Bioinformatics Robert W. Góra Quality management systems

Transcription

1 Bioinformatics

2 Chapter 1 Institute of Physical and Theoretical Chemistry Wrocław University of Technology 1.2

3 Medieval Guilds. Hallmarking as a certification? Italian vambrace of an Italian armour c , Art Gallery and Museum, Kelvingrove, Glasgow, Inv. (Source: Tobias Capwell) Figure 1: Armourer s mark The modern quality movement is usually associated with works of Shewhart, Deming, Juran or Ishikawa before and shortly after the Second World War. However, its roots could be traced to medieval Europe and the unions of craftsmen called guilds. 1 Guilds developed strict rules to maintain high standards of product and flawless goods were marked with a special mark or symbol. 2 1 Robert P. Merges. From Medieval Guilds to Open Source Software: Informal Norms, Appropriability Institutions, and Innovation. In: Conference on the Legal History of Intellectual Property. Madison, Wisconsin, Steven A. Epstein. Wage Labor and Guilds in Medieval Europe. The University of North Carolina Press, 1995, Andrew Walker. A Brief History of Quality URL: Availablefrom: 1.3

4 Industrial Revolution. January "A little spinner in Globe Cotton Mill. Augusta, Ga. The overseer admitted she was regularly employed." (Source: shorpy.com) Figure 2: A little spinner The Industrial Revolution in the early 1800s introduced the factory system and organized forms of production. Quality in the factory system was ensured by a foreman who supervised a group of low qualified laborers. Further development of mass production led to the formation of whole quality control departments in the production plants in USA in 1920s. This process was accompanied by the increasing use of scientific instruments in industry, e.g. the use of thermometers and hydrometers in brewing, which also led to improved quality control. 3 3 Patrick O Brien and Roland Quinault. The Industrial Revolution and British Society. Cambridge University Press,

5 A pint of statistics at brewery. Student in 1908, Wikimedia Commons Figure 3: William Sealy Gosset, statistician, Actually, the first important application of statistics in the industry occurred in the Guinness brewery in Dublin, Ireland, where W. S. Gosset applied his knowledge in mathematics and chemistry to control the quality of finished products. 4 Gosset is the author of the famous Student s t-distribution commonly used nowadays in statistical hypothesis testing. 4 Zivorad R. Lazic. Design of Experiments in Chemical Engineering: A Practical Guide. 2004, Wikipedia. URL: 1.5

6 Chapter 2 Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of Institute of Physical and Theoretical Chemistry Wrocław University of Technology 2.6

7 Between the Wars. The birth of Statistical Process Control. (Source: Figure 4: Walter Andrew Shewhart, physicist, engineer and statistician, The early industrial quality control was limited to inspecting finished products and removing defective items, which were then scraped or reworked. In 1924 Dr. Shewhart, working for the Western Electric Company Inspection Engineering Department at the Hawthorne Works, realized that such a process is difficult to control and not very cost effective. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of He posed a fundamental question: how much may the quality of a product vary and yet be controlled and prepared a little memorandum that featured a sketch of a modern control chart. 2.7

8 Between the Wars. The birth of Statistical Process Control. Shewhart continued his work at Bell Telephone Laboratories and summarized the results in his book Economic Control of Quality of Manufactured Product (1931). 5 Based on his observations he proposed three postulates: Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 5 W. A. Shewhart. Economic Control of Quality of Manufactured Product. New York, Van Nostrand,

9 Between the Wars. The birth of Statistical Process Control. Shewhart continued his work at Bell Telephone Laboratories and summarized the results in his book Economic Control of Quality of Manufactured Product (1931). 5 Based on his observations he proposed three postulates: Shewhart postulates All chance of causes are not alike in the sense that they enable us to predict future in terms of the past. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 5 W. A. Shewhart. Economic Control of Quality of Manufactured Product. New York, Van Nostrand,

10 Between the Wars. The birth of Statistical Process Control. Shewhart continued his work at Bell Telephone Laboratories and summarized the results in his book Economic Control of Quality of Manufactured Product (1931). 5 Based on his observations he proposed three postulates: Shewhart postulates All chance of causes are not alike in the sense that they enable us to predict future in terms of the past. Constant of causes do exist in nature. (e.g. Brownian motion) Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 5 W. A. Shewhart. Economic Control of Quality of Manufactured Product. New York, Van Nostrand,

