Setting up a Quality Management System

Transcription

1 Innovation Seminar Series 1: Setting up a Quality Management System Peter CHOW January 9,

2 What is Quality? 2

3 Definition of Quality Quality Degree to which a set of inherent characteristics fulfils requirements ISO 9000:2005 Quality management systems -- Fundamentals and vocabulary 3

4 Definition of Quality To my Satisfaction! by Customer 4

5 Definitions Quality Management Coordinated activities to direct and control an organization with regard to quality ISO 9000:2005 Quality Management System Management system to direct and control an organization with regard to quality ISO 9000:2005 5

6 Introduction of ISO 9001 QMS Representing a Thorough Revision Including New Requirements Sharpening Customer Focus Reflecting Developments in Quality Management & Experience Gained Adopt Process Approach Fine-tuning No Additional Requirements No Specific Reassessment for Certification Same Intention as Version 2000 Customer Satisfaction Statutory and Regulatory Compliance Continual Improvement 6

7 Introduction of ISO 9001 QMS Since ISO 9001:2000 7

8 Introduction of ISO 9001 QMS 1,200,000 Worldwide Total of ISO 9001 Certificates 1,000, , , , , Source: ISO Survey 2009 Data extracted from:

9 Introduction of ISO 9001 QMS Top 10 Countries for ISO 9001 Certificates (2011) 9 Source: ISO Survey 2009 Data extracted from:

10 Introduction of ISO 9001 QMS The ISO Survey of Management System Standard Certifications 2011 Extracted from: 10

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12 Process Approach INPUT (Resources) PROCESS OUTPUT (Product / Service) Control, Monitoring & Measurement (throughout the process) 12

13 P-D-C-A Cycle Take actions to continually improve process performance Act Plan Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization s policies Monitor and measure processes and product against policies, objectives and requirements for the product and report the results Check Do Implement the processes 13

14 Customer Requirements Customer Satisfaction QMS Process Model QMS Continual Improvement Management Responsibility Resource Management Measurement, Analysis & Improvement Input Product Realization Product Output 14

15 ISO 9001:2008 Standard 1 Scope 2 Normative Reference 3 Terms and Definitions 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement, analysis and improvement 15

16 4 Quality management system 4 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement, analysis and improvement 16

17 5 Management Responsibility 4 Quality Management System 5 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority and Communication 5.6 Management Review 6 Resource Management 7 Product Realization 8 Measurement, analysis and improvement 17

18 6 Resource Management 4 Quality Management System 5 Management Responsibility 6 Resource Management 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment 7 Product Realization 8 Measurement, analysis and improvement 18

19 7 Product Realization 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 7.1 Planning of Product Realization 7.2 Customer-related Processes 7.3 Design and Development 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Monitoring and Measuring Equipment 8 Measurement, analysis and improvement 19

20 8 Measurement, analysis and improvement 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement 20

21 Setting up a Management System 4 Phases Approach Phase I : System Review & Gap Analysis Phase II : System Design & Development Phase III : System Implementation Phase IV : System Certification

22 Training Management Process Setting up a Management System Phase I : System Review & Gap Analysis Phase I Phase II Phase III Phase IV - As-is Process Evaluation - Project Planning - Management Direction - Competency - Design and Development of Processes - Formation of Steering Team, Management Committee - Implementation of Processes - Coaching - Review, Fine-tune - Internal Audit - Management Review - Certification Audit - Continual Improvement - Awareness Training - Implementation Training - Internal Auditor Training - Auditor / Lead Auditor Training - On-going needs

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25 Business Improvement Consultancy STARTING FROM TOP MANAGEMENT Evaluation - as-is process - Improvement opportunities Implementation - trial-run - fine-tune Standardisation - standardise - sustain - control 25

26 Six Sigma Methodology 26

27 Mindset Transformation 思想轉變 27

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30 From where? 30

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32 Transform your mindset Believe that everything is possible Do not say NO at the first moment 32

33 Break your Inertial Thinking Experience maybe your stumbling block ( 絆腳石 ) to move forward Innovative mindset can let you stand at the leading position 33 Photo credit: from Internet

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35 Methods are always not alone There are plenty of solutions Compare Practical, Effective 35

36 Continual Improvement Don t strike for perfection at once 50% score is sometimes good enough Panasonic s Target: everyday improve 1% Long-term continual improvement is more important 36