Calibration

What is calibration
As per ISO/IEC Guide 99 ; International vocabulary of metrology — Basic and general concepts and associated terms(VIM) and
or as per JCGM 200:2012*

Calibration consists of operation that, under specified conditions, in a first step, establishes a relation between the quantity values with
measurement uncertainties provided by measurement standards and corresponding indications with associated measurement
uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication

Note 1 : A calibration may be expressed by a statement, calibration function, calibration diagram, calibration curve, or calibration table.
In some cases, it may consist of an additive or multiplicative correction of the indication with associated measurement uncertainty
Note 2 :Calibration should not be confused with adjustment of a measuring system, often mistakenly called “self-calibration”, nor with
verification of calibration.

*JCGM : Joint Committee for Guides in Metrology

Calibration : Let us make it simple
Let us make it simple
• Calibration is the documented comparison of the measurement device to be calibrated against a traceable
reference device.
• The reference standard may be also referred as a ‘calibrator’.
• The reference is more accurate than the device to be calibrated.
• The reference device should be also calibrated traceably, more on that later on.
• With some quantities the reference is not always a device, but can also be for example a mass, mechanical
part, physical reference, reference liquid or gas.

Wrong concept
Calibration refers to the act of evaluating and adjusting the precision and accuracy of measurement
equipment. Instrument calibration is intended to eliminate or reduce bias in an instrument's readings over
a range for all continuous values.
Why calibration is necessary ?
• It is impossible to make perfect hardware that would not need any form of error correction. Even
making the hardware good enough to eliminate the need for error correction for most devices would
be extremely expensive.
• The best balance is to make the hardware as good as practically possible, balancing performance and
cost. Calibration is then a very useful tool to improve measurement accuracy.
• Calibration of a measuring equipment or working standard enables the user to take note of the
deviations and errors from the nominal values so that corrections can be made to minimize the errors
during measurement.
• A well-calibrated instrument provides the confidence to the user as well as the consumer that the
service or the product meets the required specifications and ensures the acceptance in international
market.
Steps of calibration
1. Determine which procedure to be used during calibration.
2. Compare to a reference standard (full-range or as per customer test point).
3. Find out the error.
4. Adjust the equipment if capable. This step is not included in calibration. Still some organizations does it.
5. Check the traceability .The traceability, the unbroken chain of comparison linking to the highest level (At least to national level).
6. Estimate measurement uncertainty.
7. Record results to a calibration certificate.

Most common mistake : Calibration agency writes next calibration due on

What we do in calibration
Calibration refers to the act of evaluating and adjusting the precision and accuracy of measurement
equipment. Instrument calibration is intended to eliminate or reduce bias in an instrument's readings over
a range for all continuous values.
Three new terminology
• Bias is defined as the difference between the measurement result and its unknown 'true value'. It can
often be estimated and/or eliminated by calibration to a reference standard.
• Precision is the degree to which repeated measurements under unchanged conditions show the same
result.
• Accuracy is the degree of closeness of measurements of a quantity to its actual true value.
Types of calibration
Calibration is basically of three types:
1. Electro-technical Calibration: It consist calibration of electronic devices like resister, capacitor etc.
2. Non Electrical Calibration: It consist calibration of mass, pressure etc.
3. On Site Calibration: It consist calibration of any other type of quantity which contain both
quantities.
Where to calibrate
1. Calibration is performed in the I/II/III party laboratory under controlled environment.
(The environment need only to be controlled to the extent required.)
2. Accredited Calibration Laboratory here NABL
3. Manufacturer’s / Supplier’s Laboratory ensuring valid traceability
Types of measurement standards
Traceability

• Traceable to a national standards.

• In India it is with National Physical Laboratories, New Delhi.
 Calibration laboratory - Basic requirements
• Temperature
• Humidity
• Location – Permanent/On-site • Air flow
• Filtration
• Environment
• Electromagnetic Screening
• Equipment • Noise Level
• Vibration
• Staff • EMI/EMC
• Management Reference standards Transfer
• Cleanliness
Standards Working • Lighting
Documents standards Connecting leads • Power supply
Records adaptors/accessories • Accessibility
Calibration Subsidiary equipment • Receiving & Calibration area
Computers & automation
Training software
Authority
Responsibility
Technical
Competence
Requirements of calibration management system
Each instrument requires:
• Unique identification
• A recorded history and current calibration status
• Use appropriate for the function of the instrument
Calibration procedures require
Approved procedures for calibration
Schedule for calibration
Process range limits
Calibration standards and test equipment
• Must be more accurate than the required accuracy of the instrument
• Traceable back to national or international standards
Personnel
• Proof of appropriate training
• Perform within an established change management process
Calibration report

A calibration report usually provides a set of results that show the performance of the instrument being
calibrated in comparison to a reference instrument or standard. Measurements are recorded for each
function, range and points tested, and the uncertainty of each measurement is reported.
Calibration certificate

A calibration certificate usually states the compliance of an instrument with the manufacturer's specification.
Measurements made by the instrument being calibrated are compared to the manufacturer's specification. If
the instrument is within specification, a statement that the instrument meets the manufacturer's specification
at the points tested is made in the conformance certificate.
Sample
calibration
certificate
Thank you
Verification
 What is verification ?

