Quality assurance

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Quality assurance, or QA for short, refers to planned and systematic processes that
provide confidence of a product's or service's effectiveness.

More accurately, quality assurance is a standard for meeting customer requirements. It

documents how a company will meet the requirements of a client or customer in a
systematic, reliable fashion. It shows a companies commitment to delivering quality
products and services to the purchaser. It does not however guarantee a quality product
nor should the quality assurance logo or stamp of approval be placed on the product as it
is the company and not the product or service that is quality assured.

Contents
[hide]

• 1 History
o 1.1 Early efforts to control the quality of production
o 1.2 Wartime production
o 1.3 Postwar
• 2 Quality assurance
• 3 Quality control activities
o 3.1 Peer reviews
o 3.2 Failure testing
o 3.3 Statistical control
o 3.4 Total quality control
o 3.5 ISO 17025
• 4 Company quality
• 5 Using Contractors and/or consultants
• 6 Academic resources
• 7 See also
• 8 References

• 9 External links

[edit] History
[edit] Early efforts to control the quality of production

When the first specialized craftsmen arose manufacturing tools for others, the principle of
quality was simple: "let the buyer beware" (caveat emptor).

Early civil engineering projects needed to be built from specifications. For example in
order to ensure the four sides of the base of the Great Pyramid of Giza would be
perpendicular to within 3.5 arcseconds.

During the Middle Ages, guilds took the responsibility of quality control upon
themselves.

Royal governments purchasing material were interested in quality control as customers.

For this reason , King John of England appointed a certain William Wrotham to report
about the construction and repair of ships. Some centuries later, but also in England,
Samuel Pepys, Secretary to the Admiralty, appointed multiple such overseers.

Prior to the extensive division of labor and mechanization resulting from the Industrial
Revolution, it was possible for workers to control the quality of their own products.
Working conditions then were more conducive to professional pride.

The Industrial Revolution led to a system in which large groups of people performing a
similar type of work were grouped together under the supervision of a foreman who was
appointed to control the quality of work manufactured.

[edit] Wartime production

During World War I, the manufacturing process became more complex, and the
introduction of large numbers of workers being supervised by a foreman designated to
ensure the quality of the work, which was being produced. This period also introduced
mass production and piecework, which created problems as workmen could now earn
more money by the production of extra products, which in turn led to bad workmanship
being passed on to the assembly lines.

Due to the large amount of bad workmanship being produced, the first full time
inspectors were introduced into the large-scale modern factory. These full time inspectors
were the real beginning of inspection quality control, and this was the beginning the large
inspection organizations of the 1920s and 1930s, which were separately organised from
production and big enough to be headed by superintendents.

The systematic approach to quality started in industrial manufacture during the 1930s,
mostly in the USA, when some attention was given to the cost of scrap and rework. With
the impact of mass production, which was required during the Second World War, it
became necessary to introduce a more appropriate form of quality control which can be
identified as Statistical Quality Control, or SQC. Some of the initial work for SQC is
credited to Walter A. Shewhart of Bell Labs, starting with his famous one-page
memorandum of 1924.

This system came about with the realization that quality cannot be fully inspected into an
important batch of items. By extending the inspection phase and making inspection
organizations more efficient, it provides inspectors with control tools such as sampling
and control charts.

SQC had a significant contribution in that it provided a sampling inspection system

where 100 per cent inspection was not practicable. This type of inspection however did
lead to a lack of attention to the engineering activities for producinq quality.

For example, if you have a basic sampling scheme with an acceptance level of 4%, what
happens is you have a ratio of 96% products released onto the market with 4% defective
items – this obviously is a fair risk if you are ensured that unfortunate buyers will not
complain.

[edit] Postwar

After World War II, the United States continued to apply the concepts of inspection and
sampling to remove defective product from production lines. However, there were many
individuals trying to lead U.S. industries towards a more comprehensive approach to
quality. Excluding the U.S., many countries' manufacturing capabilities were destroyed
during the war. This placed American business in a position where advances in the
collaborative approaches to quality were essentially ignored.

After World War II, the U.S. sent General Douglas MacArthur to oversee the re-building
of Japan. During this time, General MacArthur involved two key individuals in the
development of modern quality concepts: W. Edwards Deming and Joseph Juran. Both
individuals promoted the collaborative concepts of quality to Japanese business and
technical groups, and these groups utilized these concepts in the redevelopment of the
Japanese economy.

