AWARENESS OF ISO 9000 (2000) By C. Das Additional Director ERTL(E),Calcutta.
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AWARENESS OF ISO 9000 (2000)
By
C. Das
Additional Director
ERTL(E),Calcutta
Quality Management SystemISO 9000 (2000)
Cl no 4.0 : Quality Management System
Cl no 5.0 : Management responsibility
Cl no 6.0 : Resource management
Cl.no 7.0 : Product realization
Cl no 8.0 : Improvement
6.0 Resource Management
Provision ofResources
6.1
HumanResources
6.2
Infra-structure
6.3
WorkEnvironment
6.4
CompetenceAwareness& Training
PROVISION OF RESOURCES (Cl no 6.1)
• Timely determination & provision of resources needed to– Address customer satisfaction
– Implementation of QMS processes
– Improvement of QMS processes
HUMAN RESOURCES - 1(Cl no 6.2)
• Assign responsibilities to competent personnel
• Determine competence on the basis of– Education
– Training
– Skill
– Experience
HUMAN RESOURCES - 2 (Cl no 6.2)
• Training, awareness & competency– Identify competency needs
– Provide training to satisfy these needs
– Evaluate effectiveness of training
– Ensure awareness of relevance and importance of assigned activities and their role in achievement of quality objectives
– Maintain record of education, experience, training and qualifications
Identification of Training needs
Provide TRAINING as identified
Measure EFFECTIVENESS of Training
Re-training
FACILITIES ( Cl no 6.3 )
• Identify
• Provide
• Maintain
• This includes– Work space & associated facilities
– Equipment, hardware & software
– Support services
Facilities required to achieveproduct conformity
WORK ENVIRONMENT( Cl no 6.4)
• Identify & manage
• the human and physical factors of work environment needed to achieve product conformity
Examples : - Safety rules & guidance
- Heat,Humidity,Light etc.
- Ergonomics etc.
- Creative work & social interaction
7.0 Product Realization
Planning ofProduct
Realisation7.1
CustomerRelated
Processes7.2
Design and/or
Development7.3
Purchasing7.4
Production & Service Provision
7.5
Control of Meas. &
Monitoringdevice
7.6Determination of
requirements
Review ofRequirement
Customer Communication
Planning
Input
Output
Review
Verification
Process
Information
Verification
Validation
Changes
Control
Validation
Identification &Traceability
Customer Property
Preservation
34ISO/TC176/SC2/WG18 Slide Presentation
Managementresponsibility
Measurement,analysis,
improvement
Resourcemanagement
Productand/or service
realization
Customer
Requirements
Customer
Satisfaction
QUALITY MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT
Input Output Product/ Service
PRODUCT REALISATION
The sequence
of
processes and subprocesses
required to achieve the product
33ISO/TC176/SC2/WG18 Slide Presentation
Basic process model
MANAGEMENT
ACTIVITIES
ENABLERS
CUSTOMER
INPUTS
DESIRED
OUTPUTS
CUSTOMERSATISFACTION
Sub-Process
Activities
INPUT
OUTPUTInternalcustomer
External Customer
External Customer
Needs & Expectation
Product Characteristics
Product Specification
Customer requirement
Product realization• Design Development• Process identification
Process monitoring
Product conformity
Product Delivery
CUSTOMER
Product Life Cycle
Customer feedback
Cont. Improvement
PROCESS REALIZATIONTo ensure product realization, attention to be given:
• Desired output
• Activities
• Control measures
• Equipment
• Information
• Process steps
• Flows
• Training needs
• Methodologies
• Other resources
PRODUCT REALISATION PLANNING ( Cl no 7.1)
• Determine & Document Quality Plans– Quality objectives for product– Need to establish processes
– Verification & validation required and acceptance criteria
– Record that will establish conformity of product & process
Quality Plan
The document that describes,
how the processes of QMS are applied to
a specific product, project or contract
is called
Quality Plan.
IDENTIFICATION OF CUSTOMER REQUIREMENTS
(Cl no. 7.2.1)
• Product requirements specified by customer– availability
– delivery
– support
• Product requirements not specified by customer but necessary to meet intended use
• Obligations related to products
• Regulatory & legal requirements
SOURCE OF INFORMATION
• Process or activities specified by customers/ other interested parties
• Market research
• Contract requirement
• Competitor analysis
• Bench marking
• Process due to statutory/ regulatory reqm.
