ISO 9000 Family Status and Six Sigma Integration

Tony Brown MCQI and material provided by Dr. Bill Truscott FCQI

ISO 9000 Family Status and Six Sigma Integration

WELCOME GOOD TO BE BACK IN GLASGOW TALKING TO THE WEST OF SCOTLAND BRANCH OF THE CHARTERED QUALITY INSTITUTE

ISO9001 Quality management Systems Standard

BENEFITS Successfully accepted by the World Business Community by creating a common standard Pre-requisite for doing global business Provides an entry point for 3rd world economies Standardises Best Practice quality methods Its not perfect, nor is 3rd Party Accreditation always effective

ISO9000 Status
WORLDWIDE INCREASE IN CERTIFICATIONS TO 780,000 NUMBER OF ECONOMIES USING THE STANDARD INCREASED BY 50% CHINA TOP THE TABLE WITH 144,000 CERTIFICATES UK CURRENTLY HAVE 46,000 WITH SOME DECLINE

ISO9001 Quality management Systems Standard

SURVEY FEEDBACK CRITICAL ISSUES Standard doesnt guarantee product conformity. Variability of 3rd Party accreditation. Poor take up of ISO9004 ISO9001 should prescribe risk management

ISO9001 Quality management Systems Standard

SURVEY FEEDBACK CRITICAL ISSUES People Aspects not sufficiently covered by the standards

ISO9000 Quality management Systems Standard

Salient Issues: Management for Sustainability Criteria for changing words Reduction of Ambiguity Input of changes from S/C2 Relationship with ISO9001, ISO9004 and the intended family Add executive summary to the revised ISO9000

ISO9000 Quality management Systems Standard Due 2009

Salient Issues: Document/data management Add matrix of ISO9000 family of standards Sub-clause 0.2 review Culture of autonomy Review of scope Product Quality v Quality Management System

ISO9000 Quality management Systems Standard Due 2009

SUSTAINABILITY How do we make the music in our organisations last ? How do we keep the product from fading too fast ? How do we commit ourselves to our customers and keep our own identity How do we not run out of new ideas We know the world is always changing If we can try each day to make things a little better, then, with some good fortune, well survive !

ISO9000 Quality management Systems Standard Due 2009

3.2.8 Sustainability
of an organizations ability or activity to maintain or develop its performance in the long term Sustainability emphasizes the need for a balance between economic-financial interests of an organization and those of the social and ecological environment. This is sometimes referred to as the three Ps: profit, people and planet. Sustainability relates to the direct and indirect interested parties (3.3.7) of an organization (such as shareholders, employees, customers (3.4.5), users, pressure groups and communities).

ISO9001 Change Status

To address the issues raised by the sanctioned interpretations against 9001, hopefully to remove them Similarly to address the issues detailed in the ISO 9000 Introduction and Support Package guidance documents Improve clarity, remove ambiguity, and ease translation To improve compatibility with ISO 14001 The changes are limited to a small amendment, and there are no major changes to any requirement The target date for publication is Oct 2008

ISO9001 Change Status

General The phrases "monitoring", "measuring" and "measurement" are a constant source for questions of defining these terms and distinguishing them from each. General The statement of effectiveness concerning the corrective action, instead of only checking if it was carried out The new requirements about the existence of records (e.g. audit results). The establishment of statutory requirements.

ISO9001 Change Status

1.1 General
This International Standard specifies requirements for a quality management system where an organization
needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements The inclusion of the definition of effectiveness emphasizes the concept that OUTPUT MATTERS,

ISO9001 Change Status

4.1 Proposed change: The type and extent of controls
to be applied to these outsourced processes shall be defined within the quality management system

ISO9004 Managing for Sustainable Success Due 2008

4.1 Interested parties focus 4.2 Approaches of managing for sustainable success 4.2.1 General 4.2.2 Focus on Strategy

ISO9004 Managing for sustainable success

4.2.3 Process approach 4.2.4 Continual Improvement 4.3 Management Responsibility 4.4 Assessing sustainable success

ISO9004 Managing for sustainable success

5.0 The organization's environment 5.1 Changing environment 5.2 Monitoring 5.3 Analyzing

Policy and strategy formulation, planning & deployment 6.1 Policy and Strategy formulation 6.2 Policy and strategy planning and deployment 6.2.1 Planning 6.2.2 Scenarios and strategic risks 6.2.3 Deployment into processes and structures of an organization

ISO9004 Managing for sustainable success

7 7.1 7.2 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.4

Resources Management of resources Financial resources Human resources General Management of Human Resources Competence of people Involvement and motivation of people in the organization Partners

ISO9004 Managing for sustainable success

7.4.1 7.4.2 7.4.3 7.4.4 7.4.5 7.4.6

ISO9004 Managing for sustainable success

Partners and partnership Selection of partners Issues to be considered concerning partners Evaluation of relationships with partners Improvement of the partners capability Review of relationships

