UNIT 32 Quality Systems In It

UNIT 32 Quality Systems In It


QUALITY MANAGEMENT SYSTEMS.
DEFINITIONS
* A system by which an organization aims to reduce and eventually eliminate nonconformance to specifications, standards, and customer expectations in the most cost effective and efficient manner. * A quality management system (QMS) can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management * A quality management system is a management technique used to communicate to employees what is required to produce the desired quality of products and services and to influence employee actions to complete tasks according to the quality specifications

What Purpose Does a Quality Management System Serve?

✔ Establishes a vision for the employees.
✔ Sets standards for employees.
✔ Builds motivation within the company.
✔ Sets goals for employees.
✔Helps fight the resistance to change within organizations. ✔ Helps direct the corporate culture.

Quality management is becoming increasingly important to the leadership and management of all organisations. It is necessary to identify Quality Management as a distinct discipline of management and lay down universally understood and accepted rules for this discipline. Definition of Quality Management Principle:

"A quality management principle is a comprehensive and fundamental rule / belief, for leading and operating an organisation, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other stake holders". The eight principles are

1. Customer-Focused Organisation
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships..
Principle 1 - Customer-Focused Organisation : "Organisations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations". Steps in application of this principle are

1. Understand customer needs and expectations for products, delivery, price, dependability, etc. 2. Ensure a balanced approach among customers and other stake holders (owners, people, suppliers, local communities and society at large) needs and expectations. 3. Communicate these needs and expectations throughout the organisation. 4. Measure customer satisfaction & act on results, and 5. Manage customer relationships.

Principle 2 - Leadership : "Leaders establish unity of purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation's objectives." Steps in application of this principle are

1. Be proactive and lead by example.
2. Understand and respond to changes in the external environment. 3. Consider the needs of all stake holders including customers, owners, people, suppliers, local communities and society at large. 4. Establish a clear vision of the organisation's future. 5. Establish shared values and ethical role models at all levels of the organisation. 6. Build trust and eliminate fear.

7. Provide people with the required resources and freedom to act with responsibility and accountability. 8. Inspire, encourage and recognise people's contributions. 9. Promote open and honest communication.

10. Educate, train and coach people.
11. Set challenging goals and targets, and
12. Implement a strategy to achieve these goals and targets. Principle 3 - Involvement of People: "People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation's benefit". Steps in application of this principle are

1. Accept ownership and responsibility to solve problems. 2. Actively seek opportunities to make improvements, and enhance competencies, knowledge and experience. 3. Freely share knowledge & experience in teams.

4. Focus on the creation of value for customers.
5. Be innovative in furthering the organisation’s objectives. 6. Improve the way of representing the organisation to customers, local communities and society at large. 7. Help people derive satisfaction from their work, and

8. Make people enthusiastic and proud to be part of the organisation. Principle 4 - Process Approach : "A desired result is achieved more efficiently when related resources and activities are managed as a process." Steps in application of this principle are

1. Define the process to achieve the desired result.
2. Identify and measure the inputs and outputs of the process. 3. Identify the interfaces of the process with the functions of the organisation. 4. Evaluate possible risks, consequences and impacts of processes on customers, suppliers and other stake holders of the process. 5. Establish clear responsibility, authority, and accountability for managing the process. 6. Identify internal and external customers, suppliers and other stake holders of the process, and 7. When designing processes, consider process steps, activities, flows, control measures, training needs, equipment, methods, information, materials and other resources to achieve the desired result. Principle 5 - System Approach to Management: "Identifying, understanding and managing a system of interrelated processes for a given objective improves the organisation's effectiveness and efficiency." Steps in application of this principle are

1. Define the system by identifying or developing the processes that affect a given objective. 2. Structure the system to achieve the objective in the most efficient way. 3. Understand the interdependencies among the processes of the system. 4. Continually improve the system through measurement and evaluation, and 5. Estimate the resource requirements and establish resource constraints prior to action. Principle 6 - Continual Improvement: "Continual improvement should be a permanent objective of the organisation." Steps in application of this principle are

1. Make continual improvement of products, processes and systems an objective for every individual in the organisation. 2. Apply the basic improvement concepts of incremental improvement and breakthrough improvement. 3. Use periodic assessments against established criteria of excellence to identify areas for potential improvement. 4. Continually improve the efficiency and effectiveness of all processes. 5. Promote prevention based activities.

6. Provide every member of the organisation with appropriate education and training, on the methods and tools of continual improvement such as the Plan-Do-Check-Act cycle , problem solving , process re-engineering, and process innovation. 7. Establish measures and goals to guide and track improvements,and 8. Recognise improvements.

Principle 7 - Factual Approach to Decision Making: "Effective decisions are based on the analysis of data and information." Steps in application of this principle are
1. Take measurements and collect data and information relevant to the objective. 2. Ensure that the data and information are sufficiently accurate, reliable and accessible. 3. Analyse the data and information using valid methods.

