Quality Assurance

Hideo Iwasaki
(Professor Emeritus, Kinki University)

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 Table of Contents

1. What Is Quality Assurance Activity?

2. Major Quality Assurance Activity Actions
3. Tools Required for Quality Assurance Activity
4. Points for Enhancing Quality Assurance
Activity (summary)
5. Examples of Quality Assurance Activity
(manufacturing industry)

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1. What Is Quality Assurance Activity?

1.1 The need for quality assurance activity

What is quality assurance activity ?
An activity to provide customers with a sense of security and
trust in products

1.2 Quality assurance activity and quality control activity

(1) Quality assurance and quality control
Quality assurance is a purpose and quality control is a
means to fulfill this purpose

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1. What Is Quality Assurance Activity?
History of quality control and activity level

(1) Stage 1: A principle in which inspection is emphasized

An idea to assure quality by inspection

(2) Stage 2: An idea of building quality during process

An idea to build quality during the production process

(3) Stage 3: An idea to assure quality through the entire process from
development and design to sales and service

(4) Stage 4: An idea of quality assurance in which the product life cycle is
concerned
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4
 1. What Is Quality Assurance Activity?

Definition of QA (Quality Assurance)

To assure quality of a product which consumers can purchase with a

sense of security and satisfaction, from which they can feel a sense of
security and satisfaction by using, and which they can use for a long period
of time (Quality Assurance Guide Book)

In general, there are three types of concept in the term, assurance

(1) Assurance: Transparency of the process to fulfill product quality
(2) Warranty: Conformance to product quality standards
(3) Guarantee: Compensation for product quality

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1. What Is Quality Assurance Activity?

A quality assurance activity consists of three actions:

An action to build quality

An action to verify quality

An action to certify quality

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1. What Is Quality Assurance Activity?
Roles of Quality Assurance Division

(1) Collection and analysis of market and customers quality

demands and information
(2) Construction and maintenance/improvement of company-wide
control system for quality assurance
(3) Company-wide basic education on quality assurance activity
(4) Management of operating status and guidance/coordination of the
quality assurance activity
(5) Promotion of quality improvement activity (reduction of defects,
recurrence prevention and preventive actions)
(6) Maintenance and improvement of quality assurance documents
and rules
(7) Promotion of standardization and improvement of inspection
policy including inspection methods and standards
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1. What Is Quality Assurance Activity?
Roles of Quality Assurance Unit
(a) As the brains of management team
Drafting of quality policy
Reporting quality status to management team
Drafting of annual quality assurance plan
(b) Enhancement of quality assurance system on a company-wide/all
operating divisions levels
Drafting of revision or repeal of quality assurance provisions
Establishment and promotion of quality assurance systems
Establishment and promotion of the product liability prevention (PLP) systems
Planning and implementation of quality audits
Issuance of quality reports
(c) Company-wide coordination
Coordination on quality problems among all line divisions
Company-wide coordination concerning claim processing
Hosting quality meetings
Company-wide coordination concerning critical quality problem resolutions
(d) Quality assurance activity
Claim processing
Test facility management
Inspection work management
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 1. What Is Quality Assurance Activity?
What is quality?

(1) Quality is a characteristic (property) a customer demands,

and it varies from customer to customer

(2) Quality is determined by how well the product satisfies

the purchasing customer. The basic criterion is
conformance to what the customer demands of the
product

(3) The basic of quality control activity is to build quality so

that customer demand is satisfied

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 1. What Is Quality Assurance Activity?
What is control?
Control means to follow the PDCA cycle

(1) To produce the intended result according to the intended

method (as one wants it to be)

(2) To continue to get good results without fail

(3) To continuously improve an activity by repeating the

activity

The quality of control should be determined by variation

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1. What Is Quality Assurance Activity?
Quality types and division roles
[Related division] [Actions to be implemented]
Customer Expectation and demand for product

Quality assurance
Sales Division (1) Understand customer demands
(2) Marshal demands and communicate to Design Required quality
Division

Design (1) Plan/design a product

(2) Provide Manufacturing Division with Design quality
Division manufacturing conditions

