Quality Management. Lecture 7 ISO 9000 and quality control

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1 Quality Management Lecture 7 ISO 9000 and quality control doc.dr.sc. Marko Jurčević prof.dr.sc. Roman Malarić University of Zagreb Faculty of Electrical Engineering and Computing Department

2 New Standards Management standards address the needs of organizations in training, quality auditing and quality-management systems Increases in international trade during the 1980s created a need for the development of universal standards of quality. Universal standards were seen as necessary in order for companies to be able to objectively document their quality practices around the world The International Standards Organization is dedicated to creating and developing standards to help facilitate the international exchange of goods and services. It consists of members from national standard bodies of a number of different countries. Standardization has become required as a result of free market economies that encourage diverse sources of supply. Fair competition is created by creating identifiable, clearly defined common references that are recognized worldwide

3 Introduction The ISO 9000 Series is a set of international standards for quality management and quality assurance ISO 9000 family addresses various aspects of quality management and contains some of ISO s best known standards help companies effectively document the elements they need to maintain an efficient quality system they are not specific to any one industry a lot of major purchasers require their suppliers to hold ISO 9001 certification

4 ISO 9000 can help a company satisfy its customers, meet regulatory requirements and achieve continual improvement statistics shows significant financial benefits for organizations certified to ISO 9001, a 2011 survey from the British Assessment Bureau showing 44% of their certified clients had won new business this is only a first step; many quality professionals will tell this is the base level of a quality system and not a complete guarantee of quality

5 History of ISO 9000 United States Department of Defense MIL-Q-9858 standard was published in MIL-Q-9858 was revised into the NATO AQAP series of standards in 1969, which in turn were revised into the BS 5179 series of guidance standards published in 1974, and finally revised into the BS 5750 series of requirements standards in 1979 ISO 9000 was first published in based on the BS 5750 series of standards from BSI (British Standards Institution) proposed to ISO in 1979

6 Evolution of ISO 9000 standards ISO 9000 standard is continually being revised by ISO technical committees and advisory groups, who receive feedback from professionals implementing the standard around the world ISO 9000: same structure as the UK Standard BS 5750 three 'models' for quality management systems, based on the scope of activities of the organization: ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products. ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products. ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced. ISO 9000:1987 emphasis tended to be placed on conformance with procedures rather than the overall process of management

7 ISO 9000:1994 ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, also continued to require evidence of compliance with documented procedures. the down-side was that companies tended to implement its requirements by creating a lot of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system

8 ISO 9001:2000 ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and ISO Design and development procedures were required only if a company does in fact engage in the creation of new products version made a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimisation of all company's tasks and activities, instead of just final product inspection) version demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. effectiveness improvement is done via process performance metrics: numerical measurement of the effectiveness of tasks and activities. expectations of continual process improvement and tracking customer satisfaction were made explicit. ISO 9000 Requirements include: (1) approve documents before distribution; (2) provide correct version of documents at points of use; (3) use your records to prove that requirements have been met; (4) develop a procedure to control your records.

9 ISO 9001:2008 ISO 9001:2008 version introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. there were no new requirements ISO 9001 is supplemented directly by two other standards of the family: ISO 9000:2005 "Quality management systems. Fundamentals and vocabulary" ISO 9004:2009 "Managing for the sustained success of an organization. A quality management approach"

10 ISO 9001:2015? ISO 9001 Quality Management Systems is under review and an updated version is expected by the end of All ISO standards are reviewed every 5 years to make sure they remain as helpful and relevant

11 ISO 9000 Contents as already stated, there are several standards in the ISO 9000 family ISO 9001:2008 Quality management systems Requirements is a PDF/paper document (has approx. 30 pages) which is available from the national standards organization in each country or over the ISO web site only this is directly audited against for third party assessment purposes it is supplemented by two other standards: ISO 9000:2005 Quality management systems Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization A quality management approach. these two standards are only supplementary documents and contain deeper information on how to sustain and improve quality management systems they are therefore not used directly during third party assessment but only serve as an additional help ISO 19011: sets out guidance on internal and external audits of quality management systems

