Good Morning

Learning Objectives
Understanding APQP (Advanced Product
Quality Planning)
Production Part Approval Process (PPAP)
Purpose
Benefits
Standards
When is PPAP required?
PPAP submission levels
Elements of PPAP and its importance
Design Records
Process Flow Diagram
DFMEA & PFMEA
Control Plan
MSA
Initial Process Capability Study

Advanced Product Quality

Planning (APQP)

Advanced Product Quality Planning

Advanced
Product
Quality
Planning
accompanies the development of a product
and is intended to ensure that all of the
customer's requirements are met. The
objective is to provide a quality product at
the right time.

Advanced Product Quality Planning

Advanced Product Quality Planning

Definition phase
During the definition phase, design work is carried out on
products and processes and project planning takes place. The
quotation is then prepared on the basis of the results.
Prototype phase
During the prototype phase and working from the product
design, the product function is developed and proven with the
help of the Design Verification Plan (DVP). A product design is
drawn up and developed as far as the initial layout.

Advanced Product Quality Planning

Optimization phase
During the optimization phase, products and processes are
coordinated as well as matters between the customer and the
supplier. Production is also planned in detail and details
relating to packaging and logistics are also fixed.
Pre-production phase
During the pre-production phase, volume production
equipment is set up, installed and subjected to a final
inspection. The relevant personnel are trained accordingly.
Initial production samples are produced and pilot
production initiated for the purpose of process optimization.

Advanced Product Quality Planning

Ramp-up phase
The
ramp-up
phase,
which follows the start of
production,forms
a
transition
from
the
development phase to the
stable production phase.
The ramp-up of volume
production
is
accompanied by a project
team. All measures that
are required in order to
achieve the productivity
and cost objectives are
introduced.

APQP Elements
APQP 1 - Sourcing Decision
Formal commitment of the customer to work with the supplier (customer order,
Nomination Letter etc.) so that investments can be effected on schedule.
APQP 2 - Customer Specifications
To avoid misunderstandings in Customer specifications include the design criteria and
program requirements, e.g. drawings, specifications (Note if material or
coating/plating, etc. is not included on the drawing or in specifications, then there must
be a sign off between engineering, purchasing, and supplier prior to issue of purchase
order) and design requirements which are necessary for the introduction of the
supplier's APQP.
APQP 3 - Contract Review
To carry out a commercial and technical assessment of the documents provided by the
customer to check that they are complete, up-to-date and feasible.
APQP 4 - Craftsmanship
To define characteristics relating to appearance, texture, handling ability, noise and
smell.

APQP Elements
APQP 5 - Design-FMEA
To prevent defects during product development
APQP 6 - Design Review
To prevent misunderstandings and problems; to monitor the progress of measures
and to ensure that objectives are met
APQP 7 - Design Verification Plan DVP
To provide a clear illustration of the progress that a subcontractor is making on a
project
APQP 8 - Quality Planning for Subcontractor
To provide a clear illustration of the progress that a subcontractor is making on a
project
APQP 9 - Facilities, Tools
To obtain capable/released operating materials from initial samples onwards

APQP Elements
APQP 10 - Inspection Methods and Equipment
To obtain capable/released inspection equipment, which is suitable for the measuring task
required of it, from initial sampling onwards; planning (monitoring of dates) and provision
of all necessary inspection equipment; acceptance in accordance with the criteria of MSA
(ISO 9000/TS16949).
APQP 11- Inspection Method
To achieve uniform inspection methods
APQP 12 - Contingency Plan
Aim: To ensure the guaranteed delivery quantities and product quality in the event of
broken tooling, machine failures or other unforeseen events
APQP 13 - Prototype Build Control Plan/Inspection Plan
Aim: To secure the prototype quality and planning instruments for purchasing inspection
equipment
APQP 14 - Production/Inspection of Prototype Parts
Aim: To dispatch, on schedule, prototypes which meet cost and quality requirements

APQP Elements
APQP 15 - Drawings/Specifications (Design Freeze)
To provide, on schedule (customer/supplier), all drawings and specifications that
are needed to observe the initial sample date/start of production (SOP).
APQP 16 - Confirmation of Manufacturing Feasibility
To assess production feasibility (volume) relative to the intended design
APQP 17 - Process Flow Diagram and Production Layout
To provide a foundation for investment planning, System FMEA Process / Process
FMEA, production plan, control plans and visual aids
APQP 18 - Logistics/Supply Concept
To ensure delivery capability
APQP 19 - Process Freeze
To ensure that there are no problems at start of production
APQP 20 - Process FMEA
To prevent defects during process development

APQP Elements
APQP 21- Measurement Systems Evaluation and Inspection Equipment Capability
To evaluate the suitability (scatter) of inspection equipment for the required
measurement task
APQP 22 - Pre-production Inspection Plan/Pre-launch Inspection Plan
To ensure that process and product requirements are implemented
APQP 23 - Process Instructions
To ensure quality and quantity
APQP 23 - Packaging Materials and Specifications
To maintain the quality achieved
APQP 24 - Production Trial Run
To ensure that volume production starts without any problems and that the requested
values are observed (cost - profitability)
APQP 25 - Production Control Plan
To ensure that process and product requirements are implemented

APQP Elements
APQP 26 - Preliminary Process Capability Study
To provide statistical proof of capable processes
APQP 27 - Technical Tests on Production Parts
To confirm that the parts meet technical standards/customer
requirements.
APQP 28 - Initial Sampling Inspection
To provide proof of product and process release.

