QSP for Uncertainty of Measurement

Laboratory Management System - ISO 17025

Clause Title
5.4.6 Uncertainty of Measurement

DOCUMENT CONTROL BLOCK (Revision History)

Amendment Section Amendment

Date Revision# DCR # Signatures
Detail Affected Approved by

Prepared By: Reviewed By: Approved By:

Name: ______________ Name: ______________ Name: ______________

Designation: ______________ Designation: ______________ Designation: ______________

Signature: ______________ Signature: ______________ Signature: ______________

1. Purpose:

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The purpose of this procedure is to guide Laboratory staff about uncertainty of
measurement.

2. Scope:

This procedure is applicable to Company Pvt. Ltd for the tests performed in the lab where
applicable.

3. Responsibility:

Lab incharge and DMR are responsible for measurement of uncertainty of the test where it
is applicable.

4. Terms & Definitions:

4.1 Uncertainty

Uncertainty is deviation from the true value and can only be expressed in the form of a
range, e.g. +3, +10.6, +0.07, etc.

Published Definition:
Uncertainty is a quantification of the doubt about the measurement result.

4.2 Error Vs Uncertainty

Error expresses a problem and can only be expressed (in statistical terms) as either
positive or negative value, while uncertainty cannot be expressed in the form of a single
value.

Published Definition of Error:

Error is the difference between the measured value and the ‘true value’ of the thing
being measured.

5. Sources of Uncertainty

5.1Test / Calibration Performer(s)

It is the uncertainty of the person performing the test / calibration, but as a person’s error
cannot be calculated in the form of numerical values that be used in advanced combined
estimations, we determine Repeatability and Reproducibility through the test/ calibration
results they achieve.

5.1.1.Uncertainty of Repeatability:
It is the deviation found in results when an activity is repeatedly performed under
the same condition and by the same person.

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 5.1.2.Uncertainty of Reproducibility:
It is the deviation found in results when an activity is repeatedly performed on the
same type of sample under different conditions (in our case we suggest changing
the performer only and try to sustain the rest of the uncertainty sources’ condition
as much as possible).

6. Method used

It is uncertainty expressed in the test / calibration method (equipment manual, etc.) when
some assumptions have to be made due to limitation of features and/or resources.

7. Accessories

The apparatus and accessories being used have uncertainty of their own. In most cases it
can be found in their manuals, on their label or their certificates. Experienced personnel
who are capable of performing test / calibration of equipment are also able to find its
uncertainty, if it’s not given in any other source.

8. Material, Sample and Chemical

Any material and/or sample being used has its own uncertainty, which is usually provided
with its certificate, literature or container. If it’s not provided, personnel can calculate it by
comparing it with a reference standard where uncertainty is already stated.

9. Types of Uncertainty

9.1 Type A

Value of Uncertainty achieved through statistical calculation. We use Type A for

calculation of two sources of uncertainty which are Repeatability and Reproducibility.

CALCULATING TYPE A:

Note: Applicable on most Physical Testing / Calibration Activities, Electronic Test /

Calibration Activities have very low human error margin therefore reliance on TYPE B is
highly recommended.

9.1.1. Repeatability

a. Perform a Test / Calibration Activity at least 10 times and record all the results
(final result)

b. Calculate Average of Results

Average =
Sum of all Values / Total Number of Values (n)

c. Calculate Standard Deviation of Results

Standard Deviation =

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 Square Root of [(Sum of Result Values - Average) 2 / n – 1]

d. As we need the end result in Combined Uncertainty, we shall calculate its

Relative Uncertainty

Relative Uncertainty = Standard Deviation Calculated / Average

OPTIONAL NOTE: It is a common practice to multiply Relative Uncertainty

with 100 so that results can be expressed in the form of percentage which
makes them easier for calculations, so the new formula would be;

Relative Uncertainty = (Standard Deviation Calculated / Average) x 100

9.1.2. Reproducibility

First two steps of repeatability are performed (up till Average estimation) by at
least three personnel (where possible) and their Averages are considered as
Results. Through this result a New Average is calculated along with Standard
Deviation. This standard deviation is referred as Uncertainty of
Reproducibility.

After this relative uncertainty is estimated;

(Uncertainty of Reproducibility / New Average)

OPTIONAL NOTE: It is a common practice to multiply Relative Uncertainty

with 100 so that results can be expressed in the form of percentage which
makes them easier for calculations, so the new formula would be;

Relative Uncertainty = (Uncertainty of Reproducibility / New Average) x

100

9.2 Type B

Value of Uncertainty achieved from any other source e.g. manuals, certificates, etc.

CALCULATING TYPE B:

a. If the value has a confidence level of 95% divide it by 2 or if 99.7% divide it by

3, before using it in calculation
b. In case its an equipment and no confidence level is given, divide the value by
Square Root of 3 (√3)
c. In case uncertainty is provided in Percentage it shall be considered as
Relative Uncertainty, other wise

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 As in most cases of Type B, Average is not provided, the value (scale)
provided with uncertainty shall be considered. So the formula in this case shall
be;

Relative Uncertainty (Type B) =

(Uncertainty Provided / Value Provided) x 100

9.3 COMBINED UNCERTAINTY:

Combined Uncertainty = Square Root (Sum of Squares of Relative

Uncertainties of all sources of uncertainties from both Type A and Type B)

Combined Uncertainty = Square Root of (a2 + b2 + c2 + …..)

Where a, b and c represent relative uncertainties.

9.4EXPANDED UNCERTAINTY:

The standard ISO 17025:2005 requires the labs to express their estimated
uncertainties with certain confidence. This confidence is expressed through using
Confidence Level which is more commonly known as k factor.

Expanded Uncertainty =Combined Uncertainty x Confidence Level (k)

Whereas, Confidence Level, k

95%= 2
99.7% = 3
We recommend use of K=2

9.5 UNCERTAINTY BUDGET

For each TEST / CALIBRATION METHOD you’ll have to compile a separate chart /
table;

1 2 3 4 5 6
Average or Relative
S/N Sources of Uncertainty Uncertainty Type A/B
Value Uncertainty

Column 1:Serial Number for each source

Column 2:Describe the Source of Uncertainty; you need to give only those which
can be measured in terms of numerical value
Column 3:Write Calculated or stated uncertainty
Column 4:Name the Type
Column 5:In case of Type A, give average; in case of Type B, give the value against
which the uncertainty is given. In case of Type B, if Relative Uncertainty is
given, leave column 3 and 5

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 Column 6:Give calculated Relative Uncertainty

Use the values in Column 6 for combined uncertainty as well as expanded

uncertainty.

10. SUPPORTING DOCUMENTS

a. Calculating Type A

This sheet can be used for calculation of Uncertainty of Repeatability and Reproducibility
along with their Relative Uncertainties. Lab Personnel are encouraged to perform these
steps manually before using this sheet for verification of results.

b. Type B Uncertainty

This can be used for calculation of relative uncertainty of Type B uncertainties.

c. Uncertainty Finalization

This sheet can be used for calculation of Combined and Expanded Uncertainty based on
the requirement of the Person performing the test / calibration. The sheet provides
expanded uncertainty with “k” factor 2 and 3 both.

d. Uncertainty Budget

Form (HEC/LMS-FRM/TEC-14) to be used for formulation of Uncertainty Budget to be

used for formulation of Uncertainty Budget.

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