[edit] Quality assurance

Unlike Quality Control, Quality Assurance is an activity that is derived from business
objectives. As Quality Control is a production activity, Quality Assurance is an on-going
activity that serves as the eyes of upper-management. If a process activity does not
respect the previously agreed-upon steps, then QA will report this to ensure corrective
action. Quality assurance activities are executed on all development processes to help
maintain an expected level of effectiveness.

[edit] Quality control activities

Quality control applies to all forms of products and services as a verification (testing)
activity. This introduced the rules: "fit for purpose" and "do it right the first time". It
includes the regulation of the quality of raw materials, assemblies, products and
components; services related to production; and management, production, and inspection
processes. The purpose is to detect defects at the earliest stages of development. Quality
assurance is then applied to these processes to maintain the effectiveness of defect
removal.

One of the most widely used paradigms for Test management is the PDCA (Plan-Do-
Check-Act) approach, also known as the Shewhart cycle.

[edit] Peer reviews

Peer reviews are an integral part of Quality control activities. They are the most effective
means of reducing defects during the development lifecycle.

[edit] Failure testing

A valuable process to perform on a whole consumer product is failure testing, the

operation of a product until it fails, often under stresses such as increasing vibration,
temperature and humidity. This exposes many unanticipated weaknesses in a product,
and the data is used to drive engineering and manufacturing process improvements. Often
quite simple changes can dramatically improve product service, such as changing to
mould-resistant paint or adding lock-washer placement to the training for new assembly
personnel.

[edit] Statistical control

Many organizations use statistical process control to bring the organization to Six Sigma
levels of quality, in other words, so that the likelihood of an unexpected failure is
confined to six standard deviations on the normal distribution. This probability is less
than four one-millionths. Items controlled often include clerical tasks such as order-entry
as well as conventional manufacturing tasks.

Traditional statistical process controls in manufacturing operations usually proceed by

randomly sampling and testing a fraction of the output. Variances of critical tolerances
are continuously tracked, and manufacturing processes are corrected before bad parts can
be produced.

It's very necessary to monitor phase wise activities so that any variance is in any phase
project can take action and save project deliverables of next phase from delayed and
achieve customer satisfaction.

[edit] Total quality control

Deep Analysis of quality assurance practices and premisses used about them is the most
necessary inspection control of all in cases where, despite statistical quality control
techniques or quality improvements implemented, sales decrease.

The major problem which leads to a decrease in sales was that the specifications did not
include the most important factor, “What the specifications have to state in order to
satisfy the customer requirements?”.

The major characteristics, ignored during the search to improve manufacture and overall
business performance were:

• Reliability
• Maintainability
• Safety
• Strength

As the most important factor had been ignored, a few refinements had to be introduced:

1. Marketing had to carry out their work properly and define the customer’s
specifications.
2. Specifications had to be defined to conform to these requirements.
3. Conformance to specifications i.e. drawings, standards and other relevant
documents, were introduced during manufacturing, planning and control.
4. Management had to confirm all operators are equal to the work imposed on them
and holidays, celebrations and disputes did not affect any of the quality levels.
5. Inspections and tests were carried out, and all components and materials, bought
in or otherwise, conformed to the specifications, and the measuring equipment
was accurate, this is the responsibility of the QA/QC department.
6. Any complaints received from the customers were satisfactorily dealt with in a
timely manner.
7. Feedback from the user/customer is used to review designs.
8. Consistent data recording and assessment and documentation integrity.
9. Product and/or process change management and notification.

If the original specification does not reflect the correct quality requirements, quality
cannot be implemented into the product.

For instance, all parameters for a pressure vessel should include not only the material and
dimensions but operating, environmental, safety, reliability and maintainability
requirements.

To conclude, the above forms the basis from which the philosophy of Quality has
evolved, and the achievement of quality or the “fitness-for-purpose” is “Quality
Awareness” throughout the company.
The following are examples of best practice models that enhance the development
process:

[edit] ISO 17025

ISO 17025 is an international standard that specifies the general requirements for the
competence to carry out tests and or calibrations. There are 15 management requirements
and 10 technical requirements. These requirements outline what a laboratory must do to
become accredited. Management system refers to the organization's structure for
managing its processes or activities that transform inputs of resources into a product or
service which meets the organization's objectives, such as satisfying the customer's
quality requirements, complying with regulations, or meeting environmental objectives.