APQP PROCESS FLOW

Organize the Team
Define the Scope
Establish Team-toTeam Communication
Provide Core Tools
Training
Involve Customers
and Suppliers
Implement
Simultaneous
Engineering
Develop Control
Plan Format
Decide on Concern
Resolution

Voice of the

Reliability and
Quality Goals

Business
Plan/Marketing
Strategy
Product/Process
Benchmark Data
Product/Process
Assumptions
Product Reliability
Studies

Design Failure Mode

and Effects Analysis
(DFMEA)

Packaging Standards
Product/Process
Quality System Review

Preliminary Bill of
Material

Design for
Manufacturability and
Assembly

Preliminary Process
Flow Chart

Design Verification

Characteristics Matrix

Design Reviews

Process Failure Mode

and Effects Analysis
(PFMEA)

Preliminary Listing
of Special Product
and Process
Characteristics
Product Assurance
Plan
Management
Support

Develop Product
Quality Timing Plan

Prototype Build
Control Plan
Engineering Drawings
(Including Math Data)
Engineering
Specifications
Material Specifications
Drawing and
Specification Changes
New Equipment,
Tooling and Facilities
Requirements

FMEA

Process Flow Chart

Floor Plan Layout

Pre-Launch Control
Plan

INPUT

OUTPUT

Production Trial
Run
Measurement
Systems Evaluation

Production Part
Approval
Production
Validation Testing
Packaging
Evaluation

Measurement Systems
Analysis Plan

Production Control
Plan

Preliminary Process
Capability Study Plan

Quality Planning
Sign-Off and
Management Support

Gages/Testing
Equipment
Requirements

APQP

Customer
Satisfaction
Delivery and Service

MSA

PPAP

Management Support

Special Product and

Process Characteristics

Team Feasibility
Commitment and
Management Support

Reduced Variation

Preliminary
Process Capability
Study

Process Instructions

Packaging
Specifications

OUTPUT

Feedback,
Assessment and
Corrective Action

Product and
Process
Validation
INPUT

OUTPUT

Process Design and

Development

INPUT

OUTPUT

INPUT

Design Goals

Customer

Customer Inputs

Product Design
and Development

OUTPUT

Plan and Define Program

INPUT

Prepare for
APQP

SPC

What is PPAP?
Production Part Approval Process
Standard used to formally reduce risks
prior
to product or service release,
in a team oriented manner using well
established tools and techniques
Initially developed by AIAG (Auto Industry
Action Group) in 1993 with input from the
Big 3 - Ford, Chrysler, and GM
AIAGs 4th edition effective June 1, 2006 is
the most recent version
PPAP has now spread to many different
industries beyond automotive

The Purpose of PPAP

A) If all customer engineering design records and specification
requirements are properly understood by the supplier
(Customer and Supplier have a common understanding of
Customer requirements)

B)The process has potential to produce parts consistently

meeting the requirements during an actual production run at
the quoted production rate (Is the process capable of
meeting customer requirements during on going production
process)

Applicability of PPAP
PPAP shall apply to External and internal
suppliers sites of:
Bulk Material
Production Material
Production Parts
Service Parts
For Bulk material PPAP is not required unless
asked by the customer.
A supplier of production parts / service parts
shall comply with the PPAP requirements unless
the same is formally waived by the Customer
(documented evidences should be available)

Application

Something
Changed

AIAG (Automotive
Industry Action Group)
PPAP manual defines
when PPAP submission
is required
New part
Correction to discrepancy
in previous submission
Design or process change
Change in source of
subcontracted materials
or services
transfer or

Benefits of PPAP
submission
Helps to maintain design integrity
Identifies issues early for resolution
Reduces
warranty
charges
and
prevents cost of poor quality
Assists
with
managing
supplier
changes
Prevents use of unapproved and
nonconforming parts
Identifies suppliers that need more
development
Improves the overall quality of the
product & customer satisfaction

PPAP Process Requirements

SUBMISSION TO CUSTOMER LEVELS OF EVIDENCE

Submission Levels
The supplier shall submit the items and/or records specified by
the level as requested by the customer.
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 and other requirements as defined by the
customer.
Level 5 - Warrant with product samples and complete supporting
data available for review at the suppliers manufacturing location.

