to the

Training Seminar
on

APQPCP
 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.
 INTRODUCTION

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 APQP MODEL

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 is an essential

requirement for the success of this process.
 THE APQP MODEL
THE OBJECTIVENESS OF APQP

The goals of 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 APQP MODEL

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.

 THE APQP PHASES

Plan and Define

Product Design and Development

PHASES

Process Design and Development

Product and Process Validation

Feedback, Assessment and Corrective Action

 RESPONSIBILITY MATRIX
THE 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.)

INPUTS

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
 PLAN AND DEFINE PROGRAM

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 & DEVELOPMENT
OBJECTIVES

Develop design features and characteristic

Critically review engineering requirements
Assess potential manufacturing problems

INPUTS

Design goals
Reliability and quality goals
Preliminary process flow chart
Preliminary listing of special product and process
characteristics
Product assurance plan
Management support
PRODUCT DESIGN & DEVELOPMENT

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
PRODUCT DESIGN & DEVELOPMENT

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 & DEVELOPMENT

OBJECTIVES

 Develop a comprehensive and effective manufacturing system

 Ensure that the manufacturing systems meets customer
requirements.
 PROCESS DESIGN & DEVELOPMENT

INPUTS

Design failure mode and effect analysis (DFMEA)

Design for manufacturibility and assembly
Design verification
Design reviews
Prototype build-control plan
Engineering drawings (including math data)
Engineering specifications
Material specifications
Drawing and specification changes
New equipment tooling and facilities requirements
Special product and process characteristics
Gages/testing equipment requirement
Team feasibility commitment and management support
 PROCESS DESIGN & DEVELOPMENT

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
Management support
 PRODUCT & PROCESS VALIDATION

OBJECTIVES

Validate the manufacturing process & the product

Ensure that customer’s expectations will be met
Identify additional concerns
 PRODUCT & PROCESS VALIDATION

INPUTS

Packaging standards
Product process quality system review
Process flow chart
Floor plan layout
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
Management support
PRODUCT & PROCESS VALIDATION

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
FEEDBACK, ASSESSMENT & 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

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
FEEDBACK, ASSESSMENT & CORRECTIVE ACTION

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
 PROGRAM MANAGEMENT
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
 PROGRAM MANAGEMENT
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 & DEFINE PROGRAM

OBJECTIVES

Determine customer needs

Plan a quality programme
 PLAN & DEFINE PROGRAM
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
 PLAN & DEFINE PROGRAM

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
 PLAN & DEFINE PROGRAM

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 :
 PLAN & DEFINE PROGRAM
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
 PLAN & DEFINE PROGRAM

PRODUCT / PROCESS BENCHMARK DATA

Benchmarking helps to establish performance targets

Identify appropriate benchmarks

Identify comparative companies to collaborate for
benchmarking
Collect data and summarize
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
 PLAN & DEFINE PROGRAM
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
 PLAN & DEFINE PROGRAM

PRODUCT RELIABILITY

Product Reliability studies compare frequency of repair/replacement

of components and the results of long-term reliability /durability tests.
 PLAN & DEFINE PROGRAM

CUSTOMER INPUTS

OUTPUTS

DESIGN GOALS

Design goals are tentative and are measurable objectives based on :

Product assumptions
Functional performance
Dimensions
Weight
Materials
Aesthetic
 PLAN & DEFINE PROGRAM

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
 PLAN & DEFINE PROGRAM

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 :

Preliminary bill of material

Product/Process assumptions
 PLAN & DEFINE PROGRAM
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 :
 PLAN & DEFINE PROGRAM
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
 PLAN & DEFINE PROGRAM

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.
 PLAN & DEFINE PROGRAM
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.
 PLAN & DEFINE PROGRAM

- 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
 PLAN & DEFINE PROGRAM

FOR RISK ASSESSMENT CHECKLIST

CLICK HERE
APQP STATUS REPORTING PROCESS

The Status reporting should cover the following hierarchy:

COMPONENT

SUBSYSTEM

SYSTEM
APQP STATUS REPORTING PROCESS

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 & DEVELOPMENT
OBJECTIVES

Develop design features and characteristics

Critically review engineering requirements
Assess potential manufacturing problems

INPUTS

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 & DEVELOPMENT

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 :
PRODUCT DESIGN & DEVELOPMENT
- 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.
PRODUCT DESIGN & DEVELOPMENT
• 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.
 PRODUCT DESIGN & DEVELOPMENT
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 MANUFACTURABILITY 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 FOR MANUFACTURABILITY AND ASSEMBLY

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
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

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
 DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

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 FOR MANUFACTURABILITY AND ASSEMBLY

