QUALITY INHEALTHCARE DR. P. M. BHUJANG Medical Director Sir H N Hospital & RC
QUALITY• We know ….. Yet we cannot explain• Latin - Qualis: - such as Thing really is
DIFFERENT CONNOTATIONS• Peculiar and essential character• A distinguishing attribute• Fitness for purpose - use (Juran)• Quality must be worked and anxiously achieved• Quality is a means to an end• The end is continued viability
WHY INTEREST IN QUALITY?• Increasing financial investment• Emphasis on accountability• Cost effectiveness• Public scrutiny and customer forums• High level of disapproval eroding client confidence• Quality creates loyal customers.
DEFINITIONBritish Standard - or ISO 8402The totality of features and characteristicsof an entity (product or service) that bearon its ability to satisfy stated and impliedneeds.
PRODUCTS OR SERVICES MUST MEET THE FOLLOWING REQUIREMENTS• Satisfy a well defined specifications• Meet customer‟s expectations• Comply with applicable regulations and standards.• All this at a price which will yield profit for the supplier and considered reasonable by customer.
DR. EDWARD DEMINGGood quality does not necessarilymean high quality. It means apredictable degree of uniformity anddependability at low cost with aquality suited to the market.
QUALITY (MANAGEMENT)DEMANDS ATTENTION TO• Quality and suitability of inputs• The manner in which inputs are delivered, stored, and transformed into product or service.• The manner in which the product or service is delivered to the customer, used and installed. Quality : Doing right things the right way the first time.
CHARACTERISTICS OF QUALITY• Measurable Attributes - Dimensions - Composition - Specification - Purity etc.• Non Measurable Attributes - Taste - Appearance - Customer Appeal - Service - Sales support etc.
ELEMENTS• Customer focus• System view• Data driven analyses• Implement involvement• Multiple causation• Solution identification• Process optimization• Continuing improvement• Organizational learning
EVOLUTION OF QUALITY AND ITS STANDARDS• Developments• Means for meeting the needs.• The processes of managing for quality have undergone extensive and continuing change.• Ancient Principles were – - Product inspection by consumers (Still used in small markets) - The craftsmanship concept in which buyers rely on the skill and reputation of craftsman.
EVOLUTION OF QUALITY AND ITS STANDARDS (contd)• Industrial revolution - Factory system• Craftsman – became factory workers• Industrial Revolution introduced. i. Written specifications for materials finished goods and inspection criteria. ii. Measurement and associated instruments.
EVOLUTION OF QUALITY AND ITS STANDARDS (contd) - Inspection was confined to bring a post production activity. - Inspection of - Incoming goods - Manufactured components - Assemblies at appropriate points in the manufacturing process.• Non conforming products - Scrapped• It was more a screening process than a preventive process.
EVOLUTION OF QUALITY AND ITS STANDARDS (contd)• Late Nineteenth century USA - Taylor‟s System of Scientific Management (separation of planning from execution)• Central Inspection Dept. (e.g. Hawthorn‟s Electric Comp. - Out of 40,000 workers 5200 Inspection personnel)• Bell Telephone company – - After 2nd world war Defence Purchases - American Society for Quality Control (ASQC)• Concept of Statistical Control Process• Quality Control• Quality Assurance
EVOLUTION OF SOME STANDARDS.Year Stds Country1942-45 MIL STDS USA1959 MIL-Q-9858 USA1963 MIL-Q-9858-A USA1968 AQAP-1/4/9 NATO1970 DTT/STD 05-8 UK1979 BS 5750 UK1987 ISO 9000 - ISO SERIES1994 ISO-9000-SERIES ISO2000
ERA OF QUALITY1920s - Germany dominated the manufacturing industry1950s- America captures the world market1980s - Japanese rule the roost riding the quality wave.
PARADIGM SHIFTSr. No. Old Belief New Paradigm 1. Managing a job Managing is through leadership and is a way of life (It requires one to reduce the size of one’s ego and to increase the importance of all others in one’s mind). 2. Concept of external customer alone Concept of external and internal customers. 3. Marketing assignment is to sell what is Organizations must accurately assess the being produced customer’s needs and then go about satisfying them. 4. The potential in each human being is enormous and Workers are just hand and feet. They is just waiting to be used. The feelings and brains have to be told what to do. of each person are more important and not his hand and feet. 5. People don’t like to work or produce People enjoy working and produce good quality if good quality, and will always do as little they are trained properly, are given responsibility as possible unless they have strong and authority to make change at their work place supervision or incentives. and are treated with respect (Concept of TEI) 6. Quality is headache of Quality Control. Quality of everybody’s responsibility and principally of producers (Concept of TQC).
PARADIGM SHIFT (Contd)Sr. No. Old Belief New Paradigm 7. Good house-keeping is nice but not Top quality cannot be produced without important excellent house-keeping (Concept of 5S) 8. A reasonable inventory of raw The lower the sustainable level of inventory materials and in-process materials is the more efficient is the production process- essential to avoid production the target of inventory being zero (Concept stoppages. of JIT). 9. Economic batch quality quantity is Target is batch size of one. Set up time is to calculated from set up time and be made insignificant. inventory carrying cost. Generally speaking, production is best served by large batch size. 10. Supplier’s are necessary evils and Choose a supplier and build a long term trust should never be trusted. relationship. 11. Once sold, the product is forgotten. Service manuals, spare parts, service No attention is paid to after sales technology are all managed systematically. service. 12. Crisis management. Problems are PDCA wheel is conscientiously rotated. dealt with as they crop up with no People are not afraid to reveal weaknesses understanding of why they do so. and take responsibility for their work.
COMPONENTS1. Quality Policy and communication - Decided – documented – communicated to every one in the organization in the language easily understood.2. Team work and participation3. Problem solving tools and techniques e.g. - quality circles - Cross Functional Teams - One common approach
COMPONENTS (contd)DEMING’S CYCLE (PDCA) Act – Appraise Plan – approach Award and Appreciate Data to get (Change Process – then go to I) Act Plan experiments to run Check results Do the plan – Check Do Gather data Analyse data Evaluate Run experiment Experiment Demonstrating doing and counseling DeployingA problem is a gap between the actual state of affairs andgoals or way things should be.
COMPONENTS (contd)4. Standardization: It is a management tool for encouraging and securing optimum utilization of resources and maximum efficiency of operations through formal establishment of the most suitable, pre- determined solutions and answers to recurring problems and needs.5. Design and implementation of Quality System e.g. ISO6. Quality costs and measurements. Poor quality is very expensive7. Process control - Emphasis on prevention of any quality deficiencies8. Customer – supplier Integration To achieve Zero Defect.
COMPONENTS (contd)9. Education and training An important component10.Quality Audit and Review - Product oriented - Process oriented - System oriented
SOME TERMS• Quality System: Organizational structure, procedures, processes and resources needed to implement quality management.• Quality Policy: The overall intentions and direction of an organization with regard to quality, as formally expressed by top management.• Quality Planning: Activities that establish the objectives and requirements for quality and for the application of quality system elements.• Quality Management: All activities of the overall management function that determine the quality policy, objectives and responsibilities and implement them by means such as quality planning, quality control, quality assurance and quality improvement within quality system.
SOME TERMS (contd)• Quality Assurance: All the planned and systematic activities implemented within the quality system and demonstrated as needed, to provide adequate confidence that an entity will fulfil requirements for quality.• Quality Assurance aim is thus to achieve objectives, through development of people by promoting family feeling in a group.• Quality Assurance program will succeed where people are respected and are involved in decisions concerning their work life.• For its success QA program has to become an organization culture.
