Management systems are conventionally documented and administered hierarchically. Senior management sets goals and policy and delegates the responsibility for implementation and execution.
|
The everyday use of the word "quality" conjures notions of excellence, luxury and high price - high quality cars, appliances, homes, clothes, ... |
Various "professional" definitions have been used to allay confusion and introduce objectivity to the discussion; e.g. "meeting customer needs or expectations", "fitness for use", "fitness for purpose", "customer satisfaction" or "conformance to requirements".
ISO 9000:2005 defines quality as the "degree to which a set of inherent characteristics fulfils requirements".
In practice, the "requirements" are translated into product or service characteristics and specifications to enable measurement and control of the production processes. The process of translation is itself a complex discipline. For more information, search the literature for "Quality Function Deployment" and "Voice of the Customer".
The term "quality" can be used with adjectives such as poor, good or excellent but these refer to the degree to which requirements are met, not to a standard of luxury. To avoid this confusion we use the term "grade" to describe different quality requirements for things having the same functional use.
Notwithstanding the technical definitions, the customer's usage is important and valid. Quality continues to have a variety of common meanings. It is vital for designers and producers to understand the customer's meaning regardless of professional usage.
Larger organizations often have great difficulty recreating this craftsmanship paradigm because of the fragmentation of skills and breakdown of communication.
On the other hand, the quality and price of most goods and services available today in industrialized countries far surpasses what was available even half a century ago.
Quality Management (QM) is defined as "the coordinated activities to direct and control an organization with regard to quality". It includes all the management activities to determine and implement policies, objectives, processes and responsibilities to prevent things from going wrong while designing, producing and delivering a product or service, as well as to detect and fix things that do go wrong.
Quality Assurance (QA) is the "part of quality management focused on providing confidence that quality requirements will be fulfilled". It ensures and demonstrates the effectiveness of processes to give customers and other interested parties confidence in the quality of the final result.
The Quality Management System (QMS) is defined as the "management system to direct and control an organization with regard to quality". It encompasses the organization, structure, procedures, processes, resources and activities needed to define and achieve the organization's quality objectives. (definitions abstracted from ISO 9000:2005)
His system is blamed by detractors for the compartmented, adversarial environment that characterized industry through the '50s and beyond.
Arguably, it was an incomplete and perverted application of Taylorism that produced the quality vs. productivity dichotomy. The fundamental mistake made by many managers was to hold a quality control inspector accountable for quality while failing to ensure that the production processes met requirements. This is analogous to making the accountant solely responsible for the company's profitability while allowing other managers to spend without restraint.
For a provocative, sympathetic view of Taylor's contribution, see Marvin R. Weisbord, Productive Workplaces, Jossey Bass, 1987.
The original meaning of "standard" was the flag used by armies as a rallying point in the confusion of battle. The present meaning is analogous.
Daily life depends heavily on standards for convenience and safety; such as, weights and measures to ensure fair trade, traffic conventions to avoid collisions, threads on light bulbs, bolts and pipes to ensure fit, etc.
Standards for quality became necessary because of disagreements between suppliers and customers, and between producers and inspectors, as to what constituted an acceptable product or service.
Quiz: List at least ten standards that have affected your life in the past 24 hours.
Hint: Did you drive a car? Change a light bulb? Watch TV? Phone someone? Use the internet? ...
Quality assurance standards appeared first in those areas where risk of death, injury, or financial loss were greatest; the military, aerospace, pharmaceutical, medical device and nuclear power sectors.
By the 1980s, the need to comply simultaneously with several similar but different standards had become a major impediment to companies doing business with multiple customers, and the multiple audits to verify conformance were costly and disruptive to both customer and supplier.
International standardization began with the International Electrotechnical Commission (IEC) in 1906 and the International Federation of the National Standardizing Associations (ISA) in 1926. In 1946, delegates from 25 countries met in London, to create a new international organization, ISO, "the object of which would be to facilitate the international coordination and unification of industrial standards". ISO began to function officially on 23 February 1947, and published its first standard in 1951 ("Standard reference temperature for industrial length measurement ").
ISO is the short form name of the International Organization for Standardization, not an acronym. "ISO" is a word, derived from the Greek "isos", meaning "equal ", which is the root of the prefix " iso-" that occurs in a host of terms, such as "isometric" and "isotherm". The name has the advantage of being valid in all languages.
(See the ISO web site for the full story.)
|
ISO's active members are the "member bodies". Each is the national body "most representative of standardization in its country"; one per country. |
In addition there are "correspondent members", from countries that lack a fully developed national standards activity, and "subscriber members", from countries with very small economies.
The total membership presently includes over 150 countries.
|
ISO has nearly 3000 technical bodies (technical committees, subcommittees, working groups and study groups) responsible for over 15,000 International Standards on a wide range of subjects. |
The technical committee responsible for the ISO 9000 family of standards is TC 176, with a mandate for "Generic quality management, including quality systems, quality assurance, and generic supporting technologies".
The committee also strives to prevent proliferation of sector-specific standards that may lead to fragmentation of the quality systems of companies and increased costs due to multiple assessments of the separate quality systems.