As per ISO/IEC Guide 99 ; International vocabulary of metrology — Basic and general concepts and
associated terms(VIM) and or as per JCGM 200:2012*
• Provision of objective evidence that a given itemFulfils specified requirements
Example 1
Confirmation that a given reference material as claimed is homogeneous for the quantity
value and measurement procedure concerned, down to a measurement portion having a mass of 10 mg.
Example 2
Confirmation that performance properties or legal requirements of a measuring system are achieved.
 What is verification : Let us make it simple

Verification is a process of “confirming” that a given specification is fulfilled.

It is a simple check to confirm that a certain instrument or equipment meets the intended output basing it
to the requirements of certain specifications, not a comparison to a higher standard.
 Why verification is necessary

• A legal or regulatory body, examples are ASTM and ISO.

• Manufacturer requirements.
• Process or user requirements
Unlike Calibration where decisions are made based on how far or close the reading of the instrument in
comparison to the provided results of the reference standard.
 Why verification is necessary

• Confirming the performance of the instrument based on given specifications or requirements.

• Ensuring that the instrument is working correctly for its intended purpose.
• Not checking the entire range. Just only to ensure that it is acceptable on its working or intended range
• Directly deciding what to do base on the verification result.
• These decisions are either:
• to recalibrate
• to adjust,
• extend usability
• scrap or make obsolete
• repair

Note that, we perform verification after calibration..

 Steps of verification

The activities where verification is involved in a calibration lab are:

• Intermediate check, which is used
• Before and after onsite calibration
• During the acceptance of newly purchased standards
• Once a reference standard has arrived from a third party calibration
• Preventive maintenance
• Receiving process of instruments for calibration.
Calibration interval
 Calibration interval

The most asked questions

• Is a recalibration a requirement?
• How can we do interval analysis and how long can we extend ?
• Is there a standard that controls the interval between each calibration process?
• Is there a standard guide that is set to be followed?
• Is there a set of rules for the frequency of calibration of an instrument?
• It is difficult to understand the logic behind the 12-month interval, shouldn’t this depend on the
number of usages
 What is A Calibration Interval ?
Calibration interval is also known as calibration frequency, calibration period, or simply calibration due date is the number of days
between scheduled calibrations.
It will answer the question,” how often should we calibrate our instruments?” Or, “how long before we calibrate our instruments
again?”
Having a calibration interval is a must. Saying this, laboratories are not allowed to give a calibration frequency. This is as per ISO 17025
standard, under clause 7.8.4.3, which states that “A calibration certificate or calibration label shall not contain any recommendation
on the calibration interval, except where this has been agreed with the customer.”
One of the reasons is that once the instrument is out of the lab, the lab has no control over it, therefore the calibration interval is not
guaranteed.
The user should determine what are the Calibration Intervals needed for his instruments. This will now become part of the In-house
Calibration program that should be properly documented.
Any instruments that will not fall under the calibration Interval analysis may fall under ‘calibration-not-required’ status.
 Why Calibration Interval is so important
• To save cost. – by calibrating less frequently because of a longer calibration interval but ensuring reliability.
• To satisfy requirements of customer or regulatory bodies
• The need to perform recalibration –The reason why we “calibrate” also applies to why we “recalibrate”
The need to recalibrate. Below are some technical reasons why we recalibrate:
 Because of drift
 To detect any calibration problems before it affects quality.
 Exposure to harsh environment
 Over usage.
 To assure accuracy and reliability
 To ensure traceability.

• Compliance to the Requirements of ISO Standards – under ISO 17025:2017 and ISO 9001:2015 Standards which controls and
requires calibration interval analysis
 Let us check ISO 9001:2015 and ISO/IEC 17025 :2017 clause requirement
ISO 9001:2015 , Clause no 7.1.5.2 : Measurement traceability

I. When measurement traceability is a requirement or is considered by the organization to be an essential part of providing
confidence in the validity of measurement results, measuring equipment shall be: a) calibrated or verified, or both, at specified
intervals, or prior to use, against measurement standards traceable to international or national measurement standards;
II. The organization shall determine if the validity of previous measurement results has been adversely affected when measuring
equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary
 Let us check ISO 9001:2015 and ISO/IEC 17025 :2017 clause requirement
ISO/IEC 17025:2017 Cl no 6.4.7 , 6.4.13, 7.1.5.2,7.7.1