The CMMI (Capability Maturity Model Integration) model is widely used to implement
Quality Assurance (PPQA) in an organization. The CMMI maturity levels can be divided
in to 5 steps, which a company can achieve by performing specific activities within the
organization.

[edit] Company quality

During the 1980s, the concept of “company quality” with the focus on management and
people came to the fore. It was realized that, if all departments approached quality with
an open mind, success was possible if the management led the quality improvement
process.

The company-wide quality approach places an emphasis on four aspects :-

1. Elements such as controls, job management, adequate processes, performance and

integrity criteria and identification of records
2. Competence such as knowledge, skills, experience, qualifications
3. Soft elements, such as personnel integrity, confidence, organizational culture,
motivation, team spirit and quality relationships.
4. Infrastructure (as it enhances or limits functionality)

The quality of the outputs is at risk if any of these aspects is deficient in any way.

The approach to quality management given here is therefore not limited to the
manufacturing theatre only but can be applied to any business or non-business activity:

• Design work
• Administrative services
• Consulting
• Banking
• Insurance
• Computer software
• Retailing
 • Transportation
• open source development
• education

It comprises a quality improvement process, which is generic in the sense it can be

applied to any of these activities and it establishes a behaviour pattern, which supports
the achievement of quality.

This in turn is supported by quality management practices which can include a number of
business systems and which are usually specific to the activities of the business unit
concerned.

In manufacturing and construction activities, these business practices can be equated to

the models for quality assurance defined by the International Standards contained in the
ISO 9000 series and the specified Specifications for quality systems.

Still, in the system of Company Quality, the work being carried out was shop floor
inspection which did not reveal the major quality problems. This led to quality assurance
or total quality control, which has come into being recently.

[edit] Using Contractors and/or consultants

It has become customary to use consultants and contractors when introducing new quality
practices and methodologies as in some instances the relevant skill-set and experience
might not be available within the organisation. In addition, when new initiatives and
improvements are required to boost the current quality system, or perhaps improve upon
current manufacturing systems, the use of temporary consultants becomes a viable
solution when allocating valuable resources.

There are various types of consultants and contractors available in the market; most will
have the skills needed to facilitate improvement activities such as Quality Management
Systems (QMS) Auditing and procedural documentation writing. But the higher end
consultants have knowledge and experience for implementing and improving
manufacturing processes by using the latest cutting edge improvement activities such as
CMMI, Six Sigma, Measurement Systems Analysis (MSA), Failure Mode and Effects
Analysis (FMEA), Advance Product Quality Planning (APQP).

[edit] Academic resources

• Quality Assurance in Education, ISSN 0968-4883, Emerald Publishing Group
• Accreditation and Quality Assurance: Journal for Quality, Comparability and
Reliability in Chemical Measurement, ISSN: 1432-0517 (electronic) 0949-1775
(Paper), Springer

[edit] See also

 • American Society for Quality
• Best practice
• CQE
• Data quality
• Data integrity
• Farm assurance
• GxP
• ISO 9000
• Quality control
• Quality management
• Quality Management System
• Software Testing
• Software quality assurance
• Total Quality Management

[edit] References
[edit] External links
• Pyzdek, T, "Quality Engineering Handbook", 2003, ISBN 0824746147
• Godfrey, A. B., "Juran's Quality Handbook", 1999, ISBN 007034003X
• http://www.nrc.gov/reading-rm/doc-collections/cfr/part050/part050-appb.html

Retrieved from "http://en.wikipedia.org/wiki/Quality_assurance"

Categories: Quality | Management | Evaluation | Quality assurance
Hidden categories: Wikipedia articles needing context | Wikipedia introduction cleanup

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Quality control
From Wikipedia, the free encyclopedia

Jump to: navigation, search

For other uses, see Quality control (disambiguation).
This article or section includes a list of references or external links, but its sources
remain unclear because it lacks inline citations.
You can improve this article by introducing more precise citations where appropriate. (February 2008)
The neutrality of this article is disputed.
Please see the discussion on the talk page. (December 2007)
Please do not remove this message until the dispute is resolved.

In engineering and manufacturing, quality control and quality engineering are involved
in developing systems to ensure products or services are designed and produced to meet
or exceed customer requirements. These systems are often developed in conjunction with
other business and engineering disciplines using a cross-functional approach.

