BASIC QUALITY CONCEPTS

 
 
1.0  THE NATURE OF VARIATION
 
While standing on a str eet corner obser ving the passing tr affic, two cars of the same
make and model st op at a traffic light. B oth cars ar e the same color , have Goodyear
tires and have a luggage r ack on the trunk. A t first glance, the cars seem identical.
Upon closer obser vation, differences are detected. Both cars ha ve Goodyear tires, but
are the tires the same siz e? Are the radios the same? Is the upholster y the same?
There are many char acteristics for com parison.
 
The closer an item is examined, the mor e differences are found. No two objects ar e
exactly alik e. All things diff er by some degree. Some v ariation ma y be obvious, but
other variation ma y require precise mea suring equipment t o detect.
 
All manufactur ed parts exhibit v ariation. It is the concept of v ariation that forms the
basis of probability, statistics and quality contr ol. Consider a par t that is produced by a
punch press. As raw material is f ed into the press, the machine punches out the par ts.
Eventually the pr ess will produce a lar ge number of similar par ts. A visual check of the
diameters ma y reveal no differences among the par ts. If the diameter is measur ed
with a scale, some diff erences will be found. If the measur ements are made with a
micrometer, a greater number of diff erences will be detected. Each le vel of
comparison or method of measur ement reveals a greater amount of v ariation.
 
As the measur ements incr ease in precision, the diff erences among the par ts become
greater and gr eater until ultimately none of the par ts would be the same. As th e level
of comparison becomes mor e precise, the concept that no two objects ar e exactly
alike is realized.
 
 
2.0  QUALITY
 
The word quality is often used indiscrim inately for many diff erent meanings. Quality
can be defined as “fitness for use, ” “customer satisfaction, ” “doing things right the first
time,” or “zero defects.” These definition s are acceptable because quality can r efer to
degrees of excellence. W ebster’s dictionary defines quality as “ an inherent
characteristic, pr operty or attribute.” QReview will define quality as a char acteristic of a
product or pr ocess that can be measur ed. Quality contr ol is the science of k eeping
these characteristics or qualities within certain bounds.
 
In a manufacturing or ser vice environment, ther e are two major categories of quality:
quality of design and quality of conformance . A poorly designed pr oduct will not
function pr operly regardless of how well it meets its specifications. Conv ersely, a
product that does not conform t o excellent design specifications will not pr operly
perform its intended function.
 

2.1 Design Quality

 
Design quality r efers to the level of characteristics that the designers specify for a
product. High-gr ade materials, tight t olerances, special f eatures and high
performance ar e characteristics assoc iated with the term, high quality pr oduct.
 
An example of design quality ma y be shown by the comparison between an
expensive automobile and an economy model. A F errari and a Ford Escor t are
compared. Both cars will per form the same basic function of getting fr om point A
to point B. Each will gener ally conform to its design specification. The owners in
 both cases ma y be satisfied with the w ay their cars ar e put together. However, that
is where the similarity ends. The Escor t owner does not expect his car t o go 150
mph, have leather seats and ha ve twelve coats of paint, or be highly r esponsive.
The Ferrari owner expects these char acteristics or qualities.
 
The cost of making a pr oduct will usually rise as mor e characteristics ar e specified
to increase product per formance, impr ove comfor t, improve ease of use and mak e
the product look better . High-grade materials usually command a pr emium price.
However, in many cases, incr eased com petition creates an atmospher e of finding
ways to make better and less expensiv e designs. This is true for pr oducts suc h as
computers, V CRs and tele visions.
 
The reliability of a pr oduct must be con sidered in the design stage. Reliability is the
probability that a pr oduct will per form its intended function, without failur e, for a
specified length of time. Reliability is dependent on the basic design, the quality of
materials and the quality of components that go int o the final pr oduct. To achieve
the required reliability, designers ma y need to specify higher priced componen ts.
This may translate to higher prices but also higher v alue for the consumer .
 
Many products command a pr emium price because the y provide value to the
consumer. Others ma y be expensiv e because of their r ole as status symbols.  
Expensive products do not alwa ys contribute t o better product per formance or
customer satisfaction. This is par ticularly true in the softwar e industry. Many low
priced applications work just as well and sometimes better than expensiv e ones.
 
The designer ma y receive input from various sour ces when determining the le vel
of design quality . In addition t o the designer ’s own ideas, input concerning pr oduct
performance, materials t o be used and various product characteristics ma y be
received from management, mark eting, sales, other engineering or ganizations or
directly from customers. The final design specification ma y or may not be what the
designer had in mind.
 