Manufacturing Manufacture products following the design Manufacturing

Division instructions quality

Inspection Division Verify conformance of manufacturing

quality to design quality

Quality Assurance Prove validity of manufacturing quality

Division

Control of three types of basic quality and quality assurance activity

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 2. Major Quality Assurance Activity Actions
Major quality assurance activity actions
Main means and
Action Description of action to be implemented
methods
Clearly define roles, control procedures, ISO9001
Construction of company- responsibilities/authorities of divisions QA system chart
1 wide quality control pertaining to quality control, and construct
system and operate company-wide quality control
system
Standardization Cleary define and document work QC process chart
2 of production procedures/control standards of product Work procedure manual
operation manufacturing process to stabilize the process
Process Control chart
control Boost ability to achieve a quality goal of
Control of (Lecture on March 18)
manufacturing process, and construct and
process Process capability index
operate a mechanism to prevent
capability
product defects
Verify whether product quality satisfies Quality/inspection
3 Inspection standards check list
design quality
Collect and process information regarding Claim classification
4 Claim processing
market claims Claim analysis
Quality control
Continuously increase awareness, knowledge education
5 Education/training and techniques concerning work and quality QC circle activities
control to improve quality control (Lecture on March 14)

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2. How to Process Quality Assurance Activity
Classification of Claims
Complaint

Actual complaint

Complaint involving specific claim

Claim

Complaint not determined as claim

Complaint not involving specific claim

Potential complaint

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3. Tools Required for Quality Assurance Activity

3.1 Establishment of Quality Assurance System

3.2 Quality Function Development (QFD)

3.3 QC Process Chart

3.4 Design Review (DR)

3.5 Failure Mode and Effects Analysis (FMEA)

3.6 Fault Tree Analysis (FTA)

3.7 Process Capability Survey

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 3.1 Establishment of Quality Assurance System
Quality Assurance System Chart (example)
Quality Assurance Top management Sales Development Quality Assurance
Step Customer Division Division Factory Main forms and documents

Market information collection/analysis

New product

New product planning proposal

planning

Quality list
New product
planning

DR 0 (New product planning review) DR information request (sheet)

Action item list
Design
Design drawing
Product design

Test items/test standards setting Test standards

Product quality verification test
Trial production/testing report
Product standards
DR 1 (Trial design production review) Parts standards

Decision on commercialization Succession to Production Division

QA list
Production design
preparation
Production

Production preparation

Trial mass production QC process chart

Standard operating procedures
Production drawing
Testing/quality assessment
Control chart
DR 2 (Trial mass production review) Delivery inspection list
Production
Production

Inspection
Shipping
Quality audit report
Sales Quality audit Customer satisfaction survey
report
Customer satisfaction survey Claim processing slip

Claim
Sales/service

Temporary repair Critical quality issue registration

document
Claim analysis Complaint (claim) handling
measures report
Registration of Giving instructions on
critical quality issue recurrence prevention
Critical quality issue completion
Cause investigation/recurrence prevention measures
report
Quality verification

Review/evaluation of activities concerning quality assurance

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Creation of Quality List for OA chair

Current product specifications

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3.2 Quality Function Development (QFD)
Quality List for OA chair (partial)
Primary Physical valuation characteristics
Alternative characteristics
Dimension/ Dynamic Reliability
Secondary weight characteristics characteristics
characteristics

Light resistance
Tear strength
Dimension

Durability
Elasticity

coefficient
Hardness

resistance
Weight

Friction

Impact
Area
Required quality Tertiary

Importance
Primary Secondary Tertiary level
Appropriately sized seat pad
Suitable degree of firmness in the seat pad
Prevents fatigue Proper backrest inclination
even during long
periods of sitting Adjustable seat height
High quality fabric
Easy to sit on
Correctly sized backrest
Well-shape armrests
Durable wheels
Is stable Chair is equally balanced front to back
Firm reclining function
Chair legs are adequately sized
Nice color of seat and backrest
Fashionable
color scheme Many color options

Nicely Color shades of fabric and resin go well together

designed Comfortable concavo-convex seat surface
Fits body shape Right backrest curvature
Nice armrest shape

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3.3 QC Process Chart
How to Create QC Process Chart
Switch Rear cap
Contact hold-down spring
Waterproof plate
Waterproof seal ring Contact plate
Lens Reflector

Lamp Plug Case Dry-cell

battery
Ring cap
Exploded view of flashlight
Insert Insert Assemble
lens, lamp switch driver
waterproof seal ring and into plug
reflector
into ring cap

