(c) copyright nigel h croft 2005 1 keeping the qms alive dr nigel h croft mexico city april 21 st...
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(c) Copyright Nigel H Croft 2005 1
Keeping the QMS Alive
Dr Nigel H CroftMexico CityApril 21st 2005
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ISO 9001:2000 – a common starting point
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What is a Management System? ISO 9000:2000
definition:
“set of interrelated or interacting elements to establish policyestablish policy and objectivesand objectives and to achieve those achieve those objectivesobjectives”
Hardware(equipment)
Software(methods)
Humanware(people)
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ISO 9001:2000 Scope
Clause 1.1 - “Specifies quality management system requirements for organization to:demonstrate ability to consistently provide
product that meets customer and applicable regulatory requirements
enhance customer satisfaction”
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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
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Business performance
Need to integrate QMS with:VisionMissionStrategic objectivesOverall business performanceResults
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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
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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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The ISO ModelContinual Improvement of the Quality
Management System
Resource Management
Measurement, Analysis,
Improvement
Management Responsibilit
y
Product Realization Product
Inputs Outputs
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How to drive the QMS beyond “ISO 9001 compliance”??
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Typical motivation cycleM
otiv
atio
n
Time
ISO
90
01Approx 18 months
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How to maintain the motivation??
By promoting new initiatives within the within the framework of the QMSframework of the QMS
Important not to confuse these as “substitutes” for the QMS, or a “new flavours of the month”
Some useful “tools”……………
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“People-related” tools
5S 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)
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“System-related” tools Systematic Problem Solving
“QC Story” Small-step continual improvement (“Kaizen”) Breakthrough Improvement (“ Reengineering”) where where
necessary!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
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“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”
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Implementation of new initiatives
Impossible to do all at once! Need to prioritize
“Organizational profile” What is important for youryour organization?
Top management direction & support required
Long-term plan needed Allocation of adequate resources
Financial Human
Marash – “Fusion Management” QSU Publishing
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Keeping the MotivationM
otiv
atio
n
Time
ISO
90
01
Initi
ativ
e “A
”
Initi
ativ
e “B
”
Initi
ativ
e “C
”
Approx 18 months
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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”
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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 EffectPROCESS “INTENDED
PRODUCT”
“UNINTENDED PRODUCT” (WASTE)INEFFICIENCY
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ISO 9001:2000
Specifies QMS requirementsrequirements for an organization: to demonstrate ability to consistently provide
conforming productproduct to enhance customer satisfaction
Requires continual improvement of the system effectivenesseffectiveness
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ISO 9004:2000
Goes beyond requirements of ISO 9001 Provides guidanceguidance (“should”, not “shall”)
on: Effectiveness and efficiencyand efficiency Performance improvementPerformance improvement
Focuses on benefits for all Interested for all Interested Parties (“IP’s”)Parties (“IP’s”)
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The ISO ModelContinual Improvement of the Quality
Management System
Resource Management
Measurement, Analysis,
Improvement
Management Responsibilit
y
Product Realization Product
Inputs Outputs
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Interested Parties
Customers
& end users& end users
PeoplePeople in
the organization
Owners & investorsOwners & investorsSuppliers & partnersSuppliers & partners
SocietySociety
(community & the public)
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ISO 9001
ISO 9004ISO 9004 perspective:Performance Improvement; QMS efficiencyefficiency
ISO 9001 perspective: Quality of “product”;QMS effectivenesseffectiveness
Relationship ISO 9001/ISO 9004
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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
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“Comprehensive & fundamental rule, for leading & operating an organization, aimed at continually improving continually improving performance over the long termperformance over the long term by focusing on customers while addressing the needs of all other Interested Parties.”
Quality Management Principle
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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
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Linking the QMS to business performance
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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?
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Plan (Strategic level):
WhatWhat do we want to achieve? Vision Mission Objectives
HowHow can we achieve it? Business plan Strategies Resources
Dr Deming – “It’s pointless to establish an objective without defining a methodmethod to achieve it”
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Do:
Get everyone involved, committed, and motivated (“Leadership”!)
Carry out “the plan”Deploy throughout the organizationBreak 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 trendstrends
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Act Correct what went wrong (Correction)(Correction) Plan to do it right next time (Corrective action)(Corrective action) Learn to make things “error-proof” (Preventive (Preventive
action)action) Think – how can we do this……..
More consistently? Faster? Cheaper? Better? Safer? More environmentally friendly?
(Improvement)(Improvement)
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The strategic view“Where do we want to be in the long term?”
““Understand, manage and improve”Understand, manage and improve”Understand the businessDefine policy and objectives Deploy policy throughout organizationRoutine managementContinual (small-step) improvementsBreakthrough improvements
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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)?
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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
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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)
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“The forgetful organization”
Time
Improvements
Improve Improve Improve
FORGET FORGET FORGET
““SAWTOOTH” EFFECTSAWTOOTH” EFFECT
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“The learning organization”
Time
Improvements““LADDER” EFFECTLADDER” EFFECT
“KAIZEN” (
Continual i
mprovement)
ImproveStandardize
Maintain (routine)
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Conclusions
We need to keep people motivated with new ideas within the overall framework of the QMS.
Look for efficiencyefficiency, in addition to effectivenesseffectiveness 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
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Muchas Gracias!