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Copyright: Quality Institute of America
1
QUALITY INSTITUTE OF QUALITY INSTITUTE OF AMERICA, Inc.AMERICA, Inc.
PROFESSIONAL SERVICES IN ISO 9000 and QS 9000
QUALITY MANAGEMENT
•TRAINING•CONSULTING
•AUDITING
Copyright: Quality Institute of America
2
ISO 9000- 2008: Executive Briefing
AGENDA: Why ISO 9000?
• Value of Quality
• Need for Quality Management System (QMS)
• Historical evolution Requirements of ISO 9k-2k Documenting and Implementing a QMS Using professional assistance
Copyright: Quality Institute of America
3
OFFICES
PARTNERING OFFICETETRAHEDRON, INC.1414 KEY HIGHWAY
SUITE cBALTIMORE, MD 21230
(USA)
PARTNERING OFFICECM, INC.
2800 JOHN STREETSUITE 19
MARKHAM, ONTARIO(CANADA)
BRANCH OFFICE
18A, ROAD 18BANANI, DHAKA
(BANGLADESH)
CORPORATE OFFICE8951 Ruthby St.
SUITE 12HOUSTON, TX 77061
(USA)
Copyright: Quality Institute of America(SOURCE :McGraw Hill)
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GROWTH OF ISO9000 IN NORTH AMERICA
0
10000
20000
30000
40000
50000
60000
92 93 94 95 96 97 98 99 00 01
Growth Of ISO 9000 in North America
# of Registration
Copyright: Quality Institute of America(SOURCE: McGraw Hill)
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SAVINGS TO COSTS RATIOS
020406080
100120
Ra
tio
s
93 96 99
Year
Saving to Costs Ratio
Total saving Total cost
Copyright: Quality Institute of America (SOURCE: McGraw Hill)
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SYSTEM GOODNESS & SAVINGS-TO-COSTS RATIO
0
1
2
3
Rat
ios
Poor Good VeryGood
System Goodness & Saving-to-costs Ratio
Copyright: Quality Institute of America
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WHAT IS ISO 9000?
THE STORY OF SMITHY--THE VILLAGE BLACKSMITH
E- MAIL US FOR THE STORY. SEE HOW SUPERIOR BUSINESSES WORLD WIDE HAVE USED THE PRINNCIPLES OF ISO 9000
THROUGHOUT HISTORY.
Copyright: Quality Institute of America
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Resource Management
Measurement,analysis,
improvement
ProductRealization
ManagementResponsibility
CONTINUAL IMPROVEMENTOF THEQUALITY MANAGEMENT SYSTEM
INPUTProduct
Model of the process approach
Customers(and other Interested Parties)
RequirementsOUTPUT
Customers(and other Interested Parties)
Satisfaction
Value-adding activities
Information flow
Copyright: Quality Institute of America
9
EXPLODE THE MYTH!
SAY WHAT YOU DODO WHAT YOU SAY
This catchy slogan can cause a lot of headaches. E-mail us, we will tell how not to fall into traps that this very popular slogan can spring on you.
Copyright: Quality Institute of America
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The PDCA cycle is a trial and learning event that emphasizes learning by sequentially testing changes on a small scale.
This is the essence of ISO 9001:2008.
ESSENCE OF AN ISO 9000 SYSTEM
Act
Plan
DoCheck
Copyright: Quality Institute of America
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PDCA Cycle
Plan
Do
Check
Act
Possible Changes
Improvement
Copyright: Quality Institute of America
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HOW TO ACHIEVE QUALITY
• TODAY'S APPROACH--- BUILD IT IN THE PROCESS(ES) THAT CREATE PRODUCT AND SERVICES---DEFECT PREVENTION AND CONTINUOUS PROCESS IMPROVEMENT: “VARIABILITY REDUCTION” CLASSICAL APPROACH---- INSPECT IT IN, BY REMOVING DEFECTS.
• CLASSICAL APPROACH---- INSPECT IT IN, BY REMOVING DEFECTS.
