Calibration Point Selection

Who makes the call?

Presented by:
Joe Petersen
Metrology Engineer
Abbott Laboratories
Common Questions

• Do calibration points have to cover the range of the instrument?

• How many calibration points are needed?
• Are 10, 50, 90 % of full scale appropriate?
• Should zero be used? Is it valid?

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Introduction
• Calibration points effect measurement reliability
– ISO 17025 addresses many quality issues;
• calibration point selection is not directly addressed
• perhaps indirectly addressed by:
– 5.4 Methods, or
– 5.7 Sampling

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Agenda

• General principles
• Who makes the call?
• A form of sampling?

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Learning Objectives
After this session, the participant should be able to:
• List key considerations for selecting calibration points
• Promote best practices for using a team approach to define
calibration points

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Where are calibration point selection requirements defined?

QM

Policy

General Operating Procedure

Specific Calibration Procedure

(Work Instruction)

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Example of Policy / General Procedure
• “The selection of calibration points will vary with the normal use of the meter ....”
– Usage

• “For example, a meter which monitors a fixed value can be spot calibrated at the critical
value.”
– Single Point Calibration

• “Meters which may indicate any value within their ranges will require a linearity test at full
scale and at least three equally spaced divisions on one range, and a full-scale test on
each remaining range.”
– Full Calibration

• “Other meters, such as those used over a narrow range, may require calibration over a
restricted portion of the scale.”
– Limited Calibration

– CALIBRATION OR QUALIFICATION OF PANEL METERS, Metrology Bulletin, Oct

'64--USN Metrology Engineering Center, Pomona, Calif. ; as published in National
Conference of Standards Laboratories, NCSL NEWSLETTER 67-4, 1967

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Example of Policy / General Procedure
• “In general, for each TI characteristic being calibrated, the smallest number of test
points consistent with obtaining verification of the TI performance over its specified
range should be used.”
– Risk based approach
• “The number and choice of required test points will vary, depending on the
characteristics of the TI.”
– Consider design and technology
• “Guidance concerning choice of test points for selected generic classes of equipment
is contained in Calibration Requirements Documents (CRDs).”
– Specific requirements are in individual calibration procedures
• “In some cases, TI application/use requirements will dictate test point selection.”
– Consider use

– REQUIREMENTS FOR PREPARATION OF INSTRUMENT CALIBRATION PROCEDURES

• NAVAIR 17-35TR-4
• NAVY METROLOGY ENGINEERING CENTER
• 15 AUGUST 1990
• 3.7.2.10 Calibration Test Points.

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Key Considerations for Point Selection
• Measurement Technology
• External Guidance Documents
• Calibrated Range
– full or limited
• Assigned Accuracy
– (maximum permissible error)
• # of adjustment points
• User requirements
– critical usage points may be preferred calibration points

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Are 3 points sufficient?
Balance calibration guidelines

Publication Minimum # of Accuracy/Linearity Test

Points (excluding zero)
OIML R76-1 5
UKAS LAB14 10
Code of Practice for Industrial Weighing 5
Machines, United Kingdom Weighing
Federation
SANAS R15-03 (South African National 5
Accreditation System)
Mettler Balance Tolerances typically 4
Sartorius Tolerances for Testing Metrological typically 4
Specifications
ASTM E898 10
EA-10/18 Guidelines on the calibration of non- 5 or more
automatic weighing instruments

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EURAMET Guidelines on the Calibration of Digital Multimeters

• cg-15
– Previously EA-10/15

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EURAMET Guidelines on the Calibration of Digital Multimeters

– 3.4.1 “… consider the working principles of the instrument ...”

– “[obtain guidance] from the manufacturer’s instructions,
although the points listed therein should not necessarily be considered exhaustive.”

‘trust but verify’

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EURAMET Guidelines on the Calibration of Digital Multimeters

Accuracy Class Recommended # of

Table (Resolution) calibration Points*
4 1/2 digits or less
1 58 to 70
(e.g. 20,000 counts)
5 1/2 digits or more
2 100 to 114
(e.g. 200,000 counts)

* Based on five parameters and five ranges per parameter.

• Conclusion: The extent of testing should be based on instrument

accuracy.

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 Relative Humidity Performance

# of calibration Points 4

Error, % RH
• Factors to Consider 0

– Calibrated Span -2

– Assigned Accuracy -4
0 20 40 60 80 100
– Measurement Technology
% RH
• First principles
Assume
• Empirical
Relative Humidity Performance
– Cost ± 2 %RH
4
– Risk
2

Error, % RH
0

-2

-4
0 20 40 60 80 100
% RH

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Hind Sight is 20/20
• Given an excessive # of calibration points, it is easy to see which
points are unnecessary
• You generally can’t tell you have enough points until you’ve tested
more than enough
– Type testing
– Retrospective review of historical results

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Hind Sight is 20/20
Stir Plate Calibrations
Average Error, % of reading -- 1 standard deviation Error Bars
4

3
Average Error, % of reading .

-1

-2

-3

-4
0 200 400 600 800 1000 1200
Speed, rpm

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Build on Experience
“Test results showed that measurements made at 50 test points were
sufficient to allow accurate predictions of the instrument's performance
at all 255 test points specified by the manufacturer.”

