Apqp Training Manual

Nathan & nathan Consultants Pvt Ltd.
Training Material on APQP
TRAINING MATERIAL
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Nathan & nathan Consultants Pvt Ltd. Training Material on APQP
INTRODUCTION
This program is designed to provide a working knowledge of the Advance Product

Quality Planning Process as per the requirements Of QS 9000. This topics should
be understood in the broader perspective of a New Product Development rather than
as a technique.
The two main requirements of a good Product Development are developing a robust
product and developing it in a short time. All the methods discussed in this program
are oriented towards these objectives. One of the essential requirements for the
success of this approach is the ability to work in teams. Team working is a culture
which has to be developed and practiced in the organisation. If we do not adhere to
this principle of team working, we may end up without the benefits expected from
this process of product development.
Some of the techniques like FMEA are discussed in greater detail whereas other
techniques like Design of Experiments, Value Engineering, etc. are discussed as a
outline only. The participants are advised to read other text books for these
techniques to acquaint themselves with its working knowledge. Several exercises
are planned as a part of this program to enable the participants to appreciate the
application. Participants are encouraged to participate fully to obtain the maximum
benefit from this program.
The philosophy of APQP can be summed up as

“IT IS BETTER TO SPEND A LITTLE EXTRA TIME DURING THE
UPSTREAM PROCESS SO THAT THE DOWNSTREAM PROCESSES ARE
FREE FROM ERRORS”.

THE ADVANCED PRODUCT QUALITY PLANNING (APQP) MODEL
WHAT IS APQP?
Advance Product Quality Planning is a structured & systematic method of defining and
establishing the steps necessary to assure that a product satisfies the customer’s
requirements.
The commitment from the Top Management I an essential requirement for the success of
this process.
THE OBJECTIVENESS OF APQP
The goals of product quality planning are:
Effective communication with everyone involved.

On-time completion of all required steps
Minimal or no quality problems
Minimal product launch quality risks
Minimal cycle time to launch the product
THE BENEFITS OF APQP
Resources are directed toward customer satisfaction
Required changes are identified early

Changes close to or after product launch are avoided
A quality product is provided on time at the lowest cost.
An element of Continuous Improvement is built into the company.

Plan and Define
Product Design and Development
APQP
PHASES
Process Design and Development
Product and Process Validation
Feedback, Assessment and Corrective Action

PRODUCT QUALITY PLANNING RESPONSIBILITY MATRIX
Service
Supplier Heat
Design
Manufactu Treat,
Respons
ring Only Warehousing,
ible
Transportation
etc.,
Define the Scope X X X
Plan and Define Section 1.0
X
Product Design and
Development Section 2.0 X
Feasibility Section 2.13

X X X
Process Design and
Development 3.0 X X X
Product and Process Validation

Section 4.0 X X X
Feedback, Assessment and

Corrective Action-Section 5.0 X X X
Control Plan Methodology

X X X
Section 6.0
PRODUCT QUALITY TIMING PLAN

The product quality planning team’s first effort should be the development of a
timing plan. This timing plan should list all tasks with responsibility and target
dates. It is a good practice to follow the project management techniques like Gantt
Chart, Critical Path Method, PERT etc. This plan can be regularly reviewed and
updated as the planning evolves.
PLAN AND DEFINE PROGRAM
OBJECTIVES
 Determine customer needs

 Plan a quality program (which includes Scope, Time, Budget, etc.)
INPUT
 Voice of the customer
- market research
- historical warranty and quality information
- team experience
 Business plan/marketing strategy
 Product/process benchmark data
 Product/process assumptions
 Product reliability
 Customer inputs
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
PRODUCT DESIGN AND DEVELOPMENT
OBJECTIVES
 Develop design features and characteristic
 Critically review engineering requirements
 Assess potential manufacturing problems
INPUTS
 Design goals
OUTPUTS BY DESIGN RESPONSIBLE ACTIVITY
 Design failure mode and effects analysis(DFMEA)

 Design for manufacturing and assembly
 Design verification
 Design reviews
 Prototype build – control plan
 Engineering drawings (including math data)
 Engineering specifications
 Material specification
 Drawing and specification changes
OUTPUTS BY PRODUCT QUALITY PLANNING TEAM
 New equipment tooling and facilities requirements

 Special product and process characteristics
 Gages/testing equipment requirement
 Team feasibility commitment and management support
PROCESS DESIGN AND DEVELOPMENT
OBJECTIVES
 Develop a comprehensive and effective manufacturing system

 Ensure that the manufacturing systems meets customer requirements
INPUTS
 Design failure mode and effect analysis (DFMEA)

 Design for manufacturibility and assembly
 Design reviews
 Prototype build-control plan
 Material specifications
 Gages/testing equipment requirement
OUTPUTS
 Packaging standards
 Product process quality system review
 Process flow chart

 Floor plan chart
 Characteristics matrix
 Process failure mode and effects analysis (PFMEA)
 Pre-launch control plan
 Process instruction
 Measurement systems analysis plan
 Preliminary process capability study plan
 Packaging specification
PRODUCT AND PROCESS VALIDATION
OBJECTIVES
 Validate the manufacturing process & the product

 Ensure that customer’s expectations will be met
 Identify additional concerns
INPUTS
 Floor plan layout
 Process Failure Mode and Effects Analysis (PFMEA)
 Measurement Systems Analysis Plan
OUTPUTS
 Production trial run

 Measurement systems evaluation

 Preliminary process capability study
 Production part approval
 Production validation testing
 Packaging evaluation
 Production control plan
 Quality planning sign-off and management support
OBJECTIVES
 Validate the manufacturing process & the product

 Ensure that customer’s expectations will be met
INPUTS
 Measurement Systems Analysis plan
OUTPUTS


FEEDBACK.ASSESSMENT AND CORRECTIVE ACTION
OBJECTIVES
 Obtain objective feedback for future planning

 To plan the next phase of product development or modification
 To improve the system of planning (from lessons learnt)
 To identify opportunities for Improvement
INPUTS

OUTPUTS
 Reduced variation
 Customer satisfaction

 Delivery and service
PROGRAM MANAGEMENT
TEAM LEADER
Each program has a team leader, but a team leader may manage one or more
programs. The team leader:
- is typically a senior Production or Quality Manager

- interfaces with the customer
- ensures that the Program Need Dates (PND) are met
- is responsible for resources and organisation
- is responsible until product launch
- forms and manages one or more APQP Teams
APQP TEAMS
Team Composition
 Team should be cross-functional; it is not composed of only people from the

Quality Department. Typical members might come from:
- Engineering
- Manufacturing
- Material Control
- Purchasing
- Sales
- Field Service
- Subcontractors

- Quality
- Industrial Engineering
- Maintenance
- Customers(as appropriate)
- Finance
Team Responsibilities
 Success of the Product Quality Planning Team is dependent upon the interest,
commitment, support and direction of upper management. The APQP team:
- is the Product launch Steering Committee responsible for quality planning

- works with the programme manager establish PNDs
- determines the extent of require APQP activities
- determines initial risk assessments and feasibility requirements
- demonstrates that all planning requirements have been met
- ensures that concerns have been documented and scheduled for resolution
Overall, through this process, the team initiates the building of a Culture of
Simultaneous Engineering in the Organisation.

