What constitutes a definition of fascism and fascist governments has been a complicated and highly disputed subject concerning the exact nature of fascism and its core tenets debated amongst historians, political scientists, and other scholars since Benito Mussolini first used the term in 1915. Historian Ian Kershaw once wrote that "trying to define 'fascism' is like trying to nail jelly to the wall". A significant number of scholars agree that a "fascist regime" is foremost an authoritarian form of government, although not all authoritarian regimes are fascist. Authoritarianism is thus a defining characteristic, but most scholars will say that more distinguishing traits are needed to make an authoritarian regime fascist. Similarly, fascism as an ideology is also hard to define. Originally, it referred to a totalitarian political movement linked with corporatism which existed in Italy from 1922 to 1943 under the leadership of Benito Mussolini. Many scholars use the word "fascism" without capitalization in a more general sense, to refer to an ideology (or group of ideologies) which was influential in many countries at many different times. For this purpose, they have sought to identify what Roger Griffin calls a "fascist minimum"—that is, the minimum conditions that a certain political movement must meet in order to be considered "fascist". Scholars have studied the apocalyptic and millenarian aspects of fascism. By encyclopediasEncyclopaedia BritannicaThe Encyclopaedia Britannica defines fascism as a "political ideology and mass movement that dominated many parts of central, southern, and eastern Europe between 1919 and 1945 and that also had adherents in western Europe, the United States, South Africa, Japan, Latin America, and the Middle East.", adding that "Although fascist parties and movements differed significantly from one another, they had many characteristics in common, including extreme militaristic nationalism, contempt for electoral democracy and political and cultural liberalism, a belief in natural social hierarchy and the rule of elites, and the desire to create a Volksgemeinschaft (German: "people's community"), in which individual interests would be subordinated to the good of the nation." Holocaust EncyclopediaThe Holocaust Encyclopedia defines fascism as "a far-right political philosophy, or theory of government, that emerged in the early twentieth century. Fascism prioritizes the nation over the individual, who exists to serve the nation." and as "an ultranationalist, authoritarian political philosophy. It combines elements of nationalism, militarism, economic self-sufficiency, and totalitarianism. It opposes communism, socialism, pluralism, individual rights and equality, and democratic government." By fascistsBenito MussoliniBenito Mussolini, who was the first to use the term for his political party in 1915, described fascism in The Doctrine of Fascism, published in 1932, as follows:
In a speech before the Chamber of Deputies on 26 May 1927, Mussolini said:
Francisco FrancoIn an interview with Henri Massis in 1938, Spanish Nationalist leader Francisco Franco described his movement in Spain as part of a wider trend and said about this trend:
By scholarsUmberto EcoIn his 1995 essay "Ur-Fascism", cultural theorist Umberto Eco lists fourteen general properties of fascist ideology. He argues that it is not possible to organise these into a coherent system, but that "it is enough that one of them be present to allow fascism to coagulate around it". He uses the term "ur-fascism" as a generic description of different historical forms of fascism. The fourteen properties are as follows:
Emilio GentileItalian historian of fascism Emilio Gentile described fascism in 1996 as the "sacralization of politics" through totalitarian methods and argued the following ten constituent elements:
A. James GregorA. James Gregor, co-founder of the International Association for the Advancement of Ethnology and Eugenics, a prominent group in the promotion of eugenics and segregation, affirmed that fascism was a "variant of Sorelian syndicalism" which also included components of neo-idealism and elitist socialism. Gregor stated that Stalinism and Fascist totalitarianism would have been impossible without the "transmogrified Marxism, that infilled both". According to Gregor:
Furthermore, he believed that post-Maoist China displays many fascist traits. He has denied that fascism is "right-wing extremism". Gregor's work has come under increasing criticism in the 21st century. In a review of his 2006 essay on Neofascist movements, Peter H. Merkl, of the University of California, Santa Barbara, accuses Gregor of ignoring modern work in favor of his own views, and attempting to force an out of date definition of fascism. Merkl writes:
Roger GriffinHistorian and political scientist Roger Griffin's definition of fascism focuses on the populist fascist rhetoric that argues for a "re-birth" of a conflated nation and ethnic people. According to Griffin,
Griffin writes that a broad scholarly consensus developed in English-speaking social sciences during the 1990s, around the following definition of fascism:
Griffin argues that the above definition can be condensed into one sentence: "Fascism is a political ideology whose mythic core in its various permutations is a palingenetic form of populist ultra-nationalism." The word "palingenetic" in this case refers to notions of national rebirth. Ian KershawIn his history of Europe in the first half of the 20th century, To Hell and Back, British historian Ian Kershaw, while noting the difficulties in defining fascism, found these common factors in the extreme Right-wing movements of the late 1920s and early 1930s, whether they called themselves "fascist" or not:
Other features Kershaw found to be important, and sometimes central to specific movements, but not present in all:
Kershaw argues that the difference between fascism and other forms of right-wing authoritarianism in the Interwar period is that the latter generally aimed "to conserve the existing social order", whereas fascism was "revolutionary", seeking to change society and obtain "total commitment" from the population. Kershaw writes about the essential appeal of fascism and the reasons for its success, where it was successful (primarily in Italy and Germany):
George Lakoff and Mark JohnsonIn their book Philosophy in the Flesh: The Embodied Mind and its Challenge to Western Thought, philosophers George Lakoff and Mark Johnson wrote about fascism, in the chapter about morality:
John LukacsJohn Lukacs, Hungarian-American historian and Holocaust survivor, argues in The Hitler of History that there is no such thing as generic fascism, claiming that National Socialism and Italian Fascism were more different than similar and that, alongside communism, they were ultimately radical forms of populism. Ludwig von MisesClassical liberal economist and philosopher Ludwig von Mises, in his 1927 book Liberalism, argued that fascism was a nationalist and militarist reaction against the rise of the communist Third International, in which the nationalists and militarists came to oppose the principles of liberal democracy because "Liberalism, they thought, stayed their hand when they desired to strike a blow against the revolutionary parties while it was still possible to do so. If liberalism had not hindered them, they would, so they believe, have bloodily nipped the revolutionary movements in the bud. Revolutionary ideas had been able to take root and flourish only because of the tolerance they had been accorded by their opponents, whose will power had been enfeebled by a regard for liberal principles that, as events subsequently proved, was overscrupulous." He continues by defining fascism as follows:
Ernst NolteErnst Nolte, a German historian and Hegelian philosopher, defined fascism in 1965 as a reaction against other political movements, especially Marxism: "Fascism is anti-Marxism which seeks to destroy the enemy by the evolvement of a radically opposed and yet related ideology and by the use of almost identical and yet typically modified methods, always, however, within the unyielding framework of national self-assertion and autonomy." Nolte also argued that fascism functioned at three levels: in the world of politics as a form of opposition to Marxism, at the sociological level in opposition to bourgeois values, and in the "metapolitical" world as "resistance to transcendence" ("transcendence" in German can be translated as the "spirit of modernity"). Kevin PassmoreKevin Passmore, a history lecturer at Cardiff University, defines fascism in his 2002 book Fascism: A Very Short Introduction. His definition is directly descended from the view put forth by Ernesto Laclau, and is also informed by a desire to adjust for what he believes are shortcomings in Marxist, Weberian and other analyses of fascism:
Robert PaxtonRobert Paxton, a professor emeritus at Columbia University, defines fascism in his 2004 book The Anatomy of Fascism as:
In the same book, Paxton also argues that fascism's foundations lie in a set of "mobilizing passions" rather than an elaborated doctrine. He argues these passions can explain much of the behaviour of fascists:
Stanley G. PayneHistorian of fascism Stanley G. Payne created a lengthy list of characteristics to identify fascism in 1995: in summary form, there are three main strands. First, Payne's "fascist negations" refers to such typical policies as anti-communism and anti-liberalism. Second, "fascist goals" include a nationalist dictatorship and an expanded empire. Third, "fascist style", is seen in its emphasis on violence and authoritarianism, and its exultation of men above women, and young above old.
