Advanced Product Quality Planning

Advanced Product Quality Planning (or APQP) is a framework of procedures and

techniques used to develop products in industry, particularly the automotive
industry. It is quite similar to the concept of Design For Six Sigma (DFSS).
It is a defined process for a product development system for General Motors,
Ford, Chrysler and their suppliers. According to the Automotive Industry Action
Group (AIAG), the purpose of APQP is "to produce a product quality plan which
will support development of a product or service that will satisfy the customer."
The process is described in the AIAG manual 810-358-3003.
History
Advanced Product Quality Planning is a process developed in the late 1980's by
a commission of experts gathered from the 'Big Three' US automobile
manufacturers: Ford, GM and what was then Chrysler. This commission invested
five years to analyse the then-current automotive development and production
status in the US, Europe and especially in Japan. At the time, the success of the
Japanese automotive companies was starting to be remarkable in the US
market.
APQP is utilised today by these three companies and some affiliates. Tier I
suppliers are typically required to follow APQP procedures and techniques and
are also typically required to be audited and registered to ISO/TS 16949.
The APQP process is defined in the AIAG's APQP Manual, which is part of a
series of interrelated documents that the AIAG controls and publishes. The basis
for the make-up of a Process Control Plan is included in the APQP Manual. [1]
These manuals include:
The FMEA Manual
The Statistical process control (SPC) Manual
The Measurement Systems Analysis (MSA) Manual
The Production Part Approval Process (PPAP) Manual
The Automotive Industry Action Group (AIAG) is a non-profit association of
automotive companies founded in 1982.
Main content of APQP
APQP serve as a guide in the development process and also a standard way to
share results between suppliers and automotive companies. APQP specify three
phases: Development, Industrialisation and Product Launch. Through these
phases 23 main topics will be monitored. These 23 topics will be all completed
before the production is started. They cover aspects as: design robustness,
design testing and specification compliance, production process design, quality
inspection standards, process capability, production capacity, product packaging,
product testing and operators training plan between other items.

APQP focuses on:

o Up-front quality planning
o Determining if customers are satisfied by evaluating the output and
supporting continual improvement
APQP consists of five phases:
o Plan and Define Program
o Product Design and Development Verification
o Process Design and Development Verification
o Product and Process Validation
o Launch, Feedback, Assessment & Corrective Action
There are five major activities:
o Planning
o Product Design and Development
o Process Design and Development
o Product and Process Validation
o Production
The APQP process has seven major elements:
o Understanding the needs of the customer
o Proactive feedback and corrective action
o Designing within the process capabilities
o Analyzing and mitigating failure modes
o Verification and validation
o Design reviews
o Control special / critical characteristics

APQP 39 STEP PROCESS

Plan & Define
Programme
Design Goals
Reliability & Quality
Goals
Preliminary Bill of
Materials
Preliminary Process
Flow
Preliminary Listing of
Special Products and
Process Characteristics
Product Assurance Plan

Product Design
& Development
Verification

Process Design
& Development
Verification

Product &
Process
Validation

Design FMEA

Packaging Standards

Production Trial Run

DFMA

Product & process

Quality System Review

Design Verification

Process Flow Chart

Measurement Systems
Evaluation
Preliminary Process
Capability Study

Design Reviews

Floor Plan Layout

Production Part Approval

Prototype Build

Characteristics Matrix

Production Validation
Testing

Engineering Drawings

Process FMEA

Packaging Evaluation

Material Specifications

Pre-Launch Control Plan

Production Control Plan

Drawing & Specification

Changes
New Equipment, Tooling
& Facilities
Requirements
Special Product and
Process Characteristics
Prototype Control Plan
Gauges & Testing
Equipment
Requirements

Process Instructions
Measurement Systems
Analysis Plan
Preliminary Process
Capability Study Plan
Packaging Specifications

Quality Planning Sign-Off

FMEA (Failure Modes and Effects Analysis)

Failure Modes and Effects Analysis, or FMEA, is a methodology for identifying
the potential failure modes that a product or process may encounter, assessing
the risks associated with these failure modes, prioritization of these failure modes
according to their urgency, and prevention of the more urgent failure modes, i.e.,
the ones that are most likely to cause serious harm to the company.
The output of an FMEA cycle is the FMEA Table, which documents how
vulnerable a product or process is to its potential failure modes. The FMEA
table also shows the level of risk attached to each potential failure mode, and
the corrective actions needed (or already completed) to make the product or
process more robust. The FMEA Table generally consists of 16 to 17 columns,
with each column corresponding to a piece of information required by FMEA.

