iso 9000 lecture
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1ISO
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QMS Standard
ISO 9000:2000QMS Standard
ISO 9000:2000
Pakistan Institute of Quality Control
2ISO
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Principles of Auditing
Audit Terms and Definitions
CONTENTSCONTENTSCONTENTSCONTENTS1
5
4
ISO 9000 New Family of Standards
2
3
What’s New in ISO 9000:2000 (Outline)
ISO 9001:2000 New/Modified Requirements
Competence of Auditors6
Managing an Audit Program7
3
Evolution of Quality FieldEvolution of Quality Field
TQM+ TQM+ 6 Sigma
KnowledgeMgt.
IT
TQMTQMHRM
GROUPDYNAMICS
Teams
Efficiency
BPR
TPM
JIT/MRP
QAQAISO9000
JAR 145
OPR MGT.
QCQCSPC
QualityCirclesPerformance
Measure
ProcessControl
SystemOpr Mgt.
Culture /Performance
OverallCompetitiveness
ProductInspection
4
Quality Control
RootcauseAnalysis &ProblemSolving
RootcauseAnalysis &ProblemSolving
PROCESSFlight
ServicesMarketing
AirportServices
ReworkRework
Cycle B
Cycle A
OK
Errors
MIS Performance
5
CorrectionCorrection
OK
Errors
OUTCOMEPROCESSES
Root-Cause Analysis &
Problem solving
Root-Cause Analysis &
Problem solving
Customers
Quality Assurance
data
FIELDPerformance
Root-Cause Analysis &Problem solving
Root-Cause Analysis &Problem solving
data
PROCESSMeasures
6
PURCHASINGPURCHASING
PLANNINGPLANNING
ENGG.ENGG.
HRDHRD
FINANCEFINANCE
MISMIS
MkgFlightOperations
Airport ServicesAirport ServicesFlight ServicesFlight Services
QA in PIA means QA in every Dept.
7
Performance Measures for Quality
1AppropriatenessThe degree to which the service provided is relevant to The passenger needs
1AppropriatenessThe degree to which the service provided is relevant to The passenger needs
4 EffectivenessThe degree to which the service is provided in the correct manner
4 EffectivenessThe degree to which the service is provided in the correct manner
6 Efficiency The relationship between theoutcome(s) andthe resources used to deliverservice
6 Efficiency The relationship between theoutcome(s) andthe resources used to deliverservice
3 Continuity The degree to which the service for the passenger iscoordinated among providers among organizations, and overtime
3 Continuity The degree to which the service for the passenger iscoordinated among providers among organizations, and overtime
2 AvailabilityThe degree to which the appropriate service is available to meet the passenger’s needs
2 AvailabilityThe degree to which the appropriate service is available to meet the passenger’s needs
5 Safety The degree to which the risk ofan intervention and the risk in theservice environment are reduced for passengers and others
5 Safety The degree to which the risk ofan intervention and the risk in theservice environment are reduced for passengers and others
8 Respect & CaringThe degree to which the patientor designee is involved in his orher own travel decisions and towhich those providing service do so with sensitivity andrespect for the passengers needs, expectations, and Individual differences
8 Respect & CaringThe degree to which the patientor designee is involved in his orher own travel decisions and towhich those providing service do so with sensitivity andrespect for the passengers needs, expectations, and Individual differences
7 Timeliness The degree to which service is provided to the Passenger at themost beneficial or necessarytime
7 Timeliness The degree to which service is provided to the Passenger at themost beneficial or necessarytime
9 ReliabilityErrors during service 9 ReliabilityErrors during service
8ISO
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ISO 9000 QMSISO 9000 QMSIntroduction to
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ISO 9000:2000 Family of Standards
• CORE STANDARDSCORE STANDARDS– ISO 9000:2000 Fundamentals and Vocabulary
– ISO 9001:2000 QMS Requirements
– ISO 9004:2000 Guidelines for Performance Improvement
• SUPPORTING STANDARDSSUPPORTING STANDARDS– ISO 10005:1995 Guidelines for Quality Plans
– ISO 10006:1997 Guidelines for Project Management
– ISO 10007:1995 Guidelines for Configuration Mgt
– ISO 19011 on Auditing
– ISO 10012-1 & -2, Quality Assurance for Measuring Eqpt.
