IEEE_PSES_Paper_20180308
IEEE_PSES_Paper_20180308
IEEE_PSES_Paper_20180308
net/publication/325702001
CITATION READS
1 851
2 authors, including:
Sl Mak
Vocational Training Council
62 PUBLICATIONS 168 CITATIONS
SEE PROFILE
All content following this page was uploaded by Sl Mak on 24 June 2018.
Abstract — The laboratory accreditation is essential for most programmes to the accredited laboratories (e.g. acoustics
consumer product testing providers. In the current laboratory testing carried out in 2015) [4]. However; they only invited the
accreditation criteria, interlaboratory correlation study or laboratories that are already accredited by HKAS to join the
proficiency testing is one of the mandatory requirements. programme. Therefore, it is impossible to determine the
Proficiency testing can help to find out the weakness and competitive between HKAS accredited laboratories to other
potential errors sources of measurement in the testing overseas laboratories.
providers. However, there is a problem of lack of electrical
and mechanical proficiency testing programme in Hong Kong In order to the fulfill the need of the industry, the
and South China region. This paper aimed to explain the Open University of Hong Kong (OUHK) is planning to
development process of a proficiency testing programme that develop a proficiency testing programme that is suitable for
is suitable for electrical and mechanical safety tests. The electrical and mechanical safety tests in Hong Kong. This
process tested for homogeneity and stability of specimen will paper describes the development process of proficiency testing
also be discussed in this paper. programme, frequency of testing, selection of test specimen
and method of data analysis.
Keywords— Homogeneity and stability, ISO/IEC 17025,
Proficiency Testing,
II. PURPOSE OF PROFICIENCY TESTING
I. INTRODUCTION
The ISO/IEC 17025 standard was developed to
The ISO/IEC 17025 accreditation is essential to specify the general quality and technical requirements for the
consumer product testing laboratories. According to the competence of testing and calibration laboratory. It specifies
requirements of Consumer Product Safety Improvement Act both the management and technical requirements. The
(CPSIA), consumer products shall be sent to third-party management requirements require the laboratories to apply the
testing laboratories for testing before they can be put into the proficiency testing and use the results to develop appropriate
market. The certified third-party testing laboratories must preventive actions. Meanwhile, top management shall review
already obtained the ISO/IEC 17025 accreditation in the the result of interlaboratory comparisons or proficiency tests
specified test category [1]. The accreditation bodies required in the management review meeting. In the technical
the ISO/IEC 17025 accredited laboratories to regularly join requirements, on the other hand, the quality assurance system
the proficiency testing (PT) scheme in appropriate testing shall include the (1) use of certified reference materials to
areas. The Hong Kong Accreditation Service (HKAS) valid the test; (2) participate the proficiency testing; (3)
provided the ISO/IEC 17043 accreditation services to replicate tests or calibrations using the same or different
proficiency testing providers in Hong Kong [2]. Current methods; (4) retesting of retained samples; and (5) correlation
proficiency testing providers are providing three different results for difference characteristics of a specimen [5].
proficiency test areas: (1) calibration; (2) medical testing; and
(3) chemical testing [3]. As the majority of testing and Some researchers described that proficiency testing is
certification companies in Hong Kong are providing consumer a good platform to supplement a laboratory’s internal quality
product testing services, they can only join the proficiency control procedure and enables the comparability of
testing organized by overseas services providers, such as LGC measurement between laboratories. In other words, it can be
in UK, IQTC in China, ASTM in USA or IEC. In addition, the considered as an external partial audit of laboratory quality
HKAS also irregularly organized proficiency testing management system [6].
