1. Dr Nigel H Croft Mexico City April 21st 2005
Keeping the QMS Alive
Dr Nigel H Croft
Mexico City
April 21st 2005
(c) Copyright Nigel H Croft 2005

2. ISO 9001:2000 – a common starting point
(c) Copyright Nigel H Croft 2005

3. What is a Management System?
Hardware
(equipment)
Software
(methods)
Humanware
(people)
ISO 9000:2000 definition:
“set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives”
(c) Copyright Nigel H Croft 2005

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ISO 9001:2000 Scope
Clause “Specifies quality management system requirements for organization to:
demonstrate ability to consistently provide product that meets customer and applicable regulatory requirements
enhance customer satisfaction”
(c) Copyright Nigel H Croft 2005

5. Components of a management system
Administrative
Policy
Objectives
Deployment
Doc control
Internal audit
Management review
NC control
Corr/Prev Actions
Etc…………..
Technical
Knowledge of business
Product specification
Technical integrity of “product”
Legal requirements
Understanding of process
etc
(c) Copyright Nigel H Croft 2005

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Business performance
Need to integrate QMS with:
Vision
Mission
Strategic objectives
Overall business performance
Results
(c) Copyright Nigel H Croft 2005

7. Return on Investment (“ROI”)
Many organizations view QMS only as “cost”, not “investment”
Need to maximize ROI, by ensuring efficiency, as well as effectiveness
Doing things
Faster
Cheaper
“Better”
Safer
In a more environmentally friendly way
(c) Copyright Nigel H Croft 2005

8. ISO 9001:2000 as a starting point
Different approaches to ISO 9001:
“Minimalist”
Separate from other Total Quality initiatives
Integrated into the way the organization does business
How to promote this?
Process-driven
Results-focused
Aligned with overall organizational strategy and objectives
Integrated with other management systems
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9. The ISO Model CUSTOMER Requirements CUSTOMER Satisfaction
Continual Improvement of the Quality Management System
The ISO Model
CUSTOMER
Requirements
CUSTOMER
Satisfaction
Management Responsibility
Resource Management
Measurement, Analysis, Improvement
Product Realization
Inputs
Outputs
Product
(c) Copyright Nigel H Croft 2005

10. How to drive the QMS beyond “ISO 9001 compliance”??
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11. Typical motivation cycle
Approx 18 months
Motivation
ISO 9001
Time
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12. How to maintain the motivation??
By promoting new initiatives within the framework of the QMS
Important not to confuse these as “substitutes” for the QMS, or a “new flavours of the month”
Some useful “tools”……………
(c) Copyright Nigel H Croft 2005

13. “People-related” tools
Seiri – “Sort, Systematize or simplify”
Seiton – “Straighten, standardize”
Seiso – “Shine”
Seiketsu – “Sanitize”
Shitsuke – “Sustain”
Quality Improvement Teams (Inter-functional)
QC Circles
Suggestions plans
(NOTE - All rely on the QMS for support and maintenance)
(c) Copyright Nigel H Croft 2005

14. “System-related” tools
Systematic Problem Solving
“QC Story”
Small-step continual improvement (“Kaizen”)
Breakthrough Improvement (“ Reengineering”) where necessary!
Statistical techniques
7 tools / 7 “new tools”
Statistical Process Control
6-sigma
Management by policy (“Hoshin Kanri”)
Error-proofing (“Poka-yoke”)
Quality Function Deployment
Cost of quality
(c) Copyright Nigel H Croft 2005

15. “Business-related” tools
“Lean” initiatives (Toyota philosophy)
Initiatives to reduce bureaucracy
Balanced Scorecard (“BSC”)
National Quality Awards / Excellence Models
Benchmarking
Just-in-time inventories (“KANBAN”)
Theory of Constraints (Goldratt – “The Goal”)
Total Productive Maintenance
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But remember………
“A fool with a
tool is still a
fool”
(c) Copyright Nigel H Croft 2005

17. Implementation of new initiatives
Impossible to do all at once!
Need to prioritize
“Organizational profile”
What is important for your organization?
Top management direction & support required
Long-term plan needed
Allocation of adequate resources
Financial
Human
Marash – “Fusion Management” QSU Publishing
(c) Copyright Nigel H Croft 2005

18. Keeping the Motivation
Approx 18 months
Motivation
ISO 9001
Initiative “A”
Initiative “B”
Initiative “C”
Time
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19. Looking beyond “conformance” to “performance”
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EFFECTIVENESS
Dictionary definition:
“producing or capable of producing a desired effect”
ISO 9000:2000 definition:
“extent to which planned activities are realized and planned results achieved”
(c) Copyright Nigel H Croft 2005

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EFFICIENCY
Dictionary definition:
“Acting or producing effectively with a minimum of waste, expense, or unnecessary effort.”
“Exhibiting a high ratio of output to input”
ISO 9000:2000 definition:
“Relationship between the result achieved and the resources used”
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Cause and Effect
“INTENDED
PRODUCT”
PROCESS
“UNINTENDED
PRODUCT” (WASTE)
INEFFICIENCY
(c) Copyright Nigel H Croft 2005

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ISO 9001:2000
Specifies QMS requirements for an organization:
to demonstrate ability to consistently provide conforming product
to enhance customer satisfaction
Requires continual improvement of the system effectiveness
understand the role of ISO 9001 standard:
Product / service quality oriented
Confidence to own management
Confidence to customers
‘Established requirements’
Customer satisfaction
(c) Copyright Nigel H Croft 2005

