Quality assurance
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Quality assurance (QA) is the activity of providing evidence needed to establish confidence among all concerned, that quality-related activities are being performed effectively. All those planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality. Quality Assurance is a part and consistent pair of quality management proving fact-based external confidence to customers and other stakeholders that a product meets needs, expectations, and other requirements. QA assures the existence and effectiveness of procedures that attempt to make sure - in advance - that the expected levels of quality will be reached.
QA covers all activities from design, development, production, installation, servicing to documentation. It introduced the sayings "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 term Quality Assurance, as used in 10 CFR (Code of Federal Regulations) Appendix B to part 50, comprises all those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to the physical characteristics of a material, structure, component, or system which provide a means to control the quality of the material, structure, component, or system to predetermined requirements.
One of the most widely used paradigms for QA management is the PDCA (Plan-Do-Check-Act) approach, also known as the Shewhart cycle.
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[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.
QA encompasses all measures taken to ensure the reliability of investigations, starting from test selection, through obtaining a satisfactory sample, analysing it and recording the result promptly and correctly, to appropriate interpretation and reporting, with all procedures being documented for reference.
[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. For software development organization, CMMI (Capability Maturity Model Integration) standards are widely used to measure the Quality Assurance. These CMMI standards can be divided in to 5 steps, which a software development company can achieve by performing different quality improvement activities with in the organization.
[edit] Company quality
The company-wide quality approach places an emphasis on four aspects :-
- Infrastructure (as it enhances or limits functionality)
- 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.
The quality of the outputs is at risk if any of these four aspects are deficient in any way.
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] See also
- Quality control
- Best practice
- GxP
- Data quality
- Data integrity
- Software Testing
- Software Quality Assurance
- American Society for Quality
[edit] References
- Pyzdek, T, "Quality Engineering Handbook", 2003, ISBN 0824746147
- Godfrey, A. B., "Juran's Quality Handbook", 1999, ISBN 007034003
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