4.2-2 Control Of Records

5 Questions | Total Attempts: 73
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4.2-2 Control Of Records

Competency Assessment

Questions and Answers
  • 1. 
    When completing forms by hand, what color ink should be used?
    • A. 

      Red

    • B. 

      Black

    • C. 

      Blue

    • D. 

      Both B & C, but Blue is preferred

  • 2. 
    You should always use whiteout when making corrections.
    • A. 

      True

    • B. 

      False

  • 3. 
    A Device Master Record (DMR) reflects:
    • A. 

      Deviation Requests for a device

    • B. 

      The entire manufacturing process of a device

    • C. 

      All nonconformances associated with a device

  • 4. 
    How long is LSI required to keep records for implantable devices?
    • A. 

      2 years

    • B. 

      5 years

    • C. 

      7 years

    • D. 

      15 years

  • 5. 
    Who maintains the Quality Record Matrix?
    • A. 

      Receptionist

    • B. 

      Training Manager

    • C. 

      Sales Department

    • D. 

      Quality System Administrator

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