Future of The Quality Management Principles 2009 02 24 Hiroe

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Future of The Quality Management Principles 2009/02/24 Hiroe TSUBAKI Member, ISO TC 176/ SC Future of The Quality Management Principles 2009/02/24 Hiroe TSUBAKI Member, ISO TC 176/ SC 1/ WG 1 Director, Risk Analysis Research Center, The Institute of Statistical Mathematics, Tokyo.

Discussion about the QMP, Why not and now? • TC 176 needs concrete consensus Discussion about the QMP, Why not and now? • TC 176 needs concrete consensus on how to treat the current eight QMP and Fundamental parts of ISO 9000. – Internal Harmonization among • Revision of ISO 9000 by TC 176/ SC 1, • FDIS 9004 by TC 176/ SC 2, – Enhancement for Sustainability? • Different Methodology and Tools proposed by TC 176/ SC 3. • Two Key Questions on Needs of – Expansion of the QM Principles, – Enhancement of the QM Principles

Objectives of this WS from the viewpoints of SC 1 • SC 1 needs Objectives of this WS from the viewpoints of SC 1 • SC 1 needs necessary inputs for the revision of ISO 9000 from SC 2 and SC 3 as – What basic elements of QM should be added into new ISO 9000 for the enhancement relevant with the new ISO 9001, 9004 and the other standards. – Explanations to clarify the correspondence between the QMP and the requirements of the QMS in ISO 9001 and 9004. – Description of the QMP in new ISO 9004 Appendix

Role of the QMPs  in ISO 9000 series • For users’ general understanding on Role of the QMPs  in ISO 9000 series • For users’ general understanding on “What is QM in the ISO 9000 series standards? ” and “How it will work in organizations effectively? ”

The Previous Japanese Proposal for Expanding the QMPs relating to Sustainability (SC 1 N The Previous Japanese Proposal for Expanding the QMPs relating to Sustainability (SC 1 N 305) • New ISO 9004 provides new Quality Management Principles. – It does not provide the new principle but new concepts as • • Achievement of sustainable success Continual provision of the customer values through improvement and/or innovation of the product Agile adaptation to the dynamic environmental changes It will need to discuss the necessity of the revision of the Quality Management Principles. – Not the revision but the enhancement • In addition to the current 8 Quality Management Principles, following should be considered. – values • creating not only customer value but on social value – Leadership • visionary leadership – Establishment of understanding core competence – Organizational culture • organizational and personal learning, agility, autonomy – Collaboration with partners – Total optimization • Although now Most member bodies including the JNC may think – we should not change the QMP at all, however, SC 1 should enhance the current principles by adding notes, explanation etc in order to reflect the revision of ISO 9004.

Personal Observation • TC 176 including SC 1 thinks the current eight QM principles Personal Observation • TC 176 including SC 1 thinks the current eight QM principles should not be necessarily expanded but enhanced by adding several explanations or notes in order to adopt the sustainable management activities as innovation, learning et al.

Consideration of the Enhancement in SC 1 New Design Specification of ISO 9000 • Consideration of the Enhancement in SC 1 New Design Specification of ISO 9000 • Rethink fundamental parts of 9000 completely – The QMP should be common essence of ISO 9000 series standards – The new ISO 9000 should be an effective bridging document between the 9001& revised 9004 by clarifying the relationship between the QMP and basic QM elements. • Brain Storming in SC 1 WG 1 at Novi-sad • Clarification of Relation among new concepts and the eight QMP to reflect the design specification of new ISO 9000. • Development of the Design Spec. of New 9000 – Necessary Input from whole TC 176 • What should be Basic Elements of Quality Management relevant with the QMP. • Which specifications in ISO 900 and the new 9004 are directly and indirectly relevant with the QMP.

Functional Analysis of the Current Eight QMPs for Information • Value (WHY) – (1)for Functional Analysis of the Current Eight QMPs for Information • Value (WHY) – (1)for Customers consistent with (2)Mutual Beneficial Supplier Relation • Specific to Quality Management? • Common Management Principles – Objectives (WHAT) • (3)Continual Improvements by (4)Evidence-based Approaches – Scientific Approaches with Reproducibility – System Selection and Design to Optimize the Value (HOW) • Definition of (5)Processes and (6)Systems to attain the objectives and accountability – Specific to Auditable Management? – Implementation (WHO) • by (7)People with (8)Leaders – Anytime and Anywhere!

