Today, customers and consumers are no longer simply accepting products of whatever quality that are offered in the market. Quality is now in the mind of every entrepreneur because of the increasing global competition. The world-wide business competition has helped the drive towards quality improvement. In this introduction, we give a brief overview of quality concepts. We also take a look at the history of quality development to get a better understanding of this important area. Some important issues covered later on are also summarised.
1.1. Definition of Quality
A major problem in quality engineering and management is that the term quality is usually ambiguously defined. Different definitions have been given by different people. For example, Crosby (1979) defines quality as "conformance to requirements" and it is defined in Juran (1988) as "fitness for use". Taguchi (1987) loosely defines quality as the loss to the society caused by the poor quality product. The most widely acceptable definition provided by ISO is as follows:
Quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy implied or stated needs.
Today, it is commonly agreed that the quality of a product is strongly related to the degree of customer satisfaction with the product. Hence, it is essential to discuss quality from the customer’s point of view, after having identified all levels of customers, and improve the quality to not only meet, but also exceed what the customers might expect.
It has to be kept in mind that quality is not a single idea, but rather a multi-dimensional concept. Also, it is a concept that might have different levels of abstraction, which although a part of our daily language, people might have totally different views and opinions and professionals may treat it different than others.
Despite of the fact that quality can be defined differently and it includes a number of different attributes, it is a subject of growing importance. Quality engineering is aimed at Quality Engineering (SYE3102) 4 M.XIE@CITYU.EDU.HK
providing support in analysing the problems and suggestion on how to improve the product and process to meet and exceed the needs of customers.
1.2. History of Quality
The concept of quality has been around for as long as the history of humans. All products have to meet certain needs and the requirements. This was the case of the Pyramid or the Great Wall, for example. However, it is not until the beginning of this century that quality has attracted an increasing interest because of industrial revolution; more products are produced and the cost of poor quality products greatly reduces the profit of the company. Control charts and other sampling techniques were invented to reduce the cost of sampling and inspection which was usually done at the end of production line.
Although Americans like Shewhart (1932) and Deming (1986) stressed the need of using statistical techniques in quality engineering, they were not very appreciated in the United States in mid-forties. This is partially because of leading position of American companies they had in the middle of the century, and the pride of having won the Second World War.
Things were different in Japan at that time and they desperately needed help in improving product quality. Deming and Juran were invited to Japan to teach managers and engineers the concepts and techniques of quality and the way of improving it. The results are obvious to everyone now and the United States is now inviting Japanese to promote quality and quality engineering techniques.
The trend in quality engineering today is to use statistical tools in solving all problems and strive for continuous improvement. Deming has in many occasions used his famous PDCA cycle to illustrate the stages needed in a continuous improvement plan. The Plan step involves a determination of what is to be achieved and how it will be achieved. In the Do step, activities are actually performed in accordance with the established plan. A Check of the result of the plan is then made and finally, actions are taken based on the results of the analysis. Quality Engineering (SYE3102) 5 M.XIE@CITYU.EDU.HK
Plan
Deming's Act Do cycle
Check
Figure 1. Deming's PDCA cycle.
Because of the increasing importance of quality, ISO developed a series of standards for quality, ISO-9000 series. There are also a number of national and/or regional quality awards, such as the Singapore Quality Award that has helped companies to improve the product quality to stay in business in the increasing competitive marketplace.
1.3. Topics to Be Addressed
In this subject, a number of quality engineering and process control techniques are introduced. Mostly they are based on sound statistical principles so that the conclusions drawn have a sufficient level of significance. That makes it necessary to also introduce some commonly used statistical concepts.
There are a number of simple quality control techniques. One group is commonly called the basic seven tools. They include check sheet, histogram, Pareto Diagram, Control chart, Run-chart, Scatter diagram and Cause-Effect Diagram. They can be used almost at any levels, from operators, engineers, to managers or directors. Quality Engineering (SYE3102) 6 M.XIE@CITYU.EDU.HK
Although control chart is usually considered as one of the seven basic tools, it deserves a special discussion because of its wide applicability in engineering applications. It stands itself as a separate topic in quality assurance and a number of charting techniques are available. This topic will be discussed later and it forms a central part of this subject.
