Measurement Systems Analysis - ISO 9001, Medical Device
Transcript of Measurement Systems Analysis - ISO 9001, Medical Device
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MeasurementSystemsAnalysis
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Don’t Let This Happen To YOU!
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VariationThink of Measurement
as a Process
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Definition
Measurement
The assignment of numbers to materialthings to represent the relationshipsamong them with respect to particularproperties.
C. Eisenhart (1963)
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Measurement Systems Analysis
• Basic Concepts of Measurement Systems
A Process
• Statistics and the Analysis of MeasurementSystems
• Conducting a Measurement Systems Analysis
• ISO - TC 69 is the Statistics Group
• Ensures high ‘Data Quality’ (Think of Bias)
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Course Focus & FlowMeasurement as a Process
• Mechanical Aspects (vs Destructive)
Piece part
Continuous (fabric)
• Features of a Measurement System
• Methods of Analysis
• Gauge R&R Studies
• Special Gauging SituationsGo/No-Go
Destructive Tests
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Place Timeline Here
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The Target & Goal
Prototype
Pre-Launch
Production
USLLSL
Continuous Improvement
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Key Words
• DiscriminationAbility to tell things apart
• Bias [per AIAG] (Accuracy)
• Repeatability [per AIAG] (Precision)
• Reproducibility
• Linearity
• Stability
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Measurement as a Process
Basic Concepts
• Components of the Measurement System
• Requirements of a Measurement System
• Factors Affecting a Measurement System
• Characteristics of a Measurement System
Features (Qualities) of a Measurement Number• Units (Scale)
• Accuracy
• Precision (Consistency or Repeatability)
• Resolution (Reproducibility)
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Measurement Related Systems
Typical Experiences with
Measurement Systems
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Basic Concepts
• Every Process Produces a “Product”
• Every Product Possesses Qualities (Features)
• Every Quality Feature Can Be Measured
• Total Variation= Product Variation + Measurement Variation
• Some Variation Inherent in System Design
• Some Variation is Due to a Faulty Performance ofthe System(s)
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The Measurement Process
What is the ‘Product’ of the Measurement Process?
What are the Features or Qualities of this Product?
How Can We Measure Those Features?
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Measurement Systems Components• Material to be Inspected
Piece
Continuous
• Characteristic to be Measured
• Collecting and Preparing Specimens
• Type and Scale of Measurement
• Instrument or Test Set
• Inspector or TechnicianAIAG calls these ‘Appraiser’
• Conditions of Use
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Where Does It Start?
During the Design (APQP) Stage:
The engineer responsible for determining inspectionsand tests, and for specifying appropriate equipmentshould be well versed in measurement systems. TheCalibration folks should be part of the process as apart of a cross-functional team.
Variability chosen instrument must be small whencompared with:
Process Variability
Specification Limits
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Typical Progression
Determine ‘Critical’Characteristic
Determine WhatEquipment is Already
Available
Determine RequiredResolution
Consideration of the EntireMeasurement System for
the Characteristic(Variables)
Cross-Functional
Product Engineer
Product Engineer
Metrology
How will the databe used?
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Measurement Systems Variables
Measurement
Instrument Environment
Material Inspector Methods
SamplePreparation
SampleCollection
Parallax
Reproducibility
Training
Practice
Ergonomics
Test Method
Workmanship
Samples
Standards
Discrimination
Repeatability
Bias
Calibration
Linearity
Vibration
Lighting
Temperature
Humidity
These are some of the variables in a measurementsystem. What others can you think of?