PPAP Levels for Submission and Retention

Definition of Risk
High Risk
Parts associated with multiple critical features, complex
design, or high end technology that is not yet
established in the general manufacturing environment
Suppliers quality system and/or quality performance is
not to Customers satisfaction
Medium Risk
Parts that have at least one critical feature
Low Risk
Parts that have no critical features and can be
manufactured by any manufacturer in the commodity
category
Suppliers quality system and quality performance are

New
Parts
acceptable

Level 2 is required for Low Risk Parts

Level 3 is required for Medium and High Risk Parts

Part Changes
Level 3 is required for Parts produced at a new or additional location
Supplier Quality Excellence will define the level required for all other changes

PPAP Status.
Approved
The part meets all Customer
requirements
Supplier is authorized to ship
production quantities of the part

Interim Approval
Permits shipment of part on a
limited time or piece quantity basis

Rejected
The part does not meet customer
requirements,
based
on
the
production lot from which it was

Official PPAP Requirements

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.

Design Records
Authorized Engineering Change Documents
Customer Engineering Approval, if required
Design Failure Modes and Effects Analysis (DFMEA) applied in
special situations
Process Flow Diagram
Process Failure Modes and Effects Analysis (PFMEA)
Control Plan
Measurement Systems Analysis (MSA)
Dimensional Results
Records of Material / Performance Test Results
Initial Process Studies
Qualified Laboratory Documentation
Appearance Approval Report (AAR)
Sample Production Parts
Master Sample
Checking Aids
Customer-Specific Requirements
Part Submission Warrant (PSW)

1. Design Records
Design Records and & Bubbled Part Prints
Purpose:
To document & provide a copy of the formal part print.
All part prints must have clearly defined CTQs
To provide any additional engineering records for reference.
All submissions should have one copy of the formal print
Bubble print that supports the dimensional report.
Must have all notes and specifications circled and
numbered.
Must be clear and legible.
Any additional supporting information including
Reference prints
Sub-assembly prints
Component prints with a different part number
Applicable specifications

Design Record Check

List
Must be a clean and legible Bubble print
Must have correct Part Number and Revision No.
Every requirement must have a separate bubble
Dimensions
Notes
CTQs are identified
Referenced specifications
Verify that no other prints need to be submitted
Sub-assemblies
Component level detail

2. Engineering Change
Documents

The
supplier
shall
provide
authorized change documents
for those changes not yet
recorded in the design record,
but incorporated in the product,
part or tooling, such as:
ECNs (must be approved, not pending)
Specifications
Feasibility studies Advantages
Supplier change requests
Sub-assembly drawings
Life or reliability testing requirements

3. Customer Engineering
Approvals
Purpose:
To demonstrate pre-approval by Customer
to produce a product
Required only when customer demands

FMEA
Failure Mode and Effects
Analysis
What we learn?
What is it?
Motivation
FMEA Methods
Example
FMEA in-class exercise

What is FMEA?
Failure Mode & Effect
Description: Analysis
A procedure that examines each item
in a system, considers how that item
can fail and then determines how that
failure will affect the system
A structured approach to:
Identifying the ways in which a product or process can fail
Estimating risk associated with specific causes
Prioritizing the actions that should be taken to reduce risk
Evaluating design validation plan (product) or current control plan (process)

History of FMEA
First used in the 1960s in the
Aerospace industry during the Apollo
missions
In 1974, the Navy developed MIL-STD1629 regarding the use of FMEA
In the late 1970s, the automotive
industry was driven by liability costs
to use FMEA
Later, the automotive industry saw
the advantages of using this tool to
reduce risks related to poor quality

4. DESIGN FMEA
(DFMEA)
The Design FMEA is used to analyze products
before they are released to production.
It focuses on potential failure modes of products
caused
by
design
deficiencies.
Design FMEAs are normally done at three levels
system, subsystem, and component levels
This type of FMEA is used to analyze hardware,
functions or a combination

6. PROCESS FMEA (PFMEA)

The Process FMEA is normally used to
analyze manufacturing and assembly
processes at the system, subsystem
or
component
levels.
This type of FMEA focuses on
potential failure modes of the process
that are caused by manufacturing or
assembly process deficiencies.

Method to Conduct an
FMEA
Identify all components or systems at
given level of the design hierarchy.
List the function of each identified
component or system.
Identify failure modes for each
component/system.
Typically there
will be several ways in which a
component can fail.
Determine the effect (both locally
and globally) on the system.

Method to Conduct an
FMEA

Classify the failure by its effects on

the system operation.
Determine the failures probability
of occurrence.
Identify how the failure mode can
be detected
(may point out what
needs to be inspected on a regular
basis).
Identify
any
compensating
provisions or design changes to
mitigate the failure effects.

