BatStateU Quality Management Systems A Module in IE 411 QUALITY MANAGEMENT SYSTEMS 1|Page BatStateU Quality Management Systems TABLE OF CONTENTS …………………………………………. 1 Title Page Table of Contents ……………………………………. 3 Course Description and Intended Learning Objectives ……………………………………. 4 I. Concept of Quality, History of Quality Movement, Philosophies …………………………..5 II. Quality Management Systems …………………………………………………………..…17 III. Current and Emerging Quality Management Systems, Programs and Initiatives …….…. 21 IV. Total Quality Management ………………………………………………………….…… 28 V. Lean Six Sigma ……………………………………………………………………….….. 33 VI. Continuous Quality Improvement / PDCA ……………………………………………… 40 VII. Malcolm Baldrige National Quality Awards / Philippine Quality Awards ……………...46 VIII. General Problem-Solving Tools (e.g., Magnificent 7 Tools, etc.) …………………….. 51 IX. Tools for Measuring Quality (Process Charts, Process Capability Index) ……………….72 2|Page BatStateU X. Quality Management Systems Acceptance Sampling Course Description Techniques ………………………………………………………..85 This course is one of the fundamental courses in Industrial Engineering. Its focus is on the undestanding of the laws, principles and phenomena in the field of quality management. This aims to provide participants with a basic understanding on the rationale of implementing a structured management system within an organization. Its focus is on the principles and practices of quality management systems (QMS). Tools and techniques utilized in QMS will also be covered. Intended Learning Outcomes At the end of the course, you are expected to achieve the following outcomes: ILO 1 Identify concepts of quality management and improvement ILO 2 Develop an understanding of the role of technology, managers, employees, and customers in developing a quality-based workplace ILO 3 Develop abilities to apply quality improvement tools and techniques ILO 4 Develop abilities to apply quality improvement tools and techniques ILO 5 Identify current trends and benchmark organizations related to Quality Management 3|Page BatStateU Quality Management Systems Lesson 1: Concept of Quality, History of Quality Movement, Philosophies Learning Objectives: Define quality both from the customer and producer perspective Understand the historical movement of Quality Know the different Quality Gurus and contribution Demonstrate importance of quality if manufacturing Differentiate types of quality, dimensions, and cost of quality Definition Quality is …. Is that which makes a being or things such as it is distinguishing elements or characteristic. The characteristics of anything regarded as determining its values, place, worth, rank, position, etc. A moral trait or characteristic; and A degree of excellence; relative goodness; or grade. Customer: Quality is the ability of a product or service to consistently meet or exceed the expectations. Purchaser: Quality is the ability to meet all the expectations obtained in goods or services. International Organization for Standardization (ISO 8402): Quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. The strategic approach is proactive, focusing on preventing mistakes from occurring. Some of the most common definitions of Quality Conformance to specifications How well a product or service meets the targets and tolerances as determined by its designers. Fitness for use A definition of quality that evaluates how well the product performs for its intended use. Value for price paid 4|Page BatStateU Quality Management Systems Quality defined in terms of product or service usefulness for the price paid. Support services Quality defined in terms of the support provided after the product or service is purchased. History of Quality Movement The Industrial Revolution - Quality was determined who developed the process - Statistical analysis was introduced as a method of measuring the quality - Workers were judged by how much they can produce, not on the quality The Japanese Quality Revolution - Workers focused on defect prevention rather than inspection - Quality becomes everyone’s responsibility - All levels were trained on quality initiatives - Statistical method-controlled quality, but did not determine it - Employees participated in quality circles and other feedback programs - Because of this, Japanese increased their market share over the next 20 years Quality Gurus W. Edwards Deming 14 Points Plan-Do-Check-Act cycle Training & data-based problem solving Joseph M. Juran The Quality Handbook editor Management breakthrough Quality trilogy Armand V. Fiegenbaum Total Quality Control Quality costs 5|Page BatStateU Quality Management Systems “Hidden plant” Kaoru Ishikawa Quality control circles Cause-effect diagrams Elemental statistical methods Philip B. Crosby Quality Is Free Zero defects Defined quality: meeting customer Requirements Genichi Taguchi Efficient experimental design Robust design Quality loss function Importance of Quality 1. Customer satisfaction 2. Avoid rework 3. Avoid cost of losing customers 4. Increase efficiency 5. Increase productivity 6. Increase market share 7. Increase moral of workers/employees Types of Quality • Quality of Design • Quality of Product • Quality of Process • Quality of Systems • Quality of Service 6|Page BatStateU Quality Management Systems Dimensions of Quality 1. Performance - Main characteristics of the product or service 2. Aesthetics - Appearance, fee, smell, or taste 3. Special features - Extra characteristics 4. Conformance - How well a product or service corresponds to design specifications, and to the customer’s expectations 5. Reliability - Consistency of performance 6. Durability - The useful life of the product or service 7. Perceived Quality - Indirect evaluation of quality (e.g. reputation) 7|Page BatStateU Quality Management Systems 8. Service after sale - Handling of complaints or checking of customer satisfaction Cost of Quality The reason quality has gained such prominence is that organizations have gained an understanding of the high cost of poor quality. Quality affects all aspects of the organization and has dramatic cost implications. The most obvious consequence occurs when poor quality creates dissatisfied customers and eventually leads to loss of business. Two categories of cost of quality The first category consists of costs necessary for achieving high quality, which is called quality control cost. There are of two types: appraisal cost and prevention cost. The second category consists of the cost consequences of poor quality, is called quality failure cost. These include external failure cost and internal failure cost. Quality Control Cost - Appraisal cost - Prevention cost Quality Failure Cost - External Failure Cost - Internal Failure Cost 8|Page BatStateU Quality Management Systems Lesson 2: Quality Management Systems Learning Objectives Define Quality Management Systems Understand the function and purpose of QMS Define elements and design of QMS Recognize the benefits of quality management system Demonstrate how to establish and Implement QMS Definition Organization is a chain of internal suppliers and customers, who are collectively responsible to deliver finished products to end customer. Quality Management Management activities and functions involved in determination of quality policy and its implementation through means such as quality planning, quality assurance and quality control) Quality Management Systems A system comprised of quality planning and quality improvement activities, the establishment of a set of quality policies and objectives that will act as guidelines within an organization, and QA and QC. A planned and established by documenting procedures for the processes of organization to fulfill the needs and expectations of internal and end customers. ISO Refers to the International Organization for Standardization. Comes from the Greek word “isos” meaning “equal” – a standard for all. ISO establishes common worldwide standards. 