FixtureEyesightAir PressureAir MovementFatigue
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Determining What To Measure
• Voice of the CustomerYou Must Convert to Technical Features
• Technical Features
• Failure Modes Analysis
• Control Plan
Convert To
ExternalRequirements
InternalRequirements
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Voice of the Customer
• External andInternalCustomers
• Stated vs Realand PerceivedNeeds
• Cultural Needs
• UnintendedUses
• FunctionalNeeds vs.TechnicalFeatures
Customerm a y
specify
causesrather than
output
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Convert to Technical Features• Agreed upon
Measure(s)
• Related toFunctional Needs
• Understandable
• UniformInterpretation
• Broad Application
• Economical
• Compatible
• Basis forDecisions
Y
ZTechnical Feature
Functional Need
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Failure Modes Analysis
• DesignFMEA
• ProcessFMEA
• IdentifyKeyFeatures
• IdentifyControlNeeds
Critical Features are Defined Here!
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Automotive FMEAProcess Failure Mode And Effects Analysis Low - High
Process: Outside Suppliers Affected: Engineer: 1 - 10Primary Process Responsibility: Model Year/Vehicle(s): Part Number:
Other Div. Or People Involved: Scheduled Production Released: PFMEA Date: Rev.
Approvals: Quality Assurance Manager Quality Assurance EngineerOperations Manager Senior Advisor
Part Name Operation Number Process Function
Potential Failure Mode
Potential Effects Of Failure Potential Cause Of Failure Current Controls O
ccur
ed
Seve
rity
Dete
ctio
n
RPN
Recommended Actions And
StatusActions Taken O
ccur
edSe
veri
tyDe
tect
ion
RPN Responsible
Activity
SIR Take TPPE Wrong MaterialFragmented Container Insufficient Supplier Control Material Certification 1 9 2 18
Container Material Held In Unpredictable Deployment Improper Handling Required With Each1 Storage Area Misidentified Material Shipment Release Verification
Out Of Spec Fragmented Container Supplier Process Control Periodic Audit Of 3 10 3 90Material Unpredictable Deployment Supplier Material
Contaminated Fragmented Container Open Boxes Visual Inspection 1 9 7 63Material Unpredictable DeploymentMaterial Fragmented Container Engineering Change Release Verification 1 10 7 70
Composition Unpredictable Deployment Supplier Change Green "OK" TagChange Customer Notification
2 Move To Unreleased Fragmentation Untrained LTO Check For Green "OK" 5 10 1 50
Approved Untrained Personnel Tag At PressStorage Trace Card
Check ListTraining
Leading to MSA. Critical features are determined by the FMEA(RPN indicators) and put into the Control Plan.
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Control Plan / Flow Diagram• Inspection Points
• InspectionFrequency
• Instrument
• Measurement Scale
• Sample Preparation
• Inspection/TestMethod
• Inspector (who?)
• Method of Analysis
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GM Process Flow ChartProcess Flow Diagram Approved By:
Part Number: Date: 4/5/93 QA ManagerPart Description: Rev. : C Operations Manager
Prepared By: Senior AdvisorQA Engineer
Step Fabr
icat
ion
Mov
e
Stor
e
Insp
ect
Operation Description Item # Key Product Characteristic Item # Key Control Characteristic
1 Move "OK" Vinyl Material 1.0 Material Specs 1.0 Material Certification TagFrom Storage Area andLoad Into Press.
2 Auto Injection Mold Cover 2.0 Tearstrip In Cover 2.1 Tool SetupIn Tool # 2.2 Machine Setup
3.0 Hole Diameter In Cover 2.1 Tool Setup2.2 Machine Setup
4.0 Flange Thickness In Cover 2.1 Tool Setup2.2 Machine Setup
5.0 Pressure Control Protrusions 2.1 Tool SetupHeight 2.2 Machine Setup
3 Visually Inspect Cover 6.0 Pressure Control Protrusions 2.1 Tool SetupFilled Out 2.2 Machine Setup
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Standard Control Plan Example
Control Plan Number Key Contact / Phone Date (Orig.) Date (Rev.)