REVIEW OF PRODUCT REQUIREMENTS ( Cl no 7.2.2)• Review specified & additional requirements• Ensure
– Product requirements are adequately defined– Document product requirements– Resolve any differences– Assess ability to meet defined requirement
• Record results of review• In case of changes
– Repeat review– Amend documentation &Communicate to relevant persons
REVIEW OF PRODUCT REQUIREMENTS ( Cl no 7.2.2)
• Where the customer provides no documented statement of requirement , the customer requirements shall be confirmed by the organization before acceptance• Note : Formal review may not be applicable for Internet sale etc.
ORGANISATION
MANAGEMENT
DESIGN & DEVELOPMENT
Production
Human Resources
Store
Advertising
Marketing
ServicingDelivery
PublicRelation
CUSTOMER COMMUNICATION(Cl no 7.2.3)
• Identify & implement arrangements for communication with customer for– Product information
– Enquiries
– Contract (or order handling)
– Amendments
– Customer feedback, including complaints
DESIGN / DEVELOPMENT(Cl no 7.3)
• Design and/or development planning• Design and/or development inputs• Design and/or development outputs• Design and/or development review• Design and/or development verification• Design and/or development validation• Control of design and/or development changes
DESIGN / DEVELOPMENT ( Cl no 7.3.1)
• Plan and control design/development of the product.
• Determine:– Stages of design/development processes
– Review, verification and validation activities for each design/development stage
– Define responsibilities and authorities for design/development activities.
• Identify & manage interfaces
• Update design planning output
DESIGN PLANNING ACTIVITIES
Activity Resp. Period Remarks
1.0 Conceptual
Design
2.0 Block Diagram design
3.0 Detail circuit diagram
design
4.0 Design review at various stages
5.0 Prototype testing / Design verification
6.0 Design validation
INTERNAL INTERFACE
Conceptual Design Computation
Design Group(s)
Design Groups
Design Co-ordinator
Other Design Group(s)
Drawing Office
Design reviewers
EXTERNAL INTERFACE
Sales
Design
Purchasing
Manufacturing
Specialist Groups
Commission & Service
Development
DESIGN / DEVELOPMENT INPUTS ( Cl no 7.3.2 )
• Define & documented– functional and performance requirements
– applicable regulatory and legal requirements
– information derived from previous similar designs
– any other requirements essential for design/development.
DESIGN / DEVELOPMENT INPUTS (Contd...)
• Review inputs for– Adequacy.
– Completeness
– Ambiguity
– Conflicts
• Resolve, if necessary
EXAMPLE OF DESIGN INPUTS
• Customer Specification• Data Book• Statutory or regulatory standars• Company standars• Design codes• Design manual• Service reports
EXTERNAL INPUT
• Customer or market place need and/or
expectation• Contractual requirements & interested
party’s spec.• Relevant statutory & regulatory reqmnt.• International/National standards
DESIGN / DEVELOPMENT OUTPUTS( Cl no 7.3.3 )
• Document
• Verify (against design inputs)
• Approve prior to release
• Outputs shall– meet input requirements– provide adequate information for production and
service operations– contain or reference product acceptance criteria– define the characteristics of the product that are
essential to its safe and proper use
EXAMPLE OF DESIGN OUTPUT
• Detailed specifications• Layout drawing• Circuit diagrams• Manufacturing instructions• Material specifications • Special processes• Part lists• Operations / Service Manual
WHAT IS DESIGN REVIEW ?
Definition :
A formal documented , comprehensive
and systematic examination of a design
requirements and capability of the
design to meet these requirements and
to identify problems and propose
solutions
WHAT IS DESIGN REVIEW ?
A design Review is an engineering
management process : A formal ,
systematic study of a design :– Performance– Environment– Quality– Reliability & maintainability– Safety
DESIGN / DEVELOPMENT REVIEW (Cl no 7.3.4 )
• Carry out systematic review– evaluate the ability to fulfil requirements
– identify problems and propose follow-up actions
• Involve representatives of functions concerned
• Record results of the reviews and follow-up
DESIGN / DEVELOPMENT VERIFICATION( Cl no 7.3.5 )
• Perform verification
• Ensure compliance with inputs
• Record results & follow-up actions
HOW DESIGN VERIFICATION CAN BE CONDUCTED ?
• Review of the design documents
• Conducting Qualification Tests
• Alternative calculations
• Comparing with old design
DESIGN / DEVELOPMENT VALIDATION( Cl no 7.3.6)
• Validate product for intended use
• Validation prior to delivery
OR
• Partial validation to the extend possible
• Record results of validation and follow-up
DESIGN / DEVELOPMENT CHANGES( Cl no 7.3.7)
• Identify• Document• Control
– Evaluate effect on parts and delivered products– Verify– Validate– Approve.
