Instrument Calibration And Maintenance

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

Yes

No

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.

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.

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

True

False

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.

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.

3. 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)

Do nothing, maybe the verifier wont notice

Inform your supervisor

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.

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.

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

True

False

See LP-014

Explanation

See LP-014

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

True

False

See SOP LP-010 section 4.2.1

Explanation

See SOP LP-010 section 4.2.1

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

Equipment logbook

Calibration and maintenance logbook

Equipment Logbooks were removed in June 2012.

Explanation

Equipment Logbooks were removed in June 2012.

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

Clean the balance and try again

Contact your supervisor

Place a do not use label on the balance

Do nothing

You may also let your supervisor know, but you should try to assess the situation first.

Explanation

You may also let your supervisor know, but you should try to assess the situation first.

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

True

False

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.

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.

9. 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)

Inform your supervisor

Inform the production supervisor

Do nothing and go home

You should let both your supervisor and production know that there is a problem.

Explanation

You should let both your supervisor and production know that there is a problem.

Submit

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

Try again, third times a charm

Contact your supervisor

Place a do not use label on the balance

Do nothing

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.

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.

Submit