Quality assurance

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Quality assurance, or QA for short, refers to planned and systematic production processes that provide confidence in a product's suitability for its intended purpose. Refer to the definition by Merriam-Webster for further information ^[1]. It is a set of activities intended to ensure that products (goods and/or services) satisfy customer requirements in a systematic, reliable fashion. QA cannot absolutely guarantee the production of quality products, unfortunately, but makes this more likely.

Two key principles characterise QA: "fit for purpose" (the product should be suitable for the intended purpose) and "right first time" (mistakes should be eliminated). QA includes regulation of the quality of raw materials, assemblies, products and components; services related to production; and management, production and inspection processes.

It is important to realize also that quality is determined by the intended users, clients or customers, not by society in general: it is not the same as 'expensive' or 'high quality'. Even goods with low prices can be considered quality items if they meet a market need.

[edit] History

[edit] Early efforts to control the quality of production

When the first specialized craftsmen started manufacturing tools and materials for others to purchase and use, the principle of quality was simple: "let the buyer beware" (caveat emptor).

Early civil engineering projects needed to be built from specifications, for example the four sides of the base of the Great Pyramid of Giza were required to be perpendicular to within 3.5 arcseconds.

During the Middle Ages, guilds adopted responsibility for quality control of their members, setting and maintaining certain standards for guild membership.

Royal governments purchasing material were interested in quality control as customers. For this reason, King John of England appointed William Wrotham to report about the construction and repair of ships. Centuries later, Samuel Pepys, Secretary to the British 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 arguably 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

Around the time of World War I, manufacturing processes typically became more complex with larger numbers of workers being supervised. This period saw the widespread introduction of 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.

To counter bad workmanship, full time inspectors were introduced into the factory to identify, quarantine and ideally correct product quality failures. Quality control by inspection in the 1920s and 1930s led to the growth of quality inspection functions, 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.

SQC 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, even where 100 per cent inspection is not practicable. Standard statistical techniques allow the producer to sample and test a certain proportion of the products for quality to achieve the desired level of confidence in the quality of the entire batch or production run.

[edit] Postwar

In the period following World War II, many countries' manufacturing capabilities that had been destroyed during the war were rebuilt. 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.

Although there were many individuals trying to lead United States industries towards a more comprehensive approach to quality, the U.S. continued to apply the QC concepts of inspection and sampling to remove defective product from production lines, essentially ignoring advances in QA for decades.

[edit] Quality assurance versus quality control

Whereas quality control emphasizes testing and blocking the release of defective products, quality assurance is about improving and stabilizing production and associated processes to avoid or at least minimize issues that led to the defects in the first place.^{[citations needed]} In another words, if the purpose of former is to test the quality of manufactured products against their standards/specifications, then the one of later is to test the quality of the product standards/specifications systematically and scientifically in GLP laboratories. However, QA does not necessarily eliminate the need for QC: some product parameters are so critical that testing is still necessary just in case QA fails.

[edit] Failure testing

A valuable^{[citation needed]} process to perform on a whole consumer product is failure testing (also known as stress 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^{[citation needed]} 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.^{[citation needed]}

Traditional statistical process controls in manufacturing operations usually proceed by randomly sampling and testing a fraction of the output. Variances in critical tolerances are continuously tracked and where necessary corrected before bad parts are produced.

[edit] Total quality control

Deep analysis of QA practices and premises 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:

Marketing had to carry out their work properly and define the customer’s specifications.
Specifications had to be defined to conform to these requirements.
Conformance to specifications i.e. drawings, standards and other relevant documents, were introduced during manufacturing, planning and control.
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.
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.
Any complaints received from the customers were satisfactorily dealt with in a timely manner.
Feedback from the user/customer is used to review designs.
Consistent data recording and assessment and documentation integrity.
Product and/or process change management and notification.

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.

[edit] Quality awareness

Widespread awareness of quality issues throughout the organization increases the probability that product quality will be taken into account at every stage of the production process.^{[citation needed]}

[edit] QA in software development

[edit] 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.

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 :-

Elements such as controls, job management, adequate processes, performance and integrity criteria and identification of records
Competence such as knowledge, skills, experience, qualifications
Soft elements, such as personnel integrity, confidence, organizational culture, motivation, team spirit and quality relationships.
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 development
Retailing
Transportation
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 methods, particularly where the relevant skills and expertise are not available within the organization. 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. More experienced consultants are likely to have knowledge of specialized quality 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

[edit] Notes & References

^ Merriam-Webster. "quality assurance". http://www.merriam-webster.com/dictionary/quality+assurance. Retrieved on 12 April 2009.

[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

[qa1-0] Merriam-Webster. "quality assurance". http://www.merriam-webster.com/dictionary/quality+assurance. Retrieved on 12 April 2009.

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