ISO9004 Managing for sustainable success

7.5 Infrastructure 7.6 Work environment 7.7 Knowledge, information and technology 7.8 Natural resources

ISO9004 Managing for sustainable success

8 Process management 8.1 Types of processes 8.2 Managing the organizations processes 8.3 Process responsibility and authority

ISO9004 Managing for Sustainable Success

9 9.1 9.2 9.3 Measurement and analysis Purpose Key performance indicators Gathering data and information

9.3.1 General

ISO9004 Managing for Sustainable Success

9.3.2 9.3.3 9.3.4 9.4 9.5 Data in relation to key performance indicators Internal audit Self-assessment Review of data and monitoring the achievement of objectives Decisions

ISO9004 Managing for Sustainable Success

10 Improvement, innovation and learning 10.1 Aiming for sustainable success requires improvement and innovation 10.2 Improvement 10.3 Innovation 10.4 Learning

ISO 9000 Family Status and Six Sigma Integration - Overview

A number of questions are considered, such as: 1. Why should the integration of any specific continual improvement initiative within ISO 9000 be worthy of consideration? 2. Why should Six Sigma be deemed preferable by the International community to any other initiative? 3. Is the ISO 9000 family the most desirable pathway into ISO? 4. Is the development of a National Standard rather than an International one more feasible? 5. Can ISO play a useful role in the attestation of Six Sigma belts?

Question 1
Why should the integration of any specific continual improvement initiative within the ISO 9000 family be worthy of consideration?

ISO 9000 family-1

Of the 19 documents in the ISO 9000 family of quality management systems standards, three are most relevant here ISO 9000: Fundamentals and terminology ISO 9001: Requirements ISO 9004: Guidelines for performance improvements

ISO 9000 family-2

ISO TC 176 state that the greatest value is obtained if we use these standards in an integrated manner by:
adopting ISO 9001 to achieve a first level of performance then implementing ISO 9004 to increase system effectiveness beginning with ISO 9000

That is the declared intent

ISO 9000 family-3

ISO 9001 continues to have an excellent take-up Over million worldwide in 161 countries ISO 9004 has not been so successful Why is this?

ISO 9001
ISO 9001 is concerned primarily with the quality assurance aspects of quality management It specifies requirements for a quality management system for any organization that needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements

ISO 9004 - 1
Generic principles of performance improvement are enunciated in ISO 9004 There is no information on:
any specific initiative alternative approaches the HOW? to achieve the WHAT?

Organizations need to seek elsewhere for guidance on how actually to proceed

ISO 9004 - 2
ISO 9004 does, however, make reference to its compatibility with quality excellence models There is a huge gap between this ideal state and that achieved by the basic ISO 9001 Surely it is in this gap where the opportunity for providing real practical information on how to achieve significant improvement in business efficiency and effectiveness lies

ISO 9004 3 Example

ISO 9004 refers, for instance, at length, in generic terms, to the need to establish strategic objectives However no practical information is provided on HOW to achieve this even through Humphreys SWOT analysis yet alone alternative methods such as: PEST analysis Porters five forces model Value chain analysis and competitive advantage strategies Ansoffs growth matrix, Boston Consulting Group box or the McKinsey growth pyramid

ISO 9004 -4
This poses the question Should ISO 9004 fill this information opportunity gap? ISO 9004 is currently being revised Decisions on ISO Standards are made on a consensus basis by member bodies It is up to the International fraternity to decide NOW !

Question 2
Why should Six Sigma be deemed preferable by the International community to any other initiative?

Performance Improvement Initiatives - 1

Performance improvement initiatives include: Jurans trilogy, 6 stage planning, 7 stage control and 8 step breakthrough Demings 14 obligations, top down - bottom up approach ,PDCA cycle and SoPK Crosbys 4 absolutes and 14 step process Feigenbaums 4 forces Ishikawas 7 basic tools and quality circles Imias kaizen process; 5 golden rules for gemba management Ohnos lean organization; JIT and 7 types of waste Taguchis 8 key concepts and novel approach to experiments

Performance Improvement Initiatives - 2

A current popular, highly publicised, and successful improvement initiative is Six Sigma (often coupled with Lean) What makes Six Sigma different from the transient nature of most previous models? Or, perhaps, improvement initiatives are, by their very nature, transitory due to: frequency of management changes progress in outlook, ideas and methods continual need to refresh approach, outlook and enthusiasm However, sustainability is a buzz word to be mindful of today in respect to both Six Sigma and Lean.

Six Sigma - 1
Formal integration of Six Sigma into the ISO 9000 family could ensure sustainability What are the prospects? Integration into ISO 9004 is unlikely Why? Six Sigma violates the principle of non prescriptive nature of ISO/TC176 Standards Furthermore the name Six Sigma is protected by copyright Six Sigma has a strong statistical basis which is outside the ISO/TC176 remit.

