Presentation on theme: "Philosophies and Frameworks"— Presentation transcript:
1 Philosophies and Frameworks Module 3Philosophies and Frameworks
2 Quiz What were the 5 definitions of quality? Transcendent (Excellence) Product-BasedUser-BasedValue-BasedManufacturing-Based (Conformance, Little Q)
3 Medical Devices Case What is Happening? (The Trend) Margins for Improvement?Quality Checks?Feedback Analyses?Benchmarks?Transformations?Customers? End Users? Quality Recognition?
4 Deming Chain Reaction Improve quality Costs decrease Productivity improvesIncrease market share with better quality and lower pricesStay in businessProvide jobs and more jobs
5 Deming’s System of Profound Knowledge Appreciation for a systemUnderstanding variationTheory of knowledgePsychology
6 Appreciation for a System Most organizational processes are cross-functionalParts of a system must work togetherEvery system must have a purposeManagement must optimize the system as a whole
7 Knowledge of Statistical Theory Many sources of uncontrollable variation exist in any processExcessive variation results in product failures, unhappy customers, and unnecessary costsStatistical methods can be used to identify and quantify variation to help understand it and lead to improvements
8 Theory of KnowledgeKnowledge is not possible without theory (e.g = 4)Riding a bicycle (Tacit & Explicit)Experience alone does not establish a theory, it only describesTheory shows cause-and-effect relationships that can be used for prediction
9 Knowledge of Psychology People are motivated intrinsically and extrinsicallyFear is “generally” demotivatingManagers should develop pride and joy in work
10 Deming’s 14 Points (Abridged) (1 of 2) 1. Create and publish a company missionstatement and commit to it.2. Learn the new philosophy.3. Understand the purpose of inspection.4. End business practices driven by price alone.5. Constantly improve system of productionand service.6. Institute training.7. Teach and institute leadership.8. Drive out fear and create trust.
11 Deming’s 14 Points (2 of 2) 9. Optimize team and individual efforts. 10. Eliminate exhortations for work force.11. Eliminate numerical quotas and managementby objectives (MBO). Focus on improvement.12. Remove barriers that rob people of prideof workmanship.13. Encourage education and self-improvement.14. Take action to accomplish the transformation.
13 Quality is free . . . : Phillip B. Crosby “Quality is free. It’s not a gift, but it is free. What costs money are the unquality things -- all the actions that involve not doing jobs right the first time.”
14 Philip B. Crosby Absolutes of Quality Management: Quality means conformance to requirementsProblems are functional in natureThere is no optimum level of defectsCost of quality is the only useful measurementZero defects is the only performance standard
15 A.V. Feigenbaum Three Steps to Quality Quality Leadership, with a strong focus on planningModern Quality Technology, involving the entire work forceOrganizational Commitment, supported by continuous training and motivation“Accountability for quality: Because quality is everybody's job, it may become nobody's job—the idea that quality must be actively managed and have visibility at the highest levels of management.” ~ Feigenbaum
16 Kaoru Ishikawa Instrumental in developing Japanese quality strategy Influenced participative approaches involving all workersAdvocated the use of simple visual tools and statistical techniques
18 Genichi TaguchiPioneered a new perspective on quality based on the economic value of being on target and reducing variation and dispelling the traditional view of conformance to specifications:No LossLossTolerance0.5000.5200.480
19 Feedback ReportStrengths - approaches or results that demonstrate effective response to the CriteriaOpportunities for improvement - how the applicant can better address the purposes of the Criteria, or issues that require clarification
21 ISO 9000:2000Quality system standards adopted by International Organization for Standardization in 1987; revised in 1994, 2000, and 2005.Technical specifications and criteria to be used as rules, guidelines, or definitions of characteristics to ensure that materials, products, processes, and services are fit for their purpose.
22 Objectives of ISO Standards (1 of 2) Achieve, maintain, and continuously improve product qualityImprove quality of operations to continually meet customers’ and stakeholders’ needsProvide confidence to internal management and other employees that quality requirements are being fulfilled
23 Objectives of ISO Standards (2 of 2) Provide confidence to customers and other stakeholders that quality requirements are being achievedProvide confidence that quality system requirements are fulfilled
24 Structure of ISO 9000 Standards 21 elements organized into four major sections:Management ResponsibilityResource ManagementProduct RealizationMeasurement, Analysis, and Improvement
25 ISO 9000:2005 Quality Management Principles Customer FocusLeadershipInvolvement of PeopleProcess ApproachSystem Approach to ManagementContinual ImprovementFactual Approach to Decision MakingMutually Beneficial Supplier Relationships
26 ISO 9001:2008ISO 9001:2008 sets out the criteria for a quality management system and is the only standard in the family that can be certified (although this is not a requirement). Checking that the system works is a vital part of ISO 9001:2008. An organization must perform internal audits to check how its quality management system is working.