15.04.

2019

Core Tools Reference Study Material

PPAP, MSA, SPC & FMEA (AIAG V04)’

Quality HUB India

Advance Product Quality Planning

(APQP)

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What is Advanced Product Quality Planning

 The Advanced Product Quality Planning process consists of four

phases and five major activities along with ongoing feedback
assessment and corrective action.

What is Advanced Product Quality Planning

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What is Advanced Product Quality Planning

 Quality planning and more

 Total integration of quality tools with management functions
 Multi-disciplinary team approach to quality planning
 Tool to enable suppliers to not only meet but exceed customer
requirements
 To promote early identification of required changes
 To avoid late changes
 To provide a quality product on time at the lowest cost
 Facilitate communication with everyone involved
 Developing easily understandable formats by supplier and
customer

Fundamentals of Product Quality Planning

 Organize the team - Multi-disciplinary team from Engineering,

Manufacturing, Quality, Materials, Sales, Service, Sub-contractors and
Customers
 Define the Scope - Team Leader, Roles and Responsibilities,
Customer (Internal / External), Customer Requirements, Additional
Members, Feasibility Assessment , Cost , Timings, Constraints,
Customer Assistance & documentation
 Team-To-Team - Establish line of communication with customer team
and other in-house teams
 Training - Identifications and organizing for providing training
 Customer and Supplier Involvement - Identifications of issues needs
interaction with customer / sub-contractor and resolution

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APQP Major Elements

 Understand customer needs . This is done using voice of the customer

techniques to determine customer needs and using quality function
deployment to organize those needs and translate them into product
characteristics/requirements.
 Proactive feedback & corrective action. The advance quality planning
process provides feedback from other similar projects with the objective
of developing counter-measures on the current project. Other
mechanisms with verification and validation, design reviews, analysis of
customer feedback and warranty data also satisfy this objective.
 Design within process capabilities. This objective assumes that the
company has brought processes under statistical control, has
determined its process capability and has communicated it process
capability to its development personnel. Once this is done, development
personnel need to formally determine that critical or special
characteristics are within the enterprise's process capability or initiate
action to improve the process or acquire more capable equipment.

Fundamentals of Product Quality Planning (Cont.)

 Simultaneous Engineering - A process to strive for common goal.

Parallel working
 Control Plans - Prototype, pre-launch and production
 Concern Resolution - Documenting, responsibility assigned. Use of
disciplined problem solving method in difficult situations
 Product Quality Timing Plan - Developing activity plan for all activities.
Review of activities and corrective actions
 Plans Relative to the Timing Chart - Sub plans for associated
activities!

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Introduction

 When is APQP appropriate?

• For development of new product
• Incorporating changes in the product
(Your responsibility will be dependent on the nature of
what your company supplies)

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Plan and Define

 Described how to determining customer needs and

expectations
 All work done with customer in mind - providing
better product / service than competitor

VOICE OF THE CUSTOMER

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

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Plan and Define (Cont’d.)

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

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Plan and Define (Cont’d.)

HISTORICAL WARRANTY AND QUALITY INFORMATION

 List of historical customer concerns / wants to assess the potential
for recurrence during design, manufacture, installation and use.
The following item can be used:
• Things gone wrong reports
• Warranty reports
• Capability indicators
• Supplier plant
• Internal quality reports
• Problem resolution reports
• Customer plant returns and rejections
• Field return product analysis

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Plan and Define (Cont’d.)

TEAM EXPERIENCE
 The team may use other source of information such as:
• Input from higher system level or past Quality Function Deployment (QFD) projects
• Media commentary and analysis: magazine and newspaper reports, etc.
• Customer letters and suggestions
• TGR / TGW reports
• Dealer comments
• Fleet Operator’s comments
• Field service reports
• Internal evaluations using surrogate customers
• Road trips
• Management comments or direction
• Problems and issues reported from internal customers
• Government requirements and regulations
• Contract review

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Plan and Define (Cont’d.)

BUSINESS PLAN / MARKETING STRATEGY

 Customer business plan and marketing strategies will set the
frame work for APQP. Issues like timing, cost, investment, product
positioning, R&D may put constraints. The marketing strategies will
define the target customer, key sales point and key competitors
PRODUCT / PROCESS BENCHMARK DATA
 Benchmarking provides input for product / process performance
targets. R&D may provide benchmark and concept ideas. Methods
to successful benchmarking are:
• Identify appropriate benchmark
• Understanding the reasons for gap between current status and the benchmark
• Develop a plan to either close the gap, match the benchmark or exceed the
benchmark

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Plan and Define (Cont’d.)

PRODUCT / PROCESS ASSUMPTION

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

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Plan and Define (Cont’d.)

CUSTOMER INPUTS
 User of product provides valuable information relating to the needs
and expectations of customers. Additionally, user may have
conducted various studies and reviews on the product. Should be
used to develop agreed upon measures of customer satisfaction
DESIGN GOALS
 A translation of the voice of customer into tentative and measurable
design objectives. Assures that voice of customer is not lost
RELIABILITY AND QUALITY GOALS
 Reliability goals are established based on customer wants and
expectations, programme objectives and reliability benchmarks.
Should be expressed in terms of probability and confidence limits
 Quality goals are targets based on continual improvement

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Plan and Define (Cont’d.)