PLAN AND DEFINE PROGRAM
OBJECTIVE
 Determine customer needs

 Plan a quality programme
INPUTS
VOICE OF THE CUSTOMER
Market Research
Obtain market research data to reflect the needs expectations of the customer
through
 Customer interviews
 Customer questionnaires and surveys
 New Product quality and reliability studies
 Competitive product quality studies
 Things Gone Right (TGR) reports
 Focus Group discussions
Historical Warranty and Quality Information
Asses customer and wants and the potential for their recurrence

 Things Gone Wrong (TGW) reports

 Warranty reports
 Capability indicators
 Supplier plant internal quality reports
 Problem resolution reports
 Customer plant returns and rejection
 Field return product analysis
 Product Sampling & Audit Reports
Team Experience
 Various reports of the organization’s personnel

 Formal feedback from the customer’s visits tot the plant
 Past track records similar product’s performance consolidated during the various
reviews meetings
 Collective experience of the team
EXERCISE 1 :
EXERCISE 2 :
BUSINESS PLAN / MARKETING STRATERGY
The Business Plan Marketing Strategy are the basis of the Product Quality plan
 The Business Plan may define the direction the team will take regard to:
- Timing
- Cost
- Investment
- Product positioning
- Research and development (R&D)
- Target objectives for obsolescence
 The Marketing Strategy will define:

- Target customer
- Key sales points
- Key competitors
PRODUCT / PROCESS BENCHMARK DATA
Benchmarking helps to establish performance targets
 Identify appropriate benchmarks

 Identify comparative companies to collaborate for benchmarking
 Collect data and summarise
 Identify the gap between current status and the benchmark, and take one of the
following actions:
-Close the gap

-Match the benchmark
-Exceed the benchmark
PRODUCT AND PROCESS ASSUMPTIONS
Product and process assumptions presume the product has certain features, design
or process concepts.
 Technical innovations
 Advanced materials
 Reliability assessments
 New technology

PRODUCT RELIABILITY
Product Reliability studies compare frequency of repair/replacement of components

and the results of long-term reliability /durability tests.
CUSTOMER INPUTS
OUTPUTS
DESIGN GOALS
Design goals are tentative and are measurable objectives based on :
 Product assumptions
 Functional performance
 Dimensions
 Weight
 Materials
 Aesthetic
RELIABILITY AND QUALITY CONTROL
Reliability and quality goals must include the following targets:
 Things Gone Wrong (TGW) targets

 Things Gone Right (TGR) targets
 Useful Life Reliability targets
 Warranty targets
 Incoming Quality targets
 Process Quality Targets
Note: The above targets must address systems, sub-systems, Components & parts
level
PRELIMINARY BILL OF MATERIAL
The team should establish a Preliminary bill of material based on

Product process assumptions
 Include an early subcontractor list

 Select appropriate design and manufacturing process
 A preliminary make Vs buy analysis
PRELIMINARY PROCESS FLOW CHART
The manufacturing process should be described using a Preliminary Process Flow

Chart, developed from :

 Product/Process assumptions
PRELIMINARY LISTING OF SPECIAL PRODUCT AND PROCESS

CHARCTERISTICS
A Preliminary List of Special Product and Process Characteristics should be

developed based on analysis of inputs including but not limited to :
 Product assumptions based on customer needs and expectations

 Identification of reliability goals / requirements
 Identification of special process characteristics from manufacturing process

 Similar part FMEAs
 Earlier experience
EXERCISE 3 :
PRODUCT ASSURANCE PLAN
The Product Assurance Plan translates design goals into design requirements.
 Outlining of program requirements

 Identification of reliability, durability, and apportionment/ allocation goals and/or
requirements
 Assessment of new technology, complexity, skill, materials, application,
environment, packaging, service, and manufacturing requirements, or any other
factor that my place the program at risk.
 Development of Failure Mode Analysis (FMA)
 Development of preliminary engineering standards requirements
MANAGEMENTS SUPPORT
The understanding, acceptance, and commitment of the Top Management formally

provided to the team. This includes the assessment of funds, manpower and their
deployment at the appropriate time.
RISK ASSESSMENT
APQP Requirements
- APQP Scope
 If program is considered low risk or only minor changes are required, supplier may
skip some elements, such as:
- Existing control plans may be used

- Packaging evaluations may not required
 Team must conduct a risk assessment as soon as possible to determine if all

elements in the APQP process must be completed.
- Customer Inputs
 Customer may require all APQP elements to be completed
 Customer must agree to all deviations from the APQP process
 If it is agreed that an element is not required, supplier should formally record
this status
- Subcontractor APQP Status

 The supplier performs risk assessment of potential subcontractors as initial step
in evaluating subcontractor APQP status

RISK ASSESSMENT CHECK LIST YES NO
1) Quality History
Does the supplier have a history of high warranty or Things Gone

Wrong (TGWs) on currentmodel or surrogate product? ………………
.
Are there frequent Quality Rejects (QRs) and/or campaigns at the
receiving plant?……………………..
Was there a recall action due to a similar component or system?

…………………………………
.2) Supplier Profile
Is it a new supplier or new manufacturing location?………………….…
Is the product or manufacturing technology new to the supplier

Manufacturing location?………………………….
.
Is the supplier’s historic launch performance poor?…………………….
Are the supplier’s resources stretched due to significant amount of new

business?…………….
Is the supplier location under Q-1 probation?…………………………

RISK ASSESSMENT CHECK LIST YES NO
3) Engineering Profile
Is it a new design?…………………………………………….
Are the manufacturing techniques new to the industry? ……………….
Are similar products subject to numerous design changes that threaten

program timing?…………………………..
Is there high product or process complexity?……………………
Is the product strategically important due to high visibility or functional

performance? …………………………
4) Performance versus Targets
Will the design goals(weight ,materials ,functional performance, etc.)

and Reliability goals be difficult to achieve?.………………………….
Will the quality goals (warranty, TGW ,scrap rates, rework rates, etc.)
be difficult to achieve?……………………………
Is the program timing compressed?………………………………..
Are the cost targets aggressive? …………………………………..

APQP STATUS REPORTING PROCESS
The Status reporting should cover the following hierarchy:
Component
Subsystem
System
Vehicle Review
Feature of the Status Report

 Give an overview of plan vs achievement
 Identify critical success factors
 Identify potential threats to fulfillment of objectives
 Determine any resources to be provided to expedite the progress
 Facilitates communication to all concerned

 Facilitates the next process to be ready for their side of the activity
 Provides a reference for tracking for future use
 Provide assurance that all activities are considered in advance
 Provide a basis for approving change to the timing, content, scope, etc.
PRODUCT DESIGN AND DEVELOPMENT
OBJECTIVES
 Develop design features and characteristics

 Critically review engineering requirements
 Assess potential manufacturing problems
INPUTS
 Design goals
OUTPUTS BY DESIGN RESPONSIBLE ACTIVITY
DESIGN FAILURE MODE AND EFFECTS ANALYSIS (DFMEA)
OBJECTIVES
 A Design FMEA is an analytical technique utilized by a Design Responsible

Engineer/Team to ensure that potential failure modes and associated

causes/mechanisms have been considered and addressed. The Design FMEA

supports the design process in reducing risk of failures by :
- Aiding in design requirements and design alternatives

- Aiding in initial design for manufacturing and assembly requirements
- Ensuring that potential failure modes and their effects have been considered in
the
design/development process
- Exposing design deficiencies
- Providing additional information which will be useful in planning
thorough and efficient design test and development processes
- Ensuring Design controls are effective in highlighting potential threats
- Detecting potential failure modes, and listing and ranking them
according to their effect on customer
- Providing an open issue format for recommending and tracking risk actions
- Providing future reference for analysing concerns, evaluating design changes,
and
developing advanced designs.
 The Design FMEA should not relay on the process controls to overcome the
potential design weaknesses but should take into account the limitations of the
manufacturing process.
PROGRAM MANAGEMENT RESPONSIBILY
 Program Management Responsibility is to ensure that :

- A design responsible cross-functional team develops the DFMEA
- The DFMEA is prepared using a customer approved manual
- Campaigns, recalls, user plant concerns, similar part DFMEAs, things gone
wrong,
and warranty data are addressed during DFMEA development
- Every component design function is included in the DFMEA
- Failure modes are described in physical, technical and measurable terms
- Effects of failure address the effect on each part, next higher assembly system,
vehicle, customer wants, and government regulations
- Corrective actions, responsibilities, and completion dates are addressing high
severity numbers and high risk priority numbers.
- Risk priority numbers are revised to quantify the impact of corrective actions.
- Potential special product characteristics are considered in the FMEA

- Potential causes of failure are identified for all failure modes.
EXERCISE 4:
DESIGN FOR MANUFACTURIBILITY AND ASSEMBLY
 Design for Manufacturibility and Assembly is a simultaneous engineering

Process design to optimise the relationship between design function,
manufacturibility and ease of assembly.
 Customer needs and expectations will determine the extent of the APQP
Team involvement in this activity.
EXERCISE 5 :
DESIGN VERIFICATION
OBJECTIVE
To ensure that the Design Output meets the Design Input requirements
To develop a Design Verification Plan
DESIGN VERIFICATION PLAN
The Design Verification Plan is a single document containing both the Test
Plan and the Test report
 The Test Plan itemizes all tests necessary to assure that functional and
reliability criteria and target requirements are met and specifies :
- Test responsibility
- Test quantities
- Timing requirement
- Acceptance Criteria
 The Test Report provides test results and progress made toward design
targets specified by the Test Plan

