Quality assurance

Quality assurance (QA) is the term used in both manufacturing and service industries to describe the
systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and
other agreed upon performance, design, reliability, and maintainability expectations of that customer. The
core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of
both manufactured products, such as automobiles and shoes, and delivered services, such as automotive
repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when
delivering products or services to customers is what ISO 9000 defines as that "part of quality management
focused on providing confidence that quality requirements will be fulfilled".[1] This defect prevention
aspect of quality assurance differs from the defect detection aspect of quality control and has been referred
to as a shift left since it focuses on quality efforts earlier in product development and production (i.e., a shift
to the left of a linear process diagram reading left to right)[2] and on avoiding defects in the first place rather
than correcting them after the fact.

The terms "quality assurance" and "quality control" are often used interchangeably to refer to ways of
ensuring the quality of a service or product.[3] For instance, the term "assurance" is often used in a context
such as: Implementation of inspection and structured testing as a measure of quality assurance in a
television set software project at Philips Semiconductors is described.[4] where inspection and structured
testing are the measurement phase of a quality assurance strategy referred to as the DMAIC model (define,
measure, analyze, improve, control). DMAIC is a data-driven quality strategy used to improve processes.[5]
The term "control" is the fifth phase of this strategy.

Quality assurance comprises administrative and procedural activities implemented in a quality system so
that requirements and goals for a product, service or activity will be accomplished.[3] It is the systematic
measurement, comparison with a standard, and monitoring of processes in an associated feedback loop that
confers error prevention.[6] This can be contrasted with quality control, which is focused on process
output.[7]

Quality assurance includes two principles: "fit for purpose" (the product should be suitable for the intended
purpose); and "right first time" (mistakes should be eliminated). QA includes management of the quality of
raw materials, assemblies, products and components, services related to production, and management,
production and inspection processes.[8] The two principles also manifest before the background of
developing (engineering) a novel technical product: The task of engineering is to make it work once, while
the task of quality assurance is to make it work all the time.[9]

Historically, defining what suitable product or service quality means has been a more difficult process,
determined in many ways, from the subjective user-based approach that contains "the different weights that
individuals normally attach to quality characteristics," to the value-based approach which finds consumers
linking quality to price and making overall conclusions of quality based on such a relationship.[10]

History

Initial efforts to control the quality of production

During the Middle Ages, guilds adopted responsibility for the quality of goods and services offered by their
members, setting and maintaining certain standards for guild membership.[11]

Royal governments purchasing material were interested in quality control as customers. For this reason,
King John of England appointed William de Wrotham to report about the construction and repair of
ships.[12] Centuries later, Samuel Pepys, Secretary to the British Admiralty, appointed multiple such
overseers to standardize sea rations and naval training.[13]

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

Wartime production

During the time of the First World War, manufacturing processes typically became more complex, with
larger numbers of workers being supervised. This period saw the widespread introduction of mass
production and piece work, which created problems as workmen could now earn more money by the
production of extra products, which in turn occasionally led to poor quality workmanship being passed on
to the assembly lines. Pioneers such as Frederick Winslow Taylor and Henry Ford recognized the
limitations of the methods being used in mass production at the time and the subsequent varying quality of
output. Taylor, utilizing the concept of scientific management, helped separate production tasks into many
simple steps (the assembly line) and limited quality control to a few specific individuals, limiting
complexity.[14] Ford emphasized standardization of design and component standards to ensure a standard
product was produced, while quality was the responsibility of machine inspectors, "placed in each
department to cover all operations ... at frequent intervals, so that no faulty operation shall proceed for any
great length of time."[15]

Out of this also came statistical process control (SPC), which was pioneered by Walter A. Shewhart at Bell
Laboratories in the early 1920s. Shewhart developed the control chart in 1924 and the concept of a state of
statistical control. Statistical control is equivalent to the concept of exchangeability[16][17] developed by
logician William Ernest Johnson, also in 1924, in his book Logic, Part III: The Logical Foundations of
Science.[18] Along with a team at AT&T that included Harold Dodge and Harry Romig, he worked to put
sampling inspection on a rational statistical basis as well. Shewhart consulted with Colonel Leslie E. Simon
in the application of control charts to munitions manufacture at the Army's Picatinny Arsenal in 1934.[19]
That successful application helped convince Army Ordnance to engage AT&T's George Edwards to
consult on the use of statistical quality control among its divisions and contractors at the outbreak of World
War II.[20]

