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Protocol QUATEST3 (E)

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Protocol QUATEST3 (E)

Uploaded by

thang
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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DIRECTORATE OF STANDARDS, METROLOGY AND QUALITY

QUALITY ASSURANCE AND TESTING CENTER 3

PROTOCOL FOR
PROFICIENCY TESTING
PROGRAMS OF QUATEST 3
Issue no. 4 – July 2017

1.INTRODUCTION 2
1.1. About Quality Assurance and Testing Center 3 2
1.2. About proficiency testing service 2
1.3. Contact information 2
2. POLICY 3
2.1. Confidentiality 3
2.2. Personnel 3
2.3. Subcontractor 3
3. DESIGN OF PT PROGRAM 4
4. ORGANIZING PROFICIENCY TESTING PROGRAMS 5
5. STATISTICAL ANALYSIS 7
5.1. PT program for qualitative characteristics 7
5.2. PT program for quantitative characteristics 7
5.3. Measurement interlaboratory comparison program 8
6. ADDITIONAL INFORMATION AND HOW TO REGISTER 9
6.1. Regular PT programs 9
6.2. How to register 9
6.3. Use of PT results 10

Proficiency Testing Department - QUATEST 3 1


(0251) 383 6212 - Ext: 123| (0251) 882 6917 / 383 6298 | [email protected]
1. INTRODUCTION
1.1. About Quality Assurance and Testing Center 3

Quality Assurance & Testing Center 3 (in short – QUATEST 3) is a science – technology organization
under the Directorate for Standards, Metrology and Quality (STAMEQ) - Ministry of Science
and Technology (MOST), providing technical services in the field of standards, metrology, quality
and productivity on request of the requirement of governmental managament; and providing
the relevant technical services to meet the requirements of organizations and individuals.

QUATEST 3’s major fields of activities include:

Inspection
Certification
Testing
Calibration
Providing proficiency testing (PT) programs
Training and provide solution
Barcode
Instrumental service

1.2. About proficiency testing service

Proficiency testing (PT) is a powerful quality assurance tool enabling labs to compare their
results with similar labs and monitor their performance. This activity has been defined in the
section 5.9 - ISO/IEC 17025:2005 – General requirements for the competence of testing and
calibration laboratories.

Since 2005, QUATEST 3 has begun to provide PT program in microbiology for labs in Vietnam
and ASEAN that is one of functions of the ASEAN Food Reference Laboratory.

Since 2013, QUATEST 3 has been accredited conforming to ISO/IEC 17043:2010 by A2LA -
America. The scope of accreditation is detailed at the following link: http://www.a2la.org/-
scopepdf/3477-01.pdf

Presently, beside the domestic labs, PT programs of QUATEST 3 are attracting more and more
foreign labs.

1.3. Contact information

Proficiency Testing Department


Quality Assurance and Testing Center 3
No. 7, Road 1, Bien Hoa Industrial Zone 1, Dong Nai
Tel: 084 251 383 6212 - Ext: 123 - Fax: 084 251 882 6917 - 383 6298
E-mail: [email protected]
Website: http://www.quatest3.com.vn/

Proficiency Testing Department - QUATEST 3 2


(0251) 383 6212 - Ext: 123| (0251) 882 6917 / 383 6298 | [email protected]
2. POLICY
2.1. Confidentiality

All information supplied by a participant to QUATEST 3 shall be treated as confidential. The


identity of participants in a PT program shall be confidential and known only by the minimum
number of persons involved in the provision and evaluation of the program.

If any third parties require the PT results of one or some of participants to be directly provided
by the PT provider, the participants shall be made aware of the arrangement in advance of
participation. In exceptional circumstances, when a regulatory authority requires the PT
results to be directly provided by QUATEST 3, the participants shall be notified of this action in
writing.

2.2. Personnel

QUATEST 3 assures that all staffs relating to providing PT programs must have appropriate
capacity, experiences and knowledge adequately.

These staffs must be trained, re-trained and assessed conforming to assigned tasks.

2.3. Subcontractor

QUATEST 3 commits to use subcontractors that have sufficient competence for the works
requested. QUATEST 3 is responsible to the customers for all results from subcontractors.