Install in case

Insert dry-cell battery

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Install contact hold-down spring and rear cap

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 3.3 QC Process Chart
QC Process Chart
Control Method
Process Person
Process Measuring Failure
chart Control point Control level Sampling Control data in
name instrument processing
No. charge
Lens Visual Failure
Lens scratch None All Check Iwasaki report
(Component) assembly inspection sheet
Lens
Reflector Projection Component
Waterproof Lens Vertical angle Control
5 units/lot angle Iwasaki accuracy
seal ring mounting 0.5 chart testing
angle measure

Vertical Component
Reflector Vertical angle Control
5 units/lot angle Iwasaki accuracy
angle 0.5 chart
measure testing

(Component) Switch Torque Control Failure

Sliding force ooKgf 10 units/lot Kida
Spring assembly chart report
meter

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3.4 Design Review (DR)
(1) Definition of design review
What is design review? (JIS Z 8115 (2006))
Design review is a process conducted to detect requirements that may affect
various matters, such as reliability performance, maintainability performance,
demand for maintenance support performance, fitness-for-purpose and the
identification of possible improvements, and to fix flaws in design. It is an official
and independent review for the current or proposed design.

(2) Purposes of design review

(1) To review by gathering advice from specialists in various areas of expertise at
the design stage, and build quality from an early stage of development. This
helps prevent defects or malfunction in the market field.
(2) To prevent design changes that may occur at trial production after the release
of drawings or in the mass production stage to reduce development man-hours
or work loss time due to design changes.
(3) To clarify a milestone in each step of product development, and ensure
planning quality, design quality and manufacturing quality are continuously
maintained.
(4) To prevent the recurrence of problems that occurred in the past.

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 Design Review (DR) Information Request Format
Date issued month/day/year
Information Request No.
Product name
Review board name Subsystem name (No.)
Details of Questioner
inquiry Classification Technical / Control / Data

[Issues indicated]
(1)

(2)

(3)

[Responses]

Respondent
Responsible
person
Date responded month/day

[Assessment] (Enter based on the agreement on design review)

Examined by
Date examined month/day
Action required/not required No issue identified/To be submitted to comprehensive review board /Issues re-indicated

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3.5 Failure Mode and Effect Analysis (FMEA)
What is Failure Mode and Effects Analysis (FMEA)?

Failure Mode and Effects Analysis (FMEA) is a method used to identify

every potential failure of a product, and experientially, technically and
experimentally analyze the probability of failure and severity of effects
to theoretically elucidate the existence of critical issues.

More specifically, this method analyzes effects on a target product

against each of the assessment items, including the function, potential
failure mode, probable cause, severity of effects, frequency of
occurrence, detection method, and failure grade. To effectively conduct
FMEA, a worksheet which includes a list of the above-mentioned
assessment items, such as failure modes, is used.

FMEA used as a part of quality assurance activities is grouped into two

general categories, design FMEA and process FMEA.
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 Failure Mode and Effects Analysis (FMEA)

System: Marine outboard motor Date created: February 1, 2004

Failure Mode and Effect Analysis (FMEA)
Subsystem: Gear cover Created by Masaki Kida
Covered item Concerns Failure
Function Failure mode Probable cause Detection method
No. Name Subsystem System grade
Rotation Sound of rotating
Gear strength Gear breakage A
Machine Rotation Wearing of failure motor
5
fitting transmission gear Same as Same as
Tampering Same as above B
above above
Deterioration of Water
Packing defect Rotation stop Fitting level A
packing intrusion
Water
Packing not Flaw in wrench Same as Same as Tightening wrench
intrusion A
tighten enough torque setting above above torque pressure
prevention
Anomalous Decentering,
Seal damage Metal wear Visual inspection B
pressure tilting

Figure 12.1 General FMEA Format

Chart 12.1 General Classification of Failure Grade

Grade Classification State
A Fatal Significantly life-threatening
Life-threatening
B Serious
Significant performance degradation; inoperative
C Minor Slight performance degradation; slightly difficult to operate
D Minute Little-affected

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3.6 Fault Tree Analysis (FTA)

What is FTA (Fault Tree Analysis)?