Contents
[hide]

• 1 History
o 1.1 Wartime production
o 1.2 Post-war
• 2 Quality control
o 2.1 Failure testing
o 2.2 Statistical control
o 2.3 Company quality
o 2.4 Total quality control
• 3 See also

• 4 References

[edit] History
When the first specialized craftsmen arose manufacturing tools for others, the principle of
quality control was simple: "let the buyer beware" (caveat emptor).

Early civil engineering projects, however, needed to be built to specifications. For

instance, the four sides of the base of the Great Pyramid of Giza are perpendicular to
within 3.5 arcseconds.
During the Middle Ages, guilds took the responsibility of quality control upon
themselves.

Royal governments purchasing material were interested in quality control as customers.

For instance, King John of England appointed a certain William Wrotham to supervise
the construction and repair of ships. Some centuries later, but also in England, Samuel
Pepys, Secretary to the Admiralty, appointed multiple such overseers.

The Industrial Revolution led to a system in which large groups of people performing a
similar type of work were grouped together under the supervision of a foreman who also
took on the responsibility to control the quality of work manufactured.

Quality Assurance has developed a good deal during the last 80-90 years (in about 20
year intervals) from its inception to the current state of the art.

[edit] Wartime production

During World War I, the manufacturing process became more complex, and foremen
began to supervise large numbers of workers to ensure the quality of the work being
produced. This period also introduced mass production and piecework, which created
quality problems as workmen could now earn more money by the production of extra
products, which in turn led to bad workmanship being passed on to the assembly lines.

Due to the large amount of bad workmanship being produced, the first full time
inspectors were introduced into the large-scale modern factory. These full time inspectors
were the real beginning of inspection quality control, and this was the beginning of the
large inspection organizations of the 1920s and 1930s, which were separately organised
from production and big enough to be headed by superintendents.

The systematic approach to quality started in industrial manufacture during the 1930s,
mostly in the USA, when some attention was given to the cost of scrap and rework. With
the impact of mass production, which was required during the Second World War, it
became necessary to introduce a more stringent form of quality control which can be
identified as Statistical Quality Control, or SQC. Some of the initial work for SQC is
credited to Walter A. Shewhart of Bell Labs, starting with his famous one-page
memorandum of 1924.

This system came about with the realisation that quality cannot be inspected into an item.
By extending the inspection phase and making inspection organizations more efficient, it
provides inspectors with control tools such as sampling and control charts.

SQC had a significant contribution in that it provided a sampling inspection system rather
than a 100 per cent inspection. This type of inspection however did lead to a lack of
realisation to the importance of the engineering of product quality.
For example, if you have a basic sampling scheme with an acceptance level of 4%, what
happens is you have a ratio of 96% products released onto the market with 4% defective
items – this obviously is a fair risk for any company/customer – unless you happen to be
one of the unfortunate buyers of a defective item.

[edit] Post-war

After World War II, the United States continued to apply the concepts of inspection and
sampling to remove defective product from production lines. However, there were many
individuals trying to lead U.S. industries towards a more collaborative approach to
quality. Excluding the U.S., many countries' manufacturing capabilities were destroyed
during the war. This placed American business in a position where advances in the
collaborative approaches to quality were essentially ignored.

After World War II, the U.S. sent General Douglas MacArthur to oversee the re-building
of Japan. During this time, General MacArthur invited two key individuals in the
development of modern quality concepts: W. Edwards Deming and Joseph Juran. Both
individuals promoted the collaborative concepts of quality to Japanese business and
technical groups, and these groups utilized these concepts in the redevelopment of the
Japanese economy.

[edit] Quality control

Quality assurance

Quality assurance covers all activities from design, development, production, installation,
servicing and documentation. This introduced the rules: "fit for purpose" and "do it right
the first time". It includes the regulation of the quality of raw materials, assemblies,
products and components; services related to production; and management, production,
and inspection processes.

One of the most widely used paradigms for QA management is the PDCA (Plan-Do-
Check-Act) approach, also known as the Shewhart cycle.

[edit] Failure testing

A valuable process to perform on a whole consumer product is failure testing, the

operation of a product until it fails, often under stresses such as increasing vibration,
temperature and humidity. This exposes many unanticipated weaknesses in a product,
and the data is used to drive engineering and manufacturing process improvements. Often
quite simple changes can dramatically improve product service, such as changing to
mold-resistant paint or adding lock washer placement to the training for new assembly
personnel.