12 ISO 9001 Contents ISO 9001 is made up of eight sections: scope, normative reference, terms and definitions, quality management system, management responsibility, resource management, product realization and measurement, analysis and improvement first three sections provide general information about the standard, and the last five focus on how to implement it

13 Section 1 scope: specifies that the organization needs to meet customer and regulatory requirements and ensure its employees follow its policies and procedures while advancing quality through continual improvement. Section 2 normative reference: provides normative references to constitute the terms of ISO Section 3 terms and definitions: defines the terms used in the standard and highlights the differences between the 2008 version and older (2000) version.

14 Section 4 quality management system: describes the standard s general requirements, which encompass all activities from quality manual documentation and control of documents and records to determining the sequence and interaction of the processes to implementing actions to achieve planned results Section 5 management responsibility: requires management s commitment to the QMS and explains that management must be dedicated to the organization s products, customers and planning and review processes

15 Section 6 resource management: provides the criteria needed to perform a job competently and in a safe environment. Human resources, infrastructure planning and work environment are discussed in this section. Section 7 product realization: defines the steps in product development. These steps include everything from the initial design phase to the final delivery phase. For example: product realization planning, customer related processes, design and development, the product purchasing process, production and service provisions and the control of monitoring and measuring devices.

16 Section 8 measurement, analysis and improvement: focuses on measuring, analyzing and improving the QMS by having companies perform periodical internal audits, monitor customer satisfaction, control nonconforming product, analyze data and take corrective and preventive actions.

17 ISO 9001 Table of Contents Page iv: Foreword Pages v to vii: Section 0 Intro Pages 1 to 14: Requirements Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000) Section 4: Quality Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Product Realization Section 8: Measurement, analysis and improvement Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards Page 23: Bibliography

18 ISO 9001 Chapter Numbering 4.2 Documentation requirements 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review 6 Resource management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment 7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring equipment 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement

19 ISO 9001 Basic Implementation Guidelines Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 8. The standard specifies that the organization shall issue and maintain the following six documented procedures: Control of Documents (4.2.3) Control of Records (4.2.4) Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3) ISO 9001:2008 requires the organization to document any other additional procedures required for its effective operation. standard requires the organization to issue and communicate a documented quality policy, a Quality Manual (which may or may not include the documented procedures) and numerous records, as specified throughout the standard.

20 ISO 9000 Auditing AUDITING useful for continual process of review and assessment to verify that the system is working as it is supposed to, to find out where it can improve and to correct or prevent problems identified Two types of auditing are required to become certified to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits) Auditors: are expected to go beyond auditing for rote compliance by focusing on risk, status, and importance are expected to make judgments on what is effective, rather than merely adhering to what is formally prescribed

21 ISO 9001 Certification ISO does not certify organizations itself there are certification bodies (specialized companies), which audit organizations and, if successful, issue ISO 9001 compliance certificates national accreditation bodies authorize (or accredit) the certification bodies don t adapt or modify ISO s logo for your use

22 ISO 9001 process-based approach to ease implementation, ISO 9001 suggests companies adopt a process approach, which is a series of operations that transform inputs into value added output process can be measured by accuracy, timeliness, cycle time, downtime, efficiency, effectiveness, turnaround and setup time To achieve certification, a company must: follow the guidelines of the ISO 9001 standard fulfill its own requirements and those of its customers follow statutory and regulatory requirements create documents keep track of record

