Action

OUTPUT

OUTPUT

OUTPUT

OUTPUT

OUTPUT
INPUT

INPUT

INPUT
INPUT

INPUT
• Organize the Team • Voice of the • Design Goals • Design Failure Mode • Packaging Standards • Production Trial Run • Reduced Variation
Customer and Effects Analysis
• Define the Scope • Reliability and • Product/Process Quality • Measurement • Customer Satisfaction
(DFMEA)
• Business Quality Goals System Review Systems Evaluation
• Establish Team-to- • Delivery and Service
Plan/Marketing • Design for
Team Communication • Preliminary Bill of • Process Flow Chart • Preliminary Process
Strategy Manufacturability and
Material Capability Study
• Provide Core Tools Assembly • Floor Plan Layout
• Product/Process
Training • Preliminary Process • Production Part
Benchmark Data • Design Verification • Characteristics Matrix
Flow Chart Approval
• Involve Customers
• Product/Process • Design Reviews • Process Failure Mode
and Suppliers • Preliminary Listing of • Production Validation

MSA
Assumptions and Effects Analysis
Special Product and • Prototype Build – Testing
• Implement (PFMEA)
• Product Reliability Process Characteristics Control Plan
Simultaneous • Packaging Evaluation
Studies • Pre-Launch Control
Engineering • Product Assurance • Engineering Drawings
Plan • Production Control
• Customer Inputs Plan (Including Math Data)
• Develop Control Plan Plan
• Process Instructions
Format • Management Support • Engineering
• Quality Planning
Specifications • Measurement Systems
• Decide on Concern Sign-Off and
Analysis Plan
Resolution • Material Specifications Management Support
• Preliminary Process
• Develop Product • Drawing and
Capability Study Plan
Quality Timing Plan Specification Changes
• Packaging Specifications
• New Equipment,
Tooling and Facilities • Management Support
Requirements
• Special Product and
Process Characteristics

FMEA • Gages/Testing
Equipment Requirements
• Team Feasibility

SPC
Commitment and
Management Support

APQP 110
APQP PROCESS FLOW
Prepare for APQP Plan and Define Program Product Design and Process Design and Product and Feedback,
Development Development Process Assessment and
Validation Corrective Action

OUTPUT

OUTPUT

OUTPUT

OUTPUT

OUTPUT
INPUT

INPUT

INPUT
INPUT

INPUT
• Organize the Team • Voice of the • Design Goals • Design Failure Mode • Packaging Standards • Production Trial Run • Reduced Variation
Customer and Effects Analysis
• Define the Scope • Reliability and • Product/Process Quality • Measurement • Customer Satisfaction
(DFMEA)
• Business Quality Goals System Review Systems Evaluation
• Establish Team-to- • Delivery and Service
Plan/Marketing • Design for
Team Communication • Preliminary Bill of • Process Flow Chart • Preliminary Process
Strategy Manufacturability and
Material Capability Study
• Provide Core Tools Assembly • Floor Plan Layout
• Product/Process
Training • Preliminary Process • Production Part
Benchmark Data • Design Verification • Characteristics Matrix
Flow Chart Approval
• Involve Customers
• Product/Process • Design Reviews • Process Failure Mode
and Suppliers • Preliminary Listing of • Production Validation

MSA
Assumptions and Effects Analysis
Special Product and • Prototype Build – Testing
• Implement (PFMEA)
• Product Reliability Process Characteristics Control Plan
Simultaneous • Packaging Evaluation
Studies • Pre-Launch Control
Engineering • Product Assurance • Engineering Drawings
Plan • Production Control
• Customer Inputs Plan (Including Math Data)
• Develop Control Plan Plan
• Process Instructions
Format • Management Support • Engineering
• Quality Planning
Specifications • Measurement Systems
• Decide on Concern Sign-Off and
Analysis Plan
Resolution • Material Specifications Management Support
• Preliminary Process
• Develop Product • Drawing and
Capability Study Plan
Quality Timing Plan Specification Changes
• Packaging Specifications

PPAP
• New Equipment,
Tooling and Facilities • Management Support
Requirements
• Special Product and
Process Characteristics

FMEA • Gages/Testing
Equipment Requirements
• Team Feasibility

SPC
Commitment and
Management Support

APQP 111
we do some total design and development and some
reverse engineering. The methodology used for
reverse engineering is considerably different than
that used for total D&D. Within our procedures we
define the reverse engineering as “development”. Of
course, the planning, review, verification and
validation for the development process is different
that that for the D&D.

