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EFFECTIVELY MANAGE
COUNTERFEIT PARTS WITH A
QUALITY ASSURANCE SOLUTION
Jim Wright, Technical Product Lead
TIP Technologies
(262) 544-1211 Ext 205
jmw@tiptech.com
www.tiptech.com
Counterfeit Parts in the Supply Chain
 The DoD Supply Chain is at risk of counterfeit parts
which can greatly impact missions as well as
endangering service members and others. DoD and
other regulatory agencies have developed standards
and requirements to manage the Supply Chain.
 Suppliers and Processors face challenges with
delivering product to multiple customers with varying
expectations and requirements
Downsides of not complying:
• Risk to missions and personnel
• Litigation and Contractual Issues
• Cost Impact
• Business Impact
Develop a Total Supplier Quality Management Solution
 Provide real-time access to Quality & Manufacturing data including a bi-directional Supplier Portal
 Supplier Approval, Certification, ASL, Performance Measurement/Scorecard
 Audit, Compliance, Document Management, Process Control
 Inspection Planning and Execution with Correlation to Supplier Flow Down Requirements
 Nonconformance, Corrective Action, Complaint Handling
 Parts Management with Configuration Control
 Reporting and Customer Satisfaction
 ERP/PDM Bi-Directional Interface capabilities
 Web Based Supplier Quality Management Portal
Downsides of not going electronic:
• Time consuming paper processes
• No integration with manufacturing data
• May not be utilizing best practices in quality
Facilitate Compliance
 A quality assurance solution such as TIPQA, should be used to
manage regulatory compliance. Using a combination of TIPQA
and TIPSQM Supplier Quality Management capabilities and
process controls, our customers have effectively demonstrated
compliance to regulatory standards including, but not limited to
ISO / AS / QS / IPC Standards / Mil Spec Requirements
Sampling of Standards:
• ISO 9001
• AS9100, AS9102, AS5553, AS6174
• FDA 21 CFR Part 11
• DoD Flow Down
Skill/Training Management to
Enforce Product Operations and
Inspection and Test
Who can do?
MRB Approvals
Device/Flight Line Buyoffs
Who can approve?
Project Level Access
ITAR Control of Access
Comprehensive Role Based Security
Who can see?
Effective Control
Manage Your Supply Chain
Managing the supply chain through every tier is
a critical step to mitigate the growing burden of
risk. TIPQA and TIPSQM allow you to map your
supply chain by giving you the ability to indicate
primary and sub-tier supplier relations. This
provides the ability to build a standardized
approach to managing supplier information
Supplier Quality Management:
• N-Tier Supplier Approval Status
• Supplier / Distributor Control
• Performance Metrics
• Part Certification / ASL Approved Supplier List
• Fully Integrated into the QMS Solution
Easily Identify and Categorize Suppliers
Authorized Distributor
Franchised Distributor
Independent Distributor
Open Market
OCM/OEM
Manage Your Supply Chain – Audit Management
User Configurable Audit / Survey Types
User-defined Audit Criteria (Checklists)
Audit Scheduling / Automated Re-Schedule
Weighted Scoring Capability
Ability to Generate Linked Corrective
Action
Supplier Portal Availability for Self Auditing
Compliance Auditing to Regulatory
Standards
Integrated Solution:
• Real-Time Supplier Status Updates from Audit
• Associate Parts, Commodity, Process Codes
• Regulatory Compliance Auditing
• Supports Supplier, Product, Internal, EHS Process Auditing
• File attachment capability for each checklist item
Manage Your Supply Chain – Approvals and Certification
Supplier and N-Tier Capabilities
• Approval Management
• Supplier, Part, Commodity, Process Capability
• Special Processes
• Supplier Approval and Certification Supported by Audit Results
• Supplier and Part Level Certification
• Comprehensive ASL Approved Supplier List with Host Integration
• Certified Parts management including automation
• Inspection Planning
ERP Integration:
• Supplier Approval Status
• Part Certifications
• ASL Part Status
• Process Capabilities
Manage Your Supply Chain – Performance
 Delivery – Inspected and Non-Inspected Items
Metrics for both Receipts and Past Due Purchase
Orders
 Nonconformance
 Corrective Action
 Qualitative Analysis
 DPMO
 Semi Automated Scorecard Delivery
 Discrete and Blended Rating Options
Integrated Solution:
• Single Source of Truth
• 1,3,6,12 Month Performance Periods
• Automated Rating Alerts
• Individual Ratings for Supplier, Part Number, and/or Commodities
Achieve Real-time Collaboration Throughout the Supply
Chain
Rapid resolution of
Nonconformance
Rapid resolution of
Corrective Action
Manage Your Parts
End Item Organizations and System Integrators
continually face challenges with tracking and
managing inventory and allocations throughout the
product lifecycle. Effective parts management reduces
risk and provides a vehicle to track, recall and dispose
of any suspect item
Parts Management:
• Create a Digital Thread
• ERP and PDM Integration
• Pick and Allocate linking to As-Built Configuration
• Genealogy Export/Import
Manage Your Parts - Part Definition
Enforcement of Requirements (Serial Number, Lot Code, UID, etc.)
