quality assurance

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

History - Though terms like 'quality engineering' and 'quality assurance' are relatively new, the ideas have existed just as long as the very art of tool manufacture. Simple tools made of rock (geology)rock or bone were subject to familiar modes of failure. They could be fragile, dull where they should be sharp, sharp where they should be dull, etc. When the first specialized craftsmen arose, manufacturing tools for others, the principle of quality control was simple: "let the buyer beware" (''caveat emptor'').The first civil engineering projects, however, needed to be built to specifications.

Craft and tradespersons - During the Middle Ages, guilds took the responsibility of quality control upon themselves. All practitioners of a particular trade living in a certain area were required to join the corresponding guild, and the guild instituted punishments for members who turned out shoddy products. 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.Prior to the extensive division of labor and mechanization resulting from the Industrial Revolution, it was possible for a workman to control the quality of his own product. Working conditions then were more conducive to professional pride.The Industrial Revolution led to a system in which large groups of men 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.

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 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 large inspection organizations of the 1920’s and 1930’s, 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 1930’s, 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 process control (SPC). Some of the initial work for SPC is credited to Walter A. Shewhart of Bell Labs.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 that 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.

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 collabrative 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 collabrative 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 Dr. Joseph Moses 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.

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.

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.

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 1 E-6one-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.

Company quality - During the 1980’s, the concept of “company quality” with the focus on management and people came to the forefront. 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 :-# 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, organisational culture, motivation, team spirit and quality relationships.The quality of the outputs is at risk if any of these three aspects are 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.

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

SafetyAs 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 timorously and satisfactorily dealt with.# Feedback from the user/customer is used to review designs.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, natural environmentenvironmental, 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-purposeR 21;? is “Quality Awareness” throughout the company.

See also -

Go/no go

Six Sigma

Software quality and software testing

Playtest

Validation

Manufacturing

List of production topics

Total Quality Management (TQM)

List of software engineering topics

Computerized system validation

Good Manufacturing Practice

Health care quality improvement organizations, or QIOs.

Product qualification

External links -

qapodcast.com - QA Podcast: Recorded conversations about techinical and business QA topics

? saksoft.com - Saksoft

agileedge.com - Bug Tracking Software

dmoz.org - Open Directory

citeseer.org - Citations from CiteSeer

compinfo-center.com - Software Testing and Quality Control - Outline

osdl.org - Linux Kernel Scalable Test Platform

osdl.org - OSDL Data Base Test Suite

agileedge.com - Agility an Issue and Requirements Tracking Software from AgileEdge

opensourcetesting.org - Open source software testing tools

mtqainstitute.org - Medical Transcription Quality Assurance Institute

qaforums.com - The online community for software testing & quality assurance professionals

stickyminds.com - Stickyminds website for all things connected with software testing - associated with "Better Software" Magazine

methodsandtools.com - Methods & Tools: on-line magazine with many articles on software testing and quality

sqconline.com - Statistical Quality Control Online: tables, calculators and procedures

qualitytimes.co.in - Basic information on Quality

References -

Federal Standard 1037C

!MIL-STD-188Category:Engineerin gCategory:Qualitycategory:Prod uction? and !manufacturingde:Qualitätssich erunges:Control? de calidadfa:کنترل کیفیتit:Qualità dei dati (statistica)he:בקרת !איכותja:品質管理 DEBUG REDIRECT (quality control)

Medical Lawyer
John R. Irwin, A.B., J.S., B.S., M.D. Lawyer-Physician providing legal assistance regarding contemporary medical legal issues, including malpractice, licensure, hospital privileges.
http://www.lawyerdoctor.com/

ENKON Information Systems
Web based environmental and land information management systems/software
http://www.enkon.com/

www.qcmortgage.com
Mortgage compliance, Quality Assurance, Fraud prevention
http://www.qcmortgage.com/

Quality Mortgage Services
Full Service Outsource Mortgage Compliance Company
http://www.qualitymortgageservices.com/