SOME TERMS (contd)• Quality paradigm should percolate top down wards.• Concept of Quality Assurance contained all those planned and systematic actions required to provide adequate confidence that a product or service would satisfy given requirements for quality.• Based on “Process compliance” 7 M‟s• Men Milieu (Environment)• Material Measurement (Monitoring)• Machine Money (Resource)• Method• The era of “Quality Assurance” also made use of Statistical Process Control (SPC) and Reliability Engineering.•
SOME TERMS (contd)• Japanese applied the QA on company wide basis which came to be known as “Company-Wide Quality Control (CWQC)• Era of CWQC is also known as Total Quality Control (TQC)• Total Quality Management (TQM)• Came into being in 80‟s because of intense competition• Technology - Establishes strong link with HRD function• Quality Engineering - Customer focused - Employee oriented
TOTAL QUALITY MANAGEMENT• Definition (TQM) : Management approach of an organization centered on quality, based on the participation of all its members and aiming at long term success through customer satisfaction and benefits to all members of the organization and to society.• Definition from People (Employee) We are engaged in an ongoing journey of continuous measurable improvements, championed by empowered individuals a all levels of the organization, our leadership philosophy inspire teamwork, trust, and belief in people which results in an enjoyable and productive work place, dedicated o the highest possible level of customer satisfaction.
TOTAL QUALITY MANAGEMENT (contd)• Some other Definitions of TQM• A cooperative form of doing business that relies on the talents and capabilities of both labour and management to continually improve quality and productivity using teams --------------Jablansk• A structured system for creating organization wide participation in planning and implementation, a continuous improvement process to meet and exceed customer needs. -------------- Bressard
TOTAL QUALITY MANAGEMENT (contd)• Application of quantitative methods and human resources to improve the material and services supplied to an organization all the processes within an organization and the degree to which the needs of the customer are met now and in the future -------------- Mossard• Integration of all functions and processes within an organization in order to achieve continues improvement of the quality of goods and services. the goal is customer satisfaction. -----------Ross
TOTAL QUALITY MANAGEMENT (contd)• Systematic approach to implement lasting changes in an organization through the use of - Teamwork and participation - Statistical methods and analyses - Management leadership - Problem solving and process management ---------Blaunt Memorial Hospital
TOTAL QUALITY MANAGEMENT (contd)Road towards TQM Decide Prepare Start Expand Integrate TQM
TOTAL QUALITY MANAGEMENT (contd)TQM - Processes (The Juran Tirology) Quality Planning (Design for Quality) Quality control Quality improvement- TQM is an approach for continuously improving thequality goods and services, delivered through theparticipation of all levels and functions of theorganization.
TOTAL QUALITY MANAGEMENT• Customer‟s Focus• Executive Leadership• strategic quality Management• Education and Training• Measurement• Measurement and Information
TOTAL QUALITY MANAGEMENT• Total organization Involvement• Customer – Supplier Partnership• Quality System• Quality Improvement• Quality Control• Quality Planning (Designing for Quality)
LEVELS IN THE EVOLUTION OF QUALITY MANAGEMENT• Total Quality Management - Continuous improvement - Customer orientation - Empowered employees• Total Quality Control - Corrective and preventive actions - Company wide QA - Extensive use of QA tools
LEVELS IN THE EVOLUTION OF QUALITY MANAGEMENT (contd)• Quality Assurance - Corrective actions - Statistical Process control - Process compliance in manufacturing - Corrections - Grading salvage - Post production exercise
CQI - CONTINUOUS QUALITY IMPROVEMENT• CQI is a global approach to business development, that establishes an integrated programme through, which a company can achieve continuously incremented improvements in its chosen key performance measures by focusing on the better leadership of people and the improved management of business processes.• Transformation of an organizations culture to emphasize on quality of service and product as perceived by the organizations customer or those whom it serves. ----------------Mustafakhan
CQI - CONTINUOUS QUALITY IMPROVEMENT (contd)• The principal challenges are – - Shorter Product cycles - Generic Products - Increased competition for fixed or diminishing markets - Higher Customer Expectations - Higher Staff Expectation
CQI - CONTINUOUS QUALITY IMPROVEMENT (contd)• The reasons for failure of quality programmes include – i. They are imposed from above ii. They lack ownership by the staff iii. There are no clearly communicated objectives iv. They are frightening and threatening to the status quo v. There is resistance to change vi. They are seen as expensive vii. CQI is the key to business survival.• TQM Mainly - Applied to industry• CQI Mainly - Applied to Services
ELEMENTS• Customer focus• System view• Data driven analyses• Implement involvement• Multiple causation• Personally devastating review systems• Mobility of management, job hopping from one company to another.• Use of visible figures only for a management with little or no consideration of figures that are unknown or unknowable.
CQI - CONTINUOUS QUALITY IMPROVEMENT (contd)CQI uses quality management practices to obtaintop quality performance management techniquesare allied to a process- designed to make sure thecompany does not stand in the way of the staffdelivering a top performance.
CQI - CONTINUOUS QUALITY IMPROVEMENT (contd)• The core of the programme is the business survival strategy.• Determine the functions that need to be done.• Ensure the right processes are used in the right functions.• Get the right people to do the right jobs.• Have the products, services, processes and procedures that are customer focused for both external and internal customers.• When implementing the programme, one should remember that processes are rational with predictable outcomes, whereas people are so complex that their responses can be non-rational and cannot be accurately predicted).
QUALITY GURUS• Edward Deming - Father of Japanese Quality revolution• Born in 1900• Doctorate in Mathematical Physics• Worked in US Govt. - Statistical Sampling Techniques. Sent to Japan as an advisor• Attempted to make major changes in the style of Western management. (win:win situation)
QUALITY GURUS (contd)DEMING’S CHAIN• Deming has a reputation as the man who transformed Japanese industry after the Second World War.• Deming‟s definition of quality – three areas that are crucial for the overall quality of a product, quality of design, quality of conformance, quality of the sales and service functions.• Improve Quality• Improve Productivity• Decrease costs
QUALITY GURUS (contd)• Decrease prices• Increase Market• Stay in Business• Provide jobs – more jobs• Increase Return on investment
QUALITY GURUS (contd)• Deming’s Philosophy based on three basic precepts. 1. Customer orientation 2. Continuous improvement 3. Quality is determined by the system.• Demings Absolutes of Quality 1. Do it right first time 2. Defects prevention is the only acceptable approach 3. Zero defects is the only performance standards 4. Cost of quality is the only measure of quality
QUALITY GURUS (contd)Demings Five Deadly Sins of WesternManagement• Lack of constancy of purpose to plan product and services that will have a market, keep the company in business and provide jobs• Emphasis on short term profit, short term thinking fed by fear of turnover push from bankers
QUALITY GURUS (contd)Deming’s Fourteen points.1. Create constancy of purpose for improvement of product and service. Allocate resources for long range needs rather than short term profitability.2. Adopt the new Philosophy No longer to live with commonly accepted levels of delays, mistakes, defective materials and defective workmanship.3. Cease Dependence upon mass inspection.4. End “Lowest Tender” contracts (single reliable supplier)5. Improve every process
QUALITY GURUS (contd)6. Institute training on the Job7. Adopt and institute leadership8. Drive out fear Encourage effective two way communication and other means to drive out fear throughout the organization.9. Break Down Barriers Between staff areas and departments10. Eliminate slogans, exhortations and targets to the work force. Demanding zero defects and new levels of productivity without providing method
QUALITY GURUS (contd)11.Eliminate Arbitrary Numerical Targets12. Permit pride of workmanship13. Encourage education Vigorous programme of education Encourage self improvement for everyone14. Take action to accomplish the transformation. Top management‟s commitment for that.
QUALITY GURUS (contd)Joseph Juran• Born in 904• Trained as an Engineer• Juran was invited to Japan in 1950‟s• He defines quality as Fitness forum• Stresses the need to reduce the cost of quality. TQM• It is a collection of all the things, that we must do to have quality• Senior Managers must take personal charge of leading the change• Training of Management Hierarchy• Institution‟s commitment to achieve perpetuate, and institutionalize total quality.
QUALITY GURUS (contd)Ten steps to quality Improvement.1. Build awareness of the need and opportunity for improvement .2. Set goals for improvement3. Organize to reach the goals (Establish a quality council, Identify problems, Select projects, Appoint teams, Designate facilitators)4. Provide Training5. Carry out projects to solve problems6. Report Progress7. Give Recognition8. Communicate results9. Keep score10. Maintain momentum by making annual improvement part of the regular systems and processes of the company.
QUALITY GURUS (contd)He advocated –i. Quality circles – because they improve communications between management and labourii. Use of statistical process control.
