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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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Chapter 20 l.jpg

Chapter 20

Miscellaneous Issues


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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.


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Design for Failure

  • Should consider and plan for failure

  • For safety and convenience


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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


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Continued …

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


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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


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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….


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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…


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Design for the environment…

  • Goal is cleaner manufacturing processes

  • …easier mothballing or disposal

  • Minimal impact …


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Poka-Yoke

  • A stylized manner of approaching zero defect manufacturing, etc.

  • Proper contact? Proper movements? Proper steps done?

  • Forces a logical progression in assembly


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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


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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


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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


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Failure Analysis of Field Units

  • Focus on cause of problem based on symptom

  • Fault- tree analysis


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Warranty Analysis

  • Warranty cost as a % of sales

  • Warranty cost per unit

  • Installation cost per unit

  • % of shipped units experiencing problems


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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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