III. INTERNATIONAL STANDARDS FOR PROFICIENCY laboratory accreditation; (2) develop the proficiency test
TESTING PROGRAMME scheme; (3) invite laboratories to join the trial run of
proficiency testing scheme to valid the scheme; (4) modify the
Several international standardization bodies have scheme; and (5) apply for the ISO/IEC 17043 proficiency
published guidelines and criteria for the development of testing provider accreditation.
proficiency testing programmes. The ISO/IEC 17043
describes the general requirements for proficiency testing and Step (1): We will appoint a reference laboratory to
is adopted by most of the accreditation bodies to offer conduct the preliminary measurement and find the assigned
accreditation services, such UKAS, NATA, A2LA, CNAS and value for determining for interlaboratory differences. We will
HKAS. Table 1 shows other guidelines published by assign our own laboratory to be the reference laboratory and
standardization bodies in describing essential criteria of a gain the ISO/IEC 17025 accreditation.
proficiency testing programme. Most of them are applicable to
specific product, such as fabric or water. Step (2): All essential requirements of ISO/IEC
17043 must be met by the PT scheme. Table 2 shows the
Table 1: List of Standards for developing the proficiency testing programme
major essential requirements and explains how we proceed to
meet the requirements.
Standard Code Standard Description
Table 2: List of Essential requirements of ISO/IEC 17043: 2010 [9]
Conformity assessment – General
BS EN ISO/IEC 17043: 2010
Requirements for proficiency testing Requirements Standard Description
Standard Guide for Proficiency Testing by Appoint well-experienced staffs to develop and
ASTM E1301-95 maintain the PT scheme;
Interlaboratory Comparison General
requirements Gain the ISO/IEC 17025 accreditation to
Standard Guide for Proficiency Test demonstrate the competence in the measurement of
ASTM D6674-01 the properties being determined.
Program for Fabrics
Appoint qualified and well-experienced staffs to
Standard Practice for Conducting develop and maintain the PT scheme;
ASTM E2027-17 Proficiency Tests in Chemical Analysis of Personnel
Appoint expertise to form advisory group to provide
Metals, Ores, and Related Materials the comments in order to continual improvement
Statistical Methods for use in Proficiency Equipment,
BS ISO 13528: 2015 Make sure that all the facilities and equipment for
Testing by Interlaboratory Comparison accommodation
the PT scheme are to be traceable and calibrated.
and environment
Proficiency testing by Interlaboratory
PD 6644-1: 1999 comparisons – Part 1: Development and The measurands shall be properly selected by
Operation of Proficiency Testing Schemes consulting the advisory group and laboratories.
Proficiency testing by Interlaboratory The specimen shall be homogeneous or checked for
comparisons – Part 2: Selection and use of stability.
PD 6644-2: 1999
Proficiency Testing Schemes by Laboratory The assigned value shall be measured by the
Accreditation Bodies reference laboratories (either our own laboratory or
Design of PT
subcontractors)
schemes
The ASTM D6674 and ASTM E2027 are designed Clear instruction shall be made to PT participants to
pre-treat and operate the test specimen
for chemical or fabric materials testing. The OUHK, on the A laboratory ID will be randomly assigned to each
other hand, is preparing proficiency testing programme for PT participant. This ID will be used to represent the
mechanical and electrical safety testing in accordance with participant throughout the study to ensure the
ASTM E1301. confidentiality of the participant’s identity.
Data analysis and A proper statistical analysis method shall be adopted
There are other PT programmes, such as medical evaluation of PT to analyze the result provided by each PT
testing, chemical or fabric testing, available in the market. scheme results participants.
They summarized the challenges of PT development, The PT scheme provider shall design an appropriate
including (1) selection of specimen; (2) homogeneity and Management
quality management system (QMS) to meet the ISO
requirement
stability validation of specimen; and (3) selection of statistical QMS requirements.
analysis method to test the differences between laboratories
[8].
The criteria of PT specimen homogeneity and
IV. DEVELOPMENET PROCESS OF PROFICIENCY TESTING stability of shall be established and analyzed. ISO Guide 34,
PROGRAMME ISO Guide 35 and ISO 13528 can be referred to develop the
criteria. According to ISO/IEC 17043, it is acceptable to
consider the effect of uncertainty if the specimens are not
The development of a proficiency testing programme sufficiently homogeneous or stable. The ISO 13528: 2015
includes several major steps: (1) develop a Quality
Management System (QMS) and obtain the ISO/IEC 17025
Annex B suggested a four-step method to test for determine assigned value (K.E.) of the sample; (2) repeat
homogeneity. Table 3 shows the steps to test for homogeneity. operation of the sample as required for 20 times; (3) repeat
operation of the sample as required for determining the
In one of our trial PT programme, two measurands
travelling speed for 5 times; (4) determining the Kinetic
are selected to be measured, i.e., kinetic energy of projectile
energy (K.E.) of the sample; and (5) apply the statistical
toys (Fig. 1) and sound pressure level of sound-emitted
method to determine the homogeneous.