– ISO 10013:1995 Guidelines for Quality manuals
10
– ISO/TR 10014:1998 Guidelines for managing economics of quality
– ISO 10015 Guidelines for Training– ISO/TR 10017:1999 Guidelines on Statistical techniques
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Process Approach Model
Management Management responsibilityresponsibility
Measurement, Measurement, analysis and analysis and improvementimprovement
Resource Resource managementmanagement
Service Service realizationrealization
OutputInput
ProductProduct
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
CUSTOMER
CUSTOMER
Satisfaction
Satisfaction
CUSTOMER
CUSTOMER
Requirements
Requirements
12
Contents
Scope 1.1 General1.2 Application
1
Terms and Definitions3
Normative Reference2
13
Contents (cont.)
Quality Management System 4.1 General Requirements
4.2 Documentation Requirements
4
Management Responsibility
5.1 Management Commitment5.2 Customer focus5.3 Quality Policy5.4 Planning5.5 Responsibility, authority and communication5.6 Management Review
5
Resource Management 6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environment
6
Product Realization 7.1 Planning of product realization7.2 Customer-related processes7.3 Design and development7.4 Purchasing7.5 Production and service provision7.6 Control of monitoring and measuring devices
7
14
Contents (cont.)
Measurement, Analysis and Improvement 8.1 General
8.2 Monitoring and measurement8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement
8
15
1. Scope (applicability)
• Product meets customer and applicable regulatory requirements
• to enhance customer satisfaction, including continual improvement of the system and assurance of conformity to customer and applicable regulatory requirements
1.1 General1.1 General
16
• Generic requirements; applicable to all organizations, regardless of type, size and product provided
1.2 Application1.2 Application
17
Documentation Structure (Example)
QUALITYQUALITYMANUALMANUAL(SUMMARY)
RelevantRecords
RelevantRecords
RelevantRecords
RelevantRecords
RelevantRecords
QMSDept B
Procedures
QMSDept C
Procedures
QMSDept D
Procedures
QMSDept E
Procedures
Supporting Documentse.g. standards, ManualsSupporting Documentse.g. standards, Manuals
QMSDept A
Procedures
What How
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• Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction
Examples
• Customer needs identification procedure?(e.g. surveys, focus groups, contracts)
• Top management verification (through 1st, 2nd, 3rd party tests etc., that such requirements are fulfilled
Examples
• Customer needs identification procedure?(e.g. surveys, focus groups, contracts)
• Top management verification (through 1st, 2nd, 3rd party tests etc., that such requirements are fulfilled
5.2 Customer Focus5.2 Customer Focus
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Top management shall ensure that the quality policy:
• is appropriate to the purpose of the organization
• includes a commitment to comply with the requirements and continually improve the effectiveness of the QMS
• provides a framework for establishing and reviewing quality objectives
• communicated and understood in the organization
• is reviewed for continuing suitability
What broad Quality aspects should be Covered in the Quality Policy?
1. Fulfillment of Customer needs
2. Fulfillment of applicable national laws and regulations
3. Minimization of waste,errors and nonconforming
4. Continual improvement
5. Employees quality and organizational culture
What broad Quality aspects should be Covered in the Quality Policy?
1. Fulfillment of Customer needs
2. Fulfillment of applicable national laws and regulations
3. Minimization of waste,errors and nonconforming
4. Continual improvement
5. Employees quality and organizational culture
5.3 Quality Policy5.3 Quality Policy
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• Quality Objectives: – are established at relevant functions
and levels, and are measurable and consistent with the quality policy
• QMS Planning: – How to achieve the objectives
• What does Quality objectives for each function means?
• What does Quality objectives for each level means?
• What does Quality objectives for each function means?
• What does Quality objectives for each level means?
5.4 QMS Planning5.4 QMS Planning
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• Responsibility and Authority:– defined and communicated within the
organization
• Management Representative: appoint a QMS Coordination role to a
management member– ensure QMS is established,
implemented and maintained– report the performance and the need
for improvement– promote awareness– liaison with external parties
Examples• Job Descriptions• QMR’s clear role
Examples• Job Descriptions• QMR’s clear role
5.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication
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• Internal Communication:ensure effective communication regarding the effectiveness of the QMS
Examples• Team briefing and
meetings• notice boards• newsletter• intranet• employees surveys
Examples• Team briefing and
meetings• notice boards• newsletter• intranet• employees surveys
23
5.6 Management Review5.6 Management Review
ManagementManagementReviewsReviews
QUALITY REPORT covering•Audit results•Customer feedback•process performance•product conformity•C/P Action•follow-ups•changes / follow-ups•recommendationsfor improvements
QUALITY REPORT covering•Audit results•Customer feedback•process performance•product conformity•C/P Action•follow-ups•changes / follow-ups•recommendationsfor improvements
Improvements in QMSImprovements in QMS
Improvements in Products/Processes
Improvements in Products/Processes
Resource NeedsResource Needs
OUTPUTSOUTPUTSOUTPUTSOUTPUTS
INPUTSINPUTSINPUTSINPUTSQUALITYQUALITYPROCESSPROCESSQUALITYQUALITYPROCESSPROCESS
24
6.2 Human Resources
6.2.1 General6.2.1 General
Right person for the right jobRight person for the right job
qualified managers?qualified supervisors?appropriate workers?