FMEA Form

Blank FMEA form

FMEA Terminology &

Methods

Process Function / Requirements

Simple Description of the process or operations being analyzed
(eg. Turning, assembling, etc.,)
Function comes from Functional Analysis, Functional
Decomposition
Potential Failure Mode
Manner in which the design / process could potentially fail to meet
the process or requirements
Potential Failure Mode comes from things that have gone wrong in
the past, concerns of designers, and brainstorming. Possible
considerations are partial function, intermittent function, excess
function.
Potential Effects of Failure
The effect of the failure mode on customer
Potential Effects are consequences to the design, the user, and the
environment. Safety and regulation noncompliance are critical
issues.

FMEA Terminology &

Methods

Severity
Assessment of the seriousness of the effect of the potential failure
mode to the customer. Give ranking between 1 & 10 as per the
guidelines
Classification
To Classify any special characteristics such as critical, key, major,
significant, etc.,
Potential Causes / Mechanism of Failure
How failure could occur described in terms of how the failure
can be corrected or can be controlled.
Potential Causes of failure should be engineering related such as
incorrect material, corrosion, wear and human related such as
inexperience, misuse, etc.
Occurrence
How frequently the specific failure cause / mechanism is projected
to occur. Give ranking between 1 & 10 as per the guidelines

FMEA Terminology &

Methods
Current Process Control
Current process / design control methods adopted
Current Design Controls are things like inspections, testing, poke
yoke, and other design checks that are intended to prevent the
problem.
Detection
How the existing control system detects the failure mode. Give
ranking between 1 & 10 as per the guidelines
Risk Priority Number (RPN)
Assign values to Severity, Occurrence, and Detection using the tables.
Determine the Risk Priority Number (Severity* Occurrence * Detection)
Develop an action plan
Recommended Actions
Corrective actions to be first arrived for highest ranked RPN
Resulting RPN
Follow up

Effect

Guidelines for Severity

Ranking
Rank

Criteria

None

No effect

Very Slight

Negligible effect on Performance. Some users

may notice.

Slight

Slight effect on performance. Non vital faults will

be noticed by many users

Minor

Minor effect on performance. User is slightly

dissatisfied.

Moderate

Reduced performance with gradual performance

degradation. User dissatisfied.

Severe

Degraded performance, but safe and usable. User

dissatisfied.

High Severity

Very poor performance. Very dissatisfied user.

Very High
Severity

Inoperable but safe.

Extreme Severity

Probable failure with hazardous effects.

Compliance with regulation is unlikely.

Maximum
Severity

10

Unpredictable failure with hazardous effects

almost certain. Non-compliant with regulations.

Guidelines for Occurrence

Ranking
Occurrence

Rank

Criteria

Extremely
Unlikely

Less than 0.01 per thousand

Remote Likelihood 2

0.1 per thousand rate of occurrence

Very Low
Likelihood

0.5 per thousand rate of occurrence

Low Likelihood

1 per thousand rate of occurrence

Moderately Low
Likelihood

2 per thousand rate of occurrence

Medium
Likelihood

5 per thousand rate of occurrence

Moderately High
Likelihood

10 per thousand rate of occurrence

Very High
Severity

20 per thousand rate of occurrence

Extreme Severity

50 per thousand rate of occurrence

Maximum

10

100 per thousand rate of occurrence

Guidelines for Detection

Ranking

Detection

Ran
k

Criteria

Extremely Likely

Can be corrected prior to prototype/ Controls will

almost certainly detect

Very High
Likelihood

Can be corrected prior to design release/Very High

probability of detection

High Likelihood

Likely to be corrected/High probability of detection

Moderately High
Likelihood

Design controls are moderately effective

Medium Likelihood

Design controls have an even chance of working

Moderately Low
Likelihood

Design controls may miss the problem

Low Likelihood

Design controls are likely to miss the problem

Very Low
Likelihood

Design controls have a poor chance of detection

Remote Likelihood

Unproven, unreliable design/poor chance for detection

Extremely Unlikely

10

No design technique available/Controls will not detect

Failure Modes and

Effects
The relationship between failure modes
and effects
is not always 1 to 1.
Failure Mode 1

Effect 1

Failure Mode 2

Effect 2

Failure Mode 1
Effect 1
Failure Mode 2

Effect 1
Failure Mode 1
Effect 2

Process FMEA Check

List

Verify

there is a system for

prioritizing risk of failure such as
RPN numbers of 125 or above

Make

sure
that
high
RPN
process concerns are carried
over into the control plan

Make

sure that all critical failure

modes are addressed

FMEA EXERCISE

5. Process Flow
Diagrams

What is It?
A visual diagram of the entire process from receiving
through shipping, including outside processes and
services
Objective or Purpose
To help people see the real process. Process maps
can be used to understand the following characteristics
of a process:
Set-by-step process linkage

Offline activities (measurement, inspection,

handling)
Rework, scrap

When to Use a Flowchart

To develop understanding of how a process is
done.
To study a process for improvement.
To communicate to others how a process is done.
When better communication is needed between
people involved with the same process.
To document a process.
When planning a project.