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ISO 9004:2000
Goes beyond requirements of ISO 9001
Provides guidance (“should”, not “shall”) on:
Effectiveness and efficiency
Performance improvement
Focuses on benefits for all Interested Parties (“IP’s”)
Ask participants to think about who are the IP's in their own organization
(people in the organization, suppliers, owners, society)
(c) Copyright Nigel H Croft 2005

25. The ISO Model Interested Parties Requirements Interested parties
Continual Improvement of the Quality Management System
The ISO Model
Interested Parties
Requirements
Interested parties
Satisfaction
Management Responsibility
Resource Management
Measurement, Analysis, Improvement
Product Realization
Inputs
Outputs
Product
(c) Copyright Nigel H Croft 2005

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Interested Parties
Customers
& end users
Suppliers & partners
Owners & investors
People in
the organization
Society
(community & the public)
(c) Copyright Nigel H Croft 2005

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Relationship ISO 9001/ISO 9004
ISO 9004 perspective:
Performance Improvement;
QMS efficiency
ISO 9004
ISO 9004 is not just ‘more of the same’
(Seen from the front:)
Covers more activities, not just directly related to product conformity
e.g. Support services, health & safety, social, environmental & financial considerations
(Seen diagonally:)
Also covers topics within ISO 9001 (product related), but from a management viewpoint > different perspective!
ISO 9004 gives guidance on a wider range of objectives of a QMS than does ISO 9001,
particularly for the continual improvement of an organization's overall performance & efficiency, as well as its
effectiveness.
ISO 9004 is recommended as a guide for organizations whose top management wishes to move
beyond the requirements of ISO 9001, in pursuit of continual improvement of performance.
It is not intended for certification or for contractual purposes.
ISO 9001
ISO 9001 perspective: Quality of “product”;
QMS effectiveness
(c) Copyright Nigel H Croft 2005

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Relationship ISO 9001/ISO 9004
“Consistent pair”of stand-alone standards
Common format & structure
Harmonized terminology (ISO 9000:2000)
Both based on 8 “Quality Management Principles”
Emphasized more in ISO 9004
Organizations at different needs levels
ISO certified
ISO customer requirement
Certified, now what?
> Return on ISO 9001 QMS
> ISO 9004 towards performance improvement
Possible to advance from ISO 9001 to ISO 9004 within same basic structure.
Each standard can be used alone.
(c) Copyright Nigel H Croft 2005

29. Quality Management Principle
“Comprehensive & fundamental rule, for leading & operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other Interested Parties.”
Intended for top management in setting Quality policy & objectives
Managing: “ Leading & operating an organization “
Focus on both customers & IP's.
Basis for ISO 9004:2000 QMS- Guidance for Performance Improvement
(c) Copyright Nigel H Croft 2005

30. Quality Management Principles
Customer-focused organization
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationship
(c) Copyright Nigel H Croft 2005

31. Linking the QMS to business performance
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32. Keys to business success
Define and deploy the Vision, Mission and Strategic Objectives
Understand the overall business processes
Apply PDCA throughout the organization
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Plan
What to do?
(“Objective”)
How to do it?
(“Procedure”) Do
Do what was
planned
Check
Did things happen
according to plan?
Act
How to improve
next time?
DELEGATE NOTES:
(c) Copyright Nigel H Croft 2005

34. Plan (Strategic level):
What do we want to achieve?
Vision
Mission
Objectives
How can we achieve it?
Business plan
Strategies
Resources
Dr Deming – “It’s pointless to establish an objective without defining a method to achieve it”
(c) Copyright Nigel H Croft 2005

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Do:
Get everyone involved, committed, and motivated (“Leadership”!)
Carry out “the plan”
Deploy throughout the organization
Break down the objectives to the appropriate functions and levels
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Check:
Is this what we expected?
Are the results OK?
Can they be improved?
Look for trends
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Act
Correct what went wrong (Correction)
Plan to do it right next time (Corrective action)
Learn to make things “error-proof” (Preventive action)
Think – how can we do this……..
More consistently?
Faster?
Cheaper?
Better?
Safer?
More environmentally friendly?
(Improvement)
(c) Copyright Nigel H Croft 2005

38. The strategic view “Where do we want to be in the long term?”
“Understand, manage and improve”
Understand the business
Define policy and objectives
Deploy policy throughout organization
Routine management
Continual (small-step) improvements
Breakthrough improvements
(c) Copyright Nigel H Croft 2005

39. Understand the business
Why are we here?
Who is (who are) our customer(s)?
What is our product?
What are our processes?
How do they fit together?
What is important (risk analysis)?
(c) Copyright Nigel H Croft 2005

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Manage the business
Use the “Plan-Do-Check-Act” cycle at all levels, functions and processes in the organization
from the Board Room to the shop floor
from R&D through customer support
(c) Copyright Nigel H Croft 2005

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Improve the business
Focus on the customer, but don’t forget other stakeholders
Focus on the key processes
Keep an eye on the competitor
Innovate
Think ahead (future trends; technologies; economic climate etc)
(c) Copyright Nigel H Croft 2005

42. “The forgetful organization”
Improvements
“SAWTOOTH” EFFECT
Improve
FORGET
Improve
FORGET
Improve
FORGET
Time
(c) Copyright Nigel H Croft 2005

43. “The learning organization”
Improvements
“LADDER” EFFECT
“KAIZEN” (Continual improvement)
Maintain (routine)
Improve
Standardize
Time
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Conclusions
We need to keep people motivated with new ideas within the overall framework of the QMS.
Look for efficiency, in addition to effectiveness
Has to be top-management driven
Will help to achieve business objectives
Will drive improvement
There are many ways to do this
Careful not to try to do everything at once
Need to customize
Need to prioritize
(c) Copyright Nigel H Croft 2005

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Muchas Gracias!
(c) Copyright Nigel H Croft 2005