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Introduction- Quality Management/ISO. Subject- IT Quality Assurance Prof- V. Iyengar Presented by- Group-1. Topics covered by Group 1. Basic principles of Quality Management such as: Definition of Quality ( Assurance, Control, Management) Deming’s Principles of Quality
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Introduction- Quality Management/ISO Subject- IT Quality Assurance Prof- V. Iyengar Presented by- Group-1
Topics covered by Group 1 • Basic principles of Quality Management such as: • Definition of Quality ( Assurance, Control, Management) • Deming’s Principles of Quality • ISO, ISO 9000, ISO 9001 • Concepts of Reliability, Availability , Maintainability 1
ISO definition : "The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs“. • When projected on analytical work, quality can be defined as "delivery of reliable information within an agreed span of time under agreed conditions, at agreed costs, and with necessary aftercare". 3
Quality Management. “Includes all the activities that organizations use to direct, control, and coordinate quality. These activities include formulating a quality policy and setting quality objectives. They also include quality planning, quality control, quality assurance, and quality improvement”. • Quality Assurance. ”the assembly of all planned and systematic actions necessary to provide adequate confidence that a product, process, or service will satisfy given quality requirements.“ • Quality Control. “the operational techniques and activities that are used to satisfy quality requirements.” 4
1.Create constancy of purpose toward improvement of product and service, with the aim to become competitive and to stay in business, and to provide jobs. • Plan for quality in the long term. • Resist reacting with short-term solutions. • Don't just do the same things better – find better things to do. • Predict and prepare for future challenges, and always have the goal of getting better. • 2.Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge, must learn their responsibilities, and take on leadership for change. • Embrace quality throughout the organization. • Put your customers' needs first, rather than react to competitive pressure – and design products and services to meet those needs. • Be prepared for a major change in the way business is done. It's about leading, not simply managing. • Create your quality vision, and implement it. 6
3.Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place. • Inspections are costly and unreliable – and they don't improve quality, they merely find a lack of quality. • Build quality into the process from start to finish. • Don't just find what you did wrong – eliminate the "wrongs" altogether. • Use statistical control methods – not physical inspections alone – to prove that the process is working. • 4.End the practice of awarding business on the basis of price tag. Instead, minimize total cost. Move toward a single supplier for any one item, on a long-term relationship of loyalty and trust. • Quality relies on consistency – the less variation you have in the input, the less variation you'll have in the output. • Look at suppliers as your partners in quality. Encourage them to spend time improving their own quality – they shouldn't compete for your business based on price alone. • Analyze the total cost to you, not just the initial cost of the product. • Use quality statistics to ensure that suppliers meet your quality standards. 7
5.Constantly and forever improvethe system of production and service. • Accept nothing is ever good enough. Improve constantly and forever every process for planning, production and service. Build quality into the process from start to finish. • Improvement isn’t a project with a finite end. Instead, think continuous, never ending improvement. • Everyone should search continually for problems in order to improve every activity in the company, to improve quality and productivity and thus to constantly decrease costs. • Finding what’s wrong is not improvement. Plugging leaks is not improvement. Don’t look at outcomes or defects, instead look at what produces the defects. • There should be continual education on waste and continued improvement of quality in every activity, this will yield a continual rise in productivity. 8
6) Institutemodern methods of training on the job. • A trained worker has more productivity and quality than an untrained one, so giving training sessions will drastically improve the quality of the person and directly it helps in better product quality performance. • People learn in different ways. Training must be totally reconstructed. • When training, people need to understand what the job is and why it is being done. Training must be done on the job, learning by doing; going into the work and experimenting with work methods and new ideas, studying the results, and striving for perfection. • Institute modern methods of training on the job for all, including management, to make better use of every employee. • New skills are required to keep up with changes in tools, methods, techniques, product and service design. 9
7. Institute modern methods of supervision • A company can display stunning growth if potential leaders are identified and encouraged. • Leadership is required not supervision. • Adopt and institute leadership aimed at helping people to do a better job. • The basic principle is that it’s the managers job to coach their staff and improve the system • The emphasis of management must be changed from sheer numbers to quality. Improvement of quality will automatically improve productivity. • . 10
8. Drive out fear • Creating a fearful impression in the employees does not give more quality and productivity to work. If a person is not working willingly with satisfaction then he can never do a work perfectly even if he has the intention to be perfect in conscious mind, so driving out fear is essential. • Extinguish fear so everyone may work effectively for the organization. • Build trust. Cooperation and collaboration requires a whole different set of values and relationships than that used in the outdated command and control method. • People are afraid of change, any attempt to make things better will lead to a fear of the unknown. • To achieve better quality people need to feel secure. We need to eliminate fear so that everyone may work effectively for the company. Fear will disappear as management improves and as employees develop confidence in management • . 11