Process Flow Diagrams

When to Use It ?
To understand how a process is done
Prior to completing the PFMEA

Updated after production trial run.

Need to indicate special characteristics generated at
each step.
Completed Along with Control Plan (APQP Process).

Process Flow Diagram

Example

Process Flow Diagrams

Check List
Process Flow must identify each step in the process
Should include abnormal handling processes
Scrap
Rework
Process Flow must include all phases of the process
Receiving of raw material
Part manufacturing
Offline inspections and checks
Assembly
Shipping

7. CONTROL PLAN
What we learn?
What is it?
When to use?
Why Required?
Over view
Example of Control Plan
Control Plan Process
Class Exercise

Control plan types

CONTROL PLAN
What Is A Control Plan?
It is a management tool to identify and monitor the activity required
to control the critical inputs or key outputs for a process so the
process will continually meet its product or service goals.
Control plans are usually monitored at least by Quality Assurance,
departments using inspection procedures and sometimes using
quality function deployment methods.
Control charts are typically used in a control plan to monitor items.
When Is It Used?
It is used in the control phase to identify and record controls,
targets, and specification limits for Key Process Input Variables and
Key Process Output Variables.

Control Plan Process

Header information
Enter the Header information as required
Part/Process Number
This item number is usually referenced from the Process Flow Chart. If
multiple part numbers exist (assembly), list the individual part numbers
and their processes accordingly.
Process Name/ Operation Description
All steps in the manufacturing of a component are described in a process
flow diagram. Identify the process/operation name from the flow diagram
that best describes the activity being addressed.
Machine, Device, Jig, Tools for Manufacturing
For each operation that is described, name the processing equipment as
appropriate.
Number
Enter a cross reference number from all applicable documents such as,
but not limited to, process flow diagram, numbered blue print, FMEAs,
and sketches (computer generated or otherwise), if required.

Control Plan Process

Product
Product Characteristics are the features or properties of a part,
component or assembly that are described on drawings or other primary
engineering information.
The Core Team should identify the Special Product Characteristics that
are a compilation of important Product Characteristics from all sources.
All Special Characteristics must be listed on the Control Plan. In addition,
the manufacturer may list other Product Characteristics for which
process controls are routinely tracked during normal operations.
Process
Process Characteristics are the process variable (input variables) that
have a cause and effect relationship with the identified Product
Characteristic.
A Process Characteristic can only be measured at the time it occurs.
The Core Team should identify Process Characteristics for which
variation must be controlled to minimize product variation.
There could be one or more Process Characteristics listed for each
Product Characteristic. In some processes one Process Characteristic
may affect several Product Characteristics.

Control Plan Process

Special Characteristic Classification
Use the appropriate classification to designate the type of special
characteristic or this field can be left blank for other undesignated
characteristics. Please refer to the Danaher Motion Quality Manual to see
the descriptive terms and symbols.
Product/ Process/ Specification/ Tolerance
Specification/tolerance may be obtained
documents.

from

the

engineering

Evaluation/ Measurement Technique

This columns identifies the measurement system being used. This could
include gages, fixtures, tools, and/or test equipment required to measure
the part/process/manufacturing equipment. An analysis of the
reproducibility, repeatability and accuracy of the measurement system
should be done prior to relying on a measurement system and
improvements made accordingly
Sample Size/Frequency
When sampling is required list the corresponding sample size and
frequency.

Control Plan Process

Control Method
This column contains a brief description of how the operation will be
controlled, including procedure numbers where applicable.
The control method utilized should be based on effective analysis of the
process.
The control method is determined by the type of process that exists.
Operations may be controlled by, but are not limited to, Statistical
Process Control, inspection, attribute data, mistake-proofing,
(automated/non-automated), and sampling plans.
The Control Plan descriptions should reflect the planning and strategy
being implemented in the manufacturing process.
If elaborate control procedures are used, the plan will typically reference
the procedure document by a specific identification name and/or number.
The method of control should be continually evaluated for effectiveness
of process control. For example, significant changes in the process or
process capability should lead to an evaluation of the control method.

Control Plan Process

Reaction Plan
The reaction plan specifies the corrective actions necessary to avoid
producing nonconforming products or operating out of control.
The actions should normally be the responsibility of the people closest to
the process, the operator, job setter, or supervisor, and be clearly
designated in the plan.
Provisions should be made for documenting.
In all cases, suspect and nonconforming products must be clearly
identified and quarantined, and disposition made by the responsible
person designated in the reaction plan.
This column may also refer to a specific reaction plan number and
identify the person responsible for the reaction plan.

Control Plan Process

Audit Plans

Audit plans should be included in the control plan as a separate line.