Part No./ Latest Change No. Core Team Customer Engineering Approval/Date
Part Name/Description Supplier/Plant Apoproval/Date Customer Quality Approval/Date
Supplier/Plant Supplier Code Other Approval/date (If Req'd) Other Approval/date (If Req'd)
Characteristics Methods
Part/ Process Number
Process Name/ Operation
Description
Machine, Device,
Jig, Tools for Mfg. No. Product Process
Special Char. Class
Product/ Process Spec/
Tolerance
Evaluation Measurement
Technique SizeFrequ- ency
Control Method
Reaction Plan
This form is on course disk
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Ford’s Dimensional Control Plan (DCP)
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Measurement as a System• Choosing the Right Instrument
Instrument Calibration Needs
Standards or Masters Needed
Accuracy and Precision
• Measurement PracticesWhere
How Many Places
• Reported FiguresSignificant Figures Rule
2 Action Figures
Rule of 10
Individuals, Averages, High-Lows
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Measurement Error
Measured Value (y) =
True Value (x) + Measurement Error
Deming says there isno such thing as a
‘True’ Value.
Consistent (linear)?
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Sources of Measurement Error• Sensitivity (Threshold)
Chemical Indicators
• Discrimination
• Precision (Repeatability)
• Accuracy (Bias)
• Damage
• Differences in use by Inspector (Reproducibility)Training Issues
• Differences Among Instruments and Fixtures
• Differences Among Methods of Use
• Differences Due to Environment
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Types of Measurement Scales
• VariablesCan be measured on a continuous scale
Defined, standard Units of Measurement
• AttributesNo scale
Derived ‘Unit of Measurement’
Can be observed or counted
Either present or not
Needs large sample size because of low information content
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How We Get Data
• Inspection
• Measurement
• Test
Includes Sensory (e.g..: Beer)
Magnitude of Quality
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Operational Definitions
• Is the container Round?
• Is your software Accurate?
• Is the computer screen Clean?
• Is the truck On Time?
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Different Method = Different Results
In SpecOut of Spec
Method 1Method 2
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Measurement System Variability
• Small with respect to Process Variation
• Small with respect to SpecifiedRequirements
• Must be in Statistical Control
Measurement IS a Process!
Free of Assignable Causes of variation
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Studying the Measurement System
• Environmental Factors
• Human Factors
• System Features
• Measurement Studies
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Standards
• NationalIn the US - Kept or Tracked by NIST
• PrimaryCopied directly from National Standard using ‘State-of-the-Art’ Equipment
• SecondaryTransferred from Primary Standard
• WorkingUsed to calibrate laboratory and shop instruments
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Environmental Factors• Temperature
• Humidity
• Vibration
• Lighting
• Corrosion
• Wear
• ContaminantsOil & Grease
Aerosols
Where is the study performed?1. Lab?2. Where used?3. Both?
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Human Factors• Training
• Skills
• Fatigue
• Boredom
• Eyesight
• Comfort
• Complexity of Part
• Speed of Inspection (parts per hour)
• Misunderstood Instructions
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• Sources of ErrorsInadvertent Errors
• Attentiveness
• Random• Good Mistake-Proofing Target
Technique Errors• Consistent
Wilful Errors (Bad mood)
• Error Types (Can be machine or human)
Type I - Alpha Errors [ risk]
Type II - Beta Errors [ risk]
Human Measurement Errors
Accept
Reject
Good Bad
OK!
