Before we define what does calibration mean is, I want you to understand below scenario:
When you go to the market and buy some meat, you bought 1 kilo and paid it with your hard-earned money but when you checked it at home, it is only ¾ of a kilo, what would you feel?
You just gassed-up good for 2 days as your regular routine but only a day had passed and your meter indicates near empty – would this not make you mad?
Now, what do you feel if the above scenario happens to you? Of course, you may get angry, dismayed or worse complain to the services or product that you received and paid for, all because of the effect of the un-calibrated Instruments.
This is why calibration is important in our daily life not just inside a laboratory or within the manufacturing aspect. There is the involvement of quality, safety, and reliability.
Now let us define What calibration is.
Basics of Calibration
There are definitions of Calibrations by NIST or ISO that you can look for. But to easily understand, below is a simple calibration definition:
Calibration is simply the comparison of Instrument, Measuring and Test Equipment (M&TE), Unit Under Test (UUT), Unit Under Calibration (UUC), a Device Under Test (DUT) or simply a Test Instrument (TI) of unverified accuracy to an instrument or standards with a known (higher) accuracy to detect or eliminate unacceptable variations. It may or may not involve adjustment or repair.
It is making the instruments performs what it displays by referencing or adjusting it based on a Reference Standard.
- to ensure that you get what you have paid for;
- Satisfy your expectations;
- Create win-win situations
What is a Reference Standard?
A reference standard is also an Instrument, or equipment, or a measuring device with the highest metrological quality or accuracy than the Unit Under Calibration (UUC).
It is where we make comparisons between the UUC and where measurement values are derived. It is also calibrated, but by a higher level laboratory with traceability to a higher standard (See traceability below).
A reference standard is also known as Master Standard. Other terms that I sometimes hear, they refer to it as Master Calibrator.
We see the importance of calibration by basing it on the example above but for a technical reason, we need to calibrate because as components aged or equipment undergo environmental or mechanical stress, its performance gradually degrades.
This degradation is what we call the ‘drift‘. When this happens, the results or performance generated by certain equipment will be unreliable where design and quality suffer. We cannot eliminate drift, but through the process of calibration, it can be detected and contained.
While detecting inaccuracy is one of the main reason for calibration, some other reasons are:
- Customer requirements – they want to ensure that the product they buy is the most accurate one.
- Requirements of a government or statutory regulations – they want to make sure that products produce are safe and reliable for the public
- Audit requirements– as a requirement before achieving a certification like ISO 9001 certification
- Quality and Safety requirements– a reliable and accurate operation through proper use of inspection instruments provides a great deal of confidence for everyone
- Process requirements – some operations will not be executed unless the equipment is verified to be calibrated, used in equipment or product qualifications as part of quality control. To ensure that the product produced is the most accurate and reliable.
Importance of Instrument Calibration
- To establish and demonstrate traceability (I will explain the traceability below). Through calibration, the measurement established by the instrument is the same where ever you are, it means that a 1 Kg of weights in one place is also 1 Kg in other places or wherever it reaches. You can use instruments regardless of the units or parameters it measures on different occasions.
- To determine and ensure the accuracy of instrument readings- resulting in product quality and safety
- To ensure readings from the instrument are consistent with other measurements
- To establish the reliability of the instrument making sure that they function in the way they are intended to be – resulting in product quality and safety
- Provides customer satisfaction by having a product that serves what they have paid for.
What needs calibration?
- All inspection, measuring and test equipment that can affect or determine product quality. This means that if you are using the instruments to verify the acceptance of a product whether to pass or fail based on the measured value you have taken, the instrument should be calibrated.
- Equipment which, if out of calibration, would produce unsafe products.
- Equipment which requires calibration because of an agreement. An example is a customer before progressing into a contract will see to it that the equipment that will produce their product is calibrated.
- All measuring and testing equipment (standards) having an effect on the accuracy or validity of calibrations. These are the master standards that we used to verify other instruments or equipment for their accuracy.
What does a calibrated Instrument Looks like?
When you have your measuring instruments calibrated, see to it that it has a calibration label where details of its calibration
date and due date are seen, also includes a serial number, certificate number, and person-in-charge of the calibration which depends on the calibration lab. Also, if needed, avoid seal is placed to protect it from an unauthorized adjustment.