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 FOR MANUFACTURABILITY AND ASSEMBLY

PROGRAM MANAGEMENT RESPONSIBILITY

Program Management Responsibility is to ensure that :

 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
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

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.
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

PROGRAM MANAGEMENT RESPONSIBILITY

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
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

- 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
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

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
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

- 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
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

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
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

PROGRAM MANAGEMENT RESPONSIBILITY

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.
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

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.
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY

PROGRAM MANAGEMENT RESPONSIBILITY

Program Management Responsibility is to ensure that :

 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 & PROCESS CHARACTERISTIC

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

PROGRAM MANAGEMENT RESPONSIBILITY

 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 & 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.
TEAM FEASIBILITY COMMITMENT & MANAGEMENT
SUPPORT

PROGRAM MANAGEMENT RESPONSIBILITY

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 & 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 verification
 Design reviews
 Prototype build – control plan
 Engineering drawings (including math data)
 Engineering specifications
 Material specifications
 Drawing and specification changes
 New equipment tooling and facilities requirements
 Special product and process characteristics
 Gages / testing equipment requirement
 Team feasibility commitment and management support
PROCESS DESIGN & DEVELOPMENT

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

PROGRAM MANAGEMENT RESPONSIBILITY

 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.
 PROCESS FLOW CHART
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

FOR RISK ASSESSMENT CHECKLIST

CLICK HERE
 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
 CHARACTERISTIC 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.
 CHARACTERISTIC MATRIX

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
 PFMEA
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.
 PFMEA
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
 PFMEA
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
System and / or Design FMEA
PFMEA for similar products or processes
Internal Quality Reports
 PFMEA
PROGRAM MANAGEMENT RESPONSIBILITY

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
 PFMEA
 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
 PFMEA

FOR PROCESS FMEA CHECKLIST

CLICK HERE
 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
 PRE-LAUNCH CONTROL PLAN

 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
 PRE-LAUNCH CONTROL 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 Flow Chart
 System and / or Design FMEA
 Process FMEA
 PRE-LAUNCH CONTROL PLAN
PROGRAM MANAGEMENT RESPONSIBILITY

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
 PRE-LAUNCH CONTROL PLAN
 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
 PRE-LAUNCH CONTROL PLAN
 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 INSTRUCTIONS

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.
 PROCESS INSTRUCTIONS

OPERATING INSTRUCTIONS

• After ensuring setup, follow Quality Check Sheet Instructions

• Follow Process Parameter Log Instructions
• Change tool as indicated on Control Plan
• Follow SPC Instruction as noted on control plan and quality check sheet
• Master Gages per frequency indicated on control plan

REACTION INSTRUCTIONS
If Non-Conforming material is detected.

• Stop Process
• Isolate Non-conforming Material. Place in proper Quarantine Area
• Correct Problem
• Inform Supervisor if problem persists

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)

FOR MEASURE MENT SYSTEM EVALUATION PLAN

CLICK HERE
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 EVALUATION

OBJECTIVES
 To ensure that individual product packaging (including interior partitions) is
designed and developed.

PROGRAM MANAGEMENT RESPONSIBILITY

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.)

FOR CONTROL PLAN CHECKLIST

CLICK HERE
 PRODUCT & PROCESS VALIDATION
OBJECTIVES

 Validate the manufacturing process

 Ensure that customer expectations will be met
 Identify additional concerns

INPUTS
 Packaging standards
 Product process quality system review
 Process flow chart
 Floor plan layout
 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
 Management support
 PRODUCTION TRIAL RUN

OBJECTIVES

To ensure the effectiveness of the manufacturing process, using production

Tooling, equipment, environment (including production operators), facilities and
cycle times.

PROGRAM MANAGEMENT RESPONSIBILITY

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.
 PRODUCTION 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 SYSTEM 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.
PRELIMINARY PROCESS CAPABILITY STUDY

PROGRAM MANAGEMENT RESPONSIBILITY

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

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

PROGRAM MANAGEMENT RESPONSIBILITY

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.
 PRODUCTION CONTROL 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 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 Flow Chart
System and / or Design FMEA
Process FMEA
 PRODUCTION CONTROL PLAN

PROGRAM MANAGEMENT RESPONSIBILITY

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
 PRODUCTION CONTROL PLAN

 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
QUALITY PLANNING SIGN-OFF & 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 & CORRECTIVE ACTIONS

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
 CONTINUOUS IMPROVEMENT

INPUTS

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
 CONTINUOUS IMPROVEMENT

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.
 CONTINUOUS IMPROVEMENT

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.
 CONTINUOUS IMPROVEMENT

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 :

• Recognize & evaluate the potential failure of a product/process and its effects.
• Identify actions which could eliminate or reduce the chance of potential failure
occurring.
• Document the process
 COMMON DEFINITIONS

WHY FMEA?

