Productivity And Quality Management PDF

PRODUCTIVITY AND Dr Le Thai Phong Foreign Trade University QUALITY MANAGEMENT T: 0975.055.299 E:[email protected] QUALITY MANAGEMENT: Chapter 1: Quality Management: Dr Dao Minh Anh Faculty...

PRODUCTIVITY AND Dr Le Thai Phong Foreign Trade University QUALITY MANAGEMENT T: 0975.055.299 E:[email protected] QUALITY MANAGEMENT: Chapter 1: Quality Management: Dr Dao Minh Anh Faculty of Business Administration Foundation T: 094.808.9481 E: [email protected]  Chapter Dr Le Thai Phong 3: Foreign Models QM: Trade Universityand T: 0975.055.299 Frameworks E:[email protected] QUALITY MANAGEMENT: Chapter 1: Quality Management: Dr Dao Minh Anh Faculty of Business Administration Foundation T: 094.808.9481 E: [email protected]  Contents 1 Quality Management System 2 ISO 3 5S 4 TQM, Q-Based System, GMP, HACCP “Talking about goodness is easy; achieving it is difficult”. Chinese proverb  Quality management: concept Quality management is coordinated activities to direct and control an organization with regard to quality Including: – quality planning – quality control – quality improvement – quality assurance.  Quality management: concept Quality Management Quality Quality Quality Quality planning control improvement assurance Juran’s Trilogy Juran’s handbook  Quality planning ISO 9000: part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives  Quality planning QP two levels of planning: strategic & operational – Strategic: long-range goals of the organization, its vision, mission, values and the means to reach those goals – Operational: establishing product goals and the means to reach those goals  Quality Planning QP 1. Establish the goals (i.e. what it is you want to achieve). 2. Identify who is impacted by these goals (i.e. the customers and other stakeholders). 3. Determine the needs of these stakeholders relative to these goals and prioritize those for action. 4. Develop products or services with features that respond to stakeholders’ needs. 5. Develop processes able to produce, promote and distribute the product features. 6. Establish process controls and transfer the plans to the operating forces.  Quality Control (QC) part of quality management focused on fulfilling requirements – Controls regulate performance. – Control: perceived as undesirable (removes freedom), but if everyone were free to do just as they liked there would be chaos.  Quality Control (QC) Controls: prevent change =>regulate performance; prevent undesirable changes When operations are under control they are predictable – predictability is a factor that is vital for any organization to be successful Quality Control (QC)  Quality Control (QC) Universal sequence of steps 1. Determine the subject of control i.e., what is to be regulated. 2. Define a unit of measure – express the control subject in measurable terms such as quantities, ratios, indices, rating etc. 3. Establish a standard level of performance – a target to aim for. 4. Select a sensor to sense variance from specification.  Quality Control (QC) 5. Install the sensor at the stage in the process appropriate to whether you need to control before, during or after results are produced. 6. Collect and transmit data to a place for analysis. 7. Verify the results and establish whether the variance is within the range expected for a stable process 8. Diagnose the cause of any variance beyond the expected range. 9. Propose remedies and decide on the action needed to restore the status quo. 10. Take the agreed action and check that process stability has been restored.  Quality Improvement (QI) part of quality management focused on increasing the ability to fulfill quality requirements. Quality Improvement (QI) Quality Improvement (QI) Quality Improvement (QI)  Quality Improvement (QI) 1. Are we doing it right? 2. Can we keep on doing it right? 3. Are we doing it in the best way? 4. Is it the right thing to do?  Quality Improvement (QI) QI can be implemented by two approaches: – Gradually = kaizen – Step change = breakthrough = quantum leap  Quality Assurance (QA) part of quality management focused on providing confidence that quality requirements will be fulfilled – Often regarded as discreet policy by QA department – QA should be integral part of all of an organization’s processes and function Quality Management Systems (1 of 2) Can be considered a mechanism for managing and continuously improving core processes to “achieve maximum customer satisfaction at the lowest overall cost to the organization.” Provides a basis for documenting processes used to control and improve operations, drive innovation, and achieve below objectives: – Higher product conformity and less variation – Fewer defects, waste, rework, and human error – Improved productivity, efficiency, and effectiveness Quality Management Systems (2 of 2) Establish a quality policy. Establish an organizational structure for its QMS. A quality manual serves as a permanent reference for implementing and maintaining the system. The system needs to be maintained and kept up to date. This maintenance can be facilitated through internal audits.  