QUALITY GURUS (contd)Dr. Philip Crosby:• Crosby – did not (unlike other two) recognize the merit of the Japanese Quality Model.• Dr. Crosby has also come out with a 14 step prescriptions for quality management.1. Management Commitment2. The Quality Improvement Team3. Quality Measurement• To display current and potential non-conformance problems to permit objective evaluation and corrective action.
QUALITY GURUS (contd)4. The cost of Quality To define the ingredients of the cost of quality and explain its use as a management tool.5. Quality Awareness By all persons6. Corrective action Systemic method of resolving the problems.7. Zero Defects Planning (not close to)8. Supervisor Training9. Realization of Change By all the employees10. Goal setting To establish improvement goals by all individuals.
QUALITY GURUS (contd)11. Error – Cause removal Problems Faced by the employees12. Recognition To appreciate those who participate.13. Quality councils To bring together the professional quality people for planned communication on regular basis.14. Do it over again To emphasize that the quality improvement programme never ends.
QUALITY GURUS (contd)According to Crosby –• Quality does not come from a system. It comes from the understanding and application of management concepts and education.• Quality is conformance to requirements not goodness.• The system he advocates is prevention - not appraisal• Zero defect - not close enoughCrosbys absolutes of Quality• Quality means conformance not elegance• There is no such thing as quality problem• There is no such thing as economics of quality. It is always cheaper to do the job right the first time (and all the time)• The only performance measure is the cost of quality• The only performance standard is zero defect.
QUALITY GURUS (contd)Ishikawa• Quality must be company wide• The next step of a process is its customer ,as preceding step is its supplier.• Promote feedback and create channels of communication with both the above• Quality circles to emphasize, participative team work• Emphasis on education and training.• Quality audits• Rigorous use of statistics• Just in time process
QUALITY GURUS (contd)Tuguchi• He is the major name in the field of statistical process control, and the name Tuguchi methods of experimental and quality analysis.• Use of statistical techniques• Evaluation of quality from both an end user and process approach• Loss is directly related to variability from target• It variability is reduced the quality level will go up and cost will come down
QUALITY GURUS (contd)Feigenbaum• Total quality control : Quality development• Maintenance• Improvement• Cuts across all activities in the organization and involve all systems phases• Both customers and suppliers are drawn to the total quality concept.• The goal of quality is to meet satisfactorily whatever customers believe to be their requirements for the service or the product.
QUALITY IMPROVEMENT TOOLS• Quality Improvement and Measurement Tools are used to help.i. Identify Issues Problems of improvement Sourcesii Represent the Solution - to a problem Or to show the plan to be used To tackle the problem.
QUALITY IMPROVEMENT TOOLS (contd)Flow Chart• It is a pictorial representation of the steps and activities that constitute a process. They are often used to show the structure of an organization or used to show the flow of computer programmes.• Different shaped boxes represent different types of issue such as –• Document• Decision• Termination or choices
QUALITY IMPROVEMENT TOOLS (contd)• Symbols for Flow Charts - Start or stop - Document - Decision - Delay• Flow lines are inserted between the boxes to show the direction of the flow.
QUALITY IMPROVEMENT TOOLS (contd)Cause and Effect Diagram:(Fish bone diagram or Ischikawa Diagram)• This quality improvement tool is a great help in brainstorming session, because it helps to display the possible causes of a specific problem or condition.
QUALITY IMPROVEMENT TOOLS (contd)• Put the goal or idea at the head of the fish.• Divide the contributing factors to the achievement of the goal into categories such as Man Materials Machines Methods• Other factors Maintenance Measurement Markets Money
QUALITY IMPROVEMENT TOOLS (contd)• The problem solving team can analyze and fill in all the contributing factors• Cause and effect diagrams are useful to show the relationship between one issue or contributing factor and another.• They do not tell as about priorities, which are best tackled using other quality representation and measurement tools.
QUALITY IMPROVEMENT TOOLS (contd)G Natt Chart ( ? Bar Chart)• It can be used as an aid to planning of work• Primarily it shows the relationship of activities against time and highlights areas, where the time planning has gone erroneous.• Further a G Natt Chart shows where activities need to be started and finished in relation to other activities.• A G Natt is a time based chart showing the start and end points of various time based tasks.
QUALITY IMPROVEMENT TOOLS (contd) Wk 1 2 3 4• Actively 1 2 3 4• A G Natt Chart helps to do things in the right order.• Time overruns for individual activities and tasks could be estimated and monitored using these charts.
QUALITY IMPROVEMENT TOOLS (contd)Histograms• They are used to display and identify the type of distribution of data by drawing graphs for the number of units in each class of the data.• Histograms show different shape and can indicate a probable cause for the deviation from most frequent shape (normal shape).• Different shapes of histogram, provide an insight into the value of the data.
QUALITY IMPROVEMENT TOOLS (contd)The Pareto Principle:• The Pareto principle was invented by Ishikawa and is used to divide the”vital few” from the “Important many”.• It is particularly useful, where it is necessary to decide on priorities. e.g. Critical Quality Costs.• Quality problems, which are small and have low impact are accorded lower priority whereas topmost priority is given to those quality problems, which are likely to have a very great impact on the organization.• The Pareto principle is used to catch the big fish and to leave the little fish in the pond, for attention at some future time.
QUALITY IMPROVEMENT TOOLS (contd)• It is a method of showing the causes or defects which are most important. 100 – 80 – 60 – Sales 40 – 20 – 0 20 40 60 80 100This representation of the data is yet another method of “viewing a picture” of the data and can help in predicting the effectiveness of improvements and enable an understanding of problems and seriousness at a glance.
QUALITY IMPROVEMENT TOOLS (contd)Some of the conclusions drawn based on the ParetoPrinciple are –• 80% of the quality costs came from 20% of the problems• 80% of the sales go to 20% of the customers• 80% of the performance of the people comes from 20% of their activities• 85% of the problems are caused by management and 15% are caused by subordinates.
QUALITY IMPROVEMENT TOOLS (contd)Scatter Diagram:• They show the relationship between two variables and each point on the diagram represents a poor of variables. Variable Y Variable X 0Scaller diagram may explain the variations in therelationship among the two variables under consideration.The exact nature of problems and the possible reasons
QUALITY IMPROVEMENT TOOLS (contd)The Control Charts• The main tools is the control chart• There are different types of control charts depending on different ways assessing the quality of a product.• Many characteristics of co-product a measurable and they are continuous variables.• For controlling such variables two types of charts are plotted, one for mean of the measurements (X chart) and another for the range of the measurements (R chart).
QUALITY IMPROVEMENT TOOLS (contd)Activity Analysis:• Functional Analysis and Failure Mode and Effect Analysis are two of the many types of activity analysis through which the paper work jobs can be analyzed as a process just as one would analyze a manufacturing process.• Functional Analysis is a process for identifying quality improvement opportunities within a department or organization and is particularly suitable for administrative operations.
QUALITY IMPROVEMENT TOOLS (contd)• Functional Analysis helps to find out –- Who the customers and suppliers dare ?- The expectations of the consumers- The expectations, the suppliers must meet.- The tasks needed to achieve the required output- The necessary measurements- Where expectations are not being met- The improvements, which are possible.
QUALITY IMPROVEMENT TOOLS (contd)Statistical Process control (SPC)• SPC IS a quality tool. It is also quality improvement strategy, that is essential part of quality management.• Basic element of SPC is - Collection of data in an objective manner - It is analysis in graphical form to provide the input to a series of improvement processes.• SPC is a term for analyzing how the business are performing using members, diagrams and pictures.• SPC can be used to understand the workings of any activity from which numbers can be derived by measurement.
QUALITY IMPROVEMENT TOOLS (contd)• SPC helps to i. Evaluate long term process variables ii. Start short term actions on out of control situations.• It is one of the quality tools, used to quantify the progress of improvement of TQM process as a whole• As its simplest level SPC is illustrated as average The average can be used construct charts.
QUALITY IMPROVEMENT TOOLS (contd)Nominal Group Techniques: (Brain Storming)• It is for stimulating ideas, points issues or solutions among a group.• The group consists of 4-10 people. After the brain storming a vote about the ideas with the highest priority in the opinion of the group.