A calibrated Instrument with labels are useless if the calibration certificate is not available, so be sure to keep it safe and readily available once requested.
Be cautious to check calibration certificates once received, not all calibrated instruments are performing the same as you expected, some have a limited use based on the result of the calibration. you must learn how to read or interpret the results in a calibration certificate.
When is Calibration Not Required?
Every measuring instrument needs calibration but not all measuring instruments are required to be calibrated. Below are some of the reasons or criteria to consider before having an instrument calibrated. This may save you some time and money.
- It is not critical in your process ( just to display a certain reading for the purpose of functionality check).
- It functions as an indicator only (for example: high or low and close or open).
- As an accessory only to support the main instrument. For example, a coil of wire used to amplify current. Current is measured but the amplification is not that critical, used as an accessory only to amplify a measured current.
- Its accuracy is established by a higher or reference to a higher or more accurate instrument within a group. (for example a set of pressure gauges that are connected in series in which one of them is a more accurate gauge where they are compared or referenced to).
- If the instruments are verified regularly or continuously monitored by a calibrated instrument that is documented in a measurement assurance process. For example, a room thermometer that is verified by a calibrated thermometer regularly.
- If the instrument is a part of a system or integrated into a system where the system is calibrated as a whole. For example, a thermocouple that is permanently connected to the oven ( some thermocouples are detached after usage then transferred to other units).
Please visit this link for more details regarding this topic.
What is the Accuracy of an Instrument?
Accuracy is a reference number (usually in percentage) that indicates how close the measurement results to the true value. There is a true value which means that you have a source of known value to compare with.
The closer your measuring instrument reads or measure to the true value, the more accurate your instrument.
We are performing a calibration to check for accuracy of instruments, to determine how close (or far) the reading of our instruments in comparison to the reading of the reference standard.
Where can we find the Accuracy of Instruments?
- Original Equipment Manufacturer (OEM) Specifications in manual or brochure
- Publish standards or handbook
- Calibration Certificates
When calibrating, see to it that the reference standard has a higher accuracy than the Unit Under Calibration (UUC), usually, a good rule of thumb is to have an accuracy ratio of 4:1.
This means that if your UUC has an accuracy of 1, the reference standard to be used should have at least a 0.25 accuracy, four times more accurate than the UUC (1/0.25 =4). To make it more clear, since most of the time, accuracy is expressed in percentage, the closer the value is to ZERO, the more accurate the instrument.
What is the Tolerance of Instruments?
Tolerance is closely related to accuracy at some point but for clarity, it is the permissible deviation or the maximum error to be expected from a manufactured component and expressed usually in measurement units ( example are psi, volts, meter, etc.).
After calibration, we should perform a verification to determine if the reading is within the tolerance specified, it may be less accurate but if it is within the specified tolerance limit, it is still acceptable. This is where a pass or fail decision can be brought out.
The tolerance needed should be determined by the user of the UUC, which are the combinations of many factors which includes:
- Process requirements
- The capability of measurement equipment
- Manufacturer’s tolerance specifications (Related to accuracy)
- Published Standards
What is Precision in Measurement?
Precision is the closeness of a repeated measurement to each other. Precision signifies good stability and repeatability of instruments but not accuracy. A measuring instrument can be highly precise but cannot be accurate, you can only correct this if you perform calibration. This is where tolerance is observed where reading should stay within the tolerance limit in order for the data to be acceptable.
Below are the relationships of Accuracy, Precision, and Tolerance to understand better:
What is Traceability in Calibration?
As it was stated, calibration is the comparison of an instrument to a higher or more accurate instrument. These higher accuracy instruments are called the reference standard and sometimes also known as the calibrator, a master or a reference.
This reference standard that is used to calibrate your instruments has also a more accurate master being used to calibrate it and so on and so forth until it reaches the main source of that certain highest accuracy (measurement result).
There is an unbroken chain of comparison being linked from top to the bottom of the chain. It is passed to local from international standards or the BIPM (Bureau International des Poids et Measures (International Bureau of Weights & Measures))
.This means that the 1 kilogram you have is also 1 kilogram no matter where you go. There is unity to every measurement. Traceability can be determined through its calibration certificate indicating the results and reference standard used to calibrate your instrument.
