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Chapter 20

Chapter 20. Miscellaneous Issues. Learning From Failure. Technicians in an ambulance taking a heart attack victim to a hospital lost use of their heart machine every time they attempted to use their radio transmitter. (Unshielded RF interference) The patient died.

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Chapter 20

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  1. Chapter 20 Miscellaneous Issues

  2. Learning From Failure • Technicians in an ambulance taking a heart attack victim to a hospital lost use of their heart machine every time they attempted to use their radio transmitter. (Unshielded RF interference) The patient died. • Thalidomide was sold in Europe in the late 1950s, causing over 8,000 births of malformed children. The drug had not been tested adequately prior to market release.

  3. Design for Failure • Should consider and plan for failure • For safety and convenience

  4. Safety Considerations • Sprinkler Systems – the increase in temperature due to a fire causes melting of a metal plug and the opening of a sprinkler or gas quenching system to put out the fire • In the event of a power failure, a lead shield drops in front of a cobalt therapy delivery unit

  5. Continued … Shear pins, medicine coatings, bubble wrap medicine, bimetalic temperature sensors, bottle tops, peanuts in packing, feathers, eggshells, pine seeds, …

  6. Design for Convenience • Postage Stamps – sheets of postage stamps typically contain individual stamps separated by perforations. A slightly skilled user can easily separate out an individual stamp by causing failure along the perforations. • Scoring of a surface to enhance breakage is a common way to ensure easily opened bags of coffee and pop-top cans of various designs

  7. Design for assembly • A design process that tries to guarantee simple interconnections of elements that generally can only be connected in a sinple goof-proof manner. • GE design of jet engines, etc….

  8. Prevention through design • A relatively new NIOSH based effort to train designers to “design out” the likelihood of errors/mistakes/potential accidents, etc. in a device or process (~ 2007) • “at the source” effort to decrease deaths/injuries in the workplace…

  9. Design for the environment… • Goal is cleaner manufacturing processes • …easier mothballing or disposal • Minimal impact …

  10. Poka-Yoke • A stylized manner of approaching zero defect manufacturing, etc. • Proper contact? Proper movements? Proper steps done? • Forces a logical progression in assembly

  11. Product Life Issues • Necessary to determine how a product is performing during actual use • Analysis of field service reports • Failure analysis of failed units • Warranty analysis

  12. Analysis of Field Service Reports (FSR) • Type of Product • Serial # • Date of Service Activity • Symptom of the problem • Diagnosis • List of parts replaced • Labor hours required • Service representative

  13. Data Analysis • Determine most significant problem information & trend causes • Pareto Analysis – a histogram of problems • Graphical Plots • Determine what pt in life cycle • Determine efficiency of manufacturing process • Useful for analyzing warranty costs

  14. Failure Analysis of Field Units • Focus on cause of problem based on symptom • Fault- tree analysis

  15. Warranty Analysis • Warranty cost as a % of sales • Warranty cost per unit • Installation cost per unit • % of shipped units experiencing problems

  16. Product Testing Issues • HALT Testing – may indicate problems early in testing that would take some time to occur in the field. • More severe parameters • Misuse of product (type & severity testing) • Must keep data and analyze and prove responsiveness to the FDA!!!!

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