USES
The Design Verification Plan is a working document to aid engineering Personnel

in :
 Development of thoroughly planned tests needed to assure that the

Component or system meets all engineering requirements
 Ensuring that product reliability meets customer-driven objectives
 Indicating situations where customer timing requires an accelerated test Plan
 Summarizing functional, durability, and reliability testing requirements in one
document
 Providing easily prepared test status and progress reports for Design Reviews
PROGRAM MANAGEMENT RESPONSIBILITY
Program Management Responsibility is to ensure that :
 A cross-functional team is formed for the completion of the design verification

plan.
 Specified tests, methods, equipment, acceptance criteria, samples sizes, design
level, and timing are clearly documented in the design verification plan
 Tests include variation within tolerance on product characteristics selected by
the team
 The design verification plan includes testing environmental aging, dimensional
wear and material fatigue
 The plan includes testing the useful life of the product
 The plan includes testing the effects of the external environment (climate road
surface conditions, etc.,)
 The plan includes testing the effects of the internal environment created
neighboring subsystems
 The plan includes testing of the physical interfaces between components or
systems
 The plan includes testing that detect a failure using variables data. Note:
A failure is significant – partial, degraded, intermittent, or total product failure.
 The team agrees on the definitions of failure and success

 The plan includes documentation and reaction processes when product failure
distribution design and reliability goals are not met.
DESIGN REVIEWS
OBJECTIVES
Design Reviews are regularly scheduled meetings led by engineering and are
intended to prevent problems and misunderstandings and to monitor the progress of
design activities and report to management.
Design Reviews are more than engineering inspection; they are evaluations of :
 Design/functional requirement considerations

 Formal reliability and confidence goals
 Component / subsystem / system duty cycles
 Computer simulation and bench test results
 DFMEAs
 Review for the Design for Manufacturibility and Assembly effort
 Design of Experiments (DOE) and assembly build variation results
 Test failures
 Design Verification progress

 Safety Concerns
 Design feasibility concerns are resolved in time

 Issues brought up in the Design Verification Plan and Sign off Report are
addressed
 Issues brought up in the APQP Status Report are addressed
 Issues regarding reliability, quality, cost, Safety and timing are Identified

PROTOTYPE BUILD – CONTROL PLAN
OBJECTIVES
 Prototype Control Plan describes the controls to be ensured during the Prototype
build stage. These could include the dimensional measurements, materials and
functional tests that will occur during prototype build
 The Prototype Control Plan evolves into the Production Control Plan
 It is used to measure the preliminary capability of “potential” special
characteristics identified during the Design FMEA process
 It supplies information to the manufacturing / assembly about the type of
controls expected
 Specific requirements and supporting data such as P.I.P.C.% (Percent indicates
that are process capable) and P.I.S.T (percent of inspection points that satisfy
tolerance) may be required to support prototype vehicle evaluations.
 Prototypes should be manufactured using production equipment when possible.
 Program Management Responsibility is to ensure that :
- A cross – functional team is used to complete the Prototype-Build Control Plan

- The team reviews all product characteristics, identifies prototype requirements,
and obtains Design Engineering approval
- Potential special characteristics are clearly identified on the Control Plan
- Inspection plans are developed for all material and engineering specifications
- Gages and test equipment used for the prototype are identified on the Prototype
Control Plan
- Gages and test equipment must be accurate, discriminate, repeatable and
reproducible
- The control plan includes documented measurement procedures, techniques and
datums
- The reaction plan clearly states that all nonconformance and repairs require
customer authorization

- The customer has the opportunity to approve Prototype Control Plan

- Prototype processes that are different from production are identified on the
Prototype
Control Plan
ENGINEERING DRAWINGS SPECIFICATIONS MATERIAL

SPECIFICATIONS AND DRAWINGS 7 SPECIFICATION CHANGES
OBJECTIVES
 Drawings and specifications cover all engineering drawings, CAD Data,

Material specifications, and engineering specifications
 Customer designs do not preclude the planning team’s responsibility to review
engineering drawings
- Engineering drawings may include drawings special (governmental regulatory

and safety) characteristics that must be shown on the control plan
- When customer engineering drawings are nonexistent, supplier drawings should
be reviewed by the planning team to determine which characteristics affect fit,
function, durability and / or governmental regulatory safety requirements.
- Drawings should be reviewed to determine if there is sufficient information for a
dimensional layout of the individual parts
- Control or datum surfaces / locators should be clearly identified so that
appropriate functional gages and equipment can be designed for ongoing controls.
- Dimensions should be evaluated to assure feasibility and compatibility with
industry manufacturing and measuring standards.
- Team should assure that math data is compatible with customer’s system
SPECIAL PRODUCT AND PROCESS CHARACTERISTICS
 The Product Quality Planning Team should review the preliminary

 special product and process characteristics list and reach a consensus during
development and design.
 The consensus should be documented on the Control Plan
- The supplier can use any form that accomplishments the same documentation
requirements
 The customer may have unique approval requirements
 Note : Refer to Chrysler, Ford and General Motors Quality System
Requirements Section II
Program Management Responsibility ensures that :
 The customer has been given Program Need Dates

 Drawings and specifications include engineering specifications tests and
Product Validation Test requirements, and are documented in time for the
Pre-Launch Control Plan development
 Major feasibility are resolved prior to the Production Trial Run
 The supplier’s or subcontractor’s material has been approved.
OUTPUTS BY PRODUCT QUALITY PLANNING TEAM
NEW EQUIPMENT TOOLING. GAGES/TESTING AND FACILITIES

REQUIREMENTS
OBECTIVES
To ensure the facilities, tools and gages requirements are identified, procured,
And proven-out in time to meet program need dates. The DFMEA activity
considerations and / or Design Reviews may identify new equipment and
facilities requirements.
 Product APQP should add these items to the Timing Chart

 Team should ensure that the new equipment, gages and tooling is
capable and can be delivered on time.
 Facilities progress should be monitored to assure completion before
Planned production tryout.

 The product quality timing plan includes facilities, permits, planning,

approval, drawing and utilities.
 Funding approval is complete
 Tooling, equipment, and gages have been sourced with statistical
requirements.
 Acceptance criteria has been agreed upon
 Tooling and equipment comply with TE-9000 requirements
(as appropriate)
 There is a trial run at the machine builder’s location to qualify equipment,
Tooling and gages.
 Corrective Actions for all gages and tooling that do not meet customer
Requirements must be completed prior to the production trial run.
SPECIAL PRODUCT AND PROCESS CHARACTERISTICS
OBJECTIVES
To identify the Special Product & Process Characteristics

To ensure that they are adequately reviewed through FMEA and addressed in
Control Plans
Their Designation is consistent with the supplier’s system and Customer’s
Expectations
 The product Quality planning team ensures the timely identification & review
of these characteristics
 The relevant documents where they have to be identified are reviewed
 Their designation symbols are consistent with the supplier’s system
 There is an assessment of potential risks with these characteristics and corrective

actions are initiated in advance through Statistical Studies, Mistake proofing,
etc.
TEAM FEASIBILITY COMMITMENT AND MANAGEMENT SUPPORT
OBJECTIVES
 The Advanced Product Quality Planning Team must assess the feasibility of
manufacturing the proposed design.
 Customer design ownership does not preclude the supplier’s obligation to assess
design feasibility
 The team must be satisfied that proposed design is fir for its intended use and
meets customer expectations, including:
- Time schedules
- Testing requirements
- Packaging requirements
- Delivery requirements
- Cost objectives
- Quality Objectives
 Suppliers must also assess risk and determine which of their subcontractor must
do a feasibility assessment. Suppliers that affect special characteristics must do a
feasibility assessment.
Program Management Responsibility ensures that :
 The team agrees that the proposed design is suitable for its intended use and can
be manufactured, assembled, tested, packaged, and delivered in sufficient quantity
and acceptable cost and quality on schedule
 Suppliers have completed risk assessment and determined which suppliers will
do a feasibility assessment

 The team provides a feasibility document to the customer
PROCESS DESIGN AND DEVELOPMENT
OBJECTIVES
 Develop a comprehensive and effective manufacturing system

 Ensure that the manufacturing systems meets customer requirements
INPUTS
 Design failure mode and effects analysis (DFMEA)

 Design for manufacturability and assembly
 Design reviews
 Prototype build – control plan
 Material specifications
 Gages / testing equipment requirement
OUTPUTS
PACKAGING STANDARDS
This is applicable if the customer has any packaging standards to be incorporated.