Englert Technology can work with your team to provide IT solutions
Englert Technology incorporates project management capabilities with technology solutions to provide quality IT services. Our information technology professionals work as partners with your employees to understand your problems and search for cost-effective solutions. We don't take a one-size-fits-all approach. We tailor IT solutions to fit your needs.
http://www.englerttechnology.com/

Project management
Project Agency - Helping individuals and organizations deliver projects effectively. Project Agency provides a full range of project management services from training to one to one support, from putting in project management systems to auditing of projects. Contact Project Agency – info@projectagency.com – www.projectagency.co.uk
http://www.projectagency.co.uk/

Software Quality Solutions (SQS)
SQS is a leading provider of technology optimization solutions for enterprise business systems. SQS provides clients with a wide range of customized services including quality assessments, Sarbanes-Oxley compliance reviews, IT governance consulting, project management, project optimization, performance tuning, test automation, application monitoring and ESSAY methodology implementation. SQS also provides training and mentoring services that allow IT organizations to rapidly adopt automation and monitoring technologies. At SQS our mission is to provide world-class tools and outstanding expertise to our clients. Our services help organizations adopt best practices, implement workflow driven IT processes, and deploy, upgrade and manage business systems that meet defined requirements and SLA's. Our significant experience in a wide variety of industries helps us to deliver effective, customized solutions for our clients. Software Quality Solutions is a re-seller of industry leading business process automation technologies from Mercury, Compuware, and Borland.
http://www.sqs.com/

Lone Star Bakery
Manufacturer of Baked Products
http://www.lonestarbakery.com/

Chemic Laboratories, Inc.
Chemic Labs is a contract analytical chemistry organization, FDA registered and DEA licensed, servicing the pharmaceutical, biotech, veterinary medicine, medical device and specialty chemical industries. Chemic labs also manufactures a line of high purity excipients through proprietary methodology
http://www.chemiclabs.com/

Tahitian Noni Juice(tm)
For thousands of years, the people of Tahiti have benefited from the amazing noni fruit. Now, through Tahitian Noni® products, you too have access to the tremendous power of this world-renowned “super fruit”.
http://www.tni.com/dennismason

ContractPharm, an agency-independent resource for pharmaceutical research contractors.
ContractPharm - A one-stop shop for pharmaceutical clinical contractors. We have various resources for contractors including contracting advice, CV advice, clinical advice, tips on dealing with agencies and a vocal forum. when contractors are are looking to to enter the contract market, wondering how to start contracting or are simply looking for your next position, they''ll find everything they need here. We also have a significant links menu, providing our visitors with the best sites, for travel and shopping online.
http://www.contractpharm.co.uk/

SQL Database Documentation
DBDocumentor produces database documentation for the SQL objects in your database project. The list of SQL objects documented varies with the SQL dialect chosen, and DBDocumentor currently supports; Microsoft SQL Server 2005 and below, Firebird 1.5, and Sybase ASA 9 and below. Generating reference documentation for a SQL database using DBDocumentor is as simple as selecting the SQL dialect, the object types to include and the source files to process. Within a few minutes DBDocumentor generates a fully cross referenced view of the SQL database, including where data is sourced from and what objects are modifying data in what other objects. The cross referencing extends to procedure and security usage, clearly showing which procedures are used where, and under what security context. These capabilities make DBDocumentor ideal for those wishing to learn the structure of a given database, or simply to document the database for future reference. Extended capabilities include declarative object grouping, support for DBMS metadata based descriptions like those provided in SQL Server Enterprise Manager or SQL Server Management Studio, SQL dialect specific syntax color coding, control over the documentation of temporary objects and dynamic SQL, and the generation of XML output. All documentation is generated by reading the source SQL batch files and requires no active database connection, or any database connectivity tools. DBDocumentor produced documentation is perfect as printed database application documentation for: - Client documentation for software development consulting projects - Online access for middle tier developers to develop against a documented database interface - Determining the degree of data exposure and risk by specific database functions and procedures - Determining the degree of dynamic SQL used in the database, and what data sources are impacted by the use of dynamic SQL
http://www.pikauba.com/DBDoc/Details.htm

