Evaluate An Equipment Problem

7 Questions | Total Attempts: 69

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Evaluate An Equipment Problem

Based on SOPs CLE-001, CLE-002, CLE-003, CLE-004, GE-001�and FAMA-007, answer the following questions.


Questions and Answers
  • 1. 
    While performing the pre-start up checklist for reactor R-X (x meaning any reactor in the facility), the operator notices there is something at the bottom of the reactor.  The operator should (check all that apply)...
    • A. 

      Inform his supervisor

    • B. 

      Do nothing

    • C. 

      Record the observation on the batch record

  • 2. 
    The operator is draining TD-X (x meaning any tumble dryer in the facility) after performing the dryer cleaning.  He notices that the rinse water has black pieces in it.  The operator should (check all that apply)...
    • A. 

      Inform his supervisor

    • B. 

      Do nothing

    • C. 

      Record the observation on the batch record

  • 3. 
    The production supervisor has been informed by one of the operators that he saw black pieces inside the reactor R-X (X being any reactor in the plant) while performing the pre-start up checklist.  The production supervisor should....(check all that apply)
    • A. 

      Inform engineering and operations management

    • B. 

      Inform quality assurance

    • C. 

      Do nothing

  • 4. 
    Bellville Scale company has come to perform the calibration of the plant scales. They find that scale ID # XX (XX being any scale in the plant) is not within its calibration range.  The maintenance supervior should...(check all that apply)
    • A. 

      Inform production and remove from service

    • B. 

      Inform operations management and engineering

    • C. 

      Inform quality assurance so an investigation can be conducted

  • 5. 
    A CSP mechanic is performing the preventative maintenance on the plant centrifuges. He finds that centrifuge C-X (X being any centrifuge in the plant) is not rotating within the listed rpm range.  The mechanic informs his supervisor.  The maintenance supervisor should...(check all that apply)
    • A. 

      Inform production and remove from service

    • B. 

      Inform operations management and engineering

    • C. 

      Inform quality assurance so an investigation can be conducted

  • 6. 
    If there are any equipment problems found during the equipment service, pre-start up checklist, equipment cleaning or while manufacturing a batch, quality assurance must be notifed to determine if there is an impact to the quality system and to assess the impact to previous batches made using potentially defective equipment.
    • A. 

      True

    • B. 

      False

  • 7. 
    A critical piece of equipment breaks during the manufacture of product, but does not cause the product to be deviated (all critical processing parameters were still met).  Is a deviation report needed?
    • A. 

      Yes

    • B. 

      No

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