Although some quality engineers and other quality pr ofessionals get inv olved with
product design, their time and effor t is usually spent in designing and maintain ing
systems to measure and contr ol process and product characteristics after the
design is complete. A challenge t o quality engineers is t o implement the statistical
techniques used in manufacturing during the design stage. The goals would be t o
enhance pr oduct design b y eliminating pr oblems early in the design pr ocess to
ensure the ease of manufacturing.

2.2 Conformance Quality

 
After the le vel of design quality has been determined, the pr oduct characteristics
are formed int o drawings and specifications. The manufacturing engineers will use
the drawings and specifications t o develop manufacturing specifications and
design the oper ations necessar y to produce the pr oduct. This includes the flo or
layout, machiner y, test sets, t ools and other equipment. A plan for the number of
employees required may also be includ ed. The quality engineer works with the
manufacturing engineer t o make the quality system and maintenance of
conformance quality an integr al part of the manufacturing pr ocess. Any pr oduct
checks, process checks or quality impr ovement activities should be an inher ent
part of the process. Conformance quality ma y be defined as the degr ee of
adherence of the pr oduct characteristics t o the design dr awings and
specifications. The objectiv e of a qualit y program is to have a system that will
measure and contr ol the degree of product and pr ocess conformance in the most
economical wa y.
 
 The quality engineer will determine what pr oduct or pr ocess characteristics ar e to
be checked. The quality engineer will also determine the type of data t o be
collected, the corr ective actions required, and the statistical t ools or other
techniques t o be used.
 
 
3.0  QUALITY SYSTEMS
 
A quality system is a mechanism that coor dinates and maintains the activities
needed to ensure that the char acteristics of pr oducts, processes or ser vices are
within cer tain bounds. A quality system inv olves every part of an organization that
directly or indir ectly affects these activ ities. Typically, the quality system is
documented in a quality manual and in the associated documents that specify
procedures and standar ds.
 
3.1 Basic Elements in a Quality System
 
There are three basic elements in a qua lity system: Quality Management, Quality
Control, and Quality Assur ance.
 
·         Quality Management: Quality management is the means of implementing and
carrying out quality policy . They perform goal planning and manage quality
control and quality assur ance activities . Quality management is r esponsible for
seeing that all quality goals and objectiv es are implemented and that corr ective
actions have been achie ved. They periodically review the quality system t o
ensure effectiveness and t o identify an d review any deficiencies.
 
·         Quality Contr ol: The term quality contr ol describes a v ariety of activities. It
encompasses all techniques and activities of an or ganization that continuously
monitor and impr ove the conformance of pr oducts, processes or ser vices to
specifications. Quality contr ol may also include the r eview of processes and
specifications and mak e recommendat ions for their impr ovement. Quality
control aims to eliminate causes of unsatisfact ory performance b y identifying
and helping t o eliminate or at least narr ow the sour ces of variation. Quality
control has the same meaning as v ariation control of product characteristics.
The objectiv e of a quality contr ol program is to define a system in which
products meet design r equirements and checks and f eedback for corr ective
actions and pr ocess impr ovements. Quality contr ol activities should also
include the selecting and r ating of supp liers to ensure that purchased products
meet quality r equirements.
 
·         Quality Assur ance: The term quality assur ance describes all the planned and
systematic actions necessar y to assure that a product or ser vice will satisfy
the specified r equirements. Usually this tak es the form of an independent final
inspection. The distinction between quality contr ol and quality assur ance is
stated in an ANSI/ASQ standar d: “Quality control has to do with making quality
what it should be, and quality assur ance has to do with making sur e quality is
what it should be.” The quality assur ance function should r epresent the
customer and be independent of the quality contr ol function, which is an
integral part of the manufacturing oper ation.
 
3.2     The Quality A udit
 
A quality audit is an independent assessment comparing the v arious
management and quality activities t o a standar d. The word independent implies
that the person per forming the audit is not associated with the activity being
audited. Ther e are two gener al types of audits: management and quality system
audits and pr oduct specific audits.
  
The types of quality audits:
 
·         Management and Quality System A udit - Manufacturing
·         Management and Quality System A udit - Softwar e
·         Management and Quality System A udit - Service
·         Product Specific A udit - Manufacturing
·         Product Specific A udit - Softwar e
·         Activity Specific A udit - Service
 
Companies use first-par ty audits to evaluate their own per formance. Second-par ty
audits are conducted b y a customer on a supplier. Audits conducted b y
completely separ ate companies, with n o personal stak e in the audited compa ny,
are labeled thir d- party audits. A uditors in a thir d-party audit are usually registrars
that audit t o international standar ds such as the ISO 9000 series.
 