11 Between the Wars. The birth of Statistical Process Control. Shewhart continued his work at Bell Telephone Laboratories and summarized the results in his book Economic Control of Quality of Manufactured Product (1931). 5 Based on his observations he proposed three postulates: Shewhart postulates All chance of causes are not alike in the sense that they enable us to predict future in terms of the past. Constant of causes do exist in nature. (e.g. Brownian motion) Assignable causes of variation may be found and eliminated. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 5 W. A. Shewhart. Economic Control of Quality of Manufactured Product. New York, Van Nostrand,

12 Shewart s control charts... in chemical laboratory. Determination of SO 2 4 reference material concentration. 0.1% 2% 14% 34% Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 34% 14% 2% 0.1% 2.9

13 Shewart s control charts... in chemical laboratory. Determination of SO 2 4 reference material concentration. 0.1% 2% 14% 34% Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy N Pareto Principle Deming s 14 Points of 34% 14% 2% 0.1% 2.9

14 Shewart s control charts... in chemical laboratory. Determination of SO 2 4 reference material concentration. 34% 34% 0.1% 2% 14% 14% 2% 0.1% 3σ 2σ σ σ 2σ 3σ ( f x; µ,σ 2) = 1 σ (x µ) 2 2π e 2σ 2 σ 2 = 1 N N i µ) i=1(x 2 µ = 1 N N x i i=1 N Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.9

15 Shewart s control charts... in chemical laboratory. Determination of SO 2 4 reference material concentration. 34% 34% 0.1% 2% 14% 14% 2% 0.1% 3σ 2σ σ σ 2σ 3σ ( f x; µ,σ 2) = 1 σ (x µ) 2 2π e 2σ 2 σ 2 = 1 N N i µ) i=1(x 2 µ = 1 N N x i i=1 µ + 3σ µ + 2σ µ + σ N µ σ µ 2σ µ 3σ Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.9

16 Shewart s control charts... in chemical laboratory. Determination of SO 2 4 reference material concentration. 34% 34% 0.1% 2% 14% 14% 2% 0.1% 3σ 2σ σ σ 2σ 3σ ( f x; µ,σ 2) = 1 σ (x µ) 2 2π e 2σ 2 σ 2 = 1 N N i µ) i=1(x 2 µ = 1 N N x i i=1 µ + 3σ µ + 2σ µ + σ N µ σ µ 2σ µ 3σ Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.9

17 The American Who Taught the Japanese About Quality Photo: The W. Edwards Deming Institute Figure 5: W. Edwards Deming, in Brooklyn). At the time when Shewhart was beginning to apply his ideas of controlled variation to manufacturing processes, a Yale graduate student W. Edwards Deming 6 had an internship at Western Electric Hawthorne Plant in Chicago. However, they were introduced to each other later, in 1927, when Deming joined the United States Department of Agriculture (his boss shared previously an apartment with Shewhart Deming quickly realized that the statistical process control could be applied also to the management processes. Later he adopted Shewart s ideas as the fundamental principles of his quality philosophy. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 6 Jr. Robert B. Austenfeld

18 The American Who Taught the Japanese About Quality In late 1930s, Deming was responsible for courses in statistics at the USDA s graduate school. He invited Shewhart to give four afternoon lectures. These were later published by the USDA s graduate school in 1939 as Statistical Method from the Viewpoint of Quality Control. 7 In 1939 Deming joined the U.S. Census Bureau where he advocated the sampling and statistical process control techniques. After the US entered World War II, Deming was one of the lecturers for intensive courses to engineers and inspectors, which featured the statistical process control charting and the Shewhart Cycle. Although this program resulted in the substantial reductions in scrap and rework costs, its message was almost completely forgotten soon after the war ended. The quality control was no longer considered a matter associated with testing and rework but efforts focused on quality prevention. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 7 W. A. Shewhart. Statistical Method from the Viewpoint of Quality. Ed. by W. Edwards Deming. Ontario, Dover,

19 The Shewart s cycle for Learning and Improvement. The P D S A cycle. A Act S Study P Plan D Do Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.12

20 The Shewart s cycle for Learning and Improvement. The P D S A cycle. A Act P Plan Plan a test aimed at improvement. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle S Study D Do Deming s 14 Points of 2.12

21 The Shewart s cycle for Learning and Improvement. The P D S A cycle. A Act P Plan Plan a test aimed at improvement. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram S Study D Do Do the test on a small scale Juran s Trilogy Pareto Principle Deming s 14 Points of 2.12

22 The Shewart s cycle for Learning and Improvement. The P D S A cycle. A Act P Plan Plan a test aimed at improvement. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Study the results. What did we learn? S Study D Do Do the test on a small scale Juran s Trilogy Pareto Principle Deming s 14 Points of 2.12