Jason StanleyIn 2020, National Public Radio interviewed Jason Stanley, a professor of philosophy at Yale University, regarding his book How Fascism Works: The Politics of Us and Them. Stanley defined fascism as "a cult of the leader who promises national restoration in the face of humiliation brought on by supposed communists, Marxists and minorities and immigrants who are supposedly posing a threat to the character and the history of a nation" and further observed that "The leader proposes that only he can solve it and all of his political opponents are enemies or traitors." Zeev SternhellZeev Sternhell, a historian and professor of political science, described Fascism as a reaction against modernity and a backlash against the changes it had caused to society, as a "rejection of the prevailing systems: liberalism and Marxism, positivism and democracy". At the same time, Sternhell argued that part of what made Fascism unique was that it wanted to retain the benefits of progress and modernism while rejecting the values and social changes that had come with it; Fascism embraced liberal market-based economics and the violent revolutionary rhetoric of Marxism, but rejected their philosophical principles. By MarxistsMarxists argue that fascism represents the last attempt of a ruling class (specifically, the capitalist bourgeoisie) to preserve its grip on power in the face of an imminent proletarian revolution. Fascist movements are not necessarily created by the ruling class, but they can only gain political power with the help of that class and with funding from big business. Once in power, the fascists serve the interests of their benefactors. György LukácsHungarian philosopher György Lukács in his works The Destruction of Reason (Die Zerstörung der Vernunft, 1952) and Zur Kritik der faschistischen Ideologie (1989) considers the ideology of fascism as the "demagogic synthesis" of all the irrationalist trends of the 19th and early 20th centuries, such as the reaction against the ideas of the Enlightenment and the French Revolution, the Romantic critique of capitalism (Carlyle) which after 1848 turned into "indirect apologetics" of capitalism (Nietzsche), anti-democratic or "aristocratic epistemology" (Lukács' term for philosophies that considered knowledge to be the privilege of an elite, first expressed in Schelling's concept of intellectual intuition and culminating in the metaphysical views of Henri Bergson), emphasis on myth and mysticism, the rejection of humanism, a cult of personality around the leader, the subjugation of reason to instinct, the conception of the nation and people in clearly biological terms, the glorification of war, etc.. According to Lukács, the historical significance of Hitler and Mussolini lies not in that they brought anything new to the ideological field, but in that they condensed all existing reactionary and irrationalist ideologies of the past and through their successful national and social demagogy brought them "from the scholar's study and intellectual coteries to the streets." Bertolt BrechtGerman playwright Bertolt Brecht describes fascism as: "a historic phase of capitalism" and "...the nakedest, most shameless, most oppressive, and most treacherous form of capitalism" (1935). Georgi DimitrovGeorgi Dimitrov, a Bulgarian Communist, was a theorist of capitalism who expanded Lenin's ideas and the work of Clara Zetkin. Delivering an official report to the 7th World Congress of the Communist Third International in August 1935, Georgi Dimitrov cited the definition of fascism formulated with the help of Clara Zetkin at the Third Plenum as "the open, terrorist dictatorship of the most reactionary, most chauvinistic, and most imperialist elements of finance capital". According to Dimitrov:
Leon TrotskyOne of Russian Marxist revolutionary Leon Trotsky’s earliest attempts at trying to define fascism was in November 1931 when he wrote a letter to a friend titled "What is Fascism". In it, Trotsky wrote, in what is as much description as analysis:
In Trotsky’s posthumously published 1944 tract, Fascism: What It Is and How to Fight It, he noted: "The historic function of fascism is to smash the working class, destroy its organizations, and stifle political liberties when the capitalists find themselves unable to govern and dominate with the help of democratic machinery." Amadeo BordigaAmadeo Bordiga argued that fascism is merely another form of bourgeois rule, on the same level as bourgeois democracy or traditional monarchy, and that it is not particularly reactionary or otherwise exceptional. Clara ZetkinAn early study of fascism was written by Clara Zetkin for the Third Enlarged Plenum of the Executive Committee of the Communist International in 1923:
By othersLaurence W. BrittIn the Spring 2003 issue of the secular humanist magazine Free Inquiry, Laurence W. Britt, who is described as "a retired international businessperson, writer, and commentator" published "Fascism Anyone?", which included a list of 14 defining characteristics of fascism. The list has since been widely circulated in both modified and unmodified forms. In a newspaper interview in 2004, Britt expanded and clarified the meaning of some of the points in his list, and discussed how they applied to the United States at that time. The headers for Britt's original list, without his sometimes extensive explanations, are:
