Qms Notes PDF

QUALITY MANAGEMENT SYSTEM 4. Aesthetics — sense appeal, such as color, sound, I learned that quality is about meeting customer feel, and comfort. What does the product look like? expectations, while quality improvement focuses on 5. Features — things...

QUALITY MANAGEMENT SYSTEM 4. Aesthetics — sense appeal, such as color, sound, I learned that quality is about meeting customer feel, and comfort. What does the product look like? expectations, while quality improvement focuses on 5. Features — things that add to convenience and enhancing products and reducing waste. comfort. What does the product do? 6. Performance — the product’s ability to do the work PROMINENT FIGURES it is supposed to do. Will the product do the intended job? W. EDWARDS DEMING 7. Perceived Quality — the impression the product ▪ defines quality as "meeting or exceeding creates in the customer’s mind. (reputation) What customer expectations." He is credited with is the reputation of the company or its product? reviving the Japanese economy after World War II 8. Serviceability — the ability for making repairs using statistical tools. His total quality management easily, quickly, and at a reasonable cost. (How philosophy was expressed in his 14-Points for easy is it to repair the product? availability) improving quality, productivity and competitive position. SERVICE ▪ Advocated for a systematic approach to quality The SERVQUAL model was made of ten dimensions improvement through the Plan-Do-Study-Act of service quality when created: (PDSA) cycle. He emphasized the importance of data analysis, employee involvement, and 1. Convenience continuous improvement to enhance product 2. Courtesy quality and organizational performance 3. Consistency 4. Reliability PHILIP CROSBY 5. Responsiveness ▪ Introduced the concept of "zero defects" and 6. Assurance emphasized that quality should be seen as a 7. Time management responsibility, promoting the idea 8. Tangibles that prevention of defects is more cost-effective 9. Expectations than correction. 1. Reliability - The ability to consistently deliver JOSEPH JURAN promised services dependably and accurately. ▪ Focused on the importance of quality planning, - Consistently delivering what was quality control, and quality improvement. He promised, accurately and dependably. introduced the Juran Trilogy/ Quality Trilogy 2. Responsiveness - The speed and willingness to (quality planning, control, improvement) and help customers when needed. emphasized the role of leadership in fostering a - Being quick and eager to help quality culture. customers. 3. Tangible - The physical appearance of facilities DIMENSIONS OF QUALITY 4. Credibility - Being trustworthy and honest. ▪ Degree the products meet the customer 5. Competence - Having the skills and knowledge to ▪ Specific and measurable perform the service well. 6. Access - Making services easily available to If -, expectations have not been met. Performance - customers. expectation 7. Empathy - Caring, individualized attention the firm If +, the performance exceeded the expectation provides its customers. Performance = expectation : it met its expectation - Making an effort to know and address customer needs. PRODUCT 8. Assurance - Knowledge and courtesy of 1. Durability — the length of time the product will last employees and their ability to convey trust and until it is discarded. (ability to perform overtime) confidence. How long does the product last? 9. Communication - Keeping customers informed 2. Conformance — the degree to which the product and listening to them. meets codes of a state or a community. Is the 10. Security - Ensuring customer safety and product made exactly as the designer intended? protecting personal information. 3. Reliability — the ability to perform without failure over time. How often does the product fail?  