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Q A M P

I SO 9001 : 2000

K

QUALI TY ASSURANCE

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QUALI TY ASSURANCE

I SO 9001 : 2000Quali t y Management Syst ems

Gener al I nf or mat ion

I SO 9001 : 2000Qualit y Management Syst ems

Requir ement s and Maj or Changes

AGENDAAGENDA

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QUALI TY ASSURANCE

I SO 9001 : 2000

Gener al I nf or mat ion

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ISO 9001:1994ISO 9001:1994 ISO 9001 : 2000ISO 9001 : 2000

CONFORMANCECONFORMANCE PERFORMANCEPERFORMANCE

QUALI TY ASSURANCE

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ISO 9000:2000 Standards Documents

ISO 9000:2000ISO 9000:2000Quality Management Systems -Quality Management Systems -

Fundamentals and VocabularyFundamentals and Vocabulary


Guidelines for Performance ImprovementsGuidelines for Performance Improvements


RequirementsRequirements

QUALI TY ASSURANCE

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Role of ISO 9001:2000Role of ISO 9001:2000

Specifies Quality System Requirements :Specifies Quality System Requirements :44 for achieving Customer Satisfactionfor achieving Customer Satisfaction

44 applicable to entire enterpriseapplicable to entire enterprise

permissible exclusions (like design) are limitedpermissible exclusions (like design) are limited

to requirements within Clause 7 - Productto requirements within Clause 7 - Product

Realization,Realization,

ISO 9001:2000 replaces:ISO 9001:2000 replaces: ISO 9001/2/3:1994ISO 9001/2/3:1994

QUALI TY ASSURANCE

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ISO 9001: 2000 ClausesISO 9001: 2000 Clauses

1. Scope1. Scope

2. Normative References2. Normative References (part of the requirements)(part of the requirements)

3. Terms and Definitions3. Terms and Definitions

4.4. Quality Management SystemQuality Management System

5. Management Responsibility5. Management Responsibility

6. Resource Management6. Resource Management

7. Product (and/or service) Realization7. Product (and/or service) Realization

8. Measurement, Analysis & Improvement8. Measurement, Analysis & Improvement

QUALI TY ASSURANCE

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II

QUALI TY ASSURANCE

ISO 9001 : 2000ISO 9001 : 2000

Process Based Quality Management SystemProcess Based Quality Management System

CUSTOMERS

R

E

Q

U

I

R

EN

T

S

Satisfaction

Management

Responsibility

Product

Realization

Resource

Management

Measurement

Analysis &

Improvement

Continual Improvement of QMS

Product

Customers

IFIF

VAVA

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The TermThe Term ORGANIZATIONORGANIZATION

replaces the Termreplaces the Term SUPPLIERSUPPLIER of 1994of 1994

The TermThe Term SUPPLIERSUPPLIER replaces thereplaces the

TermTerm SubcontractorSubcontractor of 1994 Revisionof 1994 Revision

QUALI TY ASSURANCE

ISO 9001 : 2000ISO 9001 : 2000

SupplierSupplier OrganizationOrganization CustomerCustomer

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QUALI TY ASSURANCE

I SO 9001 : 2000QMS - Requir ement s

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Clause 4 - Quality Management System

4.1 General requirements :4.1 General requirements : Define processesDefine processes (including out-sourced(including out-sourced

processes - which typically include design,processes - which typically include design,

training, calibration, heat treat, etc.)training, calibration, heat treat, etc.)

Determine the sequence and interactionDetermine the sequence and interaction of theseof these

processesprocesses

Determine the criteria and methodsDetermine the criteria and methods needed toneeded to

ensure these processes are effectiveensure these processes are effective

And take actions toAnd take actions to improve these processesimprove these processes

QUALI TY ASSURANCE

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Sequence and Interaction of Process

Customer RequirementCustomer Requirement&&

ExpectationsExpectations

Customer FocusCustomer Focus& Internal& Internal

CommunicationCommunication

ManagementManagementResponsibilityResponsibility

Company ObjectivesCompany Objectives

( Including continual( Including continual

Improvements )Improvements )

ResourceResource

Infrastructure andInfrastructure and

PlanningPlanning

Design andDesign and

DevelopmentDevelopment

ContractContract

ReviewReview

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Human Resource &Human Resource &