A customer will usually combine a quality system audit with a pr oduct-specific
audit. Third-party audits ar e usually reviews of the management and quality
system and not pr oduct specific.
 
Quality audits assess that:
 
·         Quality plans and pr ocedures are in place
·         Documents ar e controlled to avoid misuse
·         Standards and regulations ar e being fo llowed
·         The data system pr ovides accurate and adequate information
·         Problems are addressed and corr ective action is tak en
·         Products conform t o requirements
Audits should be conducted on a scheduled basis. There should be no surprises
to the organization being audited. This policy enables all those inv olved to
organize their workloads and assign pe rsonnel to assist in the audit. The audi t
should not disrupt any pr ocesses or work being done.
 
 
3.3  Quality Systems Diagr am
 

 
 
4.0  QUALITY SYSTEMS STANDARDS
 
4.1 The International Or ganization for Stan dardization (ISO)
 
The International Or ganization for Stan dardization (ISO) was founded in 1946 t o
develop a common set of manufacturing, tr ade, and communications standar ds. It
is based in Geneva, Switzerland. ISO promotes standar ds to facilitate in ternational
trade. The American Standar ds Institute (ANSI) is the United States representative
to ISO. ISO has a full time staff plus technical committees, subcommittees,
working groups and ad hoc gr oups. ISO r eceives input from governments, industr y
and other inter ested par ties. ISO de velops and promotes but does not implem ent
or enforce international standar ds.
 
Quality systems or quality pr ograms in one form or another ha ve existed since the
beginning of fact ories. Companies de veloped and implemented a quality system
that worked for them. Although ther e was an abundance of liter ature on quality
system elements, quality t ools and statistical techniques, a standar d did not exist
until 1987. In that y ear, an ISO technica l committee de veloped and published the
ISO 9000 series of standar ds that defin e the minimum r equirements for an
adequate quality system. The ISO 9000 series standar ds were revised in 1994 and
2000.

The ISO 9000:2000 series and the joint ANSI/ISO/ASQ Q9000-2000 series of
standards are used as a t ool to establish whether companies ar e using a quality
system that will ensur e their ability t o meet product quality and ser vice
performance r equirements. The ISO 90 00 series and the ANSI/ISO/ASQ Q9000-
2000 series of standar ds are technically identical.
 
The ISO 9000 series standar ds are intended t o assure that a company has at least
a minimum adequate management and quality system in place. These generic
standards provide quality management guidance as well as quality assur ance
guidance and r equirements that apply t o all types and siz es of companies. An ISO
registration does not necessarily mean that a company pr oduces products tha t
always meet their design intent. The IS O audit is an assessment of the
management and quality system and does not addr ess product issues. Ther e are
no standar ds for product quality in the ISO 9000 series standar ds.
 
Over eighty countries ha ve adopted the ISO 9000 series as a national standar d. All
standards developed by ISO are voluntary. There are no legal r equirements to
adopt them. Howe ver countries and companies often adopt and attach legal
requirements to ISO standar ds. Each m ember countr y has an accr editation boar d
that adopts the ISO 9000 series standar ds and cer tifies independent r egistrars.
The Registrar Accreditation Boar d (ANSI/RAB) is the USA-r ecognized accreditation
board.
 
Registrars are third party companies th at evaluate quality systems for conformity
to ISO 9000 standar ds. The registrars conduct audits and issue cer tificates to
organizations that conform t o the stand ards. The audit will inv olve most
departments and functions in an or ganization. The focus of the audits is on
documentation, implementation and eff ectiveness. Organizations ar e certified by
the registrars and not b y ISO or an accr editation boar d. ISO-conforming companies
are allowed t o display the registrar’s mark on advertising and stationar y as
evidence of r egistration. Unfor tunately, not all registrars are created equal so ther e
may be significant diff erences in the wa y audits are conducted and findings
assessed.
 
The ANSI/RAB sets standar ds and spec ifies training for r egistrars but does not
maintain a list of registered companies. There are private companies that maintain
lists with voluntary information pr ovided by registrars.
 