QGMS/QS-APQP 112
APQP PPAP
APQP

A Perspective on 8-D and


PFMEA and Control Plan
During APQP and
Afterwards
What is APQP?
• APQP is a "defined" process for a product
development system for Ford, Daimler-
Chrysler, GM 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 its customer
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
Customer and Supplier Involvement

• Customer may initiate planning process.


• Supplier has the obligation to establish
cross-functional team to manage process.
• Supplier should expect the same
performance from their subcontractors.
Determine Customer Requirements

• Print
• Purchase Request or Request for Quotation.
• Statement of Work (SOW)
• Customer visits and discussions.
• Product checklists.
Training

• Customer needs and expectations.


• Working as a team.
• Requirements of APQP
• FMEA
• APQP
• PPAP
APQP Five Phase Process

Concept Program
Initiation/App Approval Prototype
Pilo Launc
roval t h
Planning Planning
Product Design and Development
Process Design and Development
Product and Process Validation
Production
Feedback Assessment and Corrective Action
Links Between the Tools
Contract Review
Program Plan Determine Customer Expectations and Plan for Phase I
Quality
Identify Key Characteristics
DFMEA
Phase II
Team Feasibility
Commitment Determine Risk and Feasibility Phase II
Produce Process
Flow Diagrams
Associate Characteristics with Process Steps and Phase III
Conduct Process Identify Key Characteristics
FMEA Expose Sources of Variation and Finalize Key Phase III
Develop Control Characteristics
Determine Methods to Improve Process and
Plan Phase III
Work Instruction Control
ImplementVariation
Control Plan and Standardize the
Development Phase III
Product and Process Process
Ensure Customer Expectations are Met
Validation Phase IV
Ensure Continuous
Improvement Exercise Management Oversight Phase V
The Target and The Goal
Link Between the Documents
Process Flow PFMEA Control Plan

Operation Number

Product/Process
Characteristic

Incoming Sources Variation Class


of Variation

Work Instructions
Process Flow Diagrams

• Updated after production trial run.


• Need to indicate special characteristics
generated at each step.
• Completed Along with Control Plan (APQP
Process).
• Generally contains same information as
process traveler.
Process Flow Diagram Example
APQP Links to PFMEA
PFMEA Control Plan Work Instructions

Change in detection
or
Change in occurence

Change in severity
or

or or
Design Change Other Action
Process FMEA

• Must follow flow of the process flow diagram.


• Must include ALL process special
characteristics (as a minimum).
How a PFMEA Works

• Where does the data for the PFMEA come


from?
• What types of people are a part of the
PFMEA team?
• What types of activities should we spend a
lot of time on?
PFMEAs/Control Plans and 8-Ds During APQP

• PFMEAs should be driven by real data, including 8-Ds (internal and


external), warranty and returned part analysis
• PFMEAs should be completed by process experts and should be a
driver of the control plans and work instructions
• Work instructions (Post control log, process parameter logs, preventive
maintenance, etc.) implement the control plan in the process
• When there is a quality problem there is an opportunity to improve the
control plan and the work instructions
APQP Links to Control Plan
Control Plan
Quality Checklist

First/Last Piece

Mistake Proofing
P/M Checklist
Control Plans

• Includes product and process special


characteristics.
• Includes SPC requirements.
• Follows flow of process flow chart and
PFMEA.
• May require customer approval.
Types of Control Plans

• Prototype build control plan(s)


• Pre-launch control plan
• Production control plan
Prototype Build Control Plan

• A description of the dimensional


measurements.
• Material tests
– Functional tests that will occur during prototype build.
Pre-launch Control Plan
• Description of dimensional measurements, materials, and
functional tests.
• Adds additional product and process controls.
• Purpose is to contain potential nonconformities utilizing:
– More frequent inspections and/or tests.
– More in-process and finsl inspection and/or check points.
– Statistical evaluations.
– Increased audits.
Production Control Plan
• Up-date pre-launch control plan.
• 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.
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.
Multiple Molds, Tools, Dies and
Patterns
• Complete dimensional layer required from
one part from each cavity as a minimum.
• Supplier must identify specific cavity for
each part submitted.
Part Submission Status

