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

(c) Copyright Nigel H Croft 2005 1

Keeping the QMS Alive

Dr Nigel H CroftMexico CityApril 21st 2005


ISO 9001:2000 – a common starting point


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)


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”


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


Business performance

Need to integrate QMS with:VisionMissionStrategic objectivesOverall business performanceResults


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


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


The ISO ModelContinual Improvement of the Quality

Management System

Resource Management

Measurement, Analysis,

Improvement

Management Responsibilit

y

Product Realization Product

Inputs Outputs


How to drive the QMS beyond “ISO 9001 compliance”??


Typical motivation cycleM

otiv

atio

n

Time

ISO

90

01Approx 18 months


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”……………


“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)


“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


“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


But remember………

“A fool with a

tool is still a

fool”


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


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


Looking beyond “conformance” to “performance”


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”


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”


Cause and EffectPROCESS “INTENDED

PRODUCT”

“UNINTENDED PRODUCT” (WASTE)INEFFICIENCY


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


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”)


The ISO ModelContinual Improvement of the Quality

Management System

Resource Management

Measurement, Analysis,

Improvement

Management Responsibilit

y

Product Realization Product

Inputs Outputs


Interested Parties

Customers

& end users& end users

PeoplePeople in

the organization

Owners & investorsOwners & investorsSuppliers & partnersSuppliers & partners

SocietySociety

(community & the public)


ISO 9001

ISO 9004ISO 9004 perspective:Performance Improvement; QMS efficiencyefficiency

ISO 9001 perspective: Quality of “product”;QMS effectivenesseffectiveness

Relationship ISO 9001/ISO 9004


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


“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


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


Linking the QMS to business performance


Keys to business success

Define and deploy the Vision, Mission and Strategic Objectives

Understand the overall business processes

Apply PDCA throughout the organization


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?


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”


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


Check:

Is this what we expected? Are the results OK? Can they be improved? Look for trendstrends


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)


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


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)?


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


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)


“The forgetful organization”

Time

Improvements

Improve Improve Improve

FORGET FORGET FORGET

““SAWTOOTH” EFFECTSAWTOOTH” EFFECT


“The learning organization”

Time

Improvements““LADDER” EFFECTLADDER” EFFECT

“KAIZEN” (

Continual i

mprovement)

ImproveStandardize

Maintain (routine)


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


Muchas Gracias!

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

Documents

c copyright nigel h

maintenance slide

useful tools slide

customer satisfaction

friendly way slide

common starting point

management systems

qms important