End Use Part/Model Relation
Host BOM Integration including Alternates Parts Definition
Manufacturer association with Preference Type
Supplier and Manufacturer Part Number Cross Reference
Diminishing Material Sources DMS Identification
Manage Your Parts – Test/Inspection
 Source, Receiving, and In-Process Inspection Data Collection
 Automate Routings & Work Instructions
 Sampling and Automated Skip Lot Processing
 Certified Instructions at Supplier / Part Level
 Measurement Data Collection with SPC
 On-Line History of Past Inspections
 Nonconformance Module Integration
 Bi-Directional Interface with ERP System
Receiving Inspection:
• Highly Configurable Inspection Planning
• Communication of Supplier Problems for Increased Inspection
• Communication of Supplier Status to Inspection Personnel
• Traceability Management: Serial Date/Lot/Trace/Heat Code Collection
• MIL-STD-1916, ANSI Z1.4, C=0, custom sampling capabilities facilitate compliance
Manage Your Parts – Nonconformance
 User Configurable Workflows - Nonconformance Document Types
 Revision Level Approvals including reversal and re-processing with audit trail
 Full MRB Accountability and Defect Collection Needs
 Suspect Parts Control / Final Disposition
 Automated Failure Chaining Process supporting Root Cause Analysis
 Automated Record Processing & Action Assignment
 On-Line Electronic Approval Signatures
 Warning and escalation notifications for overdue records
Nonconformance:
• Reasonable Material Review Turn Around Time
• Standardization of MRB Review Process
• Eliminates Lost or Incomplete Nonconformance Documentation
• Failure Chain Reporting
• Increased Visibility with Paperless Nonconformance processing
• Automated Document Routing with Visibility of Required Action Notifications
Manage Your Parts – Corrective Action
User Configurable Workflows - Corrective Action Document Types
Revision Level Approvals including reversal and re-processing with audit trail
MRB & CAPA Process Integration
TOPS 8d style CA Workflows
Automated Record Processing & Action Assignment
On-Line Electronic Approval Signatures
Warning and escalation notifications for overdue records
Corrective Action:
• Reasonable MRB / CAB Review Turn Around Time
• Standardization of CAPA Review Process
• Configurable Emergency Response, Containment, Root Cause, Risk Evaluation, Effectiveness
• Eliminates Lost or Incomplete Documentation
• Increased Visibility with Paperless Corrective Action processing
• Automated Document Routing with Visibility of Required Action Notifications
Manage Your Parts - Configuration Management
 Enforcement of Requirements (Serial Number, Lot Code, UID, etc.)
 Track Items
 Host Interface - Pick and Allocate
 Point of Use Consumption
 Full Indentured Configuration
 Validations ensure all issues are resolved before product release
 All Inspections completed
 All Nonconformance resolved
 All Deviations approved
 Process Accountability
 Real-time ability to identify suspect material for recalls with extensive query
 Export/Import
Traceable Configuration:
• Fully indentured Traceable Configuration
• Drill Down/Up capability
• Extensive data validation
• Device Approvals
• Date and Revision Effectivity
Flexible and scalable quality management solutions
Fifteen integrated modules that support the complete range of quality functions and complex business
requirements. This modular approach combines the capabilities to manage all quality and compliance issues
with the flexibility to implement across departments, process areas and locations as needed.
Supports the information technology initiatives of server consolidation and centralization and is highly
configurable, therefore adaptable to the specific needs of individual business units or locations within an
enterprise. Offers an interface for every major ERP system and can be configured for use with other business
systems.
Learn more about quality management solutions by scheduling a demo today.
TIPQA/SQM Solution – Counterfeit Parts Mitigation Management
Thank You!