If not, the design of packaging should ensure product integrity at the point of use.

PRODUCT PROCESS QUALITY SYSTEM REVIEW
OBJECTIVES
 To ensure that the existing Quality System can meet the requirements of the
new product
 To identify the system modification, additions to be done for meeting the
Quality Assurance requirements
 To ensure that the team activity considers this element and it is timed
 The responsibility for review of the system is defined
 The review considers all aspects of the Quality System (Ref: ISO 9000/QS 9000)
 The identification of new/modified documents, resources, training, etc. Are
completed on time and action initiated for their completion
PROCESS FLOW CHART
OBJECTIVES
 To ensure that all operations of a manufacturing flow have been graphically

shown to show the direct and alternate paths of production
 Customer requirements, in the form of product characteristics, are mapped to the
affected operations.
 Sources of variation and process characteristics are considered at each operation
 A comprehensive Process Flow Chart provides the foundation for the
development of an effective Process FMEA and Control Plan.

SOURCES
 Customer Prints
 In-Process Prints
 Plant Layout
 Problems reports and Logs
 System and / or Design FMEA
 Process FMEA from a similar product or process
Note: The Process flowchart and the appropriate updates to the Floor Plan shall be
completed at this level. Other documents that will be partially or fully completed at
the same time as the Process Flowchart include the following :
 Floor Plan
 Characteristics Matrix (optional)
 List of Special Product and Process Characteristics
 Process flow
 In-process prints
EXERCISE 6 :

PROCESS FLOW CHART CHECKLIST
Customer or Internal Part No………………………………….
Question Yes No Comment ActionPerson Due

Required Resp. Date
1 Does the flow chart illustrate the
sequence of production and
inspection stations?
2 Were all the appropriate FMEAs
(SFMEA,DFMEA) available and
used as aids to Develop the process
flow chart?
3 Is the flow chart keyed to product
and
Process checks in the control plan?
4 Does the flow chart describe how the
Product will move, i.e., roller conveyor,
Slide containers
5 Has the pull system/ optimisation been
Considered for this process?
6. Have provisions been made to identify
And inspect reworked products before
Being used ?
7 Have potential quality problems due to
Handling and outside processing been
Identified and corrected?
FLOOR PLAN LAYOUT
OBJECTIVES

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.
It can be also used for evaluating the ergonomics factors, requirements for
Reduced material travel, etc
CHARACTERISTICS MATRIX
A Characteristics Matrix :
 Displays the relationship between product/process characteristics and the
operations of the process
 Identified the impacts operations have on characteristics
 Identifies the impacts that characteristics have on each other
 Provides criteria for assessing importance levels of characteristics
 Indicates where common tooling is used.
THE BASIC STEPS IN CONSTRUCTING THE CHARACTEISTICS MATRIX
 List all the characteristics in order on the top row of the matrix
 List all the operations in order by OP# on the left column of the matrix
 Place a relationship symbols in interior cells in the Matrix RELATIONSHIP
SYMBOLS
Using the following symbols indicates the relationships between operations and
characteristics
* Indicates a characteristic is cut or changed

C Indicates a characteristic is used for clamping
L Indicates a characteristic is used for location in a subsequent Operation
A Affects a subsequent operation or other characteristic
T Indicates relationships within an operation, such as common tools or tool head
M Characteristic is automatically monitored
EXERCISE 7 :
PROCESS FAILURE MODE AND EFFECTS ANALYSIS (PFMEA)

OBJECTIVES
The primary objective of the Process Failure Mode Effects Analysis (PFMEA) is to
reduce manufacturing risk by :
 Aiding in the analysis of new manufacturing and assembly processes

 Assuring that potential manufacturing and / or assembly process failure modes
and effects are considered.
 Identifying process deficiencies and provide for the development of controls to
resolve the problems by :
- Eliminating or reducing the frequency of unacceptable products
- Increasing the detection of unacceptable products
 Identifying critical characteristics and significant characteristics contributing to
the development of a complete manufacturing control plan
 Establishing priorities for process improvement activities
 Providing automatic process design documentation to guide the development of
future manufacturing and assembly processes.
Note : Output from the PFMEA is used as a basis for :
 Control Plan development

 Preliminary Process Capability Study Plan development
 Finalisation of special product and process characteristics
 Development of Process and monitoring instructions
SOURCES
The data or reference documents that should be utilised by the cross-functional

team to help develop the PFMEA include :
 Process FMEA AIAG Reference Manual

 Characteristics Matrix
 Warranty information
 Customer Complaints and Returns Data

 Corrective or Preventive Actions
 Process Flow Chart

 PFMEA for similar products or processes
 Internal Quality Reports
The Team Leader and APQP team should manage the construction of the process
FMEA and assess the finished document to ensure that the following expectations
are met :
 The PFMA is developed on or before the Program Need Date

 A cross functional team has been formed to assist in the development of the
PFMEA
 Appropriate data have been identified that shall be used by the team to develop
the PFMA. Some forms of data for a similar product or process might include:
- Warranty information
- TGW data
- Corrective or preventive actions
- A list of current error proofing techniques used for similar processes
- Higher assembly of component processes
- FMEAs from similar product
- Other data that would help assist the group better understand and assess the
process
 The appropriate PFMEA is chosen

 Failure modes are quantifiable
 The effects on all customers are considered
 Causes are identified that point to process deficiencies
 Risk has been assessed and reduced to acceptable levels
EXERCISE 8 :
PROCESS FMEA CHECKLIST

Customer or Internal Part No…………………………….

Question Yes No Comment Person Due
/Action Responsible Date
Required
1 Was the Process FMEA prepared using the
Chrysler, Ford and General Motors
Guidelines?
2 Have all operations affecting fit, function,
durability, governmental regulations and
safety been identified and listed sequentially?
3 Were similar part FMEAs considered?
4 Have historical campaign and warranty data
been reviewed?
5 Have appropriate corrective actions been
planned or taken for high risk priority
numbers?
6 Have appropriate corrective actions been
planned or taken for high severity numbers?
7 Were risk priorities numbers revised when
corrective action was completed?
8 Were high severity numbers revised when a
design change was completed?
9 Do the effects consider the customer in terms
of the subsequent operation, assembly and
product?
10 Was warranty information
Used as an aid in developing the PFMEA?
11 Were customer plant problems used as an aid
in developing the PFMEA?
12 Have the causes been described in terms of
something that can be
fixed or controlled?
13 Where detection is the major factor, have
provisions been made to control the cause
prior To the next operation?
PRE-LAUNCH CONTROL PLAN
OBJECTIVES
 To ensure that a written plan for controlling all parts and process after prototype and
before full production is documented.
 The plan should include :
- All operations listed on the Process Flow Chart.

- The machine jig or tooling
- Product and process characteristics
- Designation of special characteristics
- Specifications or tolerances
- Gaging or evaluation techniques
- Sample sizes and frequency
- Control methods
- Reaction instruction at each stage of production
 The Pre-launch Control Plan will be similar to the Production Control Plan but
should include greater sampling for certain characteristics to reflect the initial
capability studies (Ppk) and audits to validate that the process is robust.
 A full layout inspection will normally be performed at this stage and then yearly or
as specified by the customer.
Note : The Pre-Launch Control Plan is used as input for finalizing:

- Measurement System Analysis Plans
- Operator Process and Monitoring Instructions
- Reaction Plan
- Preliminary Process Capability Study Plan
SOURCES
The data or inputs that will be used to develop the Pre-launch Control Plan may
include some or all of the following. This data will be reviewed By the cross-
functional team during their meetings.
 Advance Product Quality Planning and Control Plan AIAG Reference Manual
 Customer Prints
 Inspection Plans and Sampling Frequency

 Work Instructions for similar parts or processes

 List of special characteristics
 List of Machines, tools, Jigs or Fixtures
 List of Gaging with data showing calibration, discrimination, accuracy,
repeatability and reproducibility
 Performance Testing Requirements
 Design Reviews
 Optimisation Data (e.g., QFD, DOE, etc.,)
 Process FMEA
The Team Leader and APQP Team should manage the construction of the
Production Control Plan and assess the finished document to ensure that the
following expectations are met :
 A cross-functional team to assist in the development of the Control Plan

