PRODUCTION MANAGEMENT
Total quality management
SHIJIN MD
CONTENTS Description History Seven Basic Tools of Quality Quality management Quality management evolution Quality improvement improvement Quality standards Quality system for medical devices Quality management organizations and awards ISO 9000 Certification Auditing Industry-specific Industry-specific interpretations Enterprise life cycle Architecture Life Cycle Standard operating procedure Clinical Research ISO 14000
INTRODUCTION
CONTENTS Description History Seven Basic Tools of Quality Quality management Quality management evolution Quality improvement improvement Quality standards Quality system for medical devices Quality management organizations and awards ISO 9000 Certification Auditing Industry-specific Industry-specific interpretations Enterprise life cycle Architecture Life Cycle Standard operating procedure Clinical Research ISO 14000
INTRODUCTION
Total quality management 15 years back someone briefed me on TQM which was as follows : You can call it a concept or you call it a philosophy. Its application either in an organization or in a factory which are involved in offering a service or producing a finished product,quality in all its respect is drastically improved. According to this concept every employee irrespective of his or her position in the organization is regarded as equally important. They all have "We Feelings". They don't say "This is not my problem". the lower employee do not feel as "unwanted child" and the corporate management m anagement doesn't think themselves as "most wise decision makers". Every employee is a seller and a buyer at the same time. They sell their talent, their skills, their ideas to the factory/organisation, in response they are fairly compensated in salaries. At the same time they are buyers also. They buy their salaries by in lieu of their work. Everyone is important just like parts in a vehicle. Do not think engine is the most important part and the belt is least important. both are ar e equally important because if the belt stops transferring the engine power to the wheels car will not run. car will not run without one of them. Total quality management (TQM) is a management m anagement philosophy that seeks to integrate all organizational functions (marketing, ( marketing, finance, design, engineering, and production, customer service, etc.) to focus on m eeting customer needs and other organizational objectives. TQM empowers an entire organization, from the most junior employee to the CEO, with the responsibility of ensuring quality in their processes. In particular, T QM provides management with the ability to ensure quality through more streamlined and effective process-improvement channels. A great range of organisations have deployed TQM, including small companies, large companies, and government departments (e.g., NASA). TQM is no more relevant to any one type of organization than any other; on the contrary, it is a philosophy appropriate to any situation in which quality assurance is important.
Description
TQM aims to go beyond simply meeting m eeting customer requirements or responding to the customer feedback on the products and services ser vices offered by the organization. TQM is most effective when operating throughout an entire organization. Prior to the availability of TQM, testing was usually the norm for controlling quality during the final phases of a process (e.g., product development or service provision). If faults were found, the supplies were held back, reworked or rejected, and additional funds were usually required to produce the needed quantity and quality. The aim of TQM is to 'get it right the first time every time' while avoiding the cost associated with other quality management techniques such as simple testing. TQM seeks to identify the sources of possible defects and to prevent them from affecting the final product. Using a simple iterative process, TQM reinforces other methods of quality assurance to meet changes in products and services by improving the effectiveness of operational processes. TQM achieves this by identifying the root causes of the most prevalent and costly defects and to prevent such defects in the future by removing these root causes. Essentially, TQM is a people-dependent process. For total quality management to be most beneficial, people in the organization or ganization need to work together. Thus, organizations must maintain company-wide strategies that devolve responsibility to individual employees for the quality of their work and the work of their teams. TQM, as proposed by W. Edwards Deming, calls for bringing the core concept of quality to early transformatory processes. Deming's chain reaction advocates starting with quality of initial design and further systemically operating on 'Total Quality principles' to achieve the best possible outcome. When each input from raw r aw materials through resources and design produces exceedingly and continually improved finished goods, TQM is said to be operational. Quality circle
A quality circle is a volunteer group volunteer group composed of workers of workers (or even students), students), usually under the leadership of their supervisor (but they can elect a team leader), who are trained to identify, analyse and solve work-related problems and present their solutions to management in order to improve the performance of the organization, and motivate and enrich the work of employees. When matured, true quality circles become self-managing, having gained the confidence of management.
Quality circles are an alternative to the dehumanising concept of the division of labour, where workers or individuals are treated like robots. They bring back the concept of craftsmanship, which when operated on an individual basis is uneconomic, but when used in group form (as is the case with quality circles), it can be devastatingly powerful and enables the enrichment of the lives of the workers or students and creates harmony and high performance in the workplace. Typical topics are improving occupational safety and health, improving product design, and improvement in the workplace and manufacturing processes. The term quality circles derives from the concept of PDCA(Plan, Do, check, Act) circles developed by Dr. W.Edward Deming. Quality circles are not normally paid a share of the cost benefit of any improvements but usually a proportion of the savings made is spent on improvements to the work environment.They are formal groups. They meet at least once a week on company time and are trained by competent persons (usually designated as facilitators) who may be personnel and industrial relations specialists trained in human factors and the basic skills of problem identification, information gathering and analysis, basic statistics, and solution generation. Quality circles are generally free to select any topic they wish (other than those related to salary and terms and conditions of work, as there are other channels through which these issues are usually considered). Quality circles have the advantage of continuity; the circle remains intact from project to project. (For a comparison to Quality Improvement Teams, see Juran's Quality by Design.