4. Understand the value of appropriate statistical techniques, and 5. Make decisions and take action based on the results of logical analysis balanced with experience and intuition. Principle 8 - Mutually Beneficial Supplier Relationships: "An organisation and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value." Steps in application of this principle are

1. Identify and select key suppliers.
2. Establish supplier relationships that balance short-term gains with long-term considerations for the organisation and society at large. 3. Create clear and open communications.
4. Initiate joint development and improvement of products and processes. 5. Jointly establish a clear understanding of customers' needs. 6. Share information and future plans, and
7. Recognise supplier improvements and achievements.

Quality standards
What is ISO?
ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards. International Standards give state of the art specifications for products, services and good practice, helping to make industry more efficient and effective. Developed through global consensus, they help to break down barriers to international trade. Popular name for International Organization For Standardization (IOS), a voluntary, non-treaty federation of standards setting bodies of some 130 countries. Founded in 1946-47 in Geneva as a UN agency, it promotes development of standardization and related activities to facilitate international trade in goods and services, and cooperation on economic, intellectual, scientific, and technological aspects. ISO covers standardization in all fields including computers and data communications, but excluding electrical and electronic engineering (governed by the International Electro-technical Commission or IEC) and telecommunications (governed by International Telecommunications Union's Telecommunications Standards Sector or ITU-TSS).

NB: “Because 'International Organization for Standardization' would have different acronyms in different languages (IOS in English, OIN in French for Organisation internationale de normalisation), our founders decided to give it the short form ISO. ISO is derived from the Greek isos, meaning equal. Whatever the country, whatever the language, the short form of our name is always ISO.”

Popular standards
ISO 9000 - Quality management - Make sure your products and services meet customers' needs with this family of standards. ISO 14000 - Environmental management - Improve your environmental performance with this family of standards. ISO 3166 - Country codes - Avoid confusion when referring to countries and their subdivisions with this standard. ISO 22000 - Food safety management - Inspire confidence in your food products with this family of standards. ISO 26000 - Social responsibility - Help your organization to operate in a socially responsible way with this standard. ISO 50001 - Energy management - Make energy savings and help make your organization more efficient with this standard. ISO 31000 - Risk management - Manage risks that could be negative for your company’s performance with this standard ISO 4217 - Currency codes - Avoid confusion when referring to world currencies with this standard. ISO 639 - Language codes - Describe languages in an internationally accepted way with this standard Benefits of International Standards

International Standards bring technological, economic and societal benefits. They help to harmonize technical specifications of products and services making industry more efficient and breaking down barriers to international trade. Conformity to International Standards helps reassure consumers that products are safe, efficient and good for the environment. For business

International Standards are strategic tools and guidelines to help companies tackle some of the most demanding challenges of modern business. They ensure that business operations are as efficient as possible, increase productivity and help companies access new markets. Benefits include:

* Cost savings - International Standards help optimise operations and therefore improve the bottom line * Enhanced customer satisfaction - International Standards help improve quality, enhance customer satisfaction and increase sales * Access to new markets - International Standards help prevent trade barriers and open up global markets * Increased market share - International Standards help increase productivity and competitive advantage * Environmental benefits - International Standards help reduce negative impacts on the environment Businesses also benefit from taking part in the standard development process. For Society

ISO has over 19 500 standards touching almost all aspects of daily life. When products and services conform to International Standards consumers can have confidence that they are safe, reliable and of good quality. For example, ISO's standards on road safety, toy safety and secure medical packaging are just a selection of those that help make the world a safer place. For government

ISO standards draw on international expertise and experience and are therefore a vital resource for governments when developing regulations. National governments can make ISO standards a regulatory requirement (remember ISO standards themselves are voluntary). This has a number of benefits: * Expert opinion - ISO standards are developed by experts. By integrating an ISO standard into national regulation, governments can benefit from the opinion of experts without having to call on their services directly. * Opening up world trade - ISO standards are international and adopted by many governments. By integrating ISO standards into national regulation, governments help to ensure that requirements for imports and exports are the same the world over, therefore facilitating the movement of goods, services and technologies from country to country.

CHALLENGES

As commitment to provide quality, many business organisation put much effort to pursue with ISO certification. However, many camponies facing problems in applying ISO system in the company and these had created challenges in progressing to certify. * Budget - Common constraint facing by one organisation is budget. Either it is a limited budget, unwillingness to spend on ISO matters or even consider a big problem for a small business organisation.  Realizing that they required to be certified by have limitation in spending much money on it. High cost of consultancy fees including consultant's travelling expenses that normally include in the costing will be the burden to the orgsanisation. * Consultant - Many companies hire and rely on external consultant with less of involvement in setting up the ISO system. Unfortunately, they may discover that the consultant does not understand the organisation's business or process, resulting in a documented system that little or no merit to organisation. Although there are many excellent consultant out there, a company's limited financial resources may become a deciding factor between choosing a consultant who is cheap or consultant who is capable. This may result in problem in maintaining the ISO system after certification and cause wasting of money as product quality still cannot be consistently produce even the ISO system is already in place. * Time - Distruptions of consultant's onsite visit to daily operation due to tight scheduling to match with consultant's own scehdule.