DEFINITIONS OF QUALITY QUALITY ENGINEERS QUALITY ▪ Also make sure that the manufacturer makes the ▪ Fitness for use goods according to specifications. ○ Quality of design ○ Quality of conformance TYPES OF DATA ▪ Inversely proportional to variability Attribute Data: Categorical data that counts defects or classifies items as either conforming or non- ★ A continuous movement conforming (e.g., pass/fail, yes/no). ★ Prevent problems Variable Data: Numerical data that measures and ★ Continuous process quantifies characteristics on a continuous scale (e.g., ★ Meeting defined standards length, weight, temperature). ★ Reduce waste and cost ★ To satisfy the customer, Customer-centered, Customer-oriented ★ QM Objective - Delivering defective free products at minimum costs. CROSBY ▪ It must be quantified and measured. ▪ "Quality is Free" ▪ Philip Crosby argues that investing in quality management reduces the costs of poor quality (like rework and returns), leading to overall savings. Thus, good quality effectively costs nothing. JURAN Fitness for use Conformance to requirements POKA-YOKE Mistake Proofing Technique QUALITY IMPROVEMENT ▪ The reduction of variability in processes and products ▪ Also seen as “waste reduction” QUALITY CHARACTERISTICS SPECIFICATIONS 1. Technological: Length, diameter, width. Quality Characteristics being measured are often 2. Time - Oriented: Maintainability, reliability. compared to standards or specifications. 3. Psychological: Taste, beauty, odour. ▪ Nominal or target value 4. Ethical: Integrity, honesty. ▪ Upper Specification Limit (USL) 5. Contractual: Safety, guarantee. ▪ Lower Specification Limit (LSL) QUALITY ENGINEERING TERMINOLOGY NONCONFORMING QUALITY ENGINEERING ▪ When a component or product does not meet ▪ Focuses on making sure that goods and services specifications are designed, developed, and made to meet or ▪ A nonconforming product is considered defective exceed consumer’s expectations and if it has one or more defects. requirements. ▪ Includes all the activities related to the analysis of DEFECTS good’s design and development. ▪ nonconformities that may seriously affect the safe ▪ It encompasses a wide range of methodologies or effective use of the product. and tools. CONCURRENT ENGINEERING ACCEPTANCE SAMPLING ▪ Acceptance sampling is the inspection and classification of a sample of the product selected at random from a larger batch or lot and the ultimate decision about disposition of the lot. Two types: 1. Outgoing inspection - follows production 2. Incoming inspection - before use in production OTHER ASPECTS OF QUALITY CONTROL AND IMPROVEMENT A. Total Quality Management B. Quality Philosophy and Management Strategies C. The Link Between Quality and Productivity D. Quality Costs E. Legal Aspects of Quality F. Implementing Quality Improvement BRIEF HISTORY OF QUALITY CONTROL AND IMPROVEMENT TOTAL QUALITY MANAGEMENT ▪ 1924: Walter Shewhart introduced statistical ▪ A managerial framework to accomplish quality control chart concepts. improvement ▪ 1946: The American Society for Quality Control ▪ Other names and related approaches: formed in 1946 (now known as the American ○ Company-Wide Quality Control (CWQC) Society for Quality (ASQ)). ○ Total Quality Assurance (TQA) ▪ 1950s & 1960s: saw an increase in reliability ○ Six-Sigma engineering, experimental design, and statistical quality control Principles of TQM “DFSPICCE” ▪ 1970s & 1980s: Competition from foreign 1. Decision-making based on facts industries (Japan) increases. 2. Focus on Customer ▪ 1970s: Total Quality Management (TQM) emerges 3. Strategic and Systematic Approach ▪ 1980s: TQM as an important management tool to 4. Process Centered implement statistical methods. 5. Integrated System ▪ 1980s: Statistical methods for quality improvement 6. Communication use increases in the United States 7. Continuous Improvement ▪ 1988: Malcolm Baldridge National Quality Award is 8. Employee Involvement established. QUALITY PHILOSOPHY AND MANAGEMENT ▪ 1990s: ISO 9000 certification activities increase in STRATEGIES U.S. industry. Three Important Leaders ▪ 1990s: Motorola’s Six-Sigma initiative begins. A. W. Edwards Deming - Emphasis on statistical methods in quality improvement STATISTICAL METHODS FOR QUALITY (see Deming’s 14 points) CONTROL AND IMPROVEMENT Deming’s 14 Point Plan for TQM Three major areas: 1. Create constancy of purpose. STATISTICAL PROCESS CONTROL (SPC) 2. Adopt the new philosophy ▪ Control charts are used for process monitoring and 3. Crease inspection, require evidence variability reduction. 