23 ISO 9001 Certification organization that applies for ISO 9001 certification is audited based on an extensive sample of its locations, functions, products, services and processes auditor presents a list of problems (defined as nonconformities, observations) to management. in a case of no major nonconformities, the certification body issues a certificate in a case of identified nonconformities, the applicant organization will present an improvement plan to the certification body (e.g. corrective action reports showing how the problems will be resolved) once the certification body is satisfied that the organization has carried out sufficient corrective action, it will issue a certificate the certificate is limited by a certain scope (e.g. production of power meters) and will display the addresses to which the certificate refers must be renewed at regular intervals recommended by the certification body (usually once every three years)

24 ISO9001 Benefits creates a more efficient, effective operation/processes increases customer satisfaction and retention reduces audits enhances marketing improves employee motivation, awareness, and morale promotes international trade increases profit reduces waste and increases productivity common tool for standardization.

25 Some statistics - Global adoption Worldwide total of ISO Quality Management Systems - Requirements certificates Dec 2001 Dec 2002 Dec 2003 Dec 2004 Dec 2005 Dec 2006 Dec 2007 Dec 2008 Dec 2009 Dec 2010 Dec , , , , , , , ,832 1,064,785 1,118,510 1,111,698 Source: ISO Survey 2011

26 Some statistics Top 10 countries for ISO 9001 certificates Rank Country No. of certificates 1 China 297,037 2 Italy 138,892 3 Russian Federation 62,265 4 Spain 59,854 5 Japan 59,287 6 Germany 50,583 7 United Kingdom 44,849 8 India 33,250 9 USA 25, Korea, Republic of 24,778 Source: ISO Survey 2011

27 References ISO Central Secretariat, Publicizing your ISO 9001:2008 or ISO 14001:2004 certification, ISO Quality management, ISO 9000 and Other Standards - Read More ISO 9000,

28 Quality Management Lecture 8 Total Quality Management doc.dr.sc. Marko Jurčević prof.dr.sc. Roman Malarić University of Zagreb Faculty of Electrical Engineering and Computing Department

29 History in the late 1970s and early 1980s, the developed countries of North America and Western Europe suffered economically in the face of competition from Japan's ability to produce high-quality goods at competitive cost the companies began re-examining the techniques of quality control invented over the past 50 years and how those techniques had been so successfully employed by the Japanese In the spring of 1984, some of the United States Navy researchers assess statistical process control and introduced the work of several prominent quality consultants to make recommendations as to how to apply their approaches to improve the Navy's operational effectiveness. The recommendation was to adopt the teachings of W. Edwards Deming. This effort was branded as "Total Quality Management" in TQM spread throughout the US Federal Government, resulting in the following: the creation of the Malcolm Baldrige National Quality Award in 1987 the creation of the Federal Quality Institute in 1988 the adoption of TQM by many elements of government the private sector followed using TQM not only as a means to recapture market share from the Japan, but also to remain competitive when bidding for contracts from the government since "total quality" requires involving suppliers, not just employees, in process improvement efforts

30 TQM Intro core definition of total quality management (TQM) describes a management approach to long term success through customer satisfaction. consists of organization-wide efforts to install and make permanent a climate in which an organization continuously improves its ability to deliver high-quality products and services to customers, but there is no widely agreed-upon approach all members of an organization participate in improving processes, products, services, and the culture in which they work. methods for implementing this approach come from the teachings of such quality leaders as Philip B. Crosby, W. Edwards Deming, Armand V. Feigenbaum, Kaoru Ishikawa, and Joseph M. Juran.

31 TQM Elements TQM uses strategy, data and effective communications to integrate the quality discipline into the culture and activities of the organization These TQM elements are considered essential to successfull TQM that many organizations define them as a set of core values and principles on which the organization is to operate: Customer-focused Total employee involvement Process-centered Integrated system Strategic and systematic approach Continual improvement Fact-based decision making Communications

32 Customer focus The customer ultimately determines the level of quality. it is not so important what an organization does to foster quality improvement training employees, integrating quality into the design process, upgrading computers or software, or buying new measuring tools the customer determines whether the efforts were effective.