PRELIMINARY BILL OF MATERIAL

 Include bill of material based on product / process assumptions and early
sub-contractors list
PRELIMINARY PROCESS FLOW CHART
 Described anticipated manufacturing processes. Use preliminary BOM and
product / process assumptions
PRELIMINARY LISTING OF SPECIAL PRODUCT &
PROCESS
CHARACTERISTICS
 Customer and team identify based on knowledge of product and process.
List could be developed from
• Product assumptions based on the analysis of customer needs and expectations
• Identification of reliability goals / requirements
• Identification of special process characteristics from the anticipated manufacturing
process
• Similar part FMEAs
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Plan and Define (Cont’d.)

PRODUCT ASSURANCE PLAN

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

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Product Design and Development

 To develop design features and characteristics into near final

form
 Product Quality Planning Team should consider all design
factors in the planning process to ensure the final product
will satisfy the “Voice of the Customer”
 Design factors should be considered even if the
responsibility for design is owned by the customer or shared

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Product Design and Development

 Feasible design must permit meeting production volumes,

schedules, ability to meet engineering requirements with
quality, reliability, investment cost, weight, unit cost and
timing objectives
 Design planning process to assure comprehensive and
critical review

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Process Design and Development

 This section discusses the major features of developing a

manufacturing system and its related control plans to
achieve quality products
 The manufacturing system must assure that customer
requirements, needs and expectations are met
 Output established during product Design and Development
used as Input

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Product and Process Validation

• This section discusses the major features of validating the

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

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Product and Process Validation

 Production Trial Run (Contd.)
• Conduct Trial Run by using:
Production Tooling
Equipment
Environment
Operators
Facilities
Cycle Time

 Measurement Systems Evaluation

• Evaluate the measurement devices and methods used to check
the characteristics specified in the Control Plan
 Preliminary Process Capability Study
• Perform preliminary process capability studies on the
characteristics specified in the control plan (Preliminary process
capability study plan). This assessment help to evaluate process
readiness for production
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Product and Process Validation

 Production Part Approval

• The intent of product part approval is to validate that
products made from production tools and processes, meets
engineering requirements.
 Production Validation Testing
• Production validation testing refers to engineering tests that
validate that products made from production tools and
processes meet engineering standards.

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Product and Process Validation

 Packing Evaluation
• Assess the protection of the product from normal
transportation damages and adverse environmental factors.
Use test shipments & methods where feasible
 Production Control Plan
• A written description of the systems for controlling parts and
processes.
• A living document and should be updated to reflect the
addition / deletion of controls based on experience gained
by producing parts (Approval of the procuring
organization(s) may be required).
• Logical extension of the pre-launch control plan.
• Mass production provides the producer the opportunity to
evaluate output, review the control plan and make
appropriate changes.
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Product and Process Validation

 Quality Planning Sign-off and Management Support

• Ensure that all control plans and process flow charts are
being followed. It is suggested that the Product Quality
Planning Team performs its review at the manufacturing
location(s) and coordinates a formal sign-off. A review of the
following items prior to first production shipment is required:
Control Plans. Exist and be available at all times for all affected operations
Process Instructions. Verify that these documents contain all the Special
Characteristics specified in the control plan and that all PFMEA
recommendations have been addressed. Compare the process instructions and
process flow chart to the control plan
Gage and Test Equipment. Where special gages, fixtures, or test equipment are
required per the control plan, verify gage repeatability and reproducibility
(GR&R) and proper usage

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Product and Process Validation

 Quality Planning Sign-off and Management Support (Contd.)

• Management support is necessary prior to the quality planning
sign-off. The team should be able to show that all planning
requirements are met or concerns documented and schedule
a management review. The purpose of this review is to inform
upper management of program status and gain their
commitment to assist in any open issues. The Product Quality
Planning Summary and Sign-Off required to support an
effective quality planning sign-off

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Feedback, Assessment and Corrective Action

 Introduction
• Quality planning does not end with process validation and
installation
• It is the component manufacturing stage where output can be
evaluated when all special and common causes of variation
are present
• This is also the time to evaluate the effectiveness of the
product quality planning effort
It is the obligation of all suppliers to meet customer
requirements on all characteristics. Special Characteristics
must meet the indices specified by the customer
• Inputs & outputs of all previous phases used as inputs

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Feedback, Assessment and Corrective Action

 Reduced Variation
• Use Production Control Plan as the basis to evaluate
product or service. Use both variable and attribute data for
evaluation
• Supplier must ensure that
All characteristics meeting the requirements
Special characteristics meet the indices specified by the
customer
• Use control chart and other statistical technique to identify
process variation
• Use analysis and corrective actions to reduce variation
• Reduce continually variation because of special causes and
common causes
• Develop proposal for improvement in cost, timing and other
area for customer review

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Feedback, Assessment and Corrective Action

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

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Feedback, Assessment and Corrective Action

 Delivery and Service

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

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Production Part Approval Process

(PPAP)

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Why PPAP……………..
 The purpose of PPAP is to determine if
– Customer design record and specification requirements are
 Properly understood
 Process has potential to produce product consistently meeting
the requirements during an actual production run at the quoted
production rate.