9|Page BatStateU Quality Management Systems Function of the Management System Standards These standards provide requirements or guidelines for organizations to develop and systematically manage their policies, processes, and procedures to achieve specific objectives. Usually, they adopt a plan–do–check–act (PDCA) approach to achieve the objectives. QMS Purpose • Improving Process • Facilitating and Indentifying training opportunities • Engaging Staff QMS Benefits • Improve our organization. • Bring consistency and definition to processes, which will result in fewer defects and more efficient practices. • Meet a global requirement by the customers to fulfill their requirements and to be qualified as a supplier. • Solve problems (Section 8 of the ISO 9001 standard). • Increase market share by freeing up financial resources. • Reduce waste, scrap, and rework. • Increase customer confidence in our products and services. QMS Elements • The organization’s quality policy and quality objectives • Quality manual • Procedures, instructions, and records • Data management 10 | P a g e BatStateU Quality Management Systems • Internal processes • Customer satisfaction from product quality • Improvement opportunities • Quality analysis Establishing and Implementing a QMS The QMS design should be influenced by the organization’s varying objectives, needs, and products and services provided. This structure is based largely on the plan-do-check-act (PDCA) cycle and allows for continuous improvement to both the product and the QMS. The basic steps to implementing a quality management system are as follows: 1. Design 2. Build 3. Deploy 4. Control 5. Measure 6. Review 7. Improve Design and Build These portions serve to develop the structure of a QMS, its processes, and plans for implementation. Deploy Best served in a granular fashion by breaking each process down into subprocesses and educating staff on documentation, education, training tools, and metrics Control and Measure 11 | P a g e BatStateU Quality Management Systems Largely accomplished through routine, systematic audits of the quality management system Review and Improve Detail how the results of an audit are handled. 12 | P a g e BatStateU Quality Management Systems Lesson 3: Current and Emerging Quality Management Systems, Programs, and Initiatives Learning Objectives: Define the different programs of QMS Define ISO and ISO 9000 Learn the advantages of ISO Determine the eight qualtiy management priciples Definition ISO Refers to the International Organization for Standardization. ISO establishes common worldwide standards Greek word “isos” meaning “equal” – a standard for all An independent, non-governmental, international organization aims to develops standards to ensure the • quality, • safety, • efficiency of products, services, and systems It is a family of standards related to Quality Management Systems Helps organization to ensure that they meet the needs of customers while meeting statutory and regulatory requirements Advantages of ISO • Quality is maintained • ISO registration has significant bearing on market credibility 13 | P a g e BatStateU Quality Management Systems • • Opportunity to compete with larger companies More time spent on customer focus • Means that company is committed to quality • May facilitate trade and increased market opportunities • Can increase customer confidence and satisfaction INTERNATIONAL STANDARDS ISO 9000 The emphasis on customer satisfaction and continuous quality improvement has necessitated a system of standards and guidelines that support the quality philosophy. To address this need, the International Organization for Standardization (ISO) developed a set of standards, ISO 9000, 9001, and 9004 THE ISO 9000 FAMILY • ISO 9000—Quality Management Systems: Fundamentals and Vocabulary • ISO 9001—Quality Management System Requirements • ISO 9004—Managing for the Sustained Success of an Organization What is the ISO 9001 Standard? A document that describes all of the requirements needed in order to create and maintain a quality management system as described in ISO 9000. Both the ISO 9000 and 9001 standards are based on a number of quality management principles including a strong customer focus, the motivation, and implication of top management, the process approach and continual improvement. 14 | P a g e BatStateU Quality Management Systems Quality Management Principles Underlying ISO 9000:2015 1. Customer focus - Understand the needs of existing and future customers - Align organizational objectives with customer needs and expectations - Meet customer requirements - Measure customer satisfaction - Manage customer relationships - Aim to exceed customer expectations - Learn more about the customer experience and customer satisfaction 2. Leadership - Establish a vision and direction for the organization - Set challenging goals 15 | P a g e BatStateU Quality Management Systems - Model organizational values - Establish trust - Equip and empower employees Recognize employee contributions 3. Engagement of people - Ensure that people’s abilities are used and valued - Make people accountable - Enable participation in continual improvement - Evaluate individual performance - Enable learning and knowledge sharing - Enable open discussion of problems and constraints 4. Process approach - Manage activities as processes - Measure the capability of activities - Identify linkages between activities - Prioritize improvement opportunities - Deploy resources effectively 5. Systematic approach to management - Identifying, understanding and managing interrelated processes - Contributes to the organisation’s effectiveness and efficiency in achieving its objectives - Focuses its efforts on the key processes - Aligning complementary processes to get better efficiency. - his means that multiple processes are managed together as a system which should lead to greater efficiency. 6. Continual Improvement - Improve organizational performance and capabilities - Align improvement activities - Empower people to make improvements - Measure improvement consistently - Celebrate improvements 7. Factual approach to decision making 16 | P a g e BatStateU Quality Management Systems - Ensure the accessibility of accurate and reliable data - Use appropriate methods to analyze data - Make decisions based on analysis Balance data analysis with practical experience - Tools for decision making 8. Mutually beneficial supplier relations - Identify and select suppliers to manage costs, optimize resources, and create value - Establish relationships considering both the short and long term - Share expertise, resources, information, and plans with partners - Collaborate on improvement and development activities - Recognize supplier successes Why ISO 9000 or 9001? One misconception is that ISO 9000 or 9001 is only for manufactures or large organizations. As a principles-based standard, ISO 9001 can be applied to any organization regardless of what type or size it may be. The standard defines the requirements, but it does not dictate the method of application. The latest version of the standard has been specifically designed to be more accessible to organizations outside the manufacturing sector ISO 9001 Benefits Clear understanding of your objectives and new business opportunities. Identifying and addressing the risks associated with your organization. Renewed emphasis on putting your customers first. Meeting the necessary statutory and regulatory requirements. Organizational and process alignment to increase productivity and efficiency. What is an ISO 9000 Certification? To become ISO 9000 certified, should really be focused on ISO 9001. 17 | P a g e BatStateU Quality Management Systems ISO 9001 is the standard that sets out the criteria for a quality management system and is also the only standard within ISO 9000 that an organization can certify to. An organization must demonstrate the following in order to be ISO 9001 certified: • The company follows the guidelines within the ISO 9001 standard. • The company meets its own requirements. • The company meets its customer requirements and statutory and regulatory requirements; and • The company maintains documentation of its performance. How to Become ISO 9001 Certified? ISO 9001 certification process requires an organization to implement ISO 9001:2015 requirements. Once implemented, an organization must successfully complete registrar’s audit to confirm that the organization system meets those requirements. ISO 9001 and ISO 9004 are a consistent pair. They are designed for use together but may be used independently, with their structures being simila Two fundamental themes • customer-related processes • concept of continual improvement 18 | P a g e BatStateU Quality Management Systems Lesson 4: Total Quality Management Learning Objectives: Define Total Quality Management Enumerate Concept and Characteristics of TQM Discuss the Traditional approach vs TQM Identify the Elements of TQM Discuss the principles of TQM Definition Total – made up of whole Quality –degree of excellence a product or service provides Management –act, art or manner of planning, controlling, directing…. The Concept of TQM • Product quality product the first time • Focus on the customer • Have strategic approach to improvement • Improve continuously • Encourage mutual respect and teamwork Total Quality Management is a philosophy that involves everyone in an organization in a continual effort to improve quality and achieve customer satisfaction. Various Definition of TQM • TQM is the integration of all functions and processes within an organization in order to achieve continuous improvement of the quality goods and services. • The process to produce a perfect product by a series of measures require an organized effort by the entire company to prevent or eliminate errors at every stage in production is called total quality management. 