Transforming Global Test Data Into Action

1. Transforming Global Test Data Into Action www.sigmaquest.com

2. Find, Fix & Avoid - Faster 100 Today % of Total Effort Analyze Data Gather Data Management Response 0 Time 100 Tomorrow Real-Time Management Response Competitive Advantage % of Total Effort Gather Data Analyze Data 0 Time

3. Evolution To Simplicity Your Effort & Risk Exception Alerting Central Control to Enforce Consistency Genealogy to Track Components Discovery for swift Action Best Practices Adaptive Database & Reports Automated Data Collection & SPC Manual & Excel based data collection

4. Solution: SigmaSure Collect Aggregate Analyze Action

5. SigmaSure Typical Deployment Rack Func Test Field Test Factory-n SProbe SProbe Sys Func Test SConnect SConnect SProbe Board Func Test SProbe Lab Test SConnect Lab Test In-Circuit Test SProbe Lab Test SProbe SProbe SProbe Web-Based Analysis & Actions Engineering

6. How Does SProbe Work? Unit Under Test Test Engineer Test Equipment Test Program • Test Program • Visual Basic • C, C++, C# • Java • Perl • LabVIEW • TestStand • Your test Exec • etc. SProbe API Seamlessly Integrated Into Your Test Program

7. NI TestStand Seamless Integration Operator Interface(s) Sequence Editor ActiveX Clients Process Model TestStand API TestStand Engine (ActiveX Server) SConnect SProbe

8. NI LabVIEW Seamless Integration • Use powerful SigmaQuest VIs • Easily configure complex data collection • Collect any data from any tester all the time • Connect to any SQL database

9. Personalized Executive Dashboard Parametric Plots Pareto of Test Failures

10. Sample SigmaSure Screen Shots Run Chart Real-Time Global Test Monitor Parametric Plots Pareto of Test Failures

11. SigmaQuest Benefits OEMS Manufacturers • Maintain Brand Integrity • Early warning system • Consistent quality • Cost Reduction • Materials • Labor • Expenses • More predictive inventory • Ship Better Product Faster • Improved yields • Shorter NPI • Shorter upgrade & repair cycles • Increased Revenue • Remove objections to outsourcing • Shorter time-to-volume • Differentiated service level • Stay ahead of competition • Greater engineering productivity • Feedback to guide future versions • Supplier quality score card • Customer intimacy

12. Customer Engagements Customer Pain SigmaQuest Benefits No real-time visibility to test data at 11 Mfg sites Reduce failure analysis by 5X FDA regulated industry. Failure not an option Increased productivity by 60X High volume, time-to-market challenge Payback in < 6 months End customer requires real-time SPC Reduce time to $ from weeks to minutes

13. Summary • Real-time collaboration during entire product lifecycle • Faster new product introductions • Enhanced field service data collection & feedback loop • Easily installed & configured • Low cost of ownership

14. Track Effect of ECOs

15. Track Effect of Production Changes

16. SigmaSPC Web-Based SPC Reports SPC Charts SPC Charts

17. Detect Outliers

18. Real-Time Yield Reports

19. Real-Time Data Mining AS-1 AS-8

20. Real-Time Product Line Test Activity

21. Pass/Fail Report per Test Station

22. Time to Fail Report

23. Pareto of Failures Chart

24. Parametric Chart

25. FDA Good Manufacturing Practices (GMP) meeting the following • ISO 9001:1994 ``Quality Systems--Model for Quality Assurance in Design, Development, Production, Installation, and Servicing'' (Ref. 4), • ISO committee draft (CD) revision of ISO/CD 13485 ``Quality Systems-- Medical Devices--Supplementary Requirements to ISO 9001'' (Ref. 5). • Compliance with electronic records and signature standards when keeping data in electronic format • electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. It applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.

26. Corrective actions are tracked and escalated by SigmaAction. • Sigma Analysis Ties quality data to uniquely identified unit, lot or batch, across suppliers and internal manufacturing. • Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device. • Potentially SigmaProbe can provide centralized and controlled access to the following: • Setup parameters • Recipes • Acceptance criteria • Device history record (DHR) means a compilation of records containing the production history of a finished device. • “history” is any piece of quality data collected at a supplier, Incoming Quality Inspection, In-house production process and Final QC. • The DHR shall include, or refer to the location of, the following information: (a) The dates of manufacture; (b) The quantity manufactured; (c) The quantity released for distribution; (d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR; (e) The primary identification label and labeling used for each production unit; and (f) Any device identification(s) and control number(s) used.

27. Batch tracking • “Same conditions” can be tracked at a very high level of granularity, including: • Process parameters • Chemicals • Personnel • Equipment type • Calibration • Environmental conditions • Keeping track of material during process and testing for it in later stages • Validation • Pulling good data, into a centralized view and providing meaningful statistical and trending tools to draw “conformance” conclusions.

28. Quality • Gathering data for Management Quality Reviews can be substantially simplified with “end to end” visibility across the entire process • SQ database allows the auditor to pull up information on shipped units, FGI, WIP, Supplier inventory and in one glance view the entire details. • Reporting time is drastically reduced • SQ Analytics provides a comprehensive view of MOST POSSIBLE “device defects” within the factory. If a defect can be measured at any of the “test nodes”, it can be traced back to it’s root cause. • Non conforming • SigmaQuest can instantly identify all “nonconforming products” by control number and provide non-conformance detail on each part. • It also acts as a “early warning detection” system to identify trends and stop and fix the problem at the lowest possible cost and liability.

29. Manufacturing • This requires some discussion, opportunities are: • Meeting “Design History File” (DHF) requirements by measuring and archiving tangible results across a meaningful sample size of “early designs” • Verifying conformance to design, specially at early stages of New Product Introduction (NPI) • Effective communication of specification changes to Manufacturing (suppliers included) • Ability to communicate valuable expertise from Engineering to Manufacturing • Like process parameters, equipment parameters that may impact the process can be recorded and correlated • Preventive maintenance is often a function of number of cycles, time and usage scenarios. PMs can be intelligently invoked as these parameters are being monitored

30. Calibration procedures, as well as data are just like any other “process parameter” that can be constantly monitored and recorded by SigmaProbe. SigmaAnalysis can automatically notify lab technicians of due dates • Processes can be mapped to individuals who have been appropriately trained. When an individual performs a process on which they are not qualified, SigmaAnalysis creates appropriate notifications. • Receiving, in-process, and finished device acceptance. • Procedural communication • Specification Management • Data gathering and analysis to ensure conformance • Corrective Actions • SigmaAction is used to initiate corrective action “across the supply chain”. Actions are assigned to individuals, tracked and escalated until they are completed. • Detailed records can be attached for investigation and analysis.