Advantages
* Increased Customer Satisfaction
Because ISO 9000 is dedicated to the boosting the quality of your final product, successful implementation of the program should increase your customer satisfaction. A product of a high quality is less likely to malfunction or cease working, which could cause irate purchasers. High-quality products last for a long time, and happy customers will spread the word about your business. Tracking customer response will give you a way to tinker your ISO 9000 efforts as you take advantage of what you have learned. * Third party assessment

The biggest advantage of ISO certification is the perspective of a third party assessment. Frequently, companies underestimate problems or just ignore them because they are too painful. The third party audit ensures that the quality management is properly calibrated against the rest of the industry. * Executive management exposure

Executive management tends to listen to recommendations and not their own departments. ISO audits have a way of percolating to the highest levels of the organization. This enables systemic problems that may be concealed to be brought out to the appropriate levels of a company. Of course, this is a doubl eedged sword as attention may be unnecessary, but it is nonetheless an advantage for executive management to be involved in their quality system. * Common

ISO certification is also the most common type of certification. This makes it easier to implement new systems, hire personnel, and understand changes. Some of the more obtuse quality paradigms like Baldridge or TQM require specialized training or knowledge that substantially ups the ante for those organizations considering an alternative.

Disadvantages
*  Does not guarantee better quality
ISO certification definitely does not automatically lead to better quality product. While it does encourage operations to think in terms of systems, it does not require them to be good. This is definitely a problem with newer certified companies and those with purchased quality systems. * Focus on certification

For anyone that has worked with ISO certified companies, this is definitely a truth. ISO certification becomes a target, an end point, a stop on the road to quality. In reality, continuously improving the systems would lead to better quality, but for ISO certified companies, all too often the focus is on the next audit.

How do companies get ISO?
One of the strengths of ISO standards is that they are created by the people that need them. Industry experts drive all aspects of the standard development process, from deciding whether a new standard is needed to defining all the technical content. Getting involved in this process can bring significant advantages to your business. For example by: * Giving early access to information that could shape the market in the future * Giving your company a voice in the development of standards * Helping to keep market access open.

Getting involved in standards development brings your concerns and needs to bear on a process that will affect you in the future. Organizations and companies often want to get certified to ISO’s management system standards (for example ISO 9001 or ISO 14001) although certification is not a requirement. The best reason for wanting to implement these standards is to improve the efficiency and effectiveness of company operations. A company may decide to seek certification for many reasons, as certification may: * be a contractual or regulatory requirement

* be necessary to meet customer preferences
* fall within the context of a risk management programme, and * help motivate staff by setting a clear goal for the development of its management system. ISO does not perform certification
ISO develops International Standards, including management system standards such as ISO 9001, ISO 14001 and ISO 31000. However, it is not involved in the certification to any of the standards it develops. Certification is performed by external certification bodies, which are largely private. Therefore a company or organization cannot be certified by ISO. ISO does not perform certification

ISO develops International Standards, including management system standards such as ISO 9001, ISO 14001 and ISO 31000. However, it is not involved in the certification to any of the standards it develops. Certification is performed by external certification bodies, which are largely private. Therefore a company or organization cannot be certified by ISO. When a company or organization is certified to an ISO standard they will receive a certificate from the certification body. Even though the name of the ISO standard appears on this certificate, it is not ISO that has issued it. Although ISO does not perform certification, its Committee on Conformity Assessment (CASCO) has produced a number of standards that relate to the certification process. The voluntary criteria contained in these publications are an international consensus on good practice relating to certification. Companies and organizations usually operate their certification activities in accordance with these international standards Process of acquiring ISO

1. Write documentation.
You’ll need a written quality manual, certain written procedures, and probably some forms.  Some records will have to be kept.  Your documentation will have to meet the requirements of the ISO quality standard.  It will also have to fit your company’s quality goals.  Your quality documentation says what you do, how you do it, and provides proof that you do it.  You must be able to demonstrate that you are continuously improving your quality system as well as your product or service, and your customers’ satisfaction. 2. Training.

All of your people will require some training.  The amount of training is dependent on each individual’s responsibilities.   3. Practice and live with your quality system for a few months.   Undoubtedly you will find that some changes need to be made.  Keep records in accordance with your quality system.   After a few months your quality system and your people should be ready for the registration audit. 4. Get audited.

The number of auditors needed, and the time involved to conduct a registration audit will vary according to the size and complexity of your company.  During an ISO audit, the auditor(s) will examine your records and will talk with your people.  It is very important that your staff is properly trained and that your records are in order.  Auditors write up problems as “nonconformances”.  Nonconformances can be “major” or “minor”.  Auditors can also write up “observations”.  A major nonconformance will cause you not to get certified to the ISO standard.  Minor nonconformances may or may not prevent your certification, it all depends on the number and severity of your nonconformances.  Auditors have a fair amount of discretion in what they write up, and whether or not you will get certified on your first try. Observations will not cause you to lose your certification, they are usually suggestions by the auditor for how you might be able to make improvements to your quality system. 

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