23 The Shewart s cycle for Learning and Improvement. The P D S A cycle. Introduce or abandon the change or run through the cycle again. A Act P Plan Plan a test aimed at improvement. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Study the results. What did we learn? S Study D Do Do the test on a small scale Juran s Trilogy Pareto Principle Deming s 14 Points of 2.12

24 The American Who Taught the Japanese About Quality In 1947 Deming visited Japan as an adviser on sampling techniques to General MacArthur s Supreme Command of Allied Powers. Around that time The Union of Japanese Scientists and Engineers (JUSE) became interested in American quality control techniques. Few years later he received an invitation from the Union to give a series of lectures on the applications of statistics to quality improvement. However, a turning point for Japan was Deming s meeting with 21 of Japan s top managers in July of He advised them to think of manufacturing as a system that with consumer research, redesign of products and continuous improvement can be brought under statistical control with ever-increasing quality. He told them that if they followed his recommendations they would capture the world markets within five years... which wasn t that far from truth. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.13

25 Deming s diagram of production process viewed as a system. Production process viewed as a system. Suppliers of materials and equipement A B C D Design and redesign Receipt and test of materials Consumer research Production Assembly Inspection Distribtion Consumers Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.14

26 Juran s structured approach to managing for quality. In 1952 JUSE invited another quality guru Joseph M. Juran after publication of his Quality Control Handbook in Photo: The New York Times Figure 6: Joseph M. Juran, Whereas, Deming raised the significance of the statistical quality control of manufacturing processes, Juran offered a structure for their implementation. Juran stressed on the involvement of top and middle management in training, the idea that had found such an resistance in the US. After Juran s lectures JUSE started the regular courses for middle-management and workers. Since then quality control has become a concern of management and worker alike. Interestingly, in Japan standardization and quality control were in fact legally enforced by institutions! Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.15

27 The Juran Trilogy. Quality Control Quality Improvement Sporadic Spike Cost of Poor Quality Chronic Waste Opportunity for Improvement Quality Planning Breakthrough Time New Zone of Quality Control UCL LCL UCL LCL Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.16

28 The Juran Trilogy: Quality Planning. The essence of the Juran s work is the so-called Juran Trilogy. It provides a strategic framework for the implementation of quality management. Quality Planning. This is the first stage when the products and processes that will be able to meet established goals (consumer needs) are designed. Identify the customers (use Pareto principle). Determine the customers needs. Develop a product whose features align with the customers needs. Develop processes that are capable of producing such products. Establish quality controls. Transfer these plans to the operating forces. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.17

29 The Juran Trilogy: Quality Control. Quality Control. Bringing a manufacturing process under statistical control provides a tool to deal with sporadic spikes in production, but does not generally allow to eliminate the intrinsic inefficiencies in the process. Juran calls these inefficiencies a chronic waste. Evaluate actual operating performance. Compare the performance to quality goals. Act on the difference. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.18

30 The Juran Trilogy: Quality Improvement. Quality Improvement. It goes beyond control and deals with the chronic waste that was built into the products and processes at the planning stage. According to Juran, it includes the following steps: Establish the infrastructure needed to facilitate continuous quality improvement. Identify the improvement projects. For each project, establish a team that is clearly charged with the responsibility of bringing a successful resolution to the project. Provide the teams with resources, training, and motivation to: diagnose the causes, and stimulate remedies. Establish controls to hold the gains Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.19

31 Pareto principle, rule or as Juran wants it: the vital few and the useful many. Juran popularized the so called Pareto principle. It s sort of a rule of a thumb based on an observation made by Vilfredo Pareto that often 80% of an effect is caused by 20% of the causes. Juran began to apply this principle to quality issues. It is based on a power law probability distribution (known also as Bradford distribution) characteristic to various observable phenomena, ranging from Bose-Einstein condensation to the distribution of global income. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto principle 100 Distribution of world GDP, 1989 Pareto Principle Deming s 14 Points of 20% EFFORT 80% Quintile of income [%] RESULT 0 Richest 20% Second 20% Third 20% Fourth 20% Poorest 20% Quintile of population Figure 7: Pareto chart 2.20

32 If Japan can, why can t we? era It was not until 1970s, that Americans began to realize that basically everything that had been made in Japan was much better and cheaper than the domestic products. This prompted NBC to produce a documentary that would attempt to answer the question: If Japan can, why can t we?. The documentary aired in June 1980 showed that the key to Japanese success was in fact the implementation of Deming s and Juran s statistical approach to control the production and management processes. This event marks the dawn of what is commonly referred to as Quality Revolution in the Western Hemisphere. A few years before the end of his incredibly active life Deming publishes two of his classic works: Out of the Crisis (1986) 10 and The New Economics (1988) 11 which summarize his ideas for quality improvement as they had gradually evolved over the years. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 10 W. Edwards Deming. Out of the Crisis. MIT Press, W. Edwards Deming. The New Economics: For Industry, Government, Education. MIT Press,