Postwar

After World War II, many countries' manufacturing capabilities that had been destroyed during the war
were rebuilt. General Douglas MacArthur oversaw the rebuilding of Japan. He involved two key people in
the development of modern quality concepts: W. Edwards Deming and Joseph Juran. They and others
promoted the collaborative concepts of quality to Japanese business and technical groups, and these groups
used these concepts in the redevelopment of the Japanese economy.[21]

Although there were many people trying to lead United States industries toward a more comprehensive
approach to quality, the US continued to apply the Quality Control (QC) concepts of inspection and
sampling to remove defective products from production lines, essentially unaware of or ignoring advances
in QA for decades.[22]

Approaches

Failure testing

It is valuable to failure test or stress test a complete consumer product. In mechanical terms this is the
operation of a product until it fails, often under stresses such as increasing vibration, temperature, and
humidity. This may expose many unanticipated weaknesses in the 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.

Statistical control

Statistical control is based on analyses of objective and subjective data.[23] Many organizations use
statistical process control as a tool in any quality improvement effort[24] to track quality data. Product
quality data is statistically charted to distinguish between common cause variation or special cause
variation.[25]

Walter Shewart of Bell Telephone Laboratories recognized that when a product is made, data can be taken
from scrutinized areas of a sample lot of the part and statistical variances are then analyzed and charted.
Control can then be implemented on the part in the form of rework or scrap, or control can be implemented
on the process that made the part, ideally eliminating the defect before more parts can be made like it.[23]

Total quality management

The quality of products is dependent upon that of the participating constituents,[26] some of which are
sustainable and effectively controlled while others are not. The process(es) which are managed with QA
pertain to Total quality management.

If the specification does not reflect the true quality requirements, the product's quality cannot be guaranteed.
For instance, the parameters for a pressure vessel should cover not only the material and dimensions but
operating, environmental, safety, reliability and maintainability requirements.

Models and standards

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. WHO has developed
several tools and offers training courses for quality assurance in public health laboratories.[27]
The Capability Maturity Model Integration (CMMI) model is widely used to implement Process and
Product Quality Assurance (PPQA) in an organization. The CMMI maturity levels can be divided into 5
steps, which a company can achieve by performing specific activities within the organization.

Company quality

During the 1980s, the concept of "company quality" with the focus on management and people came to the
fore in the U.S.[22] It was considered that, if all departments approached quality with an open mind, success
was possible if management led the quality improvement process.

The company-wide quality approach places an emphasis on four aspects (enshrined in standards such as
ISO 9001):[28]

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

integrity criteria, and identification of records
2. Competence such as knowledge, skills, experiences, 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.

The importance of actually measuring Quality Culture throughout the organization is illustrated by a survey
that was done by Forbes Insights in partnership with the American Society for Quality. 75% of senior or C-
suite titles believed that their organization exhibits "a comprehensive, group-wide culture of quality." But
agreement with that response dropped to less than half among those with quality job titles. In other words,
the further from the C-suite, the less favorable the view of the culture of quality.[29] A survey of more than
60 multinational companies found that those companies whose employees rated as having a low quality
culture had increased costs of $67 million/year for every 5000 employees compared to those rated as
having a high quality culture.[30]

QA is not limited to manufacturing, and can be applied to any business or non-business activity, including:
design, consulting, banking, insurance, computer software development, retailing, investment,
transportation, education, and translation.

It comprises a quality improvement process, which is generic in the sense that it can be applied to any of
these activities and it establishes a quality culture, which supports the achievement of quality.[31]

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.
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.

In practice

Medical industry

QA is very important in the medical field because it helps to identify the standards of medical equipment
and services.[32][33] Hospitals and laboratories make use of external agencies in order to ensure standards
for equipment such as X-ray machines, Diagnostic Radiology and AERB. QA is particularly applicable
throughout the development and introduction of new medicines and medical devices. The Research Quality
Association (RQA) supports and promotes the quality of research in life sciences, through its members and
regulatory bodies.

Aerospace industry

The term product assurance (PA) is often used instead of quality assurance and is, alongside project
management and engineering, one of the three primary project functions. Quality assurance is seen as one
part of product assurance. Due to the sometimes catastrophic consequences a single failure can have for
human lives, the environment, a device, or a mission, product assurance plays a particularly important role
here. It has organizational, budgetary and product developmental independence meaning that it reports to
highest management only, has its own budget, and does not expend labor to help build a product. Product
assurance stands on an equal footing with project management but embraces the customer's point of
view.[9]

Software development

Software quality assurance refers to monitoring the software engineering processes and methods used to
ensure quality. Various methods or frameworks are employed for this, such as ensuring conformance to one
or more standards, e.g. ISO 25010 (which supersede ISO/IEC 9126) or process models such as CMMI, or
SPICE. In addition, enterprise quality management software is used to correct issues such as supply chain
disaggregation and to ensure regulatory compliance; these are vital for medical device manufacturers.[34]

Using contractors or consultants

Consultants and contractors are sometimes employed when introducing new quality practices and methods,
particularly where the relevant skills and expertise and resources are not available within the organization.
Consultants and contractors will often employ Quality Management Systems (QMS), auditing and
procedural documentation writing CMMI, Six Sigma, Measurement Systems Analysis (MSA), Quality
Function Deployment (QFD), Failure Mode and Effects Analysis (FMEA), and Advance Product Quality
Planning (APQP).