ISO 9000 Family of Standards (1 of 4) Five objectives – Achieve, maintain, and seek to continuously improve product quality (including services) in relationship to requirements – Improve the quality of operations to continually meet customers’ and stakeholders’ stated and implied needs – Provide confidence to internal management and other employees on quality fulfillment and improvement – Provide confidence to customers and other stakeholders that quality requirements are being achieved in the delivered product – Provide confidence that quality system requirements are fulfilled ISO 9000 Family of Standards (2 of 4) The standards consist of two major documents: – ISO 9000:2015 provides fundamental background information, such as concepts and principles, and establishes definitions of key terms used in the standards. – ISO 9001:2015 provides the specific requirements for a quality management system to help organizations consistently provide products that meet customer and other regulatory requirements. ISO 9000 Family of Standards (3 of 4) The ISO 9000 standards provide a structure for a basic quality assurance system. Specific parts of the standards address – Quality management system – Management responsibility – Resource management – Product realization – Measurement, analysis, and improvement ISO 9000 Family of Standards (4 of 4) ISO 9000 has three principal benefits: – It provides discipline. – It contains the basics of a good quality system. – It offers a marketing program.  ISO 9000 The ISO9000 family of standards consists of four primary standards: ISO9000, ISO9001, ISO9004 and ISO19011 – ISO9000: Fundamentals and Vocabulary – ISO9001: Requirements – ISO9004: Guidelines for Performance Improvement – ISO19011: Guidelines on Quality and Environmental Auditing  Principle elements of ISO 9001 1 Quality management system – General requirements (‘The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this international standard’ – BS EN ISO9001 (2000)) – Documentation requirements  Principle elements of ISO 9001 2 Management responsibility – Management commitment – Customer focus – Quality policy – Planning – Responsibility, authority and communication  Principle elements of ISO 9001 3 Resource management – Provision of resources – Human resources – Infrastructure – Work environment  Principle elements of ISO 9001 4 Product realization – Planning of product realization – Customer-related processes – Design and development – Purchasing – Production and service provision – Control of monitoring and measuring devices  Principle elements of ISO 9001 5. Measurement, analysis and improvement – General (‘The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed:(a) to demonstrate conformity of the product; (b) to ensure conformity of the quality management system and (c) to continually improve the effectiveness of the quality management system’: BS EN ISO9001 (2000)) – Monitoring and measurement – Control of non conforming product – Analysis of data – Improvement.  Benefits & limitations Improved controls, discipline, procedures, documentation, communication, dissemination and customer satisfaction, quicker identification and resolution of problems, greater consistency A reduction in errors, customer complaints and non-conforming products, services and costs and the retention of customers  Benefits & limitations Assistance with the liberalization of trade Responsibility for quality issues is placed firmly where it belongs Reduction in the number of customer audits (time saving) Identification of ineffective and surplus procedures Benefits & limitations  Benefits & limitations Lack of flexibility and perceived restrictions on creativity Lack of relevance to the real needs of the business The time and resources needed in writing procedures and training The bureaucracy involved in documentation and accreditation  Benefits & limitations The cost involved in achieving ISO9001 registration and then maintaining it Perceived by small companies to be only applicable to large companies. Considered by those companies who have mature TQM approaches to be of no value.  Building Effective Quality Management Systems Integration of the quality management system (QMS) with enterprise systems like ERP, MES, and SCM is crucial for effective decision making and process improvement. Should focus on actionable decision making, identifying root causes of problems, and improving processes and systems. Top management is required to demonstrate commitment to the development and improvement of the QMS.  5S BASIC TRAINING What is 5S and why do we want to do it?  What is 5S and why do we want to do it? 5S: Sort, Set in Order, Shine, Standardize and Sustain 5S represents 5 disciplines for maintaining a visual workplace (visual controls and information systems). These are foundational to Kaizen (continuous improvement) and a manufacturing strategy based "Lean Manufacturing" (waste removing) concepts. 5S is one of the activities that will help ensure our company’s survival.  