FTA is an abbreviation of Fault Tree Analysis, and was developed in the
United States for safety analysis. It has been used in the fields of space
and nuclear power plant development since the early 1960s. While
FMEA is a bottom up method which analyzes every possible problem
that may occur within a system by examining each product at a
component level to hammer out measures, FTA is a top down method in
which an undesired accident or problem represents a top event, and the
fault conditions of subsystems or components that could affect the top
event are combined with the failures of a series of lower-level events to
analyze potential causes. This top down analysis is similar to that of a
systematic diagram, but the characteristic of FTA is that potential
effects when multiple causes coexist are also considered.
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 Fault Tree Analysis (FTA)
Major symbols used in FTA

Symbol Name Description

Developed event (Event symbol)
An event of a result and continues to be developed

Basic event (Event symbol)

An independent event which cannot be developed further

Undeveloped (Event symbol)

event An event that can be developed further, but does not need to be.

Separately (Event symbol)

developed event An event whose further development is shown in a separate FT
chart
AND (Logic symbol)
Gate The output event occurs if all input events occur.

OR (Logic symbol)
Gate The output event occurs if at least one of the input events occurs.

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 Fault Tree Analysis (FTA)

FT Chart Example
Light bulb
Plug

Power supply
Power switch a A
Light bulb does not turn on
Power switch b Power supply
B

Lamp failure No current flows

Switch does not

Power failure
Plug failure Bulb is out come on

Power A Power B Switch a Switch b

failure failure failure failure

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 3.7 Process Capability Survey
How to calculate the process capability index Cp

R
When the process is stable, w
calculate: d2

SU S L
1) Two sided specifications Cp
6 w

2) One-sided specification

SU x x SL
Cp OR Cp
3 w 3 w

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 3.7 Process Capability Survey

How to calculate the process capability index Cp

With two-sided specifications, if the process mean is off

centered between the specification limits:

SU x x SL
C pk Min ( , )
3 w 3 w

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3.7 Process Capability Survey

Process capability index assessment

Process capability
Cp Value
assessment
Cp > 1.67 Sufficient
1.67 Cp > 1.33 Moderate
1.33 Cp > 1.00 Fair
1.00 Cp Insufficient

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3.7 Process Capability Survey
Process capability index and failure probability

Specification Process Probability of Quality guarantee level

limits capability not meeting (PPM)
index specifications Single-sided Two-sided
Cp p specification specifications
(Su-)=2 0.67 0.02275 2.27 % 4.5 5%
(Su-)=3 1.00 0.00136 0.14 % 0.27 %
(Su-)=4 1.33 0.0000317 31.7 PPM 63.5 PPM
(Su-)=4.5 1.50 0.053398 3.40 PPM 6.80 PPM
(Su-)=5 1.67 0.06301 0.301 PPM 0.602 PPM
(Su-)=5.5 1.83 0.07200 0.020 PPM 0.040 PPM

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4. Points for Enhancing Quality Assurance Activity (summary)
(1) Emphasis on human resources development

(2) Improvement of recurrence prevention activities

(3) Improvement of quality control activities by Marketing Division

(4) Importance of system improvement through standardization

(5) More emphasis on occurrence prevention, not on escape prevention

(6) Stick to market-in concept

(7) Process has a leading role in quality control activity

(8) Process-oriented activity

(9) Thorough control on a factual basis

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5. Examples of Quality Assurance Activity
(manufacturing industry)
1. Introduction
Based on the concept, customers first, as a basic action guideline for quality assurance, we
have engaged in the following activities: Building quality at the development planning stage,
implementation of thorough milestone control throughout the development process,
improvement of the manufacturing control system, swift collection and analysis of claim
information, and market-based activities.
In particular, we have focused on the enhancement of each process and milestone control to
build product quality, clarification of process capability through the introduction of the zero
defect line certification system, analysis of quality information in the market, improvement of
the quality assurance system through the introduction of TQM, and raising
employees awareness of quality improvement.
These activities have promoted the spread of the idea of quality control and the improvement of
the quality control system, all of which have helped improve customer trust, reduce loss due to
quality defects, and increase productivity.