• Record results & follow-up actions• Operate configuration control
PURCHASING ( Cl no 7.4 )
• Purchasing Control
• Purchasing Information
• Verification of purchased product
PURCHASING( Cl no 7.4.1 )
• Control purchasing processes
• Evaluate and select suppliers– Define criteria for selection and periodic
evaluation
– Record results of evaluations and follow-up actions
– Apply control to the extent required
PURCHASING INFORMATION( Cl no 7.4.2)• Purchasing documents shall include
– Unique product identification
– Requirements for approval or qualification of• product
• procedures
• processes
• equipment
• personnel
– Quality Management System requirements
• Ensure the adequate information prior to release
VERIFICATION OF PURCHASED PRODUCTS(Cl no 7.4.3)
• Identify & implement necessary verifications
• Specify need for verification at suppliers premises– Verification arrangements
– Method of product release
Production and service operations(Cl no 7.5)
• Operations control
• Identification and traceability
• Customer property• Preservation of product. Implementation of
defined processes for release, delivery and applicable post-delivery activities
OPERATION CONTROL(Cl no 7.5.1)
• Control production and service operations– Availability of information that specifies the characteristics of
the product– Where necessary, the availability of work instructions– Use of suitable equipment for production and service operations– Availability and use of measuring and monitoring devices– Implementation of monitoring activities– Implementation of defined processes for release, delivery and
applicable post-delivery activities
VALIDATION OF PROCESSESS(Cl no 7.5.2 )
• Validate production and service processes
whose resulting output can not be verified by subsequent monitoring or measurement.
VALIDATION OF PROCESSESS(Cl no 7.5.2 )
Demonstrate process capability to achieve planned results
• Define validation arrangements including• Qualification of processes
• Qualification of equipment and personnel
• Use of defined methodologies and procedures
• Requirements for records
• Re-validation
PROCESS VALIDATION
• Validation of Product> Validation of Process
• Qualification of Process, equipment , Personnel , Procedure & methods
> Special attention to :° High Value Product° Where de in product will only be apparent in use° Which cannot be repeated° Where verification of the product not possible
> When there is any change in the product characteristics arising out from any reason or feedback , subsequent change in process identified and revalidated .
IDENTIFICATION & TRACEABILITY(Cl no 7.5.3)
• Identify product uniquely
• Identify product status
• Maintain traceability– Control & record unique identification
Note : It may be the part of configuration management
CUSTOMER PROPERTY(Cl no 7.5.4)
• Exercise care & control– identify– verify– protect– maintain
• Record & report to customer– loss– damages– other unsuitability
PRESERVATION OF PRODUCT( Cl no 7.5.5)
• Preserve product conformity during internal processing & delivery
• Maintain– identification– handling– packaging precautions– storage precautions– protect against abuses
CONTROL OF MEASURING & MONITORING DEVICES - 1(Cl no 7.6)
• Assure product conformity through measurement & monitoring
• Identify measurements to be made
• Identify & control measuring and monitoring devices
• Maintain measurement capability
• Use ISO 10012 for guidance
CONTROL OF MEASURING & MONITORING DEVICES - 2(Cl no 7.6)
• Control shall include– periodic calibration & adjustment– traceability to national standards– safeguarding against unauthorized adjustments– protection against damage/deterioration during
handling, storage, maintenance & uses– recording results of calibration– in case of failure in calibration
• validation of previous results• corrective actions
8.0 Measurement , Analysis and Improvement
General8.1
Measurement &Monitoring
8.2
Control of Non
Conformity8.3
Analysis ofData8.4
Improvement8.5
Customer Satisfaction
Internal Audit
Measurement and Monitoring of Processes
Measurement and Monitoringof Product
Continual Improvement
CorrectiveAction
PreventiveAction
MEASUREMENT, ANALYSIS & IMPROVEMENT ( Cl no 8.0 )
• Plan• Measure & Monitor
– Customer Satisfaction– Internal audit– Process– Product
• Control Nonconforming Products• Analysis of Data• Improvement
– Continual Improvement– corrective Actions– Preventive Actions
PLANNING ( Cl no 8.1 )
• Identify need for measurement & monitoring– Assuring product conformity
– Assuring process capability
– Achieve improvement
• Identify – Methodologies
– Statistical Techniques
• Define & document – Measurement & monitoring plans
– Implement plans
Customer satisfaction(Cl no 8.2.1)
• Use as performance indicator of Quality Management System
