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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 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. • 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.
Design for Failure • Should consider and plan for failure • For safety and convenience
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
Continued … Shear pins, medicine coatings, bubble wrap medicine, bimetalic temperature sensors, bottle tops, peanuts in packing, feathers, eggshells, pine seeds, …
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
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….
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…
Design for the environment… • Goal is cleaner manufacturing processes • …easier mothballing or disposal • Minimal impact …
Poka-Yoke • A stylized manner of approaching zero defect manufacturing, etc. • Proper contact? Proper movements? Proper steps done? • Forces a logical progression in assembly
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
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
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
Failure Analysis of Field Units • Focus on cause of problem based on symptom • Fault- tree analysis
Warranty Analysis • Warranty cost as a % of sales • Warranty cost per unit • Installation cost per unit • % of shipped units experiencing problems
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!!!!