George OrwellAnti-fascist author George Orwell describes fascism in economic terms in a 1941 essay, "Shopkeepers At War":
Writing for Tribune magazine in 1944, Orwell stated:
Franklin D. RooseveltAmerican President Franklin D. Roosevelt, who led the US into war with the fascist Axis powers, wrote about fascism:
"Fascist" as insultSome have argued that the terms fascism and fascist have become hopelessly vague since the World War II period, and that today it is little more than a pejorative used by supporters of various political views to insult their opponents. The word fascist is sometimes used to denigrate people, institutions, or groups that would not describe themselves as ideologically fascist, and that may not fall within the formal definition of the word. As a political epithet, fascist has been used in an anti-authoritarian sense to emphasize the common ideology of governmental suppression of individual freedom. In this sense, the word fascist is intended to mean oppressive, intolerant, chauvinist, genocidal, dictatorial, racist, or aggressive. George Orwell wrote in 1944:
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Friday, December 9, 2022
Definitions of fascism
Definition of anarchism and libertarianism
Anarchism and libertarianism, as broad political ideologies with manifold historical and contemporary meanings, have contested definitions. Their adherents have a pluralistic and overlapping tradition that makes precise definition of the political ideology difficult or impossible, compounded by a lack of common features, differing priorities of subgroups, lack of academic acceptance, and contentious, historical usage.
Overview
"Anarchism" generally refers to the anti-authoritarian (libertarian) wing of the socialist movement. "Libertarian socialism" has been a synonym for "anarchism" since 1890, as has the term "libertarian" through the mid-20th century.
The terms "anarchism" and "libertarianism" represent broad political ideologies with multiple historical and contemporary meanings. Incompatibilities within their pluralistic tradition prove difficult or impossible to reconcile into a singular set of core beliefs. The range of ideological disparities within anarchism is often paradoxical and never fully coherent. In general, anarchists are opposed to hierarchy and capitalism but differ in how they believe that change should be made.
Other complicating factors in defining "anarchism" include disagreement over its status as a political ideology and contention over the term's historical usage. Anarchism's rejection of the state and state policy largely sits outside the purview of political scientists and in some formulations, its misconstruction as the antithesis of politics contributes to its marginalization as a political ideology.
History of usage
Since the 19th century, "libertarian" has referred to advocates for freedom of the will, or anyone who generally advocated for liberty. The first person to call themselves a "libertarian" in the political sense was Joseph Déjacque in 1857. Shortly after, in 1858, he created the New York anarchist journal Le Libertaire. Anarchist Sébastien Faure used the term later in the century to differentiate between anarchists and authoritarian socialists. While the term "libertarian" has been largely synonymous with anarchism, its meaning has more recently diluted with wider adoption from ideologically disparate groups. For example, "libertarians" include both the New Left Marxists (who do not associate with authoritarian socialists or a vanguard party) and extreme liberals (primarily concerned with civil liberties). Additionally, some anarchists use "libertarian socialist" to avoid anarchism's negative connotations and emphasize its connections with socialism.
Anarchism retains a historical association with chaos and violence. In the late 1800s, prominent anarchist Peter Kropotkin noted the popular connotations of "anarchy" as a synonym for chaos and disorder, and thus a disadvantageous name for a movement. He accepted the term despite this, just as the Dutch Sea Beggars and sans-culottes had their own names conferred. Anarchists throughout the 20th century have regretted the philosophy's association with chaos, explosives, wanton violence, and marauding. These connotations endure contemporaneously through the popular media's association of black bloc property destruction with the movement. As a result of anarchy's dual definitions, the idea of a society without central authority is endemically conflated with chaos, hampering one's ability to conceive of the former positively.
The term "anarchist" is also used as an empty signifier to show abrasive disdain. The term's association with societal malady has been, in part, an intentional strategy by its detractors to discredit it. "Libertarian" saw a similar diffusion of purpose within the American libertarian movement as a wider group less studied and less interested in minimal government adopted the term, diluting the potency of its association with the strict rights-based libertarianism of Ayn Rand and Murray Rothbard. Anarcho-capitalists and those who believe in abolition of the state have occupied the fringe of the libertarian movement.