A. D. Koffman, H. L. Stott, Modeling and Test Point Selection for a Thermal Transfer
Standard [AC Voltage], NCSL Workshop & Symposium, 1993

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Points associated with secondary parameters

.. depends upon..
Primary Parameter Secondary Parameter
AC voltage frequency
optical transmittance wavelength
relative humidity temperature

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Full matrix
Spectrophotometer Calibration Points
– Commercially Available Filters
– Visible Light Region

2.0
optical density or absorbance

1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0.0
380 480 580 680 780
wavelength, nm

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Risk based approach
AC Voltage Calibration Points One Intermediate Range
EURAMET cg-15/v.01
Others

100
90
80
measurement point,

70
% of full scale

60
50
40
30
20
10
0
10 100 1000 10000 100000 1000000
frequency, Hz

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Uncertainty increases as calibration points decrease

Procedure Target uncertainty,

U(pH)
Calibration (1-point), 0.3
ΔpH = |pH(X) – pH(S)| = 3 and assumed slope
Calibration (2-point) by bracketing 0.02 - 0.03

Multipoint (5-point) calibration 0.01 - 0.03

Source: R.P. Buck, et al., Measurement of pH. Definition, standards, and

procedures (IUPAC Recommendations 2002)
International Union of Pure and Applied Chemistry

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# of calibration Points

• Summary of General Requirements

– Typically three or more to verify linearity
– One is suitable for devices which are inherently linear (e.g. flow
totalizers, stopwatches, frequency counters)
– Two are suitable for very narrow portions of a range
– Five or more may be appropriate for some technologies
• Often recommended in guidance documents

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Specific Principles

• Primarily related to technology

– Analog v. Digital
– First Principles v. Empirical
– Mechanical v. Electronic

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Who makes the call?

• Instrument Manufacturer
• Calibration Supplier
• Metrological Confirmation Group
• Instrument Owner / User

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Who makes the call?
Going back to key considerations

– Instrument Manufacturer
• Measurement technology
– (perhaps biased view)
– Perhaps the most expertise
• Likely failure modes

– Calibration Supplier
• Available calibration standards
• Perhaps an unbiased view of measurement
technology based on experience with multiple
manufacturers

– Instrument Owner / User • Critical Points

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Best practice for using a team approach
1. Obtain input from stakeholders
2. Calibration laboratory proposes
calibration points
3. Owner reviews and approves

• Aligns with ISO 17025, 4.4 Review

of requests, tenders and contracts

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Is calibration point selection a form of sampling?

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Is calibration point selection a form of sampling?
• ISO 17025 - 5.7 Sampling
– 5.7.1 The laboratory shall have a sampling plan and procedures for sampling
when it carries out sampling of substances, materials or products for
subsequent testing or calibration. …
– NOTE 1: Sampling is a defined procedure whereby a part of a substance,
material or product is taken to provide for testing or calibration of a
representative sample of the whole.

• How many organizations have a defined procedure for selection

of calibration points?

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Is calibration point selection a form of sampling?

5.7 Sampling – Not Applicable for calibrations

(How many have seen this or a similar statement in a quality manual?)

• “Sampling does not apply. This laboratory only performs

calibration, not testing.”

• “The laboratory does not sample items submitted for

calibration.”

• “Sampling is not a part of our calibration process.

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Is calibration point selection a form of sampling?

• Three interpretations of ISO 17025 for point selection

1. a form of sampling covered by 5.7, “Sampling”
2. not sampling but is covered by 5.4, “Test and calibration
methods and method validation”
3. not covered by 17025

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Inadequate Calibration Points

XYZ Calibration Company

ISO 17025 Accredited Calibration
Accreditations Universal

Certificate #: 01.02.03
Item: Humidity Meter
Manufacturer: Meter Company
Model: 87Y21

Temperature
Device Standard Unit Under Error Uncertainty
Range: Test
°C °C °C °C
23.04 23.1 +0.06 0.05
-10 to 70 °C Relative Humidity
Standard Unit Under Error Uncertainty
Test
0 to 100 %RH % RH % RH % RH % RH
50.3 52.8 +2.5 1.4

Approved by: J. Jones 03/30/2013

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Between Point Uncertainty

• If user specifies range • If user specifies points

– Reliability and uncertainty between – Reliability and uncertainty between
points is lab’s responsibility points is user’s responsibility

– Mark Kuster, Enough Is Enough:

Selecting Points for Range Calibration,
Measure Journal, Sep. 2011

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Between Point Uncertainty
Sample certification statement:
• If user specifies range • If user specifies points
– “Instrument meets manufacturer’s – “Instrument meets manufacturer’s
specifications throughout all specifications at all points tested.”
functions and ranges.”

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Appeal to Accreditation Bodies

• Whether point selection is an element of calibration

methods or sampling:
– Establish directives to assure adequate calibration points
• Eliminate the quality system gap
• Level the playing field

– Prohibit single point certificates that imply a fully calibrated

instrument
• (except as appropriate)
• Some instruments, purchased new, come with an accredited calibration

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Conclusion

• Risk of too few calibration points

– Untested regions
– Undetected linearity errors
• Calibration point selection is technology dependent
• Each laboratory should establish a general policy / procedure
• Guidelines should also be defined in specific calibration
procedures
• Team approach is desirable
• Accreditation should address point selection

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