TrainingTraining

Product RealizationProduct Realization

PurchasingPurchasingCustomer SuppliedCustomer Supplied

ProductProduct

Raw materialsRaw materials

SC &SC & BOFBOF

Verification ofVerification of

ProductProduct

Manufacturing &Manufacturing &

InspectionInspection

Assembly andAssembly and

TestingTesting

Verification ofVerification of

Purchased ProductPurchased Product

DespatchDespatch

CustomerCustomer

SatisfactionSatisfactionCoreCore

ProcessesProcesses

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Clause 4 - Quality Management System

4.24.2 Documentation requirements :Documentation requirements :

Documentation requirements less prescriptive;Documentation requirements less prescriptive;

however, at a minimum must include ahowever, at a minimum must include a qualityquality

manual and the following six documentedmanual and the following six documented

proceduresprocedures

QUALI TY ASSURANCE

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Clause 4 - Quality management system

Mandatory Procedures, required forMandatory Procedures, required for

1. Control of Documents (Clause 4.2.3 )1. Control of Documents (Clause 4.2.3 )

2. Control of Quality Records (Clause 4.2.4)2. Control of Quality Records (Clause 4.2.4)

3. Internal Audits (Clause 8.2.2)3. Internal Audits (Clause 8.2.2)

4. Control of Non-conforming Product (Clause 8.3)4. Control of Non-conforming Product (Clause 8.3)

5. Corrective Action (Clause 8.5.2),5. Corrective Action (Clause 8.5.2),

6. Preventive Action (Clause 8.5.3).6. Preventive Action (Clause 8.5.3).

QUALI TY ASSURANCE

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Clause 5 - Management Responsibility

QUALI TY ASSURANCE

5.15.1 Management commitment :Management commitment :

Top management must demonstrate commitmentTop management must demonstrate commitment

to development and implementation of the qualityto development and implementation of the quality

system andsystem and continually improving its effectivenesscontinually improving its effectiveness

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QUALI TY ASSURANCE

Top Management Responsibility isTop Management Responsibility is

Communicate the Importance of meetingCommunicate the Importance of meetingCustomer as well asCustomer as well as statutory and regulatorystatutory and regulatoryrequirementsrequirements

Ensure the Quality Policy are established and isEnsure the Quality Policy are established and isreviewed for continuing suitabilityreviewed for continuing suitability

Monitor and review theMonitor and review the deployment of Qualitydeployment of QualityObjectivesObjectives

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QUALI TY ASSURANCE

Top Management Responsibility isTop Management Responsibility is

Management reviews are conducted toManagement reviews are conducted to identifyidentify

the action for improvementsthe action for improvements

Ensure theEnsure the availability of resourcesavailability of resources throughthroughreview meetingsreview meetings

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QUALI TY ASSURANCE

5.25.2 Customer focus :Customer focus :

Customer requirements must be met with theCustomer requirements must be met with theaim of enhancing customer Satisfactionaim of enhancing customer Satisfaction

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QUALI TY ASSURANCE

Customer focus :Customer focus :

## Customer SurveysCustomer Surveys

# Analysis of Complaints# Analysis of Complaints

# Key distributors world wide# Key distributors world wide

# Sales Representative# Sales Representative

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QUALI TY ASSURANCE

5.35.3 Quality policy :Quality policy :

Quality Policy must include commitment toQuality Policy must include commitment to

meeting requirements andmeeting requirements and continualcontinual

improvement of the effectiveness of theimprovement of the effectiveness of the QMSQMS,,

Provide a framework forProvide a framework for establishing/reviewingestablishing/reviewing

measurable Quality Objectives;measurable Quality Objectives;

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QUALITY POLICYQUALITY POLICY

AudcoAudco India Limited is committed toIndia Limited is committed to

Total Customer SatisfactionTotal Customer Satisfaction

We achieve this byWe achieve this by

- Maintaining a high standard of quality consistent- Maintaining a high standard of quality consistentwith the customer requirementswith the customer requirements

-- Complying with the Codes, Standards, CustomerComplying with the Codes, Standards, Customer

Specifications,Specifications, Statutory and RegulatoryStatutory and Regulatory requirementsrequirementsapplicable to our Productsapplicable to our Products

- Continually improving the effectiveness of Quality- Continually improving the effectiveness of QualityManagement System to add value to our ProductsManagement System to add value to our Products

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Quality Objectives :Quality Objectives :

1. Performance1. Performance

2. Delivery2. Delivery

3. Development3. Development4. Continual Improvement4. Continual Improvement

5. Customer Satisfaction5. Customer Satisfaction

Establish measurable Quality Objectives atEstablish measurable Quality Objectives atrelevant functions to achieve the objectiverelevant functions to achieve the objective

QUALI TY ASSURANCE

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Internal Communication :Internal Communication :