The revival of free-market ideologies during the mid-to-late 20th century came with disagreement over what to call the movement. While many of its adherents, especially in the United States, prefer "libertarian", many Conservative libertarians reject the term's association with the 1960s New Left and its connotations of libertine hedonism. The movement is divided over the use of "Conservative" as an alternative. Those who seek both economic and social liberty would be known as classical "liberals", but that term developed associations opposite of the limited government, low-taxation, minimal state advocated by the movement. Name variants of the free-market revival movement include classical liberalism, economic liberalism, free-market liberalism and neoliberalism. "Libertarian" has the most colloquial acceptance to describe a member of the movement, or "economic libertarian", based on both the ideology's primacy of economics and its distinction from libertarians of the New Left.
Though many contemporary antiglobalization activists actively identify as "anarchists", many others use anarchist principles and strategies without formally adopting the label, preferring instead terms including "antiauthoritarian", "autonomist", "libertarian socialist", or no label. These activists display anarchistic sensibilities and follow in anarchism's tradition of antiauthoritarianism, anticapitalism, antioppression, and anti-imperialism without explicitly defining themselves as ideologically anarchist.
Relation with socialism
In the 19th century, "anarchism" and "socialism" were used interchangeably, both treated as similar threats to sociopolitical order despite their differences in views towards the state. Similarly, classical anarchism is synonymous with "libertarian socialism" in their shared commitments to autonomy and freedom, decentralization, opposing hierarchy, and opposing the vanguardism of authoritarian socialism. Generally, libertarian socialism expands to include classical anarchism, council communism, Italian autonomists, and the Marxism of Luxemburg, Mattick, and Gramsci. While there are differences between each, including whether their adherents personally identify as fully "anarchist" or "Marxist", each still classifies as anti-authoritarian socialism. Classical anarchism is distinguished from general Marxism by its opposition to centralized or authoritarian organizational structures and "the dominion of man over man". Socialist-aligned forms of anarchism are also known as "social anarchism".
The terms "anarchist" and "Marxist" originally signified factions within the First International and had no theoretical basis. The Russian anti-authoritarian Mikhail Bakunin successfully argued that the International was an authoritarian organization controlled by Karl Marx, a German. The term "Marxist" first appeared in French in 1872 to associate the anti-Bakuninist group within the International. The Marxists, in return, used the pejorative "anarchist" to label the Bakuninists. These distinctions were further conflated across state lines, such that the French anarchists conflated "Marxist" with "German". A schism between "anarchist" and "socialist" affiliation was formalized with the Second International's 1896 London Congress.
The biggest divide in the definition of anarchism is between the main individualist and socialist anarchist traditions. While anarchism sits between liberalism and socialism, the definitive extent of its affiliation with either is contested. Historians (Rocker and Woodcock) have described anarchism as the confluence of liberal individualism and socialist egalitarianism. Other activists and theorists have variously argued that one tradition is "genuine anarchism" and the other tradition is oppression (Bookchin vs. anarcho-capitalists) or a combination thereof (Black). These contemporary distinctions trace to the time of early modern anarchism when Peter Kropotkin and Alexander Berkman either broke with groups or otherwise separated the traditions of communist anarchism from individualist, mutualist, and egoist anarchism. Even the very idea of the individualist–socialist divide is contested, as some types of individualist anarchism are largely socialistic. Despite these imprecise boundaries and some similarities, socialism and individualism within anarchism have a bifurcated tradition, the former associated with the history of socialism and the latter with classical liberalism and conservatism (also known as "right-libertarianism"). Even their shared belief in anti-statism does not provide a common identity, as both traditions differ in their interpretation of state-rejection in spite of the common terms.
Relation with property and capitalism
Modern American libertarians are distinguished from the dominant libertarian tradition by their relation to property and capital. While both historical libertarianism and contemporary economic libertarianism share general antipathy towards power by government authority, the latter exempts power wielded through free market capital. Historically, libertarians including Herbert Spencer and Max Stirner supported the protection of an individual's freedom from powers of government and private ownership. In contrast, modern American libertarians support freedoms on the basis of their agreement with private property rights. The abolishment of public amenities is a common theme in modern American libertarian writings.