4. Improve the quality of supplies ▪ SPC is an on-line quality control tool. 5. Continuously improve production 6. Train and educate all employees DESIGN OF EXPERIMENTS (DOX) 7. Supervisors must help people ▪ Experimental design is an approach to 8. Drive out fear systematically varying the controllable input factors 9. Eliminate boundaries in the process and determine the effect these 10. Eliminate the use of slogans factors have on the output responses. 11. Eliminate numerical standards ▪ Experimental designs are off-line quality tools. 12. Let people be proud of their work ▪ Crucial for variability reduction. 13. Encourage self-improvement 14. Commit to ever-improving quality  B. Joseph Juran - Emphasis on managerial role QUALITY COSTS in quality implementation QUALITY COSTS are those categories of costs that are Juran’s Quality Trilogy (QM) associated with producing, identifying, ○ Quality Planning avoiding, or repairing products that do not meet ○ Quality Control requirements. ○ Quality Improvement These costs are: Cost of Good Quality C. Armand V. Feigenbaum - Emphasis on ○ Prevention Costs organizational structure ○ Appraisal Costs Cost of Poor Quality 3 Principles of TQM ○ Internal Failure Costs ○ Quality Leadership ○ External Failure Costs ○ Quality Technology ○ Organizational Commitment LEGAL ASPECTS OF QUALITY ▪ The re-emergence of quality assurance as an STRATEGIES important business strategy is in part a result of ▪ Total Quality Management (TQM) 1. Consumerism ▪ Quality Standards and Registration - ISO 9000 2. Product Liability ▪ Six Sigma ▪ Just-In-Time, Lean Manufacturing, Poka-Yoke, IMPLEMENTING QUALITY IMPROVEMENT etc. ▪ Strategic Management of Quality ▪ Almost all successful efforts have been THE LINK BETWEEN QUALITY AND management-driven. PRODUCTIVITY ▪ Too much emphasis on registration and ▪ Effective quality improvement can be instrumental certification programs (ISO, QS) in increasing productivity and reducing cost. ○ Insufficient focus on quality planning and ▪ The cost of achieving quality improvements and design, quality improvement, overemphasis on increased productivity is often negligible. quality assurance ○ Poor use of available resources QUALITY MANAGEMENT AND ISO 9001:2015 ISO 9001:2015 ▪ Covers all key essential elements: activities, ▪ International standard processes, work instructions, records, service ▪ Degree to which a set of inherent processes to meet customer requirements, statutory and regulatory. CONCEPT OF QUALITY IN ISO 9001 ▪ The need, requirement or expectation (goal, ▪ QMS -- Business Processes, Procedures, Policies target, ambition, intent, aspiration, desire or – Improve overall quality of offerings and firm objective being aimed for) operations. ○ Superior quality – delighting the customer ○ Satisfactory quality – fitness for purpose,  Comprehensive system looking at the big picture meets customer needs and expectations which benefits our decision-making. ○ Inferior quality - complaints  Strategy to make sure the options are smooth ▪ The performance level (grade, accomplishment, options or no idle. attainment, achievement) reached INTERNATIONAL ORGANIZATION FOR Quality Management System STANDARDIZATION ▪ A system comprised of quality planning and ▪ The International Organization for Standardization quality improvement activities, the establishment (ISO) is an international non-governmental of a set of quality policies and objectives that will organization made up of national standards act as guidelines within an organization, and QA bodies that develops and publishes a wide and QC. range of proprietary, industrial, and commercial standards. ▪ It was founded in 1947 and is headquartered in ▪ It is the most popular standard in the ISO 9000 Geneva, Switzerland. series and the only standard in the series to which ▪ In addition to producing standards, ISO also organizations can certify. publishes technical reports, technical ▪ ISO 9001 was first published in 1987 by the specifications, publicly available specifications, International Organization for Standardization technical corrigenda, and guides. (ISO), an international agency composed of the ▪ The ISO plays an important role in facilitating national standards bodies of more than 160 world trade by providing common standards countries. among different countries. ▪ The current version of ISO 9001 was released in ▪ ISO standards cover all fields, from healthcare to September 2015. technology to manufacturing to security to the ▪ It is a quality management model that can be environment. adopted by any kind of organization ▪ The system is focused towards meeting customer WHY ISO AND QMS requirements and enhancing of customer satisfaction ISO 9001 ▪ the international standard that specifies KEYWORDS requirements for a quality management 1. Quality system (QMS). 