19 | P a g e BatStateU • Quality Management Systems According to ISO “TQM is a management approach for an organization, centered on quality, based on the participation of all members and aiming at long-term success through customer satisfaction and benefits to all members of the organization and to the society. Traditional Approach and TQM Quality Element Traditional Approach TQM Definition Product-based Customer-based Decision Short-term Long-term Emphasis Detection Prevention Errors Operations Systems Responsibility Quality control Everyone Problem solving Managers Teams Manager’s role Plan, assign, control, and enforce Delegate, coach, facilitate and mentor The Key Elements of the TQM Focus on the customer Employee Involvement Continuous Improvement Continuous Improvement 20 | P a g e BatStateU Quality Management Systems TOTAL QUALITY MANAGEMENT PRINCIPLES: 1. Customer Focus: The strategy of Total quality management is customer- oriented. 2. Process-Centered: If problems are being caused by your process, then any training or changing the workforce will not help you enough to get through the desired success. 3. Strategic Approach: A well-planned strategy can lead an organization to its desired position. Companies must focus upon planning the execution strategy and implementing them. 21 | P a g e BatStateU Quality Management Systems 4. Communication: The communication strategy focus upon the internal and external communication of an organization. The stakeholders, members, directors and even the employees must have the same goal and that is the growth of the organization 5. Statistics and Study: Comparative analysis and evaluation help an organization to decrease the number of flaws. If an organization performs well and don’t devote enough time in evaluating the workflow, the company will get less competent in no time. The competitors who are providing the same sort of products or services can get the extra benefit of the organization not caring about the flaws in their process. 6. Employee involvement: Employees are an organization’s internal customers. Without the involvement of the internal workforce, the growth of an organization is completely not workable. 7. Integrated system: It is necessary to have a company quality system following principle Process apparatus, for the understanding and handling of the quality of services or the products of a company or an integrated organization system which may be modelled for example ISO 9000. 22 | P a g e BatStateU Quality Management Systems Lesson 5: Lean Six Sigma Learning Objectives: Define Lean Discuss waste and value as the two important concepts of Lean Introduce Six Sigma concept Discuss Six Sigma and its structured problem-solving methodology. Explain the concept of lean six sigma What is Lean? It is a process that helps to reduce or eliminate processes that doesn’t add value to the product Aims to reduce the wastes involved in the process. Lean helps in: Reducing process cycle time Improving product or service delivery time Reducing or eliminating chance of defect occurrence Reducing inventory levels Optimizing resources available What is VALUE? “Value” is related to customer’s perception of product(s) or service(s), which he or she is willing to pay for. • Value added activities - These activities add value to the process and are essential. They improve processes for productivity and quality. • Non- value added (but necessary) activities -These activities do not add value to a customer. They are necessary for continuity of a process. • Non- value added (and un-necessary) activities - These activities do not add any value to the process or products. They form the wasteful steps. 23 | P a g e BatStateU Quality Management Systems What is waste? - “Muda” in Japanese term - Can be explained using “DOWNTIME” Waste Definition of waste D Defects The efforts involved inspecting for and fixing errors, mistakes through reworks. O Overproduction Producing more products or services that the customer needs or downstream process can use. W Waiting Idle time created when material, information, people, or equipment is not ready. N Non-utilized Talent Not adequately leveraging peoples’ skills and creativity. T Transporation Moving products, equipment, material, information, or people from one place to another, without any value addition to final product or service. I Invetory Unnecessary/ Unwanted stocking or storage of information and/ or material (eg WIP, WIQ – work in the queue) M Motion Unnecessary movement of people or machines that takes time and uses energy. It may cause fatigue to workman due to unwanted movement of a body. 24 | P a g e BatStateU E Quality Management Systems EXtra Processing Process steps that do not add value to the product or service, including doing work beyond a customer’s specification. What is Six Sigma? Six Sigma is a data-driven problem-solving methodology The focus is on process variations and emphasis is given to customer satisfaction. Continous process improvement with low defects is the goal of this method. The goal of Six Sigma: The aim of Six Sigma is to make a process effective with - 99.99966 % defect free. This means a six-sigma process produces in 3.4 defects per million opportunities or less as a result. THE DMAIC PROCESS 25 | P a g e BatStateU Quality Management Systems DEFINE • Define the problem • Improvement activity, opportunity for improvement, the project goals, and customer • (internal and external) requirements Project charter • Voice of the customer • Value stream map MEASURE • Measure process performance • Develop a data collection plan for the process. Collect data from many sources to determine types of defects and metrics.Compare to customer survey results to determine shortfall. • Process map • Capability analysis • Pareto chart ANALYZE • Analyze the process to determine root causes of variation and poor performance (defects). • Root Cause Analysis • Failure mode and effects analysis (FMEA) • Multi-vari chart IMPROVE • Improve process performance by addressing and eliminating the root causes. • Design of experiments (DOE) • Kaizen event CONTROL • Control the improved process and future process performance. • Quality control plan 26 | P a g e BatStateU Quality Management Systems • Statistical process control (SPC) • 5S • Mistake proofing (poka-yoke) Six Sigma Phase Description of Phase Define In this stage, project objectives are outlined. A project charter is a blueprint document for a six-sigma project. A typical charter contains business case, problem statement, project scope, resources, timeliness, estimated benefits Measure Process variables are measured at this stage. Process data is collected. The baseline is obtained, and metrics are compared with final performance metrics. Process capability is obtained. Analyse Root cause analysis is done at this stage. Complex analysis tools are utilized to identify the root causes of a defect. Improve Once final root causes are identified, solutions need to be formed to improve the process. Steps to identify, test and implement the solutions to eliminate root causes are part of this stage Control A control system must be in place to monitor the performance post improvement. And a response plan is developed to handle solution failure. 27 | P a g e BatStateU Quality Management Systems DMAIC Application Imagine you want to clean up your garage so you can fit a new motorcycle inside. You could use Lean methods to accomplish this goal. DMAIC PHASE Cleaning Your Garage Define Identify the scope of the cleaning project (cleaning the garage, not whole house). Measure Pace off the square footage of the overall garage and of the open floor space. Set a goal for required amount of open floor space. Analyze Understand the types and amounts of materials currently in place and the available storage locations. Improve Use Lean tools (e.g. 5S) to execute cleaning and organizing, including removing unessential materials. Install improved vertical storage facilities to minimize floor space used. Control Label storage spots. Put “after” photos in place as ongoing targets What is Lean Six Sigma? “Lean Six Sigma is a fact-based, data-driven philosophy of improvement that values defect prevention over defect detection. It drives customer satisfaction and bottom-line results by reducing variation, waste, and cycle time, while promoting the use of work standardization and flow, thereby creating a competitive advantage. 