Forms of libertarianism that put laissez-faire economics before economic equality are commonly viewed as incompatible with anarchism's tradition of egalitarianism and anti-capitalism. Anarcho-capitalism, which would abolish the state and create a fully laissez-faire economy, lies outside the social tradition of anarchism. It shares anarchism's antipathy towards the state but not anarchism's antipathy towards hierarchy, as theorists expect from anarcho-capitalist economic power relations. The ideology follows a different paradigm from anarchism and has a fundamentally different approach and goals. Despite the "anarcho" in its title, anarcho-capitalism is more closely affiliated with capitalism and right-wing libertarianism than with anarchism. Further, within laissez-faire libertarianism, some reject the designation "anarcho-capitalism", believing that "capitalism" may either refer to the laissez-faire market they support or the government-regulated system that they oppose.
Types of definition of anarchism
Anarchism scholar Paul McLaughlin studies the various definitions of anarchism in his book Anarchism and Authority. According to him, there are three common types of anarchism definition:
- etymological definitions
- anti-statist definitions
- anti-authoritarian definitions
But all fall short from providing a precise definition of anarchism.
Etymological definition
"Anarchy" derives from the Greek anarkhos, meaning "without authority" (as opposed to "without government/state"). Hence the etymological definition of anarchism as the negation of an authority. But anarchism is generally not simply a negative stance on authority but also a positive stance about how society should be structured.
Anti-statist definition
Anti-statist definitions place the focus of interest on the negation, and confrontation in the real world, of the state by anarchism. But as with the etymological definition, anarchism is much more than anti-statism, as it rejects all various forms of established authority.
The association between anti-statism and anarchism is both commonly understood and contested.
Anarchism, according to historian Peter Marshall, exists outside standards of political theory because its aims are not based on the struggle for power within the state. It is more concerned with moral and economic theory than participation in political systems and indeed often advocates against participation in such systems.
Anarchist libertarians and modern economic libertarians share opposition to the state as their only significant commonality.
Anti-authoritarian definitions
Anti-authoritarian definitions depicts the rejection of all kind of authorities. Even though these kind of definitions are much broader than the anti-statist ones, there are still handicaps. McLaughlin, who examines under a philosophical scope, claims that anti-authoritarianism is a conclusion of anarchist thought, not an a priori statement, therefore it can not be used as a definition.
Quality management system
From Wikipedia, the free encyclopedia
https://en.wikipedia.org/wiki/Quality_management_system
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both and deals with quality and sustainability and their integration.
Other QMS, e.g. Natural Step, focus on sustainability issues and assume that other quality problems will be reduced as result of the systematic thinking, transparency, documentation and diagnostic discipline.
The term "Quality Management System" and the initialism "QMS" were invented in 1991 by Ken Croucher, a British management consultant working on designing and implementing a generic model of a QMS within the IT industry.
Elements
- Quality objectives
- Quality manual
- Organizational structure and responsibilities
- Data management
- Processes – including purchasing
- Product quality leading to customer satisfaction
- Continuous improvement including corrective and preventive action
- Quality instrument
- Document control
- Employee training and engagement
- Supplier quality management
Concept of quality – historical background
The concept of a quality as we think of it now first emerged from 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 19th century 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. Birland 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, which were advanced by the work done of W. Edwards Deming, a statistician, after whom the Deming Prize for quality is named. Joseph M. Juran focused more on managing for quality. The first edition of Juran's Quality Control Handbook was published in 1951. He also developed the "Juran's trilogy", an approach to cross-functional management that is composed of three managerial processes: quality planning, quality control, and quality improvement. These functions all play a vital role when evaluating quality.
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
As Lee and Dale (1998) state, there are many organizations that are striving to assess the methods and ways in which their overall productivity, the quality of their products and services and the required operations to achieve them are done.
Medical devices
The two primary, state of the art, guidelines for medical device manufacturer QMS and related services today are the ISO 13485 standards and the US FDA 21 CFR 820 regulations. The two have a great deal of similarity, and many manufacturers adopt QMS that is compliant with both guidelines.