products (Fig. 2). We establish the procedure to test the
stability:
The second trial of PT programme is on electrical
Table 3: Method for testing homogeneity [10] safety testing. The measurement of creepage clearance is
selected and sent the specimens to the interested laboratories.
Step Descriptions
The creepage distance means the shortest distance along the
1 Preparation and packaging of the samples
surface of a solid insulating material between two conductive
2 Random select at least ten samples per batch
parts (Fig. 3).
3 Prepare two subsamples from each sample
Samples will be measured randomly under repeatability conditions.
4 The samples will be considered to be sufficiently homogeneous if
𝑠𝑠 ≤ 0.3𝜎̂
ACKNOWLEDGEMENT
REFERENCES
[1] Consumer Safety Improvement Act (CPSIA) of 2008
Available on https://www.cpsc.gov/s3fs-public/cpsia.pdf
Accessed on January 9, 2018
Fig. 4: Measuring Microscope
[2] HOKLAS 017: 2016 Technical Criteria for Accrediting Proficiency
Testing Providers
V. EVALUATION OF PROFICIENCY TESTING RESULT Available on
http://www.itc.gov.hk/en/quality/hkas/doc/hoklas/HOKLAS017-
The participated laboratories will submit the Abridged.pdf
measurement results to the PT provider. Then the PT provider Accessed on January 9, 2018
shall apply the pre-determined appropriate statistical method [3] HOKLAS Index of Accredited Tests & Calibrations, Proficiency
to analyze the difference between PT participants. The most Testing Providers
common methods are z scores and En scores. The assumption Available on
http://www.itc.gov.hk/en/quality/hkas/doc/common/directory/hoklas_p
of z scores are made when a hypothesized distribution of tp_en.pdf
competent laboratories and not on any assumption about the Accessed on January 9, 2018
distribution of the observed result. We can interpret the z [4] HKAS Proficiency Testing Programme, Report No. 105 “Toys
scores by: Acoustics Test” (HTC/2016/01), August 2016
[5] BS EN ISO/IEC 17025: 2005 Incorporating Corrigendum No.1,
A result that gives |z| < 2.0 is considered to be General Requirements for the Competence of Testing and Calibration
acceptable. Laboratories
A result that gives 2.0 < |z| < 3.0 is considered to be [6] Juniper, Ian Robert. "Quality issues in proficiency testing."
questionable. Accreditation and quality assurance 4.8 (1999): P. 336-341.
A result that gives |z| > 3.0 is considered to be [7] CE mark
unacceptable. Available on https://www.gov.uk/guidance/ce-mark
[8] Miller, W. Greg, et al. "Proficiency testing/external quality assessment:
En scores will be used if the PT participant’s ability current challenges and future directions." Clinical chemistry 57.12
(2011): 1670-1680.
having the result close to the assigned value within their
[9] BS EN ISO/IEC 17043: 2010 Conformity assessment – General
claimed expanded uncertainty. The method is commonly used requirements for Proficiency Testing (ISO/CASCP 17043: 2010)
for PT in calibration.
[10] BS ISO 13528: 2015 Statistical methods for use in Proficiency testing
by interlaboratory comparison
For the PT programme used in this research, the z [11] IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-11:
scores method is found to be more suitable to evaluate the General requirements for basic safety and essential performance --
difference in the conducting the quantitative measurement, Collateral standard: Requirements for medical electrical equipment and
such as kinetic energy and creepage distance. medical electrical systems used in the home healthcare environment
[12] BIPM, IEC, et al. "Evaluation of measurement data—guide for the
expression of uncertainty in measurement. JCGM 100: 2008." Citado
VI. CONCLUSION en las (2008): 167