The FMEA is a proactive analysis tool, allowing engineers to anticipate failure

modes even before they happen, or even before a new product or process is
released. It also helps the engineer to prevent the negative effects of these
failure modes from reaching the customer, primarily by eliminating their causes
and increasing the chances of detecting them before they can do any damage.
The actions generated by a good FMEA cycle will also translate to better yield,
quality, reliability, and of course, greater customer satisfaction.
There are many types of FMEA, but the most widely used are probably the
following: 1) System FMEA, which is used for global systems; 2) Design or
Product FMEA, which is used for components or subsystems; 3) Process
FMEA, which is used for manufacturing and assembly processes; 4) Service
FMEA, which is used for services; and 5) Software FMEA, which is used for
software. In the semiconductor industry, the Design or Product FMEA and the
Process FMEA are the most frequently-encountered FMEA versions.
Despite the existence of many types of FMEA today, the basic structure and
process for executing them remains the same. Any FMEA process must include
the following steps, information details of which are documented in the FMEA
Table:
1) Assembly of the team;
2) Understanding of the Product or Process to be subjected to FMEA;
3) Breaking down of the product or process into its components or steps
(components and steps are also known as items);
4) Identification and assessment of the following for every item listed:
function(s), potential failure mode(s), failure mode effect(s), failure mode
cause(s), and controls for detecting or preventing the failure mode(s);
5) Evaluation of the risks associated with the failures modes and prioritizing
them according to importance;
6) Implementation of corrective actions to minimize the occurrence of the more
significant failure modes;
7) Reassessment of the product or process by another cycle of FMEA after the
actions have been completed; and
8) Regular updating of the FMEA Table.
The most critical information on the FMEA Table is the Risk Priority Number
(RPN), which is the numerical rating given to the level of risk associated with a
failure mode, and therefore denotes the urgency of addressing that failure
mode.
The RPN is actually the product of three (3) factors, namely, the severity of the
effect of the failure mode (SEV), the probability of the occurrence of the cause of
the failure mode (PF, for probability factor), and the effectiveness of the controls

for detecting and preventing the failure mode (DET). Thus, RPN = SEV x PF x
DET. The SEV, PF, and DET are also documented in the FMEA Table.
The FMEA Table is a living document, constantly changing from the time of its
first release when the product or process is still being designed until its archiving
after the product or process has been obsoleted.
Critical times or events that require an update to the FMEA Table include the
following:
1) when a new product or process is being designed or introduced;
2) when a critical change in the operating conditions of the product or process
occurs;
3) when the product or process itself undergoes a change;
4) when a new regulation that affects the product or process is instituted;
5) when customer complaints about the product or process are received; and
6) when an error in the FMEA Table is discovered or new information that affects
its contents come to light.
.
Table 1. Example of a Simplified FMEA Table

FMEA Methodology?
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SPC (Statistical Process Control)

Introduction:
Statistical process control (SPC) involves using statistical techniques to measure
and analyze the variation in processes. Most often used for manufacturing
processes, the intent of SPC is to monitor product quality and maintain
processes to fixed targets. Statistical quality control refers to using statistical
techniques for measuring and improving the quality of processes and includes
SPC in addition to other techniques, such as sampling plans, experimental
design, variation reduction, process capability analysis, and process
improvement plans.
SPC is used to monitor the consistency of processes used to manufacture a
product as designed. It aims to get and keep processes under control. No
matter how good or bad the design, SPC can ensure that the product is being
manufactured as designed and intended. Thus, SPC will not improve a poorly
designed product's reliability, but can be used to maintain the consistency of how
the product is made and, therefore, of the manufactured product itself and its asdesigned reliability.

A primary tool used for SPC is the control chart, a graphical representation of
certain descriptive statistics for specific quantitative measurements of the
manufacturing process. These descriptive statistics are displayed in the control
chart in comparison to their "in-control" sampling distributions. The comparison
detects any unusual variation in the manufacturing process, which could indicate
a problem with the process. Several different descriptive statistics can be used
in control charts and there are several different types of control charts that can
test for different causes, such as how quickly major vs. minor shifts in process
means are detected. Control charts are also used with product measurements to
analyze process capability and for continuous process improvement efforts.

