Quality Assurace

1. Quality Assurace PMLQAL401B Apply Quality System and Continuous Improvement

2. Foundations of Quality Our customers define the quality of our products and services. Quality is what consistently pleases the customer at minimal cost to the organisation. Need to produce products and services that our customers than those of our competitors.

3. Historical Evolution of Quality Concepts • 19th century - factory concept; supervisor responsible for quality • WWII - mass production required QC approach - statistical sampling of end products • 1920’s - Dr Walter Shewhart developed statistical QC • Post-WWII: Japan rebuilt its manufacturing industry with influenece from ff: • W. E. Deming - developed stat QC into a broadly-based mg’t system • Juran - Trilogy • quality planning • quality control • quality improvement • Feigenbaum - ‘make it right the first time’ • 1960’s - development from QC to QA • 1980’s - TQM concepts

4. Deming’s Key Ideas Improve quality ß Costs decrease bec of less rework, fewer mistakes, fewer delays, snags, better use of machine-time & materials ß Productivity improves ß Capture market w/ better quality and lower price ß Stay in business ß Provide jobs and more jobs ß

5. Quality ISO: the totality of features and characteristics of a product and service which near on its ability to satisfy state or implied needs AS1057-1985: Fitness for purpose Quality values of “non-customers” • Legal - hygiene, additives, residues, contaminants, composition sterility etc 2. Method intergraty 3. OHS 4. Technological 5. Ethics 6. Socio-ecological 7. patient confidentiality A quality system must encompass what customers want, need and think.

6. Quality Assurance Involves: • management commitment to setting up a QA system • describing all operations within the company • ansuring company complies with all regulatory requirements and codes of practice • process flow diagrams • HACCP charts • staff participation • QA Manual

7. Quality System The organisational structure, responsibilities, procedures, activities, capabilities and resources that together aim to ensure that products, processes or services will satisfy stated or implied needs A QA plan is equivalent to a quality system

8. QUALITY PROCESSES • Total Quality Management • Quality Circle • Continuous Improvement • Benchmarking (Best Practice) • Just-in-Time

9. Four Significant Points of TQM • Total commitment of entire workforce • Elevates customer requirements to a central pedestal • Quality can be improved without increasing costs to consumers • Consistency of quality 3 Main Approaches to TQM • Inspection • Quality Control - hands of TQM • Quality Assurance - central to TQM

10. Ten Tools of TQM • Objectives and strategies • Quality circles • Quality manuals • Planing and problem solving • Pareto analysis • Ishikawa Cause-and-Effect diagrams • Quality cost analysis • Statistical Quality Control • HACCP • Sampling

11. Four Phases of TQM 1. Policy levels in determining market level of quality 2. Engineering design stage - quality levels specified to achieve market levels 3. Production stage - control over incoming raw materials and production operations necessary to implement policies and design specifications 4. Use stage - in field, where installation can affect final quality and where guarantee of quality and conformance must be made effective

12. Quality Management Organisation Manager, Quality Assurance QC in Engineering Quality Equipment Quality in Engineering Process Control ¯ Inspection and Testing

13. Quality Assurance Dept • QC Engineering - responsible for overall process improvement of the QA system • Quality Equipment Eng’g - responsible for the design and development of testing equipment • Process Control - responsible for monitoring application of the quality system • a function to which Inspection and Testing reports

14. Quality Control Department May be resonsible to any of the following: • General Manager (or senior executive) • Chief Engineer • Sales Manager

15. TQM is based on 3 factors Factor 1: the customers you serve - their perceptions define quality - everyone serves one or is one internal customer - a person within an organisation for whom a service is provided external customer - a person outside an organisation for whom a service is provided extended customer - a person who may at some later date be affected by an internal or external service

16. Factor 2. The system within which you work -formal or informal Causes why systems does not work: a. Common or system causes - 80% of problems poor training; poor design of goods or services; poor work instructions; failure to provide accurate info; machine condition b. Special causes - 20% of problems machine malfunction, natural disaster, power surge, supplier strike, industrial action, absenteeism Pareto principle application- An organisation should concentrate its major efforts on overcoming 80% of the problems which result from its system

17. Quality Costs: How much quality? Customers must be analysed not only in terms of product quality they require but also in terms of the price scales they will pay for the various levels of product quality • Prevention Costs • Appraisal Costs • Failure Costs

18. Prevention Costs • Costs associated with personnel engaged in designing, implementing, and maintaining the quality system • Training • Planning • Auditing • Process control engineering • Design of test system • Reporting system • Recall insurance premiums • Recall plan

19. Appraisal Costs • Costs associated with the measuring, evaluating or auditing of product, components and purchased materials to assure conformance with standards and performance requirements • Design appraisal • Receival inspection costs • Process control • Depreciation of test equipment • Consumables for testing • Reporting • End-product testing • Quarantined product testing

20. Failure Costs • Costs associated with defective products, components, and materials that fail to meet quality requirements and result in manufacturing losses • Scrap • Rework of out-of-spec materials • Reinspection and retesting • Defect diagnosis • Disposal costs • Downtime from disruption of schedules • Downgrading • Replacement of out-of-spec materials

21. Cost Graph:Quality of Conformance vs Costs

22. Quality Circles • A small formally organised group of up to 10 volunteers from the same work area who regularly meet in paid time with their area supervisor to identify, analyse, solve and recommend answers and then follow up solutions to specific problems from their work area • Problems - relate to quality, productivity, and other issues including those involving employee morale and motivation

23. Major purposes of Quality Circles • : • to improve the leadership and management abilities of supervisors in the workshop and encourage improvement by self-development • to increase employee morale and simultaneously create an environment in which everyone is more conscious of quality problems and the need for improvement • to function as a nucleus for company wide quality control at the workshop level

24. Requirements for Q Circle Members • : • well-educated and have good understanding of the organisation beyond work area • trained to use problem-solving techniques & processes

25. Continuous Incremental Improvement Kaizen - “..continuous improvement in personal life, home life, social life and working life. When applied to the workplace, kaizen means continuous improvement involving everyone - managers and workers alike.”

26. Continuous Improvement Shewhart Cycle: result of constantly planning, doing, checking, and acting Deming Cycle : never-ending upward spiral of continuous improvement of products and services and of the processes required to provide them Plan - to make decisions about what is required to be done; to set an objective and standard Do - to act or put the plan into effect using worker’s input Check - to see that the results of doing match what was planned Act - to build on the successful changes so that continuous improvement occurs

27. PDCA Cycle • PLAN • DO • CHECK • ACT

28. Benchmarking (Best Practice) Benchmark: - a point of reference - something against which other things are measured Also: best practice, world competitive manufacturing, ten percenting Internal benchmarking - an organisation measures parts of its own performance and establishes goals for each department selected to be benchmarked, e.g., storing and recording goods, customer services External benchmarking - ...against an external standard, e.g., competitor’s performance, industry standard, customer’s expectations, best practices

29. 5 Steps in Benchmarking 1. Defining areas for improvement - processes, equipment, customer-service, training, etc. 2. Identifying the benchmark - internal, external, international standards 3. Measurement and collection of data - inventory accuracy, unit cost and defect rate, number of complaints 4. Adapting the data to the organisation - in which areas are they better? Why? 5. Follow-up

30. Just-In-Time • Called Toyota Production System • Parts are provided when and only when they are required for assembly or use • Stockless production or zero inventory system • Kanban system - “card” or “signal” • a specific number of parts or components moves through stages of manufacturing process in small containers with identification • Order-driven process; an order from the customer pulls an item through the production process. • Need for storage is eliminated