QUALITY IMPROVEMENT TOOLS (contd)Steps:• Participants silently write their individual list of ideas.• They offer in rotation one idea each for recording on a flipchart until all ideas are written down• The ideas are then discussed and similar ones are grouped together as one idea, with ideas which capture the idea.• The listed ideas from which the grouped idea came are then deleted in order to avoid duplication.• Each participant votes on the idea.• Add up the individual votes to priorities the list• With the Nominal Group Techniques, silly or impractical ideas cannot be forced down the throats because they simply get voted out.
JAPANESE MANAGEMENT• Disciplined workers• Give maximum importance to their jobs and take their jobs very seriously• Sense of responsibility (the next worker need not check the machines because he is certain that previous worker has done it)• Experts in planning Scheduling Conducting in time• After 2nd World War they learnt lessons of quality rather painfully which they still continue to practise• Passion for excellence
JAPANESE MANAGEMENT (contd)• Work harder and longer on their own• Life time employment• Good industrial relations• Synergy in whole system• Concepts of Total Quality Management imbibed in entire system• Concepts like JIT• Integrated Supplier-Customer relationship• Statistical analysis• Full support from the management for quality programs• Actively practice Kai Zen – continuous improvement• Continuously educate and train the employees (at least 22 days in a year)
JAPANESE MANAGEMENT (contd)• Excellent management - Facilities - Responsible employees - Little or no inventories - Absence of work stoppages - Almost no rejected products• Absence of Crisis management and excellent maintenance of equipments• Technological advantages because of insistence on building their process in house• Skilled employees trained in-house• Effective integration of operations policy and manufacturing strategy
JAPANESE MANAGEMENT (contd)• They focus on long-term objectives and not on short cuts and small gains.• Workers belong to company unions rather than craft unions.• Practice the concept of consensus decision-making• Collective responsibility and team rewards.• Socialization of Japanese Firm to inculcate the culture of the organization in the employees by such rituals as - Singing company songs - After hours group activities - Company sponsored vacations - Develop and sustain long term commitment and loyalty to organization
JAPANESE MANAGEMENT (contd)• Directors are from Company (not form outside) they rise in the company• Dividends on the share values (not on market value)• A large part of profit is pumped back into the company to improve the techniques management etc.
JAPANESE MANAGEMENT (contd)Quality Circle• Concept originated from Japan• Dr. Ishikawa presented in April 1962Original Definition: Quality circle is a small group to perform voluntarily quality control activities within the same workshop. This small group carried on continuously as a part of company wide quality control activities self development and mutual development and improvement within the workshop utilizing control techniques with all member participating.
JAPANESE MANAGEMENT (contd)Revised:• QC is a small group in which people, who work in the first line work place, continually improve and maintain the quality of products, services job and so on.• This small group promotes the activity in such a way as to autonomously administer it, utilize the QC concept and technique and others display creativity land make self development and mutual development.• There are a number of basic factors in quality circles and their development.• Quality circles enable workers to participate in the improvement of their products and their jobs, so building pride in their product and a sense of participation in, and belonging to the organization.
JAPANESE MANAGEMENT (contd)• Quality circles recognize and use the intellectuals and practical potential of all employees of an organization and provide a safe framework within which such contributions can be made.• Quality circles provide training and structured opportunities for staff to become involved in the inter personal processes within the organization that lead to joint problem solving. The circles are employee owned and allow for personal development and growth, together with allowing a sense of achievement at work.• Quality circles flourish best in, and promote, a democratic participative and person oriented management style that values two way communication and values the contribution of all employees to the functioning of the organization.
JAPANESE MANAGEMENT (contd)QC activity intends to –• Develop their capacity• Perform the self actualization for members• Make its workplace full of brightness and vitality• To improve customer satisfaction by high quality product at lower cost free from defects, timely delivery and prompt service.
JAPANESE MANAGEMENT (contd)Introduction of QC in an organization• First requisite is the firm commitment of the top management in the Quality Programmes.• Following methods adopted before QC is introduced : i. Conduct a survey of the organizations ii. Discuss the findings with the top management iii. Conduct special programmes to executives iv. Select executives from various departments for special intensive training programme. v. Training has to be done with best faculty members available on the subject. vi. Form Quality Improvement Team, Section wise vii. Conduct awareness programme to all workers and train them in Q.C. programme.
JAPANESE MANAGEMENT (contd)• Ideal Size – 8-10 member but not more than 15• There should be a co-ordinator, Joining QC should be voluntary.• Usually from the same shift and department.• But workers from other shifts or departments working similar jobs may be included.• It is the responsibility of the management to provide some space, organize meetings and promote QC activities.• Quality circles meet regularly and periodically. The periodic meeting is normally once a week for one hour. Facilitator or co-ordinator need not be present all the time. But he should be in touch with the members, particularly with the leader before and after the meeting.
JAPANESE MANAGEMENT (contd)Problem Solving: A list of problems using brain stormingtechniques. They prioritize and classify the problems.A. Category Problems: - Minimum involvement of other departments.B. Category problems- Involvement of other departments is a necessityC. Category problems – Management section and support may be needed in implementing the solution.It is advisable to start with A type of problems and thenmore on to B and C
JAPANESE MANAGEMENT (contd)Once the problem is recognized, the following steps aretaken.• Define the problem.• Analyze the problem by collecting data• Identify the causes• Find out the root causes by data collection and analysis• Identify solutions• Select the appropriate solution• Foresee the probable resistance for its implementation.• Implement the solution on trial basis and check performance• Regular implementation• Follow up / Review
JAPANESE MANAGEMENT (contd)Need to take some specialist advice/suggestion on someoccasionsManagement Presentation - Periodically.Benefits:• Members - Improve their knowledge - Learn to work together - Learn to Interact - Learn to present before management - Improve their morale and confidence - Learn to work systematically - Learn to plan their activities - Learn the techniques of problem solving - Help preventing the problems
JAPANESE MANAGEMENT (contd)• Organization - Quality improves - Morale enhanced - Cost effectiveness - Attitudinal changes and better teamwork.• Two pillars:1. JIT2. Jidoka
JAPANESE MANAGEMENT (contd)JIDOKA (Automation with a human touch)• E.g. A machine will detect a problem and stop the production automatically rather than continue to run and produce bad output.• Jidoka is often labeled as „Stop and respond to any abnormality‟Four steps involved:• Detect the abnormality• Stop Can be easily• adopted• Fix or correct the immediate condition• Investigate the root cause and install a Human counter measure interference required
JAPANESE MANAGEMENT (contd)Some methodologies are:• Kanben: In this system, each sub-unit of the plant tailors the production precisely to the needs of the upstream unit.• Anden: Visual indication of the trouble giving instructions to stop the work / line operation E.g. Fire alarm in an office, Machine breakdown signal system• Poka-Yoke: Work process is so designed to eliminate the human mistakes• Visual Control: A System of visual control basically means sharing information.
JAPANESE MANAGEMENT (contd)JUST – IN – TIME• A structural approach in manufacturing organization focuses on improving1. Timeliness2. Quality3. Productivity4. Flexibility
JAPANESE MANAGEMENT (contd)Utilizing various methods of• Work Simplification• Waste reductionJIT is viewed as a level of perfection achieved throughcontinuous elimination of the wasteful use of resources.• Non stock• Zero inventory
JAPANESE MANAGEMENT (contd)JIT methods are:• Elimination of waste• Good Housekeeping• Jidoka (Automation)• Anden (Visual indication of trouble)• Poka-Yoke (Not allowing mistakes to occur)• Visual control• Kanben (Demand pull)• Scheduling• Set-up reduction• JIT materials management
JAPANESE MANAGEMENT (contd)KAIZENKai -- To break apart -- To modify -- To changezen -- Think about -- Make good -- Make betterKaizen ----- Continuous Improvement --- Change for the better -- To brake apart and put back together better than before
JAPANESE MANAGEMENT (contd)--Kaizen is used by the Japanese for any kind of improvement. (Both in the private and in the working life)-- It is the most important Japanese management concept.--Kaizen means “Not only product improvement but improvement of all the procedures till completion of the product up to marketing and customer care including the constant advancement of working humans”--- Kaizen is the philosophy of the eternal change and flexibility to react over to the changes of the environment.