See also
Best practice
Data quality
 Data integrity
Farm assurance
GxP, a general term for Good Practice quality guidelines and regulations
Mission assurance
Production assurance
Program assurance
QA/QC
Quality engineering
Quality management
Quality management system
Ringtest, part of a quality assurance program in which identical samples are analyzed by
different laboratories
Shift-left testing
Software testing
Verification and validation

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Further reading
Journals

Quality Progress (http://www.asq.org/qualityprogress/index.html) Archived (https://web.archiv

e.org/web/20170803151527/http://asq.org/qualityprogress/index.html) 2017-08-03 at the
Wayback Machine, ISSN 0033-524X (https://www.worldcat.org/search?fq=x0:jrnl&q=n2:003
3-524X) American Society for Quality
Quality Assurance in Education (http://www.emeraldinsight.com/loi/qae), ISSN 0968-4883 (h
ttps://www.worldcat.org/search?fq=x0:jrnl&q=n2:0968-4883), Emerald Publishing Group
Accreditation and Quality Assurance (https://link.springer.com/journal/769), ISSN 0949-1775
(https://www.worldcat.org/search?fq=x0:jrnl&q=n2:0949-1775)
Food Quality and Preference (http://www.elsevier.com/wps/find/journaldescription.cws_hom
e/405859/description), ISSN 0950-3293 (https://www.worldcat.org/search?fq=x0:jrnl&q=n2:0
950-3293), an official journal of the Sensometric Society and the official journal of the
European Sensory Science Society
Asigurarea Calitatii (http://www.asigurareacalitatii.ro/), ISSN 1224-5410 (https://www.worldc
at.org/search?fq=x0:jrnl&q=n2:1224-5410), Romanian Society for Quality Assurance
(SRAC)

Journal articles

Feldman, Stuart (2005). "Quality assurance" (https://doi.org/10.1145%2F1046931.1046943).

Queue. 3: 26. doi:10.1145/1046931.1046943 (https://doi.org/10.1145%2F1046931.104694
3).
Real Lean in Quality Assurance (https://www.bsmlean.com/reports/real-lean-quality-assuran
ce-report) Report

Conference papers

Alvaro, Alexandre; De Almeida, Eduardo Santana; De Lemos Meira, Silvio Romero (2007).
"A component quality assurance process". Fourth international workshop on Software
 quality assurance in conjunction with the 6th ESEC/FSE joint meeting – SOQUA '07. p. 94.
doi:10.1145/1295074.1295093 (https://doi.org/10.1145%2F1295074.1295093). ISBN 978-1-
59593-724-7. S2CID 15232048 (https://api.semanticscholar.org/CorpusID:15232048).
Wagner, Stefan; Meisinger, Michael (2006). "Integrating a model of analytical quality
assurance into the V-Modell XT". Proceedings of the 3rd international workshop on Software
quality assurance – SOQUA '06. p. 38. arXiv:1611.01286 (https://arxiv.org/abs/1611.01286).
doi:10.1145/1188895.1188906 (https://doi.org/10.1145%2F1188895.1188906). ISBN 978-1-
59593-584-7. S2CID 5581699 (https://api.semanticscholar.org/CorpusID:5581699).

Books

Majcen N., Taylor P. (Editors): Practical examples on traceability, measurement uncertainty

and validation in chemistry, Vol 1; ISBN 978-92-79-12021-3, 2010.
Pyzdek, T, "Quality Engineering Handbook", 2003, ISBN 0-8247-4614-7
Godfrey, A. B., "Juran's Quality Handbook", 1999, ISBN 0-07-034003-X
Marselis, R. & Roodenrijs, E. "the PointZERO vision", 2012, ISBN 978-90-75414-55-4
da Silva, R.B., Bulska, E., Godlewska-Zylkiewicz, B., Hedrich, M., Majcen, N., Magnusson,
B., Marincic, S., Papadakis, I., Patriarca, M., Vassileva, E., Taylor, P., Analytical
measurement: measurement uncertainty and statistics;ISBN 978-92-79-23070-7, 2012.

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