www.sigmaquest.com

Transforming Global Test Data Into Action

Find, Fix & Avoid - Faster

Time

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Analyze Data

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Gather Data

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Competitive Advantage

Real-Time ManagementResponse

Evolution To Simplicity

Automated Data Collection & SPC

Adaptive Database & Reports

Best Practices

Exception Alerting

Discovery for swift Action

Manual & Excel based data collection

Your Effort & Risk

Genealogy to Track Components

Central Control to Enforce Consistency

Collect

Aggregate

Solution: SigmaSure

Analyze

Action

Connect

SigmaSure Typical Deployment

Sys FuncTest

Probe

In-CircuitTest

Probe

Connect

Rack Func Test

Probe

Board FuncTest

Probe

Factory-n

Lab Test

Probe

Lab Test

Probe

Web-BasedAnalysis & Actions

Lab Test

Probe

Engineering

Connect

Field Test

Probe

How Does Probe Work?

Test Engineer

UnitUnder Test

Test Equipment

Test Program

Test Program•Visual Basic•C, C++, C#•Java•Perl•LabVIEW•TestStand•Your test Exec•etc.

ProbeAPI

Seamlessly IntegratedInto Your

Test Program

Operator Interface(s)

Sequence EditorActiveX Clients

TestStand Engine (ActiveX Server)

TestStand API

Pro

cess

Mo

del

NI TestStand Seamless Integration

Connect

Probe

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

Personalized Executive Dashboard

Parametric Plots

Pareto of Test Failures

Sample SigmaSure Screen ShotsReal-Time

Global Test Monitor

Parametric Plots

Run Chart

Pareto of Test Failures

SigmaQuest Benefits

Supplier quality score card¦ Customer intimacy

Stay ahead of competition¦ Greater engineering productivity¦ Feedback to guide future versions

Increased Revenue¦ Remove objections to outsourcing ¦ Shorter time-to-volume¦ Differentiated service level

Ship Better Product Faster¦ Improved yields¦ Shorter NPI ¦ Shorter upgrade & repair cycles

Cost Reduction¦ Materials¦ Labor¦ Expenses¦ More predictive inventory

Maintain Brand Integrity¦ Early warning system¦ Consistent quality

ManufacturersOEMS

Customer Engagements

Reduce failure analysis

by 5X

No real-time visibility to

test data at 11 Mfg sites

Reduce time to $ from

weeks to minutes

End customer requires

real-time SPC

Payback in < 6 monthsHigh volume, time-to-

market challenge

Increased productivity by

60X

FDA regulated industry.

Failure not an option

SigmaQuest BenefitsPainCustomer

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

Track Effect of ECOs

Track Effect of Production Changes

SigmaSPC

Web-BasedSPC Reports

SPC ChartsSPC Charts

Detect Outliers

Real-Time Yield Reports

Real-Time Data Mining

AS-1

AS-8

Real-Time Product Line Test Activity

Pass/Fail Report per Test Station

Time to Fail Report

Pareto of Failures Chart

Parametric Chart

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.

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.

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.

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.

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

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.