Typical charts and analyses used to monitor and improve manufacturing process
consistency and capability (produced with Minitab statistical software).
Benefits:

Provides surveillance and feedback for keeping processes in control

Signals when a problem with the process has occurred
Detects assignable causes of variation
Accomplishes process characterization
Reduces need for inspection
Monitors process quality
Provides mechanism to make process changes and track effects of those
changes
Once a process is stable (assignable causes of variation have been
eliminated), provides process capability analysis with comparison to the
product tolerance

Capabilities:

All forms of SPC control charts

o Variable and attribute charts
o Average (X ), Range (R), standard deviation (s), Shewhart,
CuSum, combined Shewhart-CuSum, exponentially weighted
moving average (EWMA)
Selection of measures for SPC
Process and machine capability analysis (Cp and Cpk)
Process characterization
Variation reduction
Experimental design
Quality problem solving
Cause and effect diagrams

More on SPC Charts

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MSA (Measurement Systems Analysis)

1. A MSA study is a method of validating a measurement system to ensure
that it is fit for purpose. A measurement system consists of measuring
devices, procedures, definitions and people. The idea of validating the
measurement system is to minimise controllable factors that could
exaggerate the amount of variation in data.
2. There are two types of measurement data collected by a measurement
system.
a. Variable data is data where an actual measurement is taken, e.g.
length, temperature .
b. Attribute data is data where the measurement result is OK or not
OK. It does not give any information about the quality of the part,
only whether the part is to be accepted or rejected, e.g. a Go/No-go
gauge.
2. A MSA study typically consists of the completion of a Gauge
Reproducibility and Repeatability Study (Gauge R&R Study), where
multiple operators measure multiple parts, multiple times. The gauge
R&R study is carried out blind, so that operators do not know which parts
they are measuring. A MSA study may also include a study on gauge bias
and linearity. Both types of measurement systems can be subjected to a
gauge R&R study.

3. For variable data measurement systems, analysis of the results from the
study using statistics (Minitab is commonly used to carry out gauge R&R
calculations) is carried out and shows how much variation comes from
differences in the operators, techniques, or the parts themselves. The
gauge R&R makes up part of the study variation, and is made up from
variation due to measuring equipment (repeatability) and variation due to
operators (reproducibility). Typically, the variation due to gauge R&R
should account for less than 30% of the study variation for a variable
study, and should demonstrate adequate discrimination with the number of
distinct categories (NDC) typically greater than 5.
4. Attribute studies are carried out out in a different way, and again it is
common to use statistical software to analyse the results. The attribute
study is looking for agreement between operators and commonly against
a known standard. Typically, agreement should be greater than 95% for
an acceptable attribute based measurement system.
5. Measurement Systems Analysis is a huge subject and the Automotive
Industry Action Group (AIAG) has devoted an inordinate amount of time to
the production of a Measurement Systems Analysis manual for guidelines
on techniques to be used in the validation of measurement systems for
use in production processes.
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SPC Charts
SPC charts are essentially a sophisticated form of Time Series plot that enable
the stability of the process, and the type of variation involved, to be understood.

What do SPC charts detect? Changes!

Changes in process average
A change in process
average: The plot shows a
very clear increase in the
process average, but SPC
charts may detect much
smaller changes that are not
obvious to the human eye.
This might be the result of an
uncontrolled change or a
deliberate improvement to
the process.

Dimension

Time
Changes in process variation
A change in process
variation: The plot shows a
clear increase in the amount
of variation in the process.
Again, this is a very marked
change, but SPC charts can
detect much smaller changes
in variation which wouldnt
normally be obvious

Dimension

Time

One off events such as special causes

Dimension

Time

One off events (Special

Causes): This plot shows a
process which appears to be
relatively stable and in
control, with the exception of
two points that are significantly
higher than the rest. These
points are known as special
causes because they fall
outside of the expected
variation range of the process
and are likely to be as a result
of a special cause.

How Do SPC Charts Detect Changes?

1. The performance of the process is plotted as a time series plot
2. The level of variation in the process
3. Control limits (see below for an explanation) are drawn on the plot based on
the variation method
4. Each data point on the chart is then assessed against a number of tests
5. If the test are broken then the process is not in control and needs
investigation or adjustment

Control Limits:
These are limits that are calculated using a statistical measure of variation, either
the standard deviation () or the range (R). They represent the limits of the
process, such that all process data should fall within these bounds.

Control Limits

The Tests:
A process is out of control if:
o Any point is outside the control lines
o There is a run of 7 points above or below the mean line
o There is a run of 7 points going in the same direction

o Any obvious non-random pattern (e.g. saw tooth shape)

There are more complex tests (carried out by software such as MiniTab) which
are designed to find much finer process changes but are not of use on the shop
floor.