Copyright: Quality Institute of America
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Increasedproductivity
Quality
Conformanceto
requirements
Meets customer
expectations
Exceedscustomer
expectations
Superiorityto
competitors
Reducedrework/repair
Reducedcosts
Avoidscustomer
dissatisfaction
Reduced returns,
complaints,warranty
Customersatisfaction
Reputation
Increasedmarket
Premiumprices
Increasedprofit
Theoretical framework relating quality and performance
Copyright: Quality Institute of America
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Lost Opportunity
Scrap
Rework
Inspection
WarrantyRejects
Lost sales
Late delivery
Engineering change orders
Long cycle times
Expediting costs
Excess inventory
The Cost of Poor Quality (COPQ) “Iceberg”
Traditional Quality Costs
Additional Costs of Poor Quality
(intangible)
(tangible)
4-8%
25-35%
(Easily Identified)
(Difficult or impossible to measure)
Lost Customer LoyaltyMore Setups
Copyright: Quality Institute of America
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EVOLUTION OF ISO 9000
INDUSTRIAL REVOLUTION--VOLUME PRODUCTION-- NEED FOR CONFORMITY--SORT GOOD FROM BAD
WORLD WAR-- NEED FOR INTERCHANGEABILITY-- INSPECTION INADEQUATE
MIL-I-45208---MIL-Q-9858
Copyright: Quality Institute of America
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EVOLUTION OF ISO 9000
ADOPTED BY NATO AS AQAP-1 (1968)
UK DEFENSE STANDARDS (1970-73)
UK BS 5179 1974--EVAL OF QA SYST
UK BS 5750--1979
TC 176: ISO--1983
ISO 9000---1987, UPDATED 1994
ISO 9000, December 2000
Copyright: Quality Institute of America
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THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ANSI: American National Standards Institute.Approximately 90 members in good standing.
USA
Bangladesh
ANSI
BSTI
Canada CSA
PakistanPSI
UKBSI
Copyright: Quality Institute of America
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ISO STANDARDS GENERATION PROCESS
Working Group Draft (WD) sent toRelevant SubcommitteeElevated to Committee DraftSent for Balloting to member countries: approved as is, Disapproved (Reasons required), Approved with comments.Typically, series of improving versions are balloted until CD is accepted.
Copyright: Quality Institute of America
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ISO STANDARDS GENERATION PROCESS
Draft International Standardonce subcommittee satisfied w/ CDelevated to DIS status.sent to all national standards bodiesmore improvements may be necessary if positive ballots do not exceed 67% or negative ballots exceed 25%.
Release as an international standardusually accepted as a national standard and published as such. (example: Q9001)
Copyright: Quality Institute of America
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ISO 9000: DEFINITIONSQUALITY
DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILLS REQUIREMENTS
FITNESS FOR PURPOSEMEET REQUIREMENTSDELIGHTING CUSTOMERSRIGHT FIRST TIME ALL THE TIME
Copyright: Quality Institute of America
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ISO 9000: DEFINITIONSQUALITY MANAGEMENT
COORDINATED ACTIVITIES TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY
STRATEGIC PLANNINGPOLICY /MISSION DEFINITIONEXECUTION OF POLICYIMPLEMENTATION
Copyright: Quality Institute of America
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ISO 9000: DEFINITIONSQUALITY SYSTEM
MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY
WHAT WHOHOWWHEREWHEN
03-00 Copyright: Quality Institute of America
ISO 9000: AN OVERVIEWTHE 1994 STANDARDS
ISO 9001: “Quality Systems- Model for QA in Design, Development, Production, Installation, and Servicing”
ISO 9002: “ --Model for QA in Production, Installation, and Servicing”
ISO 9003: “--in Final Inspection and Test”
Copyright: Quality Institute of America
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ISO 9001: DEFINITIONS
PRODUCT: Result of activities or processes-- may include service, hardware, software, processed materials or a combination thereof-- intended product offering only, not to unintended by-products.TENDER: Offer made by a supplier in response to an invitation to satisfy a contract award to provide a product.CONTRACT: Agreed requirements between a supplier and customer transmitted by any means.