Acceptance sampling can be considered as an application of statistics in quality
engineering. When the products are produced, we need to make sure that they are good. Although we can carry out 100 percent inspection meaning that we inspect all items, it may be too costly and sometimes this is impossible because of time or limited resources. Sampling meaning that a selected amount of products are inspected and decision making is based on a small amount of inspection can be used and it strongly reduced the cost and time needed.
Last, but not least, the trend of industrial quality control is through constantly improving the quality of the process and product. Industrial experiments are more and more frequently designed based on statistical principles allowing the study of many factors at the same time. Early techniques summarised in the book by Box et al. (1978) have been widely applied. The Japanese companies have been successful in using this type of statistically designed experimental approach. A good reference is Taguchi (1987).
Although quality engineering techniques can be applied by everyone and at all levels, the emphasis on quality has to come from the management. They should also provide training and allocate sufficient amount of resources. Quality activities should be put into the context of continuous improvement. Total Quality Management (TQM) is a topic that covers all these issues. Quality Engineering (SYE3102) 7 M.XIE@CITYU.EDU.HK
References
Besterfield, D.H. (2009). Quality Control. Prentice-Hall, New Jersey.
Del Castillo, E. (2002). Statistical Process Adjustment for Quality Control. Wiley, New York.
Evans, J.R. and Lindsay, W.M. (2014). Managing for Quality and Performance Excellence. Cole Cengage Learning, Belmont, CA.
Gupta, Bhisham C. (2021). Statistical quality control using Minitab, R, JMP, and Python. Wiley & Sons, New York.
Krishnamoorthi, K.S. (2012). A First Course in Quality Engineering: Integrating
Statistical and Management Methods of Quality. CRC Press, Boca Raton, FL.
Montgomery, D.C. (2019). Introduction to Statistical Quality Control. Wiley, New York.
Mundwiller, S. (2017). Statistical Process Control: A Pragmatic Approach. CRC Press,
Boca Raton, FL.
Oakland, J.S. (2018). Statistical Process Control. 7th edition, Routledge, Oxford.
Qiu, P.H. (2014). Introduction to Statistical Process Control. CRC Press, Boca Raton Fl.
Ryan, T.P. (2011). Statistical Methods for Quality Improvement. Wiley, New York.
Shewhart, W.A. (1931). Economic Control of Quality of Manufactured Product. Van
Nostrand, New York.
Smith, G. (2004). Statistical Process Control and Quality Improvement. Prentice Hall, NJ.
Su, Chao-Ton (2013). Quality Engineering: Off-line Methods and Applications. CRC Press, Boca Raton, FL.
Taguchi, G. (1987). Introduction to Off-line Quality Control. Central Japan Quality
Control Association. Tokyo.
Vardeman, S.B. and Marcus, J.J. (2016). Statistical Methods for Quality Assurance : Basics, Measurement, Control, Capability, and Improvement. Springer, New York.
Xie, M., Goh, T.N. and Kuralmani, V. (2002). Statistical Models and Control Charts for High-Quality Processes. Kluwer Academic Publishers, Boston. Quality Engineering (SYE3102) 8 M.XIE@CITYU.EDU.HK
2. ISO Quality Standards
In this part, we introduce the ISO series of quality standards which is widely recognized as the international quality standard today. Many companies are seeking the certification to demonstrate the level of quality the company has achieved. Recently, ISO 14000 has been introduced because of the environmental concern, in additional to the product quality itself. A brief discussion of ISO 14000 will also be given.
2.1. What is ISO 9000
The International Organization for Standardization (ISO) is a worldwide federation of
national standards bodies from some 100 countries, one from each country. It is a non- governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity.
ISO 9000 is a series of documented standards prescribing quality assurance management.
Written by the International Organization for Standardization, the series has been adopted by 80 countries, including the United States, Canada, the European Union and Japan.