 
4.2 The ISO 9000:2000 ( ANSI/ISO/ASQ Q9000-2000 ) Series Standar ds
 
The ISO 9000 Standar ds Year 2000 Re vision consists of:
 

ISO 9000: Quality management systems - Fundamentals and v ocabulary

ISO 9001: Quality management systems - Requirements
ISO 9004: Quality management systems - Guidelines for per formance
improvements
 
ISO 9001 registration provides confiden ce to customers and potential cust omers
that an adequate quality system is in place and that quality and ser vice
requirements will likely be met. An ISO audit or will gather pr eliminary information
on the company t o be audited and then determine if the company is actually d oing
what it has documented.
 
The ISO 9000 Standar ds have been alig ned with ISO 14001:1996 the
environmental management standar d.
 
4.3 ISO 9001:2000
 
A brief outline of the management system r equirements per ISO 9001:2000 ar e
listed below. For a complete list of requirements, please r efer to the standar d.
 
Quality Management System (P aragraph 4)
 
The organization shall establish, docum ent, implement and maintain a quality
management system and continually impr ove its effectiveness. The quality
management system documentation shall include documented statements of a
quality policy and quality objectiv es, a quality manual and r ecords.
 
Documents r equired by the quality management system shall be contr olled.
Records are a special type of document and shall be established and maintain ed
to provide evidence of conformity t o requirements and of the eff ective operation of
the quality management system. Recor ds shall remain legible, r eadily identifiable
and retrievable.
 
Management r esponsibility (P aragraph 5)
 
Top management shall pr ovide evidence of its commitment t o the development
and implementation of the quality management system and continually impr oving
its effectiveness by communicating t o the organization the impor tance of meeting
customer as well as statut ory and regulatory requirements. Management shall
ensure that customer requirements are determined and ar e met with the aim of
enhancing cust omer satisfaction. Management shall ensur e that the quality policy
is appropriate to the purpose of the or ganization, is r eviewed for continuing
suitability and is communicated and underst ood within the or ganization. Quality
objectives, including those needed t o meet product requirements are to be
established for r elevant functions and l evels within the or ganization.
 
Top management shall appoint a mem ber of management who, irr espective of
other responsibilities, shall ha ve responsibility and authority for the quality sys tem
 
Resource management (P aragraph 6)
 
The organization shall determine and p rovide the resources needed t o implement
and maintain the quality management system and continually impr ove its
effectiveness, and t o enhance cust omer satisfaction b y meeting cust omer
requirements. The necessar y competence for personnel per forming work aff ecting
product quality shall be determined and tr aining provided or other actions tak en to
satisfy these needs.
Appropriate records of education, tr aining, skills and experience shall be
maintained.
 

The infrastructure needed to achieve conformity t o product requirements shall be

determined and established. Infr astructure includes, buildings, workspace,
associated utilities, pr ocess equipment (both har dware and softwar e), and
supporting services.
 
Product realization (P aragraph 7)
 
The organization shall plan and de velop the processes needed for pr oduct
realization. In planning pr oduct realization, quality objectiv es and requirements for
the product shall be determined. Wher e product requirements are changed, the
organization shall ensur e that relevant documents ar e amended and that r elevant
personnel ar e made awar e of the changed r equirements. The design and
development of pr oduct shall be contr olled. The or ganization shall determine the
design and de velopment stages, the r eview, verification and v alidation that ar e
appropriate to each stage, and the r esponsibilities and authorities inv olved.
Systematic r eviews of design and de velopment shall be per formed per planned
arrangements.
 
The organization shall ensur e that purchased product conforms t o specified
purchasing requirements. Suppliers sha ll be evaluated and selected based on their
ability to supply pr oduct in accor dance with the or ganization's requirements.
Purchasing information shall describe t he product to be purchased.
 
Where appropriate, product shall be ide ntified by suitable means thr oughout
product realization. Pr oduct status sha ll be identified with r espect to monitoring
and measur ement requirements. Wher e traceability is a r equirement, the
organization shall contr ol and record the unique identification of the pr oduct. Care
of customer property shall be ex ercised while it is under the or ganization's control.
 
Where necessar y to ensure valid results, measuring equipment shall be calibr ated
or verified at specified inter vals, or prior t o use, against measur ement standar ds
traceable to international or national m easurement standar ds. Where no such
standards exist, the basis used for calib ration or verification shall be r ecorded;
 
Measurement, analysis and impr ovement (Paragraph 8)
 
The organization shall plan and implem ent the monit oring, measur ement, analysis
and improvement processes needed t o demonstrate conformity of the pr oduct, to
ensure conformity of the quality manag ement system, and t o continually impr ove
the effectiveness of the quality management system. The or ganization shall
conduct internal audits at planned inter vals to determine whether the quality
management system conforms t o the planned arr angements.
 
