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TV SD South Asia
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TV SD South Asia Welcomes You to the One Day Awareness Program On ISO/TS16949:2009
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QMS Objectives
1. 2. 3. 4. To Prevent Defect To Eliminate Waste in the entire Supply Chain To Reduce Variation To Continually Improve Effectiveness of Quality Management System
QMS Principles
1. 2. 3. 4. 5. 6. 7. 8. Customer Focus Meeting Current and future requirements of customer Leadership Direct and Control Involvement of People All functions, all levels and all employees Process Approach Requirements (Input ), Results (output), Resources (control) Systems Approach to Management Plan-Do-check-Act Continual Improvement Enhance probability of customer satisfaction Factual Approach to Decision Making Personally verified facts for decision making Mutually Beneficial Supplier Relationships - Win win relationship
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Process Approach Continual Improvement of The Quality Management System Customer /Other Interested Parties
6 Resource Management 7 Input
Requirements
Satisfaction
Product Realization
Product
Information Flow
Classification of processes
Purchase
Store
Customer Requirements
Planning
MOP
COP
COP :
SOP
Lab
SOP :
Support Oriented Process
MOP :
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Customer Satisfaction
Marketing
Production
Product
Logistics
Process Approach
Material :
Infrastructure (6.3)
Physical resources like Land, building, Plant, Machinery, Hardwares, Offices, etc.
Man :
From self :
Knowledge, Skill, Competency
Process Approach
From Organisation :
Roles, Responsibility Authority
Input
Requirement
Output
Process
Undesired Results Non-Conformity
Method
Generic Methods
1. 2. 3. 4. 5. Control of Documents Control of Records Training Internal Audit Control of Non Conforming Products 6. Corrective Actions 7. Preventive Actions
Measurement
Effectiveness : Extent to which the planned activities are realized and planned results are achieved. Effectiveness = Results / Requirements Efficiency : Relationship between result achieved and resources used. Efficiency = Results / Resources
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4.2.2
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4.2.4.1 Records Retention Records shall be retained and controlled as per statutory, regulatory and customer requirements.
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5.1.1 Process Efficiency Effectiveness and Efficiency of product realization and Support processes shall be reviewed. 5.2 Customer Focus Determination and meeting of Current as well as future requirements 5.3 Quality Policy Appropriate to Purpose of Organisation Include commitment to meet requirements and improving effectiveness of QMS Provides framework to review of quality objectives Communicated and understood Reviewed for continued suitability
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6.3 Infrastructure Land, Building, workspace and associated utilities Process Equipment (Hardware and Software) Supporting systems (Transport, Communication, information Systems)
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6.3.2
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7.2 Customer Related Process 7.2.1 Determination of Requirements 7.2.1.1. Customer designated special characteristics 7.2.2 Review of Requirements 7.2.2.1 Customer Authorization to waivers 7.2.2.2.Organization Manufacturing Feasibility 7.2.3 Customer Communication 7.2.3.1 Customer specified language and format 7.3 Design and Development 7.3.1 Design and Development Planning 7.3.1.1 Multidisciplinary approach 7.3.2 Design and Development Inputs 7.3.2.1 Product design Inputs 7.3.2.2 Manufacturing Process Design Inputs 7.3.2.3 Special Characteristics 7.3.3 Design and Development Outputs 7.3.3.1 Product design outputs 7.3.3.2 Manufacturing Process Design Output
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7.6 Control of Monitoring and Measurement Equipment 7.6.1 Measurement system Analysis 7.6.2 Calibration / verification records 7.6.3 Laboratory requirements 7.6.3.1 Internal Laboratory 7.6.3.2 External laboratory
7.5 Production and Service provision 7.5.1 Control of production and service provision 7.5.1.1 Control plan 7.5.1.2 Work instructions 7.5.1.3 Verification of job set ups 7.5.1.4 Preventive and predictive maintenance 7.5.1.5 Management of production tooling 7.5.1.6 Production Scheduling 7.5.1.7 Feedback of information from service 7.5.1.8 Service agreement With Customer 7.5.2 Validation of processes for production and service provision 7.5.2.1 All processes validation 7.5.3 Identification and Traceability 7.5.3.1 No exclusions to traceability 7.5.4 Customer Property 7.5.4.1 Customer-owned Production tooling 7.5.5 Preservation of product 7.5.5.1 Storage and Inventory
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8.3 Control of Non conforming Product 8.3.1 Control on non conforming product supplemental 8.3.2 Control of reworked product 8.3.3 Customer information 8.3.4 Customer waiver 8.4 Analysis of data 8.4.1 Analysis and use of data 8.5 Improvement 8.5.1 Continual Improvement 8.5.1.1 Continual improvement of organization 8.5.1.2 Manufacturing process improvement 8.5.2 Corrective action 8.5.2.1 Problem Solving 8.5.2.2 Error proofing 8.5.2.3 Corrective action impact 8.5.2.4 Rejected part test/analysis 8.5.3 Preventive action
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Program Approval
Prototype
Pilot
Launch
Planning Product Design & Development Process Design & Development Product & Process Validation
Planning
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PPAP Documentation
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. Design Records Engineering Change Records, if any. Customer Engineering approvals, If required. Design FMEA Process Flow Diagram Process FMEA Production Control Plan Dimensional Results Material test results Performance test results Measurement System Analysis Initial Process Capability Studies Appearance Approval Report Qualified Laboratory Documentation Checking Aids Master Sample Records of compliance with Customer Specific Requirements Sample Product Part Submission Warrant
8-13 During PPAP (PPAP Run Results) 14-16 During PPAP (Quality Documentation) 17-19 After PPAP (Administrative)
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Effect 1
Effect 2
Effect 3
Function
Requirement
Failure Modes
Cause 1
Cause 3
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Attribute
NO
Variable
YES
NO
NO
U Chart
C or U Chart P Chart
np Or P Chart
Are they homogeneous in nature e.g. chemical bath, paint batch, etc.
NO
YES
X s chart
YES
NO
X R chart
X s chart
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