28 | P a g e BatStateU Quality Management Systems It applies anywhere variation and waste exist, and every employee should be involved.” Method: Implement lean tools such as Uses DMAIC method and quality tools Kaizen events, Value Stream Mapping, 5S, TPM etc. Why is Lean Six Sigma gaining the importance in today’s scenario? The ultimate objective is to improve processes by reducing variation and eliminating waste. It’s a continuous improvement process, where Lean methods and Six Sigma approaches, both take their turn during PDCA. The extent of approaches may differ depending upon process complexities or improvement sought. The combination of these two methods helps to develop streamlined processes with high quality & results. It improves bottom-line profits and helps meeting business goals 29 | P a g e BatStateU Quality Management Systems Lesson 6: Continuous Quality Improvement Learning Objectives: Define CQI Define and discuss PDCA Cycle as a continuous improvement tool Know the benefits of PDCA Cycle What is CQI? Continuous Quality Improvement is a process to ensure programs are: Systematically and intentionally improving services. CQI is a proactive approach Helps organization to Reduce waste Increase Efficiency Increase Customer Satisfaction Continuous Improvement Kaizen means to change for good. Changing the process for the improvement of the product or service, Why do we even need CQI? Reduce Risk: Identify, eliminate or minimize things that go wrong 30 | P a g e BatStateU Quality Management Systems Improve care: Support care and services to go right Re-produce quality: develop care and services to achieve consistently good care for every consumer, everytime PDCA (Plan-Do-Check-Act) Cycle A continuous improvement tool with four logical sequence steps. A framework for problem solving continuous improvement and change Widely recognized as the basis of continually improving quality of process, products, and services. Provides a simple and structured approach for solving quality –related problems Also known as Deming Cycle/ wheel Shewart Cycle/ control circle/cycle Plan- Do- Study- Act (PDSA) Background of PDCA Walter shewart 1920’s : Shewart learning and improvement Cycle W. Edwards Deming 1950’s It’s a combination of the management thinking and statistical analysis BENEFITS of PDCA Encourages methodological way of problem solving and implementing solutions Ensures that you plan, test and incorporate feedback before you start full-scale implementation. Improves critical thinking skills of your team Helps to reach towards a more integrated system 31 | P a g e BatStateU Quality Management Systems Plan Do Another problem or improvement Modify Parameters Check No Goal Achieved? Yes Act Four Phases of PDCA Plan a change aimed at improvement Do – Carry out change Check/Study the results Act- Adopt, Adapt or Abandon Plan Analyze the current condition Identify exactly what the problem is 32 | P a g e BatStateU Quality Management Systems Map the process Establish the objectives Do Implement the plan Generate possible solution Execute the process Data collection Check Study the actual results Compare the results against expected results Act Take action based on the study Two possibilities: If the changed did not work, go through the cycle again with a different plan If you were successful then standardize, document, sustain the improved process and integrate into organization’s system. When to use PDCA? When starting a new improvement project When developing a new or improved design of process Exploring a range of possibilities When implementing changes 33 | P a g e BatStateU Quality Management Systems A common example often used is when a design team is planning for a new product development. Tools used for PDCA Phase Tasks Useful Tools Plan Identify the problem Brainstorming, flowchart, pareto chart, cause and effect analysis, whywhy diagrams etc. Determine the root cause Create the action plan 34 | P a g e BatStateU Quality Management Systems Do Implement the action plan Control Charts, Sampling, data collection methods, scatter diagram, checksheets, gantt chart etc. Check Review and evaluate the results of the changes made Graphical analysis, pareto charts, histogram, checksheet , control charts etc. Act Reflect on what has been learned Flowcharts, checksheets etc. Recommend changes Standardize successful changes 35 | P a g e BatStateU Quality Management Systems Lesson 7: Malcolm Baldrige National Quality Award and Philippine Quality Awards Learning Objectives: Define Malcolm Baldrige Award Discuss History of Malcolm Baldridge Award Explain reasons for establishing award and its purpose Describe the pillars of Malcolm Baldrige Define Philippine Quality Awards State objectives and benefits of PQA Malcolm Baldrige National Quality Award It was created to promote quality awareness, identify the requirements for quality excellence, and share information about successful quality strategies and benefits. An annual award given by the government of the United States to every organization in the US (both profit and nonprofit), which is considered to achieve exceptional performance or excellent. Founder of Malcolm Baldrige Award • Aims of Malcom Baldrige Award 36 | P a g e He is Secretary of Commerce Malcolm Baldrige • A proponent of quality management BatStateU Quality Management Systems Enhance competiveness and performance of U.S Organizations Identify and recognize role model organizations Establish criteria for evaluating improvement efforts Disseminate and share best practices Six eligibility categories Manufacturing Service Small business (manufacturing or service) Education (for profit & nonprofit) Health care (for profit & nonprofit) Nonprofit, including charities & government agencies How award helps an organization The criteria for winning the award are very demanding and simply trying to align a company to them is highly beneficial. It can be used as motivational toll for workers to rally behind a common goal,. Simply by competing for the award an organization sees the importance of quality in their business. The criteria they use is also known as the 7 Pillars of Malcolm Baldrige. 55% of evaluation is based on how the organization is run, 45% on the basis of performance Every major part of organizational is accessed. Continuous improvement and reavaluation is very important. Pillars of Malcolm Baldrige 37 | P a g e BatStateU Quality Management Systems How organization develops objectives? How is the performance level compared to competitors? How workforce capability were assessed and utilized? How leaders sustain and guide the organization? How firm listens to the voice of the customers and build relationship with them? How improvements were design? Leadership Strategic Planning Customer and Market Focus Performance Measurement Human Resource Development and Management Process Management Business Result How to select and analyze data and how to review findings Board of Examiners Independent board research each competing organization, and follows the specific criteria previously mentioned. Site visits consist of 4-6 examiners Examiners are volunteers Appointment of Board of Examiners is a very prestigious honour. 38 | P a g e BatStateU Quality Management Systems The Philippine Quality Award (PQA) About PQA? It is patterned after Malcolm Baldrige National Quality Award What is PQA? Promotes Performance Excellence through adoption of PQA Criteria. Offers an assessment tool to evaluate organizational processes and performance results; and Provides training for organizations and would –be assessors and best practice sharing conferences Objectives of the PQA 1. Standards on organizational performance 2. National system for assessing quality and productivity performance 3. To recognize organizations which have achieved the highest level of quality and business excellence Benefits of PQA Outside perspective of organizations strengths and opportunities for improvement Thorough evaluation and review by experts and panel of assessors Feedback Report to guide your organization’s quality and productivity improvement Increase employee involvement, customer satisfaction and retention Achieve performance results 39 | P a g e BatStateU Quality Management Systems Benchmark for exceptional management practices Program Beneficiaries Public Sector National Line Agencies Government owned and controlled corporations Local Government Units State Universities and Colleges Other Government Agencies Private Sector Agriculture Manufacturing