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Design Verification and Validation

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... etc.) Animal Studies Requirements: appropriate animal model written protocol approval of animal use committee ... in lab Animal models not ... – PowerPoint PPT presentation

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Title: Design Verification and Validation


1
Design Verification and Validation
  • Multidisciplinary Capstone Design
  • Spring 2010
  • Jay R. Goldberg, PhD, PE

2
1-10-100 Rule
3
Verification and Validation
  • Design output Design input
  • Validation Did we make the right product?
  • (Does the product meet customer needs?)
  • Verification Did we make the product
    right?
  • (Do our processes ensure that the product
    will
  • do what it is design to do?)

4
Verification and Validation
  • Required by ISO 9000 family of standards,
    regulatory agencies
  • Ethical obligation to customer to ensure that
    product works and is safe to use
  • Good engineering/design practice
  • Reduces liability

5
Testing
Analytical modeling
Bench Testing
Package Testing
Field Testing
Product Introduction
Shelf-life Studies
6
Testing (Medical Devices)
Bench Tests
Biocompatibility Tests
Animal Studies
Human Clinical Studies
Product Introduction
Package Tests
Shelf-life Studies
7
Bench Testing
  • Test per industry standards (if available)
  • Use/simulate production processes to produce test
    units
  • same tooling, assembly methods, processes,
    sterilization, etc.
  • Simulate use/function of product in laboratory
  • Simulate service environment (environmental
    testing)
  • mechanical and electrical loading
  • lubrication, wear conditions
  • fluid composition, concentration, Tº, pH
  • magnetic fields, other energy sources
  • flow rates

8
Bench Testing
  • Test for minimum number of cycles or hours until
    failure, or for expected service life
  • Monitor performance characteristics during
    testing
  • flow rates
  • wear debris
  • voltage output, leakage current
  • mechanical deformation, change in material
    properties

9
Bench Testing
  • Inspect device for signs of degradation, changes
    with continued use
  • out of calibration, decreased sensitivity/accuracy
  • wear, corrosion, oxidation
  • product failure (no longer functions)
  • loss of physical properties (strength,
    flexibility)
  • discoloration
  • obstruction, kinking
  • fracture

10
Field Testing
  • Analytical models are not definitive, must test
    actual product
  • Should be tested in environment where it will be
    used
  • Testing helps identify needed design changes
  • Conduct prior to market release to prevent
    defective or inadequate designs (those that do
    not meet customer needs) from entering market
  • Software Beta test sites
  • Consumer products limited market release
  • Medical products human clinical study

11
Benefits of Field Testing
  • RD helps identify where improvements are
    needed
  • Marketing/Sales provides data to help sell
    product, compete in market
  • Regulatory provides data to obtain necessary
    approvals to market product

12
Automobile Suspension Testing
Bench testing
Field testing
13
Electronic Devices
  • Variety of required tests for US EU
  • Leakage current
  • Electromagnetic Compatibility (EMI, immunity)

14
Consumer Products
15
Consumer Products
16
Fatigue Testing
17
Usability Studies
Customer Service Contact Center
Website testing
18
Medical Devices
  • Loading
  • magnitude
  • frequency
  • number of cycles
  • range of motion
  • Environment
  • temperature
  • chemical composition
  • proteins
  • pH
  • Cl-

19
Software Validation
  • ISO/IEC 12207 Software Life Cycle Processes
  • IEEE/IEC 1012a Standard for Software Verification
    and Validation

20
Biocompatibility Tests
  • Need to ensure that materials
  • remain stable
  • do not significantly degrade
  • do not harm body (not toxic, etc.)
  • are not adversely affected by processes
    (sterilization, lubricants, mold releases,
    cleaning agents, etc.)

21
Animal Studies
  • Requirements
  • appropriate animal model
  • written protocol
  • approval of animal use committee
  • Test for safety and efficacy
  • monitor performance of device
  • perform histological evaluation
  • inspect for damage to tissues, organs, structures

22
Human Clinical Studies
  • Rationale
  • Cannot exactly duplicate physiological
    environment in lab
  • Animal models not identical to human model
  • Need to conduct human clinical study to
    accurately evaluate performance of device in
    humans, verify claims
  • Will often encounter new problems in clinical
    study that were not observed in animal study or
    bench testing.

23
Package Testing
  • Distribution simulation
  • conduct on final product
  • simulate environmental variables
  • temperature
  • humidity
  • pressure
  • simulate distribution history
  • manual handling test
  • stacking test
  • vehicle vibration test

24
Package Testing
25
Package Testing
  • Inspect all packaging for signs of damage
  • migration of components in package, resulting in
    damage to components, product, or package
  • Conduct tests on sterile packaging materials
  • burst test, leak test
  • Evaluate device
  • inspect for damage to packaging and product
  • perform functional tests on product

26
Shelf-Life Testing
  • Determine how long product can sit on shelf with
    no significant changes in physical properties or
    performance
  • product
  • sterile packaging
  • Testing allows determination of shelf-life of
    product

27
Shelf-Life Testing
  • Real time shelf life studies
  • conduct distribution simulation
  • simulate storage environment
  • evaluate product and packaging for changes in
    properties and function over time
  • Accelerated aging studies
  • higher temperature, reduced time
  • must be correlated with real-time study

28
Shelf Life Study - Example
MW
Molecular Weight vs. Time
Shelf life
Desired Minimum
Minimum acceptable
Time
29
Summary of Packaging/Shelf-Life Testing
Packaging
Sterilization
Aging
Storage in Customer Warehouse
Use of Product
30
Summary of Testing
  • Subject product to all potential performance
    affecting variables.
  • sterilization
  • distribution simulation
  • aging
  • If product is functional with no significant
    changes in physical properties, can assume will
    perform acceptably when package is opened and
    product used
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