For More Information Contact:
TIP Technologies
(262) 544-1211
sales@tiptech.com
www.tiptech.com

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Effectively Manage Counterfeit Parts with a Quality Solution

  • 1. EFFECTIVELY MANAGE COUNTERFEIT PARTS WITH A QUALITY ASSURANCE SOLUTION Jim Wright, Technical Product Lead TIP Technologies (262) 544-1211 Ext 205 jmw@tiptech.com www.tiptech.com
  • 2. Counterfeit Parts in the Supply Chain  The DoD Supply Chain is at risk of counterfeit parts which can greatly impact missions as well as endangering service members and others. DoD and other regulatory agencies have developed standards and requirements to manage the Supply Chain.  Suppliers and Processors face challenges with delivering product to multiple customers with varying expectations and requirements Downsides of not complying: • Risk to missions and personnel • Litigation and Contractual Issues • Cost Impact • Business Impact
  • 3. Develop a Total Supplier Quality Management Solution  Provide real-time access to Quality & Manufacturing data including a bi-directional Supplier Portal  Supplier Approval, Certification, ASL, Performance Measurement/Scorecard  Audit, Compliance, Document Management, Process Control  Inspection Planning and Execution with Correlation to Supplier Flow Down Requirements  Nonconformance, Corrective Action, Complaint Handling  Parts Management with Configuration Control  Reporting and Customer Satisfaction  ERP/PDM Bi-Directional Interface capabilities  Web Based Supplier Quality Management Portal Downsides of not going electronic: • Time consuming paper processes • No integration with manufacturing data • May not be utilizing best practices in quality
  • 4. Facilitate Compliance  A quality assurance solution such as TIPQA, should be used to manage regulatory compliance. Using a combination of TIPQA and TIPSQM Supplier Quality Management capabilities and process controls, our customers have effectively demonstrated compliance to regulatory standards including, but not limited to ISO / AS / QS / IPC Standards / Mil Spec Requirements Sampling of Standards: • ISO 9001 • AS9100, AS9102, AS5553, AS6174 • FDA 21 CFR Part 11 • DoD Flow Down
  • 5. Skill/Training Management to Enforce Product Operations and Inspection and Test Who can do? MRB Approvals Device/Flight Line Buyoffs Who can approve? Project Level Access ITAR Control of Access Comprehensive Role Based Security Who can see? Effective Control
  • 6. Manage Your Supply Chain Managing the supply chain through every tier is a critical step to mitigate the growing burden of risk. TIPQA and TIPSQM allow you to map your supply chain by giving you the ability to indicate primary and sub-tier supplier relations. This provides the ability to build a standardized approach to managing supplier information Supplier Quality Management: • N-Tier Supplier Approval Status • Supplier / Distributor Control • Performance Metrics • Part Certification / ASL Approved Supplier List • Fully Integrated into the QMS Solution Easily Identify and Categorize Suppliers Authorized Distributor Franchised Distributor Independent Distributor Open Market OCM/OEM
  • 7. Manage Your Supply Chain – Audit Management User Configurable Audit / Survey Types User-defined Audit Criteria (Checklists) Audit Scheduling / Automated Re-Schedule Weighted Scoring Capability Ability to Generate Linked Corrective Action Supplier Portal Availability for Self Auditing Compliance Auditing to Regulatory Standards Integrated Solution: • Real-Time Supplier Status Updates from Audit • Associate Parts, Commodity, Process Codes • Regulatory Compliance Auditing • Supports Supplier, Product, Internal, EHS Process Auditing • File attachment capability for each checklist item
  • 8. Manage Your Supply Chain – Approvals and Certification Supplier and N-Tier Capabilities • Approval Management • Supplier, Part, Commodity, Process Capability • Special Processes • Supplier Approval and Certification Supported by Audit Results • Supplier and Part Level Certification • Comprehensive ASL Approved Supplier List with Host Integration • Certified Parts management including automation • Inspection Planning ERP Integration: • Supplier Approval Status • Part Certifications • ASL Part Status • Process Capabilities
  • 9. Manage Your Supply Chain – Performance  Delivery – Inspected and Non-Inspected Items Metrics for both Receipts and Past Due Purchase Orders  Nonconformance  Corrective Action  Qualitative Analysis  DPMO  Semi Automated Scorecard Delivery  Discrete and Blended Rating Options Integrated Solution: • Single Source of Truth • 1,3,6,12 Month Performance Periods • Automated Rating Alerts • Individual Ratings for Supplier, Part Number, and/or Commodities