The closely related TC 210 addresses "Quality management and corresponding general aspects for medical devices".
As standards are revised, the older versions typically continue to
be used for a crossover period of up to three years. Check the ISO website for complete, up-to-date
information on standards in force and under development.
|
One way of assessing the economic impact of quality is by determining and classifying the associated costs. |
Costs of Quality are conventionally grouped into a) the costs of making certain that customers receive quality products and services and b) the costs incurred when we fail to do so. These are called, respectively, costs of conformance and costs of nonconformance or failure. ("failure" means any nonconformance to requirements, not just the physical failure of the product.)
It is useful to further divide each of these two categories. The costs of conformance include both the costs of appraisal of quality and the costs of prevention of unacceptable quality. The costs of nonconformance are divided into internal failure (before delivery) and external failure (after delivery). The latter are invariably much more expensive to rectify.
Appraisal: Costs associated with measuring, evaluating or auditing products or services, components or purchased items to assure conformance with quality standards and performance requirements.
Prevention: Costs associated with planning, implementing, maintaining and auditing a quality system that will assure conformance to quality requirements at economic levels.
Internal failure: Costs incurred when products, services, components and materials fail to meet quality requirements before transfer or release to the customer or user.
External failure: Costs incurred when products or services fail to meet quality requirements after transfer or release to the customer or user.
Corporations specify quality assurance requirements in contracts with their suppliers and require objective evidence of conformance.
Regulatory bodies increasingly require registered quality systems as
a condition of business. (e.g., Canadian medical devices manufacturing.)
Independent agencies, called quality system registrars, verify conformance to the standards and issue certificates attesting to the fact. Registered companies use these certificates to support their efforts in marketing, sales and contract negotiation.
Independently of external requirements, many companies develop quality assurance systems based on ISO 9000, with or without registration, in order to improve management control and implement better business systems.
|
The full title of the ISO 9001:2000 International Standard is: "Quality management systems - Requirements" |
An organization following these requirements acts to define and control its processes, prevent problems, rectify their causes and retain convincing proof to assure its customers and its own management of the effectiveness and ongoing improvement of its management system.
The 9001 Scope statement is: "This International Standard specifies
requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product
that meets customer and applicable regulatory requirements, and
b) aims to enhance customer satisfaction through the effective
application of the system, including processes for continual
improvement of the system and the assurance of conformity to customer
and applicable regulatory requirements."
|
Any organization may adopt all or part of the ISO 9000 series of standards for internal guidance. In fact, the ISO 9004 standard is intended for just that purpose. |
ISO 9001 has the specific purpose of demonstrating the effectiveness of the quality management system to customers and other parties. Particularly where the consequences of poor quality are severe, customer corporations maintain exhaustive, and expensive, supplier surveillance systems to ensure full compliance.
The scheme of third party auditing and registration was pioneered in the Canadian nuclear power industry using the CSA Z299 series of Quality Standards. Both the supplier and customer organizations benefit as costs and disruption of multiple audits are reduced by accepting the opinion of an competent, independent auditor.
An added benefit is realized when seeking new sales and contracts. Many major corporations now strongly favour registered suppliers and some even refuse to consider approaches from unregistered companies.
Considerable effort is presently being devoted to harmonizing auditing and registration practices internationally. The ultimate goal is to permit companies to obtain one registration of their quality management system that will be accepted worldwide.
|
Management systems are conventionally documented and administered hierarchically. Senior management sets goals and policy and delegates the responsibility for implementation and execution. |
A document system naturally arises consisting of a policy manual, procedures for implementing the policies, detailed instructions for performing tasks and forms for collecting and exchanging data.
The pattern is common in Accounting and Human Resources as well as in Quality.
ISO/TR 10013, Guidelines for quality management system
documentation, provides recommendations for documentation.
 |
Despite the theoretical organization of documented policies, procedures and records, the reality for many companies is a dynamic exchange of information both within the organization and with external stakeholders. |
The job of organizing and controlling this knowledge is, by turns, both complicated and facilitated by modern electronic communication and computing.
To succeed in modern Quality Management, most organizations will need to analyze and control their management information systems.
The Standards Council of Canada accredits management system registration bodies. A list with scope of accreditation is accessible on the SCC website. Registrars must themselves conform to a standard similar to ISO 9001.
The RAB QSA International in the USA maintain lists of accredited auditors and the industry sectors they are competent to assess. National Quality Institute (NQI) in Canada has now assigned its auditor accreditation duties to RAB QSA.
Assessment and registration of a company's quality system is based on two principles:1 The documented system must conform to every relevant requirement of the appropriate International Standard.
2 There must be objective evidence that the company's activities and records conform to the documented system.
<>On the initial assessment, the registrar assigns auditors to review and compare the company's policies and procedures to the requirements of ISO 9001.Any significant discrepancies in either documentation or practice must be corrected before registration is granted.
The registrar conducts regular surveillance audits to verify continuing conformance and is authorized withdraw registration from companies who fail to maintain an acceptable system.