JAPANESE MANAGEMENT (contd)Basic principles of Kaizen• Kaizen is a process for identifying waste…. And reducing or eliminating it.• Kaizen is process for identifying and implementing standard work.5 S ---- Start ( organization ) Clearly distinguish needed from unneeded items and eliminate the latter.-- Set in order (Orderliness) Keep needed items in the correct place for easy and immediate retrieval.-- Shine – (Cleanliness) __ Keep the workplace swept and thoroughly clean.-- Standardize-- Sustain __ (Discipline)
JAPANESE MANAGEMENT (contd)Kaizen• Stresses above all humans and its potential for problem solution – Human capital.• The investments are directed less on technologies although these may not be neglected.• The workers of an enterprise are regarded as resources and /or property• Expenditures for personnel in particular for further training
JAPANESE MANAGEMENT (contd)Kaizen – some features• Speed - small steps• Time frame - continuously and rising• Participants - each employee• Proceedings - collective spirit, group work• Methodology - conventional know how• Investment - small• Success - human• Effect - on a long term basis and continuously• Evaluation - achievement and for better results• Advantages - outstanding suitable for slowly rising economy.
JAPANESE MANAGEMENT (contd)• Learn to work systematically• Learn to plan their activities• Learn the techniques of problem solving• Help preventing the problemsOrganization• Quality improves• Morale enhanced• Cost effectiveness• Attitudinal changes and better team work.
SIX SIGMA PROCESS• Six Sigma is a system of practices originally developed by Motorola to systematically improve processes by eliminating defects.• Defects are defined as units that are not members of the intended population.The term Six Sigma• Sigma (the lower-case Greek letter σ) is used to represent standard deviation (a measure of variation) of a population (lower-case „s‟, is an estimate, based on a sample.
SIX SIGMA PROCESS (contd)Definition:One that produces 3.4 defective parts per millionopportunities (DPMO).• A process that is normally distributed will have 3.4 parts per million beyond a point that is 4.5 standard deviations above or below the mean (one-sided Capability Study). This implies that 3.4 DPMO corresponds to 4.5 sigmas, not six as the process name would imply.
SIX SIGMA PROCESS (contd)Key Concepts of Six Sigma:At its core, Six Sigma revolves around a few key concepts.• Critical to Quality: Attributes most important to the customer• Defect: Failing to deliver what the customer wants• Process Capability: What your process can deliver• Variation: What the customer sees and feels• Stable Operations: Ensuring consistent, predictable processes to improve what the customer sees and feels• Design for Six Sigma: Designing to meet customer needs and process capability
SIX SIGMA PROCESS (contd)Methodology:Six Sigma has two key methodologies: DMAIC and DMADVDMAIC is used to improve an existing business process.DMADV is used to create new product designs or processdesigns in such a way that it results in a more predictable,mature and defect free performance.
SIX SIGMA PROCESS (contd)DMAICBasic Methodology consists of the following five steps:• Define the process improvement goals that are consistent with customer demands and enterprise strategy.• Measure the current process and collect relevant data for future comparison.• Analyze to verify relationship and causality of factors. Determine what the relationship is, and attempt to ensure that all factors have been considered.• Improve or optimize the process based upon the analysis using techniques like Design of Experiments.• Control to ensure that any variances are corrected before they result in defects. Set up pilot runs to establish process capability, transition to production and thereafter continuously measure the process and institute control mechanisms.
SIX SIGMA PROCESS (contd)DMADVBasic methodology consists of the following five steps:• Define the goals of the design activity that are consistent with customer demands and enterprise strategy.• Measure and identify CTQs (critical to qualities), product capabilities, production process capability, and risk assessments.• Analyze to develop and design alternatives, create high- level design and evaluate design capability to select the best design.• Design details, optimize the design, and plan for design verification. This phase may require simulations.• Verify the design, set up pilot runs, implement production process and handover to process owners.
SIX SIGMA PROCESS (contd)Roles required for implementationSix Sigma identifies five key roles for its successfulImplementation.1. Executive Leadership2. Champions3. Master Black Belts4. Experts5. Black Belts6. Green Belts
Lean• Introduced by Toyota in the 1960‟s as a systematic approach to identifying and eliminating waste or non- value-add activities in an organization through continuous Improvement with the goal of creating value.• Lean is therefore a strategy or system for remaining competitive through identifying and eliminating wasteful steps in products, services, or processes.• The key principles of Lean are based on identifying waste from the customer perspective, and determining how to eliminate it.
Lean (contd)The 7 Wastes1. Waiting - eg. Employee or equipment idle time2. Transportation - eg. Any movement that does not add value3. Processing itself - eg. Doing more work than necessary4. Motion - eg. Wasted walking or movement5. Poor “Quality” - eg. Errors or rework6. Inventory - eg. Storing excess inventory/ materials7. Overproduction – eg. Servicing more, sooner, faster than required by the next step in the process
Lean (contd)The term “Lean” is used because a Lean organization:• Optimizes human effort• Uses less space• Reduces the need for capital investment• Decreases the amount of raw materials/supplies bought and consumed• Uses less time to produce and deliver products and services
Lean (contd)A more general interpretation of Lean Healthcare is: The relentless elimination of waste in every area of operations with the aim of reducing inventory, cycle times and costs – so that delivering higher quality patient services can be provided in the most efficient, effective and responsive manner possible, while maintaining the economic viability of the organization.
Medical (Clinical) Audit• Clinical Audit is a quality improvement process that seeks to improve patient care and outcomes through systemic review care against explicit criteria and the implementation of change.• Aspects of structure, processes and outcomes of care are selected and systematically evaluated against explicit criteria• Where indicated, changes are implemented at an individual, team or service level and further monitoring is used to confirm improvement in health care delivery.
Medical (Clinical) Audit (contd)Stages of clinical auditStage I Preparing audit By creating the right environmentStage II Selecting criteriaStage III Measuring performance By using the correct methods.Stage IV Making improvementsStage V Sustaining improvements
Medical (Clinical) Audit (contd)I. Preparing for Audit:• Clinical audit is conducted with effective leadership participation by all staff . Emphasis on team working and support. This enables everyone to be responsible for reporting analyzing and improving process.• Service uses are also to be involved in the clinical audit process. The priorities of those receiving care can differ quite markedly from those of clinicians. Usual sources for this purpose are – - Letters containing comments or complaints - Critical incident reports - Individual patient‟s stories or feed back - Direct observation of care - Direct conversations
Medical (Clinical) Audit (contd)• Good documentation of clinical care• Timely• Truthful• Comprehensive• Legible• Topic selection Specific• Random• Defining the purpose of the audit To improve• To enhance• To ensure• To change
Medical (Clinical) Audit (contd)• Providing the necessary structures• A. structured audit programme (committee structure, feedback mechanisms, regular audit meetings).• A team of well qualified staff.• Identifying the skills and people needed to carry out the audit.• Training the staff and encouraging them to participate.• Audit methods• Change management• Data collection and data analysis skills• Felicitation skills
Medical (Clinical) Audit (contd)II. Selecting Criteria• Criteria are used to assess the quality of care provided by an individual, a team or an organization.• These criteria –1. Are explicit statements that define, what is being measured.2. Represent elements of care that can be measured objectively.Different professional groups use different criteria orstandards
Medical (Clinical) Audit (contd)Criteria can be classified as –1. Structure (what you need)• Staff• Skills• Space• Equipment2. Process (what you need)• They include communication assessment, education, investigations, prescribing surgical and other therapeutic interventions.
Medical (Clinical) Audit (contd)Process:• Identify key elements• Carry out focussed systematic literature reviews• Prioritize the criteria into “must do” and “should do”• Present the criteria in a protocol.• Include data collection forms instructions etc.• Submit the protocol to external pre review
Medical (Clinical) Audit (contd)III. Measure Level of Performance:• Patient registers are used to identify patients care must be taken to identify the incomplete records.• To make sure that the data collected are precise and that only essential data are collected, certain details about what is to be audited must be established from the outset.• Sampling:• How many of the users (study population) to be selected?• How to choose a representative sample? Should be decided in advance.