9. Breakdownbarriers between staff areas • People in research, design, sales, and production must work as a team, to foresee problems of production and in use that may be encountered with the product or service. • Break down barriers and silos between departments. In other words build a system. • Unless staff work jointly in a spirit of co-operation, each area will try to do what is best for itself, rather than what's good for the organization. It means cooperation not competition, everybody wins if the system wins. 12
10. Eliminate slogans, exhortations and targets for the workforce. • Let people know exactly what you want, do not make them guess • Motivational approaches overlook the major source of many problems • 11.Enumerate numerical quotas for the workforce and numerical goals for management. • Many organization managed by the numbers, focusing on quantity will lead to poor quality. • Goals are useful, but numerical goals set for others without incorporating a method to reach the goal generate frustration and resentment. • Management must understand the system and continually try to improve it, rather then focus on short-term goals. 13
12. Remove Barriers to Taking Pride in workmanship. • Allow everyone to take pride in the workplace by allowing them to express their potential and by not rating them or comparing them with other staff members. • Treat all the employees the same, do not encourage competition in the workplace. • Everyone is an integral part of the organizational success. • 13. Institute a vigorous program of education and self-improvement for everyone. • Employee must be up-to-date with current affairs in the workplace. This is important since tools, techniques and information are permanently changing. • Employees must grow with a company. • Improve the current skills of the workers. • Encourage people to learn new skills to prepare for future changes and challenges. 14
14. Take Action to Accomplish the Transformation. • The journey of thousand miles begins with a single step. • Any cultural changes begins with top management and includes everyone. • Once top management makes a commitment to change its management style, it must act on the basis of his commitment. 15
About ISO • ISO is an independent, non-governmental international organization with a membership of 163 national standards bodies. • Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges. • ISO Central Secretariat is based in Geneva, Switzerland.. 16
ISO Story • The ISO story began in 1946 when delegates from 25 countries met at the Institute of Civil Engineers in London and decided to create a new international organization ‘to facilitate the international coordination and unification of industrial standards’. • On 23 February 1947 the new organization, ISO, officially began operations. • ISO has published over 21000 International Standards covering almost all aspects of technology and manufacturing. • ISO has members from 163 countries and 3 368 technical bodies to take care of standard development. 17
ISO 9000 - Quality management • The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. • The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. 18
Standards in the ISO 9000 family • ISO 9001:2015 • sets out the requirements of a quality management system • ISO 9000:2015 • covers the basic concepts and language • ISO 9004:2009 • focuses on how to make a quality management system more efficient and effective • ISO 19011:2011 • sets out guidance on internal and external audits of quality management systems. 19
ISO 9000:2015 • ISO 9000:2015 describes the fundamental concepts and principles of quality management which are universally applicable to the following: • organizations seeking sustained success through the implementation of a quality management system. • customers seeking confidence in an organization's ability to consistently provide products and services conforming to their requirements. 20
ISO 9000:2015 • organizations seeking confidence in their supply chain that their product and service requirements will be met; • organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management; • organizations performing conformity assessments against the requirements of ISO 9001; • providers of training, assessment or advice in quality management • developers of related standards 21
Fundamental concepts • Quality • Quality is Conformance with requirements • Quality is fitness for purpose • Quality is fitness for use • Quality is user dependent 22
Fundamental concepts • Quality management system • A QMS comprises activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results. • The QMS manages the interacting processes and resources required to provide value and realize results for relevant interested parties. 23
Fundamental concepts • Context of an organization • This process determines factors which influence the organization’s purpose, objectives and sustainability. • It considers internal factors such as values, culture, knowledge and performance of the organization. • It also considers external factors such as legal, technological, competitive, market, cultural, social and economic environments. 24
Fundamental concepts • Interested parties • The concept of interested parties extends beyond a focus solely on the customer. • The relevant interested parties are those that provide significant risk to organizational sustainability if their needs and expectations are not met. Organizations define what results are necessary to deliver to those relevant interested parties to reduce that risk. • Organizations attract, capture and retain the support of the relevant interested parties they depend upon for their success. 25
Fundamental concepts • Support • Top management support of the QMS and engagement of people enables: • provision of adequate human and other resources. • monitoring processes and results. • determining and evaluating of risks and opportunities. • implementing appropriate actions. 26