Basic concept of quality assurance

Conduct activities which fully reflect the idea/system/method of quality

control throughout the quality product production process based on the
customers first concept.
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 Examples of Quality Assurance Activity
(manufacturing industry)
2. Focus of activities
Problems at the time of TQM
introduction
(1) Many problems were
identified in a new product,
which resulted in follow-up man-
hours in development and
manufacturing stages
(2) Low quality in incoming parts
and in the process interfered
with Manufacturing Divisions
productivity
(3) Insufficiently aware of the
occurrence of quality failure in
the market and delayed handing
of the problem
Focused quality assurance
activities
(1) Improve quality of a new
product by building quality at
the development planning stage
and through milestone control
(2) Enhance the manufacturing
control structure to improve
quality
(3) Establish the customers
first policy through swift
collection and analysis of
market information, and close
observation of market trends
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 3. Progress of activities (timeline)
~ 2006 2007 2008
Spread of the TQM concept Securing reliability as well as Aggressive collection of market
Purposes

and enhancement of quality quality in the manufacturing information and establishment

assurance structure process of quality assurance system
using information
Improvement of quality of a new product by building quality at the development planning stage and through
milestone control
Reduction in follow-up man-hours after Reinforcement of building the quality of a new Improvement of design
Major implementation

design release by product by utilizing reliability methods such quality by Quality

Milestone/Change Control Chart as DR and FMEA/FTA List

Enhancement of production control structure to improve quality

Detection of process failure by Control Creation of Process Capability Survey Enhancement of process capability by
Graphs and introduction of Plan and reinforced inventory Zero Defect Line Certification
reduction activities check of priority control process System
Swift collection and analysis of claim information and establishment of customers first policy by close
observation of market trends
Promotion of the effective use of market Reinforcement of the response to the customer Improvement of product life
data by constructing Market Claim demand for quality by upgrading cycle management by
Information System (ABC) Quality Information System DEF System
Problems Effects

Defects become evident, problems
are identified, and follow-up
man-hours are reduced
There is a number of market
troubles resulting from design
Reliability-oriented awareness is Quality assurance system that
increased, and market troubles anticipates customers
are reduced by improving DR needs is improved
There still remain many problems
with building quality at the
development planning stage

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5. Implementation status of activities
(strengthening of priority process control)
Coil height dimension Process Control Trio Sheet
Occurrence of
n=2

Occurrence of
Remaining
Remaining
=0 group
group
= 0= 0

73.00
0 8 16 24
defects
32 40

16
72.00

control failure
200
72.00 59.5
UCL:71.527 71.00
72.4
70.00 64.89
2.416
69.00 0.299
69.00
0.009
68.00
70.0
x bar 67.00 60.0
0.690
CL :66.526
66.00 66.00 0.675
7
65.00
3.500
64.00

63.00 63.00

60.00
LCL:61.525
62.00

61.00

60.00
Cause-and-effect
10.00
Sept. 3
93 Sept. 7
97 Sept. 14
914 Sept.
92121 Sept. 28
928 Oct. 5
105
59.00

diagram of abnormality

7.50
UCL:8.69

in coil height

5.00

CL :2.66

2.50














0.00

Sept. 3
93 Sept. 7
97 Sept. 14
914 Sept.
92121 Sept. 28
928 Oct. 5
105

Process failure/abnormality control sheet Problem analysis sheet

Coil height dimension failure Importance level A

Failure analysis
Temporary
Phenomenon Factor/Cause Measures according to problem-
repair
Difficult to Large variations Improve Correct using solving procedures
load on top of in degree of bending fixture fixture
core bending angle (jig)

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 6. Effects
(1) Tangible effect
Goal
Result

Figure 1. Initial claim rate Figure 2. Manufacturing Figure 3. Number of market claims
process failure rate

(2) Intangible effect

1) Quality has been built at the development planning stage by collaboration
between divisions.
2) Customers first concept has been established and employees have become
more sensitive to quality trends in the market.
3) It has become more common that quality is substantiated by data, enabling
unification of quality information.

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Supplement
Product Liability
1. The idea of product liability

Product Liability (PL) is a liability which manufacturers assume for the

injuries or accidents their defective products cause. Product Liability Act
sets forth regulations concerning the liability for damages.
The following four terms are key words for understanding the concept
of product liability.

1) What is a defect?
Manufacturing defect
Design defect
Warning defect
2) What is a product?
3) What is a damage?
4) What is a manufacturer?

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