33 Total employee involvement all employees participate in working toward common goals. total employee commitment can only be obtained after fear has been driven from the workplace, when empowerment has occurred, and management has provided the proper environment. High-performance work systems integrate continuous improvement efforts with normal business operations. Self-managed work teams are one form of empowerment.

34 Process-centered fundamental part of TQM is a focus on process thinking. process is a series of steps that take inputs from suppliers (internal or external) and transforms them into outputs that are delivered to customers (again, either internal or external). the steps required to carry out the process are defined, and performance measures are continuously monitored in order to detect unexpected variation.

35 Integrated system an organization may consist of many different functional specialties often organized into vertically structured departments the horizontal processes are interconnecting these functions that are the focus of TQM micro-processes add up to larger processes all processes aggregate into the business processes required for defining and implementing strategy. everyone must understand the vision, mission, and guiding principles as well as the quality policies, objectives, and critical processes of the organization. business performance must be monitored and communicated continuously. an integrated business system may be modeled after the Baldrige National Quality Program criteria and/or incorporate the ISO 9000 standards. every organization has a unique work culture, and it is virtually impossible to achieve excellence in its products and services unless a good quality culture has been fostered. an integrated system connects business improvement elements in an attempt to continually improve and exceed the expectations of customers, employees, and other stakeholders.

36 Strategic and systematic approach critical part of the management of quality is the strategic and systematic approach to achieving an organization s vision, mission, and goals. this process, called strategic planning or strategic management, includes the formulation of a strategic plan that integrates quality as a core component.

37 Continual improvement major thrust of TQM is continual process improvement. continual improvement drives an organization to be both analytical and creative in finding ways to become more competitive and more effective at meeting stakeholder expectations.

38 Fact-based decision making in order to know how well an organization is performing, data on performance measures are necessary. TQM requires that an organization continually collect and analyse data in order to improve decision making accuracy, achieve consensus, and allow prediction based on past history.

39 Communications during times of organizational change, as well as part of day-today operation, effective communications plays a large part in maintaining morale and in motivating employees at all levels. communications involve strategies, method, and timeliness.

40 Implementing a TQM System Generic steps for implementing TQM: top management learns about and decides to commit to TQM as it is identified as one of the organization s strategies the organization assesses current culture, customer satisfaction and quality management systems top management identifies core values and principles to be used and communicates them a TQM master plan is developed on the basis of steps 1, 2, and 3 the organization identifies and prioritizes customer demands and aligns products and services to meet those demands management maps the critical processes through which the organization meets its customers needs management oversees the formation of teams for process improvement efforts the momentum of the TQM effort is managed by the steering committee managers contribute individually to the effort through planning, training, coaching, or other methods daily process management and standardization take place progress is evaluated and the plan is revised as needed constant employee awareness and feedback on status are provided and a reward/recognition process is established of course, the TQM strategy will vary from organization to organization

41 Strategies to develop the TQM process following strategies as stated in Certified Manager of Quality/Organizational Excellence Handbook, pages Strategy 1: The TQM element approach takes key business processes and/or organizational units and uses the tools of TQM to foster improvements. This method was widely used in the early 1980s as companies tried to implement parts of TQM as they learned them. examples of this approach include quality circles, statistical process control, Taguchi methods, and quality function deployment

42 Strategies to develop the TQM process Strategy 2: The guru approach uses the teachings and writings of one or more of the leading quality thinkers as a guide against which to determine where the organization has deficiencies. Then, the organization makes appropriate changes to remedy those deficiencies. example: managers might study Deming s 14 points or attend the Crosby College. They would then work on implementing the approach learned.

43 Strategies to develop the TQM process Strategy 3: The organization model approach individuals or teams visit organizations that have taken a leadership role in TQM and determine their processes and reasons for success. They then integrate these ideas with their own ideas to develop an organizational model adapted for their specific organization. this method was used widely in the late 1980s and is exemplified by the initial recipients of the Malcolm Baldrige National Quality Award.

