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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
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ISO 9000:2000 Standards Documents
ISO 9000:2000ISO 9000:2000Quality Management Systems -Quality Management Systems -
Fundamentals and VocabularyFundamentals and Vocabulary
ISO 9004:2000ISO 9004:2000Quality Management Systems -Quality Management Systems -
Guidelines for Performance ImprovementsGuidelines for Performance Improvements
ISO 9001:2000ISO 9001:2000Quality Management Systems -Quality Management Systems -
RequirementsRequirements
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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
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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
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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
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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
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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).
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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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Clause 5 - Management Responsibility
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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Clause 5 - Management Responsibility
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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Clause 5 - Management Responsibility
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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Clause 5 - Management Responsibility
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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Clause 5 - Management Responsibility
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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Clause 5 - Management Responsibility
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
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Clause 5 - Management Responsibility
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
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Clause 5 - Management Responsibility
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
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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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Clause 7 - Product Realization
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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Clause 7 - Product Realization
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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Clause 7 - Product Realization
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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Clause 7 - Product Realization
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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Clause 7 - Product Realization
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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Clause 7 - Product Realization
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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Clause 7 - Product Realization
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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Clause 7 - Product Realization
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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Clause 8 : Measurement, Analysis and Improvement
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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Clause 8 : Measurement, Analysis and Improvement
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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Clause 8 : Measurement, Analysis and Improvement
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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Clause 8 : Measurement, Analysis and Improvement
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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Clause 8 : Measurement, Analysis and Improvement
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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Clause 8 : Measurement, Analysis and Improvement
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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Clause 8 : Measurement, Analysis and Improvement
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
Measurable Quality Objective :Company LevelMeasurable Quality Objective :Company Level
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
Measurable Quality Objective :Company LevelMeasurable Quality Objective :Company Level
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
Measurable Quality Objective :Company LevelMeasurable Quality Objective :Company Level
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