History Quality circles were first established in Japan in 1962; Kaoru Ishikawa has been credited with their creation. The movement in Japan was coordinated by the Japanese Union of Scientists and Engineers (JUSE). The first circles were established at the Nippon Wireless and Telegraph Company but then spread to more than 35 other companies in the first year. By 1978 it was claimed that there were more than one million Quality Circles involving some 10 million Japanese workers. There are now Quality Circles in most East Asian countries; it was recently claimed that there were more than 20 million Quality Circles in China.Quality circles have been implemented even in educational sectors in India, and QCFI (Quality Circle Forum of India) is
promoting such activities. However this was not successful in the United States, as it (was not properly understood and) turned out to be a faultfinding exercise although some circles do still exist. ref Don Dewar who together with Wayne Ryker and Jeff Beardsley first established them in 1972 at the Lockheed Space Missile Factory in California. There are different quality circle tools, namely: •
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The Ishikawa or fishbone diagram - which shows hierarchies of causes contributing to a problem The Pareto Chart - which analyses different causes by frequency to illustrate the vital cause, Process Mapping, Data gathering tools such as Check Sheets and graphical tools such as histograms, frequency diagrams, spot charts and pie charts
Student quality circles
Student quality circles work on the philosophy of Total Quality Management. The idea of SQCs was presented by City Montessori School (CIshikawa_diagramMS) Lucknow India in 1993 at a conference in Hong Kong in October 1994. It was developed and mentored by duo engineers of Indian Railways PC Bihari and Swami Das in association with Principal Dr Kamran of CMS Lucknow India. They were inspired and facilitated by Jagdish Gandhi the founder of CMS after J. Gandhi's visit to Japan where he learnt about Kaizen. The world's first student QC was made in CMS Lucknow in India with then 13 year old student Ms. Sucheta Bihari as its leader. CMS conducts international convention on student quality circles at its location in Lucknow since 1997 which it has repeated every 2 years to the present day. After seeing its utility, the visionary educationalists from many countries started these circles. The World Council for Total Quality & Excellence in Education was established in 1999 with its Corporate Office In Lucknow and Head Office at Singapore. It monitors and facilitates student quality circle activities to its member countries which is more than a dozen.This is considered to be a co-curricular activity. Students Quality Circles have been established in India, Bangladesh, Pakistan, Nepal, Sri Lanka, Turkey, Mauratius, Iran, UK (Kingston University), USA, etc.In Nepal Prof. Dinesh P. Chapagain is promoting this innovative approach through QUEST-Nepal since 1999. Prof. Chapagain has written a book entitled "A Guide Book on Students' Quality Circle: An Approach to prepare
Total Quality People" which is considered as standard guide book to promote Students' Quality Circles in academia for student's personality development. Costs
While the use of TQM methodologies reduces the cost of failure (e.g. by reducing scrap, factory re-work, and customer dissatisfaction) it may introduce other costs due to the need for staff and supplier training. The benefit of implementing TQM can be seen in the quality, brand value, decreased time to market, higher customer confidence, and greater return. Above all, TQM facilitates faster, more sustainable development. Possible lifecycle
Today, total quality management is common in modern business, with a large number of education, industry, and defense organizations implementing it. Many colleges are now offering courses in TQM at graduate and undergraduate levels. Abrahamson (1996) argued that fashionable management discourse such as quality circles tends to follow a lifecycle resembling a bell curve, indicating a possible management fad. TQM, however, normally takes a ten-year period to effect change and it takes many years to mature and it is important to note that the decline of any particular management practice is generally a result of commitment lacking at the higher levels. Product design
Example of designed product - Roomba robotic vacuum cleaner. Product design can be defined as the idea generation, concept development, testing and manufacturing or implementation of a physical object or service.
Product Designers conceptualize and evaluate ideas, making them tangible through products in a more systematic approach. The role of a product designer encompasses many characteristics of the marketing manager, product manager , industrial designer and design engineer. The term is sometimes confused with industrial design, which defines the field of a broader spectrum of design activities, such as service design, systems design, interaction design as well as product design . The role of the product designer combines art, science and technology to create tangible three-dimensional goods. This evolving role has been facilitated by digital tools that allow designers to communicate, visualize and analyze ideas in a way that would have taken greater manpower in the past. Skills needed
Product designers are equipped with the skills needed to bring products from conception to market. They should have the ability to manage design projects, and subcontract areas to other sectors of the design industry. Aesthetics is considered important in Product Design but designers also deal with important aspects including technology, ergonomics, usability, stress analysis and materials engineering. As with most of the design fields the idea for the design of a product arises from a need and has a use. It follows a certain method and can sometimes be attributed to more complex factors such as association and telesis. Also used to describe a technically competent product designer or industrial designer is the term Industrial Design Engineer. The Cyclone vacuum cleaner inventor James Dyson for example could be considered to be in this category (see his autobiography Against The Odds , Pub Thomson 2002). A quality circle is a volunteer group composed of workers (or even students), usually under the leadership of their supervisor (but they can elect a team leader), who are trained to identify, analyse and solve work-related problems and present their solutions to management in order to improve the performance of the organization, and motivate and enrich the work of employees. When matured, true quality circles become self-managing, having gained the confidence of management. Quality circles are an alternative to the dehumanising concept of the division of labour, where workers or individuals are treated like robots. They bring back the concept of craftsmanship, which when operated on an individual
basis is uneconomic, but when used in group form (as is the case with quality circles), it can be devastatingly powerful and enables the enrichment of the lives of the workers or students and creates harmony and high performance in the workplace. Typical topics are improving occupational safety and health, improving product design, and improvement in the workplace and manufacturing processes. The term quality circles derives from the concept of PDCA(Plan, Do, check, Act) circles developed by Dr. W.Edward Deming. Quality circles are not normally paid a share of the cost benefit of any improvements but usually a proportion of the savings made is spent on improvements to the work environment.They are formal groups. They meet at least once a week on company time and are trained by competent persons (usually designated as facilitators) who may be personnel and industrial relations specialists trained in human factors and the basic skills of problem identification, information gathering and analysis, basic statistics, and solution generation. Quality circles are generally free to select any topic they wish (other than those related to salary and terms and conditions of work, as there are other channels through which these issues are usually considered). Quality circles have the advantage of continuity; the circle remains intact from project to project. (For a comparison to Quality Improvement Teams, see Juran's Quality by Design. History
