Instrument Calibration And Maintenance

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Instrument Calibration And Maintenance - Quiz

Review SOPs LP-010, LP-014 and LP-015 and take the quiz below.


Questions and Answers
  • 1. 

    While calibrating the balance one morning you find the weights do not fall within the specified range you: 

    • A.

      Clean the balance and try again

    • B.

      Contact your supervisor

    • C.

      Place a do not use label on the balance

    • D.

      Do nothing

    Correct Answer
    A. Clean the balance and try again
    Explanation
    You may also let your supervisor know, but you should try to assess the situation first.

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  • 2. 

    After cleaning the balance, the weights still do not fall withing the specified range (see question 1).  You: (Check all that apply)

    • A.

      Try again, third times a charm

    • B.

      Contact your supervisor

    • C.

      Place a do not use label on the balance

    • D.

      Do nothing

    Correct Answer(s)
    B. Contact your supervisor
    C. Place a do not use label on the balance
    Explanation
    If you have cleaned the balance and the weights are still not within range, it is time to take further action. Inform your supervisor and do not use the balance for testing materials until you can determine if there is an error with the balance or the weights.

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  • 3. 

    During calibration,  if  a piece of equipment fails calibration is a deviation invesitgation needed?

    • A.

      Yes

    • B.

      No

    Correct Answer
    A. Yes
    Explanation
    The impact to the quality of the product needs to be assessed if the product was testing with a piece of equiment that was not within calibration.

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  • 4. 

    While running the reaction completion test for the Crude Iso Base (PS-209 IP# 9), the GC instrument stops working, what should you do? (Check all that apply)

    • A.

      Inform your supervisor

    • B.

      Inform the production supervisor

    • C.

      Do nothing and go home

    Correct Answer(s)
    A. Inform your supervisor
    B. Inform the production supervisor
    Explanation
    You should let both your supervisor and production know that there is a problem.

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  • 5. 

    All instruments must have a calibration due date sticker on them.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    All instruments must have a calibration due date sticker on them to ensure that they are regularly calibrated and maintained for accurate measurements. This sticker serves as a reminder for when the instrument needs to be recalibrated, helping to maintain the instrument's reliability and accuracy. It also helps in tracking the calibration history of the instrument, ensuring that it is within acceptable limits and meets the required standards.

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  • 6. 

    While writing up your data from an HPLC run, you discover that the HPLC is beyond its calibration data.  You should (check all that apply)

    • A.

      Do nothing, maybe the verifier wont notice

    • B.

      Inform your supervisor

    Correct Answer
    B. Inform your supervisor
    Explanation
    It is important to inform your supervisor when you discover that the HPLC is beyond its calibration data. This is because using an instrument that is not properly calibrated can lead to inaccurate results and compromise the integrity of the data. By informing your supervisor, they can take appropriate action to ensure that the HPLC is recalibrated or replaced, if necessary, to maintain the accuracy and reliability of the analytical results.

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  • 7. 

    You can use data obtained from an instrument that is beyond its calibration date.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    Data should be obtained from instruments that are within their calibration period. If you have tested material using an instrument that is beyond its calibration date and it has been caught before being reported to production, the results should be voided and the material retested once the instrument has been calibrated. If the error was caught after the results had been reported to production, the impact of using an instrument beyond its calibration data would need to be assess through a deviation investigation.

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  • 8. 

    Service protocols wirtten by an outside contractor should be approved by CSP prior to using to calibrate or maintain and instrument.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    See SOP LP-010 section 4.2.1

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  • 9. 

    Instrument preventative maintenance and calibrations should be documented here when competed.  (check all that apply)

    • A.

      Equipment logbook

    • B.

      Calibration and maintenance logbook

    Correct Answer
    B. Calibration and maintenance logbook
    Explanation
    Equipment Logbooks were removed in June 2012.

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  • 10. 

    Each lab instrument used for testing raw materials, in-process products, intermediates, finished products and stability samples must have a unique laboratory equipment number.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    See LP-014

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  • Current Version
  • Mar 21, 2023
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