Why is Traceability in Measurements Necessary?
- For companies engaged in manufacturing and engineering, ensures that parts produce or supplied have the same or acceptable specifications when used by customers anywhere. Compatibility is not an issue.
- A requirement by relevant laws and regulations to guarantee product quality.
- A requirement from a contract agreed by two parties ( contractual provisions)
- Statutory requirements for safety
Where can we find the traceability information of a Calibrated Instrument?
Since traceability is very important, we should have knowledge on how to determine or check the traceability information of certain calibrated instruments. We can find it through its calibration certificate, this is one of the check items in a calibration certificate once it is calibrated by an authorized laboratory.
In a calibration certificate, there is traceability information written usually in the middle part together with the reference standard used or at the bottom and or even both.
This is a requirement so it must not be neglected if the laboratory is a competent one. Moreover, the most important one is the result of its measurement uncertainty, it should be reflected with the data results to ensure that you have a traceable calibration done by an accredited laboratory.
For more details about how to use and interpret a calibration certificate, please visit this link.
What is Measurement Uncertainty?
Calibration is not complete without Measurement uncertainty or Uncertainty of Measurement. This is where the unbroken chain of comparison is being connected or linked in.
Measurement Uncertainty is the value being displayed to quantify the doubt that exists on a specified measurement result. Since no measurement is exact, there is always an error that is associated with every measurement. And in order to determine the degree, effect, or quantity of this error that exists in every measured parameter, we compute or estimate its Measurement Uncertainty.
During uncertainty computation or estimation, we identify all the valid sources of errors that have an effect on our measurement system. It can be from our procedures, instruments, environment and many more. We evaluate and quantify the value of each error and combine them to a single computed value.
Where Can we find measurement uncertainty? We can find measurement uncertainty results in the calibration certificates usually in the data results page.
Visit this link from WIKIPEDIA to learn more.
What are the Differences Between Calibration, Verification, and Validation?
Calibration, verification, and validation are the terms that are most confusing if you are not aware of their differences and true meaning when it comes to the measurement process.
To differentiate these terms, below are the main points to remember:
- Calibration is simply the “comparison” of the unknown reading of a UUC to a known reading of a Reference Standard, also known as the Master.
- Verification is a process of “confirming” that a given specification is fulfilled.
- Validation is for “ensuring” the acceptability of the implemented measurement process. Focusing on the final output of the measurement process.
To learn more about their differences including a concrete example, visit my other post in this link>>
ISO 17025 – Calibration Laboratory Quality Management System
What is ISO 17025?
- InternationalStandard ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories
- As the title implies, it is a standard for laboratory competence, to differ from ISO 9001, which is for certification.
- It is an accreditation standard used by accreditation bodies where a demonstration of a calibration laboratory competency is assessed with regards to its scope and capabilities. Accreditation is simply the formal recognition of a demonstration of that competence.
- It is also a Quality Management System that is comparable to ISO 9001 but it is designed for Calibration Laboratory specifically 3rd Party or External Calibration Labs.
- The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.
- It can be divided into two principal parts,
1. Management System Requirements- similar to those specified in ISO 9001:2015, primarily related to the operation and effectiveness of the quality management system within the laboratory.
2. Technical Requirements – include factors which determine the correctness and reliability of the tests and calibrations performed in the laboratory.
- These requirements are implementing systems and procedures to be met by testing and calibration labs in their organization and management of their quality system particularly when seeking accreditation.
- Since ISO 17025 is a quality management system specifically for calibration laboratories, it is also a good tool or a guide if you are managing an in-house or internal lab. Following its requirements will help you achieve most of the auditors’ requirements during internal or customer audits.
To learn more about the requirements of ISO 17025:2017, visit my other post in the below link:
ISO/IEC 17025:2017 Requirements: List of Documents Outline and Summary
Learn the basic elements regarding In-House Calibration Management Implementation by visiting this link. >>> ELEMENTS IN IMPLEMENTING IN-HOUSE CALIBRATION.
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