The communication methods includeThe communication methods include

SAP R/3 - Sale Order,SAP R/3 - Sale Order, Internet , AIL , Web Site , MS-OfficeInternet , AIL , Web Site , MS-Office

MeetingsMeetings

Awareness ProgramsAwareness Programs

News Letter / Bulletin / MagazineNews Letter / Bulletin / Magazine

QUALI TY ASSURANCE

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The nature of communication include informationThe nature of communication include information

regardingregarding

Quality Policy and ObjectivesQuality Policy and Objectives

Customer RequirementsCustomer Requirements

Business EnvironmentsBusiness Environments

Audit Feed backsAudit Feed backs

Customer Feed backsCustomer Feed backs

Continual Improvements PlansContinual Improvements Plans Statutory and Regulatory RequirementsStatutory and Regulatory Requirements

QUALI TY ASSURANCE

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Clause 6 - Resource Management

QUALI TY ASSURANCE

6.3 Infrastructure6.3 InfrastructureInfrastructure needed to achieve conformance toInfrastructure needed to achieve conformance to

Product requirements have been determined,Product requirements have been determined,

provided and maintained.provided and maintained.

These includeThese include

Building and Work SpaceBuilding and Work Space

Plant and MachineryPlant and Machinery

Testing and Measuring InstrumentsTesting and Measuring Instruments

IT Hardware and SoftwareIT Hardware and Software

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Clause 6 - Resource Management

QUALI TY ASSURANCE

Work Environment :Work Environment :

The Work Environment ensured to personnel toThe Work Environment ensured to personnel to

achieve conformity of product requirementsachieve conformity of product requirementsby providing appropriate facility conforming toby providing appropriate facility conforming to

safety, environment encompassing physicalsafety, environment encompassing physical

factor like heat, light, cleanlinessfactor like heat, light, cleanliness

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Clause 7 - Product Realization

QUALI TY ASSURANCE

7.2.17.2.1 Determination of requirements related toDetermination of requirements related toProduct :Product :

The organization shall determineThe organization shall determine

- Requirements specified by the customer- Requirements specified by the customerincludingincluding the requirements for delivery andthe requirements for delivery and

post delivery activitiespost delivery activities

- Requirements- Requirements not stated by the customer butnot stated by the customer but

necessary for specified or intended use, wherenecessary for specified or intended use, where

knownknown

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QUALI TY ASSURANCE

7.2.27.2.2 Review of Requirements related toReview of Requirements related to

ProductProduct ::

Where the customer requirements are changed ,Where the customer requirements are changed ,the organization shall ensure that the relevantthe organization shall ensure that the relevant

documents are amended and that relevantdocuments are amended and that relevant

personnel are made aware of the changedpersonnel are made aware of the changed

requirements.requirements.

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QUALI TY ASSURANCE

Customer Communication Processes :Customer Communication Processes :

AIL- Web Site , Internet , MS-OfficeAIL- Web Site , Internet , MS-Office

Bulletin forBulletin for

Improvements and New ProductsImprovements and New Products

Product Catalogue for New ProductProduct Catalogue for New Product

Work shop & SeminarsWork shop & Seminars

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QUALI TY ASSURANCE

7.3.6 Design and development Validation :7.3.6 Design and development Validation :

Design and Development validation shall beDesign and Development validation shall beperformed in accordance with plannedperformed in accordance with plannedarrangements to ensure that resulting productarrangements to ensure that resulting product

is capable of meeting the requirements for theis capable of meeting the requirements for thespecified application or intended use wherespecified application or intended use whereknown.known. Wherever practicable validation shallWherever practicable validation shallbe completed prior to the delivery orbe completed prior to the delivery or

implementation of the product. Records of theimplementation of the product. Records of theresults of validation and any necessary actionsresults of validation and any necessary actionsshall be maintainedshall be maintained

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QUALI TY ASSURANCE

7.3.7 Control of Design and development Changes :7.3.7 Control of Design and development Changes :

Design and Development Changes shall beDesign and Development Changes shall beidentified and records maintained.identified and records maintained. The changesThe changes

shall be reviewed , verified, and validated, asshall be reviewed , verified, and validated, asappropriate, and approved beforeappropriate, and approved beforeimplementationimplementation. The review of design and. The review of design anddevelopment changes shall includedevelopment changes shall include evaluation ofevaluation of

the effect of the changes on constitute parts andthe effect of the changes on constitute parts andproduct already delivered.product already delivered.

