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Overview & Introduction Overview & Introduction to ISO/TS 16949:2002, to ISO/TS 16949:2002,
Process ApproachProcess Approach
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IATF
ANFIA CCFA IAOB VDA SMMT
Italy France US Germany UK
OVERSIGHT OFFICE
CB CB CB CB CB
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Add compared to combined certificates European +QS 9000
Less compared to combined certificatesEuropean +QS 9000
European Catalogue(AVSQ, EAQF, VDA6.1)
Comparison of Current Automotive Industry Standards
ISO/TS 16949
QS 9000
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• ISO/TS 16949:2002-Quality Management System, 2nd edition Technical Specification
• IATF Guidance to ISO/TS 16949:2002 The reference document is to assist in the application of ISO/TS 16949:2002. It includes explanations, examples andindustry practices related to particular automotive requirements.
• Quality System Assessment Checklist, 2nd edition The checklist is used as a guide in auditing the requirements to ISO/TS 16949:2002
• ISO/TS 16949:2002 Automotive Certification Scheme – Rules for Achieving IATF Recognition
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3 Types of PROCESS
CUSTOMER ORIENTED PROCESS (COP)
SUPPORT PROCESS
MANAGEMENT PROCESS
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PROCESSOUTPUTINPUT
Set of interrelated or interacting activities which transforms inputs into outputs
NOTE 1 Inputs to a process are generally outputs of other processes
NOTE 2 Processes in an organization (3.3.1) are generally planned and carried out under controlled conditions to add value
ISO 9000:2000 clause 3.4.1
Model of a process – based quality management system
Managementresponsibility
Measurement, analysis
improvement
Resourcemanagement
SSaattiissffaaccttiioonn
CCuussttoommeerr
CCuussttoommeerr
RReeqquuiirreemmeennttss
OutputInput
Product(and/or service)Realization Product
Continual Improvement of theQuality Management System
CUSTOMER ORIENTED PROCESS
ProductRealization
Resourcemanagement
MeasurementAnalysis and improvement
Managementresponsibility
Organization
Customers
SatisfactionCustomers
Requirements
CUSTOMER CUSTOMER
OUTPUTINPUT
Continual Improvement of theQuality Management System
ProductInput
Output
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Sale Ordering
Product & Process Design
Production
CUSTOMER
CUSTOMER
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CUSTOMER ORIENTED PROCESS (COP)
• Market Analysis Customer Requirements• Bidding / Tender• Order / Request• Product and Process Design• Product and Process Verification Validation• Product Production• Delivery• Payment• Warranty / Service• Post Sale / Customer Feedback
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Input of Process A
Output of Process A
Input of Process C
Output of Process C
Process B Process CProcess A
Process D
Input of Process B
Output of Process B
Input of Process D
Output of Process D
INTERACTION OF PROCESSES
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Planning Preparation Productionline
Storage
CU
STO
ME
R
CU
STO
ME
R
Customer Oriented Process : Production
SUPPORTPROCESS
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MeasurementMaintenance
PurchasingTraining
Customer Oriented Process : ProductionC
UST
OM
ER
CU
STO
ME
R
SUPPORTPROCESS
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Process OutputInput
WHAT WHO
HOW HOW MUCH
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Process OutputInput
WHAT WHO
HOW HOW MUCH
Training, Knowledge,Skills
Equipment,Installation
Instructions,Procedures,
Methods, SupportProcess
Key Measurables
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PRODUCTIONPROCESS
OutputInput
WHAT WHO
HOWHOW MUCH
Operator (Competence)Job Setter
Machine, ToolingEquipment
- Product meet customer req.- On-time and capability
Customer TargetPPM, Del. PerformanceScrap, Cpk, Cycle TimeCustomer ComplaintNonconforming Product
-Customer Requirement-Production Scheduling-Control plan, PFMEA, WI-Qualified people
Control planPFMEA, WIDrawingManual
Customer Req.TrainingPurchasingMaintenance
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ISO/TS 16949:2002ISO/TS 16949:2002Key considerationsKey considerations
1. Critical Elements of each Customer Oriented, Support and Management Process• Process owner exists• Process is defined• Process is documented, as appropriate• Linkages of process established• Process monitored, analyzed and improve• Records maintained
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ISO/TS 16949:2002ISO/TS 16949:2002Key considerationsKey considerations
2. 8.2.1.1 Customer satisfaction –SupplementCustomer satisfaction with the organization shall be monitored through continual evaluation of performance of the realization processes. Performance indicators shall be based on objective date and include, but not be limited to:• Delivered part quality performance,• Customer disruptions including field returns,• Delivery schedule performance (including incidents of
premium freight), and• Customer notifications related to quality or delivery issues.The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process.
Process owner existProcess owner existSuggested questions about the owner:• Who is it?• How do you know they are the owner?• Does the owner know they are the owner?• Have they been given authority and responsibility for the process?
Is a process owner required by ISO/TS 16949:2002? No, but responsibility and authority is
Critical Elements of All Processes
Process is definedProcess is definedSuggested questions about process definition:• Where is it defined?• How is it defined?• Who defined it?
Is a process definition required by ISO/TS 16949:2002? Review 4.1 General requirements
Critical Elements of All Processes
Process is documentedProcess is documentedSuggested questions about process documentation:• Does it need to be documented?• Where is it documented?• How is it documented?
Is a process documentation required by ISO/TS 16949:2002? Review 4.2 Documentation Requirements
Critical Elements of All Processes
Linkage of process establishedLinkage of process establishedSuggested questions about linkages:• What are the inputs/outputs?• Where do the inputs come from?• Where do the outputs go?• How many difference inputs/outputs are there?• Who is the supplier(s) of the inputs?• Who is the customer of those outputs?• What other processes are linked to the inputs/outputs?
Are linkages being established required by ISO/TS 16949:2002? Read 4.1 and 0.2
Critical Elements of All Processes
Process is monitoredProcess is monitoredSuggested questions about process monitoring:• What is monitored?• How often?• How is it reported?• Who gets the information?• What do they do with it?• Is it what they want?• Who else might want to know?• Is there continual improvement?•Are they part of Management Review?
Is a process monitoring required by ISO/TS 16949:2002? Read 5.6.1, 4.1d), 7.4.3.2, 7.6
Critical Elements of All Processes
Records are maintainedRecords are maintainedSuggested questions about records:• What are the records?• Why these records?• Where are they maintained?• For how long?• Should there be other records?• Who needs these records?• Does anyone ever review them?
Is maintenance of records required by ISO/TS 16949:2002? Read 4.2.4,7.6.2 and other clauses.
Critical Elements of All Processes