44 Strategies to develop the TQM process Strategy 4: The Japanese total quality approach organizations using the Japanese total quality approach examine the detailed implementation techniques and strategies employed by Deming Prize winning companies and use this experience to develop a long-range master plan for in-house use.

45 Strategies to develop the TQM process Strategy 5: The award criteria approach when using this model, an organization uses the criteria of a quality award, for example, the Deming Prize, the European Quality Award, or the Malcolm Baldrige National Quality Award, to identify areas for improvement. Under this approach, TQM implementation focuses on meeting specific award criteria. although some argue that this is not an appropriate use of award criteria, some organizations do use this approach and it can result in improvement.

46 Benefits direct and indirect benefits that total quality management (TQM) can offer organizations: strengthened competitive position adaptability to changing or emerging market conditions and to environmental and other government regulations higher productivity enhanced market image elimination of defects and waste reduced costs and better cost management higher profitability improved customer focus and satisfaction increased customer loyalty and retention increased job security improved employee morale enhanced shareholder and stakeholder value improved and innovative processes

47 References ASQ, Total Quality Management (TQM), Russell T. Westcott, editor: Certified Manager of Quality/Organizational Excellence Handbook, pages D.L. Goetsch, S.B. Davis: Quality Management: Introduction to Total Quality Management for Production, Processing, and Services (5th edition), Prentice Hall, James R. Evans, James W. Dean, Jr.: Total Quality Management, Thomson Learning, John S. Oakland: Total Quality Management: Text with Cases, Butterworth-Heinemann,

48 Quality Management Lecture 9 Quality Management Programs doc.dr.sc. Marko Jurčević prof.dr.sc. Roman Malarić University of Zagreb Faculty of Electrical Engineering and Computing Department

49 Quality Management Programs International Standards: example ISO Quality Management Programs: Six Sigma (6s) Malcolm Baldrige National Program EFQM Excellence Model The Deming Prize Award many others

50 Six Sigma Six Sigma is a set of techniques, and tools for process improvement a fact-based, data-driven philosophy of quality improvement that values defect prevention over defect detection developed by Motorola in 1986

51 Six Sigma drives customer satisfaction and bottom-line results by reducing variation and waste, thereby promoting a competitive advantage. it applies anywhere variation and waste exist, and every employee should be involved Six Sigma quality performance means no more than 3.4 defects per million opportunities (products, events, services,...) uses a set of quality management methods, including statistical methods, and creates a special infrastructure of people within the organization ("Champions", "Black Belts", "Green Belts", "Yellow Belts", etc.) who are experts in the methods.

52 Opinions on the definition of Six Sigma Six Sigma is a philosophy This perspective views all work as processes that can be defined, measured, analyzed, improved and controlled. Processes require inputs (x) and produce outputs (y). If you control the inputs, you will control the outputs: This is generally expressed as y = f(x). Six Sigma is a set of tools The Six Sigma expert uses qualitative and quantitative techniques to drive process improvement. A few such tools include statistical process control (SPC), control charts, failure mode and effects analysis and flowcharting. Six Sigma is a methodology This view of Six Sigma recognizes the underlying and rigorous approach known as DMAIC (define, measure, analyze, improve and control). DMAIC defines the steps a Six Sigma practitioner is expected to follow, starting with identifying the problem and ending with the implementation of long-lasting solutions. While DMAIC is not the only Six Sigma methodology in use, it is certainly the most widely adopted and recognized. Excerpted from Donald W. Benbow and T. M. Kubiak, The Certified Six Sigma Black Belt Handbook, ASQ Quality Press, 2005, pages 1 2.