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QUALI TY ASSURANCE

7.47.4 Purchasing :Purchasing :

Establish criteria for Supplier Evaluation andEstablish criteria for Supplier Evaluation andSelection, andSelection, and Periodic Re-evaluationPeriodic Re-evaluation

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QUALI TY ASSURANCE

7.5.2 Validation of Processes for Production and7.5.2 Validation of Processes for Production and

Service provision :Service provision :

TheThe organisationorganisation shall validate andshall validate and revalidaterevalidate

any process for production where the resultingany process for production where the resulting

out put can not be verified by subsequentout put can not be verified by subsequentmonitoring or measurementsmonitoring or measurements

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QUALI TY ASSURANCE

Revalidation for Special ProcessesRevalidation for Special Processes ::

WeldingWelding

Heat TreatmentHeat Treatment

Mn PhosphatingMn Phosphating

Rubber MouldingRubber Moulding

Refractory LiningRefractory Lining

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QUALI TY ASSURANCE

7.67.6 Control of Measuring and Monitoring DevicesControl of Measuring and Monitoring Devices

Validate software used to verify productValidate software used to verify product

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Clause 8 : Measurement, Analysis and Improvement

QUALI TY ASSURANCE

8.2 Monitoring and Measurement :8.2 Monitoring and Measurement :

Must measure and monitor Customer SatisfactionMust measure and monitor Customer Satisfaction

Internal audit reportsInternal audit reports

Processes and Product used to manage the qualityProcesses and Product used to manage the quality

system must be measured/monitoredsystem must be measured/monitored

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QUALI TY ASSURANCE

Monitor and Measurement of the ProcessMonitor and Measurement of the Process

1. Product Development1. Product Development

2. Internal and External Auditing2. Internal and External Auditing

3. Supplier Delivery Performance3. Supplier Delivery Performance4. Rejection ( Supplier / AIL )4. Rejection ( Supplier / AIL )

5. Rework ( Supplier / LOFT )5. Rework ( Supplier / LOFT )

6. Customer Complaint6. Customer Complaint

7. AIL Delivery Performance7. AIL Delivery Performance8. Break down8. Break down

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QUALI TY ASSURANCE

Company Name : Contact Person :

Address : Designation :

Purchased Product : Gate / Globe / Check / Plug / Ball / Butterfly/

Nature of Business : Forged Steel / Actuators / Steel Plant Valves

S.No. Parameter Remarks ( if Less than 6 Points )

3

Order o f preference while purchasing the valves ( Rank 1 to 5 )

Quality

Delivery

Service

Technical

Price

Rating in Points

RATING OF AUDCO INDIA LTD

Please circle ap propriate for AIL on the following parameters.

Excellent Good Average Poor

4 Technical back -up

1 Quality

2 Delivery

6 5 4

Service

( Pre & Post )10 9 8 7 6 5

CUSTOMER FEEDBACK SURVEY REPORT

5 Price

10 9 8 7 3 2 1

10 9 8 7 6 5 4 3 2 1

4 3 2 1

10 9 8 7

6 5 4

3

3

6 5 4

10 9 8 7 2 1

2 1

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QUALI TY ASSURANCE

8.4 Analysis of Data :8.4 Analysis of Data :

1. Customer Satisfaction Trend1. Customer Satisfaction Trend

2. Vendor Quality Level2. Vendor Quality Level

3. Vendor on time delivery performance3. Vendor on time delivery performance

4. AIL on time Delivery Performance4. AIL on time Delivery Performance

5. Rejection of supplier supplied product5. Rejection of supplier supplied product6. Rework on supplier supplied product6. Rework on supplier supplied product

7. Rejection due to AIL7. Rejection due to AIL

8. Rework due to AIL8. Rework due to AIL

9. LOFT analysis trend9. LOFT analysis trend10.Breakdown analysis trend10.Breakdown analysis trend

11.11.IQAIQA TrendTrend

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QUALI TY ASSURANCE

8.5 Improvement :8.5 Improvement :

Must improve effectiveness of the QualityMust improve effectiveness of the QualityManagement System ( accomplish through theManagement System ( accomplish through the

use of quality policy, objectives, audit results,use of quality policy, objectives, audit results,

analysis of data, corrective/preventive actions,analysis of data, corrective/preventive actions,

and management review)and management review)