Quality circles were first established in Japan in 1962; Kaoru Ishikawa has been credited with their creation. The movement in Japan was coordinated by the Japanese Union of Scientists and Engineers (JUSE). The first circles were established at the Nippon Wireless and Telegraph Company but then spread to more than 35 other companies in the first year. By 1978 it was claimed that there were more than one million Quality Circles involving some 10 million Japanese workers.There are now Quality Circles in most East Asian countries; it was recently claimed that there were more than 20 million Quality Circles in China.Quality circles have been implemented even in educational sectors in India, and QCFI (Quality Circle Forum of India) is promoting such activities. However this was not successful in the United States, as it (was not properly understood and) turned out to be a faultfinding exercise although some circles do still exist. ref Don Dewar who
together with Wayne Ryker and Jeff Beardsley first established them in 1972 at the Lockheed Space Missile Factory in California. There are different quality circle tools, namely: •
•
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The Ishikawa or fishbone diagram - which shows hierarchies of causes contributing to a problem The Pareto Chart - which analyses different causes by frequency to illustrate the vital cause, Process Mapping, Data gathering tools such as Check Sheets and graphical tools such as histograms, frequency diagrams, spot charts and pie charts
Student quality circles
Student quality circles work on the philosophy of Total Quality Management. The idea of SQCs was presented by City Montessori School (CIshikawa_diagramMS) Lucknow India in 1993 at a conference in Hong Kong in October 1994. It was developed and mentored by duo engineers of Indian Railways PC Bihari and Swami Das in association with Principal Dr Kamran of CMS Lucknow India. They were inspired and facilitated by Jagdish Gandhi the founder of CMS after J. Gandhi's visit to Japan where he learnt about Kaizen. The world's first student QC was made in CMS Lucknow in India with then 13 year old student Ms. Sucheta Bihari as its leader. CMS conducts international convention on student quality circles at its location in Lucknow since 1997 which it has repeated every 2 years to the present day. After seeing its utility, the visionary educationalists from many countries started these circles. The World Council for Total Quality & Excellence in Education was established in 1999 with its Corporate Office In Lucknow and Head Office at Singapore. It monitors and facilitates student quality circle activities to its member countries which is more than a dozen.This is considered to be a co-curricular activity. Students Quality Circles have been established in India, Bangladesh, Pakistan, Nepal, Sri Lanka, Turkey, Mauratius, Iran, UK (Kingston University), USA, etc.In Nepal Prof. Dinesh P. Chapagain is promoting this innovative approach through QUEST-Nepal since 1999. Prof. Chapagain has written a book entitled "A Guide Book on Students' Quality Circle: An Approach to prepare Total Quality People" which is considered as standard guide book to promote Students' Quality Circles in academia for student's personality development.tain a competitive edge in innovation.
Seven Basic Tools of Quality The Seven Basic Tools of Quality is a designation given to a fixed set of graphical techniques identified as being most helpful in troubleshooting issues related to quality. They are called basic because they are suitable for people with little formal training in statistics and because they can be used to solve the vast majority of quality-related issues. The tools are: The cause-and-effect or Ishikawa diagram •
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The check sheet The control chart The histogram The pareto chart The scatter diagram Stratification (alternately flow chart or run chart)
The designation arose in postwar Japan, inspired by the seven famous weapons of Benkei. At that time, companies that had set about training their workforces in statistical quality control found that the complexity of the subject intimidated the vast majority of their workers and scaled back training to focus primarily on simpler methods which suffice for most quality-related issues anyway. The Seven Basic Tools stand in contrast with more advanced statistical methods such as survey sampling, acceptance sampling, statistical hypothesis testing, design of experiments, multivariate analysis, and various methods developed in the field of operations research
Quality management Quality management can be considered to have three main components: quality control, quality assurance and quality improvement. Quality management is focused not only on product quality, but also the means to achieve it. Quality management therefore uses quality assurance and control of processes as well as products to achieve more consistent quality.
Quality management evolution
Quality management is a recent phenomenon. Advanced civilizations that supported the arts and crafts allowed clients to choose goods meeting higher quality standards than normal goods. In societies where [[art]responsibilities of a master craftsman (and similarly for artists) was to lead their studio, train and supervise the work of their craftsmen and apprentices. The master craftsman set standards, reviewed the work of others and ordered rework and revision as necessary. One of the limitations of the craft approach was that relatively few goods could be produced, on the other hand an advantage was that each item produced could be individually shaped to suit the client. This craft based approach to quality and the practices used were major inputs when quality management was created as a management science. During the industrial revolution, the importance of craftsmen was diminished as mass production and repetitive work practices were instituted. The aim was to produce large numbers of the same goods. The first proponent in the US for this approach was Eli Whitney who proposed (interchangeable) parts manufacture for muskets, hence producing the identical components and creating a musket assembly line. The next step forward was promoted by several people including Frederick Winslow Taylor a mechanical engineer who sought to improve industrial efficiency. He is sometimes called "the father of scientific management." He was one of the intellectual leaders of the Efficiency Movement and part of his approach laid a further foundation for quality management, including aspects like standardization and adopting improved practices. Henry Ford also was important in bringing process and quality management practices into operation in his assembly lines. In Germany, Karl Friedrich Benz, often called the inventor of the motor car, was pursuing similar assembly and production practices, although real mass production was properly initiated in Volkswagen after world war two. From this period onwards, North American companies focused predominantly upon production against lower cost with increased efficiency. Walter A. Shewhart made a major step in the evolution towards quality management by creating a method for quality control for production, using statistical methods, first proposed in 1924. This became the foundation for his ongoing work on statistical quality control. W. Edwards Deming later applied statistical process control methods in the United States during World War II, thereby successfully improving quality in the manufacture of munitions and other strategically important products.