The management r esponsible for the a rea being audited shall ensur e that actions
are taken without undue dela y to eliminate detected nonconformities and thei r
causes. Follow-up activities shall include the v erification of the actions tak en and
the reporting of verification r esults. Sui table methods for monit oring and, whe re
applicable, measur ement of the quality management system pr ocesses shall be
applied. These methods shall demonstr ate the ability of the pr ocesses to achieve
planned results. When planned r esults are not achie ved, corrective action shall be
taken to ensure conformity of the pr oduct. Product characteristics shall be
 monitored and measur ed to verify that product requirements ha ve been met.
Product which does not conform t o product requirements is t o be identified an d
controlled to prevent its unintended use or delivery. The contr ols and related
responsibilities and authorities for deal ing with nonconforming pr oduct shall b e
defined in a documented pr ocedure.
 
Appropriate data shall be determined and collected t o demonstrate the suitability
and effectiveness of the quality management system and t o evaluate wher e
continual impr ovement of the quality management system can be made. The
organization shall continually impr ove the effectiveness of the quality
management system thr ough the use of the quality policy , quality objectiv es, audit
results, analysis of data, corr ective and preventive actions and management
review.
 
Action shall be tak en to eliminate the cause of nonconformities in or der to prevent
recurrence. Corrective actions shall be appr opriate for the nonconformities
encountered.
 
 
5.0     FUNDAMENTAL PRINCIPLES
 
5.1 Statistical Quality Contr ol and Statistical Pr ocess Contr ol
 
Statistical quality contr ol (SQC) and statistical process contr ol (SPC) are scientific
methods for analyzing data and k eeping the pr ocess within cer tain boundaries.
Many statistical t ools, such as contr ol charts, Pareto analysis, design of
experiments, r egression analysis and acceptance sampling ma y be used. SQC
methods can be applied t o anything that is possible t o express in the form of
numbers. SQC is concerned with pr oduct characteristics and SPC is concerned
with process characteristics.
 
The word statistical means ha ving to do with numbers, or mor e specifically, with
drawing conclusions fr om numbers. Th e word quality means much mor e than the
goodness or def ectiveness of the pr oduct. It refers to the qualities or
characteristics of the pr oduct or pr ocess being studied. The wor d control means to
keep something within boundaries or t o regulate it so that its outcome ma y be
predicted with some degr ee of accuracy. In a manufacturing oper ation,
conformance quality char acteristics ar e to be kept within cer tain bounds. Taken
together, the words Statistical Quality C ontrol or Statistical Pr ocess Contr ol
mean:     
 
Statistical - With the help of numbers or data,
       
Quality or Pr ocess - The char acteristics of a pr oduct or process are studied,
 
Control - To make them beha ve the way they are intended t o behave.
 
The most impor tant element in statistical quality contr ol is the feedback loop
between the quality contr ol function and the mak e operation. In statistical pr ocess
control, the feedback loop is between t he process contr ol function and the de vice
that regulates the pr ocess or the perso n responsible for adjustments. Continuous
feedback and the appr opriate corr ective action driv e statistical quality contr ol and
statistical pr ocess contr ol to achieve the desired results. Both SQC and SPC seem
to work best when the checks and f eedback loops ar e automated and human
intervention is minimiz ed.

5.2 The Law of Lar ge Numbers

 
 The law of lar ge numbers is a mathema tical concept that sa ys: Individual
occurrences are unpredictable and gr oup occurrences are predictable. The number
of marriages, bir ths and deaths in the United States next year can be pr edicted
with some degr ee of accuracy, but exactly who will get married, who will be bo rn or
who will die cannot be pr edicted. This c oncept can be applied t o a manufactu ring
process. For example, a statistical study can determine that pr oducts from a
certain process are on average two per cent defective. However, in any sample , the
specific par ts that will be def ective cannot be pr edicted.
 
 
5.3  Central Limit Theor em
 
The central limit theor em states that a gr oup of averages of sample siz e 4, 5 or 6
units always tends to follow the pattern of a normal distribution. If the population
distribution leans t o one side or the other , the distribution of sample a verages
from that population will tend t o be symmetrical and ha ve normal v ariation. The
central limit theor em is what legitimiz es the use of v ariables contr ol charts
regardless of the actual population distribution. The normal distribution and
control charts will be reviewed in a subsequent chapter .
 
