Transforming Global Test Data Into Action
www.sigmaquest.com
% of Total Effort
Find, Fix & Avoid - Faster
100
Today
Analyze
Management
Data
Response
Gather
Data
0
% of Total Effort
Time
100
Tomorrow
Gather
Data Analyze
Data
0
Time
Real-Time
Management
Response
Competitive
Advantage
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
Solution: SigmaSure
Collect
Aggregate
Analyze
Action
SigmaSure Typical Deployment
Rack Func
Test
Factory-n
Web-Based
Analysis & Actions
SProbe
SProbe
Sys Func
Test
SProbe
Field Test
SConnect
SConnect
Board Func
Test
SProbe
Lab Test
In-Circuit
Test
SProbe
SConnect
SProbe
Lab Test
Lab Test
SProbe
Engineering
SProbe
How Does SProbe Work?
Unit
Under Test
Test
Engineer
Test
Equipment
Test
Program
Test Program
Seamlessly Integrated
Into Your
Test Program
SProbe
API
•Visual Basic
•C, C++, C#
•Java
•Perl
•LabVIEW
•TestStand
•Your test Exec
•etc.
Operator
Interface(s)
ActiveX Clients
Sequence
Editor
TestStand API
TestStand Engine (ActiveX Server)
Process Model
NI TestStand Seamless Integration
SProbe
SConnect
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 Shots
Real-Time
Global Test
Monitor
Parametric
Plots
Run
Chart
Pareto of
Test Failures
SigmaQuest Benefits
OEMS
Maintain Brand Integrity
Early warning system
¦ Consistent quality
¦
Ship Better Product Faster
Manufacturers
Cost Reduction
¦
¦
¦
¦
Materials
Labor
Expenses
More predictive inventory
Increased Revenue
¦
Improved yields
¦
Remove objections to outsourcing
¦
Shorter NPI
¦
Shorter time-to-volume
¦
Shorter upgrade & repair cycles
¦
Differentiated service level
Stay ahead of competition
Greater engineering productivity
¦ Feedback to guide future versions
¦
Supplier quality score card
¦
Customer intimacy
Customer Engagements
Customer
Pain
SigmaQuest Benefits
No real-time visibility to
Reduce failure analysis
test data at 11 Mfg sites
by 5X
FDA regulated industry.
Increased productivity by
Failure not an option
60X
High volume, time-to-
Payback in < 6 months
market challenge
End customer requires
Reduce time to $ from
real-time SPC
weeks to minutes
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-Based
SPC Reports
SPC 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.