Quality leadership from a national perspective has changed over the past five to six decades. After the second world war, Japan decided to make quality improvement a national imperative as part of rebuilding their economy, and sought the help of Shewhart, Deming and Juran, amongst others. W. Edwards Deming championed Shewhart's ideas in Japan from 1950 onwards. He is probably best known for his management philosophy establishing quality, productivity, and competitive position. He has formulated 14 points of attention for managers, which are a high level abstraction of many of his deep insights. They should be interpreted by learning and understanding the deeper insights and include: •
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Break down barriers between departments Management should learn their responsibilities, and take on leadership Improve constantly Institute a programme of education and self-improvement
In the 1950s and 1960s, Japanese goods were synonymous with cheapness and low quality, but over time their quality initiatives began to be successful, with Japan achieving very high levels of quality in products from the 1970s onward. For example, Japanese cars regularly top the J.D. Power customer satisfaction ratings. In the 1980s Deming was asked by Ford Motor Company to start a quality initiative after they realized that they were falling behind Japanese manufacturers. A number of highly successful quality initiatives have been invented by the Japanese (see for example on this page: Taguchi, QFD, Toyota Production System. Many of the methods not only provide techniques but also have associated quality culture (i.e. people factors). These methods are now adopted by the same western countries that decades earlier derided Japanese methods. Customers recognize that quality is an important attribute in products and services. Suppliers recognize that quality can be an important differentiator between their own offerings and those of competitors (quality differentiation is also called the quality gap). In the past two decades this quality gap has been greatly reduced between competitive products and services. This is partly due to the contracting (also called outsourcing) of manufacture to countries like India and China, as well internationalization of trade and competition. These countries amongst many others have raised their own standards of quality in order to meet International standards and customer demands. The ISO 9000 series of standards are probably the best known International standards for quality management.
There are a huge number of books available on quality. In recent times some themes have become more significant including quality culture, the importance of knowledge management, and the role of leadership in promoting and achieving high quality. Disciplines like systems thinking are bringing more holistic approaches to quality so that people, process and products are considered together rather than independent factors in quality management. The influence of quality thinking has spread to non-traditional applications outside of walls of manufacturing, extending into service sectors and into areas such as sales, marketing and customer service.[1]
Quality improvement There are many methods for quality improvement. These cover product improvement, process improvement and people based improvement. In the following list are methods of quality management and techniques that incorporate and drive quality improvement: 1. ISO 9004:2008 — guidelines for performance improvement. 2. ISO 15504-4: 2005 — information technology — process assessment
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— Part 4: Guidance on use for process improvement and process capability determination. QFD — quality function deployment, also known as the house of quality approach. Kaizen — 改善, Japanese for change for the better; the common English term is continuous improvement . Zero Defect Program — created by NEC Corporation of Japan, based upon statistical process control and one of the inputs for the inventors of Six Sigma. Six Sigma — 6σ, Six Sigma combines established methods such as statistical process control, design of experiments and FMEA in an overall framework. PDCA — plan, do, check, act cycle for quality control purposes. (Six Sigma's DMAIC method (define, measure, analyze, improve, control) may be viewed as a particular implementation of this.) Quality circle — a group (people oriented) approach to improvement. Taguchi methods — statistical oriented methods including quality robustness, quality loss function, and target specifications.
10. The Toyota Production System — reworked in the west into lean
manufacturing. 11.Kansei Engineering — an approach that focuses on capturing customer emotional feedback about products to drive improvement. 12. TQM — total quality management is a management strategy aimed at embedding awareness of quality in all organizational processes. First promoted in Japan with the Deming prize which was adopted and adapted in USA as the Malcolm Baldrige National Quality Award and in Europe as the European Foundation for Quality Management award (each with their own variations). 13. TRIZ — meaning "theory of inventive problem solving" 14. BPR — business process reengineering, a management approach aiming at 'clean slate' improvements (That is, ignoring existing practices). 15.OQM — Object Oriented Quality Management, a model for quality management. Proponents of each approach have sought to improve them as well as apply them for small, medium and large gains. Simple one is Process Approach, which forms the basis of ISO 9001:2008 Quality Management System standard, duly driven from the 'Eight principles of Quality managagement', process approach being one of them. Thareja writes about the mechanism and benefits: "The process (proficiency) may be limited in words, but not in its applicability. While it fulfills the criteria of all-round gains: in terms of the competencies augmented by the participants; the organisation seeks newer directions to the business success, the individual brand image of both the people and the organisation, in turn, goes up. The competencies which were hitherto rated as being smaller, are better recognized and now acclaimed to be more potent and fruitful ". The more complex Quality improvement tools are tailored for enterprise types not originally targeted. For example, Six Sigma was designed for manufacturing but has spread to service enterprises. Each of these approaches and methods has met with success but also with failures. Some of the common differentiators between success and failure include commitment, knowledge and expertise to guide improvement, scope of change/improvement desired (Big Bang type changes tend to fail more often compared to smaller changes) and adaption to enterprise cultures. For example, quality circles do not work well in every enterprise (and are even
discouraged by some managers), and relatively few TQM-participating enterprises have won the national quality awards. There have been well publicized failures of BPR, as well as Six Sigma. Enterprises therefore need to consider carefully which quality improvement methods to adopt, and certainly should not adopt all those listed here. It is important not to underestimate the people factors, such as culture, in selecting a quality improvement approach. Any improvement (change) takes time to implement, gain acceptance and stabilize as accepted practice. Improvement must allow pauses between implementing new changes so that the change is stabilized and assessed as a real improvement, before the next improvement is made (hence continual improvement, not continuous improvement). Improvements that change the culture take longer as they have to overcome greater resistance to change. It is easier and often more effective to work within the existing cultural boundaries and make small improvements (that is Kaizen) than to make major transformational changes. Use of Kaizen in Japan was a major reason for the creation of Japanese industrial and economic strength. On the other hand, transformational change works best when an enterprise faces a crisis and needs to make major changes in order to survive. In Japan, the land of Kaizen, Carlos Ghosn led a transformational change at Nissan Motor Company which was in a financial and operational crisis. Well organized quality improvement programs take all these factors into account when selecting the quality improvement methods.
