quality control and improvement reliability liability l.
Download
Skip this Video
Download Presentation
Quality Control and Improvement, Reliability, Liability

Loading in 2 Seconds...

play fullscreen
1 / 23

Quality Control and Improvement, Reliability, Liability - PowerPoint PPT Presentation


  • 110 Views
  • Uploaded on

Quality Control and Improvement, Reliability, Liability. P. King/Chapter 13 overview. Reliability is:. A characteristic that describes how good a device is. Must be planned for, designed in both in terms of the initial product and in maintenance of that product. Failure is:.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Quality Control and Improvement, Reliability, Liability' - austin


Download Now An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
reliability is
Reliability is:
  • A characteristic that describes how good a device is.
  • Must be planned for, designed in both in terms of the initial product and in maintenance of that product.
failure is
Failure is:
  • The degradation of the performance of a device (process) outside of a specified value AND non-performance or inability to perform its function for a given time period within specified conditions.
  • Defect: imperfection
  • Deficiency: lack of conformance to specs
  • Fault: Cause of failure
  • Malfunction: unsatisfactory performance
failure measures
Failure Measures
  • Real life failure: fact of life, define normal operation, anticipate worst, try to design out.
  • Failure rate typically = #failures/unit time = failures/million hours for devices.
unreliability is
Unreliability is:
  • A measure of the potential for failure of a device (or process.)
  • Leads to high cost, wasted time, inconvenience, poor reputation, unsafe operation, …
  • - 9/9/99 more than 10,000 stepladders recalled by Home Depot – steps too short, improperly attached (RIDGID ladders, Louisville Ladder Co, Louisville KY)
quality is
Quality is:
  • The ability to provide stated needs NOW (and is implied during warranty period.)
  • Warranty period: that period of time that you guarantee to refund/replace/fix your product.
safety quality in health care
Safety & Quality in Health Care:
  • HHS Secretary Tommy G. Thompson today (10/11/2001) announced the release of $50 million to fund 94 new research grants, contracts and other projects to reduce medical errors and improve patient safety.
  • This research initiative is part of HHS' broader efforts to improve the quality of care in America and better assure safety across health care settings. 
reliability implies
Reliability Implies:
  • MTBF of x years (for example, e-1 fail in 5 years), proportional to the probability of service over a period of time, T.
  • = performs stated function, without failure (even with misuse) in the stated environment, for a specified period of time.
vanderbilt reliability risk engineering management
Vanderbilt: Reliability & Risk Engineering & Management
  • NSF IGERT awarded 2001
  • $2.7 M over 5 years
  • BME/ChE/CE/EECS/MT/Math/ME/Owen
  • 2 year support toward PhD
  • Sankaran Mahadevan, CE
slide11

Electronic Reliability

Infant Mortality

Wearout

Corrosion,

Cracking,

Wear,

Crazing,

Shorts

Failure Rate

<-Useful Life ->

Joints,

Welds,

Contamination,

Misuse

--

Design,

Preventive

Maintenance,

Replacement,

Repair

Screening,

Design,

Burn-in

Time ->

slide12

Mechanical Reliability

Friction,

Fatigue,

Erosion,

Corrosion,

Cracking,

Lack of PM

Failure Rate

Misassembly

PM,

Replacement

<- Useful Life ->

Time->

slide13

Software Reliability

Debug errors,

Spec. Errors,

Special Cases

Failure Rate

Time ->

slide14

System Reliability:

Bathtub Curve

QI

PM

QI

Lawsuit

Failure Rate

Lawsuit

Time ->

product liability
Product Liability
  • Negligence - legal
  • Strict Liability - legal
  • Breach of warranty – legal
  • Defects
  • Failure to warn
negligence
Negligence
  • You owe a duty of care to another
  • The standards for that care have been breached
  • As a result a compensable injury results
  • There are damages or injury to the plaintiff
strict liability
Strict Liability
  • The PRODUCT is defective or dangerous.
  • Risk is too high (risk/benefit higher than competition, etc.)
breach of warranty
Breach of Warranty
  • Implied Merchantability (“King’s Pacemakers”)
  • Implied Warranty for particular purpose (pacemaker)
  • Breach of express warranty (written or oral contract: cures 100%)
defect
Defect
  • Actual defect (sharp edges, …)
  • Consumer expectations
  • Risk/benefit
  • State of the art
  • Defective warnings
  • Inadequate guarding…
failure to warn
Failure to warn!
  • You have a duty to warn. If you do not warn that coffee is hot, you are likely to get in trouble…
examples
Examples
  • Coffee burn
  • “found with head trapped in side rails…”
  • Stepladder recall
  • Fluidized air therapy bed
  • X-ray/Cobalt therapy accident
  • Morphine infusion 3 hours not 24
  • LMA – cyanosis (see MAUDE)
some final key phrases
Some final key phrases
  • Misuse
  • Negligent selection
  • Failure to inspect
  • Use with knowledge of defect
  • Alterations
  • Disclosure through MAUDE (FDA)
  • Disclosure through CPSC (non-FDA)