Qualified / Qualified / Appropriate means Appropriate means
1. Education1. Education2. Training2. Training3. Skills3. Skills4. Experience4. Experience
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• Provide necessary infrastructure for the QA program, e.g.
– building, workspace, utilities– process equipment (hardware/
software)– supporting services, e.g. transport,
communication,
6.3 Infrastructure6.3 Infrastructure
Examples• suitable machines,
workspaces, software, hardware, information
Examples• suitable machines,
workspaces, software, hardware, information
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• The organization shall determine and manage the work environment needed to achieve conformity to product requirements
Examples
• work space• heat, humidity, light
airflow,• hygiene, cleanliness,
noise, vibration and pollution, etc.
Examples
• work space• heat, humidity, light
airflow,• hygiene, cleanliness,
noise, vibration and pollution, etc.
6.4 Work Environment6.4 Work Environment
27
7. Service Realization
7.1Planning 7.2
CustomerRelated
Processes
7.3Design &
Development
7.5Service
Provision7.4
Purchasing
7.6Monitoring &
MeasuringDevices PROCESS
MANAGEMENTPROCESS
MANAGEMENT
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7.1 Planning
• Quality objectives and requirements for the services
• establish processes, documents, and provide resources specific to the services
• required verification, validation, monitoring, inspection and test activities specific to the service and the criteria for service acceptance
• identification of relevant records
• Service Quality Plans?
• Service Quality Plans?
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7.2 Customer-related Processes
• Determine:– customer’s requirements– unstated but necessary requirements– statutory and regulatory product req’t– any additional requirement
determined by the organization
7.2.1 Determination of requirements related to the Services7.2.1 Determination of requirements related to the Services
Examples• contracts• customer surveys,
focus groups• applicable national
regulations
Examples• contracts• customer surveys,
focus groups• applicable national
regulations
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7.2 Customer-related Processes
• review contract before acceptance• ensure service reqts are defined• resolve issues before acceptance• confirm organization capability• maintain records• ensure amendments properly
Examples• Contract review• review of results of
surveys and focus groups, etc.
Examples• Contract review• review of results of
surveys and focus groups, etc.
7.2.2 Review of requirements related to the Services7.2.2 Review of requirements related to the Services
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7.2 Customer-related Processes
• Make effective arrangements for communicating with customers in relation to:– service information– inquiries, order handling, including
changes, and– customer feedback, including
customer complaints
Examples• Printed information• Telephonic info• Mail info• Web info• Airport
announcements.• Aircraft
announcements
Examples• Printed information• Telephonic info• Mail info• Web info• Airport
announcements.• Aircraft
announcements
7.2.3 Customer Communication7.2.3 Customer Communication
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CustomerRegulatory
ProfessionalReqts.
CustomerRegulatory
ProfessionalReqts.