 All operations and special characteristics are included on the Control Plan
 Recommended actions from the PFMEA are incorporated in the Control Plan
 Sampling plans are included as defined by customer requirements
 Sampling Plans for Ppk studies for Special Characteristics are included on the
Control Plan
 Work Instructions for setup, operation, testing, inspection, SPC and reaction are
indicated on the Control Plan
 The Production Control Plan identifies all qualified measurement and test
equipment
 The customer is given the opportunity to approve the Control Plan
 Tests and measurements for PPAP approval are included on the Control Plan
 Instructions are defined for all material and engineering specifications

 Only rational sampling plans are used.
 Control methods are defined to produce only acceptable product output
 Control methods should focus on :

- meeting all customer requirements

- process control rather than product control
- prevention rather than detection
- targeting nominal rather than specification limits
- error proofing rather than inspection
- managing the control method
 Process data have been used to confirm cause and effect relationships between
product and process characteristics. The PFMEA should be a primary tool for
exposing process deficiencies and potential product/ process relationships.
 The Production Control Plan and PFMEA are consistent in defining current
process controls
PROCESS INSTRUCTION
OBJECTIVES
To ensure that documented instructions are available at all operations where the
absence of such instructions could adversely affect quality. Instructions shall
include specific information that describes in a step-by-step fashion
‘how to’ perform an activity.
Instructions provide all the required information to perform a job and shall be
referenced by an operator for a number of different circumstances required on-the-
job Work Instructions shall be referenced by the Control Plan.
OPERATING INSTRUCTIONS
1. After ensuring setup, follow Quality Check Sheet Instructions

2. Follow Process Parameter Log Instructions
3. Change tool as indicated on Control Plan
4. Follow SPC Instruction as noted on control plan and quality check sheet
5. Master Gages per frequency indicated on control plan
REACTION INSTRUCTIONS
If Non-Conforming material is detected.
1. Stop Process
2. Isolate Non-conforming Material. Place in proper Quarantine Area
3. Correct Problem
4. Inform Supervisor if problem persists
5. Note all out of control conditions on control chart (only for charted
Characteristics)
MEASUREMENT SYSTEM EVALUATION PLAN
OBJECTIVES
A plan must exist for the evaluation of measurement devices and methods specified in
the Control Plan to ensure gage linearity, accuracy, repeatability, reproducibility, and
correlation (for duplicate gages)

MEASURMENT SYSTEM EVALUATION PLANS
OPN Parameters Spec.//Instru Applicability Resp. When

No. Tole ment Variable Attribute
R&R Bias Lin. Stabi Short Long

PRELIMINARY PROCESS CAPABILITY STUDY PLAN
OBJECTIVES
 To ensure that there is a plan for conducting the Process Capability Study for
characteristics identified as Special Characteristics. This plan should include the
methodology to be adopted, the responsibility, the timing etc.
 Appropriate training needs have to be identified and the measurement systems to

be used are covered under Measurement Systems Analysis plan.
PACKAGING SPECIFICATIONS
OBJECTIVES
 To ensure that individual product packaging (including interior partitions) is

designed and developed.
Manage and assess packaging design and evaluation to ensure meeting the
Following expectations:
 Packaging requirements will be agreed upon by the supplier and the customer
 The packaging design must assure that the product performance and
characteristics will remain unchanged during packing, shipping and unpacking

 Packaging evaluations must test the packaging under the expected conditions of
transport and material handling. (Customer-specified packaging does not
preclude Advance Product Quality Planning Team involvement in evaluating the
packaging method.)
CONTROL PLAN CHECKLIST
Customer or Internal Part No………………………………..
Question Yes No Comment /Person Due

Action ResponsibleDate
Required
1 Was the control plan methodology
Referenced in Section 6 used in
preparing the control plan ?
2 Have all known customer concerns
Been identified to facilitate the
selection of special product/process
Characteristics
3 Are all special product/process
Characteristics included in the
control plan ?
4 Were SFMEA, DFMEA, and
PFMEA Used to prepare the control
plan ?
5 Are material specifications requiring
Inspection identified ?
6 Does the control plan address
incoming (material / components)
through processing / assembly
including packaging?
7 Are engineering performance testing
Requirements identified ?
8 Are gages and test equipment
available as required by the control

plan?
9 If required, has the customer
approved the control plan ?
10 Are gage methods compatible
between supplier and customer ?
OBJECTIVES
 Validate the manufacturing process

 Ensure that customer expectations will be met
INPUTS
 Measurement Systems Analysis Plan
OUTPUTS
PRODUCTION TRAIL RUN
OBJECTIVES

To ensure the effectiveness of the manufacturing process, using production Tooling,

equipment, environment (including production operators), facilities and cycle times.
Manage and assess the production trial run to ensure meeting the following
expectations :
 The pre-launch control plan is followed during the production trial run.
 The trial run must be used to confirm or add linkages between product and
process characteristics.
Note : Linkages should be captured in the PFMEA.
 Corrective design and process actions must be established for concerns

identified during the trial run.
OUTPUT
 Production Part Approval

 Preliminary Process capability Study
 Measurement Systems Evaluation
 Final Feasibility
 Process Review (feedback to process flow and Process FMEA, input to
Production Control Plan)
 Production Validation Testing
 Packaging Evaluation
 First Time Capability (FTC)
 Quality Planning sign-off
MEASUREMENT SYSTEMS EVALUATION

 The study should be done as per the Plan defined in Process Design &
Development. This study should address all the Measurement Systems listed in
the Control plan and the measurement systems used for SPC.
PRELIMINARY PROCESS CAPABILITY STUDY
OBJECTIVES
 To ensure the determination of an acceptable level of process capability for all

characteristics designated by the customer or supplier as Special Characteristics,
prior to part submission.
 To provide a statistical assessment of the readiness of the process for production
prior to program launch to determine if the production process is likely to
produce product that will meet the customer’s requirements.
Manage and assess the Preliminary Process Capability Study to ensure meeting the
following expectations :
 All special characteristics must be studied and have Pp and Ppk >1.67.
 Statistical and analytical techniques used to determine capability must be
acceptable to the customer.
 Preliminary capability studies must be performed as documented in the pre-
launch control plan
 Preliminary capability studies must be completed and the customer given the
opportunity for review prior to Production Part Approval.
PRODUCTION PART APPROVAL PROCESS (PPAP)
OBJECTIVES

 To ensure there is documented verification that all customer the supplier meets
engineering design requirements and the process has the potential to produce to
these requirements during an actual production run.
 To validate that the products made from the production tools and processes meet
the engineering requirements.
 To ensure that all the requirements mentioned in PPAP manual are adhered to.
PRODUCTION VALIDATION TESTING
OBJECTIVES
 To ensure that products made from production tools and processes meet
engineering standards
Manage and assess production validation testing to ensure meeting the following
expectations:
 Parts for testing must be selected from the production trial run per the sample
sizes and frequencies outlined in the pre-launch control plan
 All customer specified dimensional, material, functional and reliability tests
must be completed prior to production part approval
 For tests not completed prior to production part approval, appropriate action
plans and customer approvals are required.
PACKAGING EVALUATION
OBJECTIVES
 To ensure that the packaging material meets both the specification requirements
and the performance requirements.
 The packaging material in full packaged condition is tested in conditions that
resemble the conditions of use and / or tested in actual user conditions.
 The program should allow appropriate timing for completion of this activity.
 Feedback received from this stage should be used for modifying the packaging
specifications.
PRODUCTION CONTROL PLAN
OBJECTIVES
 To ensure that a comprehensive plan for controlling all parts and processes
before full production is documented.
 The plan includes all operations listed on the Process Flow Chart, including :
- The machine jig or tooling
- Special product and process characteristics
- Designation of special characteristics
- Specification or tolerances
- Gaging or evaluation techniques
- Sample sizes and frequency
- Control method and reaction instructions at each stage of production.
SOURCES
The data or inputs that will be used to develop the Pre-launch Control Plan may
include some or all of the following. This data will be reviewed by the cross-
functional during their meetings.
 Advanced Product Quality Planning and Control Plan AIAG Reference Manual
 Customer Prints
 In-process Prints
 Customer and Internal Specifications
 Inspection Plans and Sampling Frequency
 Work Instructions for similar parts or processes
 List of Special Characteristics
 List of Machines, tools, Jigs or Fixtures
 List of Gaging with data showing calibration, discrimination, accuracy,

repeatability and reproducibility
 Performance Testing Requirements
 Design Reviews
 Optimisation Data (e.g, QFD, DOE etc.,)
 Process FMEA
The Team Leader and APQP Team should manage the construction of the
Production Control Plan and assess the finished document to ensure that the
following expectations are met :
 A cross-functional team to assist in the development of the Control Plan