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Submission Levels (cont’d)

 There are five different submission levels

– Level 1 - Warrant only (and for designated appearance items,
an Appearance Approval Report) submitted to the customer
– Level 2 - Warrant with product samples and limited supporting
data submitted to the customer
– Level 3 - Warrant with product samples and complete
supporting data submitted to the customer
– Level 4 - Warrant (no product samples) with complete
supporting data submitted to the customer upon request
– Level 5 - Warrant with product samples and complete
supporting data reviewed at the supplier’s manufacturing
location
LEVEL 3
It is the Default level, to be utilized for all submissions unless
specifically advised otherwise by the customer’s part approval activity

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Retention / Submission Requirements Table

Submission Level

Requirement Level 1 Level 2 Level 3 Level 4 Level 5

1. Part submission Warrant S S S S R

2. Appearance Approval Report S S S ** R
3. Sample product R S S ** R
4. Master sample R R R ** R
5. Design records R# S# S# ** R#
- f or proprietary components R# R# R# ** R#
6. Engineering Change documents (if any) R S S ** R
7. Dimensional results R S S ** R
8. Material performance Test results R S S ** R
9. Process flow charts R R S ** R
10. Process FMEAs R R S ** R
11. Design FMEAs R# R# S# ** R#
12. Control Plan R R S ** R
13. Initial Process studies R R S ** R
14. Measurement system studies R R S ** R
15. Checking aids R R R ** R
16. Customer specific requirement compliance R R S ** R
17. Qualif ied laboratory documents R S S ** R
18. Customer engineering approval (if required) R R S ** R

S - Submit to designated customer part approval activity. Retain copy at manufacturing location.
R - Retain at manuf acturing location. Available to customer representative upon request.
** - Submit upon customer request
# - Applicable if supplier has design responsibility

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Master Sample

 Master Sample: Physical Sample or Analytical Sample Record.

 Physical sample:
– Some bulk materials are stable and unchanging over an extended period of time
(e.g. they do not significantly change physical or chemical composition, if
properly stored, for decades). In this case, a physical sample will serve as Master
Sample.

 Analytical Sample Record: Other bulk materials change with time, but can
be precisely quantified by appropriate analytical techniques. In this case the
analytical record (e.g. Ultra- Violet or Infra- Red spectra “finger print”, e.t.c.) is an
appropriate Master Sample.

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PPAP Requirements

 PPAP requirements: General: The supplier shall obtain full

approval from the customer product approval activity for
– A new part or product (grade, color, thickness, e.t.c.).
– Correction of a discrepancy submitted part.
– Product modified by an engineering change to design records, specifications,
or materials (e.g. Drawings, specification).
– Customer Notification and Submission requirements.
– Use of other construction or material than was used in the previously
approved part or product.
– Production from new or modified tools/ dies, etc.
– Production from tooling and equipment transferred to a different plant
location or from an additional plant location.
– Change of sub-contractor for parts or service.

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PPAP Process Requirements

 PPAP PROCESS REQUIREMENTS

– Significant Production Run: for production parts, products for PPAP shall be
taken from a significant production [Link] production run shall be from one
hour to eight hours of production, and with the specific production quantity to
total a minimum of 300 consecutive parts, unless otherwise specified by the
authorized customer quality representative.
– This run shall be manufactured at the production site using the tooling, gauging,
process, materials, and operators from the production environment.
– Parts from each unique production process e.g. each position of a multiple cavity
die, shall be measured and representative parts tested.

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PPAP Requirements

PPAP Requirements
 Design Records: The supplier shall have all design records for the
saleable product, including design records.
 Any authorized Engineering Change Documents: The supplier shall
have any authorized engineering change documents not yet recorded in the
design record but incorporated in the product, part or tooling.
 Engineering Approval, when required: Where specified by the design
record, the supplier shall have evidence of customer engineering approval.
 Design FMEA: The supplier shall have a design FMEA developed in
accordance with the customer requirements.

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PPAP Process Requirements

 PPAP PROCESS REQUIREMENTS - contd...

– Process Flow diagrams: The supplier shall have a process flow diagram that clearly
describes the production process steps and sequence
– Process FMEA: The supplier shall have a Process FMEA developed in accordance
with the customer requirements
– Dimensional results: The supplier shall provide evidence that dimensional
verification required by the design record and the Control Plan have been completed
and results indicate compliance with specified requirements. The supplier shall have
dimensional results for each unique manufacturing process, e.g. all cavities of
mould/ die, etc.

 Records of material/ performance test results

 Material Test Results: The supplier shall perform tests for all part(s) and product
material (s) when chemical, physical or metallurgical requirements are specified by
the design record or Control plan.
 Performance Test Results: The supplier shall perform tests for all part (s) or
product material (s) when performance or functional requirements are specified by
the design record or Control Plan.

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PPAP requirements

 PPAP PROCESS REQUIREMENTS - contd.