Medical (Clinical) Audit (contd)• Electronic information systems can contribute to audit in many ways like improving access to research evidence identifying users, collecting data, prompting change through record templates, and enabling revised systems of care to be introduced.• In this exercise care should be taken to maintain confidentiality of the patients.
Medical (Clinical) Audit (contd)IV Making improvements A systematic approach to implementation is moreEffective. Approach should include -• Identification of local barriers to change.• Investigation of potential barriers to change assists in the development of implementation plans.• The support of teamwork• Train the people to effect changes after taking them into confidence.• Use of a variety of specific methodsUse of multifaceted interventions chosen to suit theparticular circumstances is more likely to be effective inchanging performance than the use of singleintervention alone.
Medical (Clinical) Audit (contd)V. Sustaining Improvements - Very Important• Monitor and evaluate change• Collecting data for a second time, after changes have been introduced in central to both assessing and maintaining the improvements made during clinical audit. The same procedures of sample selection, information collection and analysis.• If performance, targets have not been reached during implementation, modifications to the plan or additional interventions will be needed.• Maintaining and reinforcing improvement.
Medical (Clinical) Audit (contd)• It is a complex process• It includes - Reinforcing or motivating factors built in by the management to support the continual cycle of quality improvement. - Integration of audit into the organization‟s wider quality systems.
Medical (Clinical) Audit (contd)Factors that promote the success of clinical audit –• Sound leadership• A conducive / supportive organizational environment• Structures and systems to support audit including mechanisms to make data collection easier.• A well managed audit programme.• Giving adequate attention to all stage of audit .• Addressing a range of issues important to the trust and individual clinicians.• Top management commitment and participation of every member of the organization.
BENCH-MARKINGDefinition:• Bench Marking is the process of identifying understanding and adapting outstanding practices from within the same organization or from other business to help improve performance.• This involves a process of company practices and procedures to those of the best to identify ways in which an organization can make improvements. Thus new standards and goals can be set, which in turn will help better satisfy the customer‟s requirements for quality cost, product and service.• In this way, organizations can add value to their customers and distinguish themselves from their competitors.
BENCH-MARKING (contd)Bench marking:• “A perfect legal way of copying the smartest business practices”• “How to steal the best ideas around”What to bench mark?• Vital few• Key successful factors• Key performance indicatorsBench marking is probably the single must important thing acompany can do when beginning the quality improvementprocess.It is a continuous learning and improvement process, whichensures that best practices are uncovered, analyzed,adapted and implemented where appropriate.
BENCH-MARKING (contd)What bench marking can achieve?• Incremental improvements to existing performance standards.• Quantum leaps by instigating new practices and ways of working.• The road to excellence creating the learning organization.Success of bench marking:• Baldridge award winners• Deming prize winners• ISO 9000 certificate holders• Organization with other accreditation• Documentation of best practices• Benchmarking consortia
BENCH-MARKING (contd)Bench marking protocol• Keep it legal• Be willing to give what you get• Keep information internal• Don‟t refer without permission• Use benchmarking contacts• Be prepared from the start• Understand expectations• Act in accordance with expectations• Be honest• Follow through with commitment.
BENCH-MARKING (contd)What benchmarking is NOT:• Stealing• Copying• Sleeping with the enemy• Industrial tourism• Recreational TQM.
BENCH-MARKING (contd)Types of Bench Marking• Internal• Competitive - Organisation• Non competitive - Organisation• Best Practice/world class.• Benefits of Benchmarking• It sets performance goals• It helps accelerate and manage change• It improves processes• It allows individuals to see the “outside the box”• It generates an understanding of world class performance.
BENCH-MARKING (contd)Pit falls:• Lack of focus and priority• Lack of strategic relevance• Lack of leadership• Lack of perseverance• Lack of planning - Management not burying into the idea - No clear owner of the programme - Failure to consider customer requirements - Change of sponsor before completion of the programme - Not involving “right staff” in the programme - Team not measuring issues it agreed to addresses - Programme causing too much of disruption of work - Conflicting objectives of the organisation.
EDUCATION AND TRAINING"If I am asked to cut a tree in eight hours I spend six hoursin sharpening the knife"Fortune:• If you want to build a high tech performance flexible organization then you have to train your workers.• Japanese Excellence in quality is due to training.Training:• Should be to everybody• Mandatory• Regular• No gaps in knowledge and skill at any level• Must include technical and behavioral aspects.
EDUCATION AND TRAINING (contd)Determining training needs:• Detailed study.• Do not rush in designing the programme• Not just general training• Individualization• Grouping• Duration• Content To be specified• Methodology• Timing
EDUCATION AND TRAINING (contd)Training by whom?• Internal Advantages and• External Disadvantages• Facilitator• CoordinatorHow much and when• 4-6% of the total working hours• 92-120 hours i.e. 12-15 days/year.• During working hours• At intervals• Timing choice to worker (preferably)
EDUCATION AND TRAINING (contd)Must become conversant with• Absolute quality• Problem solving• Statistical process control• Reducing waste• Process simplification• Team work• Meeting customer‟s expectationsEvery employee must be aware that• His performance has an effect in the end service• His high motivation should deliver constant good quality product/service
EDUCATION AND TRAINING (contd)• Benefits/impact• Evaluation - Hours of training of every employee - Results - Feedback from participants - Cost-benefit analysis• Review: - Periodic review - Reassessment of needs methodology - Decide the future programme - Continuous process
LEADERSHIP• Leadership is the process of influencing group activities, towards the accomplishment of goals in a given situation.• Leadership is responsible for promoting commitment in an institution.• Commitment is the foundation of an effective total quality programme.• Leadership which promote such quality programme is known as Total Quality Leadership.
LEADERSHIP (contd)Role of Leaders:• To develop team work• Creating cordial relationships• Act as counselor• Time management• Motivator• Source of inspiration• Power and authority for constructive purposes• Proper delegation• Managing and leading the group.
LEADERSHIP (contd)Qualities of a Quality Leader:• Mentor• Facilitator• Innovator• Co-ordinator• Monitor• Coach• Teacher• DirectorManager DO THINGS RIGHT; Leaders DO RIGHT THINGS
LEADERSHIP (contd)Ten commandments of leadership:• Search for challenging opportunities to change, grow, innovate and improve.• Experiment, take risk, and learn from mistakes.• Have a great vision for people.• Make others participate in the vision by convincing them.• Bring about collaboration by building trust among members.• Strengthen others by sharing all relevant information and delegate authority.
LEADERSHIP (contd)• Set an example for others by behaving in ways that are suited to your personality.• Plan for small successes that can promote constant progress and bring about commitment.• Recognize individual contributions to the success of every project.• Celebrate team accomplishments and success regularly.
LEADERSHIP (contd)Managing resistance to change:• To address the facts which lead to resistance.• Usually they are: - People look for stability and security - Since change requires additional skills and knowledge they are reluctant to acquire them. - Leadership should understand these factors and adopt strategies to convince and bring about attitudinal changes• Once that is done, to motivate, train, guide the people.• Successful leaders are those who succeed in challenging the present method of doing things and make things happen.
LEADERSHIP (contd)Leadership to ensure quality:• Set personal example of practicing what you preach about quality.• Establish a quality vision and translate it into mission statements• Institutionalize the initiative and not individualize.• Instill in every employee a sense of pride in the work he/she does.• Empower employees• Document every process to create a manual for conformance• Devise systems that can function even if the individuals change
LEADERSHIP (contd)• Use external quality audits to benchmark efficacy of the systems.• Customers‟ complaints to be monitored, analyzed and attended to immediately.• To measure customer satisfaction levels to generate ideas• Delegate specified decision making powers down the line• Improve communication at all levels• Provide transparency in information• Focus on preventive rather than curative maintenance• Develop quality culture in the organization.
LEADERSHIP (contd)Best Practices for Quality Leadership:• Set a personal example or practicing what you preach about quality.• Establish a quality vision and translate it into mission statements• Institutionalize the initiative, don‟t individualize it.• Instill in every employee a sense of pride in the work that he must do.• Invest in training people at all levels in quality theory and practices.• Empower employees to go to any length to satisfy the customer.