2. Management system ▪ Organizations use the standard to demonstrate 3. Customer requirements the ability to consistently provide products and 4. Customer satisfaction services that meet customer and regulatory requirements. ISO 9001 is for the QM AS 90100 - QMS AeroSpace EVOLUTION OF ISO WHAT IT MEANS TO BE CERTIFIED: ISO 9001 QMS ▪ It provides guidelines to make sure that the ▪ The ISO 9001:2015 specifies requirements for a customer is happy/satisfied. QMS for an organization which incorporates a ▪ Reduce waiting/idle time and Increase efficiency. cycle of Plan-Do-Check-Act and Continual ▪ Better risk management and enhanced Improvement. competitiveness. Plan SEVEN QUALITY MANAGEMENT PRINCIPLES ▪ Establish objectives 1. Customer Focus ▪ Plan processes 2. Leadership 3. Engagement of People Do 4. Process Approach. ▪ Implement plan 5. Improvement ▪ Execute processes 6. Evidence-Based Decision Making 7. Relationship Management Check 6 MANDATORY ISO 9001 PROCEDURES ▪ Study actual results 1. Control of Documents ▪ Compare against expected results 2. Control of Records Act 3. Internal Audits ▪ Corrective actions 4. Control of Nonconforming Products ▪ Analyze differences 5. Corrective actions 6. Preventive Actions COST OF QUALITY TYPES Cost of Poor Quality equals the Cost of Quality, as COST OF GOOD QUALITY represented in the basic equation below: PREVENTION COSTS CoQ = CoGQ + CoPQ ▪ Planning ▪ Maintenance ▪ The basic equation can be expanded by applying ▪ Training the categories within both the Cost of Good Quality and the Cost of Poor Quality. APPRAISAL COSTS ○ The Cost of Good Quality is the sum of ▪ Inspection Prevention Cost and Appraisal Cost (CoGQ = ▪ Calibration PC + AC) ▪ Audits ○ The Cost of Poor Quality is the sum of Internal COSTS OF BAD QUALITY and External Failure Costs (CoPQ = IFC + EFC) INTERNAL FAILURE COSTS ▪ By combining the equations, COQ = (PC + AC) + ▪ Rework (IFC + EFC) ▪ Scrap ▪ Delays HOW TO REDUCE THE COSTS OF QUALITY 1. Process standardization EXTERNAL FAILURE COSTS ▪ Customer Returns 2. Training ▪ Warranty Claims 3. Quality Inspections ▪ Low Quality Image 4. Monitoring HOW TO MEASURE COST OF QUALITY 5. Supplier Performance Management (COQ) 6. Returns Management ▪ The Cost of Quality can be represented by the sum 7. Root Cause Analysis of two factors. The Cost of Good Quality and the 7 QUALITY MANAGEMENT TOOLS The Seven Quality Control Tools (Kerzner, 2009) ▪ They were introduced by Kaoru Ishikawa, are Check sheet, Pareto analysis, Histograms, Scatter diagrams, Control Charts, Cause and Effect Analysis, and Stratification (flowchart). CAUSE AND EFFECT DIAGRAM (ISHIKAWA OR FISHBONE DIAGRAM) ▪ The cause-and-effect diagram, also known as the fishbone diagram, helps identify possible causes of an issue using a template with a resemblance to a fishbone ▪ Quality management teams can identify a quality- related problem on the right-hand side of the THE 7QC (SEVEN QUALITY CONTROL) diagram, with individual root causes and sub- TOOLS causes branching off to its left. ▪ They are a series of essential problem-solving ▪ The generic categories of the cause and effect approaches used to detect and handle difficulties diagram are usually six elements (causes) such in the world of quality management and process as environment (mother earth), materials, development machine, measurement, man, and method.  