Transcript Slide 1

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
• It’s 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 doesn’t 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, we’ll
survive !
ISO9000 Quality management
Systems Standard – Due 2009
3.2.8 Sustainability
• of an organization’s 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
6
ISO9004 Managing for
sustainable success
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
7
7.1
7.2
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.4
ISO9004 Managing for
sustainable success
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
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 organization’s
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 ¾ 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 Humphrey’s
SWOT analysis yet alone alternative methods such
as:
• PEST analysis
• Porter’s five forces model
• Value chain analysis and competitive advantage
strategies
• Ansoff’s 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:
• Juran’s trilogy, 6 stage planning, 7 stage control and
8 step breakthrough
• Deming’s 14 obligations, top down - bottom up
approach ,PDCA cycle and SoPK
• Crosby’s 4 absolutes and 14 step process
• Feigenbaum’s 4 forces
• Ishikawa’s 7 basic tools and quality circles
• Imia’s kaizen process; 5 golden rules for gemba
management
• Ohno’s lean organization; JIT and 7 types of waste
• Taguchi’s 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/TC176’s
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 176’s 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?