Quality standards The International Organization for Standardization (ISO) created the Quality Management System (QMS) standards in 1987. They were the ISO 9000:1987 series of standards comprising ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were applicable in different types of industries, based on the type of activity or process: designing, production or service delivery. The standards are reviewed every few years by the International Organization for Standardization. The version in 1994 was called the IS O
9000:1994 series; comprising of the ISO 9001:1994, 9002:1994 and 9003:1994 versions. The last major revision was in the year 2008 and the series was called ISO 9000:2000 series. The ISO 9002 and 9003 standards were integrated into one single certifiable standard: ISO 9001:2008. After December 2003, organizations holding ISO 9002 or 9003 standards had to complete a transition to the new standard. ISO released a minor revision, ISO 9001:2008 on 14 October 2008. It contains no new requirements. Many of the changes were to improve consistency in grammar, facilitating translation of the standard into other languages for use by over 950,000 certified organisations in the 175 countries (as at Dec 2007) that use the standard. The ISO 9004:2000 document gives guidelines for performance improvement over and above the basic standard (ISO 9001:2000). This standard provides a measurement framework for improved quality management, similar to and based upon the measurement framework for process assessment. The Quality Management System standards created by ISO are meant to certify the processes and the system of an organization, not the product or service itself. ISO 9000 standards do not certify the quality of the product or service. In 2005 the International Organization for Standardization released a standard, ISO 22000, meant for the food industry. This standard covers the values and principles of ISO 9000 and the HACCP standards. It gives one single integrated standard for the food industry and is expected to become more popular in the coming years in such industry. ISO has also released standards for other industries. For example Technical Standard TS 16949 defines requirements in addition to those in ISO 9001:2008 specifically for the automotive industry. ISO has a number of standards that support quality management. One group describes processes (including ISO 12207 & ISO 15288) and another describes process assessment and improvement ISO 15504.
The Software Engineering Institute has its own process assessment and improvement methods, called CMMi (Capability Maturity Model — integrated) and IDEAL respectively. Quality software
The software used to track the three main components of quality management through the use of databases and/or charting applications. Quality terms •
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Quality Improvement can be distinguished from Quality Control in that Quality Improvement is the purposeful change of a process to improve the reliability of achieving an outcome. Quality Control is the ongoing effort to maintain the integrity of a process to maintain the reliability of achieving an outcome. Quality Assurance is the planned or systematic actions necessary to provide enough confidence that a product or service will satisfy the given requirements.
Quality management system
A quality management system (QMS) can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management. Elements of a Quality Management System
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Organizational Structure Responsibilities Procedures Processes
Concept of quality - historical background
The concept of quality as we think of it now first emerged out of the Industrial Revolution. Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet 'quality criteria'. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. In the late
1800s 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 established Quality Departments to oversee the quality of production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure a standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to 'catch' defects. Application of statistical control came later as a result of World War production methods. Quality management systems are the outgrowth of work done by W. Edwards Deming, a statistician, after whom the Deming Prize for quality is named. Quality, as a profession and the managerial process associated with the quality function, was introduced during the second-half of the 20th century, and has evolved since then. Over this period, few other disciplines have seen as many changes as the quality profession. The quality profession grew from simple control, to engineering, to systems engineering. Quality control activities were predominant in the 1940s, 1950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like medicine, accounting, and engineering, quality has achieved status as a recognized profession.
Quality system for medical devices Quality System requirements for medical have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983, and were instituted as requirements in a final rule published on October 7, 1996 . The U.S. Food and Drug Administration (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place. The rule is promulgated at 21 CFR 820. According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the F DA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation. As with GMP, operating within
this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements. The FDA has identified in the QS regulation the essential elements that a quality system shall embody for design, production and distribution, without prescribing specific ways to establish these elements. These elements include:
Quality System •
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personnel training and qualification; controlling the product design; controlling documentation; controlling purchasing; product identification and traceability at all stages of production; controlling and defining production and process; defining and controlling inspection, measuring and test equipment; validating processes; product acceptance; controlling nonconforming product; instituting corrective and preventive action when errors occur; labeling and packaging controls; handling, storage, distribution and installation; records; servicing; statistical techniques;
all overseen by Management Responsibility and Quality Audits. Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label to each product, then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling. Drug manufactures are regulated under a different section of the Code of Federal Regulations: 21 CFR 211. However, the FDA has instituted new policies requiring QS for pharmaceuticals.
Quality management organizations and awards The International Organization for Standardization 's ISO 9001:2008 series describes standards for a QMS addressing the principles and processes surrounding the design, development and delivery of a general product or service. Organizations can participate in a continuing certification process to ISO 9001:2000 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e. planned) improvement of the QMS. (ISO 9000:2005 provides information the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements). The Malcolm Baldrige National Quality Award is a competition to identify and recognize top-quality U.S. companies. This model addresses a br oadly based range of quality criteria, including commercial success and corporate leadership. Once an organization has won the award it has to wait several years before being eligible to apply again. The European Foundation for Quality Management' s EFQM Excellence Model supports an award scheme similar to the Malcolm Baldrige Award for European companies.
In Canada, the National Quality Institute presents the 'Canada Awards for Excellence' on an annual basis to organisations that have displayed outstanding performance in the areas of Quality and Workplace Wellness, and have met the Institute's criteria with documented overall achievements and results. The Alliance for Performance Excellence is a network of state, local, and international organizations that use the Malcolm Baldrige National Quality Award criteria and model at the grassroots level to improve the performance of local organizations and economies. NetworkforExcellence.org is the Alliance web site; browsers can find Alliance members in their state and get the latest news and events from the Baldrige community.
