1. Philosophies and Frameworks
Module 3
Philosophies and Frameworks

2. Quiz What were the 5 definitions of quality? Transcendent (Excellence)
Product-Based
User-Based
Value-Based
Manufacturing-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 improves
Increase market share with better quality and lower prices
Stay in business
Provide jobs and more jobs

5. Deming’s System of Profound Knowledge
Appreciation for a system
Understanding variation
Theory of knowledge
Psychology

6. Appreciation for a System
Most organizational processes are cross-functional
Parts of a system must work together
Every system must have a purpose
Management must optimize the system as a whole

7. Knowledge of Statistical Theory
Many sources of uncontrollable variation exist in any process
Excessive variation results in product failures, unhappy customers, and unnecessary costs
Statistical methods can be used to identify and quantify variation to help understand it and lead to improvements

8. Theory of Knowledge
Knowledge is not possible without theory (e.g = 4)
Riding a bicycle (Tacit & Explicit)
Experience alone does not establish a theory, it only describes
Theory shows cause-and-effect relationships that can be used for prediction

9. Knowledge of Psychology
People are motivated intrinsically and extrinsically
Fear is “generally” demotivating
Managers should develop pride and joy in work

10. Deming’s 14 Points (Abridged) (1 of 2)
1. Create and publish a company mission
statement 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 production
and 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 management
by objectives (MBO). Focus on improvement.
12. Remove barriers that rob people of pride
of workmanship.
13. Encourage education and self-improvement.
14. Take action to accomplish the transformation.

12. Juran’s Quality Trilogy
1) Quality planning, 2) Quality control, and 3) Quality improvement

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 requirements
Problems are functional in nature
There is no optimum level of defects
Cost of quality is the only useful measurement
Zero defects is the only performance standard

15. A.V. Feigenbaum Three Steps to Quality
Quality Leadership, with a strong focus on planning
Modern Quality Technology, involving the entire work force
Organizational 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 workers
Advocated the use of simple visual tools and statistical techniques

17. Kaoru Ishikawa

18. Genichi Taguchi
Pioneered 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 Loss
Loss
Tolerance
0.500
0.520
0.480

19. Feedback Report
Strengths - approaches or results that demonstrate effective response to the Criteria
Opportunities for improvement - how the applicant can better address the purposes of the Criteria, or issues that require clarification

20. Sample Feedback Report Types

21. ISO 9000:2000
Quality 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 quality
Improve quality of operations to continually meet customers’ and stakeholders’ needs
Provide 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 achieved
Provide confidence that quality system requirements are fulfilled

24. Structure of ISO 9000 Standards
21 elements organized into four major sections:
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis, and Improvement

25. ISO 9000:2005 Quality Management Principles
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach to Management
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships

26. ISO 9001:2008
ISO 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.