Copyright: Quality Institute of America
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ISO 9000-2000 MAJOR CHANGES
Family of standards: ISO 9000: Normative reference, provides
fundamentals and terminology. ISO 9001: Requirements, provides ability to
demonstrate capability for quality. ISO 9004: Guidelines for system, continual
improvement- ‘consistent pair’ ISO 19011: Guidance on quality and
environmental audits
Copyright: Quality Institute of America
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ISO 9000-2000 MAJOR CHANGES
Eliminated 9002, 9003. Only 9001 with permissible exclusions in clause 7.Eight clauses (No- not lesser total requirements) Essentially five groups of requirements:
Quality System Management Responsibility Resources Product Realization Measurement, analysis, improvement
Copyright: Quality Institute of America
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ISO 9000: 2000
1994 Changes: No big deal, Registered companies had one year.2000 Changes: Big deal. Got 3 years. Should take time to do it right, do all the right things.
Copyright: Quality Institute of America
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EIGHT MANAGEMENT PRINCIPLES
Principle 1- Customer-Focused Organization
Principle 2- Leadership
Principle 3- Involvement of People
Principle 4- Process Approach
Copyright: Quality Institute of America
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EIGHT MANAGEMENT PRINCIPLES (contd.)
Principle 5- System Approach to Management
Principle 6- Continual Improvement
Principle 7- Factual approach to decision making
Principle 8- Mutually beneficial supplier relationships
Copyright: Quality Institute of America
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FOUR MAIN GROUPS
1. Management Responsibility.
2. Resource Management.
3. Management of Process.
4. Measurement, Analysis and Improvement.
Copyright: Quality Institute of America
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HIERARCHY OF DOCUMENTS
POLICY
PROCEDURES
INSTRUCTIONS
RECORDS/ FORMS
Copyright: Quality Institute of America
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POLICY
WHAT THE COMPANY WANTS EMPLOYEES TO DOTOP LEVEL : COMPANY WANTS EVERYONE TO FOLLOW ISO 9001
Copyright: Quality Institute of America
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PROCEDURES
HOW DOES THE COMPANY WANT TO ACHIEVE ITS POLICY TO FULFILL THE VARIOUS REQUIREMENTS OF ISO 9001. PROCEDURES ARE MANDATORY.A WRITTEN STATEMENT OF RESPONSIBILITIES AND THE ORGANIZED SEQUENCE OF ACTIONS WHICH COLLECTIVELY FULFILL A PARTICULAR FUNCTION, AND FULFILL THE REQUIREMENTS OF A PARTICULAR CLAUSE OF ISO 9001.SEVERAL PROCEDURES MAY BE NECESSARY TO COMPLY WITH A PARTICULAR CLAUSE OF THE STANDARD.
Copyright: Quality Institute of America
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WORK INSTRUCTION
A WRITTEN STATEMENT OF HOW AN ACTIVITY IS TO BE PERFORMED (USUALLY) BY A PERSONAN INSTRUCTION SUPPORTS A PROCEDURE: SEVERAL INSTRUCTIONS MAY BE NECESSARY TO SUPPORT A PROCEDUREAN INSTRUCTION IS NECESSARY WHERE THE ABSENCE OF THE INSTRUCTION WOULD ADVERSELY AFFECT THE OBJECTIVE OF THE PROCEDURE THAT THE INSTRUCTION SUPPORTS
Copyright: Quality Institute of America
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ISO 9000: IMPLEMENTATION
ORGANIZATIONAL CHECKPOINTS:
Executive Steering CommitteeExecutive ChampionProject TeamProject LeaderTask TeamsConsultants
Copyright: Quality Institute of America
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ISO 9000: IMPLEMENTATION
IMPLEMENTATION CHECKPOINTS:Design Structure of SystemDesign Document Control SystemIdentify Procedures and InstructionsCreate Procedures and InstructionsImplement Procedures and InstructionsTraining in Internal Audits
Copyright: Quality Institute of America
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ISO 9000: IMPLEMENTATION
IMPLEMENTATION CHECKPOINTSUse Internal Audits in detecting system inadequaciesTake Corrective ActionsSelect RegistrarPre- assessment (optional, by registrar-- somewhat discouraged by RAB)
Registration AuditCelebrateSurveillance (by Registrar)Triennial Recertification