OK!alpha
betaTraining
Issue
Process in control,but needs
adjustment, Falsealarm
Unaware ofproblem
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Measurement System Features
• DiscriminationAbility to tell things apart
• Bias [per AIAG] (Accuracy)
• Repeatability [per AIAG] (Precision)
• Reproducibility
• Linearity
• Stability
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Discrimination
• Readable Increments of Scale
• If Unit of Measure is too course: Processvariation will be lost in Rounding Off
• The “Rule of Ten”: Ten possible valuesbetween limits is ideal
Five Possible Values: Marginally useful
Four or Less: Inadequate Discrimination
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Discrimination
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Range Charts & Discrimination
IndicatesPoorPrecision
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Bias and Repeatability
Precise Imprecise
Accurate
InaccurateBias
You can correct for BiasYou can NOT correct for Imprecision
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Bias• Difference between
average ofmeasurements and anAgreed Upon standardvalue
• Known as Accuracy
• Cannot be evaluatedwithout a Standard
• Adds a Consistent “BiasFactor” to ALLmeasurements
• Affects all measurementsin the same way
StandardValue
Measurement Scale
Bias
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Causes of Bias
• Error in Master
• Worn components
• Instrument improperly calibrated
• Instrument damaged
• Instrument improperly used
• Instrument read incorrectly
• Part set incorrectly (wrong datum)
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Bias and QS9000BIAS - The difference between the observedAverage of measurements and the masterAverage of the same parts using precisioninstruments. (MSA Manual Glossary)
The auditor may want evidence that the concept ofbias is understood. Remember that bias is nothingmore than an offset from ‘zero’. Bias is linked toStability in the sense that an instrument may be‘zeroed’ during calibration verification. Knowing thiswe deduce that the bias changes with instrumentuse. This is in part the concept of Drift.
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Bias
• I choose a caliper (resolution 0.01) forthe measurement. I measure a set ofparts and derive the average.
• I take the same parts and measurethem with a micrometer (resolution0.001). I then derive the average.
• I compare the two averages. Thedifference is the Bias.
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Repeatability• Variation among
repeatedmeasurements
• Known as Precision
• Standard NOTrequired
• May add or subtractfrom a givenmeasurement
• Affects eachmeasurementrandomly
Measurement Scale
Repeatability
Margin of ErrorDoesn’t address Bias
5.15 = 99%
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Repeatability Issues
• Measurement StepsSample preparation
Setting up the instrument
Locating on the part
• How much of the measurement processshould we repeat?
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Using Shewhart Charts I
Repeatability
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Using Shewhart Charts II
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Evaluating Bias & Repeatability• Same appraiser, Same part, Same instrument
• Multiple readings (n≥10 with 20 to 40 better)
• Analysis� Average minus Standard Value = Bias
� 5.15* Standard Deviation = Repeatability
� or +/- 2.575 [99% repeatability]
� or +/- 2 [95% repeatability]
• Histogram
• Probability
AIAGTrue
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Repeatability Issues
• Making a measurement may involvenumerous steps
Sample preparation
Setting up the instrument
Locating the part, etc.
• How much of the measurement processshould we repeat? How far do we go?
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Bias & Repeatability Histogram
Never include assignable cause errors
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Linearity
• The difference in the Bias or Repeatability acrossthe expected operating range of the instrument.
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Plot Biases vs. Ref. Values
Linearity = |Slope| * Process Variation = 0.1317*6.00 = 0.79% Linearity = 100 * |Slope| = 13.17%
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Causes of Poor Linearity
• Instrument not properly calibrated atboth Upper and Lower extremes
• Error in the minimum or maximumMaster
• Worn Instrument
• Instrument design characteristics
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Reproducibility• Variation in the
averages amongdifferentappraisersrepeatedlymeasuring thesame partcharacteristic
• Concept can alsoapply to variationamong differentinstruments
Includes repeatability which must be accounted for.
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Reproducibility Example
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Calculating Reproducibility (I)
• Find the range of the appraiser averages (R0)
• Convert to Standard Deviation using d2*(m=# of appraisers; g=# of ranges used = 1)
• Multiply by 5.15
• Subtract the portion of this due torepeatability
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Calculating ReproducibilityPeople variance
Trials
Times done
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Stability• Variation in
measurements of asinglecharacteristic
• On the samemaster
• Over an extendedperiod of time
• Evaluate usingShewhart charts
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Evaluate Stability with Run Charts
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Stability
Both gages are stable, but.....
