AWARENESS OF ISO 9000 (2000) By C. Das Additional Director ERTL(E),Calcutta

Quality Management System ISO 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 of Resources 6.1 Human Resources 6.2 Infra- structure 6.3 Work Environment 6.4 Competence Awareness & 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

Provide TRAINING as identified Measure EFFECTIVENESS of Training Identification of Training needs Provide TRAINING as identified Re-training Measure EFFECTIVENESS of Training

FACILITIES ( Cl no 6.3 ) Identify Provide Maintain This includes Work space & associated facilities Equipment, hardware & software Support services Facilities required to achieve product 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 of Product Realisation 7.1 Customer Related Processes 7.2 Design and/or Development 7.3 Purchasing 7.4 Production & Service Provision 7.5 Control of Meas. & Monitoring device 7.6 Planning Determination of requirements Process Control Input Validation Information Review of Requirement Output Identification & Traceability Verification Review Validation Customer Property Customer Communication Verification Changes Preservation

PRODUCT REALISATION The sequence of processes and subprocesses required to achieve the product

Process Sub-Process OUTPUT Internal customer Activities INPUT External

Product Life Cycle CUSTOMER Customer feedback Product realization Design Development Process identification CUSTOMER Needs & Expectation Process monitoring Product Characteristics Product conformity Cont. Improvement Product Specification Product Delivery Customer requirement

PROCESS REALIZATION To 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 Production Human Resources Finances Public Advertising Public Relation Marketing DESIGN & DEVELOPMENT Production Finances Human Resources Store Delivery Servicing

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) Other Design Group(s) Design Groups Drawing Office Design Co-ordinator Design reviewers

EXTERNAL INTERFACE Sales Purchasing Design 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 Contractual requirements & interested party’s spec. 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 Monitoring 8.2 Control of Non Conformity 8.3 Analysis of Data 8.4 Improvement 8.5 General 8.1 Continual Improvement Customer Satisfaction Internal Audit Corrective Action Measurement and Monitoring of Processes Preventive Action Measurement and Monitoring of Product

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 Use Quality 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

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