[edit] Statistical control

Many organizations use statistical process control to bring the organization to Six Sigma
levels of quality, in other words, so that the likelihood of an unexpected failure is
confined to six standard deviations on the normal distribution. This probability is less
than four one-millionths. Items controlled often include clerical tasks such as order-entry
as well as conventional manufacturing tasks.

Traditional statistical process controls in manufacturing operations usually proceed by

randomly sampling and testing a fraction of the output. Variances of critical tolerances
are continuously tracked, and manufacturing processes are corrected before bad parts can
be produced.

[edit] Company quality

During the 1980s, the concept of “company quality” with the focus on management and
people came to the fore. It was realised that, if all departments approached quality with
an open mind, success was possible if the management led the quality improvement
process.

The company-wide quality approach places an emphasis on three aspects :-

1. Elements such as controls, job management, adequate processes, performance and

integrity criteria and identification of records
2. Competence such as knowledge, skills, experience, qualifications
3. Soft elements, such as personnel integrity, confidence, organisational culture,
motivation, team spirit and quality relationships.

The quality of the outputs is at risk if any of these three aspects is deficient in any way.

The approach to quality management given here is therefore not limited to the
manufacturing theatre only but can be applied to any business activity:

• Design work
• Administrative services
• Consulting
• Banking
• Insurance
• Computer software
• Retailing
• Transportation

It comprises a quality improvement process, which is generic in the sense it can be

applied to any of these activities and it establishes a behaviour pattern, which supports
the achievement of quality.
This in turn is supported by quality management practices which can include a number of
business systems and which are usually specific to the activities of the business unit
concerned.

In manufacturing and construction activities, these business practices can be equated to

the models for quality assurance defined by the International Standards contained in the
ISO 9000 series and the specified Specifications for quality systems.

Still, in the system of Company Quality, the work being carried out was shop floor
inspection which did not control the major quality problems. This led to quality assurance
or total quality control, which has come into being recently.

[edit] Total quality control

Total Quality Control is the most necessary inspection control of all in cases where,
despite statistical quality control techniques or quality improvements implemented, sales
decrease.

The major problem which leads to a decrease in sales was that the specifications did not
include the most important factor, “What the customer required”.

The major characteristics, ignored during the search to improve manufacture and overall
business performance were:

• Reliability
• Maintainability
• Safety

As the most important factor had been ignored, a few refinements had to be introduced:

1. Marketing had to carry out their work properly and define the customer’s
specifications.
2. Specifications had to be defined to conform to these requirements.
3. Conformance to specifications i.e. drawings, standards and other relevant
documents, were introduced during manufacturing, planning and control.
4. Management had to confirm all operators are equal to the work imposed on them
and holidays, celebrations and disputes did not affect any of the quality levels.
5. Inspections and tests were carried out, and all components and materials, bought
in or otherwise, conformed to the specifications, and the measuring equipment
was accurate, this is the responsibility of the QA/QC department.
6. Any complaints received from the customers were satisfactorily dealt with in a
timely manner.
7. Feedback from the user/customer is used to review designs.
8. Consistent data recording and assessment and documentation integrity.
9. Product and/or process change management and notification.
If the original specification does not reflect the correct quality requirements, quality
cannot be inspected or manufactured into the product.

For instance, all parameters for a pressure vessel should include not only the material and
dimensions but operating, environmental, safety, reliability and maintainability
requirements.

To conclude, the above forms the basis from which the philosophy of Quality Assurance
has evolved, and the achievement of quality or the “fitness-for-purpose” is “Quality
Awareness” throughout the company.

[edit] See also

[edit] References
• Federal Standard 1037C
• Good Manufacturing Practice
• Good Automated Manufacturing Practice (GAMP)
• Corrective and Preventative Action (CAPA)
• MIL-STD-188
• Pyzdek, T, "Quality Engineering Handbook", 2003, ISBN 0824746147
• Godfrey, A. B., "Juran's Quality Handbook", 1999, ISBN 007034003

Retrieved from "http://en.wikipedia.org/wiki/Quality_control"

Categories: Quality control | Management | Manufacturing | Production and
manufacturing | Design for X
Hidden categories: Articles lacking in-text citations | NPOV disputes from December
2007 | All NPOV disputes