– Initial Process Studies
 General: The level of initial process capability or
performance shall be determined to be acceptable prior to
submission for all special Characteristics designated by the
customer or supplier. The supplier shall perform measurement
system analysis to understand how measurement error is
affecting the study measurements.
 Quality Indices: Initial process studies should be summarized
with capability or performance indices, if applicable. Refer to
the Statistical Process Control reference manual for
information on evaluating stability and a detailed description
of Capability indices.
 Acceptance Criteria for Initial Study: The supplier shall use
the following as acceptance criteria for evaluating initial
process study results for processes that appear stable.
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 PPAP PROCESS REQUIREMENTS - contd.

PPAP requirements
 Index value >1.67- The process currently meets customer requirements.
After approval, begin production and follow Control Plan.
 1.33 /< (Index value) ./< 1.67- The process is currently acceptable but may
require some improvements.
 Index Value< 1.33 - The process does not currently meet the acceptance
criteria.
 Unstable Process- Depending upon nature of the instability, an unstable
process may not meet customer requirements.
 Process with one- sided specifications or non- normal distributions The
supplier shall determine with the customer an alternate acceptance criteria
fro processes with one sided specifications or non- normal distributions.
 Strategy when acceptance criteria are not satisfied: The supplier shall
contact the customer if the process cannot be improved.

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PPAP requirements

– PPAP PROCESS REQUIREMENTS - contd.

– Measurement system Analysis studies: The supplier shall
have applicable Measurement System Analysis Studies, e.g.
gauge R & R, bias, linearity, stability studies for all equipment
used for new or modified gauges, measurement and test
equipment. For details Refer Measurement System Analysis
Manual
– Qualified Laboratory Documentation:The supplier shall have
a laboratory scope and documentation showing that laboratory
used comply with ISO/TS 16949 requirements.

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PPAP requirements

– PPAP PROCESS REQUIREMENTS - contd.

– Control Plan: The supplier shall have a Control Plan that
defines all controls used for process control and complies with
QS 9000/ ISO/TS 16949 requirements
– Part Submission Warrant: Upon satisfactory completion of
all required measurements and tests, the supplier shall record
the required information on the Part Submission Warrant
(PSW). A separate PSW shall be completed for each customer
part number unless otherwise agreed to by the customer.

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PPAP requirements

– PPAP PROCESS REQUIREMENTS - contd.

– Appearance Approval report: A separate Appearance
Approval report (AAR) shall be completed for each part or
series of parts for which a submission is required if the product/
part has appearance requirements on the design record.
– Bulk Material requirements: For bulk material, The Bulk
Material requirement Check list shall be jointly agreed upon by
the customer and supplier.

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PPAP requirements

– PPAP PROCESS REQUIREMENTS - contd.

– Sample production Parts: The supplier shall provide sample
product as requested by the customer and as defined by the
submission request.
– Master sample: The supplier shall retain a master sample for
the same period as the production part approval records. The
supplier shall retain a master sample for each position of a
multiple cavity die, mould, etc.

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PPAP requirements

–PPAP PROCESS REQUIREMENTS - contd.

–Checking Aids:If requested by the customer, the
supplier shall submit with the PPAP submission any
part- specific assembly or component checking aid.
–Customer specific Requirements:The supplier shall
have records of compliance to all applicable customer
specific requirements.

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Part Submission Status

 Part Submission status

– Customer PPAP status
 Full approval: Parts or material can be shipped as per schedule
 Interim approval: Parts or material can be shipped for a limited time or quantity
only
 Rejected: Corrected product and documentation shall be submitted and approved
before production quantities may be shipped.

 Record Retention
– Production part approval records, regardless of submission
level, shall be maintained for the length of time that the part is
active plus one calendar year.

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Measurement System Analysis

(MSA)

Is our Data Accurate?

• Gauge R & R is a means of assessing the

repeatability and reproducibility of our
measurement systems.

• Gauge R & R studies are carried out in order to

discover how much of the process variation is
due to the measurement device and
measurement methods.

?
Dimension

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Measurement Accuracy & Precision

Measurement is accurate Measurement is precise but

but not precise not accurate

Measurement is accurate
and precise

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Measurement System Variation

Bias

Accuracy Linearity

Measurement
System Stability
Variation
Repeatability
Precision
Reproducibility

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Bias

Bias

True Observed
Value Average

Bias is the difference between the observed

average of the measurements and the true
value.

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Linearity

Non-Linearity
Gauge is measuring lower
Measured Value

than true value at high

end

Reference Value

Linearity is the difference in bias values over the

expected operating range of the measurement
gauge.

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Stability

Stability

Time Time
1 2

Stability is the variation (differences) in the average

over extended periods of time using the same gauge
and appraiser to repeatedly measure the same part

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Repeatability

Repeatability

Repeatability is the variation between

successive measurements of the same part,
same characteristic, by the same person using
the same gauge.

Also called Equipment Variation- EV

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Reproducibility

Reproducibility

Operator Operator
1 2

Reproducibility is the difference in the average of the

measurements made by different people using the
same instrument when measuring the identical
characteristic on the same pieces.
Also called Appraiser Variation- AV
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Measurement System Variation

Bias

Accuracy Linearity Calibration

Stability

Repeatability
Gauge R&R
Precision
Reproducibility

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Gauge R & R

• Gauge R & R is a means of assessing the

repeatability and reproducibility of our
measurement systems.

