- Quality assurance
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. 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
qualityof 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 lowly bottom-of-the-range goods can be considered quality items if they meet a market need.
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").
civil engineeringprojects needed to be built from specifications, for example the four sides of the base of the Great Pyramid of Gizawere required to be perpendicular to within 3.5 arcseconds.
Middle Ages, guilds adopted responsibility for quality control of their members, setting and maintaining certain standards for guild membership.
Royal governments purchasing
materialwere interested in quality control as customers. For this reason, King John of Englandappointed 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 laborand mechanizationresulting 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.
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 productionand 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 factoryto 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 scrapand 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. Shewhartof 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.
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 MacArthurto oversee the re-building of Japan. During this time, General MacArthur involved two key individuals in the development of modern quality concepts: W. Edwards Demingand 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.
Quality Assurance versus Quality Control
Whereas Quality Control emphasises 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. 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 controls fail.
A valuable process to perform on a whole
consumerproduct is failure testing, the operation of a product until it fails, often under stresses such as increasing vibration, temperatureand 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 paintor adding lock-washerplacement to the trainingfor new assembly personnel.
Many organizations use
statistical process controlto bring the organizationto Six Sigmalevels 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 in critical tolerances are continuously tracked and where necessary corrected before bad parts are produced.
Total quality control
Deep analysis of QA 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:
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
# Conformance to specifications i.e.
drawings, standards and other relevant documents, were introduced during manufacturing, planningand 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 equipmentwas accurate, this is the responsibility of the QA/QC department.
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, reliabilityand maintainabilityrequirements.
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.
QA in software development
The following are examples of QA models relating to the software development process.
ISO 17025is an international standardthat 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 meetsthe organization's objectives, such as satisfying the customer's quality requirements, complying with regulations, or meeting environmental objectives.
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.
During the 1980s, the concept of “company quality” with the focus on
managementand peoplecame 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 improvementprocess.
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 spiritand 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
* Computer software
* open source development
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 unitconcerned.
In manufacturing and
constructionactivities, these business practices can be equated to the models for quality assurance defined by the International Standards contained in the ISO 9000series 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.
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 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. More experienced consultants are likely to have knowledge of specialised quality improvement activities such as
CMMI, Six Sigma, Measurement Systems Analysis(MSA), Failure Mode and Effects Analysis(FMEA), Advance Product Quality Planning(APQP).
* Quality Assurance in Education, ISSN 0968-4883,
Emerald Publishing Group
* , ISSN: 1432-0517 (electronic) 0949-1775 (Paper), Springer
American Society for Quality
Quality Management System
Society of Quality Assurance
Software quality assurance
Total Quality Management
*Pyzdek, T, "Quality Engineering Handbook", 2003, ISBN 0824746147
*Godfrey, A. B., "Juran's Quality Handbook", 1999, ISBN 007034003X
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