I. Establishing calibration program for calibrated Instruments

As per clause 6.4.7 The laboratory shall establish a calibration program, which shall be reviewed and adjusted as necessary in order to
maintain confidence in the status of calibration.
II. Monitor Validity of results.
As per clause 7.7.1 The laboratory shall have a procedure for monitoring the validity of results. g) retesting or recalibration of retained
items;
III. For documentation as part of Technical Records,
As per clause 6.4.13 Records shall be retained for equipment that can influence laboratory activities. The records shall include the
following, where applicable: e) calibration dates, results of calibrations, adjustments, acceptance criteria, and the due date of the next
calibration or the calibration interval;
 Let us check ISO 9001:2015 and ISO/IEC 17025 :2017 clause requirement
Related Calibration Interval Requirements under ISO 9001:2015, as per clause 7.1.5.2 Measurement traceability

I. When measurement traceability is a requirement or is considered by the organization to be an essential part of providing
confidence in the validity of measurement results, measuring equipment shall be: a) calibrated or verified, or both, at specified
intervals, or prior to use, against measurement standards traceable to international or national measurement standards;
II. The organization shall determine if the validity of previous measurement results has been adversely affected when measuring
equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

If you read these requirements, there are no specific guides or standards that are required to follow for calibration interval analysis or
method, therefore, any methods that work for you are ok.

But it is better to have published documents or guides as a reference like the ILAC G24
 Objectives of calibration interval analysis

1. To designate Initial Calibration Interval – this is the starting calibration interval based on experience and recommendations.
2. Use to extend interval of calibration – this means that a given calibration interval will be extended for a specific period until a fixed
interval is reached. This is also applicable like for example during this pandemic where calibration is difficult to access and we want
to extend a little more temporarily.
3. Use to reduce interval of calibration – this is applicable when we encounter out of tolerance where calibration is reduced as per
implementation rule. See below example presentation
4. Use to determine the fixed calibration interval (final interval) – this is the main calibration interval that we need to achieve based
on actual use which should be adequately justified.
 Types of interval

1. Initial calibration interval.

2. Final or Fixed Calibration Interval.
 Objectives For Implementing Calibration Interval Analysis: Big 4 CTQ

1. To designate Initial Calibration Interval – this is the starting calibration interval based on experience and recommendations.
2. Use to extend interval of calibration – this means that a given calibration interval will be extended for a specific period until a fixed
interval is reached. This is also applicable like for example during this pandemic where calibration is difficult to access and we want
to extend a little more temporarily.
3. Use to reduce interval of calibration – this is applicable when we encounter out of tolerance where calibration is reduced as per
implementation rule. See below example presentation.
4. Use to determine the fixed calibration interval (final interval) – this is the main calibration interval that we need to achieve based
on actual use which should be adequately justified.
 Initial Calibration Interval

1. Initial Calibration Interval means an interval that we used initially as per the decision of the expert, this should not be the final
calibration frequency to be used, this is just our starting point. Since we do not have yet data to justify this interval (in most cases
for start up), it is known as ‘Engineering Intuition’.

2. ILAC G-24 : “The so-called “engineering intuition” which fixed the initial calibration intervals, and a system which maintains fixed
intervals without review, are not considered as being sufficiently reliable and are therefore not recommended. “
 Initial Calibration Interval determination helplines

The decision on where to base the initial calibration interval depends solely on you as the user. These could be based on below criteria:
1. Manufacturer Requirements – recommended by manufacturer.
2. On the frequency of use – the more it is used, the shorter the calibration interval.
3. Required by the regulatory bodies (example: required by the government).
4. Past experience of the user with the same type of instrument.
5. Based on the criticality of use. – more critical instruments have higher accuracy or very strict tolerance, therefore shorter calibration
interval.
6. Customer Requirements.
7. Conditions of the environment where it is being used.
8. Published Documents
 Initial interval

Initial calibration intervals in some cases could become the ‘fixed/final calibration interval’, considering that we already have evidence
to justify why we decide this calibration interval for a specific instrument
 Determination of fixed interval : Floating interval method

To establish a fixed interval, below is the calibration interval analysis procedure:

1. Gather historical records of the instrument using its calibration report for the past 2 years or more.
2. Choose at least 3 readings that are mostly used, for example, the min, middle, and max to determine stability or drift.
3. Use excel or any other spread sheet to summarize the readings.
4. Using the specifications and the calibration results, create a chart with control limits (a control chart)-see below the table using
excel (there are many tutorials about control chart in Google that you can follow).
5. Understand and analyze the trend.
6. Based on the trend, you can decide whether to increase or decrease the calibration interval based on the Implementation Rule
that you created for the Floating Interval Method. (See below presentation).
1. Implementation Rule #1: 100% Increased on the next calibration interval after the 2 years if results are within 80% – Max 24 months interval.
2. Implementation Rule #2: 50% reduced on the next calibration interval every time As-Found results are within warning interval or OUT-OF-
TOLERANCE (and adding back the 50% after passing on the next recalibration) –see the flow below second scenario.