• Gauge R & R studies are carried out in order to

discover how much of the process variation is
due to the measurement device and
measurement methods.

?
Dimension

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Variable Gauge R&R

Part-to-Part
Variation
Operator
Overall
Variation Reproducibility
Operator
Measurement
by part
System
Interaction
Variation

Repeatability

We want the Part-to-Part component to be large!

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Is the Gauge Good?

% P/T
(6R&R/Process Tolerance) Acceptability

0 - 10% Very Good (Six Sigma Gauge)

10 - 30% May be Acceptable

>30% Probably Not Acceptable

The interpretation will also depend

on the current level of process
variation
Note that these guidelines are as recommended in ”Measurement Systems Analysis Third Edition” published in March 2002 as
part of QS-9000 and developed in conjunction with AIAG.

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Improving the Measurement System

Gauge incapable:
• Repeatability (Gauge)
• Take multiple measurements and use average (short term fix)
• Mistake proofing (e.g. provision of tooling to hold part during
measurement)
• May need maintenance

• Reproducibility (Operators)
• Use 1 operator (short term fix during improvement only)
• Have several operators measure the part and take the average (short
term fix)
• Ensure consistency (training, SOPs, WIS, …)
• Mistake proofing (e.g. provision of tooling to hold part during
measurement)
• Calibrations on the gauge dial may not be clear

• Reproducibility Operator x Part Interaction

• Identify cause of interaction and then as Operator
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Destructive Gauge R&R (Nested Study)

• Destructive gauge testing means that it is

impossible to carry out repeat tests!

• To complete an assessment of a destructive

gauge it is therefore necessary to assume
homogeneity within batches.

• Ifthere is much more difference in parts between

batches than within batches, then a standard
variable Gauge R & R may be sufficient.

64

Attribute Gauge R&R

 A Gauge R&R study can also be carried out on attribute data

 Using attribute data, we would have a problem with the measurement system
if:

– Operators disagree with each others’ evaluation of a piece

– The same operator gains different results from a repeat evaluation of the
same piece

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Attribute Measurement System

 An attribute measurement system compares each part to a standard and either
accepts or rejects the part.

 The screen effectiveness is the ability of the attribute measurement system to

properly discriminate good from bad.

 Screen effectiveness of 100% is desirable.

1. Select a minimum of 30 parts from the process. These parts should represent
the full spectrum of process variation (good parts, defective parts, borderline
parts).
2. An “expert” inspector performs an evaluation of each part, classifying it as
“Good” or “Not Good.”
3. Independently and in a random order, each of 2 or 3 operators should assess
the parts as “Good” or “Not Good.”
4. Calculate effectiveness scores.

66

Failure Modes & Effects Analysis

(FMEA) AIAG V04

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Introduction to FMEA

 Failure Mode and Effects Analysis, FMEA is:

– A systematic method of identifying and investigating potential design or process weaknesses.

– A means to evaluate and manage product risks.

– A means of evolving organizational knowledge.

 Developed in the aerospace industry in the mid 1960’s

 Also sometimes referred to as Failure Mode Effect and Criticality Analysis, FMECA

68

Application of FMEA in Six Sigma

 In Design for Six Sigma - (Design FMEA) :

– to identify potential failure modes
– to identify potential causes of failure
– to eliminate/minimise the potential failure modes within the Design
process

 In Transactional/Operational Six Sigma (Process FMEA) :

– to analyse the existing processes (identify possible x’s)
– to improve the process (elimination/reduction of failure modes)
– to select new process alternatives
– to develop control plans

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[Link]
Process
[Link] [Link]
Results Functions

[Link] Action Process FMEA Roadmap [Link] Potential Failure

Modes

[Link] Risk [Link] Effects of

Failure

[Link] [Link]
Controls Causes

Step 6: Current Controls

Identify the current controls to prevent / detect

the failure before it reaches the customer
[Link]
Controls

In order of preference there are three types of current

controls :
1. Prevent the cause
2. Detect the cause, leading to corrective action
3. Detect the failure (defect)

These might include:

• Control Charts
• Check Sheets
• Mistake Proofing
• Training
• Information Technology

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Step 7: Calculate Risk

[Link]
Risk

Probability Detection Risk

Severity of of
X
Occurrence X (Capability of = Priority
the Effect Current Controls) Number

72

Process FMEA Severity Rating

Rank Effect Severity of Effect on Product

Affect safe vehicle operation and/or involves noncompliance with government

10 Failure to meet Safety regulation without warning.
and/or Regulatory
requirements Affect safe vehicle operation and/or involves noncompliance with government
9
regulation with warning.
Loss of primary function (vehicle inoperable, does not affect safe vehicle
8
Loss or degradation of operation).
Primary function Degradation of primary function (vehicle operable but at reduced level of
7
performance).
Loss of secondary function (vehicle operabel, but comfort / convenience functions
6
Loss or degradation of inoperabel).
Secondary function Degradation of secondary function (vehicle operabel, but comfort / convenience
5
functions at reduced level of performance).
Appearance or Audible Noise, vehicle operable, items does not conform and
4
noticed by most customers (>75%)
Appearance or Audible Noise, vehicle operable, items does not conform and
3 Annoyance
noticed by many customers (50%)
Appearance or Audible Noise, vehicle operable, items does not conform and
2
noticed by discriminating customers (<25%)