33 Deming s 14 points for transformation and management In Out of the Crisis Deming enclosed his ideas in the following fourteen points.[8] 1 Create constancy of purpose for improvement of product and service. The point stresses the need for a mission statement which must be understood by all employees, suppliers, and customers. The strategic plan should look for the long-term payback. 2 Adopt the new philosophy. must learn the responsibilities and take on leadership for change. Poor workmanship, defective products, or bad service are not acceptable. 3 Cease dependence on mass inspection. Eliminate the need for inspection on a mass basis by building quality into the product in the first place. Statistical methods of quality control are more efficient. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.22

34 Deming s 14 points 4 End the practice of awarding business on the basis of a price tag alone. Instead, minimize the total cost. The aim in the purchase of new tools and other equipment should be to minimize the net cost per hour of operation or per piece produced. Move toward a single supplier for any one item, on a long-term relationship of loyalty and trust. 5 Improve constantly and forever the system of production and service. The improvement of the product and service is an ongoing process. The Deming cycle involves the four-step process of plan, do, check, act. At the plan stage, the opportunities for improvement are identified. The theory is tested on a small scale at the do stage, the results of the test are analyzed at the check stage, and the results are implemented in the act stage. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.23

35 Deming s 14 points 6 Institute training. On-the-job training must be provided for all employees. Employees must be encouraged to implement the knowledge developed through training. 7 Adopt and institute leadership. The aim of supervision should be to help people to do a better job using machines. Supervision must create an environment where the workers take leadership roles in accomplishing their work. 8 Drive out fear. must create an environment where workers are encouraged to ask questions and make suggestions. A climate of innovation leads to progress. 9 Break down barriers between departments. People in research, design, material procurement, sales, and production must work as a team. They must understand the requirements and specifications. Teamwork leads to improvements in quality and productivity. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.24

36 Deming s 14 points 10 Eliminate slogans, exhortations, and targets for the work force. Exhortations such as asking for zero defects and new levels of productivity only create adversarial relationships. The bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the work force. 11 Eliminate numerical quotas for the work force and eliminate numerical goals for people in management. Quotas lead to the deterioration of quality. Learn the capabilities of processes and methods to improve them. 12 Remove barriers that rob people of pride of workmanship. Quality is achieved in the company when all employees are satisfied and motivated. must create an environment where the workers take pride in their job. 13 Encourage education and self-improvement for everyone. An organization needs people that are improving with education. 14 Take action to accomplish the transformation. The transformation is everybody s job. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.25

37 Deming s system of profound knowledge I In The New Economics Deming explains his system of profound knowledge.[9] It s a management philosophy based on the principle that each organization is a system of interrelated processes. Deming believed that a system cannot understand itself and the profound knowledge can only come from the outside of the system. It is a method that ties together all of his former teachings and consisted of four elements that should be used together to truly affect the transformation of management. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.26

38 Deming s system of profound knowledge II Appreciation for a system. It must have an aim. The performance of each component must be judged on the basis of its contribution to the aim. The system must be actively managed. Recognizing the importance of the system to individual performance. Knowledge about variation. Variation is normal. There are two kinds of causes of variation: common and special. System should be stable in order to distinguish the two. Managers should not blame their workers for poor performance. Theory of knowledge. Theories need to be developed and tested to advance knowledge. The plan-do-study-act (PDSA) cycle should be used to develop theories (predictions) systematically and test them. Learning should be continuous and organization-wide. Psychology. People are born with intrinsic motivation. They have right to enjoy their work and to pride of workmanship. Elliminate fear, break down barriers. Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.27

39 In the early 1980s, Western companies introduced their own quality programs to counter the Japanese success. Deming s 14 points became a core concept in the development of a new management philosophy the so-called (TQM). The term was first used by the Naval Air Systems Command in 1985 to describe its Japanese-style management approach. TQM is a management approach to long-term success through customer satisfaction in which all members of an organization must be involved in continuous improvement of their products, services and processes. TQM, however, is more a philosophy than the actual guideline for an implementation. An emerging need for standards led to the establishment of the Malcolm Baldrige National Quality Award by the US Congress in The criteria used for the award incorporate all major elements of TQM and are in fact its definition C. P. Kharta. TQM implementation. A comparison of ISO 9000:2000 quality system standards, QS9000, ISO/TS and Baldrige criteria. In: The TQM Magazine 16.5 (2004), pp DOI: / Shewart s Control Charts Statistical Control of Processes Deming s Production Diagram Juran s Trilogy Pareto Principle Deming s 14 Points of 2.28