Consideration for Enhancement from the new DS Customer Focus • • • • Voice Consideration for Enhancement from the new DS Customer Focus • • • • Voice of the customer (listening) Providing value to the customer Provide information to the customer Extend customer focus to future customers Extend customer focus to stakeholders (internal and external) Extend customer focus to end users Next process is your customer (supply chain) Customer satisfaction and ensuring repeat customers Customer value creation Researching and understanding customer needs and expectations. Ensuring that the objectives of the organization are linked to customer needs and expectations. Communicating customer needs and expectations throughout the organization. Measuring customer satisfaction and acting on the results. Systematically managing customer relationships. Ensuring a balanced approach between satisfying customers and other interested parties (such as owners, employees, suppliers, financiers, local communities and society as a whole).

Leadership • • • • • Leadership vision Core value statement Providing clear vision, Leadership • • • • • Leadership vision Core value statement Providing clear vision, mission, purpose Strategies, effective strategic planning and its accomplishment, goals and objectives Leadership communication with owners Quality policy deployment Adaptability to changes Motivation of employees Participative management Management by factual data decision making Considering the needs of all interested parties including customers, owners, employees, suppliers, financiers, local communities and society as a whole. Establishing a clear vision of the organization's future. Setting challenging goals and targets. Creating and sustaining shared values, fairness and ethical role models at all levels of the organization. Establishing trust and eliminating fear. Providing people with the required resources, training and freedom to act with responsibility and accountability. Inspiring, encouraging and recognizing people's contributions.

Involvement of People • • • • • Maximizing and harnessing people’s capabilities Employee Involvement of People • • • • • Maximizing and harnessing people’s capabilities Employee retention Employee satisfaction Awareness of the significance of roles and responsibilities Culture of continuing learning and knowledge management Culture of developing, deploying and living by Core Values Maintaining effective communications with all employees Empowerment of employees to contribute to decision making process Facilitate workers councils Providing facilities, equipment, and tools to do their job right People understanding the importance of their contribution and role in the organization. People identifying constraints to their performance. People accepting ownership of problems and their responsibility for solving them. People evaluating their performance against their personal goals and objectives. People actively seeking opportunities to enhance their competence, knowledge and experience. People freely sharing knowledge and experience. People openly discussing problems and issues

Process Approach • • • • Define and document the processes, including process capability Process Approach • • • • Define and document the processes, including process capability Process standard (ongoing accumulated knowledge of the process) Voice of the process (understanding and managing variability) Inter-relationship of processes to overall system Validation of processes Design based on process capability Resources, controls, process parameters, inputs and outputs Importance of clarifying critical to quality processes and characteristics Establishing and applying a process for continuing improvement of processes. Systematically defining the activities necessary to obtain a desired result. Establishing clear responsibility and accountability for managing key activities. Analyzing and measuring of the capability of key activities. Identifying the interfaces of key activities within and between the functions of the organization. Focusing on the factors such as resources, methods, and materials that will improve key activities of the organization. Evaluating risks, consequences and impacts of activities on customers, suppliers and other interested parties.

System Approach to Management • • • • Quality comes out of the system System Approach to Management • • • • Quality comes out of the system Accumulative effect of individual process capability on overall system performance Systems are management responsibility Organization’s effectiveness and efficiency in achieving its objectives Various dimensions of quality relating to organizations (performance, return on investment, features, reliability, serviceability, dependability, conformance, durability, aesthetics, perceived quality) Strategic quality planning Structuring a system to achieve the organization's objectives in the most effective and efficient way. Understanding the interdependencies between the processes of the system. Structured approaches that harmonize and integrate processes. Providing a better understanding of the roles and responsibilities necessary for achieving common objectives and thereby reducing cross-functional barriers. Understanding organizational capabilities and establishing resource constraints prior to action. Targeting and defining how specific activities within a system should operate. Continually improving the system through measurement and evaluation.

Continual improvement • • • • Introduce concept of continual improvement of processes, as Continual improvement • • • • Introduce concept of continual improvement of processes, as well as systems Based on factual data Communicate improvement goals and achievements Continual improvement of product and process innovations Twin concepts of incremental improvements and break-through improvements to achieve sustainable success. Concept of continual improvements by actually observing the process Maximize work force participation Continual improvements applies to management, too Continual improvement of work environment by use of IT Employing a consistent organization-wide approach to continual improvement of the organization's performance. Providing people with training in the methods and tools of continual improvement. Making continual improvement of products, processes and systems an objective for every individual in the organization. Establishing goals to guide, and measures to track, continual improvement. Recognizing and acknowledging improvements.