1 No effect No discernible effect.

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Process FMEA Occurrence Rating

Occurance of Cause
Rank Likehood of Failure
(Incident per items/vehicles)
> 100 per thousand
10 Very High
> 1 in 10
50 per thousand
9
1 in 20
20 per thousand
8 High
1 in 50
10 per thousand
7
1 in 100
2 per thousand
6
1 in 500
0.5 per thousand
5 Moderate
1 in 2000
0.1 per thousand
4
1 in 10000
0.01 per thousand
3
1 in 100000
Low
< 0.001 per thousand
2
1 in 100000
Failure is eliminated through
1 Very Low
preventive control

74

Process FMEA Detection Rating

Rank Likehood of Failure Likelihood of Detection by process control

No detection opportunity
10 No current process control; Cannot detect or is not analyzed.
(Almost impossible)
Not likely to detect at any stage
9 Failure mode and/or error (Cause) is not easily detected (e.g. random audits)
(Very remote)
Problem detection post
Failure mode detection post - processing by operator through visual/ audible
8 processing
means.
(Remote)
Problem detection at source Failure mode detection in-station by operator through visual / audible means
7
(Very low) or post processing through use of attribute gauging.
Problem detection post
Failure mode detection post-processing by operator through use of variable
6 processing
gauging or in-station by operator through use of attribute gauging.
(Low)
Error detection in-station by operator thorugh use of variable gauging or by
Problem detection at source
5 automated controls in-station that will detect discrepant part and notify
(Moderate)
operator (light, buzzer etc)
Problem detection post
Failure mode detection post-processing by automated controls that will detect
4 processing
discrepant part and lock part to prevent further processing.
(Moderately high)
Problem detection at source Failure mode detection in-station by automated controls that will detect
3
(High) discrepant part and lock part to prevent further processing.
Error detection and/or problem Error detection in-station by automated controls that will detect error and
2
prevention (Very high) prevent discrepant part from being made.
Detection not applicable; Error Error prevention as a result of fixture design, machine design or part design.
1 75
prevention (Almost certain) Discrepant parts can not be process/product design.

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Step 8: Take Action

Failure Mode
[Link]
Action Incorrect Stock Check
Effect
• Incomplete order, delay, customer Severity = 3
dissatisfaction

Cause
• Multiple orders in process Occurrence = 3

Current Controls
• No Controls Detection = 5

Stock is temporarily reserved

RPN = 3 x 3 x 5 = 45 against enquiry
76

Step 9: Assess Results

Review corrective actions and modify

RPN figure based on results.
[Link]
Results
Before Improvement
Reduced
Risk
RPN

After Improvement

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FMEA Form
FAILURE MODE & EFFECTS ANALYSIS – PROCESS FMEA

Product: PROCESS FMEA No. Page : of

Application: Issue No. Originators:
Customer: Date:

ITEM PROCESS POTENTIAL POTENTIAL POTENTIAL CURRENT RECOMMENDED RESP. ACTION RESULTS
FUNCTION FAILURE MODE EFFECTS OF SEV CAUSE(S) OF FAILURE OCC CONTROLS DET RPN ACTIONS FOR ACTIONS SEV OCC DET RPN
FAILURE ACTION TAKEN
3 Checks Incorrect Incomplete 3 Multiple orders in process 3 No controls 5 45 Stock reserved SCB 18.08.03 3 3 2 18
sufficient stock Stock Check order, against enquiry
(Concludes delay,
sufficient customer
stock when dissatisfacti
insufficient on
available)

78

Statistical Process Control

(SPC)

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 Statistical Process Control is a method of

monitoring and detecting changes in processes.
 SPC uses an advanced form of Time Series plots.
 SPC provides an easy method of deciding if a
process has changed (in other words, is the process
“in-control”?).

80

WHY SPC….

This is necessary to :

 Reduce scrap and rework

 Improve overall quality

 Increase productivity

 Compete in today’s world markets

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DATA GATHERING

• What is Data ?
Data is a numerical expression of an activity.

Conclusions based on facts and data are

necessary for any improvement.
-K. Ishikawa

If you are not able to express a phenomenon in

numbers, you do not know about it adequately.
-Lord Kelvin
82

TYPES OF DATA

CONTINUOUS DISCRETE
Measurable Nominal
e.g. :Length, Temperature e.g. :Number of defects

Ordinal
e.g. :Ranking in Customer
feedback

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WHICH OF THE BELOW ARE CONTINUOUS AND DISCRETE DATA?

 Width of sheet
 No. of liners thinned
 Tubes rejected by Go- No go Gauge
 Diameter of Piston
 Height of a Man

 Sheet thickness
 Out of 100 sheets the numbers that meet the thickness 4  0.9
 Time taken to process a purchase order
 No. of bugs in a program

84

SOURCES OF FALSE DATA

• Fear : Because of unfavorable results
• Frustration : Because of non-use or misuse of data
“Data must be collected, not cooked”.

