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