Quality Systems

Although guilds were the first organizations to ensure quality standards, there are a number of different organizations and approaches for defining and implementing quality standards in organizations. Standards are documented agreements, protocols, or rules that outline the technical specifications or criteria to be used to ensure that products, services, processes, and materials meet their intended purpose. Standards also provide a basis for measurement because they provide criterion, or basis, for comparison.

International Organization for Standardization (ISO)

One of the most widely known standards organizations is the International Organizations for Standardization (ISO). Although you may think the acronym should be IOS, the name for the organization is ISO and was derived from the Greek word isos, which means equal. The name avoids having different acronyms that would result from International Organization for Standardization being translated in different languages.

ISO was officially formed in 1947 after delegates from twenty-five countries met in London the previous year with the intention of creating an international organization whose mission would be "to facilitate the international coordination and unification of industrial standards." ISO is not owned or managed by any national government, and

today it has over 130 member organizations, with one member per country. Each participating member has one vote, regardless of its country's size or economic strength, to ensure that each member country's interests are represented fairly. As a result, each country has an equal say with respect to the standards that are adopted and published. Each member is then responsible for informing other interested organizations in his or her country of any relevant international standard opportunities and initiatives.

International standards are established for many technologies and industries. Countries that do business with each other need to have an agreed upon set of standards to make the process of trade more logical and because a lack of standardization can create trade barriers. For example, credit cards adhere to a standard size and thickness so that they can be used worldwide.

Although most of the ISO standards are specific to a particular product, material, or process, a set of standards make up the ISO 9000 and ISO 14000 families. These are known as "generic management system standards" in which the same standards can be applied to any size or type of organization in any industry. The term management system refers to the processes and activities that the organization performs. ISO 9000 was originally initiated in 1987 and focuses on quality management with respect to improved customer satisfaction and the continuous improvement of an organization's performance and processes. On the other hand, standards that fall under the ISO 14000 came about in 1997 and are concerned primarily with environmental management—that is, how an organization can minimize any harmful effects on the environment that may be caused by its activities and operations.

The ISO 9000 standards were revised in 2000 (and are now called ISO 9000:2000) and focus on eight quality management principles that provide a framework for organizations:

1. Customer Focus—The customer is key for all organizations. Therefore, organizations should strive to meet and exceed the current and future needs of their customers.

2. Leadership—Strong leaders create a sense of purpose and direction for an organization by establishing and communicating a vision and mission for the organization. In addition, leaders inspire and provide their people with adequate resources, training, and empowerment to act within a set of well-defined responsibilities.

3. Involvement of People—To be successful, an organization must involve people at all levels so that individuals accept ownership for problems and the responsibility for solving them. This involvement requires the sharing of knowledge and experiences freely, while supporting and encouraging the open discussion of problems and issues.

4. Process Approach—In order to achieve a desired result, activities and related resources should be managed as a process, which allows for lower costs, improved cycle times, predictable results, and a focused approach for identifying opportunities for improvement.

5. System Approach to Management—To achieve its objectives, an organiza tion must identify, understand, and manage its interrelated processes as a system. This system provides a more structured and integrated approach that recognizes the interdependencies among processes and reduces cross-functional barriers.

6. Continual Improvement—Continuous improvement of the organization's products, processes, and systems should be a permanent objective. It should entail an organizationwide approach with established goals to guide and measure progress.

7. Factual Approach to Decision Making—Decision making should be based on data and facts. Data and information should be accurate and reliable, and should be analyzed using valid methods. However, informed decision making should be balanced between analysis based on facts or data and experience and intuition.

8. Mutually beneficial supplier relationships—An interdependent relation ship exists between an organization and its suppliers. This relationship can be mutually beneficial if it increases the ability to create value for both parties. This value can support a long-term relationship that allows for pooling expertise and resources, while improving flexibility and speed in jointly responding to changing markets or customer needs. This relationship requires trust, open communication, and the sharing of information that will support joint activities between an organization and its suppliers.

To show that a product, service, or system meets the relevant standards, an organization may receive a certificate as proof. For example, many organizations have been issued ISO 9000 certificates as testaments that they have quality management systems in place and that their processes conform to the ISO 9000 standards. Keep in mind that these standards focus on processes not products. An organization can be certified in one of three quality systems under ISO 9000:

• ISO 9001—For organizations whose business processes range from design through development, as well as production, installation, and service. ISO 9001 contains twenty standards, or requirements, that must be met for a quality system to be in compliance. Although ISO 9001 can be applied to all engineering disciplines, it is the one most relevant to software development.

• ISO 9002—For organizations that do not design and develop products. With the exception of design control requirements, the requirements are similar to ISO 9001.

• ISO 9003—For organizations whose business processes do not include design control, process control, purchasing, or service. The focus is on inspection and testing of final products and services in order to meet speci fied requirements.