Pharmaceutical Medicines Consumer/ Industrial Goods Foods/processed foods Electronics Services Educational Institution Healthcare Institution Financial Institution Other industries 40 | P a g e BatStateU Quality Management Systems Assessment process Submission of Application Report Eligibility Determination Independent Review Initial Consensus Review Site Visit Review Final Judges Review Recognition Levels Lesson 8: General Problem-Solving Tools Learning Objectives: Explain the different tools and techniques for Quality Improvement Perform each tools and techniques based on scenario. Introduction All organizations need to improve continuously. There is increasing pressure from customers, competitors, regulators and employees to do things better, faster and at lower cost. 41 | P a g e BatStateU Quality Management Systems What is a problem? • A problem is • “a deviation from normal expectations.” • “a gap between desired and actual situation” THE PROBLEM-SOLVING PROCESS A methodical and effective approach for analysing problems and generating workable solutions to them. When to use it • • A problem exists Needs improvement Why use it? • Can identify quick fixes as well as permanent solutions to the ROOT CAUSES. The Problem-Solving Process 1. Identify Possible Cause Define the Problem 2. Investigate & Fix 3. Analyse Data & Identify Root Causes 42 | P a g e BatStateU Quality Management Systems 4. Identify Possible Solutions 5. Select & Implementation stages Test Solutions Implementation stages if viable, Review/re-start if not viable It is often necessary to step back from your first thoughts on what a problem is, so that you truly understand what it is that needs to be solved. Define the Problem STEP 1: Identify Possible Causes • Aim: To generate a list of all the possible causes of a defined problem. 43 | P a g e BatStateU Quality Management Systems STEP 2: Investigate and Fix • Aim: To identify which possible causes actually contribute to the problem and fix those that can be acted upon immediately. STEP 3: Analyse Data and Identify Root Causes • Aim: To identify the root causes of a problem. STEP 4: Identify Possible Solutions 44 | P a g e BatStateU • Quality Management Systems Aim: To identify possible solutions which could be used to eliminate the identified root cause(s). Main tools to use: Brainstorming STEP 5: Select and Test Solutions • Aim: To select an effective, practical and implementable solution that will remove the root cause of a problem Implementation Stages Once a viable solution has been identified, you can move on to the Implementation Stages. This involves the implementation of the solution generated at the previous stage together with the establishment of indicators to monitor the effectiveness of the solution. Education, Training and Communication 45 | P a g e BatStateU Quality Management Systems • Involve all those affected by the problem solution • Listen to feedback • Consider education and training needs Implementation Planning • Identify planned activities and critical path • Identify measures and resource requirements • Involve and train those affected by the solution Implementation and Follow Up • Implement your solution • Measure improvement • Follow up – make sure it sticks • Report on success BRAINSTORMING Brainstorming is a technique that encourages creative thinking and the generation of ideas. When to use it • To generate a list of potential problems to solve • To identify possible causes of a problem • To identify possible solutions to a problem • To develop action plans Rules for Brainstorming • Choose the right team and have a leader • Ensure everyone knows the rules • • Define the problem/topic clearly Allow time for individual thought before generating ideas as a group 46 | P a g e BatStateU Quality Management Systems • Ensure everyone participates • Generate as many ideas as possible • Ban discussion and evaluation during the idea generation stage • Record every idea, on a Flipchart • Allow incubation time before evaluating the ideas • Keep a relaxed atmosphere Affinity Diagram Allow individuals to Brainstorm onto Cards or Post-it Notes (one idea per card), stick all the ideas on a wall, then arrange them into groups of similar ideas. The Magnificent 7 Tools 1. Checksheets 47 | P a g e BatStateU Quality Management Systems • It is used to document data at a certain point over a period of time. • It is an easy data collection tool that can be applied in a variety of applications Applications: – To collect and analyze data at a fixed place, usually by the same person. – To record the probability and pattern of events, defects or similar issues. – To keep track of steps of an established procedure in a production process. 2. Histogram • Graphical representation of the distribution of numerical data • Values are assigned “bins or intervals” and frequency of each bin is plotted. Applications: To represent numerical data. To see the shape of the distribution of data. To see the change in process for different periods of time. To provide an easy and efficient way of sharing data. To check the frequency of occurrences between different ranges. 3. Cause and Effect Analysis/Fish- Bone Diagram It is a cause analysis tool which is used to identify all possible causes leading to an event or a problem. It is also useful for sorting all ideas into categories. Alternate Names to this approach are known as Ishikawa diagram and cause-and-effect diagrams. • It usually classifies causes into 6 categories: • Man • Materials • Machine • Methods • Measurements • Environment/Mother nature Applications: 48 | P a g e BatStateU Quality Management Systems • Detecting the possible causes of a problem. • For collective brainstorming about resolving the problem with the team. • For designing a new product. • Troubleshooting for a business challenge 4. Pareto Charts It is fundamentally a bar chart. The chart was named after the Pareto principle (80/20 rule). As the principle suggests Pareto charts are used to observe the factors which carry the highest weight Applications: When using the 80/20 rule to analyze the most important causes of a process or event(s). When analyzing the frequency of recorded occurrences. To distinguish the biggest causes in a large set of defects or problems. 5. Control Charts A control chart is a statistical tool for monitoring the behaviour of the processes with respect to time against the controls dictated by the process itself. The control charts were introduced by Walter A. Shewhart, who was working for Bell Labs, in order to control the quality of their transmission systems Purpose: to monitor process output to see if it is random (in control) or not (out of control). A time ordered plot representative sample statistic obtained from an ongoing process (e.g. sample means). Upper and lower control limits define the range of acceptable variation Applications: Used to determine if a manufacturing or business process is in a state of statistical control Used to detect/identify assignable causes. One of the most commonly used methods of Statistical Process Control (SPC), which monitors the stability of a process. 49 | P a g e BatStateU Quality Management Systems Reading Control Charts Control chart is out of statistical control if: Control Charts Types of control charts 50 | P a g e BatStateU • Quality Management Systems Control charts for attributes are used to monitor characteristics that have discrete values and can be counted, e.g. defective, number of flaws in a shirt, number of broken eggs in a box, etc. • Control charts for variables are used to monitor characteristics that can be measured, e.g. length, weight, diameter, time, etc. Are typically used used in pairs: monitors process average monitors the variation in the process Variables Control Charts • Mean control charts – Used to monitor the central tendency of a process. – X-bar charts • Range control charts – Used to monitor the process dispersion – R charts Guidelines in X Bar and R Chart: • The R chart is examined first before the X bar chart • If the R chart indicates the sample variability is in statistical control, the X bar chart is examined to determine if the sample mean is also in statistical control. • If the sample variability is not in statistical control, then the entire process is judged to be not in statistical control regardless of what the X bar chart indicates. Steps in Constructing the X Bar Chart 1.Find the mean of each subgroup and the grand mean of all 51 | P a g e subgroups. BatStateU Quality Management Systems 2. Find the UCL and LCL 3. Plot the LCL, UCL, center line, and subgroup means 4. Interpret the data and determine if the process is in control. Mean Chart (X-bar chart) • The control limits of the mean chart is calculated as follows: (first approach) • Upper Control Limit (UCL) = • Lower Control Limit (LCL) = Where: n = sample size z = standard normal deviation (1,2 and 3; 3 is recommended) = process standard deviation x x = standard deviation of the sampling distribution of the mean = average of sample means Mean Chart (X-bar chart) Example A quality inspector took five samples, each with four observations of the length of time for glue to dry. The analyst computed the mean of each sample and then computed the grand mean. All values are in minutes. Use this information to obtain three-sigma (i.e., z = 3) control limits for the means of future time. It is known from previous experience that the standard deviation of the process is 0.02 minute. 