ISO 13485 are harmonized with the European Union Regulation 2017/745 as well as the IVD and AIMD directives. The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS).
Quality System requirements for medical devices 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 FDA 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 7 essential subsystems of a quality system. These subsystems include:
- Management controls;
- Design controls;
- Production and process controls
- Corrective and preventative actions
- Material controls
- Records, documents, and change controls
- Facilities and equipment controls
all overseen by management 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 manufacturers are regulated under a different section of the Code of Federal Regulations:
Organizations and awards
The International Organization for Standardization's ISO 9001:2015 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 9001:2015 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e. planned) improvement of the QMS, as well as more foundational QMS components such as failure mode and effects analysis (FMEA).
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a 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 Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award. The Baldrige Award recognizes U.S. organizations for performance excellence based on the Baldrige Criteria for Performance Excellence. The Criteria address critical aspects of management that contribute to performance excellence: leadership; strategy; customers; measurement, analysis, and knowledge management; workforce; operations; and results.
The European Foundation for Quality Management's EFQM Excellence Model supports an award scheme similar to the Baldrige Award for European companies.
In Canada, the National Quality Institute presents the 'Canada Awards for Excellence' on an annual basis to organizations 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 European Quality in Social Service (EQUASS) is a sector-specific quality system designed for the social services sector and addresses quality principles that are specific to service delivery to vulnerable groups, such as empowerment, rights, and person-centredness.
The Alliance for Performance Excellence is a network of state and local organizations that use the Baldrige Criteria for Performance Excellence at the grassroots level to improve the performance of local organizations and economies. browsers can find Alliance members in their state and get the latest news and events from the Baldrige community.
Process
A QMS process is an element of an organizational QMS. The ISO 9001 standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence and interaction of these processes. Butterworth-Heinemann and other publishers have offered several books which provide step-by-step guides to those seeking the quality certifications of their products.
Examples of such processes include:
- order processes,
- production plans,
- product/ service/ process measurements to comply with specific requirements e.g. statistical process control and measurement systems analysis,
- calibrations,
- internal audit,
- corrective and preventive action,
- identification, labeling and control of non-conforming products to prevent its inadvertent use, delivery or processing,
- purchasing and related processes such as supplier selection and monitoring
ISO 9001 requires that the performance of these processes be measured, analyzed and continually improved, and the results of this form an input into the management review process.
Software
Quality management software offers the techniques, processes, structure, and resources needed to simplify manufacturing and ERP activities while handling quality concerns efficiently and cost-effectively.
Helps manufacturers to monitor, control, and document quality processes electronically to guarantee that goods are made within tolerance, meet all necessary requirements, and are defect-free. Quality management software is often used in the manufacturing industry to identify potential issues before they occur.
Some benefits of quality management software include:
- real-time data monitoring
- issue prevention
- risk management
- increased efficiency and productivity
- process consistency
- increased employee participation
Quality management software can be integrated with manufacturing execution systems (MES). A MES is a complete, dynamic software system for monitoring, tracking, documenting, and controlling the manufacturing process from raw materials to final products. When combined with QMS, these systems:
- ensure compliance
- enable quality programs
- eliminate waste
- less product recalls
- lower per-product cost
- higher product quality
- real-time information for increase in quality control
- realistic production schedules
- up-to-date inventory
- product tracking
Quality management software focuses on 4 main elements:
- Document management: Quality management software enables companies to manage all product and quality records and documents, including product specifications, work instructions, standard operating procedures (SOPs), quality policies, and training records, among other things, to fulfill highly regulated requirements. Quality management software centralizes the storage of these documents.
- Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures (CAPA) possible, which result in faster issue resolution and issue prevention.
- Feedback loops: Quality management software permits staff to submit feedback or recommendations through centralized software. In turn, this way, managers gather insights from the shop floor creating a feedback loop.
- Training and skill management: To maintain product quality, quality management software can provide a fixed system through which employees and staff can be trained. This fixed system provides more clarity in the different tracking processes of the company and simplifies the tracking of different skill levels of employees.
Most quality management software are cloud-based and offer software as a service.
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