Ketertelusuran Pengukuran Di Laboratorium - Dr. Clemens

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TECHNICAL

COOPERATION

Measurement Traceability in Laboratories

Symposium:
Quality Infrastucture Festival 2023

15 June 2023
BSD City/Indonesia

Dr.-Ing. Clemens Sanetra


Consultant, Technical Cooperation

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TECHNICAL
COOPERATION

Traceability Requirements of ISO/IEC 17025


In section 5.6 of the ISO/IEC 17025, the standard states the
following:

5.6.1 General
All equipment used for tests and/or calibrations, including
equipment for subsidiary measurements (e.g. for
environmental conditions) having a significant effect on the
accuracy or validity of the result of the test, calibration or
sampling shall be calibrated before being put into service. The
laboratory shall have an established program and procedure
for the calibration of its equipment.

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TECHNICAL
COOPERATION

Traceability Requirements of ISO/IEC 17025


General:
§ If the equipment has a significant effect on the measurement results, it
should be calibrated.

In summary for calibration laboratories:


§ Establish traceability via an unbroken chain of calibrations to
the International System of Units (SI) (Système international d’unités).
§ Calibration services must be competent, capable, and traceable.

In summary for testing laboratories:


§ If laboratory equipment affects the uncertainty of test results, it should be
calibrated.
§ If laboratory equipment might not affect the uncertainty of the test result
better have objective evidence whether measurement traceability is
needed.

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Quality Infrastructure & Value Chain TECHNICAL
COOPERATION
Customer

Farm to Fork System Quality Infrastructure

sanitary surveillance ISO/IEC 17021, IAF ILAC


Accreditation
Ministry Product ISO/IEC 17065, etc APAC
Technical Regulations
with
Certificate
HACCP
Shrimp Farm Certification
Process

ISO 9000
- products
Good Practices - processes
Processing
ISO 14000
ISO CODEX
Standardization
Deep freezing PASC
Certificate
Testing ISO/IEC
Transport 17025 Intercomparisons
Laboratories
Proficiency tests

trazeability
ISO/IEC
17025
Product
(Shrimp) BIPM
Metrology
APMP
- Calibration
- Reference materials

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How to assure that 1 kg in company A in Indonesia weighs exactly TECHNICAL
COOPERATION
the same as 1 kg in company B in Germany ?
BIPM
mg...1 kg...t mg...1 kg...t
Intercomparison measurements

Indonesia Germany

NMI NMI

?!
SNSU-BSN PTB

ility
trac

eab
eab

trac
ility

Accredited Accredited
calibration calibration
laboratories laboratories

Internal calibration Internal calibration


laboratories 1 mg in lab. A laboratories

Company A = Company B
Measuring instruments 1 mg in lab. B Measuring instruments

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How to assure that 1 kg in company A in any country weighs exactly TECHNICAL
the same as 1 kg in company B in another country ? COOPERATION

BIPM
1 kg international prototype

trac
ability eab
e ility
trac KCDB
- CMC
-
1 kg national standard A 1 kg national standard B

Intercomparison measurements

Country A Country B
tra

NMI better smaller NMI

ity
cea

accuracy uncertainty

bil
bil

cea
ity

Accredited Accredited

tra
calibration calibration
laboratories laboratories
1 kg in lab. A
Company A Company B
=
Measuring instruments Measuring instruments
1 kg in lab. B
BIPM = International Bureau of Weights and Measures, KCDB = Key Comparison Data Base, CMC = Calibration and Measurement Capability

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National Metrology SI TECHNICAL
COOPERATION
Infrastructure BIPM KCDB
ILAC
CMCs

National
Accreditation
Metrology in Chemistry (MIC) NMI Body

MiC laboratories Accredited


-Traceable PT provider
calibration
-Traceable RM provider
laboratories

Accredited Metrology in state


testing regulated areas
laboratories Internal calibration
and testing laboratories

Metrology users
need reliable measurement services!!!

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TECHNICAL

Traceability in Chemical Laboratories: COOPERATION

Accredited Accredited
Calibration Reference
Laboratory Materials
Provider
Testing Laboratory

Calibrated Certified
Reference Standards Reference Material

Accredited
Proficiency
Testing
Provider
Measuring Analytical
Instruments Instruments

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TECHNICAL
COOPERATION

Measurement Uncertainty
No measurement is exact.

Uncertainty of measurement is the doubt that exists about the result of any
measurement. Even the most careful - there is always a margin of doubt.

Any parameter which cannot be expressed with certainty is associated with


uncertainty.

The true value is not known! A measurement value with the associated
measurement uncertainty is the best possible approximation.

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TECHNICAL
COOPERATION

Buyer measures 110

National Institutes

Testing
laboratories
Seller measures 55

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TECHNICAL
COOPERATION

Which Measurement Uncertainty (MU) is necessary?


Ø What does the customer need?

Ø Which MU for production process (improvement)?

Ø Which MU for technical regulation requirement?

Ø Shall my laboratory have a small or large measurement uncertainty?

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TECHNICAL
COOPERATION
Mean Value and Uncertainty

Testing Laboratories

not acceptable

? x limit

! ?

acceptable

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TECHNICAL
COOPERATION

The role of Proficiency Tests (PT) and


Intercomparisons:
§ PT are an external quality and accuracy assessment to demonstrate competence.

§ If results are not good, missing or inadequate traceability could be the reason.

§ Accreditation bodies normally require a PT before accreditation to underpin the


competence in the scope for accreditation and subsequent PT during accreditation to
demonstrate that competence in the accredited scope is maintained.

§ PT should reflect the accredited:


§ range
§ accuracy
§ measurement uncertainty.

Proficiency Tests are NOT traceability and DO NOT replace calibrations or traceability.
They confirm correct results because of traceability and correctly estimated MU.

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TECHNICAL
COOPERATION
Reference Value and Uncertainty

Calibration Laboratories


Reference Value
x
with
Measurement
Uncertainty
x ?

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TECHNICAL
COOPERATION

Conclusions:

§ Without correct traceability to SI (or where not possible to other Reference values)
measurement and testing values cannot be reliable!

§ A measurement or testing value without associated measurement uncertainty is useless!

§ Not the smallest but the most accurate measurement uncertainty is the most reliable (and
the easiest to proof by PT).

To assure the correct traceability:


Accredited calibration laboratory or National Metrology Institute, which
provides the required measurement uncertainty!

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