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QUALI TY ASSURANCE

8.5.1 Continual Improvement :8.5.1 Continual Improvement :

1.1. Supplier on time delivery trendSupplier on time delivery trend

2. Customer complaint trend2. Customer complaint trend

3. Customer satisfaction trend3. Customer satisfaction trend

4. Supplier Rating trend4. Supplier Rating trend5. Break down trend5. Break down trend

6. Rejection trend6. Rejection trend

7. Rework trend7. Rework trend

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QUALI TY ASSURANCE

8.5.2 Corrective Action :8.5.2 Corrective Action :To prevent Re-occurrenceTo prevent Re-occurrence

1. Customer Complaint1. Customer Complaint

2. NCR of Product supplied by supplier2. NCR of Product supplied by supplier

3. NCR of Product3. NCR of Product

4. NCR of4. NCR ofIQAIQA

5. LOFT5. LOFT

6. Break down6. Break down

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QUALI TY ASSURANCE

8.5.3 Preventive Action :8.5.3 Preventive Action :

To Prevent occurrence of NCRTo Prevent occurrence of NCR

1.1. FMEAFMEA, Risk Analysis, Finite Element analysis on, Risk Analysis, Finite Element analysis on

Design stageDesign stage

2. Customer Feed back2. Customer Feed back

3. Action taken on Quality Reports and Audit reports3. Action taken on Quality Reports and Audit reports

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QUALI TY ASSURANCE

Measurable Quality Objective :Company LevelMeasurable Quality Objective :Company Level

Objective Quality

Factors

Measure Periodicity Reviewed

by

Customer

Complaint

Trend

No. of Complaints Quarterly Product

Head

Performance

Warranty Cost

Trend

Free replacement cost /

Total Invoice

Quarterly Product

Head

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QUALI TY ASSURANCE


On time

Supplier

Delivery

Adherence to Schedule

/ No. of Schedule

Quarterly Product

Head

Delivery

On time

Delivery by

AIL

Adherence to CDD Monthly Product

Head

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QUALI TY ASSURANCE


SelfCertification

Vendor

No. of SelfCertification Vendors

Quarterly ProductHead

Development

Product

Designing

Time

Time Taken / No. of

New design

Quarterly Design

Head

Vendor

Quality

No. of Vendor above 90

Pointage

Half Yearly Product

Head

Continual

Improvement

Reduction in

Scrap

Cost of Scrap Monthly Product

Head

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QUALI TY ASSURANCE


Rework /

LOFT

Re Work Hours Monthly Product

Head

Machine

Availability

Break down hours of

critical machines /

Total machine hours of

critical machine

Monthly Plant

Engineering

Trend in

System NCR

No. of NCR Half Yearly QA

TPM

Participation

No. of TPM activities

initiated

Quarterly Plant

Engineering

Continual

Improvement

No. of

Improvements

Case studies Quarterly Design,

PED, & QC

Customer

Satisfaction

Customer

Satisfaction

Satisfaction Index Half Yearly Product

Head

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QUALI TY ASSURANCE

Customer

Complaint

Response Time

No. of Days

for closure/

No. of

Complaints

Quarterly

Timelyconfirmation of

sales order

Time takenfor closure

of sale

order/ No. of

Sale order

Monthly

Customer

Satisfaction

Delivery

Performance CustomerComplaints

No. ofComplaints

Quarterly

Measurable Quality Objective : SCDMeasurable Quality Objective : SCD

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QUALI TY ASSURANCE

Measurable Quality Objective : PurchaseMeasurable Quality Objective : Purchase

On time

Delivery of

Suppliers

Adherence

to Schedule /

No. of

Schedule

Quarterly

Vendor Quality

Rating (Critical

Vendors )

No. of

Vendors >90 Points

Half yearly

Delivery

Continual

Improvement

Development Self

CertificationVendor

No. of self

certificationvendors

Quarterly

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QUALI TY ASSURANCE

Measurable Quality Objective : PEDMeasurable Quality Objective : PED

Set up time

reduction

In Hours Quarterly

Delivery

ContinualImprovement

Improvementin Tooling

case studies

No. ofImprovements

Quarterly

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QUALI TY ASSURANCE

Measurable Quality Objective : ProductionMeasurable Quality Objective : Production

Adherence to

Schedule

Planned /

Achieved

Monthly

Leakage in

First Time

No. of Valves

Leaked / Total

No. of Valves

Monthly

Delivery

Continual

Improvement

Rework In Hours Monthly

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QUALI TY ASSURANCE

Measurable Quality Objective : QCMeasurable Quality Objective : QC

GRNClearance

Time

Time Takenfor GRN

clearance/

Total No. of

GRN

Monthly

Quality

Improvement

No. of

Improvements

Quarterly

Delivery

ContinualImprovement

Development

Self

certification

Vendor

No. of Self

certification

vendor

Quarterly

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TU

OY

KN

A

H

QUALI TY ASSURANCE