 
5.4  Data
 
Webster's dictionar y defines the wor d data as a plur al noun por traying factual
information such as measur ements or statistics used as a basis for r easoning,
discussion, or calculation. Data ar e categorized in two wa ys: attribute data and
variables data. Data classified as good /bad, pass/fail, go/no-go, etc., ar e called
attribute or discr ete data. When actual measurements are taken and recorded, the
data are called variables or continuous data. In many cases (but not all cases) ,
variables data will be distributed in a sy mmetrical bell-shaped cur ve called the
normal cur ve. The known ar eas under the cur ve allow for inf erences to be made
about the pr ocess with r elatively small amounts of information. By using the
known areas under the cur ve, the fraction of measur ements that will lie between,
above, or below cer tain values can be p redicted with a high degr ee of accuracy.
 
 
5.5  Distributions
 
Because of v ariation between measur ements of individual par ts, data when
plotted will form a distribution. A distribution model describes how the data ar e
dispersed. A plot of the distribution will show a center v alue and the r ange of
measurements. The v ariation between data v alues will usually be quite small and
follow a natur al pattern. Lar ge variation indicates that the pattern is unnatur al.
This may be attributed t o external or as signable causes. When a pattern is
unnatural, the cause should be inv estigated and eliminated. Statistical techniques
such as contr ol charts are used to identify the unnatur al patterns. A plot of the
actual data showing the data v alues versus the number of occurr ences is called a
histogram. A mathematical estimate of the shape of the hist ogram is called a
frequency distribution. Distributions ar e formed b ecause everything in the world
that can be measur ed exhibits v ariation. If the measuring instrument is v ery
precise, it will be disco vered that like the snowflak e, no two measur ements are
exactly the same.
5.6  Precision and Accur acy
 
In addition t o the objects that ar e measured, the measuring instrument itself has
variability. Two different instruments m ay measure the same par ts and yield
different results. In many cases, measu ring par ts a second time with the same
instruments will giv e a different result. A low v alue of the instrument’ s standard
deviation indicates gr eater precision. W hen an instrument is accur ate but not
precise, the measur ements are distributed about the true v alue within the
acceptable r ange. When an instrument is precise but not accur ate, the
 measurements are clustered close together but at a distance fr om the true v alue.
When an instrument is both accur ate and precise, the data ar e clustered close
together around the true v alue.
 
5.7     Statistical Techniques
 
Many statistical techniques ar e used in quality contr ol and inspection. Listed
below are the most widely used statisti cal methods.
 
·         Histograms ·         Acceptance Sampling
·         Statistical Inf erence ·         Process Capability Analysis
·         Hypothesis Testing ·         Reliability
·         Decision Err ors ·         Regression & Corr elation
·         Statistical Pr ocess Contr ol ·         Design of Experiments
·         Control Charts ·         Pareto Analysis
 
Basic probability is the foundation of statistical methods. Its impor tance cann ot
be understated. T o really understand statistical methods, an understanding of
probability concepts is essential.
 
It must be str essed that the application of statistical techniques alone will not fix
any problems or impr ove product or pr ocess quality. Statistical techniques ar e
tools to identify pr oblems and pr ovide data for decisions. F or problems to be fixed
or improvements to be made, some action must be tak en. The action ma y be
automated or conducted b y humans, but ne vertheless, action must be tak en.
Automated actions work best in manufacturing situations.
 
The chapters that follow co ver the essential elements of the v arious statistical
techniques. QReview presents the material fr om an enginee ring point of view and
assumes that the student has some pr evious back ground in statistical concepts
and methodology . Mathematical deriv ations and in-depth explanations ar e not
included. These ar e tasks for textbooks on mathematical statistics. The subject
of metrology and calibr ation is covered in chapter twelv e.
 
 
6.0     HUMAN FACTORS
 
Human fact ors focuses on human beings and how the y interact with equipment,
products, envir onments, other people and da y to day activities. The goal of human
factors in a company is t o match the workplace and management appr oach to the
capabilities, needs and limitations of people. The par t of human fact ors addressing
human and machine inter actions is cal led ergonomics.
The first thrust of human fact ors was to study the workplace and design the
environment and machiner y to better accommodate the person doing the job. This
goal has been expanded t o include the wa y management manages and the
involvement of emplo yees in the decision making pr ocess.
 