• Never ship production parts before receiving


customer approval.
• Supplier must ensure that future production
continues to meet customer requirements.
• No production parts can be shipped until
approval is received.
Automotive Documentation Development
Develop Process Flow Check for Customer
Listing Requirements

Enter Every “Major” Give careful consideration to


Process from Flow Listing what you consider a “Major”
into FMEA Form process

Use the appropriate RPN


numbers and considerations of
Develop FMEA Element
other appropriate information /
for Every Process
data to determine Critical
characteristics

Give careful consideration to


defining Control Plan stages Develop the Control Plan Develop control mechanisms
with Critical appropriate for Critical
Prototype
Characteristics characteristics.
Pre-launch
Production
• Provides Proof of Capability
• Made up of Documents from APQP
PPAP Purpose

• Ensure that customer design record and


specification requirements are understood.
• Ensure that the process has the potential
for producing product meeting those
requirements
PPAP Scope
• Production parts - generally 300 pieces.
• Includes internal and external sources for
information.
• Submission required prior to first production
shipment.
Base Documentation

• Critical characteristics matrix.


• Process flow diagram.
• Design FMEA (supplied by customer).
• Process FMEA.
• Control plan.
General
• Supplier is responsible for meeting all applicable
specifications.
• Do not submit parts and documentation results if they
are outside specification.
• Take corrective action to meet all design record
requirements.
• Contact customer if unable to meet all requirements
• Comply with customer developed material
specifications and/or approved source list.
General

• Suppliers are required to complete and


maintain copies of all documentation
identified in “requirements for approval”
regardless of submission level.
• Records of PPAP are to be retained for the
life of the part plus one calendar year.
Elements of a PPAP
• Part submission warrant
• Subcontractor warrants
• Design record (customer/design documentation)
• Sample/Master sample (Master sample retained by supplier)
• Dimensional analysis
• Test data
• Flow diagram
• Control plan
• PFMEA
• Measurement Systems Analysis (GR&R)
• Capability studies
Parts Submission Warrant
• Upon satisfactory completion of all required
measurements and tests, enter all required
information on the warrant.
• A separate is required for each part number.
• Responsible supplier official verifies
– Measurements and tests conform to customer requirements
– Required documentation is available for proper submission level.
– Signs warrant and provided date, title and telephone number.
Part Weight
• Determine part weight without packaging or shipping
material.
• Report weight in kilograms to three decimal places.
• Weight determination
– Weigh 10 parts randomly selected and report the average
weight.
– For parts less than 0.100 kilogram, weigh 10 parts
together and report the average weight.
Master Sample

• Retain same as PPAP, or


• Until new master sample is produced for the
purpose of a customer approval.
• Identify master sample by:
– Part number
– Drawing level or revision level
– Customer approval date
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.
Production Trial Run

• Production tooling, equipment, environment,


facilities and cycle time.
• Process Instructions and control plans.
• Minimum quantity set by the customer.
• 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
Measurement System 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.
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.
Floor Plan Layout
• Determine acceptability of inspection and test points.
• Control chart locations
• Visual aides
• Interim repair stations
• Nonconforming material storage
• Keyed to material flow and control plan
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 sign-off
• Schedule and conduct management review
• Obtain management commitment to assist in open
issues
Quality Problems

Quality Problem Occurs

Customer Problem
n yes
o
Cause known? no Conduct Disciplined Problem Solving
yes Revisit PFMEA ye Cause known?
s no
Corrective Action Conduct D.O.E.
ye
n
Update Control Plan and Plant Work Instructions s Cause known?
o
Cause unknown

• Use PFMEA

Note: When a customer problem occurs, follow customer prescribed


methodology
When to use 8-D

• When the cause is unknown


• When you need to get input from several
parties
• When customers dictate use

Note: We use voting techniques, X to Y variable testing, and IS/IS Not


to determine the root cause. However, you still may not know what the
root cause is?
Update the PFMEA & Control Plans

Scrap, Rework Data

Process PFMEA Control Work


Flow Plan Instruction

Warranty & Assembly Plant Data

After the 8-D is completed, the PMEA and the control plan should be
revised and updated as applicable

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