 All operations and special characteristics are included on the Control Plan
 Recommended actions from the PFMEA are incorporated in the Control Plan
 Sampling plans are included as defined by customer requirements
 Sampling Plans for Ppk studies for Special Characteristics are included on the
Control Plan
 Work Instructions for setup, operation, testing, inspection, SPC and Reaction are
indicated in the Control Plan
 The Production Control Plan identifies all qualified measurement and test
equipment
 The customer is given the opportunity to approve the Control Plan
 Tests and measurements for PPAP approval are included on the Control Plan
 Instructions are defined for all material and engineering specifications
 Only rational sampling plans are used
 Control methods are defined to produce only acceptable product output
 Control methods should focus on :
- meeting all customer requirements

- process control rather than product control
- prevention rather than detection
- targeting nominal rather than specification limits
- error proofing rather than inspection
- managing the control method

 Process data have been used to confirm cause and effect relationships between
product and process characteristics. The PFMEA should be a primary tool for
exposing deficiencies and potential product/ process relationships.
 The Production Control Plan and PFMEA are consistent in defining current
process controls
EXERCISE 10 :
CONTROL PLAN CHECKLIST
Customer or Internal Part No………………………………………….
Question Yes No Comment/Action Person Due

Required Responsible Date
1 Was the control plan Methodology

referenced in Section 6 used in
preparing the Control plan?
2 Have all known customer Concerns
been identified to Facilitate the
selection of special Product/process
characteristics?
3 Are all special product/ process
Characteristics included in the Control
plan?
4 Were SFMEA, DFMEA, and PFMEA
used to prepare the Control plan ?
5 Are material specifications requiring
inspection identified ?
6 Does the control plan address Incoming
9 material components) through
processing /assembly including
packaging ?
7 Are engineering performance Testing
requirements identified ?

8 Are gages and test equipment

Available as required by the Control
plan?
9 If required, has the customer Approved
the control plan?
10 Are gage methods compatible
Between supplier and customer ?
QUALITY PLANNING SIGN-OFF AND MANAGEMENT SUPPORT
OBJECTIVES
 The APQP team should review all the activities have been successfully
Completed and make a formal sign-off. Management support is necessary prior
to the quality planning sign-off. The format given below is an example of the
documentation required to do this sign-off.

CONTINUOUS IMPROVEMENT
FEEDBACK, ASSESSMENT AND CORRECTIVE ACTION
OBJECTIVES
 Obtain objective feedback for future planning

 To plan the next phase of product development or modification
 To improve the system of planning (from lessons learnt)
 To identify opportunities for Improvement
INPUTS

OUTPUTS
REDUCED VARIATION

Control charts and other statistical techniques should be used as tools to identify
process variation. Analysis and corrective actions should be used to reduce
variation. Continual improvement required attention not only to the special causes
of variation but understanding common causes and seeking ways to reduce these
sources of variation. Proposals should be developed including costs, timing, and
anticipated improvement for customer review. Often the reduction or elimination
of a common cause results in lower costs. Suppliers should not be reluctant to
prepare proposals based on value analysis, reduction of variation, etc., The decision
to implement, negotiate, or progress to the next product design level is the
customer’s prerogative.
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 required 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.
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 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 and
supplier and customer listen to the Voice of the Customer. The experience gained
in this provides the customer and supplier with the necessary knowledge to
recommend price reductions achieved by reducing process, inventory, and quality
costs to provide the right component or system for the next product.

APPENDIX
PROCESS FMEA
FAILURE MODE AND EFFECT ANALYSIS (FMEA)
ORIGIN
US – SPACE PROGRAM & DEFENCE SAFETY SYSTEM IN 1960’S.
COMMON DEFINITIONS
FAILURE:
A ‘Failure’ is that a component, assembly or system which does not meet the
requirements or function in accordance with design intent. Ex: Not meeting the
specification
FAILURE MODE:
A ‘Failure Mode’ is the manner in which a component, assembly or system failure

occurs. ex: How the component could not meet the specifications.
WHAT IS FMEA ?
FMEA IS A SYSTEMISED GROUP OF ACTIVITIES TO :

1. Recognize & evaluate the potential failure of a product/process and its effects.
2. Identify actions which could eliminate or reduce the chance of potential failure
occurring.
3. Document the process
WHY FMEA?
1. For a company policy where continuous improvement is emphasized for its

product, process.
2. FMEA is a living document.
WHO SHOULD DO FMEA?
1. Cross functional team effort – with a leader.

2. Team of knowledgeable individuals Ex : Expertise in mfg., Assly., Quality,
etc.,
WHEN FMEA SHOULD MBE DONE?
1. Essence is timeliness.
2. Pro-active rather than reactive.
3. Before process failure mode occurs.
ADVANTAGES OF FMEA:
1. Avoids late change crisis

2. Reduces or eliminates chance of implementing corrective change
3. Excellent technique for preventive action
4. Interactive process which is never ending
TYPES OF FMEA
1. Design FMEA
2. Process FMEA
3. System FMEA
POTENTIAL – PROCESS FMEA
 Potential means ‘anticipated’.

 It is an analytical technique to assure that potential failure mode and their
associated causes have been considered and addressed
 Collection of teams thought as a process is developed.
AIMS OF POTENTIAL PROCESS FMEA
1. Identifying potential product related process failure mode.

2. Assessing the potential customer effects of the failures
3. Identifying the potential mfg., or assembly process causes & process variables
on which to focus controls for occurrence reduction or detection of the failure
conditions.
4. Developing a ranked list of potential failure modes.
5. Documenting the results of the mfg. Or assembly process
CUSTOMER MEANS – NORMALLY ‘END USER’
BUT CAN ALSO BE A SUBSEQUENT OR DOWN STREAM MFG. OR

ASS’LY OPN.,
WHEN SHOULD POTENTIAL PROCESS FMEA DONE (AS PER

QS 9000 REQUIREMENT)
- For all new parts/processes

- Changed parts/processes
- Carryover parts / processes in new application or environment
- Before or at feasibility stage
- Prior to tooling for production
HOW TO DEVELOP & COMPLETE POTENTIAL PROCESS FMEA ?
ASSUMPTION – 1 :
PROCESS FMEA ASSUMES THE PRODUCT AS DESIGNED WILL MEET

THE DESIGN INTENT.
STEP NO .
1. Assemble a team (cross functional)

2. Assign responsibilities
3. Develop flowchart for risk assessment
4. Collect data/information
5. Arrive at RPN for each potential causes of failure
6. Based on pareto rankings of RPN’s for respective potential cause of failure,
priortise preventive action directed fist at highest ranked RPN’s and severity
rank.
7. Formulate the recommended/preventive action for each potential failure Cause
after examining the inadequacy of the present/current design & process control
8. Implement actions & record results
9. Estimate & record the new resulting severity., occurrence & detection ranking &
calculate RPN
COLLECT DATA / INFORMATION
 Develop FMEA form

 Process function requirement
- description of the process (ex : Gear cutting, broaching, hobbing, et.,)
& purpose in brief

 Potential failure mode :

- is defined as the manner in which the process could potentially fail to meet the
process requirements and/or design intent.
- is a description of non-conformance a that specific operation.
ASSUMPTION - 2 : ALL INCOMING PARTS/MATERIALS ARE CORRECT.
 List each potential failure mode for the particular operation.
ASSUMPTION – 3 : ASSUMPTION IS MADE THAT THE FAILURE COULD

OCCUR, BUT MAY NOT NECESSARY OCCUR.
TIPS ON THOUGHTS : FOR CFT
 How can the process/part fail to meet the specifications

 Regardless of engineering, Spec., what would a customer consider objectionable
 Comparison of similar processes/customer claims
TYPICAL FAILURE MODES :
 Bent, Binding, Burred, Handling Damage, Cracked, Deformed, Dirty, Improper

setup, Grounded, Tool Worm, etc.,
 Only specific errors or malfunctions should be listed.

