Calibration is the
method of setting a measuring device by adjusting it with a known accuracy,
also called as ‘standard’. This technique determines if an instrument or device is producing
accurate and measurable results within the specified limits as compared to
those produced by a traceable standard over an appropriate range of
measurements.
With calibration, you
achieve 2 main objectives:
a)
Checking the accuracy of an
instrument
b)
Determining the traceability of
the measurement
If the equipment and
instruments you use are not regularly calibrated, you risk reducing their
consistency, quality and safety.
Why is
Calibration Necessary
Even if the
instruments produce accurate measurements today, you can’t
be assured of accurate measurements over a period of time. You will observe a ‘drift’ in
the readings which is a shift from the specified limits. Factors such as
overuse, environmental and external factors such as electrical and mechanical shocks, and wear
and tear causes a drift. Calibration helps in minimizing these uncertainties
and eliminating drift right at the beginning instead of letting it become
significant. Calibration helps in controlling and quantifying uncertainties and
errors to an acceptable level. It also helps in improving the accuracy of the
measuring device, thus improving the quality of the end product. With
calibration you can be confident in your results which you can record, control
and monitor.
How Frequently
Should You Calibrate
There is no correct
answer to ‘how frequently should you calibrate?’. Different
instruments have different calibration needs. If you don’t
calibrate frequently, the measurements will suffer; at the same time
calibrating too frequently isn’t ideal as it is expensive. Let us look at
7 different factors that help in determining the calibration frequency.
1.
Consider the criticality of the
measurement location. You must calibrate more critical locations more
frequently as compared to the less critical locations.
2.
Keep a check on the operating
conditions and workload of the instruments. Those taking a lot of workload or
operating in tough conditions must be calibrated more frequently.
3.
Check the frequency of
calibration the equipment required in the past. The stability history of the
instrument will give you a good idea on how to plan and schedule calibration.
4.
Calibrate an
instrument before you have to take extremely important measurements.
5.
If sudden unforeseen events,
such as electric fault, extreme weather conditions or damage to the instruments
due to an impact or falls occur, conduct a calibration process immediately.
6.
If you think that there are any
discrepancies in the final product or if there is a visible shift from the
acceptable criteria, it means you have to calibrate that instrument. Small
variations are normal but if it crosses the acceptable limit, calibrate
immediately.
7.
Adhere to the timelines and
frequencies suggested by the instrument manufacturer.
Risks of Not
Calibrating Frequently
You couldn’t
be more wrong if you think that it won’t matter if you skip one calibration
schedule or that frequent calibration isn’t necessary.
If you do not calibrate regularly, you may face one of following 4 issues:
1.
You will see numerous
discrepancies and faulty readings in the final product, which will compromise
the overall quality of the product.
2.
In every pharmaceutical product,
safety is absolutely essential. If the product isn’t safe to use
or lies low on quality, you can put thousands of lives at risk. Using
non-calibrated instruments will almost always cause wrong measurements of raw
materials while producing medicines or sensitive instruments such as
thermometers, causing safety threats to the consumers.
3.
When you use non-calibrated
instruments, your end product will show discrepancies. This would mean that you
will have to shut down the concerned processes and conduct a complete
recalibration, increasing downtime. When you calibrate equipment regularly, the
downtime will be minimized. Furthermore, it will also help you identify warning
signs before they cause any significant damage to the end product.
4.
If the consumers receive subpar
medical products, they will ask for a refund or even press legal charges
against your company due to the damage caused to them. You won’t
just lose money but also put your reputation at risk. You may even face product
recall, which is an expensive affair. The risk of litigation increases
significantly if you use do not calibrate your equipment frequently.
What are the Instrument Calibration
Regulations
There are numerous instrument calibration requirements that pharmaceutical companies must adhere to. In
Europe, industry calibration requirements fall under the jurisdiction of the
EMEA (European Medicines Agency), as well as local legislation, and in the US,
the FDA
oversees it. You must keep your calibration records up to date and ensure that
you execute instrument calibration to the exact standards of written and
approved procedures. Keep a master history record of every instrument in the
plant. All the instruments must have a unique ID and all the product, process
and safety instruments must be physically tagged and color-coded.
Set a calibration
period and error limits for each instrument, which should tally with national
and international standards. Ensure that they are more accurate than the
required accuracy of the equipment being calibrated. Train your team properly
and make sure they are competent to execute various calibration tasks and
provide documented evidence of this.
Author Bio: Edward Simpson is a seasoned
Calibration and Technical Engineer working for RS Calibration
Inc. Edward has a knack for finding faults in machines and does not
rest until they are rectified to perfection. He lives in Pleasanton, CA and can
be contacted anytime for matters related to machines. He also invites people to
visit his company www.rscal.com to learn more about the type of calibration
work he does.
Posted by Dr. Tim Sandle
Posted by Dr. Tim Sandle
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Posted by Dr. Tim Sandle
Posted by Dr. Tim Sandle