LEADERSHIP (contd)• Do not dogmatically stick to any; one TQM model.• Calculate the savings from every TQM project.• Document every process to create a manual for conformance.• Devise systems that can function even if the individuals changes.• Keep the processes fixed but the organizational structure flexible.• Use external quality audits to benchmark efficacy of systems.
LEADERSHIP (contd)Best Practices for Quality Customer Care:• Measure customer satisfaction levels to generate ideas.• Log, monitor, and analyse customer complaints every day.• Depend on market research to fine tune customer communication strategy.• Listen to the customer continuously and not at discrete intervals.• Use feedback to identify new segments and customer expectations.
LEADERSHIP (contd)• Design varying customer listening devices for different needs.• Convert every point of customer interaction into a listening post.• Use feedback data to update, monitor, and correct complaints.• Eliminate non-value-adding activities from every process.• Reduce paperwork to make it easier for customers.• Reduce the time customers spend waiting in offices.
LEADERSHIP (contd)Best Practices for Institutionalizing Quality:• Delegate specified decision making powers down the line.• Use technology to speed up communications and cut cycle time.• Identify steps that can be merged or eliminated altogether.• Provide transparency in information exchange and reduce transaction times.• Recruit inexperienced people to eliminate detraining.
LEADERSHIP (contd)• Devise systems that can function even if the individuals change.• Launch TQM with a pilot project which is small but important.• Issue constant reminders on cost of poor quality.• Focus on preventive rather than curative maintenance.• Modify technology to match local conditions and customer needs.• Technology should be serviceable from within the organization to a large extent.
STRATEGIES• Mission, values, quality policy organizational goals.• Organization for quality programmes• Education and training• Customers and their requirements• Improvement opportunity identification• Every activity standard Assessed• Integrating quality programmes with existing ones• Organizational culture towards quality consciousness• Communication• Recognition and reward.
COST OF QUALITY• Cost of quality is described as the measure of how much it costs the institution to provide quality in everything the institution does whether it manufactures products or provides services.• Other terms used are –1. Cost of nonconformance (to specifications)2. Price of quality.• Quality is often associated with expense.• Japanese proved that quality goods and services cost less to produce, not more though-1. Reduced waste2. Greater productivity3. Increased sales.• All these three factors are interactive.
COST OF QUALITY (contd)Cost of quality has following elements.A. Cost of Errors or Cost of Rework• Rework Necessary: When product is redesigned, especially in creative work Unnecessary: Information - Material mistake or Process – Equipment Fault
COST OF QUALITY (contd) Internal: Within the Institution• Rework External: Outside the Institution Direct• Rework Indirect: e.g. Inspection, Replacing, Repairing• Costs associated with errors and defects are significant in non-manufacturing and service sector.• Deming says that 85 % of the quality problems are created by people who never touch the product.
COST OF QUALITY (contd)B. Cost of Inspection• These costs include: - Cost of enforcing quality control - Cost of calibrating and measuring instruments and gauges - Cost of toolingCost of Inspection is high, especially in administrative areas.Inspection does not bring quality. Prevention and doing itright the first time are the keys.
COST OF QUALITY (contd)The Cost of Quality is easy to measure in the productionareas and difficult in the service areas.• The cost sometimes can exceed 25% of the sales revenue, which may be surprising. This is because, 90 % of the non-conformance costs are invisible.• When the company is perfect, total costs of quality might drop to only 7 % of the sales value. This needs continuous hard work.Purpose of measuring Cost of Quality:• To set priorities• Provide an Incentive
COST OF QUALITY (contd)Measuring the cost of quality helps to• Save Money• Makes the organization more competitive• Provides greater job security for the staffCost of implementing quality programs is far less than thecosts of not implementing it.• Cost of implementing quality management programs is recouped by greater productivity and lower total product and service costs.• The cost of producing high quality products and services is zero, while the cost of producing low quality products in services is equal to the cost of putting things right and dealing with disgruntled customers.
COST OF QUALITY (contd)• Singular pursuit of productivity through a focus on efficiency is self-defeating• Merril Lynch and Company estimated that the cost of correcting mistakes and placating dissatisfied customers was costing them more than $ 200 million a year.• Hewlett Packard company discovered that rework and dealing with customer complaints cost the company 20 % revenues and involved time and effort of 25 % of company employees.• Cost of not doing things right the first time for a typical service organization is equal to around 40 % of the total operating costs.• For the whole decade of the 1980‟s about 1/3rd of all the work performed by all American Companies was actually rework because of quality problems.
CERTIFYING BODIESISOISO is the abbreviation for International Organization forStandardization. It is a Worldwide Federation of standardsbodies from more than 100 countries. The mission of ISO isto promote the development of standardization and relatedactivities in the world with a view to facilitating exchange ofgoods and services and to developing co-operation in thespheres of intellectual, scientific technological economicactivity.• ISO is a non-governmental organization with members from different countries.• ISO standards are voluntary and ISO has no authority to enforce their implementation.
CERTIFYING BODIES (contd)• ISO has developed several International standards covering almost all technical fields.• ISO does not carry out conformity assessment activities, although it develops guidelines for those, which establish the foundations for good practice.• ISO standards are market driven. They are developed on the basis of international consensus among experts from the sector which has expressed a requirement for a particular standard.• ISO – 9000 certification – is obtained by interested organization.• ISO series came into being in 1987, which were later revised in 1994 and recently in 2000.
CERTIFYING BODIES (contd)QMS ISO 9001 – 200 (E)4. Quality Management System4.1General Requirements• The organization shall establish, document implement and maintain a quality, management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
CERTIFYING BODIES (contd)4.2 Documentation Requirement:4.2.1 Documented statements of a quality policy and quality objectives. • Quality Manual • Documented procedures required by this International Standard. • Documents needed by the organization to ensure the effective planning, operation and control of its process. • Records required by this International Standard.
CERTIFYING BODIES (contd)4.2.2 Quality Manual:The organization shall establishes and maintain aquality manual that includes:• The scope of the quality management system, including details of and justification for any exclusions.• The documented procedures established for the quality management system or reference to them.• A description of the interaction between the process of the quality management system.4.2.3 Control of Documents:• The documental procedures shall be established to define the controls needed.
CERTIFYING BODIES (contd)4.2.4 Records shall be maintained to provide evidenceof uniformity to requirements and of the effective operationof the quality management system. Records shall remainlegible, readily identifiable and retrievable.
CERTIFYING BODIES (contd)5. Management responsibility:5.1 Management commitment• Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by :a) Communicating to the organization the importance of meeting customers as well as statutory and regulating requirements.b) Establishing the quality policy.c) Ensuring that quality objectives are established.d) Conducting management reviews.e) Ensuring the availability of resources .
CERTIFYING BODIES (contd)5.2 Customer Focus:• Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.5.3 Quality Policy:Top management shall ensure that the quality policy :1. Is appropriate to the purpose of the organization.2. Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system.3. Provides a framework for establishing and reviewing quality objectives.4. Is communicated and understood, within the organization and,5. Is reviewed for continuing suitability.
CERTIFYING BODIES (contd)5.4 Planning:5.4.1 Quality Objectives:• Top management shall ensure that quality objectives including those needed to meet requirements for product, are established at relevant function and levels within organization.• The quality objectives shall be measurable and consistent with the quality policy.• 5.4.2 Quality Management System Planning
CERTIFYING BODIES (contd)5.5 Responsibility, authority and communication5.5.1 Management Representative:• Top management shall appoint a member of management, who irrespective of other responsibilities shall have responsibility and authority that includes:• Ensuring that processes needed for the quality management system are established, implemented and maintained.• Reporting to top management on the performance of the quality management system and any need for improvement and.• Ensuring the promotion of awareness of customer requirements throughout the organization.
CERTIFYING BODIES (contd)5.5.2 Internal CommunicationAppropriate - regarding the quality management system.5.6 Management Review :• Review - QMS - at planned intervals to ensure suitability, adequacy and effectiveness.• Records - of review maintained.