40 Chapter 3 ISO 9000 Series of Standards for Quality Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems Institute of Physical and Theoretical Chemistry Wrocław University of Technology 3.29

41 ISO 9000 series of standards for quality management In the same year that the Malcolm Baldrige award was established, the International Organisation for Standardisation (ISO) publishes the standard ISO 9000 requirements for Quality Systems (QMS). The core standard is named ISO The history of ISO 9001 standard can be traced to the US military standard 105 for purchases of military goods. In 1963, this standard was used by the NATO as the US MIL-Q In 1979 the British Standards Institute (BSI) published BS 5750, based on the NATO standard and adapting it for a non-military context. The British Standard for quality was a prototype for the ISO 9000 series. 13 In 1994 the ISO 9000 series was revised to focus more on quality assurance, commitment of executive management and to include service as a product. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 13 Constanze Clarke. Automotive Production Systems and Standardisation. From Ford to the Case of Mercedes-Benz. Physica-Verlag, Springer,

42 ISO 9000 series of standards for quality management In 2000 a new series was conglomerated into 4 main documents from around 20 of the previous revision with an intention to support process-oriented quality management and incorporate continuous improvement as an additional demand. The core of ISO 9000 standard series ISO 9000:2005 (PN-EN ISO 9000:2006) - Quality Systems - Fundamentals and Vocabulary ISO 9001:2008 (PN-EN ISO 9001:2009) - Quality Systems - Requirements ISO 9004:2009 (PN-EN ISO 9004:2009) - Managing for the sustained success of an organization - A quality management approach ISO 19011:2002 (PN-EN ISO 19011:2003) - Guidelines on Quality and Environmental Systems Auditing Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.31

43 The ISO 9000 Quality Principles The ISO 9000 standard provides the fundamentals and vocabulary used in the entire family of standards. It introduces the following eight Quality Principles that relate to Deming s and Juran s teachings: 1 Customer focus: organizations depend on their customers and therefore should understand current and future customers needs, meet customers requirements, and strive to exceed customer expectations. 2 Leadership: leaders establish unity of purpose and the direction of the organization. They should create and maintain an internal environment in which people can become fully involved in achieving the organization s objectives. 3 Involvement of people: people at all levels are the essence of an organization, and their full involvement enables their abilities to be used for the organization s benefit. 4 Process approach: a desired result is achieved more efficiently when related resources and activities are managed as a process. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.32

44 The ISO 9000 Quality Principles The ISO 9000 standard provides the fundamentals and vocabulary used in the entire family of standards. It introduces the folowing eight Quality Principles: 5 System approach to management: identifying, understanding, and managing a system of interrelated processes for a given objective improve the organization s effectiveness and efficiency. 6 Continual improvement: continual improvement should be a permanent objective of the organization. 7 Factual approach to decision-making: effective decisions are based on the analysis of data and information. 8 Mutually beneficial relationships with suppliers: an organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.33

45 ISO 9000 series key concepts, terms and definitions Concepts relating to quality Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.34

46 ISO 9000 series key concepts, terms and definitions Concepts relating to management Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.35

47 ISO 9000 series key concepts, terms and definitions Concepts relating to organization Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.36

48 ISO 9000 series key concepts, terms and definitions Concepts relating to process and product Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.37

49 ISO 9000 series key concepts, terms and definitions Concepts relating to characteristics Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.38

50 ISO 9000 series key concepts, terms and definitions Concepts relating to conformity Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.39

51 ISO 9000 series key concepts, terms and definitions Concepts relating to documentation Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.40

52 ISO 9000 series key concepts, terms and definitions Concepts relating to examination Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.41

53 ISO 9000 series key concepts, terms and definitions Concepts relating to audit Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.42

54 ISO 9000 series key concepts, terms and definitions Concepts relating to quality assurance for measurement processes Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.43

55 Corrective Actions Continual Improvement Objectives Customer focus Quality policy Quality Manual Preventive Actions Resource management Procedures & Instructions Documentation Quality System Planning Product Records Measurement & Analysis Customer requirements review Customer satisfaction Monitoring Realization Design & Development Nonconforming product Internal Audit

56 ISO 9001 Quality System - Requirements 4.1 General requirements To identify the QMS processes, their application and their mutual interactions. To determine criteria and ensure resources for their effective operation and monitoring. To maintain and continually improve these processes. To document the organization s process-based QMS. 4.2 Documentation requirements To establish and maintain Quality Manual including: the scope of the QMS, the references to the documented procedures and a description of the processes and their interactions. To establish procedures for: control of documents and records, internal audits, control of nonconforming product, preventive and corrective actions. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.45