CHECK SHEET ▪ It highlights the relative importance of a variety of ▪ Check sheets are simple and straightforward data parameters to analyze and determine the most gathering forms used to collect and organize data. impactful factor on a specific process or system ▪ A check sheet is a structured presentation of gathered data that is collected repeatedly by the STRATIFICATION ANALYSIS (DIVIDE AND same person from the production process. CONQUER) ▪ It helps identify defects based on type, location, or ▪ The stratification analysis helps quality managers cause. divide different factors such as objects, data, and people into distinct groups to determine the CONTROL CHART revealing patterns that are not visible when those ▪ A control chart is also known as the Shewhart factors are lumped together chart and is used to study the changes in the process over time. SCATTER DIAGRAM ▪ It shows whether the process variation is in ▪ A scatter diagram is the most useful tool in control or is affected by different causes of describing the cause and effect relationship variation, which is based on a comparison of between two variables. historical control limits and current data. ▪ It uses the X and Y axis to look for relationships between quality defects and possible causes PARETO CHART ▪ A Pareto chart is used to identify the most HISTOGRAM significant issue in the production processes that ▪ A histogram is utilized to show frequency needs immediate rectification distribution using numerical data. ▪ It uses a combination of line and bar graphs to ▪ It helps quality management teams analyze the present the frequency of issues in the production output from the processes of suppliers and process check whether a process has changed from one period to another STATISTICAL PROCESS CONTROL ▪ One way to produce a quality product is to integrate STATISTICAL PROCESS CONTROL (SPC) quality into the process. ▪ A process is functioning properly or not ▪ Good for measuring the quality of product or DATA COLLECTION services ▪ Types of data ▪ Identify the problems during production unlike ▪ Data sources Acceptance Sampling QUALITY IMPROVEMENT ▪ Identify what to change or improve in the quality ▪ Defect reduction process ▪ Continuous improvement ACCEPTANCE SAMPLING STATISTICAL ANALYSIS ▪ A tool used to decide whether to accept or reject a ▪ Descriptive statistics batch. ▪ Inferential statistics PROCESS MONITORING VARIATION ▪ Sources of Variation in production process: ▪ Control charts 1. Inputs: Materials, Tools ▪ Process capability 2. Process: Operators, Methods, Machines, CORE PRINCIPLES OF STATISTICAL Environment PROCESS CONTROL 3. Outputs: Measurement Instruments, Human 1. Understanding Variation Inspection Performance. 2. Process Stability SOURCES OF VARIATION 3. Continuous Improvement ▪ Variation exists in all processes. 4. Prevention over Detection ▪ Variation can be categorized as either; 5. Data-driven Decision Making ○ Common or Random causes of variation, or Random causes that we cannot identify CATEGORIES OF SQC Unavoidable: e.g. slight differences in DESCRIPTIVE STATISTICS process variables like diameter, weight, service time, temperature  ○ Assignable causes of variation WHEN TO USE A CONTROL CHART? Causes can be identified and eliminated: ▪ Controlling ongoing processes by finding and e.g. poor employee training, worn tool, correcting problems as they occur. machine needing repair ▪ Predicting the expected range of outcomes from a process. SPC METHODS ▪ Determining whether a process is stable (in PROCESS CONTROL statistical control). ▪ Refers to procedures or techniques adopted to ▪ Analyzing patterns of process variation from evaluate, maintain and improve the quality special causes (non-routine events) or common standard in various stages of manufacture. causes (built into the process). ▪ A process is considered satisfactory as long as it ▪ Determining whether the quality improvement produces items within designed specification. project should aim to prevent specific problems or ✓ Process should be continuously monitored to to make fundamental changes to the process. ensure that the process behaves as expected. CONTROL CHART BASIC PROCEDURE ▪ Salient features of process control ▪ Choose the appropriate control chart for the data. ✓ Controlling the process at the right level and ▪ Determine the appropriate time period for variability. collecting and plotting data. ✓ Detecting the deviation as quickly as possible ▪ Collect data, construct the chart