52 | P a g e BatStateU Quality Management Systems Solution n=4z= 3 = 0.02 53 | P a g e BatStateU Quality Management Systems Mean Chart A second approach to calculate the control limits: This approach assumes that the range is in control UCL=x+A2R LCL=x−A2R Where: A2 = A factor from table R = Average of sample ranges This approach is recommended when the process standard deviation is not known 54 | P a g e BatStateU Quality Management Systems Example Twenty samples of n = 8 have been taken from a cleaning operations. The average sample range for the 20 samples was 0.016 minute, and the average mean was 3 minutes. Determine three-sigma control limits for this process. Solution x = 3 min. , R = 0.016, A2 = 0.37 for n = 8 UCL=x+A2R= 3+ 0.37(0.016) = 3.006 LCL=x−A2R= 3−0.37(0.016) = 2.994 Range Control Chart (R-chart) • The R-charts are used to monitor process dispersion; they are sensitive to changes in process dispersion. Although the underlying sampling distribution of the range is not normal, the concept for use of range charts are much the same as those for use of mean chart. • Control limits: UCL=D4R LCL=D3R 55 | P a g e BatStateU Quality Management Systems R-chart • Example Twenty-five samples of n = 10 observations have been taken from a milling process. The average sample range was 0.01 centimeter. Determine upper and lower control limits for sample ranges. • Solution R = 0.01 cm, n = 10 From table, for n = 10, D4 = 1.78 and D3 = 0.22 UCL = 1.78(0.01) = 0.0178 or 0.018 LCL = 0.22(0.01) = 0.0022 or 0.002 Using Mean and Range Charts • • Mean control charts and range control charts provide different perspectives on a process. The mean charts are sensitive to shifts in process mean, whereas range charts are sensitive to changes in process dispersion. • Because of this difference in perspective, both types of charts might be used to monitor the same process. Control Chart for Attributes • Control charts for attributes are used when the process characteristic is counted rather than measured. Two types are available: • P-Chart - Control chart used to monitor the proportion of defectives in a process • C-Chart - Control chart used to monitor the number of defects per unit • Attributes generate data that are counted. 56 | P a g e BatStateU Quality Management Systems Use of p-Charts • When observations can be placed into two categories. – Good or bad – Pass or fail – Operate or don’t operate • When the data consists of multiple samples of several observations each • The theoretical basis for the P-chart is the binomial distribution, although for large sample sizes, the normal distribution provides a good approximation to it. • A P-chart is constructed and used in much the same way as a mean chart. • The center line on a P-chart is the average fraction defective in the population, P. • The standard deviation of the sampling distribution when P is known is: p(1−p) p= n The Control limits If p is unknown, it can be estimated from the samples. That estimates , replaces p in the preceding formulas, and replaces p. p = Total number of defectives Total number of observations P-Chart Example 57 | P a g e BatStateU • Quality Management Systems An inspector counted the number of defective monthly billing statements of a company telephone in each of 20 samples. Using the following information, construct a control chart that will describe 99.74 percent of the chance variation in the process when the process is in control. Each sample counted 100 statements. Solution p= = 0.11 ^ p(1−p) p = = = 0.03 n 100 0.11(1− 0.11) Control limits are ^ UCL = p+z p = 0.11+ 3(0.03) = 0.20 ^ 58 | P a g e BatStateU Quality Management Systems LCL = p−z p = 0.11−3(0.03) = 0.02 Use of c-Charts Use only when the number of occurrences per unit of measure can be counted; non-occurrences cannot be counted. – Scratches, chips, dents, or errors per item – Cracks or faults per unit of distance – Breaks or Tears per unit of area – Bacteria or pollutants per unit of volume • – Calls, complaints, failures per unit of time When the goal is to control the number of occurrences (e.g., defects) per unit, a C-chart is used. • Units might be automobiles, hotel rooms, typed papers, or rolls of carpet. • The underlying sampling distribution is the Poisson distribution. • Use of Poisson distribution assumes that defects occur over some continuous region and that the probability of more than one defect at any particular point is negligible. 59 | P a g e BatStateU • Quality Management Systems The mean number of defects per unit is c and the standard deviation is: c UCL =c+z c LCL =c−z c If the value of c is unknown, as is generally the case, the sample estimate, c , is used in place of c. where: c = Number of defects ÷ Number of samples C- Chart Example Rolls of coiled wire are monitored using c-chart. Eighteen rolls have been examined, and the number of defects per roll has been recorded in the following table. Is the process in control? Plot the values on a control chart using three standard deviation control limits. Solution 60 | P a g e BatStateU Quality Management Systems Average number of defects per coil = c = 45/18 =2.5 UCL=c+3 c = 2.5+3 2.5 = 7.24 LCL=c−3 c = 2.5−3 2.5 =−2.24 → 0 When the computed lower control limit is negative, the effective lower limit is zero. The calculation sometimes produces a negative lower limit due to the use of normal distribution as an approximation to the Poisson distribution. 6. Scatter Diagram It is commonly recognized as the most powerful analysis tool. It is a plot to show the relationship between “paired data”. The data is plotted in the form of points with the horizontal and vertical axis determining the value. Applications: To find the correlation between two variables. To find relationships between two seemingly unrelated variables objectively. To find the root cause of a problem or an event. After using an Ishikawa diagram to better analyze data and determining whether a particular cause and effect are related. When multiple points can be plotted for a dependent variable. Correlation describes the type of relationship between two data sets. The line of best fit is the line that comes closest to all the points on a scatter plot. 61 | P a g e BatStateU Quality Management Systems Positive correlation; both data No correlation sets increase together. Negative correlation; as one data set increases, the other decreases. Data of Technicians' Education, No. of complaints Received for Scatter Diagram 7. Flow Charts Process Flowcharts are used to show the steps in a process. These include the inputs and outputs as well as the intermediate steps and decision points. A process is a series of activities that converts an input to an output, by doing work. Process Flowcharts create a common understanding of the steps involved in carrying out any process. They can be used to highlight opportunities to streamline a process, making it both more effective and more efficient. Applications: • Organize a team for the purpose of examining the process • Construct a flow chart to represent each process step 62 | P a g e BatStateU Quality Management Systems • Discuss and analyze each step in detail • Ask the key question, “Why do we do it this way?” • Compare the actual process to an imagined “perfect” process • Is there unnecessary complexity? • Does duplication or redundancy exist? • Are there control points to prevent errors or rejects? Should there be? • Is this process being run the way it should? • Improvement ideas may come from substantially different processes • Lesson 9: Tools for Measuring Quality: Process Capability Index Learning Objectives: To present some of the commonly used process capability measures Demonstrate procedures for their computation, interpret them, and discuss any associated assumptions SPECIFICATION LIMITS AND CONTROL LIMITS Specifications limits and tolerance limits are often used interchangeably and are defined as the