Ex. Improper Heat Treat – Time, Temperature Improper Torque – Over, Under
 Ambiguous phrase should not be used

Ex : Operator Error, Machine Malfunction
OCCURRENCE (O) :
DEFINITION :
Occurrence is how frequently the specification failure cause / mechanism is

projected to occur only occurrences resulting in the failure mode should be

Considered for ranking. Estimate the likelihood of the occurrence a ‘1’ to ‘10’
scale.
CURRENT PROCESS CONTROLS :
DEFINITION :
 Current control are descriptions of the control that either prevent to the extent
possible.
 The failure mode from occurring or detecting.
 The failure mode should it occur.
THREE TYPES OF PROCESS CONTROL /FEATURES TO CONSIDER:
1. Prevent the cause/mechanism or failure mode effect from occurring or Reduce

their rate
2. Detect the cause/mechanism & lead to corrective action.
3. Detect the failure mode
DETECION (D):
DEFINITION :
Is an assessment of the probability that the current process controls will detect a
potential cause/mechanism or subsequent failure mode.
ASSUMPTION – 4 :
ASSUME THE FAILURE HAS OCCURRED AND THEN ASSESS THE

CAPABILITIES OF ALL ‘CURRENT PROCESS CONTROLS’ TO PREVENT
SHIPMENT OF THE PART HAVING THE FAILURE MODE OR DEFECT.
A ‘1 ‘ TO ‘10’ SCALE IS USED.

RISK PRIORITY NUMBER : (RPN)
RPN IS THE PRODUCT OF SEVERITY (S), OCCURRENCE (O)

& DETECTION (D) RANKINGS
i.e., RPN = (S) x (O) x (D)
RPN WILL BE BETWEEN “1” & “1000”
THIS VALUE SHOULD BE USED TO TANK THE CONCERN IN THE

PROCESS IN THE “PARETO FASHION”
RECOMMENDED ACTIONS (S)
ACTIONS ON
1. HIGHEST RANK RPN/SEVERITY
2. WHICH COULD BE HAZARDOUS TO MFG/ASS’LY PERSONNEL
- PERMANENT CORRECTIVE ACTION IS REQUIRED

- EMPHASIS MUST BE ON PREVENTING DEFECTS

DESIGN FMEA
1. FMEA NUMBER
2. SYSTEM, SUB SYSTEM OR COMPONENT NAME AND NUMBER
3. DESIGN RESPONSIBILITY
4. PREPARED BY
5. MODE YEAR (s) / VEHICLE(s)
6. KEY DATE
7. FMEA DATE
8. CORE TEAM
9. ITEM / FUNCTION
10. POTENTIAL FAILURE MODE
11. EFFECT(s) OF FAILURE
12. SEVERITY
13. CLASSIFICATION
14. POTENTIAL CAUSE(s) / MECHANISM (s) OR FAILURE
15. OCCURRENCE(O)
16. CURRENT DESIGN CONTROLS
17. DETECTION(D)
18. RISK PRIORITY NUMBER (RPN)
19. RECOMMENDED ACTION(s)
20. RESPONSIBILITY (for the Recommended Action)
21. ACTION TAKEN
22. RESULTING RPN

PROCESS FMEA
1. FMEA NUMBER
2. ITEM
3. PROCESS RESPONSIBILITY
4. PREPARED BY
5. MODE YEAR(s) / VEHICLE(s)
6. KEY DATE
7. FMEA DATE
8. CORE TEAM
9. PROCESS FUNCTION/REQUIREMENTS
10. POTENTIAL FAILURE MODE
11. POTENTIAL EFFECT(s) OF FAILURE
12. SEVERITY (S)
13. CLASSIFICATION
14. POTENTIAL CAUSE (s) / MECHANISM (s) OR FAILURE
15. OCCURRENCE(O)
16. CURRENT DESIGN CONTROLS
17. DETECTION (D)
18. RISK PRIORITY NUMBER (RPN)
19. RECOMMENDED ACTION (s)
20. RESPONSIBILITY AND TARGET COMPLETION DATE
21. ACTION TAKEN
22. RESULTING RPN

PROCESS FMEA FLOW CHART /RISK ASSESSMENT EXAMPLE
(Application of Wax to Inside of Door)
Process Step Risk Assessment
1. Get wax applicator wand from holder Low Risk
2. Open vehicle door Low Risk
4. * Insert wand and pull trigger for 12 seconds while High Risk
making three passes
4. Release trigger wait 3 seconds Medium Risk
5. Remove wand Medium Risk
6. Close vehicle door Low Risk
7. Replace applicator wand in holder Low Risk
* FMEA Required (high risk)

EQUIPMENT : TOOLING DOMINANT PROCESS :
Tool life and design characteristics are the variables affecting the process output.
A sheet metal stamping die is used to form a steel bracket that has several angles
and a pierced hole. The pierced hole diameter will not vary significantly, therefore
it is not marked as a Special Characteristic. The presence of the hole is critical to
the part. The angles on the part are critical and two angles are marked as Special
Characteristics. Historically, broken hole punches are a problem with this type of
tooling. Further, moving parts in the tool can vary when forming the angles in the
bracket.
 The process characteristic is the tooling. Tools can have details that break or
moving parts that intermittently/permanently fail to move. Tools can also be
repaired incorrectly. The product characteristics are affected by these
tooling problems.
 Types of controls for tooling dominant processes are mainly seen in the
Product. First piece check can verify that a tool has been properly repaired.
When in operation a tool failure may go unnoticed except in the part,
therefore, lot control is appropriate. Error proofing techniques that check for
holes or a dimension are also needed.
 Product characteristic are a very important measure of proper tool life
performance.
EQUIPMENT : TOOLING DOMINANT PROCESS:
Tool life and design characteristics are the variables affecting the process output.
A broach is used to form the internal spline teeth on a steel propshaft yoke. The
pitch diameter of internal spline is the Special Product Characteristic
 The sharpened tool is checked on a visual comparator for correct pitch diameter
and relief angle prior to being approved for production.

 First piece of a production run is checked for sharpness of cut and correct pitch
diameter.
PEOPLE: OPERATOR DOMOINANT PROCESS:
The system is sensitive /dependent upon operator knowledge and control.
Headlamp aim is one of the final operations during car and truck assembly. An
aiming device, which contains two bubble levels, attaches to the headlamp. The
operator adjusts the headlamps by turning aiming Screws until bubbles center the
level. Proper headlamp aim is an FMVSS requirement and therefore a Special
Product Characteristic. The Special Process Characteristic is operator knowledge
and control, ensuring the two bubble levels center during aiming. The Special
Product Characteristic is measured by shining the headlamps on a headlamp aim
board that measures beam pattern.
MATERIAL : MATERIAL OR COMPONENT DOMINANT PROCESS
Characteristics of materials/components are the variables affecting the Process

output.
An automobile hood is made of SMC. SMC is a molding compound that is

temperature sensitive, has a specific shelf life, and for which mixing is critical. The
parts produced from this material can become brittle when the material is
improperly mixed, handled or rotated. A force specification on one end of the
bracket is a Special Product Characteristic. The Special Process Characteristics are
the proper formulation, storage, and use of material date control. The customer
requires a laboratory report on each lot of compound and the lots of material are
dated for proper rotation.
 The materials or components are the process characteristics for this process. The
variation found in the materials or components will affect the output of the
process.

 Types of controls for the process characteristics include the various ways of
testing and controlling the specification on the material or component being used
(i.e, control charts, lab reports, error proofing)
METHODS: PREVENTIVE MAINTANANCE DOMINANT PROCESS:
Equipment maintenance is the main variable that effects the process output.
A painting operation for a decorative parts requires clean equipment and dirt-free
work area. Dirt-free paint a Special Product Characteristic. Periodic cleaning of the
paint equipment and paint room prevents the problem of dirt in the paint. The
process characteristic is a scheduled routine cleaning, repair and replacement.
 Periodic maintenance is the process characteristic. Where input variables

exist, replacing worn out parts, cleaning, calibration, tool adjustments, and
other maintenance activities have an effect on the product characteristics, and
must be controlled.
 Types of controls for these process characteristics include scheduled
maintenance programs and warning devices for monitoring.
 Product characteristics are checked after each maintenance to verify the
Process is properly performed.
ENVIRONMENT : CLIMATE DOMINANT PROCESS :
Climate variables such as temperature, humidity, noise, vibrations, have major

impact on the process outputs.
Humidity adversely affects the function of plastic molding machines. Plastic

material absorbs dampness from the air, causing defects in the molded part.
Material dryers are installed on the molding machines to eliminate the problem.
 The proper functioning of the dryer is the process characteristic in having the
process perform properly
 Type of control for this process characteristic is a planned, periodic check to
make sure the dryer is turned on and performing properly.