In the 1930s, a study was conducted at W estern Electric ’s Hawthorne W orks in
Chicago, Illinois. Employees complained of bad lighting in an assembly ar ea. New
lighting was installed that brightened the ar ea. The emplo yees seemed t o be much
happier and as expected, pr oductivity incr eased. It was decided t o increase the light
intensity and measur e productivity. As the intensity incr eased, productivity inc reased.
The first assumption was that brighter lights contribute t o employee morale and
higher productivity. One day the lights w ere dimmed; howe ver, productivity did not
drop. Productivity k ept increasing as th e light intensity decr eased. The study team
concluded that it was not the lighting that contributed t o increased productivity, but
the mere fact that somebody was pa ying attention t o them. This study is called the
Hawthorne study and the conclusion is r eferred to as the Hawthorne effect.
 
In an authoritarian company , the boss giv es orders and the emplo yees carry them out.
In these situations, emplo yees often complain about job satisfaction. In r ecent years,
some companies ar e shedding the bos s-worker image b y allowing managers to
assume the r esponsibility of coach. W orkers are referred to as production associates.
The coach’s job is to coordinate the work and motiv ate employees. The emplo yees,
whether the y are engineers or pr oduction associates, become par t of the team , not
just someone who carries out or ders. This approach yields significant r ewards for the
company and the emplo yee. Company objectiv es and tasks ar e carried out in an
efficient manner and the emplo yee, by making a contribution, f eels good about a job
well done.
 
Human conflict can be minimiz ed but never eliminated. Ther e may be times when
engineering decisions ar e overruled or employee suggestions not adopted. In these
cases, the findings should be documented for possible r eview at a later date, then the
engineer or emplo yee can move on to the next assignment. In any conflict, wh ether it
is between management and emplo yees, between management and unions, or
between emplo yees, good judgement must be used.
 
Juran and Deming agr ee that the majority of pr oblems arise fr om flaws in the system
and not because of emplo yee motivation or emplo yee errors. Deming has stat ed that
80% of problems are management or s ystem related. When the system is the pr oblem,
the output will not meet specifications r egardless of emplo yee effor t. The outcome is
substandar d products and emplo yee dissatisfaction. The situation is changing as
management appr oaches are changing . In many companies, management and
system problems are being addr essed and the outcome is v ery positive. Management
is investing in new equipment, adv anced emplo yee training and r espect for emplo yee
judgement. This r esults in emplo yee satisfaction, high quality pr oducts and in creased
productivity.
 
In recent years, computers ha ve changed the wa y people work. The computer has
become an indispensable t ool. Former mundane tasks ar e easier to accomplis h and in
some cases e ven fun. In addition t o increasing productivity at the workplace,
computers and the computer industr y have made a significant impact in all ar eas of
human activity.
 

7.0     A BRIEF HIST ORY OF QUALITY

 
1550 BC -   Egyptian royal cubit was standar dized. It was about 20.63' ' ± .02''.
 
1654 - Blaise Pascal with Pierr e de Fermat developed the theor y of probability. They
were prompted by the inquiries of gamb lers seeking inside information t o help
them win at car ds and dice.
 
Early 1800's - Concepts of t olerances and gauging w ere developed in American
armories.
 
1861-1865, Civil W ar - Tolerance and gauging concepts wer e used to mass produce
arms with inter changeability of par ts.
 
After the Civil W ar - Tolerance and gauging concepts wer e used and impr oved by
companies such as Singer and McCormick.
 
1916 - Ford Motor Company de veloped system atic material handling, machine t ool
design, fact ory layout and final inspection. A utomobile pr oduction went fr om
ten thousand cars in 1909 t o sixty thousand in 1916. The price decr eased from
$850 to $350 per car.
 
1917 - The first published use of the term Contr ol of Quality appear ed in Industrial
Management in an ar ticle by G. S. Radfor d.
 
1922 - G. S. Radfor d published the first book o n Quality Contr ol: The Control of Quality
of Manufacturing .
 
1924 - Dr. Walter A. Shewhar t of AT&T developed the concept of contr ol charts. Dr.
Shewhar t is referred to as the father of statistical quality contr ol.
 
1925 - Harold F. Dodge of AT&T developed sampling concepts and terminology used
in acceptance sampling.
 
1931 - Dr. Walter A. Shewhar t published Economic Contr ol of Manufactur ed Product.
This was the first in-depth book on statistical quality contr ol.
 
1941-1945 - The United States was involved in World War II. The war gener ated the
first extensiv e use of statistical concep ts. U.S. Government suppliers wer e
required to use statistical quality contr ol. The government sponsor ed many
statistics and quality contr ol training classes.
 