57 The ISO 9000 process approach for continual improvement The ISO 9000 standard advocates the process approach to manage an organization and to achieve continual improvement of QMS. Customers Plan responsibility Act Customers Brief history of ISO 9000 Quality Resource management Measurement analysis and improvement Satisfaction Principles The ISO 9000 Requirements Environmental Systems Requirements Do Input Product realization Check Product Output Value-adding activities Information flow 3.46

58 5. responsibility To commit oneself to the development, implementation and continuous improvement of the organization s QMS. To ensure customer focus in the organization. To establish measurable quality objectives and quality policy. To appoint the management representative and systematic management review of the QMS. 6. Resource The organization should: Determine and provide the resources sufficient to implement, maintain and continually improve the QMS and to enhance customers satisfaction. Determine the necessary competence for personnel, provide training, and evaluate effectiveness of the actions taken. Determine, provide and maintain the appropriate infrastructure and work environment. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.47

59 7. Product realization The organization should determine: The quality objectives and requirements for the product. The necessary processes, documentation, records, validation, monitoring and test activities specific to the product and the criteria for product acceptance. The requirements specified by the customer, including service. All the relevant statutory and regulatory requirements. Customer communication including inquiries, contracts and customer feedback. The organization should: Plan and control the design and development of the product. Evaluate and select suppliers based on their ability to meet the organization s requirements and specifications. Plan and carry out production and service provision under controlled conditions. Determine the monitoring and measurement activities to provide the evidence of conformity of the product to the requirements. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.48

60 8. Measurement, analysis and continual improvement The organization should: Plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate conformity of the product and to continually improve and ensure conformity of the QMS. Monitor customers satisfaction. Conduct internal audit at planned intervals. Perform monitoring and measurement of the products and processes. Ensure that the nonconforming product is identified and controlled Collect and analyze appropriate data to demonstrate effectiveness of QMS and its continual improvement. Undertake corrective actions to eliminate the causes of encountered nonconformities. Determine preventive actions to eliminate the causes of potential nonconformities. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.49

61 Concluding remarks Although there is a common opinion that the ISO 9001 appear to be very bureaucratic, it depends heavily on the particular implementation. The ISO 9001 standard is designed to be applicable for any company of any size, and of any profile of business activity. This makes the requirements very broad and general. An organization implementing ISO 9000 QMS usually creates many different documents and procedures in order to meet requirements of the standard (and registrar) instead of documenting its factual practices. This often leads to a cumbersome and bureaucratic system. ISO 9001 is meant to be a very flexible standard and there are countless ways of implementing its requirements. Although the auditors of registrars should be equally flexible, this is not always the case. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.50

62 Concluding remarks Ultimately, ISO 9001 is meant to provide a structural approach for an organization to: meet their customers and any applicable regulatory requirements, enhance their customers satisfaction, and achieve continual improvement of its performance Only so much and so many. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.51

63 Environmental Systems Industrial development comes with a price. Although there is an ongoing dispute about the extent of the effects of human activity on global climate, the observed depletion of the ozone layer, air, water and soil pollution, global warming, and deforestation are nowadays widely acknowledged as the major environmental issues. An increased ecological awareness of general public, governments and interest groups affects strongly the policies of many companies. This is particularly true for a large international corporations which, in order to gain competitive advantage, want to provide environment-friendly products and services. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.52

64 Environmental Systems To meet these expectations, in 1996 the ISO family of standards was established. The standards were revised in The core standard, ISO 14001, provides a framework of tools for managing environmental issues and is the most recognized Environmental System (EMS). Generally, ISO is a documented management system for environment-related functions of an organization, including collection of environmental policies and procedures. Brief history of ISO 9000 Quality Principles The ISO 9000 Requirements Environmental Systems 3.53

65 Chapter 4 Systems Certification Accreditation Standards for Accreditation Polish Center for Accreditation Institute of Physical and Theoretical Chemistry Wrocław University of Technology 4.54

66 , Certification and Accreditation Certification against ISO 9001:2008 is a process in which the system is audited against the requirements of the standard by an independent third-party certification or registration body which, if the requirements have been met, issues a certificate of conformity. Certification is not a requirement of any of the standards in the ISO 9000 family. An organization can implement the standards without seeking certification. However, up to the end of December 2008, at least ISO 9001:2000 certificates had been issued in 176 countries ( in Poland). 14 Certification Accreditation Standards for Accreditation Polish Center for Accreditation So what are the certification pros and cons? 14 The ISO Survey of Certifications