ISO 9000 is intended to be used for four purposes:
(i) As guidance for quality management - it contains useful advice for managing a business;
(ii) In contractual situations, between first and second parties - it can be part of a legal contract between customers and suppliers providing the customer assurances that the supplier will carry out work in a controlled manner and that the product will consistently meet established requirements;
(iii) As part of a second-party approval or registration system - a customer gives formal
recognition to a supplier of conformance with the Standard; Quality Engineering (SYE3102) 9 M.XIE@CITYU.EDU.HK
(iv) In a third-party certification or registration situation - recognized assessment firms,
called registration agencies, register companies that are compliant with the Standard. This reduces the need for customers to perform assessments of their suppliers' Quality Systems. The Standard Interpretation concentrates on third-party registration because it is the primary use of the Standard.
2.2. Contents of ISO 9000
ISO 9000 is the "guidelines for selection and use of quality management and assurance standards". It helps in obtaining an understanding of what the ISO 9000 series really is about, for both supplier and customer. ISO 9000 elaborates on the general philosophy of quality systems standards, their characteristics, the existing types, where and when they are best used, and describes what elements quality assurance models should incorporate. It also deals with demonstration and documentation requirements, pre-contract assessment and contract preparation.
ISO 9000 is the introduction to the quality systems and ISO 9004 is the set of which makes it possible to customize quality standards and make them conform to real life situations. ISO 9004 is the basic element in the building up process of a quality system suited to specific situations. It is the tool for internal quality management purposes. A chemical company may, for instance, decide to put in place its 9000 quality system. It will look through all the elements in ISO 9004, and decide which ones it will retain and which ones it can do without. The company must be sure however that it takes everything it needs for incorporation into its own quality management specifications. Another chemical company will probably come to about the same choice.
The earlier version of ISO certification contains three standards, ISO 9001 – ISO 9003. ISO 9001 covers the areas of design and development, production, installation and servicing of products or services. ISO 9002 is limited to quality management in production and installation. Both include contract review, document control, purchasing, process control, handling, storage, packaging and delivery, training and internal quality audits. ISO 9003 covers quality assurance obligations of the supplier in the areas of final inspection and testing, assessment and registration procedures. These three systems have been merged into one system, ISO9001 with flexibility of application depending the nature of the business. Quality Engineering (SYE3102) 10 M.XIE@CITYU.EDU.HK
The elements in ISO 9001 include the need for: an effective quality system; ensuring that measurements are valid, that measuring and testing equipment is calibrated regularly; the use of appropriate statistical techniques; having a product identification and traceability system; maintaining an adequate record keeping system; having an adequate product handling, storage, packaging and delivery system; having an adequate inspection and testing system as well as a process for dealing with nonconforming items; and ensuring adequate personnel training and experience.
2.3. Steps to ISO 9000 Certification
The certificate process usually takes 6 months to 2 years. It can be divided into the following eight steps. Step 1: Evaluation of existing quality procedures against the requirements of the ISO 9001 standard Step 2: Identification of corrective action needed to conform with ISO 9000 series standards Step 3: Preparation of a quality assurance programme Step 4: Definition, documentation and implementation of new procedures Step 5: Preparation of a quality manual Step 6: Pre-assessment meeting with registrar to analyse quality manual Step 7: Actual assessment visit
Step 8: Certification
The implementation of ISO 9000 is carried out through a third-party process. Some of the key elements that the third -party auditors check for a company are as follows.
whether the company has a documentation process
whether everyone in the company is following the documented process how materials are selected how in-house inspections of supplier's deliveries are carried out how the calibrations and measurements are done Quality Engineering (SYE3102) 11 M.XIE@CITYU.EDU.HK
etc,
2.4. Pros and Cons of the Certification
ISO 9000 has been adapted worldwide and there is no doubt of its influence in promoting quality product. However, it has been some discussion about its effectiveness. There is general sentiment that quality is important, but that ISO 9000 as currently designed may not be the ticket to quality or competitiveness that its boosters claim. They're concerned that ISO 9000 is just the latest management buzzword--a costly buzzword. Companies will spend about $35,000 for basic ISO 9000 registration fees and that doesn't count hidden costs such as employee time.