7. Determine the final interval.

Determination of fixed interval : Floating interval method

ILAC-G24:2007 / OIML D 10:2007 (E)

Case Study – Decrease calibration interval
Test gauge Specification
80%
Acceptance Criterion = 0.1% Full Scale 100 % Toleranc
Tollerance e
Full scale (Mpa) 500 Mpa 0.5 0.4
Range of result 250 Mpa
Upper Lower Upper
Lower Control Control Control
Interval(months) UUC value
Calibration Standard Control Limit-Limit- Limit - Limit -
date value 100% 100% 80% 80%
6 10-02-2017 250 250.08 249.5 250.5 249.6 250.4
6 06-07-2017 250 250.06 249.5 250.5 249.6 250.4
6 28-02-2018 250 250.03 249.5 250.5 249.6 250.4
6 30-08-2018 250 249.93 249.5 250.5 249.6 250.4
12 30-08-2019 250 249.95 249.5 250.5 249.6 250.4
12 29-08-2020 250 250.15 249.5 250.5 249.6 250.4
24 29-08-2022 250 250.18 249.5 250.5 249.6 250.4
24 28-08-2024 250 250.45 249.5 250.5 249.6 250.4
12 28-08-2025 250 250.4 249.5 250.5 249.6 250.4
6 24-02-2026 250 250.05 249.5 250.5 249.6 250.4

UUC : Unit Under Calibration

 Recalibration Status of calibration Interval
Case Study – Decrease calibration interval sequence
1
interval
Initial interval
(months)
6

2 Initial interval 6
251.0 3 Initial interval 6
250.8 4 Initial interval 6
Standard value (MPa)

250.6 5 New adjusted 12( 6+6X100%)

UCL at 100% Tol interval(Additional 100%)
250.4 UCL at 80% Tol 6 Fixed interval 12
250.2 UUC value 7 New adjusted 24(12+12X100
interval(Additional 100%) %)
250.0
8 Final interval 24
Standard value
249.8 9 New adjusted 12
interval( Failed less 50%) 24-24X50%
249.6 LCL at 80% Tol
10 New adjusted 6
LCL at 100% Tol interval( Failed less 50%) 12-12X50%
249.4
11 New adjusted 3 months
249.2 interval( Failed less 50%) Instrument
changed
249.0 Continue for accepted 12 months
6 6 6 6 12 12 24 24 12 6 result
New adjusted
Interval (Month) interval(Additional 100%)
Case Study – Increase calibration interval
Test gauge Specification
80%
Acceptance Criterion = 0.1% Full Scale 100 % Toleranc
Tollerance e
Full scale (Mpa) 500 Mpa 0.5 0.4
Range of result 250 Mpa
Upper Lower Upper
Lower Control Control Control
Interval(months) UUC value
Calibration Standard Control Limit- Limit- Limit - Limit -
date value 100% 100% 80% 80%
6 10-02-2017 250 250.08 249.5 250.5 249.6 250.4
6 06-07-2017 250 250.06 249.5 250.5 249.6 250.4
6 28-02-2018 250 250.03 249.5 250.5 249.6 250.4
6 30-08-2018 250 249.93 249.5 250.5 249.6 250.4
12 30-08-2019 250 249.95 249.5 250.5 249.6 250.4
12 29-08-2020 250 250.15 249.5 250.5 249.6 250.4
24 29-08-2022 250 250.18 249.5 250.5 249.6 250.4
24 28-08-2024 250 250.19 249.5 250.5 249.6 250.4
24 28-08-2026 250 250.2 249.5 250.5 249.6 250.4
24 24-02-2028 250 250.19 249.5 250.5 249.6 250.4

UUC : Unit Under Calibration

 Case Study – Increase calibration interval
Recalibration Status of calibration Interval
sequence interval (months)
1 Initial interval 6
251.0
2 Initial interval 6
250.8
3 Initial interval 6
Standard value (MPa)

250.6
UCL at 100% Tol 4 Initial interval 6
250.4 UCL at 80% Tol
5 New adjusted 12( 6+6X100%)
interval(Additional 100%)
250.2 UUC value
6 Fixed interval 12
250.0
Standard value 7 New adjusted 24(12+12X100
interval(Additional 100%) %)
249.8
8 Final interval 24
249.6 LCL at 80% Tol
LCL at 100% Tol 9 Fixed interval 24
249.4
10 Fixed interval 24
249.2 12-12X50%

249.0
6 6 6 6 12 12 24 24 24 24

Interval (Month)
Thank you