5S 1. Sort - All unneeded tools, parts and supplies are removed from the area 2. Set in Order - A place for everything and everything is in its place 3. Shine - The area is cleaned as the work is performed 4. Standardize - Cleaning and identification methods are consistently applied 5. Sustain - 5S is a habit and is continually improved Also - Work areas are safe and free of hazardous or dangerous conditions  Some New Words Red Tag -Process for tagging, removing and disposing of items not needed in the work area. Lean Manufacturing -concepts that seek continuous improvement by removing waste in processes Some Japanese words you need to know: Kaizen- (pronounced “ki zen”) - improvement Kaizen Event and 5S Event-Planned improvements to a specific area or process (usually take 3 to 5 days). 5S Events focus on making 5S improvements. Muda-(pronounced “moo da”) - waste Gemba-(pronounced “gim ba”) - workplace  New Words - Continued Kanban-(pronounced “kon bon”) - Pull type inventory control system. Items are only produced to meet customer needs. The request to produce more is signaled from an upstream operation and/or customer orders. Value Stream Map - A diagram of all processes needed to make and deliver the product to the customer.  Some 5S Examples After 5S - Cleaned, organized and drawers labeled (less time and frustration hunting) Before 5S 5S Examples - Sort, Set in Order See the difference? 1. Sort - All unneeded tools, parts and supplies are removed from the area 2. Set in Order - A place for everything and everything is in its place  5S Examples - Shine 3. Shine - The area is cleaned as the work is performed (best) and\or there is a routine to keep the work area clean.  5S Examples - Standardize 4. Standardize - Cleaning and identification methods are consistently applied Departments have weekly 5S tours Every job has duties that use Sort, Set in Order and Shine We all have common duties to do our part to keep all areas of the plant in shape - breakroom, restrooms, locker area, parking lot, etc  5S Examples - Sustain 5. Sustain - 5S is a habit and is continually improved 5S is a simple concept with powerful results. You will get additional information on 5S so that you will be well equipped. Our experience is that the more we do 5S the better the work environment becomes: cleaner, safer, more organized, the work is easier, less confusion and less stress. Use the 5S (work\home\play) - The more you use it the easier it becomes and life just gets better and better. The Good, Bad and the Ugly First the Bad and the Ugly - Life Without 5S The Good  What is Waste (Muda)? Some of the main forms of waste are: Overproduction Waiting for materials, machines, or instruction Transportation or movement Excessive inventory Inefficient machine processing and/or operation Producing defects Part or line changeover or machine setup Inadequate housekeeping Miscommunication or inadequate instruction  Improvement (Kaizen) Principles Get rid of all old (false) assumptions. Don't look for excuses, look for ways to make it happen. Don't worry about being perfect - even if you only get it half right “start NOW”! It does not cost money to do KAIZEN. If something is wrong “Fix it NOW”. Good ideas flow when the going gets tough. Ask "WHY" five times - get to the root cause. Look for wisdom from Ten people rather than one. Never stop doing KAIZEN.  Summary 5-S is for you. Clean-up and organize your work area every day so that each new day is easier and safer than the day before Share your input with your leaders so that the tools you need will be available to you, increasing your efficiency. Volunteer to help with the 5S tours and 5S events. Take a good look around...Imagine zero waste/zero confusion!  The quality mantra “Quality can not be tested into products; it has to be built in by design”  Practice Apply 5S to your chosen restaurant/food shop/cafeteria  Work in team Present the following systems: ISO 14000 SA8000 (ISO 26000) ISO 31000 HACCP (ISO 22000) – food safety GMP – phama products 6 sigma 5S  GMP: Good Manufacturing Practice GMP ensures that quality is built into the organization & processes involved in manufacture GMP covers all aspects of manufacture including collection, transportation, processing, storage, QC & delivery of the finished product – Good Manufacturing Practice – Good Management Practice – Get More Profit – Give more Production – GMP Training with out tears  GMP Part of QA which ensures that products are consistently produced & controlled to the quality standards appropriate to their use. GMP is an integral part of QA.  GMP GMP in solid dosage forms GMP in semisolid dosage forms GMP in Liquid orals GMP in Parenterals Production GMP in Ayurvedic medicines GMP in Biotechnological products GMP in Nutraceuticals & cosmeceuticals GMP in Homeopathic medicines  Ten Principles of GMP 1. Design & construct the facilities & equipments properly 2. Follow written procedures & Instructions 3. Document work 4. Validate work 5. Monitor facilities & equipment 6. Write step by step operating procedures & work on instructions 7. Design, develop & demonstrate job competence 8. Protect against contamination 9. Control components & product related processes 10. Conduct planned & periodic audits  Beyond GMP Reduce pollution -→ Zero discharge Adaptation of environment friendly methods Consideration for better & healthier life tomorrow Consideration of ethics in life One should begin with end in mind otherwise it will be the beginning of the end  The head of QM (QA) The head of QM (QA) should be a qualified pharmacist, have adequate training & practical experiences which enable him/her to perform him/her function personally. The head of QM (QA) should given full authority & responsibility in all quality system/assurance duties.  