The PT Dept. is using subcontractors (internal or external) for the following works:

Sample preparation (just for some PT programs)


Homogeneity and stability check
Sample delivery

Proficiency Testing Department - QUATEST 3 3


(0251) 383 6212 - Ext: 123| (0251) 882 6917 / 383 6298 | [email protected]
3. DESIGN OF PT PROGRAM
QUATEST 3 is now applying the following PT schemes:

1. Simultaneous 2. Split-sample 3. Sequential

Frequency: regular Frequency: rarely, be


(according to the reviewed when Frequency: sometimes
annual plan of sustomer request when customer
QUATEST 3) (*) (individual lab.) request.

PT test items are


randomly selected Samples of a product 01 proficiency test
from a lot os sample to are divided into 2 or items is circulated
distribute simultaneously more part (often only 2) successively from one
to participants and sent to participants participant to the next

Assigned value s and


Assigned values are
standard deviation for Assigned value is
determined by a
proficiency assessment provided by a
reference laboratory or
are determined based reference laboratory
from the certificate of
on consensus value
analysis (if it is CRM)
from participants

Participants' results are


Paticipants' results are evaluated depending
Participants' results are
evaluated based on on nature of samples
evaluated based on En
z-score and characteristics

Scheme type 1 and type 2 is usually applied in area of chemical and microbiological testing. But
scheme type 2 is rarely applied, so in this protocol, PT programs for testing area are considered
being organized according to scheme type 1.

Scheme type 3 is usually applied in area of measurement. Accordingly, measurement comparison


programs mentioned in this protocol are scheme type 3.

(*) This type of PT scheme is also be applied to organize PT programs requested by customers, in
case that customer is an organization which can find more than 10 participating laboratories,
such as: Department of Crop Production – Minister of Agriculture and Rural Development,
Department of Food and Safety – Minister of Health, etc.

Proficiency Testing Department - QUATEST 3 4


(0251) 383 6212 - Ext: 123| (0251) 882 6917 / 383 6298 | [email protected]
4. ORGANIZING PROFICIENCY TESTING PROGRAMS

Get back Get back


Dispatch- result Sending
registra- Sample Data Collecting
Annouce- ing PT test sheets final
tion forms prepara- collection feedback
Planning ment of the items to from reports to
from tion and of partici-
program partici- partici- partici-
partici- analysis pants
pants pants pants
pants

4.1. Planning

Anually, at the 4th quarter, QUATEST 3 make schedule of PT programs for the next year. This
schedule is both available in the website of QUATEST 3 and sent to concerned customers.

4.2. Announcement of programs – Get back registration forms

Please see the section 5.2.

4.3. Sample preparation

QUATEST 3 assures PT samples have been done sufficient homogenity and stability check
before being dispatched to participants to ensure that PT test items will not be changed
significantly during the programs.

4.4. Dispatching samples to participants

QUATEST 3 shall control packaging and labeling processes to ensure conformity with the regulations
on safety and transport related national and / or international areas.

Packaging must ensure that the sample remains in character throughout the process form
transporting and storing in the laboratory to doing the test. Labels must include enough identify
information and the storage conditions (temperature and other condition (if necessary)).

Before dispatching samples, PT provider will inform participants through email. If there are
any changes in plan (time, characteristics, etc.), PT provider will update the schedule in the
website as well as to inform participants through email.

The following documents will be enclosed with PT test items:

Instructions to participants,
Instructions for preparing sample (if any),
Receipt form,
Result sheet,
Others (when necessary).

Participants please notice and follow the instructions.

Proficiency Testing Department - QUATEST 3 5


(0251) 383 6212 - Ext: 123| (0251) 882 6917 / 383 6298 | [email protected]
4.5. Get back result sheets

QUATEST 3 receives test results by post, fax or email. Each program is assigned a due date of
replies. For overdue participants’ results, QUATEST 3 will not take them in the statistical process.

For results being sent by post, QUATEST 3 will base on stamps on envelops for date of sending.

4.6. Data collection and analysis

The result sheets will be copied after give code for each participant. The original result sheets
will be kept for reference while each copy will be cut into 2 parts (part of participants’ information
and pat of results). These two parts will be given to different NP to keep participants’ information
confidential absolutely.

