reliability engineering richard c. fries, pe, cre corporate manager, reliability engineering baxter...
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Reliability Engineering
Richard C. Fries, PE, CRECorporate Manager, Reliability EngineeringBaxter HealthcareRound Lake, Illinois
Definition of Reliability
The probability, at a desired confidence level,
that a device will perform a specified function,
without failure,under stated conditions,
for a specified period of time
Customer’s Definition of Reliability
A reliable product:
One that does what the customer wants,
when the customer wants to do it
Reliability Basics
Reliability cannot be tested into a product
It must be designed and manufactured into it
Testing only indicates how much reliability is in the product
Purpose of the Reliability Group
Determine the weaknesses in a design
AND correct them
before the device goes to the field
Areas Covered by Reliability
Electrical
Mechanical
Software
System
Electrical ReliabilityF
ailu
re R
ate
T im e
Mechanical ReliabilityF
ailu
re R
ate
T im e
Theoretical Software Reliability
Fa
ilure
Ra
te
T im eX -Axis
X-A
xis
Practical Software ReliabilityF
ailu
re R
ate
T im eX -Axis
X-A
xis
System ReliabilityF
ailu
re R
ate
T im e
Set the Reliability Goal
Based on similar equipmentUsed as the basis for a reliability
budgetListed as Mean Time Between Failures
(MTBF) in hours or cyclesMTBF = the time at which 63% of the
units in the field will have failedMinimum goal is ten years with a 98%
reliability
Parts Count Prediction
Uses MIL-HDBK-217
Indicates whether the design approximates the reliability goal
Indicates those areas of the design with high failure rates
Chemical Compatibility
Test plastics with typically used chemical agents (alcohol, anesthetic agents, cleaning agents)
Cleaning agents are the worst
Force Puller
Component Testing
Cycle/life testing of individual components
Comparison of multiple vendors of components
Determine applicability for the intended use
Philosophy of Testing
Test to have the units pass
Test with the addition of stresses to check the margins of functionality
Types of Tests
Time terminated, failed parts replacedTime terminated, no replacementFailure terminated, failed parts
replacedFailure terminated, no replacementTest until first failureTest until all samples fail
Determining Sample Size
Uses Chi-Square table
SS = Chi-square Value(MTBF goal)/2
Chi-square value includes confidence level and degrees of freedom = 2f+2
Component testing – 90% confidence levelLife testing – 95% confidence level
Sample Calculation
Want to test valves to be used for 2,000,000 cycles per year with a 10% failure rate after 10 years
Reliability = e(-t/MTBF)MTBF = -t/ln Reliability = -20,000,000/ln 0.90 = 389,914,514 cycles
Sample Calculation
MTBF = 389,914,514 cycles
Number of Samples Number of Cyles10 89,777,817
50 17,955,563 100 8,977,782
Component Test Setup
Component Test Setup
Component Test Setup
Calculating Sample MTBF
MTBF = (# of samples)(length of test) # of failures
Calculating MTBF Where No Failures Occur
A sample MTBF cannot be calculatedA lower one-sided confidence limit is
calculated and the MTBF stated to be greater than that number
One-sided limit = 2(#units)(test time) Chi square value for the confidence limit and 2 degrees of freedom
Sample Calculation for a No Failure Test
10 valves are tested for 10,000 cycles with no failures. Calculate using a 90% confidence level.
One-sided limit = 2(10)(10,000) 4.605 = 43,431 cycles MTBF > 43,431 cycles
HALT
Acronym for Highly Accelerated Life Testing
Used to find the weak links in the design and fabrication process
Usually performed during the design phase
HALT Testing
Possible stresses that can be applied:random vibrationrapid temperature transitionsvoltage marginingfrequency margining
The product is stressed far beyond its specifications
The test can be set up to find the destruct limits
HALT Chamber
Goal of HALT Testing
Overstress the productQuickly induce failuresBy applying the stresses in a
controlled, stepped fashion, while continuing monitoring for failures, the testing results in the exposure of the weakest points in the design
This test, if successful, will expose weak points in the design
Environmental Testing
Operating temperature/humidityStorage temperature/humidityEMC
Surges/transients Brown-outs Electrocautery Cell phones
ESDAltitude
Environmental Testing
AutoclaveShockVibrationShipping Tip testingThreshold testing
Temperature Chamber
Walk-In Temperature Chamber
Autoclave Testing
Customer Misuse
Excess weight on tabletopFluid spillageCross connection of wiresPulling unit by non-pulling partsWrong order of pressing keys“Knowing” how to operate the unit without
reading the manual
Making a Design Foolproof
The biggest mistake engineers makewhen trying to make a design
completely foolproofis underestimating the ingenuity
of complete fools
Failure Analysis
Failure: device does not operate according to its specification
Determine root cause of the failure
Suggest methods to address the failure
Prototype Front Panel
Plastic Structure
Plastic Structure
Autoclave Testing
Manifold Port
Prototype Port
Life Testing
Operate the device in its typical environment and application
Use appropriate on/off cyclesCan be used to verify the reliability
goal or a specific period of time, such as the warranty period
Tracking Reliability Growth in the Field
Collect manufacturing data on how many units were manufactured by month
Collect field failure data, by monthDevelop a reliability growth chart
Reliability Growth Example
Ventilator Reliability Growth
0
20000
40000
60000
80000
1997 1998 1999 2000
Year of Report
MT
BF
(H
ou
rs)
Reliability Growth Example
Ventilator Reliability Growth
0
50000
1996 1997 1998 1999 2000
Year of Report
MT
BF
(ho
urs
)
Reliability Growth Example
Estimate of Two Vaporizer Builds
0
50000
100000
150000
200000
Year of Build
MT
BF
(h
ou
rs)
Pre-June, 1997Build
Post-June, 1997Build
The Reliability Group
You make it,We’ll break it