PREMISES Specify the requirements of location, design , constructions and maintenance of manufacturing premises with respect to the following: a. prevention of contamination from surrounding environment and pests b. prevention of mix up of materials and products c. facilities such as toilet, changing rooms, sampling areas and QC lab d. defined areas for certain activities e. wall, ceiling, drains , air intake and exhaust, lighting and ventilation, pipe work and light fitting f. storage areas  PREMISES Suitable location, design , constructions and maintenance for manufacturing premises : – defined areas for certain activities (e.g material sampling & dispensing) – wall, ceiling, drains , air intake and exhaust, lighting and ventilation, pipe work and light fitting – storage areas of adequate space – Physical separation of toilets and QC lab from production  Building & facilities 1. Design and construction features. 2. Lighting. 3. Ventilation, air filtration, air heating and cooling. 4. Plumbing. 5. Sewage and refuse. 6. Washing and toilet facilities. 7. Sanitation. 8. Maintenance.  Paint Finish… Not only building paintwork must be considered but also equipment  Building Finishes Not Acceptable Acceptable PVA Paint L Epoxy or Enamel paint J Window sills L Flush glazed windows J Exposed pipes L Smooth surfaces J Horizontal pipes & services L Concealed services J Open floor drains L Hygienic drains J Floor cracks, flaking floor Homogonous sealed floors – surfaces L epoxy finish or welded vinyl J Ceiling cracks & joints L Smooth sealed ceilings J Exposed, open light fittings L Flush light fittings J Wooden furniture L S/Steel or Melamine furniture J Poor & Good Windows  HACCP In the early 1960s, food scientists at Pillsbury, in collaboration with NASA scientists realized that traditional food safety methods – testing and analysis - would be inadequate to guarantee food quality in space. Taking strategy from munitions makers, they were asked to identify certain “critical failure areas” and eliminate them from the system.  What is HACCP? NASA had already mandated the use of “Critical Control Points” in their engineering management, so Pillsbury adopted it for food. In 1971 and 1972 there were numerous incidents of botulism poisoning from commercially canned foods in the US. – The US Government asked Pillsbury to train its inspectors and help with a new food safety program based on Pillsbury’s NASA experience, which eventually became HACCP.  What is HACCP? “Hazard Analysis and Critical Control Points”. This program is often cited as a very successful collaboration between industry and government.  The initial HACCP system was based on three principles: – 1. Conduct a hazard analysis. – 2. Determine critical control points. – 3. Establish monitoring procedures. Based on its experience, Pillsbury quickly adopted two additional principles: – Establish corrective actions to take when deviations occur at a CCP. – Establish critical limits to be enforced at CCPs. The first HACCP foods  HACCP Today 1. Conduct a hazard analysis. 2. Determine the CCPs. 3. Establish critical limit(s). 4. Establish a system to monitor control of the CCPs. 5. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control. 6. Establish procedures for verification to confirm that the HACCP system is working effectively. 7. Establish documentation concerning all procedures and records appropriate to these principles and their application.  HACCP Today Used in all types of manufacturing, not simply food or beverages. Adopted by brewers in the early 1990s.  Other models 6 sigma JIT – Just in Time Benchmarking SA 8000 TQM 6 sigma 6 sigma  6 sigma 68.26% of the population within 1 standard deviation around the mean 95.46% of the population within 2 standard deviations around the mean 99.74% of the population within 3 standard deviations around the mean  6 sigma in different industries DPMO 1000000 Restaurant bills (defectsper 100000 million Airlines baggagecheck in opportunities) 10000 1000 100 Egypt Air (5,8) 10 Air India(5,8) Lufthansa (6,6) 1 0,1 Best-in-class Quantas, SAS 0,01 2σ 3σ 4σ 5σ 6σ 7σ Source: Motorola, Air Safety Online Quelle: Motorola, Air SafetyOnline  6 sigma in different industries DPMO 1000000 Restaurant bills (defectsper 100000 million Airlines baggagecheck in opportunities) 10000 1000 100 Egypt Air (5,8) 10 Air India(5,8) Lufthansa (6,6) 1 0,1 Best-in-class Quantas, SAS 0,01 2σ 3σ 4σ 5σ 6σ 7σ Source: Motorola, Air Safety Online Quelle: Motorola, Air SafetyOnline  Contents 1 Quality Management System 2 ISO 3 5S 4 TQM, Q-Based System, GMP, HACCP