acceptable bounds on quality characteristics. Tolerance limits - generally preferred in evaluating manufacturing or service requirements Specification Limits - more appropriate for categorizing materials, products, or services in terms of their stated requirements. Specification limits are determined by the needs of the customer Tolerance Limit Can be two-sided (with upper and lower limits) or one-sided with either upper or lower limits 63 | P a g e BatStateU Quality Management Systems A lower tolerance limit defines the lower conformance boundary for an individual unit of manufacturing or service operation; an upper tolerance limit defines the upper conformance boundary. Specification Limit Specification limits are determined by the needs of the customer These limits are placed on a product characteristic by designers and engineers to ensure adequate functioning of the product. Specification limits and Control limits PROCESS CAPABILITY ANALYSIS • The determination of process capability begins only after the process has been brought to a state of statistical control. • A process is said to be in statistical control when the only sources of variation in the system are common causes Process Capability • Represents the performance of a process in a state of statistical control. It is determined by the total variability that exists because of all common causes present in the system • A common measure of process capability is given by 6σ, which is also called the process spread 64 | P a g e BatStateU Quality Management Systems Process Capability Analysis • Estimates process capability • Involves estimating the process mean and standard deviation of the quality characteristic. • Additionally, the form of the relative frequency distribution of the characteristic of interest is estimated. If specification limits are known, a process capability analysis will also estimate the proportion of nonconforming product Benefits of Process Capability Analysis 1. Uniformity of output 2. Maintained or improved quality 3. Product and process design facilitated 4. Assistance in vendor selection and control 5. Reduction in total cost NATURAL TOLERANCE LIMITS • Natural tolerance limits, also known as process capability limits, are established or influenced by the process itself. • They represent the inherent variation in the quality characteristic of the individual items produced by a process in control. 65 | P a g e BatStateU • Quality Management Systems They are estimated based on the population of values or, more typically, from large representative samples μ represents the process mean and σ represents the process standard deviation, which is the standard deviation of the individual items Example The diameter of a part has to fit an assembly. The specifications for the diameter are 5 ± 0.015 cm. The samples taken from the process in control yield a sample mean X of 4.99 cm and a sample standard deviation * of 0.004 cm. Find the natural tolerance limits of the process. Would you consider adjusting the process center? Solution: The upper and lower natural tolerance limits based on the sample estimates are found using eq • UNTL = 4.99 + (3) (0.004) = 5.002 • LNTL = 4.99 - (3)(0.004) = 4.978 • Assuming a normal distribution of diameters, the process spread is (6)(0.004) = 0.024 cm, which is the difference between the natural tolerance limits • For the current process, we would expect the diameters to lie between 5.002 and 4.978 cm • The difference between the specification limits is 0.03 cm. If the process were left in its original state, some proportion of the parts would fall below the lower specification limit of 4.985 cm. 66 | P a g e BatStateU Quality Management Systems Thus, it would be desirable to adjust the process center to the target value of 5 cm. If this is done, since the process spread is 0.024 cm and the difference between the specification limits is 0.03 cm, virtually all parts would fall between the specification limits, and we would have a capable process. SPECIFICATIONS AND PROCESS CAPABILITY • Technically, there might not be any mathematical relationship between the process capability limits (or the natural tolerance limits) and the specification limits. The former are determined by the condition of the process and its inherent variability; the latter are influenced by the needs of the customer. SPECIFICATIONS AND PROCESS CAPABILITY Case I: Process Spread Less Than Specification Spread If the process spread is less than the difference between the specification limits, the process is quite capable. 67 | P a g e BatStateU Quality Management Systems Case II: Process Spread Equal to Specification Spread If the process spread is the same as the difference between the specification limits, we have an acceptable or adequate situation in which there is no room for error If the distribution of the characteristic can be assumed to be normal and the process is in control, virtually all (99.74%) of the items produced will be within specifications. 68 | P a g e BatStateU Quality Management Systems Case III: Process Spread Greater Than Specification Spread An undesirable situation exists when the process spread is greater than the difference between the specification limits. The inherent variability in the process exceeds the specification spread even though the process is in control. PROCESS CAPABILITY INDICES • A process should first be analyzed to verify that it is in control before its capability is estimated. 69 | P a g e BatStateU • Quality Management Systems In this section we assume that the process output (i.e., the distribution of the quality characteristic under consideration) is normal. • The process capability index is an easily understood aggregate measure of the goodness of the process performance. • The ability to meet specifications is the criterion used for measuring the attractiveness of the process. • The capability indices we describe here are nondimensional, which makes them even more versatile and appealing because they do not depend on the specific process parameter units (Kane 1986). • The indices incorporate the location and/or the variation in the process. Process Capability Cp • A common measure for describing the potential of a process to meet specifications is the Cp • It relates the process spread (the difference between the natural tolerance limits) to specification spread, assuming two-sided specification limits. It is given by Cp • It is desirable to have Cp ≥ 1 • Cp = 1, the process spread equals the specification spread, and the process is said to be barely capable. • If the process is centered, only 0.26% of the parts will fall outside the specification limits. (demonstrated in case II) • If the process is not centered, it is possible that even for a process with Cp > 1, some proportion of the product will be nonconforming. 70 | P a g e BatStateU • Quality Management Systems However, when Cp > 1, there is some flexibility; that is, the process can go out of control yet still produce conforming items (case 1) Cp Index • If Cp < 1, it implies that the inherent variability in the process, as measured by the process spread 6σ, is greater than the specification spread. • For this situation, a process can be in control and still not meet specifications, as described in case III • Other capability indices, such as CPU, CPL, Cpk, Cpm, and Cpmk, measure process performance. Upper and Lower Capability Indices • Upper capability index (CPU, or Cp upper) It is desirable to have CPU ≥ 1. Note that the denominator is half the process spread. • If only lower specification limit is given, the lower capability index (CPL, or Cp lower) is given by 71 | P a g e BatStateU Quality Management Systems Companies desiring a goal of a "six sigma process" are aiming for a Cp-value of 2 Example In a GE insurance claims process, x = 210.0 minutes, and s = .516 minutes. The design specification to meet customer expectations is 210 ±3 minutes. So the Upper Specification is 213 minutes and the lower specification is 207 minutes. The OM manager wants to compute the process capability ratio. Because a ratio of 1.00 means that 99.74% of a process’s outputs are within specifications, this ratio suggests a very capable process. Cpk Index • The location of the process mean is another parameter that affects process capability. Although the Cp index does not incorporate the process location, other indices do. • One index that accounts for this location, the Cpk index, is used when the process mean is not at the target value, which is assumed to be halfway between the specification limits. The Cpk index is given by • Whereas the Cp index represents the process potential, the Cpk-value represents the actual capability