ISO 9000 ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. The rules are updated, as the requirements motivate changes over time. Some of the requirements in ISO 9001:2008 (which is one of the standards in the ISO 9000 family) include •
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a set of procedures that cover all key processes in the business; monitoring processes to ensure they are effective; keeping adequate records; checking output for defects, with appropriate and corrective action where necessary; regularly reviewing individual processes and the quality system itself for effectiveness; and facilitating continual improvement
A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered". Certification to an ISO 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied. Marketing departments take advantage of public confusion and ignorance about ISO 9000. Goods and services outstanding proclaim their ISO 9000 STATUS. Most consumers suppose that ISO 9000 is the same as ISO 9001.
Although the standards originated in manufacturing, they are now employed across several types of organizations. A "product", in ISO vocabulary, can mean a physical object, services, or software. Quality is a "culture" - ISO 9001 "Quality" is an important Accreditation to achieve, it is also essential for maximum benefit that information is shared so that the culture of the business ensures that the Quality culture is embedded Contents of ISO 9001
ISO 9001 certification of a fish wholesaler in Tsukiji ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Outline contents are as follows: •
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Page iv: Foreword Pages v to vii: Section 0 Intro Pages 1 to 14: Requirements Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000) Pages 2 to 14 Section 4: Quality Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Product Realization o o o
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In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS. •
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Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards Page 23: Bibliography
The standard specifies six compulsory documents: •
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Control of Documents (4.2.3) Control of Records (4.2.4) Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3)
In addition to these, ISO 9001:2008 requires a Quality Policy and Quality Manual (which may or may not include the above documents). Summary of ISO 9001:2008 in informal language •
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The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards. Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness. Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source. You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints. When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs. o
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You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness (note: you need a documented procedure for internal audits). You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem seeking and keep records to use as a tool to improve the system.
1987 version
ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization: •
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ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products. ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products. ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent. 1994 version
ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an
ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system. 2000 version
ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, called 9001. Design and development procedures are required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product). The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit. The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There are no new requirements. Explanation of changes in ISO 9001:2008. A quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.Practical Guide to Implementing ISO 9001:2008
Certification ISO does not itself certify organizations. Many countries have formed accreditation bodies to authorize certification bodies, which audit organizations applying for ISO 9001 compliance certification. Although commonly referred to as ISO 9000:2000 certification, the actual standard to which an organization's quality management can be certified is ISO 9001:2008. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the Accredited Certification Bodies (CB) are accepted worldwide.
The applying organization is assessed based on an extensive sample of its sites, functions, products, services and processes; a list of problems ("action requests" or "non-compliances") is made known to the management. If there are no major problems on this list, or after it receives a satisfactory improvement plan from the management showing how any problems will be resolved, the certification body will issue an ISO 9001 certificate for each geographical site it has visited. An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually around three years. In contrast to the Capability Maturity Model there are no grades of competence within ISO 9001.
Auditing Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment, to verify that the system is working as it's supposed to, find out where it can improve and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments. Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing": •
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Tell me what you do (describe the business process) Show me where it says that (reference the procedure manuals) Prove that this is what happened (exhibit evidence in documented records)
The 2000 standard uses a different approach. Auditors are expected to go beyond mere auditing for rote "compliance" by focusing on risk, status and importance. This means they are expected to make more judgments on what is effective, rather than merely adhering to what is formally prescribed. The difference from the previous standard can be explained thus: Under the 1994 version, the question was broadly "Are you doing what the manual says you should be doing?", whereas under the 2000
version, the question is more "Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?" The ISO 19011 standard for auditing applies to ISO 9001 besides other management systems like EMS ( ISO 14001), FSMS (ISO 22000) etc.
Industry-specific interpretations The ISO 9001 standard is generalized and abstract. Its parts must be carefully interpreted, to make sense within a particular organization. Developing software is not like making cheese or offering counseling services; yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations—police departments (US), professional soccer teams (Mexico) and city councils (UK)—have successfully implemented ISO 9001:2000 systems. Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them. •
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The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development. AS9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt & Whitney, Rockwell-Collins, Sikorsky Aircraft, and Sundstrand. The current version is AS9100. PS 9000 is an application of the standard for Pharmaceutical Packaging Materials. The Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance (IQA) has developed PS 9000:2001. It aims to provide a widely accepted baseline GMP framework of best practice within the pharmaceutical packaging supply industry. It applies ISO 9001: 2000 to pharmaceutical printed and contact packaging materials.
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QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS 16949. ISO/TS 16949:2002 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2000. The emphasis on a process approach is stronger than in ISO 9001:2000. ISO/TS 16949:2002 contains the full text of ISO 9001:2000 and automotive industry-specific requirements. TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is 4.0 and unlike ISO 9001 or the above sector standards, TL 9000 includes standardized product measurements that can be benchmarked. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry. ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with ISO 9001:2000. ISO/TS 29001 is quality management system requirements for the design, development, production, installation and service of products for the petroleum, petrochemical and natural gas industries. It is equivalent to API Spec Q1 without the Monogram annex.
Debate on the effectiveness of ISO 9000
The debate on the effectiveness of ISO 9000 commonly centers on the following questions: 1. Are the quality principles in ISO 9001:2000 of value? (Note that the version date is important: in the 2000 version ISO attempted to address many concerns and criticisms of ISO 9000:1994). 2. Does it help to implement an ISO 9001:2000 compliant quality management system? 3. Does it help to obtain ISO 9001:2000 certification?
Advantages
It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade, and Barnes, who says "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Barnes also cites a survey by Lloyd's Register Quality Assurance which indicated that ISO 9000 increased net profit, and another by Deloitte-Touche which reported that the costs of registration were recovered in three years. According to the Providence Business News, implementing ISO often gives the following advantages: 1. 2. 3. 4. 5. 6. 7. 8.
Create a more efficient, effective operation Increase customer satisfaction and retention Reduce audits Enhance marketing Improve employee motivation, awareness, and morale Promote international trade Increases profit Reduce waste and increases productivity
However, a broad statistical study of 800 Spanish companies found that ISO 9000 registration in itself creates little improvement because companies interested in it have usually already made some type of commitment to quality management and were performing just as well before registration.