67 Certification pros and cons Customer or regulatory requirements. An independent confirmation of conformity adds value. to ISO 9000 is a major criteria for the selection of suppliers. Marketing. International recognition. Greater degree of bureaucracy? Expensive quality? Discrepancies between the intention of ISO standards and their practical application? Certification Accreditation Standards for Accreditation Polish Center for Accreditation 4.56

68 assessment, Certification and Accreditation ISO itself does not perform certification to its standards, issue certificates or control certification performed by other organizations. So who does all those things? The so called accreditation bodies and the registrars and certifiers accredited by them. 16 Accreditation Accreditation is third-party attestation related to a conformity assessment body CAB (laboratory, certification body or inspection body) conveying formal demonstration of its competence to carry out specific conformity assessment tasks. a a EN ISO-IEC-17021:2006 Certification Accreditation Standards for Accreditation Polish Center for Accreditation 16 APEC SCSC Education Guideline 3. Standardization: Fundamentals, Impact, and Business Strategy. Textbook for Higher Education. Asia Pacific Economic Cooperation Secretariat,

69 Accreditation The International Picture The accreditation bodies are usually recognized by, their national government and are authorized to accredit registrars of QMS or EMS, inspection bodies, and certifiers of products. In Europe, most countries have a single accreditation body dealing with all these activities. Certification Official IAF logo In 1993, a group of accreditation bodies met in Houston for the first meeting of Organizations Accrediting Quality System Registrars and Certification programs and began an organization that is now named the International Accreditation Forum (IAF). 17 Accreditation Standards for Accreditation Polish Center for Accreditation

70 Accreditation The International Picture IAF has developed a peer evaluation process for signatories of the so-called Multilateral Recognition Agreement (MLA), in order to ensure continuing compliance with the international standard for accreditation bodies (currently EN ISO/IEC 17011: ). MLA signatories are obliged to recognize on an equal basis with their own the certificates and reports from the organizations accredited by the signatories and to recommend and promote such an acceptance in their countries. Certification Accreditation Standards for Accreditation Polish Center for Accreditation 18 PN-EN ISO/IEC 17021:2007. assessment Requirements for bodies providing audit and certification of management

71 Accreditation The International Picture Official ILAC-MRA logo In 1997, the International Laboratory Accreditation Cooperation (ILAC) was established and assumed a similar to IAF peer evaluation process of its members. 19 IAF and ILAC now work closely together and have a Joint Executive Committee. Certification Accreditation Standards for Accreditation Polish Center for Accreditation Source:

72 Accreditation The International Picture Official EA logo In Europe, the European co-operation for Accreditation (EA) was established in 1997 and it is an active member of ILAC and IAF. 20 EA is the Association of the national accreditation bodies (EA MLA signatories) that provide accreditation for the following conformity assessment activities: Calibration and Testing Inspection Certification of quality and environmental management (QMS and EMS) Certification of products Certification of persons EMAS verifiers Certification Accreditation Standards for Accreditation Polish Center for Accreditation

73 Standards for accreditation 21 Accreditation Bodies (AB) ISO/IEC Certification Bodies (CAB) EMAS Verifiers Council Regulation 761/2001 ISO/IEC ISO Guide 65 (EN 45011) ISO/IEC ISO/IEC Eco- and Audit Scheme Environmental Systems Products Quality Systems Persons 21 Source: EA

74 Standards for accreditation Accreditation Bodies (AB) ISO/IEC Laboratories Certification Bodies (CAB) Inspection Bodies ISO/IEC ISO/IEC ISO/IEC Testing and Calibration Inspection

75 International recognition of accreditation All signatories of IAF Multilateral Recognition Arrangement (MLA) and ILAC Mutual Recognition Arrangement (MRA) were positively verified in a peer review process which evaluated: their compliance with ISO/IEC standard, the performance of their assessors during actual assessments/reassessments in order to determine if the accredited laboratories are in compliance with ISO/IEC or ISO MLA/MRA signatories are obliged to recognize on an equal basis with their own the certificates, calibration and testing reports from the organizations accredited by the signatories. Ultimately, MLA/MRA help to reduce some of the technical barriers to trade products tested once and accepted everywhere. MLA/MRA signatories can enter into a licensing agreement with ILAC and IAF to use the ILAC-MRA and IAF-MLA marks in combination with their own accreditation body symbol. Certification Accreditation Standards for Accreditation Polish Center for Accreditation 4.64