and analyze the so as to take immediate corrective actions. data. ▪ Look for "out-of-control signals" on the control ✓ Ultimate aim is not only to detect trouble, but chart. When one is identified, mark it on the chart also to find out the cause. and investigate the cause. Document how you ✓ Developing an efficient information system in investigated, what you learned, the cause and how order to establish an efficient system of it was corrected. process control. ▪ Continue to plot data as they are generated. As each new data point is plotted, check for new out- CONTROL CHART of-control signals ▪ A graphical display of data over time (data are INTERPRETATION OF CONTROL CHART displayed in time sequence in which they ▪ Points between control limits are due to random occurred/measured) used to differentiate common chance variation cause variation from special cause variation. ▪ One or more data points above an UCL or below a ▪ Control charts combine numerical and graphical LCL mark statistically significant changes in the description of data with the use of sampling process distribution ✓ normal distribution is basis for control A PROCESS IS IN CONTROL IF ▪ No sample points outside limits chart. ▪ Most points near process average ▪ Goal of using this chart is to achieve and maintain ▪ About equal number of points above and below process stability centerline ✓ A state in which a process has displayed a ▪ Points appear randomly distributed certain degree of consistency ○ Consistency is characterized by a stream of A PROCESS IS ASSUMED TO BE OUT OF data falling within the control limits. CONTROL IF ▪ Rule 1: A single point plots outside the control BASIC COMPONENTS OF A CONTROL CHART limits; ▪ A control chart always has ▪ Rule 2: Two out of three consecutive points fall ✓ a central line usually mathematical average outside the two sigma warning limits on the same of all the samples plotted; side of the center line; ✓ upper control and lower control limits ▪ Rule 3: Four out of five consecutive points fall beyond the 1 sigma limit on the same side of the defining the constraints of common variations center line; or range of acceptable variation; ▪ Rule 4: Nine or more consecutive points fall to one ✓ Performance data plotted over time. side of the center line; ▪ Lines are determined from historical data. ▪ Rule 5: There is a run of six or more consecutive points steadily increasing or decreasing  TYPES OF CONTROL CHART P CHART (PERCENT DEFECTIVE) ATTRIBUTE ▪ The P chart is used to monitor the proportion or ▪ Count, Categorical or Discrete Numerical Data percentage of defective items in a sample or ▪ Used for product characteristics that can be subgroup. It is particularly useful when dealing with evaluated with a discrete response (pass/fail, defects or non-conformities in a process. yes/no, good/bad, number defective) NP CHART (NUMBER DEFECTIVE) ▪ less costly when it comes to collecting data ▪ Similar to the P chart, the NP chart tracks the ▪ can plot multiple characteristics on one chart number of defective items in a sample or subgroup. ▪ loss of information vs variable chart It is often used when the sample size varies, ▪ P chart and C Chart making it more appropriate than the P chart in VARIABLE certain situations. ▪ Fluctuating values, Continuous Numerical Data C CHART (COUNT DEFECTS) ▪ Used when the quality characteristic can be ▪ The C chart is used to monitor the number of measured and expressed in numbers defects or non-conformities in a given unit, such as ▪ must be able to measure the quality characteristics the number of scratches on a product surface or in numbers the number of errors in a software program. ▪ may be impractical and uneconomical ▪ 𝑥̅ Chart and R Chart U CHART (DEFECTS PER UNIT) ▪ The U chart, also known as the defects per unit CONTROL CHART FOR ATTRIBUTES chart, is used to track the average number of 1. Nonconforming Units (based on the Binomial defects per unit or product. distribution): p chart, np chart. 2. Nonconformities (based on the Poisson ADVANTAGES OF SPC distribution): c chart, u chart. ▪ Improved Quality Control ▪ Reduced Costs ▪ Increased Customer Satisfaction ▪ Data-Driven Decision Making ▪ → Enhanced Process Efficiency