Problems
A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration. According to Barnes, "Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed." ISO 9001 is not in any way an indication that products produced using its certified systems are any good. A company can intend to produce a poor quality product and providing it does so consistently and with the proper documentation can put an ISO 9001 stamp on it. According to Seddon, ISO 9001 promotes specification, control, and procedures rather
than understanding and improvement. Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality, ... [undermining] the need for an organization to set its own quality standards." Paraphrased, Wade's argument is that reliance on the specifications of ISO 9001 does not guarantee a successful quality system. The standard is seen as especially prone to failure when a company is interested in certification before quality. Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality. "If you just want the certificate on the wall, chances are, you will create a paper system that doesn't have much to do with the way you actually run your business," said ISO's Roger Frost. Certification by an independent auditor is often seen as the problem area, and according to Barnes, "has become a vehicle to increase consulting services." In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved.Another problem reported is the competition among the numerous certifying bodies, leading to a softer approach to the defects noticed in the operation of the Quality System of a firm. Abrahamson argued that fashionable management discourse such as Quality Circles tends to follow a lifecycle in the form of a bell curve, possibly indicating a management fad. Summary
A good overview for effective use of ISO 9000 is provided by Barnes: "Good business judgment is needed to determine its proper role for a company... Is certification itself important to the marketing plans of the company? If not, do not rush to certification... Even without certification, companies should utilize the ISO 9000 model as a benchmark to assess the adequacy of its quality programs."
Enterprise life cycle
Illustration of the Enterprise Life Cycle. Enterprise Life Cycle (ELC) in enterprise architecture is the dynamic, iterative process of changing the enterprise over time by incorporating new business processes, new technology, and new capabilities, as well as maintenance and disposition of existing elements of the enterprise. Overview
The enterprise life cycle is a concept in Enterprise Architecture (EA). The Enterprise Architecture process is closely related to other processes, such enterprise engineering and program management cycle, more commonly known as the Systems Development Life Cycle. This concept aids in the implementation of an Enterprise Architecture, and the Capital Planning and Investment Control (CPIC) process that selects, controls, and evaluates investments. Overlying these processes are human capital management and information security management. When these processes work together effectively, the enterprise can effectively manage information technology as a strategic resource and business process enabler. When these processes are properly synchronized, systems migrate efficiently from legacy technology environments through evolutionary and incremental developments, and the Agency is able to demonstrate its return on investment. The figure on top illustrates the interaction of the dynamic and interactive cycles as they would occur over time.
Enterprise Life Cycle topics Enterprise Architecture Process
Enterprise Architecture Process. As a prerequisite to the development of every enterprise architecture, each Agency should establish the need to develop an EA and formulate a strategy that includes the definition of a vision, objectives, and principles. The figure shows a representation of the EA process. Executive buy-in and support should be established and an architectural team created within the organization. The team defines an approach and process tailored to Agency needs. The architecture team implements the process to build both the baseline and target EAs. The architecture team also generates a sequencing plan for the transition of systems, applications, and associated business practices predicated upon a detailed gap analysis. The architecture is employed in the CPIC and the enterprise engineering and program management processes via prioritized, incremental projects and the insertion of emerging new technologies. Lastly, the architectures are maintained through a continuous modification to reflect the Agency's current baseline and target business practices, organizational goals, visions, technology, and infrastructure.
Architecture Life Cycle
DoDAF Architecture Life Cycle. The figure depicts the life of the architecture as it evolves and shows the process that the architecture description supports in the development, analysis, and evolution of the implemented architecture. In this illustration, the Operational View is used to drive the requirements that are evaluated against the Systems View. Operational deficiencies are derived from the analysis, and viable candidates are identified. These candidates can take the form of either materiel or non- materiel solutions and are modeled back into the Operational and Systems Views of the architecture. The architecture is re-analyzed, and the process continues until the operational deficiencies are minimized. The final sets of viable candidates are assessed for operational viability. Based on the results of the assessments, design changes are made and submitted for inclusion into the budgeting process. This process of developing, analyzing, and modifying continues throughout the architecture’s life cycle. Enterprise Life Cycle activities
TEAF Enterprise Life Cycle activities
An Enterprise Life Cycle integrates the management, business, and engineering life cycle processes that span the enterprise to align its business and IT activities. Enterprise Life Cycle refers generally to an organization’s approach for managing activities and making decisions during ongoing refreshment of business and technical practices to support its enterprise mission. These activities include investment management, project definition, configuration management, accountability, and guidance for systems development according to a System Development Life Cycle (SDLC). The Enterprise Life Cycle applies to enterprise-wide planning activities and decision making. By contrast, a System Development Life Cycle generally refers to practices for building individual systems. Determining what systems to build is an enterprise-level decision. The figure on the right depicts notional activities of an Enterprise Life Cycle methodology. Within the context of this document, Enterprise Life Cycle does not refer to a specific methodology or a specific bureau’s approach. Each organization needs to follow a documented Enterprise Life Cycle methodology appropriate to its size, the complexity of its enterprise, and the scope of its needs. Enterprise Performance Life Cycle
Illustration of the Enterprise Performance Life Cycle of the U.S. Department of Health & Human Services. The Enterprise Performance Life Cycle (EPLC) encompasses the major business functions executed under the Office of the Chief Information Officer (CIO), and in particular shows at a high level the relationship among the different business functions and both the general order and the iterative nature of their execution. The placement of enterprise architecture in the center of the EPLC conceptual diagram, shown in the figure, reflects the supporting and enabling role that enterprise architecture serves for the major
business functions in the Enterprise Performance Life Cycle. The Enterprise Architecture (EA) Program explicitly considers the information needs of the Enterprise Performance Life Cycle (EPLC) processes in developing and enhancing the EA Framework, collecting and populating data in the EA Repository, and developing views, reports, and analytical tools that can be used to facilitate the execution of the EPLC processes. The EPLC conceptual diagram in the figure provides a Departmental perspective of key business functions. The EPLC is also relevant from an individual investment or project perspective, as each new investment passes through each phase of the EPLC. The investment-level perspective is detailed in the an Enterprise Performance Life Cycle Framework.
