quality system introductionvlinkoptics.com/upfiles/image/file/20190418/... · 2019-04-19 · select...
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Quality System Introduction
Quality Assurance Department
Q2, 2019
Confidential www.vlinkoptics.com 1
Quality Policy
质量第一 Quality Priority 、诚信务实 Integrity and Pragmatic
科技创新 Technological Innovation、持续改进 Continuous Improvement
• 公司始终敏锐地关注、识别并理解顾客明示的、通常隐含的或必须履行的需求或期望,以精密策划、精心设计将其转换为技术规范,以诚信承诺实现每一份合约,制定并实施内控标准以确保产品上乘,精益求精不断追求卓越,力求向顾客提供超出其想象的精良产品。
• Company has always been keeping to focus, identify and understand
customer requirements and expectations, with advance scheme, well-
designed, right specification to commit customers, monitor the quality and
reliability to meet specification with continuous improvement to
achieve/beyond requirements.
Confidential www.vlinkoptics.com 2VLINK
QA Organization
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Headcount = 11
ReliabilityAssurance
ReliabilityTesting
Customer QualityAssurance
CustomerQuality
Engineering, CQE
Production QualityAssurance
Quality System
Quality AssuranceVice President
Paul Yi
Process QualityEngineering, PQE
Supplier Quality Engineer, SQE
Incoming QualityControl, IQC
Quality System
DocumentControl
Calibration
Quality AssuranceManagerAlpha Xu
Final QualityControl, FQC
President / CEOJeff He
VLINK
Quality Management Philosophy
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Design-inQ/R
Built-inQ/R
Stage-Gate Design ReviewV-Link accumulated Engineering Knowledge ManagementCustomer Know-how and Technology Transfer Reliability Verification Product Certification
Robust Process Design, Process Variation ControlProcess Q/R monitoring, FMEA, Process Capability AnalysisOn-Going Reliability Test, Product Screening …. Practical Process Control Principle 6S, Discipline, Process Audit, …
CustomerFeedback
Q/R: Quality/Reliability
Continuous Improvement, Correction and PreventionFailure Analysis Knowledge, FMEA… FIT Data Monitoring Total Customer Satisfaction
JHWJ-QP-56 Quality System Planning Management Procedure
VLINK
Standards Compliance of Quality System
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ISO 9001:2015 and ISO 14001:2015 are Followed
Products are ROHS ComplianceVLINK
Product Management System Model
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CustomerSales & service
input
Production Development & Manufacturing
Sales & Serviceoutput
Customer
Input
New Production Introduction
Vendor & Material Selection
Incoming Quality Control
Manufacturing Process Control
Transportation Management
Information
TimeResource
ProcessesProcessPlanning
Facility
OutputCustomer Voice
Vendor Change
Design process
Manufacture Process
Marketing Feedback
Regulation Standard
…….
Product
Production
Process
Improvement
Continuous Processes Improvement
JHWJ-QM-01 Quality ManualVLINK
Authorized Doc. Control Management
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Process Procedure JHWJ-QP-01 Documentation Control Procedure
Formation/Revision/Cancellation of first
edition
Register
Distribution
File Reservation
Document Review
Document Approval
Document Construction
Quality Manual
Standard Operation Procedure
Guidelines / Work Instructions
Records / Forms / Reports
42 SOPs
Context of the
organization
Leadership
Planning
Support
Operation
Quality
ManualDocumental Management Flow Chart
Performance
evaluation
ImprovementVLINK
New Production Management
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CDR
Telcordia GR-1221Telcordia GR-468CO RequirementDH Test for 500hrs
DQT• Production Flow Chart• FMEA• Work Instruction• Tooling• Yield Report• SPC
PDR
TelcordiaGR-1209
Telcordia GR-1221Telcordia GR-468UNC Requirement DH Test for 2000 hrs
DVT
FSR : Feasibility Study ReviewPDR : Preliminary Design ReviewCDR : Critical Design ReviewFDR : Final Design Review
ReleaseFreeze DesignSchemes
Define all Spec & Rel. Criteria's
Start Product Pilot Run
FDR
Trial Samples to Customer
* Design-In Reliability and Quality System
FSR
MP
Time to the Market(Customer Approval)
JHWJ-QP-26 New Product Development Management Procedure
JHWJ-QP-19 Design & Development Control Procedure
Mass Production
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Reliability System Management
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JHWJ-QP-47 Product Reliability Management ProcedureQualification Plan
On-Going Reliability Test & Re-Qualification
Surveillance Qualification
FIT Report and other Related Reliability Test Service
Strict Design Qualification Tests (DQT) comply with respective
Telcordia standards or Special requirements of customers.