The certification does not imply high quality product. Even ISO officials recognize this by saying that "It is possible to have an ISO 9000 system and still manufacture poor quality products (ISO 9000 News, July/August 1993)". There are ISO members calling for the Geneva-based organization to create a regulatory arm rather than leave that task to a myriad of national accreditation bodies all of whom function differently. There is also talk of creating one international accreditation body to create a far more integrated program. And there is growing concern that the ISO 9000 standards better reflect individual industry needs and are more closely connected to product standards.
It is difficult to maintain a common standard for the certification and the certification process. Interpretation of the Standard also varies from one auditor or consultant to the next and from one registration agency to the next.
The certification has mainly been successful in demonstrating a minimum level of level of quality system that is considered acceptable. There is no distinction between the companies certified and hence there is little incentive for further quality improvement after certification. This has lead to many middle-class companies and organizations in hurry to seek the certification and make use of the name of ISO certificate.
Achieving certification should not be the final goal. As people have to keep learning, companies have to adapt a never-ending improvement approach; at the end, they can leave the certificate behind. Merely following the crowd and seeking ISO 9000 certification, for example, will not benefit a company in its efforts to stay ahead. Quality Engineering (SYE3102) 12 M.XIE@CITYU.EDU.HK
2.5. Recent Trend and Interest in ISO 14000
The ISO 9000 series of Quality Management standards, with over 70,000 registrations around the world, is used by organizations as a model for a quality management system. Now make way for the new kid arriving on the block - the ISO 14000 series of standards -- the model for an environmental management system.
ISO 9000 is aimed at meeting customer requirements, control of the process and continuous improvement. ISO 14000 is aimed at these, and more: 'customer requirements' has expanded to include regulatory and other mandatory environmental requirements; and 'continuous improvement' is not only driven by customer expectations but also by priorities and objectives generated internally by the organization.
The ISO 14000 series of standards is comprised of several guideline standards and one compliance standard -- ISO 14001 Environmental Management Systems. Although publication of the standards is about a year away, five standards are in Committee Draft form and the Draft International Standards will be available shortly for public comment through the International Organization of Standardization based in Geneva. When ISO 14001 is published, organizations meeting the requirements will be able to seek registration to the standard in a process similar to ISO 9000 registration.
The ISO 14000 series is modelled after the BS 7750 (Environmental Management Systems) originally published in 1992 and updated in 1994. The BS 7750 standard has been the subject of a pilot implementation program involving nearly 500 participants from various industries. ISO 14000 does not replace ISO 9000. A company with an ISO 9000 registration has a good foundation for ISO 14000 and both are part of an organization's overall Management System. ISO 14000 also does not replace regulations, legislation and codes of practice (such as Responsible Care) that an organization has to comply with. Rather it provides a system for monitoring, controlling and improving performance regarding those requirements.
ISO 14000 is the package that ties the mandatory requirements into a management system which is made up of objectives and targets focusing on meeting and exceeding the mandatory requirements with a focus on prevention and continuous improvements. ISO 14001 uses the same fundamental systems as ISO 9000 such as documentation control, Quality Engineering (SYE3102) 13 M.XIE@CITYU.EDU.HK
management system auditing, operational control, control of records, management
policies, audits, training, statistical techniques, and corrective and preventive action.
There are also some definite differences. Besides the similarities, ISO 14001 has clearer statements about communication, competence and economics than are currently found in ISO 9000. Also, ISO 14001 incorporates the setting of objectives and quantified targets, emergency preparedness, considering the view of interested parties and public disclosure of the environmental policy.
An organization with an ISO 9000 registration will find that they are a long way towards an ISO 14001 registration from the outset. Even though there are differences, the management system is generally consistent in both the standards. The ISO approach to management serves as a "model" which needs to be adapted to meet the needs of the organization and integrated into existing management systems. The standards have been designed to be applied by any organization in any country regardless of the organization's size, process, economic situation and regulatory requirements.