Auditing is an important tool for control.
Process auditing should be a key element of the quality system of a
business.
Audits generally cover:

Effectiveness of controls
Control plan (say) vs. what is actually done
(do)

Audits should be objective (done by internal or external third parties if

possible).
Audit frequencies should be based on balancing level of risk (FMEA)
and cost.

Control Plan Check List

Use process flow diagram and PFMEA to build the control plan; keep
them aligned
Controls must be used to be effective. Keep it simple.
Ensure that the control plan is in the document control system of the
business
Good control plans address:
All testing requirements - dimensional, material, and performance
All product and process characteristics at every step throughout
the process
The control method should be based on an effective analysis of the
process
Such as SPC, Error Proofing, Inspection, Sampling Plan
Control plans should reference other documentation
Specifications, tooling, etc.

Control Plan Class Exercise

Prepare a control plan for the a drilling process on a rectangular block
Critical parameters
Big Hole diameter 15+/- 0.05
Small Hole diameter 10+/- 0.05
Distance between the holes 70 +/- 0.1

8. Measurement System
Analysis (MSA)
What is It?
An MSA is a statistical tool used to determine if a
measurement system is capable of precise measurement.
Objective or Purpose
To determine how much error is in the measurement due to
the measurement process itself.
Quantifies the variability added by the measurement
system.
Applicable to attribute data and variable data.
When to Use It
On the critical inputs and outputs prior to collecting data
for analysis.
For any new or modified process in order to ensure the
quality of the data.

Measurement System
Analysis (MSA)
Attribute Data Examples:

Count, Pass/fail, yes/no, red/green/yellow,

timekeeping buckets

Variable Data Examples:

Physical measurement (length, width, area, )
Physical conditions (temperature, pressure)
Physical properties (strength, load, strain)
Continuous or non-ending
IMPORTANT!
Measurement System Analysis is
an analysis of the measurement
process, not an analysis of the
people!!

Who Should be Involved

Everyone who measures and makes

decisions about these measurements
should be involved in the MSA.

Measurement System
Analysis (MSA)
Repeatability
Error in Repeatability

The inability to get the same answer

from repeated measurements made of
the same item under absolutely identical
conditions.

Possible Cause

Lack of standard operating procedures

(SOP), lack of training, measuring
system variablilty.

Equipment Variation

Measurement System
Analysis (MSA)
Reproducibility
Error in Reproducibility

The inability to get the same answer

from repeated measurements made
under various conditions from different
inspectors.

Possible Cause

Lack of SOP, lack of training.

Appraiser Variation

Variable MSA Gauge R&R

Study

Gauge R&R is the combined

estimate of measurement
system Repeatability and
Reproducibility
Typically, a 3-person study is
performed

Each person randomly measures 10 marked parts per

trial
Each person can perform up to 3 trials

There are 3 key indicators

EV or Equipment Variation
AV or Appraiser Variation

Variable MSA Gauge R&R

Steps
Step 1

Step 2

Step 3

Step 4

Step 5

Step 6

Step 7

Step 8

Step 9 Step 10

1. Select 10 items that represent the full range of long-term

process variation.
2. Identify the appraisers.
3. If appropriate, calibrate the gage or verify that the last
calibration date is valid.
4. Open the Gauge R&R worksheet to record data.
5. Have each appraiser assess each part 3 times (trials first
in order, second in reverse order, third random).
6. Input data into the Gauge R&R worksheet.
7. Enter the number of operators, trials, samples and
specification limits
8. Analyze data in the Gauge R&R worksheet.
9. Assess MSA trust level.
10. Take actions for improvement if necessary.

Measurement System
Analysis (MSA)

Tips and Lessons Learned

Important: An MSA is an analysis of the process, not an analysis of the

people. If an MSA fails, the process failed.

A Variable MSA provides more analysis capability than an Attribute MSA.

For this and other reasons, always use variable data if possible.

The involvement of people is the key to success.

Involve the people that actually work the process
Involve the supervision
Involve the suppliers and customers of the process
An MSA primarily addresses precision with limited accuracy information.

MSA Check List

If the gauge/inspection affects
quality, then conduct a Gauge R&R
Make sure the study is recent less than 1 year
Compare the control plan against
the Gauge R&Rs
If you question that gauge, then
Question the technique and part
sampling
Ask for additional studies

9. Dimension Test
Results
What is It?
Evidence that dimensional verifications have been completed
and results indicate compliance with specified requirements.
Objective or Purpose
To show conformance to the customer part on dimensions
and all other noted requirements.
When to Use It
For each unique manufacturing process (e.g., cells or
production lines and all molds, patters, or dies

Dimension Test Results

Thirty-five

critical data points & 5 non-critical data points are

required for part qualification
Critical and non-critical data points must be taken from the
same 35-piece sample
Five parts from a production run must be shipped to customer
for verification of form, fit, and function
The same 5 parts will be used to verify both critical and noncritical dimensions
Supplier must clearly identify which of the 35 parts are being
shipped
Supplier should make every effort to ship 5 parts that represent
both the low and high ends of the specifications for non-critical
dimensions
Capability must be greater than 1.67 for critical dimensions and
greater than 1.33 for non-critical dimensions