7.3 Development of New Services
InputsInputs ReviewReview Designing Output
VerificationVerification
ValidationValidation
Development ReviewDevelopment Review
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7.4 Purchasing
PURCHASINGPURCHASINGPURCHASINGPURCHASING
Pur
chas
ing
Proc
ess Purchasing Information
Verification of Purchased Product/Services
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7.5 Service Provision
7.5.1Control of
Service Provision
7.5.1Control of
Service Provision
7.5.2Validation ofProcesses
7.5.2Validation ofProcesses
7.5.6Control of
Monitoring andMeasuring
Devices
7.5.6Control of
Monitoring andMeasuring
Devices
7.5.4CustomerProperty
7.5.4CustomerProperty
7.5.5Preservation of Luggage& products
7.5.5Preservation of Luggage& products
7.5.3Identification
andTraceability
7.5.3Identification
andTraceability
35
8. Measurement, Analysis and Improvement
8.38.3Control of Control of
non-conformingnon-conformingserviceservice
8.38.3Control of Control of
non-conformingnon-conformingserviceservice
8.58.5ImprovementImprovement
8.58.5ImprovementImprovement
8.28.2Monitoring &Monitoring &MeasurementMeasurement
8.28.2Monitoring &Monitoring &MeasurementMeasurement
8.48.4Analysis ofAnalysis of
DataData
8.48.4Analysis ofAnalysis of
DataData
8.18.1GeneralGeneral
8.18.1GeneralGeneral
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8 Measurement, Analysis and Improvement
• Ensure conformity of the service• ensure conformity of the QMS• ensure effectiveness and
continually improving the QMS
8.1 General8.1 General
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8 Measurement, Analysis and Improvement
• Customer Satisfaction– device a method to measure and
monitor customer satisfaction from customer perception point of view
• Internal Audit– regularly carry out internal audit to
check conformity and effectiveness of the QMS
– design an effective audit program and plan, criteria
– competent auditors
– audit results and records
– follow-ups and timely C/A
Examples of CS:• Direct interfaces• focus groups• surveys• sector and industry
studies
Examples of IA:• Main objective is to
check the correctness and performance of functions and processes
Examples of CS:• Direct interfaces• focus groups• surveys• sector and industry
studies
Examples of IA:• Main objective is to
check the correctness and performance of functions and processes
8.2 Monitoring and Measurement8.2 Monitoring and Measurement
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8 Measurement, Analysis and Improvement
• Processes– apply suitable monitoring of processes
where required– C/A when deviation occurs
• Services– measure service characteristics to
confirm fulfillment of quality– at appropriate stages in accordance
with the quality plans– define acceptance criteria– authorize release and records
8.2 Monitoring and Measurement8.2 Monitoring and MeasurementExamples
• use of SPC, especially control charts
• monitoring and supervision of process parameters
• daily morning reviews of quality by workers and their supervisors
• Appropriate product measurement scheme
Examples
• use of SPC, especially control charts
• monitoring and supervision of process parameters
• daily morning reviews of quality by workers and their supervisors
• Appropriate product measurement scheme
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8 Measurement, Analysis and Improvement
• Determine, collect and analyze appropriate data from measurement sources to check conformance and analysis for improvement in:– customer satisfaction– service conformance– process– suppliers
8.4 Analysis of Data8.4 Analysis of Data
• Analysis is not compiling of data
• Analysis is after compiling of quality data
• Analysis is part of Quality Report
• Sources of data?
• Analysis is not compiling of data
• Analysis is after compiling of quality data
• Analysis is part of Quality Report
• Sources of data?
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8 Measurement, Analysis and Improvement
• Continual Improvement– identify opportunities of improvement
from quality policy, objectives, audit results, analysis of data, C/P actions, and management reviews
– mobilize improvement programs
8.5 Improvement8.5 Improvement
• Clear evidence of improvement processes
• Clear evidence of improvements
• Clear evidence of improvement processes
• Clear evidence of improvements
41
8 Measurement, Analysis and Improvement
• Corrective Action– take timely action to eliminate the
cause of nonconformities.– Review nonconformities– determine causes– evaluate – determine and implement action– records of results– review and confirm results
8.5 Improvement8.5 Improvement
• What is the difference between Correction, Corrective Action and Preventive Action?
• Corrective Action Form
• Control of Corrective Actions
• What is the difference between Correction, Corrective Action and Preventive Action?
• Corrective Action Form
• Control of Corrective Actions
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8 Measurement, Analysis and Improvement
• Preventive Action– determine potential nonconformities
current mistakes and future planning– determine their causes– device actions– implement actions– record results– review action taken
8.5 Improvement8.5 Improvement
• Outputs of management reviews or corrective actions
• Outputs of management reviews or corrective actions
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System Maturity Logic
SYS
TEM
1ST Year 2nd Year 3rd Year
Em
bryo
nic
Mat
urit
yImpr
ovem
ent
An S-Curve
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System Maturity
C
A
B
3 6 9 12 18 Time (months)
Mat
urit
y
Acceptable
Satisfactory
Good
Excellent
After 1 1/2 years
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Poor
60%
Satisfactory
40%
Good
Satisfactory
25%15%
QUALITY ASSURANCE (ISO 9000)
1998 Survey Result by KM
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ISO
900
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Thank You
Lets Create Lets Create
QUALITYQUALITYTRADITIONSTRADITIONS
The End
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