 Product characteristics are checked by visual examination during first piece

check and by subsequent periodic checks.
GLOSSARY
COMPONENT – The individual parts that are linked or integrated into a subsystem,
system, or vehicle.
CRITICAL CHARACTERISTICS - Product requirements (dimensions,

performance tests) or process parameters that can compliance with government
regulations of safe vehicle / product function and which require specific supplier,
assembly, shipping or monitoring.
CUSTOMER - The next operation, department, person or company WHETHER

internal or external, that receives or purchases product or services.
DYNAMIC CONTROL PLANNING (DCP) - A methodology to ensure customer

expectations in the form of product design requirements are understood, deployed
and controlled in the manufacturing and assembly processes. A team approach is
used for the step-wise understanding and control of manufacturing process and
products.
DESIGN FREEZE – A point in time determined by the Program Management when

the design must be completed to support a prototype Test program. Subsequent
changes to the frozen design are not accepted without agreement from the
Program’s Chief Engineer and Team Leader.
ELEMENT - Specific documents, tasks and disciplines which must be Completed

to support the customer’s program.
FAILURE MODE ANALYSIS (FMA) – A disciplines systematic approach to

quantify the failure modes, failure rates and root causes of known failures. FMAs
are based on historical information including warranty data, field data, service data,
and / or process data.

FAULT MODE ANALYSIS (FMA) - A disciplines systematic approach to

quantify the failure modes, failure rates and root causes of known failures. FMAs
are based on historical information including warranty data, field data, Service data,
and / or process data.
FAULT TREE ANALYSIS - A deductive analytical technique that uses a

Graphical tree to show cause and effect relationships between a single undesired
event (failure) and the various contributing causes.
FUNCTIONAL CHECK REPORT - Certifies that a physically representative part

installed in a vehicle performs in a accordance with the design intent. Element will
be completed by program need date and will meet quality expectations.
LESSON LEARNED - Problems, mistakes, things gone wrong / right (TGR,

TGW) learned from reviewing similar part data. Information from in-plant
manufacturing data, 8Ds, ES test data, user plant data, warranty data, Field data,
service data, campaigns, recalls or other sources of information.
MISTAKE PROOFING - Techniques that use simple and inexpensive devices to

prevent errors about to occur or detect errors and defects that have occurred.
PERCENT INDICES WHICH ARE PROCESS CAPABLE (PIPC) - The

minimum number of points continually monitored to ensure control of the special
characteristics or each operation of the manufacturing process. These points may be
developed from surrogate parts if required.
PERCENT INSPECTION POINTS WHICH SATISFY TOLERANCE (PIST)

PIST is the number of conforming inspection checks divided by the total number of
checks made, times 100.
PRODUCT ASSURANCE PLAN - A prevention oriented management tool that

addresses product and process design. It emphasizes FMA and process simulation.
This plan is part of the overall Product Quality Plan.
PRODUCT TO PROCESS CHARACTERISTIC LINKAGES _ A

statistical relationship between product characteristics and key process

characteristics found, using tools such as scatter plots and design of experiments.
PRODUCT QUALITY TIMING PLAN - A supplier imitated plan that supports all
elements of the APQP process. This plan includes supplier tasks, assignments,
events, and timing required to ensure the system, subsystem or component meets
customer expectations.
PROGRAM METRICS TRACKING AND TRENDS - A supplier led team that

defines and monitors the status of key metrics used throughout the APQP process.
Metrics may include cost, weight, quality targets, mean time to failure, reliability
growth curves, 8D status, CR/ CR status and functional performance.
PROGRAM NEED DATA _ The last possible date the elements can be completed
and not adversely affect quality or timing of program.
PROTOTYPE - An initial or original model from subsequent copies are Made or

improved models are developed.
QUALITY OPERATING SYSTEM (QOS) - A systematic disciplines approach

that uses standardized tools and practices to manage the business and achieve ever
increasing levels of customer satisfaction.
RED - Element will not be completed by program need date or will not Meet
quality expectations. Program is at risk.
SYSTEM DESIGN SPECIFICATION (SDS) - A compilation of performance

metrics for a system or subsystem. Performance metrics are measurable
characteristics derived from customer expectations.
SUBCONTRACTOR - Provides of materials, parts, or services to a supplier
SUBSYSTEM - A major part of a system which itself has the characteristics of a

system, usually consisting of several components.
SUPPLIER - A provider of production materials, parts or service parts.
SYSTEM - A set of interdependent subsystems or parts linked to perform a

specific function.
THINGS GONE RIGHT (TGR) - Product attributes or characteristics that produce

a positive reaction from customers.
THINGS GONE WRONG (TGW) - Product attributes or characteristics that

produce a negative reaction from customers. TGW includes both components and
correct component functions that do not meet customer expectations.
YELLOW - Element may not be completed by program need date or may not
meet quality expectations. Recovery plan is in place.
ACRONYMS
AIAG Automotive Industry Action Group

CFT Cross Functional Team
DCP Dynamic Control Plan (Dimensional
Control Plan)
DFMEA Design Failure Mode and Effect Analysis
DOE Design of Experiments
DVP&R Design Verification Plan and Report
FMA Failure Mode Analysis
FMEA Failure Mode and Effect Analysis
FTC First Time Capability
GR&R Gage Repeatability and Reproducibility
PFMEA Process Failure Mode and Effect Analysis
PQP Product Quality Planning
PQPT Product Quality Planning Team
QFD Quality Function Deployment
QSR Quality System Requirements
SFMEA System Failure Mode and Effects Analysis
TGR Things Gone Right
TGW Things Gone Wrong
VE/VA Value Engineering / Value Analysis

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Nathan & nathan Consultants Pvt Ltd.

Training Material on APQP

Nathan & Nathan consultants Pvt.Ltd., Page 1 of 75

This program is designed to provide a working knowledge of the Advance Product

The philosophy of APQP can be summed up as

Nathan & Nathan consultants Pvt.Ltd., Page 2 of 75

THE ADVANCED PRODUCT QUALITY PLANNING (APQP) MODEL

THE OBJECTIVENESS OF APQP

The goals of product quality planning are:

Effective communication with everyone involved.

THE BENEFITS OF APQP

Resources are directed toward customer satisfaction

Required changes are identified early

Nathan & Nathan consultants Pvt.Ltd., Page 3 of 75

Plan and Define

Product Design and Development

Product and Process Validation

Feedback, Assessment and Corrective Action

Nathan & Nathan consultants Pvt.Ltd., Page 4 of 75

PRODUCT QUALITY PLANNING RESPONSIBILITY MATRIX

Feasibility Section 2.13

Product and Process Validation

Feedback, Assessment and

Control Plan Methodology

PRODUCT QUALITY TIMING PLAN

Nathan & Nathan consultants Pvt.Ltd., Page 5 of 75

PLAN AND DEFINE PROGRAM

 Determine customer needs

Nathan & Nathan consultants Pvt.Ltd., Page 6 of 75

 Preliminary listing of special product and process characteristics

PRODUCT DESIGN AND DEVELOPMENT

OUTPUTS BY DESIGN RESPONSIBLE ACTIVITY

 Design failure mode and effects analysis(DFMEA)

OUTPUTS BY PRODUCT QUALITY PLANNING TEAM

 New equipment tooling and facilities requirements

PROCESS DESIGN AND DEVELOPMENT

 Develop a comprehensive and effective manufacturing system

 Design failure mode and effect analysis (DFMEA)

 Process flow chart

 Validate the manufacturing process & the product

 Production trial run

 Measurement systems evaluation

PRODUCT AND PROCESS VALIDATION

 Validate the manufacturing process & the product

 Production trial run

 Preliminary process capability study

FEEDBACK.ASSESSMENT AND CORRECTIVE ACTION

 Obtain objective feedback for future planning

 Production trial run

Nathan & Nathan consultants Pvt.Ltd., Page 11 of 75

 Delivery and service

- is typically a senior Production or Quality Manager

 Team should be cross-functional; it is not composed of only people from the

Nathan & Nathan consultants Pvt.Ltd., Page 12 of 75

- is the Product launch Steering Committee responsible for quality planning

Nathan & Nathan consultants Pvt.Ltd., Page 13 of 75

PLAN AND DEFINE PROGRAM

 Determine customer needs

VOICE OF THE CUSTOMER

Historical Warranty and Quality Information

Nathan & Nathan consultants Pvt.Ltd., Page 14 of 75

 Things Gone Wrong (TGW) reports

 Various reports of the organization’s personnel

BUSINESS PLAN / MARKETING STRATERGY