SPC for In-Process Control

This historical data is used to
construct the control limits

Each future point will be

plotted here as is occurs

Time

As each result occurs it is plotted on the SPC chart and assessed using the tests
above to detect any change in the process. This gives real time information to the
operator of the process who may make adjustments based on data rather than
opinion or gut feel.
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PPAP: Production Part Approval Process

1. The purpose of PPAP is to determine if all customer engineering design
record and specification requirements are properly understood by the
supplier and that the process has the potential to produce product
consistently meeting these requirements during an actual production run
at the quoted production rate.
2. Typically, a Customer will ask for PPAP in the following situations:
a. A new part or product (i.e. a specific part, material, or colour not
previously supplied to the customer).
b. Correction of a discrepancy on a previously submitted part.
c. Product modified by an engineering change to design records,
specifications or materials.
d. Significant process changes as detailed within AIAG PPAP Manual
Fourth Edition (e.g. supplier change, new tooling, etc).
2. PPAP has 19 elements/requirements, and a typical submission would
feature the production of a pack of documentation which provides
objective evidence to show that the requirements detailed in paragraph 1
have been met. The customer would review the pack and master sample
parts and either approve or reject the PPAP. If the PPAP is approved, this
is permission to ship production parts to the customer facility. If the PPAP
is rejected, dependent on the nature of the rejection, parts would either be
supplied under waiver, or with a serious issue, the customer may not grant
permission to ship product. Whenever a PPAP is rejected, a corrective
action plan would need to be submitted to the customer to show how a
supplier plans to achieve full approval.
3. When PPAP is called up on a purchase order, production parts may not be
shipped to the customer without a customer approved PPAP or a waiver
from the customer granting permission to ship in lieu of PPAP approval.

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FMEA Methodology
Fundamental to a Process FMEA is the production of a process map that charts
the constituent discrete steps or parts of the relevant process.
In the case of a Design FMEA the Bill of Material is used (BOM)
For each discrete step identified above, an analysis is made of all conceivable
failure modes.
For each failure mode the Root Cause(s) are then identified.
This is undertaken in close association with the Process or Design Owner
(Brainstorming and the 5Ys techniques are usually applied.)
For each Root Cause an assessment is then made of the risks involved in terms
of:
a. Its Occurrence
b. Its Severity
c. Its Detection
d. Its Extent (environmental only)
Each risk element is then ranked using the relevant tables to a ranking number
between 1 and 10.
(1 meaning Virtually Zero Risk, 10 meaning Extreme High Risk)

Each of these Rankings are then multiplied together to give an overall risk rating.
This composite rating is called the Risk Priority Number or RPN.
The RPNs can then be prioritised (highest first) so as to ascertain the most
significant areas for corrective action.
By closely reviewing the individual RPN factors strong guidance is naturally given
as to the actions necessary to reduce the overall RPN.
The conclusions from this exercise (there may be more than one corrective
action possible) are then assessed as to outcome on the overall RPN from which
an actionable corrective action can be taken.
The process can then be repeated for the next highest RPN and so on.
Equally once a FMEA has been produced, investigations of any individual failure
mode or root cause can be individually assessed and the effect of any specific
corrective action evaluated.

Process FMEA Rankings

SEVERITY
Rankin
g

Description

10

Highly
Hazardous

Hazardous

Very High

High

Moderate

Low

Very Low

Minor

Very Minor

None

Criteria
Failure without Warning
Product is hazardous for production personnel,
Failure affects safe product operation or noncompliance with government regulations
Failure with Warning
Product is hazardous for production personnel,
Failure affects safe product operation or noncompliance with government regulations
Major production disruption,
High rework or scrap potential,
Loss of primary function
Minor disruption to production
Probable sort and scrap procedure.
Primary function is impaired
Minor disruption to production,
A portion of the product may have to be scrapped
(no sorting)
Products primary function continues,
Secondary function is impaired
Minor disruption to production,
High rework potential,
Products primary function continues,
Secondary function is impaired
Minor disruption to production,
Sort and rework potential
Product is non-conformant,
some Customer dissatisfaction expected
Minor disruption to production,
A portion of the product may be reworked
Product is non-conformant,
some Customer dissatisfaction may occur
Minor disruption to production,
A portion of the product may be reworked
Product is non-conformant,
Customer dissatisfaction is unlikely
No Effect