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Importance of Stability
• Statistical stability, combined with subject-matter knowledge, allows predictions ofprocess performance
• Action based on analysis of Unstable systemsmay increase Variation due to ‘Tampering’
• A statistically unstable measurement systemcannot provide reliable data on the process
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Methods of Analysis
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Analysis Tools
• Calculations of Average and StandardDeviation
• Correlation Charts
• Multi-Vari Charts
• Box-and-Whisker Plots
• Run charts
• Shewhart charts
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Average and Standard Deviation
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Correlation Charts
Describe Relationships
• Substitute measurement for desiredmeasurement
• Actual measurement to reference value
• Inexpensive gaging method versusExpensive gaging method
• Appraiser A with appraiser B
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Substitute Measurements
• Cannot directlymeasure quality
• Correlatesubstitute measure
• Measure substitute
• Convert to desiredquality
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Comparing Two Methods• Two
methods
• Measureparts usingboth
• Correlatethe two
• Compareto “Line ofNo Bias”
• Investigatedifferences
Magnetic
Stripping
Line of Perfect Agreement
Line of Correlation
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Measurements vs. Reference Data
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Measurements vs. Reference Correlation
Disparity
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Comparing Two Appraisers
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Run Charts Examine Stability
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Multiple Run Charts
More than 3 appraisers confuses things...
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Multi-Vari Charts
High Reading
Low Reading
Average Reading
• Displays 3 points
• Length of bar; bar-to-bar;Bar cluster to cluster
• Plot High and Lowreadings as Length of bar
• Each appraiser on aseparate bar
• Each piece in a separatebar cluster
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Multi-Vari Type I• Bar lengths
are long
• Appraiserdifferencessmall incomparison
• Piece-to-piece hard todetect
• Problem isrepeatability
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Multi-Vari Type II• Appraiser
differences arebiggest sourceof variation
• Bar length issmall incomparison
• Piece-to-piecehard to detect
• Problem isreproducibility
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Multi-Vari Type III• Piece-to-piece
variation is thebiggest source ofvariation
• Bar length(repeatability) is smallin comparison
• Appraiser differences(bar-to-bar) is small incomparison
• Ideal Pattern
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Multi-Vari Chart ExampleNormalized Data
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Multi-Vari Chart, Joined
Look for similar pattern
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Using Shewhart Charts
• Subgroup = Repeated measurements,, same piece
• Different Subgroups = Different pieces and/orappraisers
• Range chart shows precision (repeatability)
• Average chart “ In Control” shows reproducibilityIf subgroups are different appraisers
• Average chart shows discriminating powerIf subgroups are different pieces
(“In Control” is BAD!)
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Shewhart Charts
This is not a good way to plot this data
Too many lines
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Shewhart Chart of Instrument
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Gage R&R Studies
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Gauge R&R Studies
• Developed by Jack Gantt
• Originally plotted on probability paper
• Revived as purely numericalcalculations
• Worksheets developed by AIAG
• Renewed awareness of MeasurementSystems as ‘Part of the Process’
Consider Numerical vs. Graphical Data Evaluations
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Terms Used in R&R (I)
• n = Number of Parts [2 to 10]Parts represent total range of process variation
Need not be “good” parts. Do NOT use consecutive pieces.
Screen for size
• a = Number of AppraisersEach appraiser measures each part r times
Study must be by those actually using
• R - Number of trials
– Also called “m” in AIAG manual
• g = r*a [Used to find d2* in table 2, p. 29 AIAG manual]
1 Outside Low/High1 Inside Low/High
Target
Minimum of 5.2 to 10 To accommodate
worksheet factors
1 2 3 4 5
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• R-barA = Average range for appraiser A, etc.
• R-double bar = Average of R-barA, R-barB
• Rp = Range of part averages
• XDIFF = Difference between High & Low appraiseraveragesAlso a range, but “R” is not used to avoid confusion
• EV = 5.15 = Equipment variation (repeatability)
• EV = 5.15 = Equipment variation (reproducibility)
• PV = Part variation
• TV = Total variation
Terms Used in R&R (II)
Process Variation
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R&R Calculations
MeasurementSystem Variation
Product ProcessVariation
Left overRepeatability
Remember -Nonconsecutive
Pieces
Left overRepeatability
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Accumulation of Variances
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Evaluating R&R
• %R&R=100*[R&R/TV] (Process Control)
• %R&R=100*[R&R/Tolerance] (Inspection)
• Under 10%: Measurement System Acceptable
• 10% to 30%: Possibly acceptable,depending upon use, cost, etc.