CERTIFYING BODIES (contd)5.6.1 Review in put shall include• Results of audits• Customer feed back• Process performance and product conformity• Status of preventive and corrective actions• Follow up actions from previous management reviews• Changes that could affect the quality management system• Recommendations for improvement
CERTIFYING BODIES (contd)5.6.2 Review OutputThe output from the management review shall include anydecisions and actions related to :• Improvement of the effectiveness of the quality management system and its processes.• Improvement of product related to customer requirements• Reserve needs.6.1 Provision of Resources:• To meet the customer‟s requirements6.2 Human Resources6.2.2 Competence, awareness and training
CERTIFYING BODIES (contd)6.3 Infrastructure6.4 Work Environment7. Product realization7.1 Planning of product realization• Establish processes, documents• Required verification, validation, monitoring inspection and test activities• Records needed to provide evidence that realization.Support processes:• Training /competence of people• Marketing inputs• Management of data/information
CERTIFYING BODIES (contd)7.2 Customer related process7.2.1 - Review of requirements related to product7.2.2 - Customer communicationSystems in relation to -• Product Information• Schedule, contract, amendments (if any)• Feedback .complacent from customer
CERTIFYING BODIES (contd)7.3 Design and Development Planning• Stages• Review verification, validation• Resources required along with their responsibility and authority7.3.1 Design Development Inputs• Products requirements• Statutory and regulatory requirements• Results of contract review• Competence requirements for people performing design and development• Feed back information from past experience
CERTIFYING BODIES (contd)7.4 Purchasing The organization shall establish• Effective and effective purchasing process• Criteria, based on which suppliers are selected and evaluated.They should include following –• Evaluation of past experience with supplier• Criteria for evaluating suppliers• Audit of supplier management systems.7.4.1 Purchasing Information7.4.2 Verification of purchased product
CERTIFYING BODIES (contd)7.5 Production and service provision in respect to-• Choosing appropriate and competent Men• Having documented (where required) Method• Selecting appropriate – Machine• Use of appropriate grade – Materials• Monitoring and observing process at vital points through Measurement.7.5.1 Validation of Processes for production and service provision
CERTIFYING BODIES (contd)7.5.2 Identification and Traceability for the purpose of –• Contractual requirement• Organizations own requirements to take corrective actions• Legal/statuary requirement7.5.3 Customer property• Control of verification storage, maintenance of customer supplied properly.7.5.4 Preservation of Product
CERTIFYING BODIES (contd)7.6 Control of Monitoring land measure device.8. Measurement, Analysis and ImprovementShall plan monitor, analyze and improve processes for –• Production Evaluation• Process Evaluation• Customer Satisfaction• Quality objectives8.1 Monitoring and Measurement
CERTIFYING BODIES (contd)8.2 Customer Satisfaction – include• Customer and surveys• Feed back on product• Customer complaints• Contract information• Market needs• Information relating to competition8.2.1 Internal Audit (Quality)8.2.2 Monitoring and Measurement Product
CERTIFYING BODIES (contd)8.3 Control of non conforming product by –• Rework to meet specified requirements• Accepted as its under concession• Regarded for alternative application• Rejected or scrapped.
CERTIFYING BODIES (contd)8.4 Analysis of DataTo achieve information for –• Customer satisfaction• Product characteristics• Process capability/validation• SuppliersResults of such analysis can be useful to determine –• Trends• Effectiveness and efficiency processes• Customer satisfaction• Bench marking of its performances
CERTIFYING BODIES (contd)8.5 Improvement8.5.1 Continual Improvement8.5.2 Corrective ActionTo prevent re-occurrence of non conformities documentedprocedures for -• Identifying• Analyzing &• Taking corrective actions including those arising from customer complaints
CERTIFYING BODIES (contd)8.5.3 Preventive Action• Action taken to prevent occurrence of potential non- conformitySome measures are –• Institute reward system• Cross functional, quality improvement teams• Quality circles• Kaizen Clubs
CERTIFYING BODIES (contd)Route Certification• Pre-Certification Requirement Organizations interested Should establish Quality Management System Commitment from the top Quality Manuals Quantity Plans Documents Executive procedures Work Instructions
CERTIFYING BODIES (contd)• Quotation from different ISO certifying bodies• Choice – based on - Market Target• Preliminary Information - Sought by organization• Application - in the prescribed form with fees.• Pre-Assessment process: - Detailed examination of the application to ensure compliance. - Correction – Amendments suggested - Preliminary visit
CERTIFYING BODIES (contd)After compliance• Assessment Process After intimating the dates and composition of the team is advancea) Introductory / opening meetingb) Brief tourc) Assessment execution • Each member – accompanied by local guide • Record Compliance Non conformance • Closing meeting and Report
CERTIFYING BODIES (contd)Post Assessment Process• Corrective Action - Minor noncompliance• Certification - Indicating conformance to specified standards Valid for 3 years
CERTIFYING BODIES (contd) SurveillancePost certification surveillance visits(Generally in once in six months) to verify maintenance ofQMS and continued requirements.• Modification to scope of certification• Suspension of Registration - for minor nonconformance• Withdrawal of Registration• For major nonconformance• Appeals• Renewal of Registration - To apply 3 months before the expiry - Fees - Reassessment
CERTIFYING BODIES (contd)Benefits of Q.M.S. Certification A. To organizations• Clearly indicates compliance with QMS standards• Improves credibility and enhances customer confidence• Reduces the need for multiple assessments• Provides opportunity for continuous improvement through regular audits• Provides more avenues for trade in the global market through bilateral agreements on mutual recognition of certification. B. To customers• Assure continued capability of organization to meet the requirements through regular surveillance• Reduces the need for assessment of organizations• Simplifies purchase procedures and decisions.
CERTIFYING BODIES (contd) MALCOLM BALDRIDGE NATIONAL QUALITY AWARD• Malcolm Baldridge National Quality Award was established by U.S. Congress in 1987 to recognize U.S. companies for their achievements in quality and business performance and to raise awareness about the importance of quality and performance excellence as competitive edge.• The awards are not given to any specific products or services.• Three awards are given in the following categories. - Manufacturing - Service - Small business - Education - Health care since 1999
CERTIFYING BODIES (contd)Baldridge Criteria:They are a frame work that any organization can use toimprove overall performance. Seven categories make upthe award criteria.• Leadership• Strategic Planning Strategic Directions Key Action Plans• Customer and Market Focus• Information and analysis Management Effective use of Data and Information Analysis
CERTIFYING BODIES (contd)• Human Resources Focus• Process Management• Business results: In Key areas like Customer satisfaction Financial Market Place Human Resources Supplier - Partner Operational• Company‟s Performance in relation to competitors.
CERTIFYING BODIES (contd)Selection• Applications for the award are evaluated by an independent Board of Examiners composed of primarily private sector experts in quality and business. Examiners look for achievements and improvements in all seven categories.• Each applicant receives a written summary of strengths and areas for improvement in each area addressed by the criteria.
CERTIFYING BODIES (contd)Seven Criteria: 1. Leadership - 9% 2. Information Analysis - 8% 3. Strategic Quality Planning - 6% 4. HRD & HRM - 15% 5. Management of Process Quality - 14% 6. Quality and Operational Results - 18% 7. Customer Focus and Satisfaction - 30% ---------- Total 100% ======
CERTIFYING BODIES (contd)INDIAN STANDARD ON QUALITY SYSTEMS Bureau of Indian Standards Indian Standards Manual was published• IS 10201 (1982): This descries the basic set of quality elements by which the quality management systems could be developed and implemented.• IS 13999 (1990): This defines the basic and fundamental terms relating to the quality concepts, as they apply to the products and services for the preparation and the use of quality standards and to facilitate mutual understanding in international communication.
CERTIFYING BODIES (contd)• IS 14000 (1990): Provides guidelines for the selection and the use of series of Indian standards on quality systems that can be used for internal quality management (IS 14004) as well as external quality assurance purposes (IS 14001) (IS 14002) and (IS 14003).• IS 14004 (1990) This standard together with IS 14000 provides guidance to all organizations on quality management. The standard helps in developing and implementing a quality system as also determining the extent to which each quality element is applicable
CERTIFYING BODIES (contd)• IS 14001 (1990) This standard is applicable when conformance to the specified needs is to be assured by the supplier throughout the whole cycle. From design through to servicing.• IS 14002 (1990) This standard is for use when the specified requirements for the products are stated in terms of an already established design or specification. Only the suppliers‟ capabilities in production and installation are to be demonstrated