CAUSES FOR MISTAKEN DATA

• Wrong choice of instrument
• Lack of calibration
• Improper sampling
• Lack of standards
• Inadequate test facilities
• Lack of training
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WHAT IS THE MEASURE

OF CENTRAL TENDENCY OF A SET OF NUMBERS?

 There are three ways in which Central Tendency of

Numbers can be measured.

 These are the 3 M’s

MEAN
MEDIAN
MODE

86

MEAN

Mean or Average is normally signified by

Summation of all the values

Mean 
Number of values

Mathematically it can be represented as :

n

X i
X  i1

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MEAN CAN ALSO BE FOUND

AS FOLLOWS
Summation of product of mid point of class and its frequency
Mean 
Summation of frequency

f X i i
i 1
Mathematic ally , X  n

f
i 1
i

88

MEDIAN

 This is the value which has equal number of

values above it and below it, when arranged in
ascending /descending order.
 Mathematically :
th th
 n n 
   Value    1  Value
  2   2  ; when n is even
 2

Median  

 th
 n  1 
  2  Value ; when n is odd


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MODE

This is the value which occurs with the

highest frequency.

•We have thus calculated, The Mean, Median and Mode for a
given data set
•The Mean, Median and Mode are equal for a symmetric
unimodal distribution.
•They are not equal if distribution is not symmetric.

90

MEASURES OF DISPERSION

 The extent of the spread of the values from the

mean value is called Dispersion.

 The measures of Dispersions are

– Range (R)
– Standard Deviation (s)
– Variance (s 2)
– Co-efficient of Variation (CV)

 Standard deviation is the most commonly used measure of

dispersion.

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STANDARD DEVIATION

OF POPULATION:

If X , X ,......., X are sample values and  is their poulation mean.

1 2 n

 (X -  )
2
( X   )  ( X   )  .....  ( X   )
2 2 2
i
  1 2 n
 i 1

n n

OF SAMPLE :
If X 1 , X 2 ,......., X n are sample values and X is their sample mean.
n

 (X - X )2
( X 1  X ) 2  ( X 2  X ) 2  .....  ( X n  X ) 2 i 1
i
sn-1 
( n  1) (n - 1)

92

Range, R = Largest Observation - Smallest Observation

= Xmax -Xmin

Variance (s2 ) is the Square of Standard Deviation.

SD s
C oefficient of Variation, CV  
Mean X

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Process Control

• Process control refers UCL

to the evaluation of
LCL
process stability over
0 5 10 15 20 25
time Time

LSL USL
• Process Capability
refers to the evaluation
of how well a process
meets specifications

94

Variation

 fundamental law of nature that no two things are exactly alike.

 Even “Identical Twins” are different from one another in some ways.
 The same is true of all parts produced in a manufacturing operation.

 If we could measure with enough precision, we would see that No

two parts are truly identical.
 We call these differences Variation.

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Relationship Between Input & Output Variation

Transmission of Variation, y = f(x)

Transmitted
O Variation
Relationship Between
U
Input and Output
T
P
U
T

Variation of Input

INPUT

96

Total Variation

Within Subgroup
Variation

Between Subgroup Total

Variation Variation

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Variation

Control Limits Use Within Subgroup Variation

 The total variation and Within Subgroup variation are the same
only if the process is stable

 The Within Subgroup variation is an estimate of what the total

variation would be if the process were stable

 The Within Subgroup variation is used to calculate the control

limits since these limits represent the range of values expected
for a stable process

98

Causes of variation

TYPES OF CAUSES OF VARIATION

COMMON CAUSE SPECIAL CAUSE

* Process under influence of
* Process under influence of special causes will not be stable
common causes will always and repeatable.
be stable and repeatable.
* Not always present in a
* Always present in a process process.

* Output of the process will * Output of the process will

be predictable not be predictable.

* Almost always needs a * Almost always needs a local

management action on action usually by people
system for correction. close to the process for
correction.
* Almost 85% of the total
causes are common causes * Almost 15% of the total
causes are special causes
* PROCESS IS SAID TO BE * PROCESS IS SAID TO BE OUT
UNDER STATISTICAL CONTROL OF CONTROL

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CONTROL CHART

100

A SHEWHART CONTROL CHART LOOKS LIKE THIS

Upper Control Limit = Target + 3 SD

S ample quality
characteristic

Target

Lower Control Limit = Target - 3 SD

S ample Number or Time

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Control Charts Flow

CHOOSING A CONTROL CHART
Determine
Data Type
u-chart

Y or N
Attribute
Attribute or Defects
(data discrete) Defects Inspection Y
Variable or Defective c-chart
unit same?
Data? Units?
Variable
(data Defectives
continuous)

IX-MR Y Sample
Chart Size=1? Sample Y or N
p-chart
SizeConstant?

N
Y

Xbar-R Y Sample N Xbar-S np-chart

Chart Size<10? Chart

102

The X-bar And R Chart

When to Use:
When studying the behavior of a single measurable characteristic produced in relatively
high volumes.