• For a company policy where continuous improvement is

emphasized for its product, process.
• FMEA is a living document.

WHO SHOULD DO FMEA?

• Cross functional team effort – with a leader.

• Team of knowledgeable individuals Ex : Expertise in mfg., Assly., Quality,
etc.,

WHEN FMEA SHOULD MBE DONE?

• Essence is timeliness.
• Pro-active rather than reactive.
• Before process failure mode occurs.
 COMMON DEFINITIONS

ADVANTAGES OF FMEA:

• Avoids late change crisis

• Reduces or eliminates chance of implementing corrective change
• Excellent technique for preventive action
• Interactive process which is never ending

TYPES OF FMEA

• Design FMEA
• Process FMEA
• 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.
 COMMON DEFINITIONS

AIMS OF POTENTIAL PROCESS FMEA

• Identifying potential product related process failure mode.

• Assessing the potential customer effects of the failures
• Identifying the potential mfg., or assembly process causes
& process variables on which to focus controls for
occurrence reduction or detection of the failure conditions.
• Developing a ranked list of potential failure modes.
• 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.,
 COMMON DEFINITIONS

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
 COMMON DEFINITIONS

HOW TO DEVELOP & COMPLETE POTENTIAL PROCESS

FMEA ?

ASSUMPTION – 1 :

PROCESS FMEA ASSUMES THE PRODUCT AS DESIGNED WILL

MEET THE DESIGN INTENT.

STEPS :
• Assemble a team (cross functional)
• Assign responsibilities
• Develop flowchart for risk assessment
• Collect data/information
• Arrive at RPN for each potential causes of failure
• 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.
 COMMON DEFINITIONS

• Formulate the recommended/preventive action for each potential

failure Cause after examining the inadequacy of the present/current
design & process control
• Implement actions & record results
• 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.
 COMMON DEFINITIONS

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.
 COMMON DEFINITIONS

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
 COMMON DEFINITIONS

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.
 COMMON DEFINITIONS

THREE TYPES OF PROCESS CONTROL /FEATURES TO

CONSIDER:

• Prevent the cause/mechanism or failure mode effect from occurring

or Reduce their rate
• Detect the cause/mechanism & lead to corrective action.
• 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.
 COMMON DEFINITIONS

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”
 COMMON DEFINITIONS

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
 COMMON DEFINITIONS

DESIGN FMEA

• Fmea number
• System, sub system or component name and
number
• Design responsibility
• Prepared by
• Mode year (s) / vehicle(s)
• Key date
• Fmea date
• Core team
• Item / function
• Potential failure mode
• Effect(s) of failure
• Severity
• Classification
 COMMON DEFINITIONS

DESIGN FMEA

• Potential cause(s) / mechanism (s) or failure

• Occurrence(o)
• Current design controls
• Detection(d)
• Risk priority number (rpn)
• Recommended action(s)
• Responsibility (for the recommended action)
• Action taken
• Resulting rpn
 COMMON DEFINITIONS

PROCESS FMEA

• Fmea number
• Item
• Process responsibility
• Prepared by
• Mode year(s) / vehicle(s)
• Key date
• Fmea date
• Core team
• Process function/requirements
• Potential failure mode
• Potential effect(s) of failure
 COMMON DEFINITIONS

PROCESS FMEA

• Severity (s)
• Classification
• Potential cause (s) / mechanism (s) or failure
• Occurrence(O)
• Current design controls
• Detection (d)
• Risk priority number (RPN)
• Recommended action (s)
• Responsibility and target completion date
• Action taken
• Resulting RPN
 COMMON DEFINITIONS

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
2. Open vehicle Door Low
3. Insert wand and pull trigger for 12 secs. High
While making three passes
4. Release trigger wait 3 secs. Medium
5. Remove Wand Medium
6. Close vehicle door Low
7. Replace applicator wand in holder Low
* FMEA required ( high risk )
 COMMON DEFINITIONS

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.
 COMMON DEFINITIONS

 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.
 COMMON DEFINITIONS

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.
 COMMON DEFINITIONS

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.
 COMMON DEFINITIONS

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.
 COMMON DEFINITIONS

 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)
 COMMON DEFINITIONS

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.
 COMMON DEFINITIONS

 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.
 COMMON DEFINITIONS

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.
 GLOSSARY

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.
 GLOSSARY

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.
 GLOSSARY

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.
 GLOSSARY

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.
 GLOSSARY

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.
 GLOSSARY

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
 GLOSSARY

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.
 GLOSSARY

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.
 ACRONYMS

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.