PT provider will contact participants to confirm about test results in cases of:

Information, test results are blurred or not clear;


It is suspected that there are mistakes in the unit or identification number of test methods;
The number of significant digit or rounded number do not follow the defined regulations;
The results are non-numerical for quantitative tests;
The result is largely different from the others;
Participants do not provide enough information as requested in the result sheets;
One participant send more than one result sheet for one item.

After the deadline for resending test results, if PT provider still not receive the response of related
participants, those results (not satisfy the request of PT provider) will be removed (for wrong
unit and blurred results) or pre-process (for excess or lacking in significant digit number)
before statistical process.

Participants’ results will be process statistically according to section 4.

4.7. Sending final reports to participants

The interim reports will be sent to participants within 2 – 4 weeks since the deadline of receiving
results.

The final reports shall be sent to participants by post within 1 – 2 months since the issue of interim
report.

4.8. Collecting feedback of participant

Questionnaire forms will be sent to participants in the end of year. After getting back ques-
tionnaire forms, PT provider will make the summary of feedbacks and have response to par-
ticipants having special feedbacks.

Proficiency Testing Department - QUATEST 3 6


(0251) 383 6212 - Ext: 123| (0251) 882 6917 / 383 6298 | [email protected]
5. STATISTICAL ANALYSIS

5.1. PT program for qualitative characteristics

Evaluation of PT results for qualitative characteristics is to compare the results of participants


to assign value which is determined from results of reference labs or from samples with known
value.

5.2. PT program for quantitative characteristics

5.2.1. Determining the assigned value and standard deviation for proficiency assessment

Normally, the assigned values of PT program for quantitative characteristics of QUATEST 3 are
determined by robust analysis (*) (refer to ISO 13528:2005). To minimize the risk that the
extreme outliers will affect the assigned value, QUATEST 3 will consider and remove these
results before analysis base on the histogram. The uncertainty of assigned value from robust
analysis will be determined as follows:

1,25⋅ s*
ux =
p

Where p is the number of participants’ results, not including removed extreme outlier (if any).

If ux > 0.3.σ, z’-score is used to evaluate the performance of participants (see the section 5.2.2)..

The standard deviation for proficiency assessment is normally determined from the participants’
results: σ = s*.

In some cases, the standard deviation could be determined from the history of QUATEST 3 or by
Horwitz curve:

0,22 ⋅ c if c < 1,2 ⋅ 10 −7 


 
σ = 0,02 ⋅ c0,8495 if 1,2 ⋅ 10 ≤ c ≤ 0,138 
−7

0,01⋅ c0,5 if c > 0,138 

Where c is the assigned value expressed as mass fraction, c > 1 µg/kg.

Note: (*) In some cases, QUATEST 3 could apply other appropriate method to determine the
assigned value and the standard deviation for proficiency assessment. The statistical design will
be stated clearly in the final report.

Proficiency Testing Department - QUATEST 3 7


(0251) 383 6212 - Ext: 123| (0251) 882 6917 / 383 6298 | [email protected]
5.2.2. Evaluation

Base on z (z-score) or z’ (z’-score):

xi − X
z=
σ

xi − X
z’ =
σ2 + ux2
Where:

xi : The result of laboratory i


X : The assigned value
σ : Standard deviation for proficiency assessment
ux : The standard measurement uncertainty of assigned value.

Evaluation of z and z’:

|z|;|z’|≤ 2.0 : Test result is “Satisfactory”.


2.0 <|z|;|z’|< 3.0 : Test result is “Questionable”. Participants should find out the cause of
suspected results. If a laboratory attended two consecutive rounds with the same
characteristics and have z-score in the range 2,0 <|z|< 3.0, that laboratory should also
consider for corrective action.
|z|;|z’|≥ 3.0 : Test result is “Unsatisfactory”. Participants should consider for corrective
action (if necessary).

5.3. Measurement interlaboratory comparison program

The results of interlaboratory comparison are evaluated through the standardized ratio En
and En is calculated as follows:
x i − X REF
En =
U LAB,
2
i
+ U REF
2

Where:

xi : Result/ correction of participant i;


XREF : Assigned value (Result of the reference lab);
ULAB,i : The expanded measurement uncertainty of xi;
UREF : The expanded measurement uncertainty of XREF.