• Determine customer satisfaction / dissatisfaction status– Determine methodology
– Document
– Implement
Source : Measurement of customer satisfaction
• Customer complaints
• Direct communication with customer
• Questionnaire and surveys
• Focus groups
• Report from customer organization
• Reports from various media
• Sector studies
INTERNAL AUDITS - 1( Cl no 8.2.2)
• Conduct periodic internal audits
• Determine effective implementation & maintenance of QMS
• Plan audit program considering– status
– importance
– results of previous audit
• Use ISO10011 for guidance
INTERNAL AUDITS - 2(Cl no 8.2.2)
• Define & document– Audit scope– Audit frequency– Audit methodology– Responsibilities for
• conducting audit• ensuring independent• recording results• reporting to management
– Ensure timely corrective actions– Verification of corrective actions– Reporting verification results
MEASUREMENT & MONITORING : PROCESSES
(Cl no 8.2.3)
• Apply suitable methods
• Cover product realization processes
• Confirm continuing ability of each process to meet customer requirements
MEASUREMENT & MONITORING:PRODUCTS (Cl no 8.2.4)
• Product characteristics– Verify product requirements are met
• Identify stages
• Document acceptance criteria
• Document method of verification
• Document extent of verification
• Document responsibility for verification
• Document resources to be used
– Record results
• Establish compliance • Control further processing/release/delivery
CONTROL OF NONCONFORMITY( Cl no 8.3)
• Hold further processing– Identify
– Prevent unintended use
– Correct• Re-verify after correction
• If detected after delivery/use, take appropriate actions
• If necessary, obtain concession
ANALYSIS OF DATA( Cl no 8.4)• Determine suitability & effectiveness of Quality
Management System
• Determine improvement opportunities– Collect & Analyse data
– Use data generated by measurement / monitoring & other sources
– Generate & use information on• Customer satisfaction/dissatisfaction• Conformance to requirements• Characteristics of product, processes• Trend of characteristics• Suppliers
IMPROVEMENT( Cl no 8.5.1 )
• Continual improvement– Facilitate continual improvement
– Identify, Plan & Manage continual improvement processes
– UseQuality policy Quality objectives
Audit results Analysis of data
Corrective actions Preventive actions
Management Review Other means
CORRECTIVE ACTIONS( Cl no 8.5.2)• Eliminate cause of nonconformity
• Define & document procedure for– Identifying nonconformity– Determining cause of nonconformity– Evaluating actions needed to eliminate cause of nonconformity– Determination & implementation of corrective actions– Recording results of actions taken– Reviewing corrective action taken
• Corrective actions shall be appropriate to the impact of problem
Source of information for CA
• Customer complaints
• Nonconformity reports
• Internal audit reports
• Output form management reviews
• Output form Data analysis
• Output form Satisfaction measurement
• Relevant Quality Management System records
• The Organization’s people
• Process measurement
• Result of self assessment
PREVENTIVE ACTIONS( Cl no 8.5.3)
• Prevent occurrence of potential problem
• Define & document procedure for– Identifying potential nonconformity
– Determine their cause
– Determine preventive actions
– Record result of actions taken
– Review effect of preventive action
Source of information for PA
• Use of Risk analysis tools
• Review of Customer needs & expectations
• Market analysis
• Management Review output
• Output form Data analysis
• Satisfaction measurement
• Process measurement
• Systems that consolidate sources of info from interested party
Source of information for PA(Cont.)
• Relevant quality system management records
• Lessons learned form past experience
• Result of self assessment
• Process that provide early warning of approaching out-of-control operating conditions
How to plan CONTINUAL Improvement ?
• Setting of Objectives for people, project and the organization
• Benchmarking competitor performance & best practice
• Recognition and reward for achievement of improvement
• Suggestion scheme including timely reaction by management
Indicators of Improvement Process
• Effectiveness• Efficiency• External effect ( Statutory /Regulatory changes)• Potential weakness ( Lack of capability,consistency)• The opportunity to employ better methods• Control of plan & unplanned changes• Measurement of planned benefits
Sources of Information for improvement assessment
• Validation data• Process yield data• Test data• Data from self assessment• Stated requirement and feedback from interested parties• Experience of people in the organization• Financial data• Product performance data• Service delivery data
THANK YOU
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