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Transcript of Www.sigmaquest.com Transforming Global Test Data Into Action.
![Page 1: Www.sigmaquest.com Transforming Global Test Data Into Action.](https://reader035.fdocuments.net/reader035/viewer/2022062322/56649e265503460f94b15df7/html5/thumbnails/1.jpg)
www.sigmaquest.com
Transforming Global Test Data Into Action
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Find, Fix & Avoid - Faster
Time
Gather Data
Today
Analyze Data
% o
f T
otal
Eff
ort 100
0
ManagementResponse
Gather Data
0
100Tomorrow
Time
% o
f T
otal
Eff
ort
Analyze Data
Competitive Advantage
Real-Time ManagementResponse
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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
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Collect
Aggregate
Solution: SigmaSure
Analyze
Action
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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
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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
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Operator Interface(s)
Sequence EditorActiveX Clients
TestStand Engine (ActiveX Server)
TestStand API
Pro
cess
Mo
del
NI TestStand Seamless Integration
Connect
Probe
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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
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Personalized Executive Dashboard
Parametric Plots
Pareto of Test Failures
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Sample SigmaSure Screen ShotsReal-Time
Global Test Monitor
Parametric Plots
Run Chart
Pareto of Test Failures
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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
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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
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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
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Track Effect of ECOs
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Track Effect of Production Changes
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SigmaSPC
Web-BasedSPC Reports
SPC ChartsSPC Charts
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Detect Outliers
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Real-Time Yield Reports
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Real-Time Data Mining
AS-1
AS-8
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Real-Time Product Line Test Activity
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Pass/Fail Report per Test Station
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Time to Fail Report
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Pareto of Failures Chart
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Parametric Chart
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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.
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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.
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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.
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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.
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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
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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.