BIOE 498 FMEA Answers

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BIOE 498FMEA Answers
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Quick Announcement

• HW 2 is posted online (due 9/24) and HW 1 has
  been handed back
• If you missed, Ill leave it in the main office
  for you to pick up
• If you turned in a FMEA worksheet to me late, via
  email, I accepted it as is (since its the first
  time weve done this)
• If you didnt turn one in, this is your free pass
  
• You only get 1 without an excuse
• This is a reminder that although attendance is
  not mandatory, you are still responsible for all
  content presented and assignments turned in

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Design Projects

• There are
• 2 programming projects
• 2 projects that involve working with animals
  and/or human subjects
• 1 project that involves circuits and signal
  processing
• 1 that involves nanotechnology and drug
  delivery/cancer research
• 1 project that involves imaging techniques
• 1 that is based on the human genome project and
  evolution

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Design Projects

• They have been posted on the website
• Some are vague, some are more detailed
• Look over them and be ready for presentations on
  October 6th, 8th, 13th, and 15th
• Please attend all of those days unless you have
  already spoken with me about missing

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Examples from your work
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FMEA Spreadsheet

• Occurrences obtained by diligent search
• Wikipedia
• RPNs calculated
• SeverityOccurrenceDetection
• Actions specified
• Mostly stolen from your Control statements
• Sorted by RPN

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Sorted by RPN
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Next?

• Controls are what you have in place
• Actions are things you can do in addition
• Actions cost (extra) money
• It is typical to threshold around 200
• Consider the Actions
• Revise the Detections
• All of them, since some Actions affect other
  Modes
• Re-compute the RPN
• Assuming the Actions to be in place as Controls
• Iterate, until you run out of budget

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Severity vs Occurrence

• RPN includes detection
• The manufacturer control the Controls
• But not the User
• And most (all?) of the misuse takes place outside
  of the manufacturers influence
• And you are the manufacturer of your Project!
• Severity vs Occurrence graph
• To consider the risk outside of your control

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Severity vs Occurrence
Warranty Issues
Legal Issues
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Severity vs Occurrence

• Note that the top RPN items are not in the upper
  right corner!
• When you take Detection out, the risk changes
• Legal Issues and Warranty Issues deserve
  attention
• Acceptable Risks?
• You may not be able to do anything about these,
  but you should know where they are

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Liability and Labeling

• You can be criminally liable for bad design
  choices
• But how do you handle misuse?
• Documentation
• User Manual
• Training Video
• On/off site training
• Labeling

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Thermo Scientific Model 1284

• Warning
• Operate this cabinet with the window in the
  specified operating position only. Any position
  other than specified may result in an unsafe
  condition.
• The agents used and/or work performed in this
  cabinet may be hazardous to your health and the
  health of others. (The cabinet must be used
  properly. You must read the operators manual
  before using.)
• This unit must be level before operating.
• Do not use explosive or flammable substances in
  this cabinet.
• Do not use Iodine, Chlorine, or other halogens
  for cleaning. They can cause rusting or pitting.
• Unit to be serviced by qualified personnel only.
  Improper service methods may result in personal
  injury, Contact Thermo Forma for qualified
  service. 1-800-848-3080
• Do Not Remove This Label

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ANSI Standard Hazards
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Custom Symbology
Not suitable forsmall primate
Operation requiresconsciousness
But beware of interpretation
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From Ready.gov (anti-terrorism)What do you think
they mean?