ISO 9000:2005 – Vocabulary (examples) • Process– set of interrelated or interacting activities which transform inputs into outputs • Product– result of a process • Top management – a person or group of people who direct and control an organization at the highest level • Requirement – need or expectation that is stated, generally implied or obligatory • Customer satisfaction– customer’s perception of the degree to which the requirements have been fulfilled
ISO 9001 • ISO 9001 is a standard that sets out the requirements for a Quality Management System • It helps businesses and organizations to be more efficient and improve Customer Satisfaction • A new version of the standard, ISO 9001:2015, has just been launched, replacing the previous version (ISO 9001:2008). 28
ISO 9001- At a Glance • Can be applied to all types and sizes of organizations • Helps them put systems and processes in place to ensure that the organization is focussed on understanding and meeting customers’ requirements • Requires organizations to Identify, Manage, Control and Improvethose business processes that can have an impact on Customer Satisfaction 29
ISO 9001- At a Glance • ISO 9001 is built on the Plan-Do-Check-Act (PDCA) approach. This is the operating principle of all ISO management system standards • Plan. • Understand the business environment and customer requirements • Identify how they affect the organization • Define the objectives, targets and action plans to improve customer’s satisfaction – all in line with the company’s policy 30
ISO 9001- At a Glance • Do • Implement quality and management action plans. • Check • Monitor and measure the processes and operations against the company’s objectives and report the results • Act • Take actions to improve your customer satisfaction performance on an ongoing basis. 31
ISO 9001:2015The Seven Quality Management Principles • 1. Customer focus. • Meeting – and exceeding – customer needs • Not only attract but also retain the confidence of your customers • 2. Leadership. • Having a unified direction or mission • Everyone in the organization understands what you are trying to achieve 32
ISO 9001:2015The Seven Quality Management Principles • 3. Engagement of people • Creating value for your customers by having • Competent, empowered and engaged people at all levels of business or organization 33
ISO 9001:2015The Seven Quality Management Principles • 4. Process approach • Understanding activities as processes that link together • Function as a system achieves more consistent and predictable results • People, teams and processes do not exist in a vacuum • Ensuring everyone familiar with organization’s activities & how they fit together will ultimately improve efficiency. 34
ISO 9001:2015The Seven Quality Management Principles • 5. Improvement • Ongoing focus on improvement • Reacting to changes in the internal and external environment necessary to continue to deliver value for customers • Of paramount importance today when conditions evolve so quickly • 6. Evidence-based Decision Making. • Ensuring decisions based on analysis and evaluation of data more likely to produce the desired result. 35
ISO 9001:2015The Seven Quality Management Principles • 7. Relationship Management • Businesses and organizations do not work in a vacuum • Identifying important relationships with interested parties such as suppliers – and setting out a plan to manage them – will drive sustained success. 36
How is 9001:2015 different? • The emphasis on Leadership • The focus on Risk Management • Emphasis on Objectives, Measurement & Change • Communication & Awareness • Fewer Prescriptive Requirements 38
How is 9001:2015 different? • It’s all about integration, a new high level structure has been introduced to ensure that differing standards support each other • Based on Annex SL High Level Structure: standards consistent in their structure, simple language and better integrated as other ISO standards. Useful where Multiple Management Systems being followed • Greater emphasis on the objectives and goal setting – puts Leadership at the centre of its thinking 39
How is 9001:2015 different? • Managing change in business, Understanding the Risks and Challenges which may impact organizations ability to meet customer requirements and taking a preventativeapproach • Addresses Supply Chain Managementmore effectively • Is more User-friendlyfor Service & Knowledge-based Organizations 40
Annex SL High Level Structure Annex SL harmonizes structure, text and terms and definitions, while leaving the standard’s developers with the flexibility to integrate their specific technical topics and requirements. 41
Leadership • Increased reference to “organizational” context - the need to demonstrate an understanding of the internal and external issues that impact on the business. • Clauses are closely linked to “leadership” which require that the management system is not held at arm’s length by management, but linked to the strategic direction of the business. • This means the business has to align its processes effectively. 44
Leadership vs Management • Management is mostly about processes • Leadership is mostly about behaviour • Management relies heavily on: • Tangible measurable capabilities such as effective planning • The use of organizational systems • Use of appropriate communications methods. 45
Leadership vs Management • Leadership instead relies most strongly on less tangible and less measurable things like: • Trust, Inspiration, Attitude, • Decision-making, and Personal Character. • These are all necessary to motivate an organization to achieve its Management Systems Objectives. 46
Leadership 47
Focus on Risk Management • Senior management must demonstrate an understanding of business risks and impact on impact on the ability to meet customer requirements • It must ensure the management system can achieve its intended outcomes and achieve continual improvement. • Clause 6.1 Actions to address risks and opportunities, is where this is covered and it addresses the ‘What, Who, How & When of Risk Management 48
Focus on Risk Management • The organization should plan actions to address these risks and opportunities, how to integrate and implement the actions into its management system processes and evaluate the effectiveness of these actions • So Risk replaces preventive action. • Risk: “The effect of uncertainty on an expected result” and the new standard makes risk-based thinking more explicit throughout. 49