of the process with the existing parameter values; it measures process performance. • It measures the difference between the desired and actual dimensions of goods or services produced. • When the Cpk index for both the upper and lower specification limits equals 1.0, the process variation is centered and the process is capable of producing within {3 standard deviations 72 | P a g e BatStateU • Quality Management Systems A C pk of 2.0 means the process is capable of producing fewer than 3.4 defects per million. Example: You are the process improvement manager and have developed a new machine to cut insoles for the company’s top-of-the-line running shoes. You are excited because the company’s goal is no more than 3.4 defects per million, and this machine may be the innovation you need. The insoles cannot be more than {.001 of an inch from the required thickness of .250 ″ . You want to know if you should replace the existing machine, which has a Cpk of 1.0. Mean of the new process X = .250 inches Standard deviation of the new process = s = .0005 inches You decide to determine the Cpk Upper specification limit = .251 inches Lower specification limit = .249 inches Because the new machine has a Cpk of only 0.67, the new machine should not replace the existing machine. Meanings of Cpk Measures 73 | P a g e BatStateU Quality Management Systems Process Performance: Pp - For process performance - Process is too new (at development stage) - Sample size is larger from process - Use sample sigma for calculation Pp = (USL – LSL) / 6* s where s the standard deviation, or the ‘fatness’ or dispersion of the bell curve. Process Performance Index Ppk Ppk is another performance index that measures how close the current process mean’s proximity is to the specification limits. In other words, does this process deliver acceptable results? Process Performance Index basically tries to verify if the sample that you have generated from the process is capable to meet Customer CTQs (requirements). Ppk = {(µ −𝑳𝑺𝑳)/ "σ" , (𝑼𝑺𝑳 −µ)/ "σ" } Ppk = min{𝑷𝒑𝒌𝒍, 𝑷𝒑𝒌𝒖} Cp, Cpk, Pp, Ppk Value Ranges 74 | P a g e BatStateU Quality Management Systems When to Use Pp, Ppk, Cp, and Cpk “Cpk is for short term, Ppk is for long term.” Cp and Cpk are for computing the index with respect to the subgrouping of your data (different shifts, machines, operators, etc.), while Pp and Ppk are for the whole process (no subgrouping). Pp and Ppk 75 | P a g e BatStateU Quality Management Systems Use an estimate for sigma that takes into account all or total process variation including special causes (should they exist) and this estimate of sigma is the sample standard deviation, s, applies to most all situations. Example: Food kept at a restaurant should be between 38°C and 49°C . The process used to keep the food at the same temperature has a process standard deviation of 2°C. What is the process performance of the process? Pp = (USL – LSL) / 6* s = (49 - 38) / (6 * 2) = 0.917 PpkL = (mean-LSL/3*std.Dev) = (43.5 - 38) / (3 * 2) = 0.917 PpkU = (USL-mean/ 3*std.Dev) = 49 - 43.5) / (3 * 2)= 0.917 Ppk = min (0.917, 0.917) = 0.917 76 | P a g e BatStateU Quality Management Systems Lesson 10: Acceptance Sampling Techniques Learning Objectives: Define acceptance sampling Discus Operating Characteristics Curve Learn how to develop OCC Acceptance Sampling The third branch of SQC refers to the process of randomly inspecting a certain number of items from a lot or batch in order to decide whether to accept or reject the entire batch Acceptance sampling is performed either before or after the process rather than during – Sampling before typically is done to supplier material – Sampling after involves sampling finished items before shipment or finished components prior to assembly A method of measuring random samples of lots or batches of products against predetermined standards. Used where inspection is expensive, volume is high, or inspection is destructive. 77 | P a g e BatStateU Quality Management Systems Operating Characteristic Curve A graph that describes how well an acceptance plan discriminates between good and bad lots. A curve pertains to a specific plan—that is, to a combination of n (sample size) and c (acceptance level). It is intended to show the probability that the plan will accept lots of various quality levels. With acceptance sampling, two parties are usually involved: the producer of the product and the consumer of the product. Producer usually has the responsibility of replacing all defects in the rejected lot or of paying for a new lot to be shipped to the customer. Producer’s risk -- The mistake of having a producer’s good lot rejected through sampling. Consumer’s risk -- The mistake of a customer’s acceptance of a bad lot overlooked through sampling. Acceptable quality level (AQL) The quality level of a lot considered good. Lot tolerance percentage defective (LTPD) The quality level of a lot considered bad. To derive a sampling plan, producer and consumer must define not only “good lots” and “bad lots” through the AQL and LTPD, but they must also specify risk levels Producer’s risk ( ) is the probability that a “good” lot will be rejected. This is the risk that a random sample might result in a much higher proportion of defects than the population of all items. A lot with an acceptable quality level of AQL still has an a chance of being rejected. Sampling plans are often designed to have the producer’s risk set at = .05, or 5%. Consumer’s risk ( β ) is the probability that a “bad” lot will be accepted. This is the risk that a random sample may result in a lower proportion of defects than the overall population of items. A common value for consumer’s risk in sampling plans is β = .10, or 10% 78 | P a g e BatStateU Quality Management Systems An Operating Characteristic (OC) Curve Showing Producer’s and Consumer’s Risks A good lot for this particular acceptance plan has less than or equal to 2% defectives. A bad lot has 7% or more defectives. Operating Characteristic Curve For example, you sample 52 pens from a shipment of 5000. If the actual % defective is 1.5%, you have a 0.957 probability of accepting this lot based on the sample and a 0.043 probability of rejecting it. If the actual % defective is 10%, you have a 0.097 probability of accepting this lot and a 0.903 probability of rejecting it. 79 | P a g e BatStateU Quality Management Systems Use an OC curve to choose an appropriate sampling plan. • Producer’s risk (β) is the chance a lot containing an acceptable quality level will be rejected; 80 | P a g e BatStateU Quality Management Systems • Type I error Statistically, the probability of rejecting a good lot • Consumer’s Risk (α) is the chance of accepting a lot that contains a greater number of defects than the LTPD limit • Type II error Statistically, the probability of accepting a bad lot. 81 | P a g e BatStateU Quality Management Systems Developing OC Curves • OC curves graphically depict the discrimina ting power of a sampling plan 82 | P a g e BatStateU • Quality Management Systems Cumulative binomial tables like partial table below are used to obtain probabilities of accepting a lot given varying levels of lot defectives • Top of the table shows value of p (proportion of defective items in lot), Left hand column shows values of n (sample size) and x represents the cumulative number of defects found. Example: Constructing an OC Curve Average Outgoing Quality In most sampling plans, when a lot is rejected, the entire lot is inspected, and all defective items replaced. Use of this replacement technique improves the average outgoing quality in terms of percent defective. In fact, given (1) any sampling plan that replaces all defective items encountered and (2) the true incoming percent defective for the lot, it is possible to determine the average outgoing quality (AOQ) in percentage defective. The equation for AOQ is: 83 | P a g e BatStateU Quality Management Systems AOQ = Pac (p) The maximum value of AOQ corresponds to the highest average percentage defective or the lowest average quality for the sampling plan. It is called the average outgoing quality limit (AOQL). Implications for Managers • How much and how often to inspect? – Consider product cost and product volume – Consider process stability – Consider lot size • Where to inspect? – Inbound materials – Finished products – Prior to costly processing • Which tools to use? – Control charts are best used for in-process production – Acceptance sampling is best used for inbound/outbound 84 | P a g e BatStateU Quality Management Systems The Application of Statistical Process Control Techniques Contributes to the Identification and Systematic Reduction of Process Variability 85 | P a g e