10. Records of
Material/Performance Test
Results

Material Test Results

The supplier shall perform tests for all parts and product
materials when chemical, physical, or metallurgical
requirements are specified by the design record or
Control Plan
For products with NCR-developed material specifications and/or
an NCR-approved supplier list, the supplier shall procure
materials and/or services from suppliers on that list

Performance Test Results

The supplier shall perform tests for all parts or product
materials when performance or functional requirements
are specified by the design record or Control Plan

Material Test Results

Material Results shall include:

The name of the laboratory that conducted the test
The type of test that was conducted
The number, date, and specification to which the part was tested
The actual test results

Performance Test Results

Performance Test Results shall include:

The name of the laboratory that conducted the test
The type of test that was conducted
A description of the test
The parameters tested
The actual test results

11. Initial Process Study

What is It?
A set of tools used to understand process capability.
To evaluate the performance of
specification limits.

your process as compared to

To determine if the production process is likely to produce product

that will meet customer requirements

When to Use It ?
1. To establish baseline capability.
2. To validate process improvements.

Steps for Determining

Process Capability
Step 1

Step 2 Step 3

Step 4

Step 5

Step 6

Step 7

1. Decide on the product or process

characteristic to be assessed
2. Validate the specification limits
3. Validate the measurement system
4. Collect data
5. Assess data characteristics
6. Assess process stability
7. Calculate process capability

Focus on Variable Data

The initial process study should be focused
on variable,
variable not attribute data
Assembly errors, test failures, and
surface defects are examples of attribute
data, which is important to understand,
but is not covered in this initial study
Unless
approved
by
an
authorized
Customer representative, attribute data
are not acceptable for PPAP submission

Capability Indices
Capability
Index

Cp

Cpk

PP
Ppk

Formula
(USL LSL)

6*sshort-term
Min{(USL X), (X LSL)}

3*sshort-term
(USL LSL)

6*slong-term
Min{(USL X), (X LSL)}

3*slong-term

What it shows
Relates short term (within subgroup) standard
deviation to tolerance
Sometimes called Entitlement, meaning it is the
best the current process can do, if centered
Relates short term mean & short term (within
subgroup) standard deviation to tolerance
Only tells you about the nearest spec limit; doesnt
tell anything about the other side

Relates long term (overall) standard deviation to

tolerance
Relates mean & long term (overall) standard
deviation to tolerance
Only tells you about the nearest spec limit; doesnt
tell anything about the other side

Capability Indices - Cpk

Cp predicts capability
Based on short term within subgroup variation
Does not measure how well the process distribution / off the
centre of limits.

Cpk Index of of Cp
measures the variation of Cp value
between U and L and consider the
variation closest to Specification limit.

Capability Indices - Ppk

Ppk indicates past performance
Based on long term total variation
Unlike Cpk, Ppk is not limited to variation within subgroups
When calculated from the same data set, Cpk and Ppk can
be compared to analyze the sources of process variation
Ppk should be used when:
when
The part are newly designed.
The supplier is new to Customer, but has already been
manufacturing a part
The supplier is existing, but has produced a number of
nonconforming parts

Comments On Cp, Cpk

Cp<1 means the process variation exceeds
specification, and a significant number of defects are
being made.
Cp=1 means that the process is just meeting
specifications. A minimum of .3% defects will be made
and more if the process is not centered.
Cp>1 means that the process variation is less than
the specification, however, defects might be made if
the process is not centered on the target value
Cp = Cpk when process is centered
Cpk Cp always this situation
Cpk < 1.00 process producing rejects
Cpk = 0 process center is at one of spec. limit (U
or L)
Cpk < 0 i.e. ve value, average outside of limits
Cpk > 1to 3 i.e process cabable but normal
(Sampling inspection required)

Initial Process Study Check List

Ensure

that the results are acceptable, and

that the process is stable and capable of
producing a quality part

PPAPs

should only be approved if the

capability is greater than 1.67 for critical
dimensions and greater than 1.33 for noncritical dimensions

12. Qualified Laboratory

Documentation
Inspection and testing for PPAP shall
be
performed
by
a
qualified
laboratory as defined by Customer
requirements (e.g., an accredited
laboratory).
The qualified laboratory (internal or
external to the supplier) shall have a
laboratory scope and documentation
showing that the laboratory is
qualified
for
the
type
of
measurements or tests conducted
When an external laboratory is used, the supplier shall
submit the test results on the laboratory letterhead or the
normal laboratory report format

Qualified Laboratory Documentation Check List

Third party labs that measure parts for performance,
material or dimensional should be accredited.
If any testing is performed to measure or monitor
part quality they should have:
Lab Scope internal labs
Evidence of Calibration- in process
Accreditation: Minimum third party accreditation
by:
Either ISO 17025 or A2LA (A2LA-American
Association for Laboratory Accreditation)
Lab Scope: Make sure internal labs have a
System defining what can be measured, method,
training etc.