53 Six Sigma term Six Sigma originated from terminology associated with manufacturing, specifically terms associated with statistical modeling of manufacturing processes maturity of a manufacturing process can be described by a sigma rating indicating its yield or the percentage of defect-free products it creates processes that operate with "six sigma quality" over the short term are assumed to produce long-term defect levels below 3.4 defects per million opportunities (DPMO)

54 Six Sigma six sigma process if one has six standard deviations between the process mean and the nearest specification limit, as shown in the graph, practically no items will fail to meet specifications

55 on the previous slide, graph of the normal distribution is shown, which underlies the statistical assumptions of the Six Sigma model. the Greek letter σ (sigma) marks the distance on the horizontal axis between the mean, µ, and the curve's inflection point the greater this distance, the greater is the spread of values encountered the upper and lower specification limits (U/USL and L/LSL, respectively) are at a distance of 6σ from the mean because of the properties of the normal distribution, values lying that far away from the mean are extremely unlikely experience has shown that processes usually do not perform as well in the long term as they do in the short term. The number of sigmas that will fit between the process mean and the nearest specification limit may well drop over time, compared to an initial short-term analysis.to account for this reallife increase in process variation over time, an empirically-based 1.5 sigma shift is introduced into the calculation even if the mean were to move right or left by 1.5σ at some point in the future (1.5 sigma shift), there is still a good safety zone this is why Six Sigma aims to have processes where the mean is at most 6σ away from the nearest specification limit

56 Software used for Six Sigma Some well-known programs used for six-sigma data analysis: Mathematica MATLAB or GNU Octave Microsoft Visio Minitab Origin (software) SDI Tools SigmaXL STATISTICA

57 Six Sigma Six Sigma's implicit goal is to improve all processes, (but not to the 3.4 DPMO level necessarily). organizations need to determine an appropriate sigma level for each of their important processes and strive to achieve these it is up to management of the organisation to prioritize areas of improvement ISO has published ISO 13053:2011 defining the six sigma process

58 Six Sigma Six Sigma projects follow two project methodologies inspired by Deming's Plan-Do-Check-Act (PDCA) Cycle. these methodologies, composed of five phases each, bear the acronyms DMAIC and DMADV: DMAIC is used for projects aimed at improving an existing business process DMADV is used for projects aimed at creating new product or process designs

59 Six Sigma DMAIC project methodology has five phases: Define the system, the voice of the customer and their requirements, and the project goals, specifically. Measure key aspects of the current process and collect relevant data. Analyze the data to investigate and verify cause-and-effect relationships. Determine what the relationships are, and attempt to ensure that all factors have been considered. Seek out root cause of the defect under investigation. Improve or optimize the current process based upon data analysis using techniques such as design of experiments, poka yoke or mistake proofing, and standard work to create a new, future state process. Set up pilot runs to establish process capability. Control the future state process to ensure that any deviations from target are corrected before they result in defects. Implement control systems such as statistical process control, production boards, visual workplaces, and continuously monitor the process. more info about Six Sigma DMAIC tools can be found here:

60 Six Sigma The DMADV project methodology has also five phases: Define design goals that are consistent with customer demands/enterprise strategy Measure and identify CTQs (characteristics that are Critical To Quality), product capabilities, production process capability, and risks Analyze to develop and design alternatives Design an improved alternative, best suited per analysis in the previous step Verify the design, set up pilot runs, implement the production process and hand it over to the process owner(s)

61 Six Sigma Quality management tools and methods used in Six Sigma: 5 Whys Analysis of variance Axiomatic design Business Process Mapping Control chart Cost-benefit analysis Design of experiments Histograms Pareto chart Process capability Quality Function Deployment (QFD) Scatter diagram Taguchi Loss Function

62 Six Sigma Belts, Executives and Champions Six Sigma professionals exist at every level each with a different role to play absolute "professionalizing" of quality management functions at the project level, there are black belts, master black belts, green belts, yellow belts and white belts. These people conduct projects and implement improvements. Black Belt: Leads problem-solving projects. Trains and coaches project teams. Green Belt: Assists with data collection and analysis for Black Belt projects. Leads Green Belt projects or teams. Master Black Belt: Trains and coaches Black Belts and Green Belts. Functions more at the Six Sigma program level by developing key metrics and the strategic direction. Acts as an organization s Six Sigma technologist and internal consultant. Yellow Belt: Participates as a project team member. Reviews process improvements that support the project. White Belt: Can work on local problem-solving teams that support overall projects, but may not be part of a Six Sigma project team. Understands basic Six Sigma concepts from an awareness perspective.