Evaluation:

|En| ≤ 1,0 : Satisfactory;


|En| > 1,0 : Unsatisfactory.

If|En| > 1,0: Participants must find out the root cause for necessary corrective or preventive
actions.

Proficiency Testing Department - QUATEST 3 8


(0251) 383 6212 - Ext: 123| (0251) 882 6917 / 383 6298 | [email protected]
6. ADDITIONAL INFORMATION AND HOW TO REGISTER
6.1. Regular PT programs

QUATEST 3 now usually organizes PT programs in following areas:

Milk and milk product: microbiological and chemical characteristics (nutritions)


Other food: microbiological and chemical characteristics (nutritions, antibiotics residues,
toxins, heavy metals, etc.)
Fertilizers: chemical characteristics (compositions, macro and micro-nutrients, heavy
metals, etc)
Feeding stuffs: chemical characteristics (nutritions, antibiotics, toxins, heavy metals, etc.)
Cement, diesel oil, lubricant, steel, etc.: chemical and physical characteristics.

Beside, QUATEST 3 also provide customized PT programs.

6.2. How to register

6.2.1. Search for information

Laboratories that have demand of PT programs can find information by:

Contact directly to PT Dept. – QUATEST 3 (Please see section 1.3 for detail)
Website of QUATEST 3;
Invitation letter from QUATEST 3;
Information from authorities (such as Department of Crop Production, Department of
Food and Safety, etc.)

6.2.2. Registration

Participant can get Registration forms by following method:

Downloading from website of QUATEST 3,


Being enclosed with invitation letters,
Sending request to QUATEST 3.

Return Registration forms to PT provider through email, fax or by post.


It is required that there is stamp of your company on the form
Deadline of registration: Depending on each program.
Base on Registration forms, QUATEST 3 will make list of participants.

Note:

Subcontractors that are used to check homogeneity and stability are allowed to participate
in the PT programs of QUATEST 3 in case that the assigned value is determined from participants’
results.

Within 2 working days since sending registration forms, participants will receive confirmation
from PT provider. If not, please contact us by phone.

Proficiency Testing Department - QUATEST 3 9


(0251) 383 6212 - Ext: 123| (0251) 882 6917 / 383 6298 | [email protected]
6.2.3. Fee

Fee of PT program vary depending on each program and be announced in the website or
in the invitation letter at the beginning.

Participants are requested to make payment since receiving the PT test items till before the
issuance of final report.

6.2.4. Requirements for participants

Participants are requested to read the following items and regulations carefully before registering
each PT program provided by QUATEST 3.

Participants must provide exact contact information and contact person in registration
forms. PT provider will only contact that person. If there are any changes in contact
persons, please inform to PT provider in writing (email or fax) with your company stamp.

In case that participants would like to change or cancel the PT program:

To change delivery address after the PT sample(s) have been delivered: it will be
charged at full shipping fee;
To cancel registration after deadline but the PT sample(s) have not been delivered:
it will be charged at 20 % of the total fee/program;
To cancel registration after the PT sample(s) have been delivered: it will be charged
at 50 % of the total fee/program.

Participants must commit to prevent dishonest results, avoiding collusion and falsification
of results. If PT provider discover any dishonest results, collusion and falsification of
results, those results will be removed.

If there is any change in final reports after sending to participants, PT provider will have
notifications in writing. Otherwise, PT provider does not take responsibility for any other
difference from original final reports.

6.3. Use of PT results

The participating laboratories have to see the results received from the PT program as basic
source of information that show the quality and capacity of laboratories. All results in one
final report (assigned value, standard deviation for proficiency testing assessment …) are
only valuable for that program and just for reference for any other cases.

Where results of one laboratory are not consistent and compatible with the results of refer-
ence or with other laboratories, that laboratory should investigate the cause and appropri-
ate corrective action, timely.

If there are any questions about PT results or need technical consultation, participants can
contact PT provider by contact information in the final report.

Proficiency Testing Department - QUATEST 3 10


(0251) 383 6212 - Ext: 123| (0251) 882 6917 / 383 6298 | [email protected]

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