Appearance Approval
Report
What is It?
A report completed by the
appearance and color criteria

supplier

containing

Objective or Purpose

To demonstrate that the part has met the appearance

requirements on the design record
When to Use It
Prior to tooling for production

Typically only applies for parts with color, grain, or surface appearance requirements

14. Sample Production

Parts
What is It?
Actual samples that reflect the parts documented in
the PPAP.
Objective or Purpose
Confirm cosmetic or functional part approval.

When to Use It
Sample parts should be delivered WITH the PPAP
submission

The sample parts provided should be the same parts measured for the dimensional results
Default quantity for all submissions is 3 parts unless otherwise requested

Sample Production Parts

Sample production parts MUST
be properly identified
Include the following information on the
part label:
Date parts were packed
Customer part number
Quantity
Serial number
Supplier part number (optional)
Part description
Country of origin
Approval markings (CE, etc.) where

15. Master Sample

Purpose: The original intent was that a Master part must be
maintained throughout a products production life for all revision
levels.
Concept is good but difficult to maintain and store parts.
The automotive industry relaxed this requirement in various
ways.
Customer does not require Master Part maintenance except
when:
A Level 5 PPAP is requested.
Typically a high risk part
The critically of the product warranted on site review
Therefore Master Part maintenance is a useful tool
Customer requires Master Part maintenance as follows:
1 Master part for every part number at the most recent
revision level.
Must be maintained for the life of the product.

Sample Production Parts and

Master Samples Check List
Sample Parts should be received with every PPAP submission and
examined thoroughly,
Reviewer needs to determine if any value added analysis can be
gained using the Sample Parts:
Get additional dimensional data
Feedback and questions from engineering
Perform additional testing
Functional analysis
Fit Analysis
Sample Parts must be properly tagged, if not reject
If Master samples are requested make sure the supplier has a
system for maintaining the parts

16. Checking Aids

Purpose: To provide evidence that the checking aids used to
verify product exist and have been properly validated.
There are many different types of checking aids.
Certified Check Fixtures
Un-certified check fixtures
Templates
Custom Gauges
In-house developed test stands (ex: leak test)
Customer may require the following for all checking aids.
Copy of a controlled print that documents the design of the
checking aid
If the aid confirms form or fit, then there should be a third
party certification
Evidence that the checking aid has been verified
successful.
Example: Gage R&R

Checking Aids Check List

Reviewers Checklist
If a fixture is used to check physical print dimensions either
in process or off line then it is a checking aid.
Checking aids must be documented through a print and
submitted with PPAP.
Check Fixtures
Templates
Assembly fixtures that confirm fit
Checking aids must have evidence of:
Conformance to the provided print
Repeatability
GRR for CTQ features
Encourage suppliers that utilize critical checking aids to get
third party certification

17. Customer Specific Requirements

Purpose: Provide a placeholder for all customer specific
requirements that are not covered in the first 16 elements of PPAP.
Used differently by every customer for all types of requirements!
There are 5 specific requirements defined for PPAP submissions.
Tooling Information Form
Packaging Form
Inspection Plan
Specification Deviation Form
Supplier PPAP Checklist
Each customer may request additional documents on a case by
case basis.

18. Parts Submission

Warrant
Upon satisfactory completion of all
required measurements and tests, enter
all required information on the warrant.
A separate PSW is required for each
part number.
Responsible supplier official verifies
Measurements and tests conform to customer
requirements
Required documentation is available for proper
submission level.
Signs warrant and provided date, title and
telephone number.

Part Submission Warrant

What is It?
Document required for all newly tooled or revised
products in which the supplier confirms that
inspections and tests on production parts show
conformance to Customer requirements
Objective or Purpose
Used to :
document part approval
provide key information
declare that the parts meet specification
When to Use It
Prior to shipping production parts

Part Submission Warrant

Check List
Must be completely filled out
Must be signed by the supplier
Must match the PO
Submitted at the correct revision level
Submitted at the correct submission level

Points to Remember ..
Supplier is responsible for meeting all applicable specifications.
Do not submit parts and documentation results if they are
outside specification.
Take corrective action to meet all design record requirements.
Contact customer if unable to meet all requirements
Comply with customer developed material specifications and/or
approved source list.
Suppliers are required to complete and maintain copies of all
documentation identified in requirements for approval
regardless of submission level.
Records of PPAP are to be retained for the life of the part plus
one calendar year.

References
PPAP 4TH Edition
Quality Planning and Analysis by J.M.Juran & Frank.M.Gryna
www.citehr.com
Production Operations Management Dr.B.S.Goel
Wikipedia