63 Six Sigma Belts, Executives and Champions provide organizational support for project. Six Sigma executives and champions set the direction for selecting and deploying projects. They ensure, at a high level, that projects succeed, add value and fit within the organizational plan. Champions: Translate the company s vision, mission, goals and metrics to create an organizational deployment plan and identify individual projects. Identify resources and remove roadblocks. upper management Executives: Provide overall alignment by establishing the strategic focus of the Six Sigma program within the context of the organization s culture and vision. CEO and other members of top management

64 Advantages of Six Sigma & ISO 9000 Six Sigma mostly finds application in large organizations ISO 9000 and Six Sigma are two systems for measuring and assessing a quality management process Six Sigma may be a more affordable option for smaller businesses as it is not as standardized as ISO 9000, meaning there is a wider range of formal to informal verification services available small-firms html

65 MBNQA Malcolm Baldrige National Quality Award formal recognition of the performance excellence of both public and private U.S. organizations administered by the Baldrige Performance Excellence Program, which is based at and managed by the National Institute of Standards and Technology (NIST) established by US Congress in 1987 for manufacturers, service businesses and small businesses designed to raise awareness of quality management and recognize U.S. companies that have implemented successful quality-management systems the Baldrige Award is named after the late Secretary of Commerce Malcolm Baldrige, a proponent of quality management

66 MBNQA three awards may be given annually in each of six categories: Manufacturing Service company Small business Education Healthcare Nonprofit organizations that apply for the Baldrige Award are judged by an independent board of examiners (volunteers).

67 MBNQA MBNQA recipients are selected based on achievement and improvement in seven areas, known as the Baldrige Criteria for Performance Excellence: Leadership: How upper management leads the organization, and how the organization leads within the community (120 points) Strategic planning: How the organization establishes and plans to implement strategic directions (85 points) Customer and market focus: addresses how the company collects market and customer information. Successful companies should use a variety of tools toward this end, such as market surveys and focus groups. The company then needs to demonstrate how it acts on this information (85 points) Measurement, analysis, and knowledge management: Examiners evaluate how the company obtains data and how it acts on the information. The company needs to demonstrate how the information is shared within the company as well as with other parties, such as suppliers and customers (90 points) Human resource focus: How the organization empowers and involves its workforce (85 points) Process management: How the organization designs, manages and improves key processes (85 points) Business/organizational performance results: How the organization performs in terms of customer satisfaction, finances, human resources, supplier and partner performance, operations, governance and social responsibility, and how the organization compares to its competitors (450 points)

68 MBNQA to receive a Baldrige Award, an organization must have a rolemodel organizational management system that ensures continuous improvement in delivering products and/or services, demonstrates efficient and effective operations, and provides a way of engaging and responding to customers and other stakeholders. the award is not given for specific products or services more info at:

69 EFQM European Foundation for Quality Management: non-profit membership foundation in Brussels was established in 1989 to increase the competitiveness of the European economy, with 67 members first version of the EFQM Excellence Model was created by a group of experts from various sectors and academic institutions and launched in 1992

70 EFQM Model Fundamentals Concepts are shown on this picture

71 EFQM Concepts 8 Fundamentals Concepts for excellent organisations: Adding Value for Customers - consistently add value for customers by understanding, anticipating and fulfilling needs, expectations and opportunities Creating a Sustainable Future - have a positive impact on the world around them by enhancing their performance whilst simultaneously advancing the economic, environmental and social conditions within the communities they touch. Developing Organisational Capability - enhance their capabilities by effectively managing change within and beyond the organisational boundaries Harnessing Creativity & Innovation - generate increased value and levels of performance through continual improvement and systematic innovation by harnessing the creativity of their stakeholders.