1941 -  Harold F. Dodge and Harr y G. Romig published a unique book on sampling
procedures. Single and Double Sampling Inspection T ables. These tables wer e
the forerunners of the militar y standard sampling tables.
 
1944 - The Dodge-Romig Sampling T ables were published. OC cur ves, lot sizes and
sample siz es are given by AOQL. The tables include single and double
sampling plans.
 
1946 - The ASQC was or ganized and Geor ge Edwards of AT&T became the first
president.
1947 - ASQC created the Shewhar t medal to recognize outstanding contribut ors to the
quality profession.
 
1950 - Joseph M. Jur an and W. Edwards Deming taught statistical methods and
statistical quality contr ol to the Japanese.
 
1950 - Military Standard for Sampling b y Attributes was published as Mil-Std 105A .
 
1951 - Joseph M. Jur an published the first ed ition of Quality Contr ol Handbook .
 
1968 - ASQC administers the first examination for Cer tified Quality Engineer . There
were 147 successful candidates.
 
1970's - The focus was on continuous impr ovement and emplo yee involvement.
 
1980's - The emphasis was on quality of design and design for manufactur ability.
Computers wer e used extensiv ely in all aspects of quality .
 
1987 - The International Or ganization for Stan dardization (ISO) establishes ISO 9000
Series Quality System Standar ds.
 
1987 - Congress established the Malcolm Bal drige National Quality A ward to promote
quality awar eness, to recognize significant quality achie vements of U.S.
companies, and t o call public attention t o successful quality str ategies. The
award is not for specific pr oducts or se rvices.
 
1988 - The first Baldrige awar d winners wer e announced. The y were Globe
Metallurgical Inc. (small business), Mo torola Inc. (manufacturing) and
Westinghouse Electric Corpor ation’s Commercial Nuclear F uel Division
(manufacturing).
 o:p> 
1989 - Military Standard for Sampling b y Attributes is r eissued as Mil-Std 105E .
  The organization shall establish, docum ent, implement and maintain a quality management system
1990's
and-continually
Quality Concepts
impr oveweritseeffectiveness.
extended t o service industries.
The quality Emphasis
management is on tdocumentation
system otal shall
quality management (T QM) and cust omer satisfaction.
include documented statements of a quality policy and quality objectiv es, a quality manual and
 
records.
1993 - ANSI/ASQC Z1.4 Sampling T ables and P rocedures replaced Mil-Std 105E .
 
 
Documents
1994 - ISO 9000r equired
Standar byds the
werequality
revisedmanagement system ANSI/ASQC
(for clarification?). shall be contr olled. Recor ds are a special
series
typestandards
of document and shall be established and
renamed from Q90 series t o Q9000 series.maintained t o provide evidence of conformity t o
  requirements and of the eff ective operation of the quality management system. Recor ds shall remain
legible,
1996 - Eightreadily
thousandidentifiable and r etrievable.
U.S. companies ha ve achieved ISO registration since its
  inception. Eight per cent of all companie s that are ISO registered are located in
Management
North Americar esponsibility
. Forty six (P aragraph
percent are 5)
located in the United Kingdom .
   
Top
1996 management
- Since the ASQCshall pr ovide evidence
cer tification pr ogram of its commitment
began, t o the development
more than 55,000 people ha ve and implementation
of the qualitycer
become management
tified in onesystem
or mor eand continually
of the impr aroving
certification eas. its effectiveness by communicating t o
  the organization the impor tance of mee ting customer as well as statut ory and regulatory
1997 - The American
requirements. Society forshall
Management Quality Contr
ensur ol (ASQC)
e that customerofficially changedare
requirements its determined
name t o and ar e met with
the the
aimAmerican
of enhancingSociety
custfor Quality
omer (ASQ). Management shall ensur e that the quality policy is
satisfaction.
appropriate to the purpose of the or ganization, is r eviewed for continuing suitability and is
communicated and underst ood within the or ganization. Quality objectiv es, including those needed t o
meet product requirements are to be established for r elevant functions and le vels within the
organization.
 
Top management shall appoint a mem ber of management who, irr espective of other r esponsibilities,
shall have responsibility and authority f or the quality system
 
Resource management (P aragraph 6)
 
The organization shall determine and p rovide the resources needed t o implement and maintain the
quality management system and continually impr ove its effectiveness, and t o enhance cust omer
satisfaction b y meeting cust omer requirements. The necessar y competence for personnel per forming
work affecting product quality shall be determined and tr aining provided or other actions tak en to
satisfy these needs.
Appropriate records of education, tr aining, skills and experience shall be maintained.