• Over 30%: Needs serious improvement
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Analysis of Variance I
• Mean squares and Sums of squares
• Ratio of variances versus expected F-ratio
• AdvantagesAny experimental layout
Estimate interaction effects
• DisadvantagesMust use computer
Non-intuitive interpretation
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Analysis of Variance II
• The n*r measurements must be done inrandom sequence [a good idea anyway]
• Assumes that EV [repeatability] is normaland that EV is not proportional tomeasurement [normally a fairly goodassumption]
• Details beyond scope of this course
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Special Gauging Situations
• Go/No-Go
• Destructive Testing
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If Gauges were Perfect
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 98, Printed 2/9/04Measurement Systems Analysis
But Repeatability Means We NeverKnow The Precise Value
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 99, Printed 2/9/04Measurement Systems Analysis
So - Actual Part Acceptance Will Look LikeThis:
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 100, Printed 2/9/04Measurement Systems Analysis
The Effect of Bias on Part Acceptance
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 101, Printed 2/9/04Measurement Systems Analysis
Go/No-Go gauges
• Treat variables like attributes
• Provide less information on the process,but...
• Are fast and inexpensive
• Cannot use for Process Control
• Can be used for Sorting purposes
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 102, Printed 2/9/04Measurement Systems Analysis
“Short” Go/No-Go Study
• Collect 20 parts covering the entireprocess range
• Use two inspectors
• Gage each part twice
• Accept gauge if there is agreement oneach of the 20 parts
* May reject a good measuring system
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 103, Printed 2/9/04Measurement Systems Analysis
Destructive Tests
• Cannot make true duplicate tests
• Use interpenetrating samples
• Compare 3 averages
• Adjust using √n
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 104, Printed 2/9/04Measurement Systems Analysis
Destructive Tests: Interpreting Samples
AIAG does not address
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 105, Printed 2/9/04Measurement Systems Analysis
Summary
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 106, Printed 2/9/04Measurement Systems Analysis
Measurement Variation
• Observed variation is a combination ofthe production process PLUS themeasurement process
• The contribution of the measurementsystem is often overlooked
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 107, Printed 2/9/04Measurement Systems Analysis
Types of Measurement Variation
• Bias (Inaccuracy)
• Repeatability (Imprecision)
• Discrimination
• Linearity
• Stability
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 108, Printed 2/9/04Measurement Systems Analysis
Measurement Systems
• Material
• Characteristic
• Sampling and Preparation
• Operational Definition of Measurement
• Instrument
• Appraiser
• Environment and Ergonomics
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 109, Printed 2/9/04Measurement Systems Analysis
Measurement Systems Evaluation Tools
• Histograms
• Probability paper
• Run Charts
• Scatter diagrams
• Multi-Vari Charts
• Gantt “R&R” analysis
• Analysis of Variance (ANOVA)
• Shewhart “Control” Charts
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 110, Printed 2/9/04Measurement Systems Analysis
Shewhart Charts
• Range chart shows repeatability
• X-bar limits show discriminating power
• X-double bar shows bias(if a known standard exists)
• Average chart shows stability(sub-groups overtime)
• Average chart shows reproducibility(sub-groups over technicians/instruments)
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Cayman Business Systems 980820 Revision J(513) 777-3394 Elsmar.com Slide 111, Printed 2/9/04Measurement Systems Analysis
Conclusion
• Rule of Ten
• Operating Characteristic Curve
• Special Problems
Go/No-Go Gages
Attribute Inspection
Destructive Testing