72 EFQM Concepts 8 Fundamentals Concepts (... continued): Leading with Vision, Inspiration & Integrity - have leaders who shape the future and make it happen, acting as role models for its values and ethics. Managing with Agility - are widely recognised for their ability to identify and respond effectively and efficiently to opportunities and threats. Succeeding through the Talent of People - value their people and create a culture of empowerment for the achievement of both organisational and personal goals. Sustaining Outstanding Results - achieve sustained outstanding results that meet both the short and long term needs of all their stakeholders, within the context of their operating environment.

73 EFQM Model Criteria can be applied to any organisation, regardless of size, sector or maturity non-prescriptive and it takes into account a number of different concepts EFQM Excellence Model is based on nine criteria. Five of these are "Enablers" and four are "Results".

74 EFQM Model The "Enabler" criteria cover what an organisation does and how it does it. The "Results" criteria cover what an organisation achieves. arrows on the picture emphasise the dynamic nature of the Model, showing learning, creativity and innovation helping to improve the Enablers that in turn lead to improved Results.

75 EFQM Enablers there are five Enablers, pictured on the left-hand side of the Model. these are the things an organisation needs to do to develop and implement its strategy. Leadership - excellent organisations have leaders who shape the future and make it happen, acting as role models for its values and ethics and inspiring trust at all times. They are flexible, enabling the organisation to anticipate and reach in a timely manner to ensure the on-going success of the organisation Strategy they implement their Mission and Vision by developing a stakeholder focused strategy. Policies, plans, objectives and processes are developed and deployed to deliver the strategy People organizations value their people and create a culture that allows the mutually beneficial achievement of organisational and personal goals. They develop the capabilities of their people and promote fairness and equality. They care for, communicate, reward and recognise, in a way that motivates people, builds commitment and enables them to use their skills and knowledge for the benefit of the organisation Partnerships & Resources - organisations plan and manage external partnerships, suppliers and internal resources in order to support their strategy, policies and the effective operation of processes. They ensure that they effectively manage their environmental and societal impact Processes, Products & Services - organisations design, manage and improve processes, products and services to generate increasing value for customers and other stakeholders

76 EFQM Results four Results areas, shown on the right-hand side of the Model are the results an organisation achieves, in line with their strategic goals: Customer Results - achieve and sustain outstanding results that meet or exceed the need and expectations of their customers People Results - achieve and sustain outstanding results that meet or exceed the need and expectations of their people Society Results - achieve and sustain outstanding results that meet or exceed the need and expectations of relevant stakeholders within society Business Results - achieve and sustain outstanding results that meet or exceed the need and expectations of their business stakeholders

77 EFQM Excellence Award EFQM Excellence Award was created by the organisation EFQM the prize recognises companies with excellent and sustainable results across all areas of the EFQM Excellence Model. the assessment process is one of the most robust of any award, with a team of independent assessors spending an average of 500 hours per applicant reviewing documentation and conducting interviews on-site open to organisations from both the Private and Public Sectors 4 categories: 1. Large Private Sector (over 1000 employees) 2. Small / Medium Private Sector (less than 1000 employees) 3. Large Public Sector (over 1000 employees) 4. Small / Medium Public Sector (less than 1000 employees) applicants will either be recognised as Finalists, Prize Winners or Award Winners Award Winner is an organisation that is able to demonstrate that they are considered a role model for the Fundamental Concepts of Excellence, as defined in the EFQM Excellence Model

78 EFQM More Info more info at

79 References Six Sigma Belts, Six Sigma DMAIC Roadmap, DMAIC Versus DMADV, Six Sigma Software, MBNQA at NIST, EFQM,

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