Field failure data monitoring and releasing FIT data quarterly for
each product type.
Periodical Re-qualification Tests for continuous product reliability
assurance. VLINK
Sourcing Management
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Raw Material Specification
Supplier (Part) Certificates
Disposal of Nonconforming Materials
Supplier Corrective Action
Critical Part List Selection
Re-qualification Process
Qualified Vendor List(QVL)
Qualified Part List (QPL)
Vendor Surveys and Audits
Vendor management (TQRDC)
Local infrastructure such as machine shop, plastics
molding is readily available at good cost and cycle time
Fully functional forecast, BOM control, procurement,
inventory, transaction to shipping system
JHWJ-QP-10 Purchasing Control Procedure
JHWJ-QP-11 Supplier Control Procedure
SUPPLIERSupplier
SupplierQualification
Process
Supplier QualificationProcess
Critical Part List
Incoming Quality Control
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Incoming Material Management
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Process Procedure JHWJ-QP-27 Incoming Quality management Procedure
Activity Requirement
Work Instruction / Drawing
Qualified Tooling
First Article Inspection
International Requirement (MIL-STD-1916, GB/T2828)
Daily work and record
Receiving Raw Material
Select Inspection MethodInspection & Approve
Record and Evaluate Inspection Result
Confirm & Approve:Line Manager&QA
Define in Material System to identify if the inspection is required or not
Link Inspection CriteriaSampling levelToolingJudgment
Nonconformance System MRB
In-process feedbackAction improvement to supplier
Approve IQCEntering WarehouseVL
INK
Process Control Management
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JHWJ-QP-09 Production Planning Control Procedure
JHWJ-QP-13 Product Identification and Traceability Control Production
JHWJ-QP-08 Manufacturing Process Control Procedure
JHWJ-QP-16 Non-conformance Control Procedure
Production Schedule
ManufacturingIn Process
Quality Control
Entering Warehouse
Pass
NG
Work InstructionInstrument/ToolingData CollectingStandardizationDeming CirclePoka-YokeCost ControlLean productionYield Control
Fail/Rework
ECN/PCN ControlProcess/Parts abnormal controlSPC MonitoringSpecificationData Backup
Production preparation
FQC
PassVLINK
Traceability and Packaging Management
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Products S/N
1. Key component LOT2. Epoxy LOT3. Build Date/ Operator Employee No.4. Test Operator Employee No./Test Data5. Software Version6. Rework Information (if reworked)
a. Failure Modeb. Rework Action/Operator Employee No.c. Rework Data
Supplier Built Information
Key material LOT
Supplier Built Information
Epoxy LOT
Operators
Traceability SystemJHWJ-QP-13 Product Identification and Traceability Control Production
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Stock & Transportation Management
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Process Document JHWJ-QP-18 Stock Management Procedure
JHWJ-QP-64 Transportation and Preservation Management Procedure
Vendor
Receiving
IQC
Manufacturing
FQC
Packaging
Delivery
Preservation
Define transportation Way for Raw Material,
Semi-finished and Finished Goods
Manual work (Loading, Safety, Packaging,
Shock against etc.)
Trolley, Hydraulic car
Packing and Shipping
Select Shipping carton: W/H Operator
Sealing: W/H Operator
Checking: OQC
Transportation (Stack Height should be less
than 75cm, sealing completely, )
Environment
Stock time control for raw material and FGs
Environment control limit for temperature,
humidity, Cleanness Level
6S
VLINK
Quality Assurance Management
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Men
Machine
Material
Method
Quality TrainingQualified Op.
Skill Grade
CalibrationMaintenance
APL SystemIncoming Control
Standardization,SPEC, QCFC
Product
ECRECN
Failure AnalysisContinuous Improvement
Customer Input
Process
ORT & Re-Qual.FQC & OQC
Customer
RMA,Complaint,
Voice
IPQC
Abnormal management
Quality audit (System / Process / Product)
Quality Tooling Application (SPC/FMEA/8D…)FIT Data MonitoringTotal Customer Satisfaction
Management Review Input
JHWJ-QP-06 Customer Satisfaction Control Procedure
JHWJ-QP-27 Incoming Quality management Procedure
JHWJ-QP-08 Manufacturing Process Quality Control Procedure
JHWJ-QP-70 Final Quality Control Procedure
ISO9001 & ISO14001Certificate
VLINK
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Thank you !
VLINK