RPN process = S x O x D

Process FMEA Rankings

OCCURANCE
Rankin
g

Description

10

Very High:
Failure is
almost
inevitable

9
8
7

High:
Frequent
Failures

Moderate:
Mild level of
failure

2
1

10% Probability
(100,000 PPM)
5% Probability
(50,000 PPM)
2% Probability
(20,000 PPM)

0.2% Probability
(2,000 PPM)
0.04% Probability
(400 PPM)

4
3

20% Probability
(200,000 PPM)

1% Probability
(10,000 PPM)

6
5

Failure Rate

Low:
Isolated
Failures
Very Low:
Infrequent
Failures
Remote:
Failure is
unlikely

0.0067% Probability
(67 PPM)
0.0007% Probability
(7 PPM)
> 0.0007% Probability
(> 7 PPM)

RPN process = S x O x D

Process FMEA Rankings

DETECTION
Rankin
g

Description

Criteria

10

NonDetectable

Current Control either does not exist or will not

detect the Cause of Failure or its Failure Mode

Very Remote

Current Control is Very Unlikely to detect the

Cause of Failure or its Failure Mode

Remote

Current Control is Unlikely to detect the Cause of

Failure or its Failure Mode

Very Low

Current Control has a Very Low Capacity to detect

the Cause of Failure or its Failure Mode

Low

Current Control has a Low Capacity to detect the

Cause of Failure or its Failure Mode

Moderate

Current Control has a Moderate Capacity to

detect the Cause of Failure or its Failure Mode

Moderately
High

Current Control has a Moderately High Capacity

to detect the Cause of Failure or its Failure Mode

High

Current Control has a High Capacity to detect the

Cause of Failure or its Failure Mode

Very High

Current Control has a Very High Capacity to

detect the Cause of Failure or its Failure Mode

Highly
Detectable

The Design Control will almost certainly detect the

potential Cause of the Failure or its Failure Mode

RPN process = S x O x D

Design FMEA Rankings

SEVERITY
Rankin
g

Description

Criteria
Failure without Warning
Product is unsafe for customer use,
or violates government regulations
Failure with Warning
Product is unsafe for customer use,
or violates government regulations

10

Highly
Hazardous

Hazardous

Very High

Products primary function fails

High

Products primary function is impaired

Moderate

Products primary function is unaffected,

Secondary function fails

Low

Products primary function is unaffected,

Secondary function is impaired

Very Low

Product is non-conformant, some Customer

dissatisfaction expected

Minor

Product is non-conformant, some Customer

dissatisfaction may occur

Very Minor

Product is non-conformant, Customer

dissatisfaction is unlikely

None

No Effect

RPN design = S x O x D

Design FMEA Rankings

OCCURANCE
Rankin
g

Description

10

Very High:
Failure is a
Continuous
Problem

9
8
7

Failure Rate
20% Probability
(200,000 PPM)
10% Probability
(100,000 PPM)
5% Probability
(50,000 PPM)

High:
Frequent
Failures

2% Probability
(20,000 PPM)
1% Probability
(10,000 PPM)

6
5

Moderate:
Sporadic
failures

0.2% Probability
(2,000 PPM)
0.04% Probability
(400 PPM)

4
3
2
1

Low:
Relatively few
Failures
Remote:
Failure is
unlikely

0.0067% Probability
(67 PPM)
0.0007% Probability
(7 PPM)
> 0.0007% Probability
(> 7 PPM)

RPN design = S x O x D

Design FMEA Rankings

DETECTION
Rankin
g
10

Description

Criteria

NonDetectable

No Known Controls available

Failure Mode or its Cause is undetectable

Very Remote

Remote

Very Low

Low

Moderate

Moderately
High

High

Very High

Highly
Detectable

Very Remote Likelihood

that Current Controls will detect Failure Mode or
its Cause
Remote Likelihood
That the Current Controls will detect Failure Mode
or its Cause
Very Low Likelihood
That the Current Controls will detect Failure Mode
or its Cause
Low Likelihood
That the Current Controls will detect Failure Mode
or its Cause
Moderate Likelihood
That the Current Controls will detect Failure Mode
or its Cause
Moderately High Likelihood
That the Current Controls will detect Failure Mode
or its Cause
High Likelihood
That the Current Controls will detect Failure Mode
or its Cause
Very High Likelihood
That the Current Controls will detect Failure Mode
or its Cause
The Design Control will almost certainly detect the
potential Cause of the failure or its Failure Mode

RPN design = S x O x D
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