If an organization decides that it would like to be ISO certified as meeting the ISO standards, it usually begins by studying the ISO guidelines and requirements. The organization then conducts an internal audit to make sure that every ISO requirement is met. After deficiencies or gaps are identified and corrected, the organization then has a third party called a registrar audit its quality management system. If the registrar finds that the organization meets the specified ISO standards and requirements, it will issue a certificate as a testament that the organization's products and services are managed and controlled by a quality management system that meets the requirements of ISO 9000. ISO does not conduct the audits or issue certificates. In addition, an organization does not have to have a formal registration or certificate to be in compliance with the ISO standards; however, customers may be more likely to believe that an organization has a quality system if an independent third party attests to it.

TickIT

The TickIT initiative began in 1991 following a report on software quality published by the British Department of Trade and Industry. The report reviewed the state of software quality and suggested that many software organizations were reluctant to adopt the ISO 9000 standards because they believed them to be too general or difficult to interpret.

The British government then asked the British Computer Society (BCS) to take on a project called TickIT, which would provide a method for registering software development systems under the ISO 9000 standards. TickIT guides a company through certification of software quality under the ISO 9001 framework. This certification is applicable to all types of information systems that include software development processes—from software houses that produce software as an end product or service to in-house software development supported by an internal IS function.

TickIT certification relates directly to ISO 9001:2000. More than 1,400 ISO 9001/TickIT certificates have been issued worldwide by twelve certification bodies accredited in Britain and Sweden. Certification is conducted by an independent external auditor who has been specially trained under the International Register of Certified Auditors (IRCO), which is supported by the British Computer Society. After being successfully audited by a TickIT certified auditor, an organization receives a certificate that it is in compliance with ISO 9001:2000 and it is endorsed with a TickIT logo. Subsequently, TickIT gives software developers an accredited quality certification specialized to software organizations and, hopefully, increases the confidence of customers and suppliers.

The term Six Sigma was originated by Motorola (Schaumburg, Illinois) in the mid-1980s. The concept of Six Sigma came about as a result of competitive pressures by foreign firms that were able to produce higher quality products at a lower cost than Motorola. Even Motorola's own management at that time admitted that "our quality stinks" (Pyzdek 1999).

Sigma (a) is a Greek letter and in statistics represents the standard deviation to measure variability from the mean or average. In organizations, variation is often the cause of defects or out-of-control processes and translates into products or services that do not meet customer needs or expectations. If a manufacturing process follows a normal distribution, then the mean or average and the standard deviation can be used to provide probabilities for how the process can or should perform.

Six Sigma focuses on defects per opportunities (DPO) as a basis for measuring the quality of a process rather than products it produces, because products may vary in complexity. A defect may be thought of as anything that results in customer dissatisfaction. The sigma value, therefore, tells us how often defects are likely to occur. The higher the value of sigma, the lower the probability of a defect occurring. As illustrated in Table 10.1, a value of six sigma indicates that there will only be 3.4 defects per million, while three sigma quality translates to 66,807 defects per million. Table 10.2 provides several real-world examples that compare the differences between three sigma and six sigma quality.

Therefore, Six Sigma can be viewed as a quality objective whereby customer satisfaction will increase as a result of reducing defects; however, it is also a business-driven approach for improving processes, reducing costs, and increasing profits. The key steps in the Six Sigma improvement framework are the D-M-A-I-C cycle:

• Define—The first step is to define customer satisfaction goals and subgoals—for example, reduce cycle time, costs, or defects. These goals then provide a baseline or benchmark for the process improvement.

• Measure—The Six Sigma team is responsible for identifying a set of rele vant metrics.

• Analyze—With data in hand, the team can analyze the data for trends, pat terns, or relationships. Statistical analysis allows for testing hypotheses, modeling, or conducting experiments.

• Improve—Based on solid evidence, improvements can be proposed and implemented. The Measure - Analyze - Improve steps are generally itera tive to achieve target levels of performance.

• Control—Once target levels of performance are achieved, control methods and tools are put into place in order to maintain performance.

To carry out a Six Sigma program in an organization, a significant investment in training and infrastructure may be required. Motorola adopted the following martial arts terminology to describe these various roles and responsibilities (Pyzdek 1999):

Table 10.2 Comparison of Three Sigma and Six Sigma

Table 10.1 Sigma and Defects per Million

Sigma Defects Per Million

4 CT

6 IT

690,(XI0 308,537 66.807 6,210

Five short or long landings at any major airport

Approximately 1,350 poorly performed surgical operations in one week

Over 40,500 newborn babies dropped by doctors or nurses each year

Drinking water unsafe to drink for about 2 hours each month

One short or long landing in 10 years at all airports in the U.S. One incorrect surgical operation in 20 years

Three newborn babies dropped by doctors or nurses in 100 years

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