CCSi Testing Instruments, Equipment, Physical Testing, Calibration & Related Services
CCSi provides the rubber, plastic, and textile processing industries with laboratory instrumentation, processing and test specimen preparation equipment, physical testing, instrument calibration and related services.
http://www.ccsi-inc.com/

medicomp GmbH
medicomp Gesellschaft für Versuchsplanung und Datenanalyse mbH CRO in München
http://www.medicomp-cro.de/

Merlin Industrial Products Ltd
Industrial Products including Storage and Handling Equipment, Office Furniture, Health and Safety and Security products.
http://www.merlin-industrial.com/

Digital Inkwell
Digital Inkwell Inc provides Documentation and Training expertise ranging from early stage Requirements Analysis to end-of-cycle Evaluation and Improvement.
http://www.digitalinkwell.ca/

Ottaway & Associates Ltd
Management Consultants specialising in Safety, Quality and Environmental Management
http://www.ottawayconsultants.com/

QA/QC Inspections and Auditing
C. Brian Mintus CET Mintus Inspections Inc. Lead Auditor Training ISO 9001 2000 QA/QC Management and Vendor Surveillance NDE & Visual Level III Inspector Construction Safety Supervisor (CSS) Mintus Inspections offers a variety of Inspection Services, from Quality Assurance and Quality Control through to NDT Examinations. Our experience gives you the confidence required, and our qualifications are beyond reproach. Home:1-902-446-9410, Fax: 1-902 425-7173 Cel: 1-902-488-0050, Car: 1-604-376-4883
http://www.mintus.net/

TeamHeadquarters - Work Management Software
Entry Software Corporation is the global leader in work management solutions for IT departments, product departments, and service organizations. Our software solutions create value through cost reduction, improvements in operating efficiency, and increased strategic advantage. With the ability to distribute and support our solutions remotely, we enjoy a proven track record around the globe. Entry Software Corporation can reduce your IT costs, increase your organizational efficiency, and improve your client service with a low risk, highly adopted, collaborative suite that is configurable to any sector of the global economy.
http://www.entry.com/

Biosystems, Inc., Biosystems America, Biosystems Atlanta
Biosystems, Inc., is a private, for profit company chartered in 1976, the oldest biotechnology company in Georgia, and perhaps the entire SE US. It specializes in providing technical services such as research, development, laboratory analyses and scientific studies for quality assurance and regulatory affairs/compliance for agricultural, biotechnology, drug, environmental health, food and pharmaceutical industries.
http://www.biosystemsamerica.com/

AMA Management Consultants Ltd
Training and Consultancy Services for Quality Assurance, Health & Safety and Environmental Management Systems
http://www.ama-qhse.com/

NCQA: National Committee for Quality Assurance
Provides information about the quality of national managed care plans to enable consumers to evaluate health plan performance. Includes links to accreditation and certification programs, compliance audits, health plan report cards, and credentialing data.
http://www.ncqa.org/

Quality Assurance Agency for Higher Education - Home Page
Includes site search, review reports and the latest projects.
http://www.qaa.ac.uk/

Springer LINK
Information about scientific books and journals of the Springer publishing group, CD-ROM publications, software products, and catalogues, and online access (by subscription) to some contents.
http://link.springer.de/

Institute of Quality Assurance (IQA)
Promotes the education, training, qualification and professional development of those who value quality, and is a leading body for the advancement of quality practices. Based in London, UK.
http://www.iqa.org/

World Wide Web Consortium
International industry consortium founded in 1994 whose purpose is to develop specifications, guidelines, software, and tools to promote the Internet's evolution and ensure its interoperability.
http://www.w3.org/