How:
By plotting sample averages (X, pronounced X-bar) and ranges (R) on
separate charts. This allows for independent monitoring of the process
average and the variation about that average.

Conditions:
• Constant sample size.
• One characteristic per chart.
• Should have no less than 20 samples before calculating control limits.

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Formula for The X-bar and R Chart

Chart Control limits Centerlines Plot point Sample size

UCL = X-dbar + A2. Rbar

X-dbar =
X-bar Xbar =X/n
X-bar/k
LCL = X-dbar - A2. Rbar
2 to 9 but
3 to 5
preferred
UCL = D4. Rbar
Rbar = 
R R
R/k
LCL = D3. Rbar

104

Xbar, R Chart

X, R Chart
14
UCL =13.1
12
X = 11.2
10
LCL = 9.3
8
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

6 UCL = 5.9

4
R = 2.6
2

0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

An X bar, R chart uses the variation within subgroups to establish limits for the averages of
the subgroups. When there is more variation between subgroups than within subgroups, a
special cause will be signaled. The chart will NOT detect special causes within a subgroup.
Selection of the subgroups is of primary importance..

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Xbar, R Charts Features

Data points = Xs X, R Chart Centerline = average of the Xs

14
UCL =13.1
12
X = 11.2
10
LCL = 9.3
8
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

Chart of Subgroup Averages (Xs) appears on top;

Chart of Subgroup Ranges appears immediately below

6 UCL = 5.9

R = 2.6
2

0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

Centerline = average of
Data points = the subgroup ranges
Subgroup ranges

106

Interpreting Control Charts….1

The control charts would indicate that a process is out

of control if either one of these is true:
1. One or more points fall outside the control limits
2. When the control chart is divided into 3  zones, as
shown below:
a. Nine consecutive points are on one side of the average.
b. There are six consecutive points, increasing or decreasing. Zone A
c. There are fourteen consecutive points that alternate up or
down. Zone B
d. Two points, out of three consecutive points, are on the Zone C
same side of the average in Zone A or beyond.
e. Four points, out of five consecutive points, are on the Zone C
same side of the average in Zone B or beyond.
Zone B
f. There are fifteen consecutive points within Zone C (above
and below the average) Zone A
g. There are eight points in a row in zone B or beyond

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Interpreting Control Charts….2

108

Interpreting Control Charts….3

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CAPABILITY RATIOS
Cp, Cpk, Pp, Ppk

110

Process Capability, Cp Index

 Defined as:

USL  LSL  LSL

Cp   USL
6Within  
6 R 
 d2 
 USL-LSL represents the width of the spec

 6Within represents width of process (±3)

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PROCESS POTENTIAL INDEX (Cp)

The numerator is
controlled by Design
Engineering
Maximum Allowable Range of Characteristic
Cp =
Normal Variation of Process

The denominator is controlled by

Process Engineering

112

USL - X
Cpu 
3s
This gives us the positioning of the mean vis-a-vis the USL
and the relationship between the two.
X  LSL
Cpl 
3s
This gives us the positioning of the mean vis-a-vis the LSL
and the relationship between the two.
Cpk - Process Performance Index. This is important

Cpk = Minimum of (Cpu and Cpl) ; for bilateral tolerances

+Y
= Cpu ;for unilateral tolerance on upper side i.e.. X -O
+O
= Cpl ;for unilateral tolerance on lower side i.e.. X -Y
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Process Capability, Cp Index

USL

Cp = 0.5 Cp = 1 Cp = 1.5 Cp = 2

LSL

114

Process Capability, Cpk Index

 Defined as:

min( USL  X , X  LSL) R

Cpk  Within
3Within d2
 Numerator represents the distance
to the nearest spec

 Denominator represents the amount of this distance consumed by variation

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Process Capability, Cpk Index

Numerator
LSL USL
Denominator

Target

116

Cpk When Cp=2

USL
Cpk = 0.5
Cpk = 1
Cpk = 1.5
Cpk = 2
Cpk = 1.5
Cpk = 1
Cpk = 0.5

LSL

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Cpk = 1

USL

Cp= 2

Cp= 1
Cp= 2 Cp= 4

LSL

118

Cpk and Cp

 Cpk  Cp

 Cpk = Cp only when the process is perfectly centred

 Cp represents the highest possible value for Cpk

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One Spec Limit

 Cp is not defined – requires 2 spec limits

 Cpk can still be calculated – requires only one spec

limit

120

IMPORTANT SPC RATIOS USED

Maximum allowable range of characteri stic

Pp 
Long Term Normal variation of process
Tolerance USL - LSL
 
6sLT
6s LT

• Pp is based on same equation as Cp with one exception;

Pp employs the long term standard deviation (whereas Cp
employs the short term standard deviation).

• Ppk is based on same equation as Cpk with one

exception; Ppk employs the long term standard deviation
(whereas Cpk employs the short term standard deviation).

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Cpk / DPM Conversion Table

• We need a minimum Cpk value of 1.5 to achieve 3.4 DPM

when we have a stable process
• We can test for stability and calculate Cpk for variable data
using the Capability Study described earlier

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