Standard operating procedure The terms standard operating procedure and standing operating procedure, both abbreviated by the initialism, SOP, occur in a variety of different contexts, such as healthcare, education, industry, the military, etc. General use
A Standing Operating Procedure: A set of instructions covering those features of operations which lend themselves to a definite or standardized procedure without loss of effectiveness. The procedure is applicable unless ordered otherwise. Also called SOP. See FM 6-0 or FM 1-02 (FM 101-5-1). Military use
In military terminology SOPs describe a procedure or set of procedures to perform a given operation or evolution or in reaction to a given event. There is a popular misconception that SOPs are standardized. However, the very nature of an SOP is that it is not standardized across a large military element (such as a corps or division) but rather describes the unique operating procedure of a smaller unit (such as a battalion or company) within that larger element. "Standing" operating procedures take effect until further notice, at which time the issuing authority amend or dissolve them. Therefore, the military more correctly uses the term "standing operating procedure" in lieu of "standard operating procedure."
Unit members typically promulgate SOPs, based on unit experience and local conditions. They are normally approved by the unit's Officer Commanding or Commanding Officer . SOPs differ from tactics and strategy in that they are unit-orientated and -formulated and are not the product of the unit's parent service's doctrinal agencies. Tactics and strategy are generally formulated by official agencies (often service branches, corps or arms) who are tasked for the purpose by the parent service and published in the service's official service manuals, for example, the United States Field Manuals (FMs), the Australian Manual of Land Warfare (MLW), and others. In cases where the unit's SOPs cover the same topical area as doctrine generated by the unit's parent service, the SOP may be considered to be the unit's interpretation of the official doctrine. SOPs often offer guidance where official doctrine does not cover a situation, or treats a situation only in extremely broad terms. SOPs are often used to provide practical detail to the some times high level guidance of official doctrine. Where official doctrine exists, SOPs will usually, at least in general terms, adhere to the official doctrine. However SOPs may on occasion ignore official doctrine, especially when a service/corps generally regards official doctrine as out-of-date, inadequate or incorrect. SOPs also differ from standing orders in that personnel may legally disregard or interpret them, as required by the situation; however, acting contrary to a posted command-signed SOP is generally considered the same as violating a published order and punished accordingly.
Clinical Research In clinical research, the International Conference on Harmonisation (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function". Organizations involved in clinical research —whether pharmaceutical companies, sponsors, contract research organizations, investigator sites, ethics committees or any other parties— require SOPs to achieve maximum safety and efficiency of the performed clinical research operations. All people and sites involved in clinical studies (both at the sponsor and at the investigative sites) must have appropriate
SOPs in place in order to conduct clinical research in compliance with current regulations. In the United States of America, the ICH GCP ( good clinical practice) Step 5 Guideline (Section 3.2.2) also suggests that an Institutional Review Board (IRB) have its own SOPs or written standard procedures. This itself proves that the presence of SOPs form an integral part of clinical trials at all levels. Inspections target these quality documents since the most frequent reported deficiencies during inspections are the lack of written SOPs and/or the failure to adhere to them. The risk of GCP non-compliance is high at organizations with a poor availability of clinical-research-specific SOPs. The risk of GCP non-compliance is also high where SOPs exist but the staff or the people for whom they were written lack awareness of them or of the need for them. The training of staff using SOPs therefore becomes very important, so that staff actually become aware of why and how SOPs can play an important role in fulfilling the ICH and other regulatory requirements. Good manufacturing practice
An SOP is a written document or instruction detailing all steps and activities of a process or procedure. These should be carried outwithout any deviation or modification to guarantee the expected outcome. Any modification or deviation from a given SOP should be thoroughly investigated and outcomes of the investigation documented according the internal deviation procedure. All quality impacting processes and procedures should be laid out in Standard Operating Procedures (SOPs). These SOPs should form the basis for the routine training program of each employee. SOPs should be regularly updated to assure compliance to the regulatory requirements and the working practice. A minimum review schedule of 3 years is recommended. Changes of SOPs are in general triggered by process or procedural changes / adjustments. The internal site change-control procedure should manage these changes. Part of the activity list of such changes should be to update the related SOP. SOPs should be in place for all quality systems plus the specific operational activities on site. The structure of an SOP System and the total amount of individual SOPs should be carefully taken into consideration. Too many
SOPs could lead to a collapse of the SOP System. System SOPs should not be mixed up to keep systems and interaction between quality systems easy. ISO 9000 is essentially requires the documention of all procedures used in any manufacturing process that could affect the quality of the product. Information-technology industry use
The information technology industry uses the terms "Standard Operating Procedure" and "SOP" interchangeably to describe a best-practice approach to executing tasks related to the production and maintenance of hardware and software, as well as to incident and change management. A number of packages may aid in the automation of the execution of informationtechnology SOPs for large enterprises, note for example Creekpath, iConclude and Stratavia's Data Palette.
ISO 14000 ssThe ISO 14000 is a standard for environmental management systems that is applicable to any business, regardless of size, location or income. The aim of the standard is to reduce the environmental footprint of a business and to decrease the pollution and waste a business produces. The most recent version of ISO 14001 was released in 2004 by the International Organization for Standardization (ISO) which has representation from committees all over the world. The major objective of the ISO 14000 series of norms is "to promote more effective and efficient environmental management in organizations and to provide useful and usable tools - ones that are cost effective, system-based, flexible and reflect the best organizations and the best organizational practices available for gathering, interpreting and communicating environmentally relevant information". The intended end result is the improvement of environmental performance. It offers source of guidance for introducing and adopting environmental management systems based on the best universal practices, in the same way that the ISO 9000 series on quality management systems, which is now widely applied, represents a tool for technology transfer of the best available quality management practices.