Six Sigma - 2
Formal integration of Six Sigma into ISO 9004 would thus not appear to be feasible However ISO/TC176 would claim that: ISO 9001 provides the basic regulatory platform ISO 9004 presents the generic concepts to further encourage and support organizations These enable any organization to adopt and implement the specific performance improvement initiative best suited to their own needs and aspirations

Six Sigma 3
Individual organizations are free to use the ISO 9000 family as a platform to adopt and deploy the Six Sigma Initiative ISO 9000, 9001 and 9004 are completely compatible with that of Six Sigma and are intended to foster and encourage such a response

Question 3
Is the ISO 9000 family the most desirable pathway into ISO for Six Sigma?

Six Sigma Integration into ISO Standards

Formal integration into ISO/TC176s ISO 9000 family is not feasible What are the alternatives? ISO consists of some 177 active Technical committees Many have a bearing on Six Sigma (and its associated Body of Knowledge) One of particular interest is ISO/TC69: Applications of statistical methods

ISO/TC 69 and Six Sigma-1

In 2004 the Charter and Scope for a TC 69 Ad-Hoc Committee on Six Sigma was published Two recent recommendations to TC 69 have arisen:
Recommendation 1 contained 4 scenarios describing how TC 69 can serve the needs of the Six Sigma community Recommendation 2 was to develop a communication note to ASQ: highlighting the existing contributions of TC 69

ISO/TC 69 and Six Sigma-2

The four scenarios of recommendation 1 were:
Create a new TC69 sub committee dedicated to Six Sigma Commit to start work on a new ISO Standard focused on Statistical Methods for Six Sigma Create a new TC 69 group, to also address Six Sigma needs from other bodies such as TC 176 Partner with a management standards body to address the full scope of knowledge and skills demanded within the Six Sigma community

ISO/TC 69 and Six Sigma-3

At its 2006 plenary ISO/TC69 decided to: Create a formal ISO Working Group, directly linked to TC 69, charged with the creation of an ISO Standard on Statistical Techniques for the Six Sigma Community with Ms. Michele Boulanger as Convenor This Six Sigma Working Group is currently active A proposal for a new ISO/TC 69 Standard on Six Sigma will be raised in early 2007

ISO/TC69 Applications of Statistical Methods

ISO/TC 69 has decided, at this point of time:

not to take up the recommendation to initiate action to integrate the statistical tools of Six Sigma with Management System Performance Improvement Standards through partnering with a Management Standards Body (e.g. TC 176s ISO 9000 family)

Question 4
Is then the development of a National Standard rather than an International one more feasible?

British Standards Institution

A proposal to commission flagship British Standards on Process Performance Improvement is on the table It is intended that one multi-part British Standard be dedicated specifically to the Six Sigma Initiative The other Standard would deal with a wide range of performance improvement methods covering various classes of business process and types of approach

Proposal for new British Standards integrating improvement initiatives with ISO 9000 family
The intent of these British Standards is to fill an existing void: to provide the specific HOW? to match the generic WHAT? Of Management Systems Standards such as the ISO 9000 family

Process Performance Improvement methods, tools and techniques

These new British Standards are intended to: provide specific methods, tools and techniques of process performance improvement be descriptive and explanatory rather than prescriptive provide the bridge between the generic ISO 9000 family and specific business improvement initiatives such as Six Sigma

Question 5
Can ISO play a useful role in the attestation of Six Sigma belts?

Attestation of Six Sigma Belts

ISO 9001 has spawned a new generation of trainers, accredited auditors and registrars Worldwide, it is big business A similar, but informal, commercial situation has mushroomed with Six Sigma with the training and attestation of Belts

ISO 9001 v Six Sigma Belt Accreditation - 1

ISO 9001 accreditation is standardized worldwide (ref ISO 17011:2006) Six Sigma Belt attestation is not so There are extremes in the current requirements to achieve Belt accreditation This situation seriously undermines the validity and integrity of Six Sigma Belt status

ISO 9001 v Six Sigma Belt Accreditation -2

In this situation it requires prior determination of whether, say, the black belt insignia is based on a: $995, on-line training and certification course with no project fulfilment $3200 five day course with in-class project and examination $10,925 four week comprehensive course with stringent examination and external project criteria In the UK, in the absence of a British Standard, a 20 day course based on the ASQ Book of Knowledge (endorsed by the European Organization for Quality) would be the current expected norm

Six Sigma Belt Accreditation

This is probably not a significant issue from an internal organization point of view It can, however, become important from the viewpoint of an individual There is no expectation of ISO action in the foreseeable future

Summary of Conclusions
Q1: There is a gap in ISO Standards between the WHAT of the ISO/TC 176 ISO 9000 family and the HOW of quality improvement initiatives Q2: The Six Sigma initiative is widespread and commercial training schemes are well established Q3: ISO/TC69 is the only current feasible pathway into ISO for Six Sigma Q4: National Standards are being proposed in the UK to integrate the methods and tools of quality improvement initiatives with the ISO 9000 generic family Q5: The validity and integrity of current Six Sigma belt attestation is questionable. No early ISO solution is expected

The Core Message

A Six Sigma Initiative integrated with the ISO9001 and ISO 14001 regulatory platforms can produce an high performance enterprise

ISO9001 Quality management Systems Standard

Question What can the CQI and the UK do to improve the effectiveness of the standard to produce quality products?