Factual approach to decision making • • • • Speak with data not “PHOG” Factual approach to decision making • • • • Speak with data not “PHOG” (Perception, Hearsay, Opinion, Guessing) Ensure accuracy and timeliness of data Voice of the customer demands accurate and timely data Establish and maintain a measurement system in support of decision making Appropriate analysis and reporting of data Field data collection of external factors Factual problem solving and corrective and preventive action taken based on data Validation of data for accuracy and consistency Importance of statistical thinking and methods Ensuring that data and information are sufficiently accurate and reliable. Making data accessible to those who need it. Analyzing data and information using valid methods. Making decisions and taking action based on factual analysis, balanced with experience and intuition.

Mutually beneficial supplier relationships • • • • Alignment of philosophies between the organization Mutually beneficial supplier relationships • • • • Alignment of philosophies between the organization and their suppliers and transparency in fairness Establishing partnerships, building trusts through open two-way communications Establish long term customer-supplier relationships based on common vision and mission Mutual respect Buy on process capability not first cost alone Synchronize continual improvements with suppliers Supporting technical capability building of the supplier Assist the suppliers with their process improvements Supplier recognition system Establishing relationships that balance short-term gains with long-term considerations. Pooling of expertise and resources with partners. Identifying and selecting key suppliers. Clear and open communication. Sharing information and future plans. Establishing joint development and improvement activities. Inspiring, encouraging and recognizing improvements and achievements by suppliers.

The JNC proposals for new structures of ISO 9000 fundamental parts • 2 Fundamentals of The JNC proposals for new structures of ISO 9000 fundamental parts • 2 Fundamentals of QMS – 2. 1 Significance of QMS and rationale for QMS model • use the text in ISO 9000: 2000 – 2. 2 8 QMP • organize the contents of the current Design Spec. Clause 8 – 2. 3 Basic elements of QMS • • • 2. 3. 1 Requirements for QMS and requirements for products 2. 3. 2 Approach to establishment and implementation of QMS 2. 3. 3 The process approach 2. 3. 4 Role of top management within the QMS 2. 3. 5 Mission, vision and strategy 2. 3. 6 Quality policy and quality objectives 2. 3. 7 Evaluating QMS (Internal audit, management review, self-assessment) 2. 3. 8 Continual improvement, innovation, learning 2. 3. 9 Documentation 2. 3. 10 Role of statistical techniques • • 2. 3. 11 QMS and other management system focuses 2. 3. 12 Relationship between QMS and excellence models – 2. 4 Relationship between 8 QMP and basic elements of QMS (organize in a form of matrix)

New Idea through Tentative Discussions on the structures of the fundamental parts in SC New Idea through Tentative Discussions on the structures of the fundamental parts in SC 1/ WG 1 Quality Management System – Model and Terminology • 2 Quality Management Model • 2. 1 Generals – Relationship between principles, fundamentals and QMS model • 2. 2 Principles – Principles relevant with philosophical aspects of QM: • (1)Customer Focus, (2)Mutual supplier relation – Principles relevant with management aspects • Target – (Systematic and Reproducible) (3)Continual improvement – by Approaches for internal and external quality assurance » (4)Factual based Decision Making for reproducibility » (5)Systems approaches along(6) processes – Principles relevant with human or motivation aspects • (7)People involved • (8)with leadership

2. 3 Fundamental (Methodology) (briefly described and attached by appendix) • 2. 3. 1 2. 3 Fundamental (Methodology) (briefly described and attached by appendix) • 2. 3. 1 PDCA approaches • 2. 3. 2 Process approaches • 2. 3. 3 How to connect these fundamentals to QMS models – Common MS models • refer and modify the ISO 9004 model – QMS and other management system focuses – Relationship between QMS (9001) and excellence models(9004 etc. )

2. 4 QMS model • New structure should be based on the expanded QMS 2. 4 QMS model • New structure should be based on the expanded QMS model in ISO 9004 and also taken several new activities around MSs as SR etc into consideration.

Thank you very much for your attention We highly appreciate your active inputs to Thank you very much for your attention We highly appreciate your active inputs to the new ISO 9000 fundamental parts.




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