76 Accreditation system in Poland In Poland the accreditation system is administered by the Polish Center for Accreditation (PCA). PCA is the national accreditation body authorized to accreditation of certification and inspection bodies, Official PCA logo testing and calibration laboratories and other entities conducting conformity assessments and verifications on the basis of the Act of Parliament of 30 August 2002 on System (the consolidated text Dz.U. of 2004, No 204, item 2087 with further changes). 22 PCA is signatory of EA MLA, IAF MLA and ILAC MRA On 24 November 2004, PCA signed EA Multilateral Agreement within QMS, EMS, products and persons certification bodies, and testing and calibration laboratories. On 19 January 2005 PCA signed ILAC Mutual Recognition Arrangement in the scope of testing and calibration laboratories On 16 February 2005 PCA signed IAF Multilateral Recognition Arrangement in the scope of QMS, EMS and products certification bodies. Certification Accreditation Standards for Accreditation Polish Center for Accreditation 22 Source:

77 World Accreditation Day 2010 Global Acceptance Global Acceptance World Accreditation Day 9 June 2010 Certification Accreditation Standards for Accreditation Polish Center for Accreditation 10 th Anniversary ILAC MRA 12 th Anniversary IAF MLA Official WAD 2010 poster 4.66

78 Chapter 5 in calibration and Technical competence underpinned by a quality system Accreditation vs. Certification Organization and management requirements Monitoring of the quality system Institute of Physical and Theoretical Chemistry Wrocław University of Technology 5.67

79 Laboratory Accreditation vs. ISO 9001 Certification? Laboratories are organizations that produce test and/or calibration results. They can implement, be audited, and certified to ISO 9001 international standard. However, ISO 9001 does not address the technical competence of the laboratory. Therefore, it does not assure that the produced test or calibration results are accurate and reliable. Most economies now rely on a process called Laboratory Accreditation to evaluate laboratory competence. Accreditation vs. Certification Accreditation is a procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. Accreditation vs. Certification Organization and management requirements Monitoring of the quality system is a fulfillment by a product, process or service of specified requirements. 5.68

80 ISO/IEC General Requirements for the Competence of Testing and Calibration Laboratories Accreditation bodies now use ISO/IEC international standard as the basis for their accreditation of testing and calibration laboratories. 24 Prior to issuing of ISO/IEC 17025:1999 there was no internationally accepted standard for laboratory accreditation. However, ISO/IEC Guide 25 provided a considerable level of uniformity. The first edition (1999) of ISO/IEC standard was in fact a revision of the third edition of ISO Guide 25 and EN standard. 25 There was a minor revision of the standard in 2005, to ensure compliance with the new revision of ISO 9001:2000 standard. 23 PN-EN ISO/IEC 17025:2005. General requirements for the competence of testing and calibration laboratories C. D. Faison et al., eds. NIST Handbook 150, Procedures and General Requirements. National Institute of Standards and Technology, 2006, Complying with ISO A practical guidebook. United Nations Industrial Development Organization, Vienna, PN-EN 45001:1993. General criteria for the operation of testing laboratories. (Superseded, Withdrawn). Accreditation vs. Certification Organization and management requirements Monitoring of the quality system 5.69

81 Brief History of Accreditation in Poland The first certificate of accreditation in Poland, was issued for testing laboratory in 1992, for certification body in 1993 and for calibration laboratory in All accreditations were carried out in accordance with the requirements of EN standards series. Accreditation vs. Certification Organization and management requirements Monitoring of the quality system 5.70

82 Is accreditation truly voluntary? Although, it was the original intention, the accreditation is no longer voluntary! Currently in Poland there are at least 96 regulatory acts referring to or requiring the test and/or calibrations to be performed by the accredited laboratories: The Law on Construction Products (Dz.U. No 92 item 881 from ). The Law on Prevention and Suppression of Infections and Infectious Diseases in Humans (Dz.U. No 234 item 1570 from ). The Ministry of Health Regulation on the Sampling and Testing of Chemical Substances and Chemical Preparations and Products Under the Supervision Exercised by the Chief Sanitary Inspectorate (Dz.U. No 165 item 1122 from ). The Cosmetics Act (Dz.U. No 42 item 473 from ). The Law on monitoring and controlling the quality of fuels (Dz.U. No 169 item 1200 from ). The Law on Fertilizers and Fertilization (Dz.U. No 147 item 1033 from ). The Law on the Prevention and Remedying of Environmental Damage (Dz.U. No 75 item 493 from ). The Veterinary Inspection Act (Dz.U. No 112 item 744 from ) Accreditation vs. Certification Organization and management requirements Monitoring of the quality system 5.71