  • 10. Achieve Real-time Collaboration Throughout the Supply Chain Rapid resolution of Nonconformance Rapid resolution of Corrective Action
  • 11. Manage Your Parts End Item Organizations and System Integrators continually face challenges with tracking and managing inventory and allocations throughout the product lifecycle. Effective parts management reduces risk and provides a vehicle to track, recall and dispose of any suspect item Parts Management: • Create a Digital Thread • ERP and PDM Integration • Pick and Allocate linking to As-Built Configuration • Genealogy Export/Import
  • 12. Manage Your Parts - Part Definition Enforcement of Requirements (Serial Number, Lot Code, UID, etc.) End Use Part/Model Relation Host BOM Integration including Alternates Parts Definition Manufacturer association with Preference Type Supplier and Manufacturer Part Number Cross Reference Diminishing Material Sources DMS Identification
  • 13. Manage Your Parts – Test/Inspection  Source, Receiving, and In-Process Inspection Data Collection  Automate Routings & Work Instructions  Sampling and Automated Skip Lot Processing  Certified Instructions at Supplier / Part Level  Measurement Data Collection with SPC  On-Line History of Past Inspections  Nonconformance Module Integration  Bi-Directional Interface with ERP System Receiving Inspection: • Highly Configurable Inspection Planning • Communication of Supplier Problems for Increased Inspection • Communication of Supplier Status to Inspection Personnel • Traceability Management: Serial Date/Lot/Trace/Heat Code Collection • MIL-STD-1916, ANSI Z1.4, C=0, custom sampling capabilities facilitate compliance
  • 14. Manage Your Parts – Nonconformance  User Configurable Workflows - Nonconformance Document Types  Revision Level Approvals including reversal and re-processing with audit trail  Full MRB Accountability and Defect Collection Needs  Suspect Parts Control / Final Disposition  Automated Failure Chaining Process supporting Root Cause Analysis  Automated Record Processing & Action Assignment  On-Line Electronic Approval Signatures  Warning and escalation notifications for overdue records Nonconformance: • Reasonable Material Review Turn Around Time • Standardization of MRB Review Process • Eliminates Lost or Incomplete Nonconformance Documentation • Failure Chain Reporting • Increased Visibility with Paperless Nonconformance processing • Automated Document Routing with Visibility of Required Action Notifications
  • 15. Manage Your Parts – Corrective Action User Configurable Workflows - Corrective Action Document Types Revision Level Approvals including reversal and re-processing with audit trail MRB & CAPA Process Integration TOPS 8d style CA Workflows Automated Record Processing & Action Assignment On-Line Electronic Approval Signatures Warning and escalation notifications for overdue records Corrective Action: • Reasonable MRB / CAB Review Turn Around Time • Standardization of CAPA Review Process • Configurable Emergency Response, Containment, Root Cause, Risk Evaluation, Effectiveness • Eliminates Lost or Incomplete Documentation • Increased Visibility with Paperless Corrective Action processing • Automated Document Routing with Visibility of Required Action Notifications
  • 16. Manage Your Parts - Configuration Management  Enforcement of Requirements (Serial Number, Lot Code, UID, etc.)  Track Items  Host Interface - Pick and Allocate  Point of Use Consumption  Full Indentured Configuration  Validations ensure all issues are resolved before product release  All Inspections completed  All Nonconformance resolved  All Deviations approved  Process Accountability  Real-time ability to identify suspect material for recalls with extensive query  Export/Import Traceable Configuration: • Fully indentured Traceable Configuration • Drill Down/Up capability • Extensive data validation • Device Approvals • Date and Revision Effectivity
  • 17. Flexible and scalable quality management solutions Fifteen integrated modules that support the complete range of quality functions and complex business requirements. This modular approach combines the capabilities to manage all quality and compliance issues with the flexibility to implement across departments, process areas and locations as needed. Supports the information technology initiatives of server consolidation and centralization and is highly configurable, therefore adaptable to the specific needs of individual business units or locations within an enterprise. Offers an interface for every major ERP system and can be configured for use with other business systems. Learn more about quality management solutions by scheduling a demo today. TIPQA/SQM Solution – Counterfeit Parts Mitigation Management
  • 18. Thank You! For More Information Contact: TIP Technologies (262) 544-1211 sales@tiptech.com www.tiptech.com